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Good Research Practice
https://www.vr.se/download/18.5639980c162791bbfe697882/1555334908942/Good-Research-Practice_VR_2017.pdf
http://leaux.net/URLS/ConvertAPI Text Files/530832A9A5A0A6F897AFD1BB0F10D104.en.txt
Examining the file media/Synopses/530832A9A5A0A6F897AFD1BB0F10D104.html:
This file was generated: 2020-12-01 07:10:34
| Indicators in focus are typically shown highlighted in yellow; |
Peer Indicators (that share the same Vulnerability association) are shown highlighted in pink; |
"Outside" Indicators (those that do NOT share the same Vulnerability association) are shown highlighted in green; |
Trigger Words/Phrases are shown highlighted in gray. |
Link to Orphaned Trigger Words (Appendix (Indicator List, Indicator Peers, Trigger Words, Type/Vulnerability/Indicator Overlay)
Applicable Type / Vulnerability / Indicator Overlay for this Input
Political / Criminal Convictions
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p.000027: the same time, one also should not refrain from publishing results due to exaggerated caution. The most important thing
p.000027: is to be clear, critical and honest in evaluating sources of error.
p.000027: The evaluation of error sources is often limited by the research tradition and method a researcher is working within.
p.000027: Some sources of error do not “show” if one performs the analysis based on a certain theoretical standpoint or model. It
p.000027: is thus important in the error analysis not to limit yourself to the possible “internal errors” within the frame of
p.000027: your chosen viewpoint, but rather to allow the analysis to broaden the perspective to show other, alternative
p.000027: viewpoints. This can be very difficult, however. One is often forced to lower the level of ambition, but in such cases,
p.000027: it is all the more important to be accurate in explaining the basis for the analysis and its limitations.
p.000027:
p.000027: 2.4 Research ethics from a dynamic perspective
p.000027: The landscape of research ethics is changing. When researchers ask new questions, use new methods and work with new
p.000027: materials, new research ethics issues arise. Early on, the purpose of research ethics was to keep researchers from
p.000027: harming or violating patients and research subjects in numerous ways in the name of science. This was the overarching
p.000027: purpose of the Declaration of Helsinki, against a background of events including the research that had been conducted
p.000027: on prisoners in concentration camps and jails. Therefore, the Declaration stressed standards for informed consent and
p.000027: risk-benefit analysis, as well as that the interests of science and society not being allowed to carry more weight than
p.000027: the protection of the individual’s well-being and safety.
p.000027: With the development of epidemiological research and register data research of diverse types, some other issues have
p.000027: now come to the fore. The persons who are subject to such research, where data about them is collected and analysed,
p.000027: participate in a different way than those who take part directly in clinical trials of new medicines, for instance.
p.000027: Those who contribute to a register study do not need to be aware that they are part of the study and thereby a subject
p.000027: of research. Meanwhile, this type of research can be sensitive from an integrity perspective, and the knowledge that
p.000027: information, which the people in question may not even know has been recorded, can be gathered and analysed can be
p.000027: cause for concern. The study design and the presentation of results are essential elements in alleviating unfounded (or
p.000027: well-founded) worry over discrimination and stigmatisation. The likely value of new knowledge must thus be weighed
p.000027: against the risk that subjects’ integrity will be compromised and the need to protect individuals’ right to privacy.
p.000027: New methods, and/or those coming into more frequent use, in humanities and social science research, such as
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Political / Illegal Activity
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p.000054: the pipeline.
p.000054: Then one of your colleagues discovers an irritating error in one of your computer programs. It is probably of no
p.000054: significance, but it will take at least six months to fully investigate the consequences. If your work is not published
p.000054: before the next application round, or the Germans beat you to it, the livelihoods of a postdoc scholarship holder and a
p.000054: postdoctoral research fellow funded from your council grant will be put in jeopardy.
p.000054: What do you do?
p.000054:
p.000054: 6.7 The author
p.000054: The author is responsible for the contents of a book or article presenting his or her research. That includes
p.000054: everything related to the actual project – methods, validity and reliability of the results, etc. – but also the
p.000054: quality of the manuscript. It is also the author’s responsibility to check a journal’s or publisher’s terms regarding
p.000054: parallel publishing before one and the same manuscript is simultaneously submitted to or published in several different
p.000054: journals. Another responsibility is of course to make sure that the references and quotations in the text are correct.
p.000054: In the case of research based on statistical analysis, a scientific interpretation has to be undertaken, taking careful
p.000054: account of all the basic assumptions and limitations of the procedure used to test the hypothesis. The results also
p.000054: have to be interpreted in the light of previously published findings, and other investigators’ results cited where
p.000054: relevant.
p.000054: Researchers studying, for example, the links between gender and absence from the workplace, the incidence of crime in
p.000054: different groups in the community, or the economic situation, genetics and dietary habits of
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p.000054: GOOD RESEARCH PRACTICE
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p.000055: different ethnic groups, must make sure they present their statistical interpretation of the data, in relation to
p.000055: their scientific hypotheses, and explain what that interpretation shows and what underlying assumptions have been made,
p.000055: not least when the results are published outside traditional academic circles. If the author foresees a risk of
p.000055: over-interpretation in the media, he or she has a responsibility to try to preclude or prevent that risk, especially if
p.000055: it might cause harm to the research subjects or any third parties.
p.000055: A good scientific presentation will include an active discussion of the results by the author. This means that the
p.000055: author should not only cite or refer to works which support the proposition advanced. It is also necessary to present
p.000055: possible arguments against it, and try to respond to them in the text.
p.000055:
p.000055: 6.8 Multiple authors – responsibility – publication rules
p.000055: Why is the question of authorship important?
p.000055: One reason is that the authors’ names are, rightly or wrongly, seen by colleagues in their field as an indication of
p.000055: the quality of a publication. Consequently, it is important to know who actually did the work, so as to be able to
p.000055: evaluate the results. A second reason is that researchers applying for positions are assessed to a large degree on the
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p.000071: and reputation. Everyone has the right to the protection of the law against such interference or attacks.” Article 29
p.000071: Item 2 further states that “In the exercise of his rights and freedoms, everyone shall be subject only to such
p.000071: limitations as are determined by law solely for the purpose of securing due recognition and respect for the rights and
p.000071: freedoms of others and of meeting the just requirements of morality, public order and the general welfare in a
p.000071: democratic society.”
p.000071: The Universal Declaration is not binding upon member states, but may be seen as an expression of common law rules
p.000071: within the area.
p.000071:
p.000071: 9.1.4 The European Convention on Human Rights
p.000071: The Convention for the Protection of Human Rights and Fundamental Freedoms of 4 November 1950 (“European Convention on
p.000071: Human Rights”) was incorporated into Swedish law on 1 January 1995, and has since then applied as law in Sweden.
p.000071: Article 8 of the European Convention on Human Rights states that “Everyone has the right to respect for his private and
p.000071: family life, his home and his correspondence”. It further states that “There shall be no interference by a public
p.000071: authority with the exercise of this right except such as is in accordance with the law and is necessary in a democratic
p.000071: society in the interests of national security, public safety or the economic well-being of the country, for the
p.000071: prevention of disorder or crime, for the protection of health or morals, or for the protection of the rights and
p.000071: freedoms of others”. The European Court of Human Rights was established to monitor that the obligations under the
p.000071: European Court of Human Rights are fulfilled.
p.000071:
p.000071: 9.1.5 The Council of Europe’s Data Protection Convention
p.000071: In 1981, the Committee of Ministers of the Council of Europe adopted the Convention for the Protection of Individuals
p.000071: with regard to Automatic Processing of Personal Data. The Convention came into force on 1 October 1985. All EU member
p.000071: states have ratified the Convention. The Convention is binding on the countries who have ratified it. The Convention is
p.000071: associated with a number of recommendations on how personal data should be handled in various areas. The
p.000071: recommendations are not directly binding.
p.000071: According to Article 1, the Convention aims “to secure in the territory of each Party for every individual, whatever
p.000071: his nationality or residence, respect for his rights and fundamental freedoms, and in particular his right to privacy,
p.000071: with regard to automatic processing of personal data relating to him ("data protection”)”. According to Article 2, the
p.000071: Convention’s area of application is "automated data files" and "automatic processing" of personal data in public and
p.000071: private activities. Each Convention state may, however, introduce certain general restrictions or expansions of the
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Political / criminal
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p.000029: • entails studies on biological material taken from a living human being and can be traced to this person
p.000029: • entails physical encroachment on a deceased human being
p.000029: • entails studies on biological material taken for medical purposes from a deceased human being and can be traced to
p.000029: this person. Act (SFS 2008:192).
p.000029:
p.000029: A research project shall also be reviewed if it (B)
p.000029:
p.000029: • entails the handling of sensitive personal data according to Section 13 of the Personal Data Act (SFS 1998:204),
p.000029: including information on race, ethnic origin, political views or religious conviction, or personal
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p.000029: 3The research principal is the government authority or the physical or legal entity within whose organisation the
p.000029: research is conducted. A researcher employed at a university or a county council has the same as his or her research
p.000029: principal. The research principal, through its internal work or delegation order or through power of attorney,
p.000029: determines who is authorised to represent the research principal. The research principal always has ultimate
p.000029: responsibility for the research.
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p.000029: GOOD RESEARCH PRACTICE
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p.000030: data according to Section 21 of the Personal Data Act, including information on judgements in criminal cases.
p.000030:
p.000030: Condition (B) thus means that all research dealing with sensitive personal data shall be ethically reviewed, regardless
p.000030: of how the data has been collected and whether or not the researcher has obtained the participants’ consent.
p.000030: When an ethics review board evaluates a project, it has a number of aspects to note and consider. Generally, the
p.000030: research in question can be approved only if it can be conducted with respect for human dignity. In the review, the
p.000030: board should also evaluate how the human rights and basic freedoms of those involved are treated in relation to the
p.000030: value of the research. The welfare of human beings should be placed before the needs of society and science, and the
p.000030: knowledge value of the research must be assessed as outweighing the risks. The research cannot be approved if the
p.000030: expected results can be reached in another way that presents fewer risks, for instance using other categories of
p.000030: research subjects, or an alternative study design.
p.000030: For the board to be able to approve certain types of research, informed consent must have been obtained from the
p.000030: participants (research subjects, stakeholders). The law also briefly describes how this consent should be constituted,
p.000030: and from whom and how it may be obtained.
p.000030: The law requires informed consent in the first three types of projects in (A) above; that is, research entailing
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p.000071: states have ratified the Convention. The Convention is binding on the countries who have ratified it. The Convention is
p.000071: associated with a number of recommendations on how personal data should be handled in various areas. The
p.000071: recommendations are not directly binding.
p.000071: According to Article 1, the Convention aims “to secure in the territory of each Party for every individual, whatever
p.000071: his nationality or residence, respect for his rights and fundamental freedoms, and in particular his right to privacy,
p.000071: with regard to automatic processing of personal data relating to him ("data protection”)”. According to Article 2, the
p.000071: Convention’s area of application is "automated data files" and "automatic processing" of personal data in public and
p.000071: private activities. Each Convention state may, however, introduce certain general restrictions or expansions of the
p.000071: area of implementation. The central part of the Convention is Chapter II (Articles 4–11), which comprise the
p.000071: fundamental principles for data protection. They include requirements that personal data that is processed
p.000071: automatically shall be “obtained and processed fairly and lawfully”, “adequate, relevant and not excessive in relation
p.000071: to the purposes for which they are stored” and “preserved ... for no longer than is required” (Article 5). Personal
p.000071: data “revealing racial origin, political opinions ... health or sexual life”, as well as “personal data relating to
p.000071: criminal convictions” “may not be processed automatically unless domestic law provides appropriate safeguards” (Article
p.000071: 6). The Convention also includes provisions governing requirements on safety measures and information to those whose
p.000071: data is being processed.
p.000071:
p.000071: 9.1.6 OECD’s Guidelines
p.000071: The Organisation for Economic Cooperation and Development (OECD) has produced Guidelines Governing the Protection of
p.000071: Privacy and Transborder Flows of Personal Data. These Guidelines were adopted by the OECD Council in 1980,
p.000071: simultaneously with a recommendation to the governments of the member countries to consider the Guidelines in national
p.000071: legislation. Sweden has adopted these recommendations, and by this means undertaken to follow the Guidelines. The
p.000071: Guidelines are minimum rules, which means that protection in the countries that have undertaken to follow the
p.000071: Guidelines may be made more comprehensive than the protection given by the Guidelines. The Guidelines include eight
p.000071: fundamental principles to protect personal integrity; for
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p.000071: GOOD RESEARCH PRACTICE
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p.000072: example, they state that personal data shall be collected for specific purposes, be relevant to the purpose for which
p.000072: they are intended, and shall be correct, complete and up-to-date.
p.000072:
p.000072: 9.1.7 The European Union’s Charter of Fundamental Rights
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p.000072: or other statute, to systematically and continuously develop and safeguard the quality of the activities,
p.000072: administration, planning, follow-up, evaluation and supervision of the activities, or to produce statistics relating to
p.000072: health and medical care; see Chapter 2 Section 4 of the Patient Data Act. The aim of stating purposes is to establish
p.000072: an outer-most limit for when personal data may be collected and then processed. The starting point is thus that only
p.000072: such personal data handling may take place as is covered by one or several of the stated purposes, see Govt. Bill
p.000072: 2007/08:126 p. 228.
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p.000072: GOOD RESEARCH PRACTICE
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p.000073: 9.2.2 The Act concerning the Ethical Review of Research Involving Humans
p.000073: Since 1 January 2004, the Act concerning the Ethical Review of Research Involving Humans has been in force. It covers
p.000073: research involving living persons, but also research involving deceased persons and biological material from humans,
p.000073: and also research involving the handling of sensitive personal data. The purpose of the Act is to protect the
p.000073: individual person and ensure respect for human dignity in research.
p.000073: The Act (SFS 2003:460) concerning the Ethical Review of Research Involving Humans shall apply to research involving
p.000073: sensitive personal data under Section 13 of the Personal Data Act, or personal data on breaches of the law that
p.000073: includes statutory offences, judgements in criminal cases, criminal procedural coercive measures or administrative
p.000073: deprivation of liberty according to Section 21 of the Personal Data Act. The Act is also applicable to research that
p.000073: involves physical encroachment on a research subject, that is carried out using a method aimed at influencing the
p.000073: research subject physically or mentally, or that entails a clear risk of physical or mental harm to the research
p.000073: subject, that relates to studies of biological material taken from a living person that can be attributed to this
p.000073: person, that involves a physical encroachment on a deceased person, or relates to studies of biological material taken
p.000073: for medical purposes from a deceased person that can be attributed to this person.
p.000073: By means of the ethics review procedure, support can be created for personal data handling in research projects that
p.000073: are carried out without consent, but the Act gives no support for personal data handling carried out before the actual
p.000073: research process begins.
p.000073: The Act applies to all such research, regardless of in what institutional setting it is carried out, or how it is
p.000073: funded. The regional ethics review board’s review involves an examination of the project description to establish
p.000073: whether it involves any infringement of human rights or hard-to-capture concept of human dignity. An assessment is also
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Political / political affiliation
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p.000017: GOOD RESEARCH PRACTICE
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p.000018:
p.000018: 2 ABOUT RESEARCH – WHAT, WHY, HOW AND FOR WHOM?
p.000018:
p.000018:
p.000018: 2.1 Starting points for research
p.000018:
p.000018: 2.1.1 Some types of research
p.000018: There are diverse types of research. Distinctions can be drawn between hypothesis-generating and hypothesis- testing
p.000018: research, and between research using qualitative and quantitative methods. One can also distinguish between research
p.000018: that tries to explain why something has happened by showing that it can be subsumed under a natural law and research
p.000018: that that tries to increase and deepen our knowledge about events, processes or texts. From a research ethics
p.000018: perspective, another distinction is interesting. One usually distinguishes between three forms of research: basic,
p.000018: applied and commissioned (there are also other terminologies and distinctions).
p.000018: Basic research entails the researcher seeking new knowledge without a particular application in mind, and can lead to
p.000018: unexpected and ground-breaking discoveries. Applied and commissioned research both have a particular aim. They are
p.000018: aimed at being of use to the party who initiated or ordered the research.
p.000018: Commissioned research is more directly and clearly driven by the commissioning party than applied research is.
p.000018: As opposed to other knowledge-seeking activities, research entails a systematic search for knowledge. This knowledge
p.000018: must also be new, not simply a compilation of what is already known. However, attempting to replicate previously
p.000018: published (and thus not new) results with the aim of confirming them is also research. If the results can be
p.000018: replicated, this increases our belief in the soundness of the conclusions, and we learn something we did not know
p.000018: before. A systematic-critical review and compilation of previous results in a certain area can also raise knowledge
p.000018: levels, and can therefore also be regarded as research.
p.000018:
p.000018: 2.1.2 Why conduct research?
p.000018: The reasons for research vary, partly depending on the type of research. Basic research is conducted to develop new
p.000018: knowledge, which can be valuable in its own right – but can sometimes also lead to valuable consequences, for instance
p.000018: new products. Applied research, on the other hand, primarily aims to develop knowledge that can lead to improved
p.000018: clinical diagnostics and treatment in medicine, or be applied in practice in the production or improvement of products,
p.000018: in planning and decision-making, for example in changes to organisations and communication strategies, etc. Besides
p.000018: providing knowledge about a specific area, all types of research provide methodological education and training in
p.000018: critical thinking. Thus, research can contribute in many ways to the development of both individuals and society.
p.000018: Today, scientific research is a crucial element of society. The value of new knowledge is underlined in many different
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p.000019: question. Neither could the first question be studied by looking at who is the most successful in pushing their
p.000019: proposals through in political deciding bodies at various levels.
p.000019: Another example: Determining whether there is a difference in the effect and safety of a flu vaccination between
p.000019: children who have not previously had the vaccination and those who have is a reasonable and interesting task. To study
p.000019: this, you should be able to conduct a controlled study of these two groups of children and examine whether there is any
p.000019: statistically significant difference. But if you want to answer the question by comparing to children previously
p.000019: vaccinated for something else, for instance hepatitis, it becomes unclear what function the control group has and what
p.000019: question is being answered.
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p.000019: GOOD RESEARCH PRACTICE
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p.000020:
p.000020: 2.1.4 Who bears the responsibility?
p.000020: When it comes to how research should be conducted and who has the responsibility for its being conducted in a
p.000020: satisfactory way scientifically and ethically, it can help to distinguish between the respective responsibilities of
p.000020: the individual researcher, the project leader, the department head and the research principal, even if the borders
p.000020: between them are not always sharp. In certain types of research another aspect also arises: the responsibility of the
p.000020: commissioning party or funding body.
p.000020: An issue for the individual researcher to consider is the choice of research question. This choice can be between, for
p.000020: example, a well-defined problem that can give relatively quick publishable results but does not seem to have any
p.000020: greater significance for society on the one hand and a more diffuse or less meritable project of substantial societal
p.000020: significance. This choice must be made by the individual researcher.
p.000020: Within all disciplines the researcher also chooses among the various subject areas, focuses and problems. For instance,
p.000020: within history a researcher can take an interest in the history of individuals, groups or countries from many
p.000020: perspectives, including mentality, political, legal, economic and/or others.
p.000020: A task of the supervisor is to monitor the doctoral student’s choices. Those responsible for the academic merit system
p.000020: should give the right signals so that a researcher can avoid the temptation of defining his or her research task based
p.000020: more on the merit possibilities instead of on the importance of the research question.
p.000020: Today, a great many studies are conducted that do not allow conclusions to be drawn – and “unnecessary” research is
p.000020: also conducted, in the sense that its questions have already been answered. This has been shown, for example, in
p.000020: systematic reviews by the Swedish Council on Health Technology Assessment (SBU) carried out in various medical fields.
p.000020: Funding bodies naturally have an interest in their resources leading to research of high quality. The evaluation of a
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p.000022: slick plastic. Eventually it came to be used to coat fishing line and frying pans, and was also used on spacecraft
p.000022: because it does not react to UV light, ozone or oxygen and tolerates temperatures from -200 to over 200 °C.
p.000022: Dark energy became a concept in 1998 when scientists were studying gravitation and cosmic acceleration. It suddenly
p.000022: became evident to them that we can only see around 30% of the universe – the other 70% is called dark energy.
p.000022: A perhaps not completely comparable, but revolutionary, discovery from the humanities is Linear B, a script found on
p.000022: clay tablets at an archaeological dig at Knossos on Crete in 1900. The script was long indecipherable. Then a British
p.000022: architect, Michael Ventris, who first thought the scripts were Etruscan, made a guess that they might instead be Greek.
p.000022: With the help of Linear B findings from the Greek mainland, which did not contain certain words found in the texts from
p.000022: Crete, he guessed that these words might be Cretan place names. This allowed him, in 1951, to decipher Europe’s first
p.000022: written language.
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p.000022: 2.2.2 Research funding and collaboration
p.000022: All research requires resources: time, place and equipment. Funding can be obtained through a position a researcher
p.000022: holds at a company, in which the research aspect is part of his or her duties. In such cases it can be the employer who
p.000022: formulates the research question. Research can also be conducted as an assignment the researcher has received, in
p.000022: competition with others or not. Finally, funding can also be obtained through grants from a funding body in the
p.000022: governmental or private sphere, or some other party.
p.000022: You could say that there are two types of funders: those who do not have a direct interest in the results and those who
p.000022: do. The first group includes the government in the form of various foundations or research councils, as well as
p.000022: research foundations, based on collections and private donations with a specific focus, for instance the Swedish Cancer
p.000022: Society and the Heart-Lung Foundation. The second group includes commercial, non- profit and public actors who need
p.000022: research to develop their activities and, in some cases, to earn money.
p.000022: External funding creates opportunities for research that otherwise might not have been conducted, but the ties and
p.000022: control it can entail are not without risk. This is illustrated in the many conflicts over publishing, access to data
p.000022: and the interpretation of results that are often debated in the media.
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p.000022: What would you do in the following situation?
p.000022: You are researching the effectiveness of different toothpastes in a study commissioned by one of the larger
p.000022: manufacturers in this field. You design a comparative study in which the qualities and effects of different toothpastes
p.000022: from a number of aspects are compared.
p.000022: However, the results are not what the funding body had hoped for and they want to stop publication or at least divide
p.000022: the report into multiple studies, which would make it difficult or even impossible to draw any conclusions. When you
p.000022: object to this they threaten to revoke their grants for a number of projects on which your doctoral students are
p.000022: dependent.
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p.000023: of many types: everything from ground-breaking research to research activities more closely connected to the company’s
p.000023: marketing. Researchers should be aware that this span exists to allow for positive and constructive collaboration with
p.000023: maintained integrity. The research community, for its part, should strive to take an open-minded position and evaluate
p.000023: each scientific contribution based on scientific quality and its own merits.
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p.000023: 2.2.4 Problems and pitfalls
p.000023: Quick publication and transferral to practical use are important goals, which we have just discussed. But there are
p.000023: many obstacles along the way: amateurishness in the ability to convert research results into practical use, attitude
p.000023: problems of the various actors towards each other and structures involving slow publication processes, sluggish
p.000023: handling of patent applications and a lack of risk capital.
p.000023: Without the cooperation of the researcher, it is often difficult to convert academic research results into a benefit
p.000023: for society at large. Therefore, great demands must be placed on the individual researcher’s awareness and on the
p.000023: environment in he or she works when it comes to handling situations and contacts involving profit motive.
p.000023: In such cases, all researchers should carefully consider any agreements with other parties in order to maintain their
p.000023: personal integrity and scientific credibility. Two cornerstones in this stance are openness regarding ties and
p.000023: dependencies, as well as openness regarding all research results. This is important, regardless of whether the results
p.000023: meet or contradict a commissioning party’s expectations. Conflicts have often arisen between funding bodies and
p.000023: researchers over the publication and interpretation of results, sometimes leading the researcher to suppress
p.000023: “undesirable” results. A researcher should also not let him or herself be convinced to over-interpret results in a
p.000023: certain direction. Angled reports can cause a great deal of harm, irrespective of whether they have a commercial angle
p.000023: or are affected by the ambitions of a public authority.
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p.000023: GOOD RESEARCH PRACTICE
p.000024: 24
p.000024:
p.000024: What would you do in the following situation?
p.000024: You are working with technical research on new light, strong materials. You see an opportunity to apply for a patent
p.000024: and have started a company along with some entrepreneurs to commercialise the products. However, the commercialisation
p.000024: takes longer than expected and the company starts having economic problems.
p.000024: A co-worker points out that fibres in the new material have qualities reminiscent of asbestos, and therefore suggests
p.000024: additional toxicological studies. But you want to speed up the development work.
p.000024: Do you choose to interrupt the development work and examine the health risks? If no, how do you respond to the
p.000024: criticism from your co-worker?
p.000024:
p.000024: 2.2.5 Openness is your guiding light
p.000024: Just like everyone else, a researcher has a legitimate need for appreciation. This can consist of economic
p.000024: compensation, honour and recognition or academic advancement, often in combination. But the way to attain recognition
...
p.000036: ethically reviewed before it can begin – is not always self-evident in other countries. The Declaration of Helsinki
p.000036: requires this review for all medical research performed on humans, and this requirement is held by many funding bodies
p.000036: and journals.
p.000036: Here, the Swedish legal requirement of ethics review is less comprehensive. However, as mentioned earlier, in Sweden
p.000036: there is the option to request an advisory statement from an ethics review board regarding a project that does not
p.000036: formally need to be reviewed. It is good research practice to request a statement in the event research collaborations
p.000036: in other countries are expected to present ethical difficulties for the researchers.
p.000036: The ethics review boards have no obligation to issue these advisory statements however, just the right to do so. If the
p.000036: regional ethics review board refuses to issue such a statement, however, this may cause profound consequences for the
p.000036: researchers’ chances of obtaining further funding and being published.
p.000036: There are issues concerning the withdrawal of consent that are problematic for research ethics. In biobank research,
p.000036: the research subject has the option of withdrawing consent. If this happens, it is the responsible party at the biobank
p.000036: who determines whether the biological material should be destroyed – which is likely to be the research subject’s wish
p.000036: – or only de-identified. In the latter case, the research subject can feel tricked. In research projects using video or
p.000036: audio recording, the research subject is often told he or she can withdraw consent after the recording and that the
p.000036: tape will be destroyed. However, this is in conflict with the regulations governing archiving and storage of research
p.000036: material, as well as with the rules regarding withdrawal of consent in the Act concerning the Ethical Review of
p.000036: Research Involving Humans.
p.000036:
p.000036: References
p.000036: 1. Alexius Borgström, Katarina, Djuren, läkarna och lagen: en rättslig studie om djurförsöksetik. Uppsala, Iustus
p.000036: förlag, 2009. Arkivlag (SFS 1990:782).
p.000036: 2. Brambell, Rogers, F.W. (Chairman), Report of the Technical Committee to enquire into the Welfare of Animals
p.000036: kept under Intensive Livestock Husbandry Systems, London, HMSO, 1965. This states five freedoms for farm animals:
p.000036: freedom from hunger and thirst, from discomfort in housing, from pain and injury, from fear and worry and the
p.000036: opportunity to exhibit natural behaviour.
p.000036: 3. Cavalieri, Paola & Singer, Peter (red.), The Great Ape Project: Equality Beyond Humanity. New York, St.
p.000036: Martin’s Press, 1994. A proclamation from 34 researchers and authors for three rights for certain primates: the right
p.000036: to life, the right to freedom and a prohibition against torture.
p.000036:
p.000036:
p.000036:
p.000036: GOOD RESEARCH PRACTICE
...
p.000059: Students have a right to set high standards for their teachers to be competent and to stay informed on developments
p.000059: within their field. To uphold good quality, a teacher must not only maintain his or her knowledge and skills, but also
p.000059: seek to broaden them. Teaching staff should not – at least not without declaring their limitations – address problems
p.000059: in their lectures and classes which do not fall within their field of expertise.
p.000059: Basically, these standards are no different from those placed on many other occupations. For instance, who wants to see
p.000059: a doctor or hire a computer consultant who hasn’t kept up with current developments since graduation?
p.000059: It is important to be aware that the teacher is in a position of power in relation to the students; a position which
p.000059: must not be abused. Certain departments and other course providers have special ethical rules for teachers. In
p.000059: addition, the Swedish Association of University Teachers (SULF) has adopted ethical guidelines for university teaching
p.000059: staff (Etiska riktlinjer för universitetslärare, 2005). Those working as teachers should be familiar with and seek to
p.000059: comply with such documents.
p.000059:
p.000059: 7.3 Assessing applications and proposals
p.000059: Researchers are frequently called upon to review colleagues’ research proposals or to act as external assessors in
p.000059: conjunction with appointments. It is important in such contexts to decline invitations to provide an assessment when a
p.000059: conflict of interest might arise. It is sufficient that a circumstance exists that, seen from outside, may reduce the
p.000059: confidence that the researchers will make an objective assessment. If you are uncertain whether a conflict exists, you
p.000059: should disclose this to the party requesting your participation. Provisions relating to conflict of interest are
p.000059: included in the Administrative Procedure Act (for national public authorities) and in the Local Government Act (for
p.000059: municipalities). To help in the interpretation of conflict of interest rules in research funding, the Swedish Research
p.000059: Council has produced a policy on conflicts of interest (2014).
p.000059: It is also important to base assessments of this nature on an objective and careful analysis of the documents and
p.000059: qualifications presented, and to maintain a critical stance towards unfounded claims and opinions aired by others. It
p.000059: should go without saying that the analysis in any assessment should be well founded.
p.000059:
p.000059:
p.000059:
p.000059:
p.000059: GOOD RESEARCH PRACTICE
p.000060: 60
p.000060:
p.000060: 7.4 Reviewing manuscripts for publication
p.000060: Another situation where ethics may be tested is when a researcher reviews an article or a larger manuscript submitted
p.000060: to a journal or publishers for publication. It is very common in the academic world for a researcher’s work to be
p.000060: assessed by his or her colleagues. Since such assessments presuppose expert knowledge in the field concerned, there are
p.000060: few alternatives to this system, which is generally referred to as “peer review”. Thus, clear rules to counteract
p.000060: various types of conflict of interest are crucial.
p.000060: One reason the system has been challenged is a number of flagrant cases of peer reviewers abusing the trust which being
p.000060: given access to a colleague’s work to assess it entails. Such abuses have included reviewers stealing ideas from
...
p.000071: family life, his home and his correspondence”. It further states that “There shall be no interference by a public
p.000071: authority with the exercise of this right except such as is in accordance with the law and is necessary in a democratic
p.000071: society in the interests of national security, public safety or the economic well-being of the country, for the
p.000071: prevention of disorder or crime, for the protection of health or morals, or for the protection of the rights and
p.000071: freedoms of others”. The European Court of Human Rights was established to monitor that the obligations under the
p.000071: European Court of Human Rights are fulfilled.
p.000071:
p.000071: 9.1.5 The Council of Europe’s Data Protection Convention
p.000071: In 1981, the Committee of Ministers of the Council of Europe adopted the Convention for the Protection of Individuals
p.000071: with regard to Automatic Processing of Personal Data. The Convention came into force on 1 October 1985. All EU member
p.000071: states have ratified the Convention. The Convention is binding on the countries who have ratified it. The Convention is
p.000071: associated with a number of recommendations on how personal data should be handled in various areas. The
p.000071: recommendations are not directly binding.
p.000071: According to Article 1, the Convention aims “to secure in the territory of each Party for every individual, whatever
p.000071: his nationality or residence, respect for his rights and fundamental freedoms, and in particular his right to privacy,
p.000071: with regard to automatic processing of personal data relating to him ("data protection”)”. According to Article 2, the
p.000071: Convention’s area of application is "automated data files" and "automatic processing" of personal data in public and
p.000071: private activities. Each Convention state may, however, introduce certain general restrictions or expansions of the
p.000071: area of implementation. The central part of the Convention is Chapter II (Articles 4–11), which comprise the
p.000071: fundamental principles for data protection. They include requirements that personal data that is processed
p.000071: automatically shall be “obtained and processed fairly and lawfully”, “adequate, relevant and not excessive in relation
p.000071: to the purposes for which they are stored” and “preserved ... for no longer than is required” (Article 5). Personal
p.000071: data “revealing racial origin, political opinions ... health or sexual life”, as well as “personal data relating to
p.000071: criminal convictions” “may not be processed automatically unless domestic law provides appropriate safeguards” (Article
p.000071: 6). The Convention also includes provisions governing requirements on safety measures and information to those whose
p.000071: data is being processed.
p.000071:
p.000071: 9.1.6 OECD’s Guidelines
...
Searching for indicator political:
(return to top)
p.000019: method. Textbooks on theory of science discuss quantitative and qualitative methods, but the focus in this book is on
p.000019: research ethics.
p.000019: A fundamental question in a research ethics review concerns the balance between risk and benefit. This always starts as
p.000019: a negative value, as every study demands time of its participants and exposes them to a certain amount of risk, even if
p.000019: it is sometimes minimal. A necessary condition for a balance to be reached is that the method used answers the question
p.000019: asked. The question should preferably also be important and its answer clearly and strictly formulated. If a study does
p.000019: not answer its question, it should not be conducted in its current design.
p.000019: When you decide to begin a research project, you should choose a method with the fewest imaginable harmful consequences
p.000019: on the people and/or animals involved, if the methods are otherwise somewhat equal. Additionally, the benefit of the
p.000019: planned research and the scientific value of its expected results should always be weighed against its harmful
p.000019: consequences. This is discussed further in Chapter 3.
p.000019: An example can illustrate how important is it to think about whether a certain study might provide an answer to the
p.000019: question you have decided to study. Assume that you want to determine who has power in a certain community. First, you
p.000019: have to specify what you mean by power. It is one thing to have the power to keep certain issues from being brought up
p.000019: on the agenda of meetings of political deciding making bodies, and quite another to have a reputation as powerful and
p.000019: influential. The latter phenomenon can be studied through interviews and questionnaires in which people are asked who
p.000019: they believe has power in certain issues, but it is doubtful that this method would help in answering the first
p.000019: question. Neither could the first question be studied by looking at who is the most successful in pushing their
p.000019: proposals through in political deciding bodies at various levels.
p.000019: Another example: Determining whether there is a difference in the effect and safety of a flu vaccination between
p.000019: children who have not previously had the vaccination and those who have is a reasonable and interesting task. To study
p.000019: this, you should be able to conduct a controlled study of these two groups of children and examine whether there is any
p.000019: statistically significant difference. But if you want to answer the question by comparing to children previously
p.000019: vaccinated for something else, for instance hepatitis, it becomes unclear what function the control group has and what
p.000019: question is being answered.
p.000019:
p.000019:
p.000019:
p.000019: GOOD RESEARCH PRACTICE
p.000020: 20
p.000020:
p.000020: 2.1.4 Who bears the responsibility?
p.000020: When it comes to how research should be conducted and who has the responsibility for its being conducted in a
p.000020: satisfactory way scientifically and ethically, it can help to distinguish between the respective responsibilities of
p.000020: the individual researcher, the project leader, the department head and the research principal, even if the borders
p.000020: between them are not always sharp. In certain types of research another aspect also arises: the responsibility of the
p.000020: commissioning party or funding body.
p.000020: An issue for the individual researcher to consider is the choice of research question. This choice can be between, for
p.000020: example, a well-defined problem that can give relatively quick publishable results but does not seem to have any
p.000020: greater significance for society on the one hand and a more diffuse or less meritable project of substantial societal
p.000020: significance. This choice must be made by the individual researcher.
p.000020: Within all disciplines the researcher also chooses among the various subject areas, focuses and problems. For instance,
p.000020: within history a researcher can take an interest in the history of individuals, groups or countries from many
p.000020: perspectives, including mentality, political, legal, economic and/or others.
p.000020: A task of the supervisor is to monitor the doctoral student’s choices. Those responsible for the academic merit system
p.000020: should give the right signals so that a researcher can avoid the temptation of defining his or her research task based
p.000020: more on the merit possibilities instead of on the importance of the research question.
p.000020: Today, a great many studies are conducted that do not allow conclusions to be drawn – and “unnecessary” research is
p.000020: also conducted, in the sense that its questions have already been answered. This has been shown, for example, in
p.000020: systematic reviews by the Swedish Council on Health Technology Assessment (SBU) carried out in various medical fields.
p.000020: Funding bodies naturally have an interest in their resources leading to research of high quality. The evaluation of a
p.000020: project proposal is often based on the weighing of a number of different criteria, listed, for example, in the Swedish
p.000020: Research Council’s instructions to grant applicants and reviewers (see www.vr.se). Besides the scientific quality and
p.000020: the researcher’s or research group’s competence to conduct the project, originality, significance and in some cases
p.000020: also some form of benefit aspect may be considered.
p.000020: The researcher is responsible for seeing to it that the research subjects 1 have satisfactory insurance coverage.
p.000020: Patient insurance covers injury in connection with research or treatment, as well as injury caused by treatment given
p.000020: due to an incorrect diagnosis. However, it does not cover injury or side effects caused by medication, or side effects
p.000020: of medication, which are instead covered by pharmaceutical insurance. Patient insurance applies within Swedish
...
p.000021:
p.000021:
p.000021: Meanwhile, it is also important that a researcher be loyal to his or her research task. With a decision to terminate,
p.000021: you should also consider the fact that other researchers may be depending on the work’s completion. Loyalty to the
p.000021: research task, diligence and an ability to concentrate are therefore important qualities for a researcher as well as a
p.000021: research environment to have. Most research projects demand a great work effort and a high level of concentration. As a
p.000021: rule, the time it takes from the first ideas to results is both long and uncertain. Most research work certainly
p.000021: contains creative elements, but there are often long, laborious periods of routine and transition in between.
p.000021: A researcher can have several reasons for leaving a project he or she has undertaken. Ethical reasons can include the
p.000021: research risking violating people’s integrity or the published results being misused. Scientific reasons can include
p.000021: new discoveries making the purpose of the research no longer fruitful.
p.000021:
p.000021: 2.2 Making research results useful
p.000021:
p.000021: 2.2.1 The elusive and multidimensional benefit2
p.000021: It is natural to connect the question of how research results will be made useful with the questions “Useful – in what
p.000021: sense?” and “For whom?”. This is true for the simple reason that something that is of use to one person is not always
p.000021: of use to another. A product or method can also benefit many people in diverse ways: some may increase their income,
p.000021: others may get treatment that increases their life expectancy, and still others may experience an improved quality of
p.000021: life.
p.000021: From a broader perspective, the concept can also include new knowledge that can lead to political decisions being made
p.000021: in a more insightful way or new unforeseen aspects arising and resulting in completely new considerations. For the
p.000021: researcher him or herself, or for other researchers, this new knowledge can lead to innovative ideas and hypotheses for
p.000021: future research.
p.000021: Many important discoveries have been unexpected, and have sometimes occurred in the search for something else
p.000021: (Teflon). They have occurred purely coincidentally (dark energy) or by mistake (penicillin). But it is obviously
p.000021: necessary that the researcher realises the significance of the effects this coincidence or mistake can lead to.
p.000021: The following examples show that research should not be driven all too strictly.
p.000021:
p.000021:
p.000021:
p.000021:
p.000021:
p.000021:
p.000021:
p.000021: 2 In its upcoming report on future research strategies, the Swedish Research Council will address the question of a
p.000021: research project’s benefit from a comparative international perspective.
p.000021:
p.000021:
p.000021: GOOD RESEARCH PRACTICE
p.000022: 22
p.000022:
p.000022: Some facts on chance
p.000022: Penicillin was discovered in 1928 by Alexander Fleming. After having accidentally left his staphylococci cultures in
p.000022: his laboratory for a longer time, he noticed that the mould growing on some of them had killed the surrounding
p.000022: bacteria.
p.000022: Teflon was invented by chance by Roy Plunkett when he was trying to make the gas tetrafluoroethylene work as a
p.000022: refrigerator cooling agent. A bottle of the gas was left overnight and polymerised into polytetrafluoroethylene, a very
p.000022: slick plastic. Eventually it came to be used to coat fishing line and frying pans, and was also used on spacecraft
p.000022: because it does not react to UV light, ozone or oxygen and tolerates temperatures from -200 to over 200 °C.
...
p.000029: of its content. What is to be reviewed therefore has nothing to do with how the project is funded. Also, research that
p.000029: is not funded by external bodies, but is carried out within a position at an institution, shall therefore be reviewed
p.000029: if the content so requires.
p.000029: A research project shall be reviewed by an ethics review board if any of the following conditions exist.
p.000029: Namely, if the project (A)
p.000029:
p.000029: • entails physical encroachment on the research subject
p.000029: • will be conducted using a method aiming to affect the research subject physically or psychologically, or that
p.000029: carries an obvious risk of physical or psychological harm to the research subject
p.000029: • entails studies on biological material taken from a living human being and can be traced to this person
p.000029: • entails physical encroachment on a deceased human being
p.000029: • entails studies on biological material taken for medical purposes from a deceased human being and can be traced to
p.000029: this person. Act (SFS 2008:192).
p.000029:
p.000029: A research project shall also be reviewed if it (B)
p.000029:
p.000029: • entails the handling of sensitive personal data according to Section 13 of the Personal Data Act (SFS 1998:204),
p.000029: including information on race, ethnic origin, political views or religious conviction, or personal
p.000029:
p.000029:
p.000029:
p.000029:
p.000029: 3The research principal is the government authority or the physical or legal entity within whose organisation the
p.000029: research is conducted. A researcher employed at a university or a county council has the same as his or her research
p.000029: principal. The research principal, through its internal work or delegation order or through power of attorney,
p.000029: determines who is authorised to represent the research principal. The research principal always has ultimate
p.000029: responsibility for the research.
p.000029:
p.000029:
p.000029: GOOD RESEARCH PRACTICE
p.000030: 30
p.000030:
p.000030: data according to Section 21 of the Personal Data Act, including information on judgements in criminal cases.
p.000030:
p.000030: Condition (B) thus means that all research dealing with sensitive personal data shall be ethically reviewed, regardless
p.000030: of how the data has been collected and whether or not the researcher has obtained the participants’ consent.
p.000030: When an ethics review board evaluates a project, it has a number of aspects to note and consider. Generally, the
p.000030: research in question can be approved only if it can be conducted with respect for human dignity. In the review, the
p.000030: board should also evaluate how the human rights and basic freedoms of those involved are treated in relation to the
...
p.000032: In Sweden, the legal requirement of the advisory ethics review of animal experiments was introduced in 1979. Since
p.000032: 1988, the ethics committees on animal experiments have had the task of approving or rejecting applications, and since
p.000032: 1998 their ruling has been legally binding. In total, around 1,700 applications are reviewed each year.
p.000032: The responsibility for the ethics committees on animal experiments and the review function rests on the Board of
p.000032: Agriculture since 2007.
p.000032: There are six ethics committees on animal experiments in Sweden, and each committee has fourteen members.
p.000032:
p.000032:
p.000032:
p.000032:
p.000032:
p.000032:
p.000032:
p.000032: 4A summary of its development is given in the Swedish Board of Agriculture’s regulations on change in the Central
p.000032: Laboratory Animals Board’s regulations from 1988; see the Board of Agriculture’s Code of Statutes 2008:70 as well as
p.000032: Borgström 2009.
p.000032: 5http://ec.europa.eu/environment/chemicals/lab_animals/index_en.htm
p.000032:
p.000032:
p.000032: GOOD RESEARCH PRACTICE
p.000033: 33
p.000033:
p.000033: Some facts
p.000033: The chair and vice chair of the ethics committees on animal experiments are lawyers with experience of court work. Of
p.000033: the other twelve members, one half are scientists or staff who work with laboratory animals and other half are laymen,
p.000033: of whom at least one represents an animal welfare organisation. It is a stated political goal that the laymen should
p.000033: represent the general public to the greatest degree possible. The composition of the research group should be such that
p.000033: the committee as a whole has broad competence.
p.000033:
p.000033: 3.2.4 Ethics review
p.000033: The main task of an ethics committee on animal experiments is to weigh the purpose of the experiment against the
p.000033: suffering that may be inflicted on the animals, and determine whether the purpose is sufficiently important to justify
p.000033: the animals’ expected suffering. This is a challenging task. It is important that the application be clear and
p.000033: informative, so that the committee can form an opinion on how important the experiment is, and how the animals may be
p.000033: affected.
p.000033: Central questions that must be answered by the applicant to enable the committee to make an adequate assessment are:
p.000033: the purpose of the research, whether this can be achieved using another method than animal experimentation or with
p.000033: another type of animal, whether the animals will be subjected to greater suffering than is absolutely necessary,
p.000033: whether anaesthesia or painkillers will be required, and whether the experiment is an unnecessary repetition of an
p.000033: earlier one.
p.000033: A report on the ethics review of animal experiments (Etisk prövning av djurförsök, SOU 2002:86) contains a
p.000033: well/structured suggestion for discussion subjects that highlight which ethical aspects need to be stressed in
p.000033: connection with each application.
p.000033: A researcher who wishes to make a sound decision in the question of whether or not an animal experiment is justified
...
p.000068: to take the broader view. This code was revised most recently in 2017 (European Code of Conduct for Research Integrity
p.000068: Revised Edition). ALLEA emphasises that, besides avoiding FFP, there are a number of ethics principles with which all
p.000068: researchers should comply. Worth mentioning are (in the most recent version, the number of principles has been slightly
p.000068: reduced):
p.000068:
p.000068: • honesty
p.000068: • reliability
p.000068: • objectivity
p.000068: • impartiality and independence
p.000068: • open communication
p.000068: • obligation to safeguard the interests of research subjects
p.000068: • fairness
p.000068: • obligation to nurture the next generation of researchers.
p.000068:
p.000068: It cannot be said that these principles are each one clearly defined. But together they create a multi-dimensional
p.000068: moral space within which the researcher shall work - they stake out the borders for what can be regarded as good
p.000068: research practice.
p.000068: It is the researcher’s obligation to present the purpose and the aim of his or her research honestly, and it is crucial
p.000068: that the scientific findings are reported in a reliable and defensible way. A prerequisite for research that it worthy
p.000068: of its name is that it is possible to scrutinise data, the scientific argumentation and not least the
p.000068:
p.000068:
p.000068: GOOD RESEARCH PRACTICE
p.000069: 69
p.000069:
p.000069: conclusions. To make this possible, the results have to be made available and communicated in a trustworthy manner to
p.000069: colleagues and the general public. Open communication is crucial.
p.000069: ALLEA underlines the importance of research not being improperly influenced by ideologies, political pressure or
p.000069: financial interests. ALLEA also emphasises our obligations as researchers to give guidance on these issues to future
p.000069: generations, and to monitor them collegially, which for example includes taking measures against all forms of
p.000069: harassment.
p.000069: In a report from 2016, Science Europe has moved in the same direction; that is to say emphasising the importance of
p.000069: researchers receiving good instruction in research ethics and researcher ethics, and that the values mentioned above
p.000069: are discussed and taught. This research and researcher ethics training shall start already during the first cycle, and
p.000069: the knowledge shall then be updated and expanded in width and depth throughout the career.
p.000069: The European Code of Conduct for Research Integrity (2017) is an important document that clearly indicates a code of
p.000069: conduct in a wider sense than the more narrow definition of misconduct emphasised by Good Research Practice. If
p.000069: researchers complied with this code, a large proportion of the current misconduct would probably be avoided. The few
p.000069: pathological cases of misconduct would not be prevented through this type of code of conduct, for which severe
p.000069: sanctions would instead be required. However, this entails a problem: if issues of research ethics are dealt with in
p.000069: legislation, and the concept becomes too comprehensive or multi- dimensional, the legal codification will be difficult
p.000069: to handle. Instead, the definition of good research ethics should be seen as a code of conduct that covers a more
...
p.000071: with regard to Automatic Processing of Personal Data. The Convention came into force on 1 October 1985. All EU member
p.000071: states have ratified the Convention. The Convention is binding on the countries who have ratified it. The Convention is
p.000071: associated with a number of recommendations on how personal data should be handled in various areas. The
p.000071: recommendations are not directly binding.
p.000071: According to Article 1, the Convention aims “to secure in the territory of each Party for every individual, whatever
p.000071: his nationality or residence, respect for his rights and fundamental freedoms, and in particular his right to privacy,
p.000071: with regard to automatic processing of personal data relating to him ("data protection”)”. According to Article 2, the
p.000071: Convention’s area of application is "automated data files" and "automatic processing" of personal data in public and
p.000071: private activities. Each Convention state may, however, introduce certain general restrictions or expansions of the
p.000071: area of implementation. The central part of the Convention is Chapter II (Articles 4–11), which comprise the
p.000071: fundamental principles for data protection. They include requirements that personal data that is processed
p.000071: automatically shall be “obtained and processed fairly and lawfully”, “adequate, relevant and not excessive in relation
p.000071: to the purposes for which they are stored” and “preserved ... for no longer than is required” (Article 5). Personal
p.000071: data “revealing racial origin, political opinions ... health or sexual life”, as well as “personal data relating to
p.000071: criminal convictions” “may not be processed automatically unless domestic law provides appropriate safeguards” (Article
p.000071: 6). The Convention also includes provisions governing requirements on safety measures and information to those whose
p.000071: data is being processed.
p.000071:
p.000071: 9.1.6 OECD’s Guidelines
p.000071: The Organisation for Economic Cooperation and Development (OECD) has produced Guidelines Governing the Protection of
p.000071: Privacy and Transborder Flows of Personal Data. These Guidelines were adopted by the OECD Council in 1980,
p.000071: simultaneously with a recommendation to the governments of the member countries to consider the Guidelines in national
p.000071: legislation. Sweden has adopted these recommendations, and by this means undertaken to follow the Guidelines. The
p.000071: Guidelines are minimum rules, which means that protection in the countries that have undertaken to follow the
p.000071: Guidelines may be made more comprehensive than the protection given by the Guidelines. The Guidelines include eight
p.000071: fundamental principles to protect personal integrity; for
p.000071:
p.000071:
p.000071: GOOD RESEARCH PRACTICE
p.000072: 72
p.000072:
p.000072: example, they state that personal data shall be collected for specific purposes, be relevant to the purpose for which
p.000072: they are intended, and shall be correct, complete and up-to-date.
p.000072:
p.000072: 9.1.7 The European Union’s Charter of Fundamental Rights
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Health / Drug Dependence
Searching for indicator dependence:
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p.000034: 34
p.000034: 3.2.5 Alternatives to using laboratory animals
p.000034: 34
p.000034: 3.2.6 Evaluating the ethics of animal experiments
p.000035: 35
p.000035: 3.3 Genetically modified organisms
p.000036: 36
p.000036: 3.4 Examples of problems that are still unsolved
p.000036: 36
p.000036: References
p.000037: 37
p.000037: 4 HANDLING OF RESEARCH MATERIAL - THINK FIRST
p.000039: 39
p.000039: 4.1 Background and problems
p.000039: 39
p.000039: 4.2 Interest considerations and various types of research
p.000039: 39
p.000039: 4.3 Four concepts
p.000040: 40
p.000040: 4.4 What can researchers promise?
p.000040: 40
p.000040: 4.4.1 Secrecy
p.000040: 40
p.000040: 4.4.2 Professional secrecy
p.000041: 41
p.000041: 4.4.3 Anonymity
p.000041: 41
p.000041: 4.4.4 Confidentiality
p.000041: 41
p.000041: 4.4.5 Conclusions
p.000041: 41
p.000041: 4.5 Documentation
p.000042: 42
p.000042: References
p.000043: 43
p.000043: 5 RESEARCH COLLABORATION
p.000044: 44
p.000044: 5.1 Introduction
p.000044: 44
p.000044: 5.2 Relations with fellow researchers
p.000044: 44
p.000044: 5.3 Interaction with funding and commissioning bodies
p.000045: 45
p.000045: 5.4 Commercial aspects
p.000046: 46
p.000046: 5.5 Responsibility for a collaborative project: general
p.000047: 47
p.000047: 5.6 Issues of responsibility in multinational research projects
p.000047: 47
p.000047: 5.6.1 Starting points
p.000047: 47
p.000047: 5.6.2 Conditions of responsibility
p.000048: 48
p.000048: 5.6.3 Moral and legal responsibility
p.000049: 49
p.000049: 5.6.4 The extent of responsibility
p.000050: 50
p.000050: References
p.000051: 51
p.000051: 6 PUBLISHING RESEARCH RESULTS
p.000052: 52
p.000052: 6.1 Why publish?
p.000052: 52
p.000052: 6.2 Disclosure of financial and scientific dependence
p.000052: 52
p.000052: 6.3 Background, materials and conclusions
p.000052: 52
p.000052: 6.4 The third task and the media
p.000053: 53
p.000053: 6.5 Open access
p.000054: 54
p.000054: 6.6 Publication as a measure of worth
p.000055: 55
p.000055: 6.7 The author
p.000055: 55
p.000055: 6.8 Multiple authors – responsibility – publication rules
p.000056: 56
p.000056: 6.9 The responsible publisher and the editor
p.000057: 57
p.000057: GOOD RESEARCH PRACTICE
p.000004: 4
p.000004:
p.000004: References
p.000058: 58
p.000058: 7 OTHER ROLES OF THE RESEARCHER
p.000059: 59
p.000059: 7.1 The supervisor and postgraduate supervision
p.000059: 59
p.000059: 7.1.1 The tasks of the supervisor
p.000059: 59
p.000059: 7.1.2 Whose ideas?
p.000059: 59
p.000059: 7.1.3 The thesis and its presentation
p.000059: 59
p.000059: 7.1.4 Responsibility for ethical and legal compliance
p.000060: 60
p.000060: 7.2 The teacher
p.000060: 60
p.000060: 7.3 Assessing applications and proposals
p.000060: 60
p.000060: 7.4 Reviewing manuscripts for publication
p.000061: 61
p.000061: 7.5 Committee work
p.000061: 61
p.000061: References
p.000062: 62
p.000062: 8 RESEARCH MISCONDUCT
p.000063: 63
p.000063: 8.1 Introduction
p.000063: 63
p.000063: 8.2 Questions of definition and scope
p.000063: 63
p.000063: 8.3 Fabrication and falsification
p.000064: 64
p.000064: 8.4 Plagiarism
p.000065: 65
p.000065: 8.5 Unpublished material and self-plagiarism
p.000066: 66
p.000066: 8.6 Establishing plagiarism
p.000066: 66
p.000066: 8.7 Prevention
p.000067: 67
p.000067: 8.8 Sanctions for misconduct
p.000068: 68
p.000068: 8.9 Addressing issues of misconduct
p.000068: 68
p.000068: 8.10 A broader perspective
p.000069: 69
p.000069: References
p.000070: 70
p.000070: 9. KEY LEGISLATION AND OTHER REGULATIONS WITH WHICH RESEARCHERS SHOULD BE FAMILIAR
p.000071: 71
...
p.000024:
p.000024:
p.000024: GOOD RESEARCH PRACTICE
p.000025: 25
p.000025:
p.000025: The criteria discussed above are by no means a complete list; nor can each individual requirement be regarded as a
p.000025: necessary condition for quality in a certain project. There must, for instance, be room for explorative studies without
p.000025: clear goals. The specification and application of these criteria are not the same in quantum mechanics and hermeneutics
p.000025: (interpretation theories), but if a project is lacking in many of the aspects discussed above, this is a clear warning
p.000025: signal.
p.000025:
p.000025: 2.3.2 Research question and method
p.000025: In many fields, the research group’s activities can be quite strongly method-oriented, based on a method developed
p.000025: within the group, which is the connecting link for various research efforts in which it is used. In such cases, the
p.000025: choice of research question can be driven by the method. This is in opposition to the schematic representation of the
p.000025: researcher as a problem-solver, first asking a question and then choosing a method to answer it. The research of
p.000025: method-based groups often becomes splintered, and many contributions can be rather superficial. On the other hand, a
p.000025: systematic study of the strengths of a newly developed method can be highly valuable.
p.000025: In general, it should also be mentioned that advances in modern natural science, from astronomy to brain research, must
p.000025: be regarded as being greatly due to developments in technology that have allowed the use of new methods. The
p.000025: development of methods within areas like mathematics, statistics and information science should also not be
p.000025: underestimated. There is every reason for researchers and research groups to acknowledge their dependence on these
p.000025: contributions and give them the credit they deserve.
p.000025: The choice of method for a research task is decisive for the value and character of the results. It is often difficult
p.000025: and requires a good deal of experience, often even boldness. Sometimes the method choice is based on existing knowledge
p.000025: and contributions, perhaps by previous generations in the same research group or at the department where the research
p.000025: is being conducted. It can happen that the research environment at a department is so focused on a certain method that
p.000025: alternatives are not discussed or even considered. In such a case, it can be beneficial to consciously seek out
p.000025: alternatives and – possibly in collaboration with researchers within other method traditions – conduct parallel studies
p.000025: using different methods.
p.000025: In science, method issues are a hot topic and are linked to criteria for scientific quality. This is also the case in
p.000025: the humanities and social sciences. There is thus not only a practical difference between studies on people that are
p.000025: based on measurements, e.g. of reaction times or response frequency in schematic questionnaire surveys on the one hand,
p.000025: and on the other hand studies in which people’s views are interpreted – as in letter collections or interviews. In
p.000025: discussions, the generalisability and more or less claimed objectivity of the results can end up being in opposition to
p.000025: the interest and “depth” of the scientific claims. This does not mean that research collaboration combining different
p.000025: methods cannot be fruitful, however.
p.000025: Method choice also has an ethical aspect. In studies of the first type mentioned above, the researcher’s relation to
p.000025: the people being studied is often more distant, while in the second type it is more involved. In both cases, the
...
p.000051: is currently the normal form of publication used for doctoral theses. After completing their doctorates, too,
p.000051: researchers in these fields often publish their results in book form and as sole authors.
p.000051: Publication serves several purposes. Only if the results are made public does the research conducted contribute
p.000051: effectively to the dissemination of new knowledge to the wider society. What is more, publication is often essential if
p.000051: others are to build on the researcher’s ideas or to develop practical applications. But it is also necessary to enable
p.000051: the scientific community to scrutinise and discuss the results achieved. The report that the researcher presents
p.000051: consequently has to meet a number of quality standards.
p.000051: In addition, publication serves as an announcement of what the researcher (or group of researchers) concerned has
p.000051: accomplished. The work published is thus of importance when it comes to assessing the worth of a contributing
p.000051: researcher, for example when he or she is applying for a position. The citation of published work nowadays also
p.000051: influences the distribution of governmental research funding to different universities and colleges.
p.000051: When projects are funded by public agencies, researchers are required to make their results available to others (open
p.000051: access). According to the Swedish Research Council general rules for research grants, a researcher may currently not
p.000051: allow an agreement with a commercial actor or other stakeholder to delay publication of results for more than two
p.000051: months, unless a patent application is planned, in which case publication may be delayed by up to four months.
p.000051:
p.000051: 6.2 Disclosure of financial and scientific dependence
p.000051: A researcher publishing results must clearly disclose any ties or dependencies that may exist. Details should also be
p.000051: given of any individuals or bodies providing financial support for the work, and if the research is commissioned, the
p.000051: commissioning organisation should be named.
p.000051: A researcher often builds on other people’s results, uses ideas, concepts, theories and methods drawn from their work,
p.000051: or develops his or her arguments in dialogue with others. It is important to describe such relationships too, to make
p.000051: clear what the researcher’s (research group’s) own contribution is.
p.000051:
p.000051: 6.3 Background, materials and conclusions
p.000051: When a researcher publishes research results, he or she must fulfil a number of crucial requirements. If these are not
p.000051: met, other researchers will not be able to scrutinise the results, and the research community will not be able to
p.000051: assess the quality of the project or the significance of the results.
p.000051: An honest and clear account of the background to the study should always be included in the published report, which
p.000051: will involve quoting and referring to relevant earlier publications. Materials and methods must be described with
p.000051: sufficient clarity and detail to allow a reasonably well-informed reader to assess the scientific quality or
p.000051: significance of the results.
p.000051:
p.000051:
p.000051: GOOD RESEARCH PRACTICE
p.000052: 52
p.000052:
p.000052: Where research is based on empirical data and statistical methods, for example, any dropout and excluded observations
p.000052: must be reported, along with the reasons for the latter. The statistical analysis must be clear and adequate for the
p.000052: method used. Experimental studies must also be presented in such a way that their reproducibility can be tested. The
...
Searching for indicator dependency:
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p.000027:
p.000027:
p.000027: GOOD RESEARCH PRACTICE
p.000028: 28
p.000028:
p.000028: some types of stem cell research bring up specific issues regarding both the research object and the methods being
p.000028: used. These concern the moral status of fertilised eggs, and, for instance, whether methods such as nucleus transfer
p.000028: from one cell to another are ethically acceptable. The existence of gaps in knowledge and uncertainty, such as about
p.000028: what happens when nano particles enter the body, is highlighted when results from nano research are applied within new
p.000028: areas, such as the automobile industry, medicine, cosmetics, etc. Limited toxicological studies have been conducted,
p.000028: but the gaps in knowledge make it difficult to perform a meaningful risk-benefit analysis and points to the need for
p.000028: method development in this area.
p.000028: Issues concerning the commercialisation of research and the effects of research on the environment and society from a
p.000028: more global perspective have recently attracted growing interest; these issues are discussed earlier in this chapter as
p.000028: well as in Chapter 5. The background is not only globalisation and the increased international collaboration between
p.000028: research groups in different countries, but also the fact that large-scale research demands significant resources and
p.000028: public funding is not sufficient. Research groups are therefore becoming increasingly dependent on collaboration with
p.000028: and financial contributions from non-public funding bodies. This enables research that might otherwise not have been
p.000028: possible to be conducted, but also brings to the fore issues of control, dependency and the supervision of research.
p.000028: Human rights are universal. To the extent research ethics principles are based on and protect these rights, they can be
p.000028: accepted in various cultures. At the same time, they then have to be formulated with a certain amount of vagueness. For
p.000028: example, the requirement of informed consent can be interpreted and applied as a requirement of individual informed
p.000028: consent in liberal, western societies. But in cultures where the family, group, clan or village elder gives consent,
p.000028: this requirement must be interpreted slightly differently. Research ethics are thereby placed in a cultural and social
p.000028: context. Some values reflect technical and economic development, while others are slower to change and are based on
p.000028: more basic human needs.
p.000028:
p.000028: References
p.000028: 1. Chalmers, Alan F., Vad är vetenskap egentligen? Nora, Nya Doxa, 2003.
p.000028: 2. Föllesdal, Dagfinn & Wallöe, Lars & Elster, Jon, Argumentationsanalys, språk och vetenskapsfilosofi. Stockholm,
p.000028: Thales, 2001.
p.000028: 3. Gilje, Nils & Grimen, Harald, Samhällsvetenskapernas förutsättningar. Göteborg, Daidalos, 1993, tredje upplagan
p.000028: 2007.
p.000028: 4. Hermerén, Göran, Kunskapens pris: forskningsetiska problem och principer i humaniora och samhällsvetenskap.
p.000028: Stockholm, Swedish Science Press & HSFR, 1986, andra upplagan, 1996.
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Health / Drug Usage
Searching for indicator drug:
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p.000030: of Research Involving Humans and the regulations issued based on the Act.
p.000030:
p.000030: Some facts
p.000030: A regional ethics review board is divided into two or more departments. As a rule, there are one or more departments
p.000030: for medical research and one for what is called “other research”. Each department is headed by a chairperson who is or
p.000030: has been a regular judge, and also has ten members with scientific competence, of whom one serves as scientific
p.000030: secretary and five represent the public interest.
p.000030: The central ethics review board is also headed by a chair who is or has been a regular judge. It has six further
p.000030: members, of whom four have scientific competence and two represent the public interest. At the central board, one of
p.000030: the scientific members serves as scientific secretary too.
p.000030: In addition to the task of addressing decision appeals and cases referred from regional boards, the central board also
p.000030: supervises compliance with the Act concerning the Ethical Review of Research Involving Humans and the regulations
p.000030: issued with support of the Act.
p.000030:
p.000030:
p.000030:
p.000030: GOOD RESEARCH PRACTICE
p.000031: 31
p.000031:
p.000031: 3.1.2 Other approval
p.000031: Besides approval from an ethics review board, other approval can also be required for research involving humans.
p.000031: In clinical trials, except so-called non-intervention studies, it is a requirement that approval is obtained from the
p.000031: Swedish Medical Products Agency (see Chapter 7 Section 9 of the Medicinal Products Act SFS 2015:315). This also applies
p.000031: to trials of a drug for an approved indication, at an approved dosage and with an approved method of administration
p.000031: with the aim of further showing effect and/or safety. The Agency has issued detailed rules for how clinical trials of
p.000031: drugs for humans shall be conducted. Applications to the Swedish Medical Products Agency shall be made by the sponsor,
p.000031: i.e. the individual, company, institution or organisation that assumes responsibility for starting, organising and/or
p.000031: funding the clinical trial. More information on regulations and the steps of the application process can be found on
p.000031: the Agency’s website (www.lakemedelsverket.se.).
p.000031: Applications for clinical trials within the EU are registered in the database Eudra CT (European Clinical Trials
p.000031: Database). Currently, this database is only accessible to national medical products agencies, for instance the Swedish
p.000031: Medical Products Agency, the European Medicines Agency (EMA), and the Commission. As a step towards increasing the
p.000031: transparency within the EU, access to certain parts of the database’s content will soon be given to the general public
p.000031: via the website www.clinicaltrialsregister.eu. On this website, information on issues such as ethics committee
p.000031: decisions regarding clinical trials on children will be publicly accessible. In the US, the corresponding database is
p.000031: ClinicalTrials.gov.
p.000031: To conduct a research project involving the irradiation of research subjects with ionising radiation, the project must
...
p.000045: happening in the organisations concerned.
p.000045:
p.000045: 5.4 Commercial aspects
p.000045: A growing proportion of Swedish research is paid for by external funding organisations, some of which provide their
p.000045: support in pursuit of commercial goals. Such research is often directly commissioned by the companies concerned, and to
p.000045: a certain extent they may temporarily reserve an exclusive right to make use of the results by deferring publication. A
p.000045: reason for this is that patent rights must be secured before a decision can be made regarding larger investments in
p.000045: costly, risk-filled development projects. However, this gives rise to problems regarding the openness otherwise
p.000045: practised in international research today.
p.000045: In terms of the principles involved, these problems are accentuated by the fact that, when all is said and done,
p.000045: central government generally pays part of the bill for such research projects. According to the Swedish Research
p.000045: Council’s current rules, an agreement with a commercial actor or other stakeholder may not limit the opportunity to
p.000045: publish the results of research carried out with a grant from the Swedish Research Council. Nor may such an agreement
p.000045: delay publication by more than two months. However, the delay may amount to at most four months if the purpose is to
p.000045: enable a patent application based, wholly or partly, on the research results referred to above. Many public funding
p.000045: bodies have similar rules.
p.000045: The largest international database for the registration of clinical trials is currently the US-based
p.000045: ClinicalTrials.gov, developed by the National Institutes of Health (NIH) in collaboration with the Food and Drug
p.000045: Administration (FDA). There are rules stating the conditions under which ongoing studies are to be reported to and
p.000045: registered in the database, one reason being to reduce the risk of the unnecessary duplication of work. Many prominent
p.000045: medical journals currently require that a study be registered in a database of ongoing clinical studies for it to be
p.000045: considered for publication.
p.000045: Matters become especially complicated in projects co-funded by commercial organisations when, as often happens, they
p.000045: involve doctoral students, or assume the form of major international collaborations. A doctoral thesis is fundamentally
p.000045: a public document – the whole point of it is that it should be open to public scrutiny by critics. But if the doctoral
p.000045: student’s work has been funded by an industrial company that wishes to use the results in product development and
p.000045: therefore wants to defer publication, problems can arise.
p.000045:
p.000045: What would you do in the following situation?
p.000045: A company is funding a series of drug studies. Your research group has been given a large grant for such a study, in
p.000045: which you are comparing the company’s products with similar products from other manufacturers, under varying conditions
p.000045: and on different target groups. The company has views on the publication, and tries to influence it so that the studies
p.000045: with the results most positive to the company are published first, the less positive ones much later, and the negative
p.000045: ones not at all. You protest at this.
p.000045: What action do you take?
p.000045:
p.000045: When commercial aspects arise in an international project, the diverging regulatory frameworks of different countries
p.000045: can cause particular problems. In Sweden, the “teacher exemption” allows research results arrived at during working
p.000045: hours, for example at a university department, nevertheless to be patented by the individual researcher concerned,
p.000045: resulting in private financial gain. In other countries, such as the United States, patent rights shall instead be
p.000045: assigned (either wholly or partially) to the university where the work was done. The question of ownership of the
p.000045: results of an international collaborative study can be extremely complex, and can easily poison the atmosphere in such
p.000045: a project.
p.000045: Issues of this kind, including purely practical aspects of how any commercially exploitable results are to be handled,
p.000045: must be discussed in detail by the research groups concerned – preferably before they become a
p.000045:
p.000045:
p.000045:
p.000045: GOOD RESEARCH PRACTICE
p.000046: 46
p.000046:
p.000046: pressing concern. All participants in the project, and not least any doctoral students involved, should be informed
p.000046: about what rules apply.
p.000046:
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Searching for indicator influence:
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p.000008: I forskning ställs krav såväl på kvalitet i arbetet som på integritet hos forskaren. Ett reflekterat etiskt
p.000008: förhållningssätt och agerande i forskarens olika roller är därvid grundläggande. För att konkretisera har
p.000008: framställningen kompletterats med ett antal exempel från forskarlivet, många tillvaratagna från den tidigare boken God
p.000008: forskningssed?, andra nytillkomna. Exemplen är fiktiva men inte orealistiska. En av avsikterna med exemplen är att visa
p.000008: att god forskningssed i praktiken kan innebära svåra val mellan olika handlingsalternativ. Frågan är hur man bör handla
p.000008: i en komplicerad verklighet, där olika principer och intressen kan stå mot varandra.
p.000008:
p.000008:
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p.000008: GOOD RESEARCH PRACTICE
p.000009: 9
p.000009:
p.000009: SUMMARY
p.000009:
p.000009: Research occupies a prominent position in today’s society and much is expected of it. This places a focus on
p.000009: researchers, who have a specific responsibility not only towards the people and animals participating in their
p.000009: research, but also towards all those who may be affected indirectly, positively or negatively, by their results.
p.000009: Researchers are expected to strive to conduct research of high quality. Accordingly, their work must be free of
p.000009: external influence and manipulation, and they should not act in their own personal interests or in the interests of
p.000009: other stakeholders. Good research depends on robust, well-founded trust.
p.000009: The various requirements of proper research conduct are in line with the role of the researcher as that role is
p.000009: perceived today. These requirements are built into the research process and based on society’s general ethical norms
p.000009: and values. Those who read the recommendations presented in this text will discover that much of what is said can be
p.000009: summarised in a few general rules which are broadly in keeping with the familiar general rules of life:
p.000009:
p.000009: 1) You shall tell the truth about your research.
p.000009: 2) You shall consciously review and report the basic premises of your studies.
p.000009: 3) You shall openly account for your methods and results.
p.000009: 4) You shall openly account for your commercial interests and other associations.
p.000009: 5) You shall not make unauthorised use of the research results of others.
p.000009: 6) You shall keep your research organised, for example through documentation and filing.
p.000009: 7) You shall strive to conduct your research without doing harm to people, animals or the environment.
p.000009: 8) You shall be fair in your judgement of others’ research.
p.000009:
p.000009: This summary provides a brief general overview of the field of research ethics. It should be followed up with further
p.000009: reading of other material if you would like to learn more about the subject. Some references are mentioned in the text,
p.000009: but you are referred primarily to the website: CODEX – Rules & Guidelines for Research (codex.vr.se/en/). In addition
...
p.000012: When assessing the validity of the results, we are to take no account, for example, of the researcher’s race, gender or
p.000012: position in society. The norm of disinterestedness (D) means that the researcher must have no other motive for his or
p.000012: her research than a desire to contribute new knowledge. The fourth norm, organised scepticism (OS), requires the
p.000012: researcher to constantly question and scrutinise, but also to refrain from expressing an assessment until he or she has
p.000012: sufficient evidence on which to base it.
p.000012: Since these principles were put forward, the position of the researcher, or at least the general perception of it, has
p.000012: changed in many respects. Being a researcher can no doubt colour an individual’s whole way of being and thinking, but
p.000012: these days it is quite a common professional role, and researchers are employed specifically as researchers. They, too,
p.000012: are expected to be loyal to organisations and superiors, and have to take financial factors and their own job security
p.000012: into account.
p.000012: In many cases, therefore, Merton’s norms will be difficult to live up to in reality. His requirement for
p.000012: disinterestedness, which says that the researcher’s main reason for doing research should be to contribute new
p.000012: knowledge, is a case in point. Researchers must surely be allowed to have other motives as well, such as promoting
p.000012: their prospects of employment through the work they do. The important thing, rather, is that motives of this kind do
p.000012: not influence the researcher in such a way that he or she arrives at interpretations or conclusions for which there is
p.000012: no scientific basis, or withholds findings for which evidence does exist.
p.000012: Merton’s strict requirement of communism is also difficult to live up to in many types of research and in certain
p.000012: research environments, for example in an industrial setting, although the importance of publishing results and
p.000012: communicating them to society and to other researchers will nevertheless often be acknowledged in such environments as
p.000012: well. However, when it comes to publicly funded research, the requirement of openness is clear.
p.000012: There are various problems with Merton’s other norms, too. The ideals expressed in the CUDOS norms nevertheless provide
p.000012: one of the cornerstones for the present-day discussion about research misconduct (see Chapter 8). They are also
p.000012: reflected in the requirements of honesty and openness that were formulated in our introduction.
p.000012:
p.000012: 1.4 Ethics codes
p.000012: While individuals participating in research should be protected from harms or wrongs (the criterion of protection of
p.000012: the individual), it is not reasonable for a trivial amount of harm to hinder important research. Research is important
p.000012: for both society and citizens due to the improvements in areas such as health, the environment and quality of life it
p.000012: can bring about. In addition to their benefits, research results are often valuable in their own right. You could say
p.000012: that there is an ethically motivated imperative to conduct research: the research criterion.
...
p.000025: number of ethical problems.
p.000025: The methods of participating, observing and/or recording can be used in several situations. A researcher may want to
p.000025: actually be in the research subjects’/informants’ environment and observe what happens, hear what is said and follow
p.000025: the persons’ interactions. In some situations, covert participant observation is used. This type of secret or disguised
p.000025: research is rare, however, and should be the exception rather than the rule.
p.000025: The ideal situation is always that those to whom the research applies should be informed that they are the subject of
p.000025: research, and should normally also have given their written consent. If the research includes handling any personal
p.000025: data, the Personal Data Act applies. If the personal data is also so-called “sensitive personal data”
p.000025:
p.000025:
p.000025: GOOD RESEARCH PRACTICE
p.000026: 26
p.000026:
p.000026: (see Chapter 3), then approval from an ethics review board must also be obtained. It is worth mentioning in this
p.000026: context that recording of sound from and/or images of persons constitutes handling of personal data (see Chapter 9).
p.000026: Overt observation studies, in which participants know research is being conducted, are used, for example, to study the
p.000026: work within different organisations, or at an emergency room or a school. The observations should be performed
p.000026: systematically using observation schedules, notes, etc. The researcher should strive for objectivity and try not to
p.000026: influence research subjects or events.
p.000026: Ethical considerations are very important in participant observation. The researcher is responsible for preventing any
p.000026: damage, and for ensuring the identities of those observed will not be revealed. Although this requirement may be
p.000026: difficult to fulfil, it is necessary.
p.000026: One way to observe human beings is through video recording. Research using a video can intrude on the private lives and
p.000026: integrity of individuals, as it is possible to identify them. Video recording should therefore only be used when it is
p.000026: impossible to achieve the same results with the help of other data collection methods. For example, masked photographs
p.000026: can be used instead of video if it is not necessary to study the subjects’ movements, facial expressions or
p.000026: interaction/communication.
p.000026: It is important that the recording is done in a respectful and responsible way. Individual integrity must be respected.
p.000026: If underage subjects are to be video recorded, the same special rules apply as for other research involving children.
p.000026: This means that if the child is less than 15 years old, both guardians and the child must have consented to the
p.000026: participation. The information should be written in such a way that the child too can understand it (according to the
p.000026: Act concerning the Ethical Review of Research Involving Humans).
p.000026: Just as for other research, the video recording shall be preceded by detailed information and consent be given
...
p.000044: same openness to non-public commissioning and funding bodies as to public ones.
p.000044: Of particular interest in this context, of course, are private companies. It is not uncommon for the researchers
p.000044: involved in a project to have partly different motives from the companies that have commissioned and supported it. This
p.000044: is not something that should be denied or hushed up – on the contrary, once again openness is to be recommended. But
p.000044: these differences in motives may very well resurface in new ways, not least when a strategy is to be adopted for the
p.000044: way ahead in the light of results necessitating a reappraisal of the project design. In such circumstances, researchers
p.000044: should make it clear where they stand, and not try to negotiate with hidden agendas.
p.000044:
p.000044: What would you do in the following situation?
p.000044: In the course of a research project, you discover that a classic problem of applied psychology, which you and others
p.000044: have long been working on, has in fact been wrongly formulated. With your deeper insight, you now realise that a number
p.000044: of earlier contributions in this field are irrelevant. Certain chemotherapeutic methods which seemed promising will
p.000044: probably not work. On the other hand, completely new possibilities have now opened up, though hardly of a kind that can
p.000044: be turned into commercial therapeutic products in the foreseeable future.
p.000044: You have an annually renewable contract with a company to develop the originally envisaged chemotherapeutic methods
p.000044: into commercial products. That grant provides funding for a PhD student who needs another three years to complete her
p.000044: doctorate.
p.000044: How do you act? Does the situation influence your eagerness to publish the new results without delay, results which you
p.000044: are almost certainly the only group in the world to have arrived at?
p.000044:
p.000044:
p.000044: GOOD RESEARCH PRACTICE
p.000045: 45
p.000045:
p.000045:
p.000045: The biggest collaborative scientific projects are funded by international research organisations. Sweden is often
p.000045: represented on the governing bodies of such organisations by researchers or officials, appointed by central government
p.000045: agencies. It is important that researchers selected for such positions do not simply regard their appointment as a
p.000045: personal distinction, but also see themselves as representatives of the country’s research agencies and its research
p.000045: community. This entails, among other things, ensuring that the positions which they adopt on important issues enjoy
p.000045: broad support from the relevant agencies and community, and regularly reporting back to their constituencies on what is
p.000045: happening in the organisations concerned.
p.000045:
p.000045: 5.4 Commercial aspects
p.000045: A growing proportion of Swedish research is paid for by external funding organisations, some of which provide their
p.000045: support in pursuit of commercial goals. Such research is often directly commissioned by the companies concerned, and to
p.000045: a certain extent they may temporarily reserve an exclusive right to make use of the results by deferring publication. A
p.000045: reason for this is that patent rights must be secured before a decision can be made regarding larger investments in
p.000045: costly, risk-filled development projects. However, this gives rise to problems regarding the openness otherwise
p.000045: practised in international research today.
...
p.000045: ClinicalTrials.gov, developed by the National Institutes of Health (NIH) in collaboration with the Food and Drug
p.000045: Administration (FDA). There are rules stating the conditions under which ongoing studies are to be reported to and
p.000045: registered in the database, one reason being to reduce the risk of the unnecessary duplication of work. Many prominent
p.000045: medical journals currently require that a study be registered in a database of ongoing clinical studies for it to be
p.000045: considered for publication.
p.000045: Matters become especially complicated in projects co-funded by commercial organisations when, as often happens, they
p.000045: involve doctoral students, or assume the form of major international collaborations. A doctoral thesis is fundamentally
p.000045: a public document – the whole point of it is that it should be open to public scrutiny by critics. But if the doctoral
p.000045: student’s work has been funded by an industrial company that wishes to use the results in product development and
p.000045: therefore wants to defer publication, problems can arise.
p.000045:
p.000045: What would you do in the following situation?
p.000045: A company is funding a series of drug studies. Your research group has been given a large grant for such a study, in
p.000045: which you are comparing the company’s products with similar products from other manufacturers, under varying conditions
p.000045: and on different target groups. The company has views on the publication, and tries to influence it so that the studies
p.000045: with the results most positive to the company are published first, the less positive ones much later, and the negative
p.000045: ones not at all. You protest at this.
p.000045: What action do you take?
p.000045:
p.000045: When commercial aspects arise in an international project, the diverging regulatory frameworks of different countries
p.000045: can cause particular problems. In Sweden, the “teacher exemption” allows research results arrived at during working
p.000045: hours, for example at a university department, nevertheless to be patented by the individual researcher concerned,
p.000045: resulting in private financial gain. In other countries, such as the United States, patent rights shall instead be
p.000045: assigned (either wholly or partially) to the university where the work was done. The question of ownership of the
p.000045: results of an international collaborative study can be extremely complex, and can easily poison the atmosphere in such
p.000045: a project.
p.000045: Issues of this kind, including purely practical aspects of how any commercially exploitable results are to be handled,
p.000045: must be discussed in detail by the research groups concerned – preferably before they become a
p.000045:
p.000045:
p.000045:
p.000045: GOOD RESEARCH PRACTICE
p.000046: 46
p.000046:
p.000046: pressing concern. All participants in the project, and not least any doctoral students involved, should be informed
p.000046: about what rules apply.
p.000046:
p.000046: 5.5 Responsibility for a collaborative project: general
p.000046: In certain contexts, it is necessary to identify the individual or individuals formally responsible for a joint
p.000046: project. If, for example, use is to be made of a major international research facility, such as CERN or ESO, a
...
p.000047: What would you do in the following situation?
p.000047: A large multinational research project, partly funded by a medical technology company, is testing a technology this
p.000047: company is marketing and is criticised for this in medical trade journals. It turns out that researchers in different
p.000047: countries have used different methods to round off numbers – in all cases to the benefit of the funding company.
p.000047: You suspect that someone has made a mistake, possibly unintentional, but perhaps to benefit certain interested parties.
p.000047: Should you report this? To whom? The project employs a considerable number of researchers at your department and has
p.000047: received a great deal of international attention.
p.000047: What do you do? If your report turns out to be unfounded, the careers of many researchers’ may be damaged. But if you
p.000047: do not report it, you could be contributing to the research being misleading and the medical technology device being
p.000047: used incorrectly and causing harm, or even risking people’s lives.
p.000047:
p.000047: 5.6.2 Conditions of responsibility
p.000047: What conditions must be met in order for responsibility to arise? This question can have both a descriptive and a
p.000047: normative sense. In the first case, it refers to the conditions that do apply in various contexts, while in the second,
p.000047: it refers to the conditions that should apply – perhaps with reference to the guidelines according to which the
p.000047: research is conducted.
p.000047: Points of departure for a discussion of this problem include varieties of causal conditions and predictability
p.000047: standards. According to the causal conditions, one of the conditions for responsibility is that the person who is held
p.000047: accountable must be able to influence or prevent things for which he or she is held responsible.
p.000047: Predictability standards refer to the aspect that he or she should be able to predict what might happen.
p.000047: Causal conditions for responsibility should at times be supplemented with other conditions. In some cases, it is not
p.000047: sufficient that a person is held accountable for something that has happened by means of the fact that he or she has
p.000047: influenced or neglected to influence the events. It is also a requirement that he or she had realised the consequences
p.000047: of these actions. Knowledge and intent clauses can thus sometimes be needed as a complement to causal conditions.
p.000047: Normative clauses on negligence may also be necessary in such a situation, based on the point that it was actually a
p.000047: person who influenced what happened. Suppose a research director created conditions for misconduct by neglecting to act
p.000047: to prevent it, though he or she neither realised he or she was doing so, nor intended to do it. But he or she should
p.000047: have realised this. In this case, a negligence clause can be cited.
p.000047:
p.000047:
p.000047:
p.000047: GOOD RESEARCH PRACTICE
p.000048: 48
p.000048:
p.000048: It might be sensible to clarify carefully the responsibility of persons further down in the hierarchy as well. This may
p.000048: encourage openness, which is healthy and contributes to increased clarity and transparency in the research. It can also
p.000048: help to reduce the risk of various forms of power abuse; but to say this is not to suggest that it is necessary to
p.000048: reduce the leadership capacity of international and national research directors.
p.000048:
p.000048: What would you do in the following situation?
p.000048: An investigation reveals that a researcher has broken international regulations and thereby proven herself unsuitable
p.000048: to continue as research director and supervisor. However, the vice-chancellor of the university where the researcher
p.000048: works chooses to ignore this, and lets her continue in as research director and supervisor. A number of colleagues who
...
p.000049: coordinating research director has to ensure that there is agreement on which rules to follow, that they are made known
p.000049: to the research groups working on the project, and that any necessary agreements are established – to prevent future
p.000049: conflict and problems within and between research groups.
p.000049: If the responsibility for certain issues within a project is delegated, the division of responsibility must be clear,
p.000049: and everyone affected by it needs to understand what they are responsible for. However, such a delegation does not
p.000049: absolve the coordinating research director from ultimate responsibility. He or she must speak up if there are
p.000049: indications that the division of responsibility is not working as intended, and ensure that the shortcomings are
p.000049: corrected.
p.000049: Within a research group, everyone has a certain degree of responsibility to make sure that certain things happen (or do
p.000049: not happen). Experimental researchers in a group should use logbooks of the same type and use the same principles to
p.000049: record information in them on the experiments they conduct and the data they obtain.
p.000049: Coordinating research directors at national and international levels are responsible for presenting the potential
p.000049: problems that can arise, and for taking action to hinder or prevent them through clear instructions. A clear division
p.000049: of responsibility is necessary to avoid problems, and preventive work to this end should be encouraged.
p.000049:
p.000049: What would you do in the following situation?
p.000049: An investigation reveals that a researcher has in many ways proven himself unsuitable to continue as research director
p.000049: and supervisor. Can he be removed from these positions?
p.000049: What do you do, if you have the possibility to influence the case? How do you justify your decision? Is there common
p.000049: practice or some rule you believe you can cite?
p.000049:
p.000049:
p.000049:
p.000049:
p.000049:
p.000049:
p.000049:
p.000049: GOOD RESEARCH PRACTICE
p.000050: 50
p.000050:
p.000050: References
p.000050: 1. Council for International Organizations of Medical Sciences (CIOMS). International ethical guidelines for
p.000050: biomedical research involving human subjects. Geneva, CIOMS, 2002.
p.000050: 2. Council of Europe. Convention for the Protection of Human Rights and Dignity of the Human Being with regard to
p.000050: the Application of Biology and Medicine: Convention on Human Rights and Biomedicine, (Oviedo Convention), European
p.000050: Treaty Series No 164, Strasbourg, 1997.
p.000050: 3. European Code of Conduct for Research Integrity Revised Edition. ALLEA, All European Academies, Berlin 2017
p.000050: 4. Directive 2001/20/EC of 4 April 2001, of the European Parliament and of the Council on the approximation of the
p.000050: laws, regulations and administrative provisions of the Member States relating to implementation of good clinical
p.000050: practice in the conduct of clinical trials on medicinal products for human use.
p.000050: 5. International Committee of Medical Journal Editors (ICMJE). Uniform Requirements for Manuscripts Submitted to
p.000050: Biomedical Journals, (Vancouver Rules), ICMJE, updated 2010.
p.000050: 6. Lag om etikprövning av forskning som avser människor (SFS 2003:460).
p.000050: 7. Läkemedelsverkets föreskrifter om kliniska läkemedelsprövningar på människor (LVFS 2011:19).
...
p.000056: version of the text. This means that he or she does not meet the authorship requirements and can thus, according to the
p.000056: rules, be left off the author list.
p.000056: Should the principle be that everyone who contributes to the research to any significant degree should also contribute
p.000056: to the writing? This is not a given, but it seems that in most cases the two aspects should go together. If a person is
p.000056: not allowed to be included on the author list due to personal conflict with the research director, this is of course
p.000056: not ethically acceptable. If, on the other hand, it is because his or her contribution is deemed to be too
p.000056: insignificant, and it is a case of one person’s word against the other’s, it is hard to come up with proof. This again
p.000056: highlights the importance of clear agreements about the conditions for authorship. Such agreements should not be
p.000056: jeopardised by personal conflict; if this happens, it is a violation of good research practice.
p.000056:
p.000056: What would you do in the following situation?
p.000056: Prior to a meeting of a PhD examining committee, one of the members discovers that three of the articles making up the
p.000056: thesis have a co-author who died three and a half years ago. The articles concerned were published this year, or have
p.000056: recently been submitted. In other words, the author in question had been dead for at least two years before the papers
p.000056: were completed. The data were collected around five years ago, however.
p.000056: Thus, the person concerned may have had a hand in planning the project and collecting the data, but hardly in their
p.000056: analysis and interpretation. Still less could this co-author have been in a position to influence the drafting of the
p.000056: articles, to have accepted the contents or the final versions of the articles.
p.000056: Is it right for the deceased researcher to be listed as a co-author? What arguments could be advanced for and against
p.000056: his inclusion? What course of action could have been chosen instead?
p.000056:
p.000056: 6.9 The responsible publisher and the editor
p.000056: The responsible publisher of a scholarly journal has a responsibility to ensure that existing rules in the area of
p.000056: research ethics and current legislation relating to research are followed. Leading international journals now insist on
p.000056: review of a project by an ethics committee or the equivalent as a condition for publishing the results. This is
p.000056: something that every scientific journal in a field involving research on humans or animal experimentation should
p.000056: require (see Chapter 3).
p.000056: The editor of a journal has the overall responsibility for its scientific quality. That means, among other things, that
p.000056: he or she should request clarifications of methods, results or interpretations, for example, if they seem unclear.
p.000056: Alongside the author, who obviously has the main responsibility, the editor is also responsible for making sure a
p.000056: published article provides accurate references to relevant earlier research, and that the choice of references is not
p.000056: improperly influenced by rivalry or a conflict of interest. The editor should also provide space in the journal for
p.000056: debate about published manuscripts.
p.000056: Researchers have found that it can be difficult to get negative results published. But what constitutes a negative
...
p.000057:
p.000057:
p.000057:
p.000057:
p.000057:
p.000057:
p.000057:
p.000057:
p.000057:
p.000057:
p.000057:
p.000057:
p.000057:
p.000057:
p.000057:
p.000057:
p.000057:
p.000057:
p.000057:
p.000057:
p.000057: GOOD RESEARCH PRACTICE
p.000058: 58
p.000058:
p.000058: 7 OTHER ROLES OF THE RESEARCHER
p.000058:
p.000058: The requirements on quality and integrity are also relevant to discuss in connection with tasks associated with the
p.000058: researcher role. This relates to the roles of supervisor, teacher, expert and reviewer.
p.000058:
p.000058: 7.1 The supervisor and postgraduate supervision
p.000058:
p.000058: 7.1.1 The tasks of the supervisor
p.000058: There are many ways of being a good supervisor. In general, someone who is appointed as a supervisor has a
p.000058: responsibility to create conditions that will help to develop the doctoral student’s knowledge and skills.
p.000058: Through discussions, teaching and their own example, good supervisors transfer knowledge, skills and experience to
p.000058: their doctoral students, and guide the research which they are undertaking.
p.000058: One important task is to work with the research student to define a suitable thesis project, and to draw up an
p.000058: individual plan of study consistent with the general guidelines laid down by the faculty and the department. The extent
p.000058: to which doctoral students are able to choose and shape their research topics can vary, however. In some research
p.000058: areas, research students will often be offered a place in an existing project group, where the problems to be
p.000058: investigated will already essentially have been formulated, whereas in other areas they will have more opportunity to
p.000058: influence their research tasks. It is therefore important for the supervisor to discuss the basic prerequisites for the
p.000058: research work with the doctoral student before a topic is chosen. Where more than one supervisor is appointed, the
p.000058: different supervisors’ functions and relationships to the research student should be clearly defined from the outset.
p.000058: In the supervision, the supervisor serves as a support, a contributor of ideas, a critic and a discussion partner.
p.000058: The supervisor is the person the doctoral student can test his or her ideas on, the person who provides encouragement,
p.000058: but also the person who reads with a critical eye the texts that the student produces. The supervisor has to give
p.000058: opinions on methodology issues, as well as on questions of interpretation and results, and thus acts as both adviser
p.000058: and critic. The role of constructive critic is both important and difficult. Criticism on a scientific point must not
p.000058: be withheld out of a misguided concern not to hurt feelings; the consequences for the doctoral student at a later stage
p.000058: could be devastating.
p.000058: Although supervisor and doctoral student often work very closely together and it is natural for them to see each other
p.000058: as friends, it is important that the professional relationship takes precedence. The supervisor has a responsibility to
p.000058: ensure that no circumstances arise that could jeopardise this relationship. If this happens, the supervisor may have to
p.000058: hand over the task to someone else.
p.000058:
...
Searching for indicator usage:
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p.000062: community that others are acting dishonestly, or bending the rules (de Vries et al. 2006, “Scientists’ Perceptions of
p.000062: organizational justice and self-reported misbehaviors”).
p.000062:
p.000062: What would you do in the following situation?
p.000062: A doctor carried out a study to establish whether high-dose chemotherapy followed by bone marrow transplantation could
p.000062: improve the survival rate of a certain group of patients with breast cancer. The results were questioned, however, and
p.000062: the doctor was unable to produce the patient records and source data to confirm them. Other researchers then tried to
p.000062: repeat the results, without success. It is one person’s word against another’s, but primary data that could clear the
p.000062: doctor’s name are not available.
p.000062: What should the next step be? Who should do what?
p.000062:
p.000062: 8.2 Questions of definition and scope
p.000062: What is research misconduct? It can be defined in several ways. In a narrow sense, it refers to obvious violations
p.000062: involving the theft of other people’s ideas and data, manipulation (or falsification) of data, and plagiarism of other
p.000062: people’s texts. In a wider sense, it also includes other forms of reprehensible behaviour, such as dishonesty towards
p.000062: funding bodies, exaggeration of one’s qualifications in applications, publication of
p.000062:
p.000062:
p.000062:
p.000062: GOOD RESEARCH PRACTICE
p.000063: 63
p.000063:
p.000063: the same study in multiple contexts, sexual harassment, defamation of colleagues, sabotage of colleagues’ work and so
p.000063: on.
p.000063: The choice between wide and narrow definitions is not only a matter of linguistic usage. It also has consequences, for
p.000063: example, when it comes to applying rules on sanctions for research misconduct. With a narrow definition, only certain
p.000063: phenomena can be acted on; with a wider one, others can as well. The requirements of due process suggest that we should
p.000063: concentrate on central, reasonably well-defined transgressions such as plagiarism, fraud (falsification, invented data)
p.000063: and manipulation of data, and deal with other forms of inappropriate behaviour in other contexts and under other
p.000063: headings.
p.000063: Another problem that is not always easy to handle is how to distinguish between intentional fraudulent behaviour on the
p.000063: one hand, and carelessness, rushed work and incompetence on the other. Research misconduct can be intentional
p.000063: behaviour, or as something that can also be perceived as being independent of the researcher’s intention, that is to
p.000063: say something that can be established without any need to speculate on whether the author intended to deceive.
p.000063: The definition of research misconduct used by the Swedish Research Council was formulated by Birgitta Forsman (2007),
p.000063: and uses the current terminology of the scientific community. It states that
p.000063:
p.000063: Research misconduct entails actions or omissions in research, which – consciously or through carelessness – lead to
p.000063: falsified or manipulated results or give misleading information about someone’s contribution to the research.
p.000063:
p.000063: This definition thus limits itself to the narrower concept of research misconduct, in which it directly concerns the
p.000063: scientific work. Sexual harassment, defamation of colleagues and the like are not included here, even though they are
...
Health / HIV/AIDS
Searching for indicator HIV:
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p.000031: because it benefits humans, and not infrequently also for the sake of animals themselves.
p.000031: The production of new medicines is highly dependent on animal experiments. A long line of medical advances that have
p.000031: saved many human lives were possible thanks to the use of animals. The law does not allow the testing of medicinal
p.000031: preparations on humans, and even less their being used in treatment, before they have been tested on animals or through
p.000031: another appropriate method to arrive at dependable research results.
p.000031: The EU’s definition of laboratory animals includes only those animals that are actually subjected to invasive
p.000031: procedures, at minimum a needle-prick. Based on this definition, the Swedish Board of Agriculture received reports that
p.000031: 258,403 laboratory animals had been used in Sweden in 2015. Sweden’s definition is considerably broader, however, and
p.000031: includes all animals used for scientific purposes. Based on the Swedish definition, the Board of Agriculture received
p.000031: reports that 16,373,330 laboratory animals were used in Sweden. The large difference is because Sweden includes the
p.000031: fish collected to evaluate or tag the fish population, which in 2015 amounted to 16,042,533 fish (the Swedish Board of
p.000031: Agriculture, Användningen av försöksdjur i Sverige under 2015, report Dnr: 5.2.17-5428/17).
p.000031: In recent years, a number of issues concerning laboratory animals have been raised in public debate, for instance the
p.000031: use of genetically modified animals as disease models. Also worth mention is the discussion of whether primates should
p.000031: be used in research on Hepatitis C and HIV, which only afflict humans and chimpanzees. Another debated issue is the
p.000031: EU’s REACH Regulation on the Registration, Evaluation, Authorisation and Restriction of Chemicals (ordinance EU
p.000031: 1907/2006). This has entailed increased requirements concerning the testing of chemicals on animals, with the aim of
p.000031: protecting human health and the environment.
p.000031:
p.000031:
p.000031:
p.000031:
p.000031: GOOD RESEARCH PRACTICE
p.000032: 32
p.000032:
p.000032: Regulations on animal experiments can also be found in the Animal Welfare Act (SFS 1988:534), which has undergone a
p.000032: number of changes since it was passed. 4
p.000032: An EU directive on the welfare of laboratory animals and the ethics review of research on animals was recently passed
p.000032: (2010/63EU)5, aimed at harmonising existing laboratory animal welfare protection and establishing common minimum and
p.000032: maximum levels within the EU. The establishment of a maximum level means that member countries cannot legislate
p.000032: stricter rules themselves in the future; however, a country is allowed to have stricter rules if they were already in
p.000032: place before the directive went into effect. Further information can be found on the Board of Agriculture’s website
p.000032: (jordbruksverket.se).
p.000032:
p.000032: 3.2.2 Laboratory animal ethics
p.000032: Work using laboratory animals raises a number of difficult ethical issues. Positions on these issues have a great deal
...
p.000034: those of a mouse, which in its turn has a shorter list of rights than a primate. The point of rights is thus not to
p.000034: argue that “pigs should have the right to vote”, but rather that animals’ physical and social needs should be met, to
p.000034: the degree they exist.
p.000034:
p.000034:
p.000034:
p.000034: GOOD RESEARCH PRACTICE
p.000035: 35
p.000035:
p.000035: A highly central issue in animal ethics concerns the fact that humans are traditionally regarded as something special –
p.000035: as having a special dignity and integrity – and therefore enjoy an elevated level of protection. It is unrealistic to
p.000035: believe that we can arrive at one single reason that is valid for everybody why humans hold this exceptional position.
p.000035: Perhaps the philosophers are right when they say it is impossible to justify it in any other way than to say that
p.000035: someone born by a human thereby has the right to a certain moral protection that is not extended to other living
p.000035: beings. If this is indeed the case, then we have just as great a responsibility to contemplate what we should do with
p.000035: this special position.
p.000035: Our rationality and knowledge allow us to exercise power over other animals. But with power comes responsibility –
p.000035: power over the animals’ situation and power over what issues we choose to research, for both the sake of the people who
p.000035: put their hopes in science and the sake of the animals whose lives are used to this end.
p.000035:
p.000035: What would you do in the following situation?
p.000035: Millions of people today have HIV and risk contracting AIDS if they do not receive effective inhibitor medications. A
p.000035: great deal of research is being conducted to find a cure for HIV/AIDS using chimpanzees which, besides humans, are the
p.000035: only animals that can get HIV/AIDS.
p.000035: You are a member of an ethics committee on animal experiments that is to ethically evaluate a research project aiming
p.000035: to test the effectiveness of a potential vaccine. The researchers inform the committee that the vaccine’s effect needs
p.000035: to be tested on advanced AIDS, which means that the chimpanzees will be in very poor health when the actual
p.000035: experimenting begins.
p.000035: What ethically significant aspects to you feel should be considered to ethically evaluate whether this experiment
p.000035: should be approved? Consider the issue from both a researcher’s and a layman’s evaluation perspective.
p.000035:
p.000035: 3.3 Genetically modified organisms
p.000035: Basic research and applied research with genetically modified organisms, i.e. organisms whose genetic material has been
p.000035: changed in a way that does not occur naturally through mating or the natural recombination of genes, is covered by a
p.000035: detailed system of regulations. Supervisory responsibilities are divided between several authorities, including the
p.000035: Swedish Work Environment Authority, the Swedish Board of Agriculture, the Swedish Board of Fisheries and the Swedish
p.000035: Medical Products Agency. The different authorities’ areas of responsibility, as well as the applicable regulations, can
p.000035: be found at the web portal of the Swedish Gene Technology Advisory Board, (genteknik.se).
p.000035: For research involving the enclosed use of genetically modified organisms, for example the growing of cultures in
p.000035: tightly shut containers or cultivation in a greenhouse, to be conducted it is necessary either for the responsible
...
Searching for indicator hiv/aids:
(return to top)
Health / Mentally Disabled
Searching for indicator mentally:
(return to top)
p.000072: such personal data handling may take place as is covered by one or several of the stated purposes, see Govt. Bill
p.000072: 2007/08:126 p. 228.
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072: GOOD RESEARCH PRACTICE
p.000073: 73
p.000073:
p.000073: 9.2.2 The Act concerning the Ethical Review of Research Involving Humans
p.000073: Since 1 January 2004, the Act concerning the Ethical Review of Research Involving Humans has been in force. It covers
p.000073: research involving living persons, but also research involving deceased persons and biological material from humans,
p.000073: and also research involving the handling of sensitive personal data. The purpose of the Act is to protect the
p.000073: individual person and ensure respect for human dignity in research.
p.000073: The Act (SFS 2003:460) concerning the Ethical Review of Research Involving Humans shall apply to research involving
p.000073: sensitive personal data under Section 13 of the Personal Data Act, or personal data on breaches of the law that
p.000073: includes statutory offences, judgements in criminal cases, criminal procedural coercive measures or administrative
p.000073: deprivation of liberty according to Section 21 of the Personal Data Act. The Act is also applicable to research that
p.000073: involves physical encroachment on a research subject, that is carried out using a method aimed at influencing the
p.000073: research subject physically or mentally, or that entails a clear risk of physical or mental harm to the research
p.000073: subject, that relates to studies of biological material taken from a living person that can be attributed to this
p.000073: person, that involves a physical encroachment on a deceased person, or relates to studies of biological material taken
p.000073: for medical purposes from a deceased person that can be attributed to this person.
p.000073: By means of the ethics review procedure, support can be created for personal data handling in research projects that
p.000073: are carried out without consent, but the Act gives no support for personal data handling carried out before the actual
p.000073: research process begins.
p.000073: The Act applies to all such research, regardless of in what institutional setting it is carried out, or how it is
p.000073: funded. The regional ethics review board’s review involves an examination of the project description to establish
p.000073: whether it involves any infringement of human rights or hard-to-capture concept of human dignity. An assessment is also
p.000073: made of the relationship between the value of the project and any burdens or risks which it might entail for the
p.000073: subjects of the research. Its value must be judged to outweigh the risks. Great importance is placed on an assessment
p.000073: of how the issue of informed consent has been handled. Regional ethics boards are also able to issue advisory
...
Searching for indicator disability:
(return to top)
p.000033: the purpose of the research, whether this can be achieved using another method than animal experimentation or with
p.000033: another type of animal, whether the animals will be subjected to greater suffering than is absolutely necessary,
p.000033: whether anaesthesia or painkillers will be required, and whether the experiment is an unnecessary repetition of an
p.000033: earlier one.
p.000033: A report on the ethics review of animal experiments (Etisk prövning av djurförsök, SOU 2002:86) contains a
p.000033: well/structured suggestion for discussion subjects that highlight which ethical aspects need to be stressed in
p.000033: connection with each application.
p.000033: A researcher who wishes to make a sound decision in the question of whether or not an animal experiment is justified
p.000033: must, just like the ethics committees on animal experiments, consider the purpose of the research by weighing the
p.000033: expected benefit of the experiment against the expected suffering of the animals. The fundamental principle in all
p.000033: research, weighing benefit against possible harm, was touched on earlier. Here, a number of factors determine the
p.000033: outcome.
p.000033: As regards benefit, the researcher should consider the importance of the knowledge gain or possible application, for
p.000033: society in general as well as for the research itself. He or she must think about whether, for example, it applies to a
p.000033: considerable number of people – each suffering relatively little – or if it is a matter of only a small number of
p.000033: people, who each suffer a great deal or have a disability that affects their everyday lives.
p.000033: The task of the committee is then to make its legally binding decision on the application and to ensure that only
p.000033: experiments that are relevant to the research and well-designed are conducted. Committee members representing the
p.000033: research community review the scientific stringency and methodical relevance of the application. The lay members’ task
p.000033: is to confirm the societal importance of the animal experimentation and to represent the general public’s observation
p.000033: and evaluation.
p.000033: The applicant must submit a complete application and describe the project in such a way that all committee members can
p.000033: understand and discuss it, based on the information it contains. As necessary, the committee may call the applicant to
p.000033: the meeting to provide clarification, or request an expert opinion. The committee may decide that a partial or pilot
p.000033: study should be conducted if a method must first be evaluated; the committee can also do this to reduce the number of
p.000033: animals used, before it has been determined to the best possible degree how the animals will feel or if their suffering
p.000033: is directly regarded as severe.
p.000033: To simplify the evaluation of the animals’ suffering and in the interest of achieving uniformity among the committees,
p.000033: a four-part categorisation has been introduced. Based on this, the applicant him or herself assesses whether the
p.000033: experiment in its entirety entails terminal, mild, moderate or severe suffering for the animal – this is the
p.000033: experiment’s so-called classification of severity. Here, both the researcher and committee may refer to the list of
...
Health / Motherhood/Family
Searching for indicator family:
(return to top)
p.000028: method development in this area.
p.000028: Issues concerning the commercialisation of research and the effects of research on the environment and society from a
p.000028: more global perspective have recently attracted growing interest; these issues are discussed earlier in this chapter as
p.000028: well as in Chapter 5. The background is not only globalisation and the increased international collaboration between
p.000028: research groups in different countries, but also the fact that large-scale research demands significant resources and
p.000028: public funding is not sufficient. Research groups are therefore becoming increasingly dependent on collaboration with
p.000028: and financial contributions from non-public funding bodies. This enables research that might otherwise not have been
p.000028: possible to be conducted, but also brings to the fore issues of control, dependency and the supervision of research.
p.000028: Human rights are universal. To the extent research ethics principles are based on and protect these rights, they can be
p.000028: accepted in various cultures. At the same time, they then have to be formulated with a certain amount of vagueness. For
p.000028: example, the requirement of informed consent can be interpreted and applied as a requirement of individual informed
p.000028: consent in liberal, western societies. But in cultures where the family, group, clan or village elder gives consent,
p.000028: this requirement must be interpreted slightly differently. Research ethics are thereby placed in a cultural and social
p.000028: context. Some values reflect technical and economic development, while others are slower to change and are based on
p.000028: more basic human needs.
p.000028:
p.000028: References
p.000028: 1. Chalmers, Alan F., Vad är vetenskap egentligen? Nora, Nya Doxa, 2003.
p.000028: 2. Föllesdal, Dagfinn & Wallöe, Lars & Elster, Jon, Argumentationsanalys, språk och vetenskapsfilosofi. Stockholm,
p.000028: Thales, 2001.
p.000028: 3. Gilje, Nils & Grimen, Harald, Samhällsvetenskapernas förutsättningar. Göteborg, Daidalos, 1993, tredje upplagan
p.000028: 2007.
p.000028: 4. Hermerén, Göran, Kunskapens pris: forskningsetiska problem och principer i humaniora och samhällsvetenskap.
p.000028: Stockholm, Swedish Science Press & HSFR, 1986, andra upplagan, 1996.
p.000028: 5. Hermerén, Göran,” Challenges in the Evaluation of Nanoscale Research: Ethical Aspects”. NanoEthics, 2007,
p.000028: 1:223–237.
p.000028: 6. Hermerén, Göran & Hug, Kristina (red). Translational Stem Cell Research: Issues Beyond the Debate on the Moral
p.000028: Status of the Human Embryo. New York, Springer, 2010.
p.000028: 7. Högskolelag (SFS 1992:1434).
p.000028: 8. Rydén, Lars (red), Etik för forskare. En antologi med utgångspunkt i arbetet med Uppsala- kodexen. Stockholm,
p.000028: UHÄ, 1990.
p.000028:
p.000028:
p.000028:
p.000028:
p.000028:
p.000028:
p.000028:
p.000028:
p.000028:
p.000028:
p.000028:
p.000028:
p.000028:
p.000028:
p.000028:
p.000028:
p.000028:
...
p.000070: Data Act. This means that the handling of personal data must be supported either by the Personal Data Act or by another
p.000070: law or ordinance that regulates the handling.
p.000070:
p.000070: 9.1.2 International regulations
p.000070: Sweden has undertaken to safeguard the respect of fundamental freedoms and rights in an international context,
p.000070: including the right to personal integrity in the handling of personal data. Below follows a brief description of some
p.000070: of the most important ones. The aim is to provide a background to the principles encompassed by the Swedish regulations
p.000070: within the area. Some of the central principles are that personal data may only be collected for one or several stated
p.000070: purposes, that they shall be fit for purpose, relevant, necessary for the purposes for which they are handled, and not
p.000070: be stored for longer than necessary.
p.000070:
p.000070:
p.000070:
p.000070:
p.000070:
p.000070:
p.000070:
p.000070: 7 Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural
p.000070: persons with regard to the processing of personal data and on the free movement of such data, and repealing Directive
p.000070: 95/46/EC (General Data Protection Regulation), EUT L 119, 4.5.2016, p. 1.
p.000070:
p.000070:
p.000070: GOOD RESEARCH PRACTICE
p.000071: 71
p.000071:
p.000071: 9.1.3 The UN’s Universal Declaration of Human Rights, etc.
p.000071: Article 12 of the United Nations’ Universal Declaration of Human Rights, etc. establishes that “No one shall be
p.000071: subjected to arbitrary interference with his privacy, family, home or correspondence, nor to attacks upon his honour
p.000071: and reputation. Everyone has the right to the protection of the law against such interference or attacks.” Article 29
p.000071: Item 2 further states that “In the exercise of his rights and freedoms, everyone shall be subject only to such
p.000071: limitations as are determined by law solely for the purpose of securing due recognition and respect for the rights and
p.000071: freedoms of others and of meeting the just requirements of morality, public order and the general welfare in a
p.000071: democratic society.”
p.000071: The Universal Declaration is not binding upon member states, but may be seen as an expression of common law rules
p.000071: within the area.
p.000071:
p.000071: 9.1.4 The European Convention on Human Rights
p.000071: The Convention for the Protection of Human Rights and Fundamental Freedoms of 4 November 1950 (“European Convention on
p.000071: Human Rights”) was incorporated into Swedish law on 1 January 1995, and has since then applied as law in Sweden.
p.000071: Article 8 of the European Convention on Human Rights states that “Everyone has the right to respect for his private and
p.000071: family life, his home and his correspondence”. It further states that “There shall be no interference by a public
p.000071: authority with the exercise of this right except such as is in accordance with the law and is necessary in a democratic
p.000071: society in the interests of national security, public safety or the economic well-being of the country, for the
p.000071: prevention of disorder or crime, for the protection of health or morals, or for the protection of the rights and
p.000071: freedoms of others”. The European Court of Human Rights was established to monitor that the obligations under the
p.000071: European Court of Human Rights are fulfilled.
p.000071:
p.000071: 9.1.5 The Council of Europe’s Data Protection Convention
p.000071: In 1981, the Committee of Ministers of the Council of Europe adopted the Convention for the Protection of Individuals
p.000071: with regard to Automatic Processing of Personal Data. The Convention came into force on 1 October 1985. All EU member
p.000071: states have ratified the Convention. The Convention is binding on the countries who have ratified it. The Convention is
p.000071: associated with a number of recommendations on how personal data should be handled in various areas. The
p.000071: recommendations are not directly binding.
p.000071: According to Article 1, the Convention aims “to secure in the territory of each Party for every individual, whatever
...
p.000071: simultaneously with a recommendation to the governments of the member countries to consider the Guidelines in national
p.000071: legislation. Sweden has adopted these recommendations, and by this means undertaken to follow the Guidelines. The
p.000071: Guidelines are minimum rules, which means that protection in the countries that have undertaken to follow the
p.000071: Guidelines may be made more comprehensive than the protection given by the Guidelines. The Guidelines include eight
p.000071: fundamental principles to protect personal integrity; for
p.000071:
p.000071:
p.000071: GOOD RESEARCH PRACTICE
p.000072: 72
p.000072:
p.000072: example, they state that personal data shall be collected for specific purposes, be relevant to the purpose for which
p.000072: they are intended, and shall be correct, complete and up-to-date.
p.000072:
p.000072: 9.1.7 The European Union’s Charter of Fundamental Rights
p.000072: The European Union’s Charter of Fundamental Rights was adopted at the meeting of the Council of Europe in Nice in 2000
p.000072: (the “EU Charter”). The EU Charter states the fundamental rights under six headings: Dignity, Freedoms, Equality,
p.000072: Solidarity, Citizens' Rights, and Justice.
p.000072: In terms of protection of personal integrity, it states that everyone has the right to physical and mental integrity
p.000072: (Article 3). Everyone has the right to respect for his or her private and family life, home and communications (Article
p.000072: 7), and to the protection of personal data concerning him or her (Article 8). Article 8 also states that personal data
p.000072: shall be processed fairly for specified purposes and on the basis of the consent of the person concerned or some other
p.000072: legitimate basis. The EU Charter is now legally binding through the Lisbon Treaty when EU institutions and EU member
p.000072: states apply the EU’s laws and regulations.
p.000072:
p.000072: 9.1.8 The Data Protection Directive
p.000072: On 24 October 1995, the EU adopted a Directive on the protection of natural persons with regard to the processing of
p.000072: personal data and on the free movement of such data, the Data Protection Directive. The provisions of the Data
p.000072: Protection Directive set the framework for what is possible to do in Sweden in terms of handling personal data. It is
p.000072: therefore not possible to create Swedish legal provisions that are not compatible with the Directive.
p.000072: The Data Protection Directive includes a number of fundamental requirements that must be fulfilled in the handling of
p.000072: personal data. These rules are largely represented in the Swedish Personal Data Act. As mentioned in Section 9.1, the
p.000072: Data Protection Directive will be replaced by a new EU Regulation on data protection.
p.000072:
...
Health / Physically Disabled
Searching for indicator physically:
(return to top)
p.000014: addresses certain specific situations and certain specific conditions.
p.000014: On 1 January 2004, the Act (SFS 2003:460) concerning the Ethical Review of Research Involving Humans came into force
p.000014: (riksdagen.se/sv/dokument-lagar/dokument/svensk-forfattningssamling/lag-2003460-om-
p.000014: etikprovning-av-forskning-som_sfs-2003-460). The purpose of the Act is to protect the individual person and ensure
p.000014: respect for human dignity in research, and it is limited to certain aspects of research; professional ethics are not
p.000014: addressed.
p.000014: This legislation has been complemented with the establishment of legal agencies – ethics review boards – which review
p.000014: research projects and decide whether they merit approval. The Act therefore also states (1) which projects must be
p.000014: board reviewed, (2) what parts of these projects are to be reviewed and what warrants approval, and (3) how the boards
p.000014: are to be composed.
p.000014: In both (1) and (2) it is important to note the difference between the law and morals. According to (1), only projects
p.000014: with a certain content are to be reviewed in concordance with the Act. However, a great deal of research falls outside
p.000014: this description; this cannot mean that all such research is ethically problem-free. It only means that the lawmaker,
p.000014: the Riksdag, has made a choice regarding what the boards should review. Research that does not use personally sensitive
p.000014: data (3 §) and does not entail physical encroachment, aim to affect subjects physically or psychologically, or entail
p.000014: an obvious risk of harming subjects (4 §) is not to be reviewed, according to the Act. But this does not mean that this
p.000014: research can be conducted without considering ethical aspects. The researcher should not simply perform this type of
p.000014: research without providing information and obtaining consent, or choose subjects arbitrarily. The subjects’ identities
p.000014: must not be revealed in the published work either.
p.000014: Research projects outside the scope described above may therefore be conducted without a legally based ethics review.
p.000014: However, the researcher must still observe the ethical criteria as cited in commonly used codes, as well as personally
p.000014: reflect on his or her project. The fact that the project does not fall under the law’s description does not provide an
p.000014: exemption from this.
p.000014: The first version of the Act came into effect in 2004, and it was revised in 2008, the most notable change being an
p.000014: increase in its scope. In the first version, a great deal of research – even though it could entail significant
p.000014: research ethics problems – was left outside the Act’s scope and was therefore not included in what was to be reviewed.
p.000014: Since the revision in 2008, which includes more project types, more projects now come under review, and society’s
p.000014: insight into the process has thereby increased. There are also laws with specific relevance to research, such as the
p.000014: Personal Data Act and the Archives Act. The most recent review of the Ethics Review Act was done in 2016.
...
p.000029: should be composed.
p.000029: It is the researcher (or the supervisor of a doctoral student project) who, together with the research principal 3
p.000029: applies for an ethics review, when the research falls within the scope of the law. Simply starting or completing a
p.000029: research project that falls within the scope of the law without approval from an ethics review board is a breach of
p.000029: law and is punishable.
p.000029: Ethics review carries a fee, which varies depending on the type of project (one or multiple principals) and the type of
p.000029: application (new project or supplementary application). For concrete information on how to apply and who should apply,
p.000029: etc., please see the Central Ethics Review Board’s website on epn.se or the CODEX website at codex.vr.se.
p.000029: A research project falls within the scope of the Act concerning the Ethical Review of Research Involving Humans because
p.000029: of its content. What is to be reviewed therefore has nothing to do with how the project is funded. Also, research that
p.000029: is not funded by external bodies, but is carried out within a position at an institution, shall therefore be reviewed
p.000029: if the content so requires.
p.000029: A research project shall be reviewed by an ethics review board if any of the following conditions exist.
p.000029: Namely, if the project (A)
p.000029:
p.000029: • entails physical encroachment on the research subject
p.000029: • will be conducted using a method aiming to affect the research subject physically or psychologically, or that
p.000029: carries an obvious risk of physical or psychological harm to the research subject
p.000029: • entails studies on biological material taken from a living human being and can be traced to this person
p.000029: • entails physical encroachment on a deceased human being
p.000029: • entails studies on biological material taken for medical purposes from a deceased human being and can be traced to
p.000029: this person. Act (SFS 2008:192).
p.000029:
p.000029: A research project shall also be reviewed if it (B)
p.000029:
p.000029: • entails the handling of sensitive personal data according to Section 13 of the Personal Data Act (SFS 1998:204),
p.000029: including information on race, ethnic origin, political views or religious conviction, or personal
p.000029:
p.000029:
p.000029:
p.000029:
p.000029: 3The research principal is the government authority or the physical or legal entity within whose organisation the
p.000029: research is conducted. A researcher employed at a university or a county council has the same as his or her research
p.000029: principal. The research principal, through its internal work or delegation order or through power of attorney,
p.000029: determines who is authorised to represent the research principal. The research principal always has ultimate
p.000029: responsibility for the research.
p.000029:
p.000029:
p.000029: GOOD RESEARCH PRACTICE
...
p.000030: of how the data has been collected and whether or not the researcher has obtained the participants’ consent.
p.000030: When an ethics review board evaluates a project, it has a number of aspects to note and consider. Generally, the
p.000030: research in question can be approved only if it can be conducted with respect for human dignity. In the review, the
p.000030: board should also evaluate how the human rights and basic freedoms of those involved are treated in relation to the
p.000030: value of the research. The welfare of human beings should be placed before the needs of society and science, and the
p.000030: knowledge value of the research must be assessed as outweighing the risks. The research cannot be approved if the
p.000030: expected results can be reached in another way that presents fewer risks, for instance using other categories of
p.000030: research subjects, or an alternative study design.
p.000030: For the board to be able to approve certain types of research, informed consent must have been obtained from the
p.000030: participants (research subjects, stakeholders). The law also briefly describes how this consent should be constituted,
p.000030: and from whom and how it may be obtained.
p.000030: The law requires informed consent in the first three types of projects in (A) above; that is, research entailing
p.000030: physical encroachment on the research subject, using a method aiming to affect the research subject physically or
p.000030: psychologically, or carrying an obvious risk of harm to the research subject. This research thus cannot be approved if
p.000030: those involved in the project have not been given sufficient information and been allowed to properly give their
p.000030: consent.
p.000030: For research projects falling under (B) above, which only involve the handling of sensitive personal data, the
p.000030: stipulations in the Personal Data Act on information and consent apply: normally, informed consent is required. An
p.000030: exception is allowed, however: it is not necessary to inform research subjects if it is impossible, or if it would mean
p.000030: an unreasonably great work effort. The possibility to conduct research without obtaining informed consent is thus not
p.000030: excluded. Each individual case is reviewed and decided on by an ethics review board.
p.000030: Research projects that fall outside the scope of the Act concerning the Ethical Review of Research Involving Humans can
p.000030: thus not be approved by an ethics review board. In many cases, however, some form of ethics review is desired for these
p.000030: types of projects. This can be in connection with applying for support from national or international research funding
...
p.000072: such personal data handling may take place as is covered by one or several of the stated purposes, see Govt. Bill
p.000072: 2007/08:126 p. 228.
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072: GOOD RESEARCH PRACTICE
p.000073: 73
p.000073:
p.000073: 9.2.2 The Act concerning the Ethical Review of Research Involving Humans
p.000073: Since 1 January 2004, the Act concerning the Ethical Review of Research Involving Humans has been in force. It covers
p.000073: research involving living persons, but also research involving deceased persons and biological material from humans,
p.000073: and also research involving the handling of sensitive personal data. The purpose of the Act is to protect the
p.000073: individual person and ensure respect for human dignity in research.
p.000073: The Act (SFS 2003:460) concerning the Ethical Review of Research Involving Humans shall apply to research involving
p.000073: sensitive personal data under Section 13 of the Personal Data Act, or personal data on breaches of the law that
p.000073: includes statutory offences, judgements in criminal cases, criminal procedural coercive measures or administrative
p.000073: deprivation of liberty according to Section 21 of the Personal Data Act. The Act is also applicable to research that
p.000073: involves physical encroachment on a research subject, that is carried out using a method aimed at influencing the
p.000073: research subject physically or mentally, or that entails a clear risk of physical or mental harm to the research
p.000073: subject, that relates to studies of biological material taken from a living person that can be attributed to this
p.000073: person, that involves a physical encroachment on a deceased person, or relates to studies of biological material taken
p.000073: for medical purposes from a deceased person that can be attributed to this person.
p.000073: By means of the ethics review procedure, support can be created for personal data handling in research projects that
p.000073: are carried out without consent, but the Act gives no support for personal data handling carried out before the actual
p.000073: research process begins.
p.000073: The Act applies to all such research, regardless of in what institutional setting it is carried out, or how it is
p.000073: funded. The regional ethics review board’s review involves an examination of the project description to establish
p.000073: whether it involves any infringement of human rights or hard-to-capture concept of human dignity. An assessment is also
p.000073: made of the relationship between the value of the project and any burdens or risks which it might entail for the
p.000073: subjects of the research. Its value must be judged to outweigh the risks. Great importance is placed on an assessment
p.000073: of how the issue of informed consent has been handled. Regional ethics boards are also able to issue advisory
...
Health / Terminally Ill
Searching for indicator terminal:
(return to top)
p.000033: considerable number of people – each suffering relatively little – or if it is a matter of only a small number of
p.000033: people, who each suffer a great deal or have a disability that affects their everyday lives.
p.000033: The task of the committee is then to make its legally binding decision on the application and to ensure that only
p.000033: experiments that are relevant to the research and well-designed are conducted. Committee members representing the
p.000033: research community review the scientific stringency and methodical relevance of the application. The lay members’ task
p.000033: is to confirm the societal importance of the animal experimentation and to represent the general public’s observation
p.000033: and evaluation.
p.000033: The applicant must submit a complete application and describe the project in such a way that all committee members can
p.000033: understand and discuss it, based on the information it contains. As necessary, the committee may call the applicant to
p.000033: the meeting to provide clarification, or request an expert opinion. The committee may decide that a partial or pilot
p.000033: study should be conducted if a method must first be evaluated; the committee can also do this to reduce the number of
p.000033: animals used, before it has been determined to the best possible degree how the animals will feel or if their suffering
p.000033: is directly regarded as severe.
p.000033: To simplify the evaluation of the animals’ suffering and in the interest of achieving uniformity among the committees,
p.000033: a four-part categorisation has been introduced. Based on this, the applicant him or herself assesses whether the
p.000033: experiment in its entirety entails terminal, mild, moderate or severe suffering for the animal – this is the
p.000033: experiment’s so-called classification of severity. Here, both the researcher and committee may refer to the list of
p.000033: experiments according to degree of severity in the Board of Agriculture’s instructions. The committee must determine
p.000033: whether the applicant has made a reasonable evaluation and, when necessary, correct the information.
p.000033:
p.000033: 3.2.5 Alternatives to using laboratory animals
p.000033: Many researchers try to find animal-free methods that allow them to reach results that are equally dependable. There
p.000033: are several reasons for this. Reasons can include the researcher not wanting to inflict suffering on
p.000033:
p.000033:
p.000033: GOOD RESEARCH PRACTICE
p.000034: 34
p.000034:
p.000034: animals, or the fact that it is relatively costly to keep animals. A third reason, which is being discussed
p.000034: increasingly, is the uncertainty of how transferable results from medical experiments are; that is, how relevant
p.000034: results from experiments using animals are in the medical treatment of humans.
p.000034: For example, comparisons between treatment effects on animals and clinical trials using humans might show poor
p.000034: correspondence. This indicates both that animal experiments and clinical trials may need to be better coordinated, and
p.000034: also that animal experiments do not always provide meaningful information for the treatment of humans. An example of
p.000034: the latter instance is studies aimed at developing methods for treating rheumatoid arthritis by studying patients’
p.000034: tissue samples. Here we can see two of the reasons for not using animals: arthritis is a painful disease even for the
...
Health / stem cells
Searching for indicator stem cells:
(return to top)
p.000048: the case of views on one’s personal moral responsibility. Important documents in this context
p.000048:
p.000048:
p.000048: GOOD RESEARCH PRACTICE
p.000049: 49
p.000049:
p.000049: are the Declaration of Helsinki, as well as the research ethical guidelines the ICH (International Conference on
p.000049: Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Beings) and CIOMS (Council for
p.000049: International Organizations of Medical Sciences) have adopted.
p.000049:
p.000049: 5.6.4 The extent of responsibility
p.000049: In a research project, a distinction can be made between a number of stages, such as planning the research and
p.000049: conducting the project – which includes collecting, interpreting and analysing data – as well as testing or generating
p.000049: hypotheses, publishing the research results and applying them. Collecting and analysing data is different from drawing
p.000049: conclusions based on them, writing a research report or publishing the report.
p.000049: The coordinating research director has a comprehensive responsibility that covers all these aspects. During the
p.000049: planning phase, this responsibility is obvious. If a research group claims to have equipment or competence it later
p.000049: turns out to lack, it can be reproached both legally and morally. But the coordinating research director is responsible
p.000049: for choosing the research group and ensuring that its members have understood what is required of them. He or she can
p.000049: therefore also not escape reproach (at least morally, and perhaps even legally), if crucial information turns out to be
p.000049: wrong.
p.000049: For projects that entail research on human embryonic stem cells, for example, the EU requires that information be
p.000049: provided on where the stem cell lines come from, when they were created, etc. It is not reasonable to require that
p.000049: these details or similar information be verified by the coordinating research director; in principle, one must be able
p.000049: to assume that the information provided is correct. However, it can be reasonable to require research directors to
p.000049: choose to work with researchers they know they can depend on – who they have good reason to believe are trustworthy.
p.000049: The coordinating research director is also responsible for organising meetings with the various research groups within
p.000049: the project on a regular basis, and for ensuring that the groups’ work is reported at these meetings, as well as
p.000049: providing the opportunity to discuss how data and results have been obtained, as well as how reliable they are.
p.000049: Alternative interpretations of conclusions and other questions of fact and method should also be addressed in such
p.000049: discussions.
p.000049: The same applies to the all-important publishing phase. There are a number of international guidelines to follow here,
p.000049: for example the Vancouver rules, the Uniform Requirements, which are discussed in other parts of this book. The
p.000049: coordinating research director has to ensure that there is agreement on which rules to follow, that they are made known
p.000049: to the research groups working on the project, and that any necessary agreements are established – to prevent future
p.000049: conflict and problems within and between research groups.
p.000049: If the responsibility for certain issues within a project is delegated, the division of responsibility must be clear,
p.000049: and everyone affected by it needs to understand what they are responsible for. However, such a delegation does not
...
Health / visual impairment
Searching for indicator blind:
(return to top)
p.000059: should go without saying that the analysis in any assessment should be well founded.
p.000059:
p.000059:
p.000059:
p.000059:
p.000059: GOOD RESEARCH PRACTICE
p.000060: 60
p.000060:
p.000060: 7.4 Reviewing manuscripts for publication
p.000060: Another situation where ethics may be tested is when a researcher reviews an article or a larger manuscript submitted
p.000060: to a journal or publishers for publication. It is very common in the academic world for a researcher’s work to be
p.000060: assessed by his or her colleagues. Since such assessments presuppose expert knowledge in the field concerned, there are
p.000060: few alternatives to this system, which is generally referred to as “peer review”. Thus, clear rules to counteract
p.000060: various types of conflict of interest are crucial.
p.000060: One reason the system has been challenged is a number of flagrant cases of peer reviewers abusing the trust which being
p.000060: given access to a colleague’s work to assess it entails. Such abuses have included reviewers stealing ideas from
p.000060: submitted manuscripts (this is addressed in Chapter 8), “sitting on” manuscripts for a long time to enable researchers
p.000060: in their own groups to publish their results first, or trying without just cause to prevent the publication of
p.000060: colleagues’ work.
p.000060: Often, the journal reviewers know the identity of the authors, while the authors do not know the identity of the
p.000060: reviewers. Temptations to abuse the system in conjunction with such tasks could be reduced if the system was either
p.000060: entirely open, or else double-blind.
p.000060: Another important reason why the peer review system has been questioned is that the volume of manuscripts submitted to
p.000060: journals is now so great that it can be difficult to find willing and competent reviewers. There is good reason to
p.000060: consider awarding greater merit than is given today for the arduous work of reviewing texts (not only when it comes to
p.000060: journal publication, but also in advisory groups and in the case of thesis defence and the awarding of positions).
p.000060: For the system of peer review to continue working, as referred to above, at least three criteria must be met: reviewers
p.000060: must submit their reports as quickly as possible, they must not use information in the manuscript for their own
p.000060: purposes without referring to the source – and if they do wish to use it, they must first contact the author and ask
p.000060: whether he or she has any objection – and they must be guided only by objective reasons in deciding whether or not to
p.000060: recommend publication.
p.000060: The system of peer review is used also in other contexts, such as when awarding positions and allocating grants.
p.000060:
p.000060: What would you do in the following situation?
p.000060: You are reviewing an article and discover that the authors have made a major issue of a discovery that you yourself
p.000060: made 20 years ago, but never wrote clearly about at the time – only a parenthesis buried in a long article. Now they
p.000060: are claiming credit for the discovery. However, you currently have an article of your own at the proof stage, and are
p.000060: now considering adding a section about your old discovery to underline your ownership of it.
p.000060: Would it be right to do so?
p.000060:
p.000060: 7.5 Committee work
p.000060: Researchers may also be appointed to serve on various committees or boards. It is perhaps appropriate to distinguish
...
Social / Access to Social Goods
Searching for indicator access:
(return to top)
p.000035: 35
p.000035: 3.3 Genetically modified organisms
p.000036: 36
p.000036: 3.4 Examples of problems that are still unsolved
p.000036: 36
p.000036: References
p.000037: 37
p.000037: 4 HANDLING OF RESEARCH MATERIAL - THINK FIRST
p.000039: 39
p.000039: 4.1 Background and problems
p.000039: 39
p.000039: 4.2 Interest considerations and various types of research
p.000039: 39
p.000039: 4.3 Four concepts
p.000040: 40
p.000040: 4.4 What can researchers promise?
p.000040: 40
p.000040: 4.4.1 Secrecy
p.000040: 40
p.000040: 4.4.2 Professional secrecy
p.000041: 41
p.000041: 4.4.3 Anonymity
p.000041: 41
p.000041: 4.4.4 Confidentiality
p.000041: 41
p.000041: 4.4.5 Conclusions
p.000041: 41
p.000041: 4.5 Documentation
p.000042: 42
p.000042: References
p.000043: 43
p.000043: 5 RESEARCH COLLABORATION
p.000044: 44
p.000044: 5.1 Introduction
p.000044: 44
p.000044: 5.2 Relations with fellow researchers
p.000044: 44
p.000044: 5.3 Interaction with funding and commissioning bodies
p.000045: 45
p.000045: 5.4 Commercial aspects
p.000046: 46
p.000046: 5.5 Responsibility for a collaborative project: general
p.000047: 47
p.000047: 5.6 Issues of responsibility in multinational research projects
p.000047: 47
p.000047: 5.6.1 Starting points
p.000047: 47
p.000047: 5.6.2 Conditions of responsibility
p.000048: 48
p.000048: 5.6.3 Moral and legal responsibility
p.000049: 49
p.000049: 5.6.4 The extent of responsibility
p.000050: 50
p.000050: References
p.000051: 51
p.000051: 6 PUBLISHING RESEARCH RESULTS
p.000052: 52
p.000052: 6.1 Why publish?
p.000052: 52
p.000052: 6.2 Disclosure of financial and scientific dependence
p.000052: 52
p.000052: 6.3 Background, materials and conclusions
p.000052: 52
p.000052: 6.4 The third task and the media
p.000053: 53
p.000053: 6.5 Open access
p.000054: 54
p.000054: 6.6 Publication as a measure of worth
p.000055: 55
p.000055: 6.7 The author
p.000055: 55
p.000055: 6.8 Multiple authors – responsibility – publication rules
p.000056: 56
p.000056: 6.9 The responsible publisher and the editor
p.000057: 57
p.000057: GOOD RESEARCH PRACTICE
p.000004: 4
p.000004:
p.000004: References
p.000058: 58
p.000058: 7 OTHER ROLES OF THE RESEARCHER
p.000059: 59
p.000059: 7.1 The supervisor and postgraduate supervision
p.000059: 59
p.000059: 7.1.1 The tasks of the supervisor
p.000059: 59
p.000059: 7.1.2 Whose ideas?
p.000059: 59
p.000059: 7.1.3 The thesis and its presentation
p.000059: 59
p.000059: 7.1.4 Responsibility for ethical and legal compliance
p.000060: 60
p.000060: 7.2 The teacher
p.000060: 60
p.000060: 7.3 Assessing applications and proposals
p.000060: 60
p.000060: 7.4 Reviewing manuscripts for publication
p.000061: 61
p.000061: 7.5 Committee work
p.000061: 61
p.000061: References
p.000062: 62
p.000062: 8 RESEARCH MISCONDUCT
p.000063: 63
p.000063: 8.1 Introduction
p.000063: 63
p.000063: 8.2 Questions of definition and scope
p.000063: 63
p.000063: 8.3 Fabrication and falsification
p.000064: 64
p.000064: 8.4 Plagiarism
p.000065: 65
p.000065: 8.5 Unpublished material and self-plagiarism
p.000066: 66
p.000066: 8.6 Establishing plagiarism
p.000066: 66
p.000066: 8.7 Prevention
p.000067: 67
p.000067: 8.8 Sanctions for misconduct
p.000068: 68
p.000068: 8.9 Addressing issues of misconduct
p.000068: 68
p.000068: 8.10 A broader perspective
p.000069: 69
p.000069: References
p.000070: 70
p.000070: 9. KEY LEGISLATION AND OTHER REGULATIONS WITH WHICH RESEARCHERS SHOULD BE FAMILIAR
p.000071: 71
p.000071: 9.1 Personal data handling
p.000071: 71
p.000071: 9.1.1 Legal support for personal data handling
p.000071: 71
p.000071: 9.1.2 International regulations
p.000071: 71
...
p.000022: Crete, he guessed that these words might be Cretan place names. This allowed him, in 1951, to decipher Europe’s first
p.000022: written language.
p.000022:
p.000022: 2.2.2 Research funding and collaboration
p.000022: All research requires resources: time, place and equipment. Funding can be obtained through a position a researcher
p.000022: holds at a company, in which the research aspect is part of his or her duties. In such cases it can be the employer who
p.000022: formulates the research question. Research can also be conducted as an assignment the researcher has received, in
p.000022: competition with others or not. Finally, funding can also be obtained through grants from a funding body in the
p.000022: governmental or private sphere, or some other party.
p.000022: You could say that there are two types of funders: those who do not have a direct interest in the results and those who
p.000022: do. The first group includes the government in the form of various foundations or research councils, as well as
p.000022: research foundations, based on collections and private donations with a specific focus, for instance the Swedish Cancer
p.000022: Society and the Heart-Lung Foundation. The second group includes commercial, non- profit and public actors who need
p.000022: research to develop their activities and, in some cases, to earn money.
p.000022: External funding creates opportunities for research that otherwise might not have been conducted, but the ties and
p.000022: control it can entail are not without risk. This is illustrated in the many conflicts over publishing, access to data
p.000022: and the interpretation of results that are often debated in the media.
p.000022:
p.000022: What would you do in the following situation?
p.000022: You are researching the effectiveness of different toothpastes in a study commissioned by one of the larger
p.000022: manufacturers in this field. You design a comparative study in which the qualities and effects of different toothpastes
p.000022: from a number of aspects are compared.
p.000022: However, the results are not what the funding body had hoped for and they want to stop publication or at least divide
p.000022: the report into multiple studies, which would make it difficult or even impossible to draw any conclusions. When you
p.000022: object to this they threaten to revoke their grants for a number of projects on which your doctoral students are
p.000022: dependent.
p.000022: Do you go along with the funding body’s demand in order to save your students’ funding? Do you try to negotiate a
p.000022: compromise? Or...?
p.000022:
p.000022: Funding bodies, no matter who they are, want to see results. Everyone wants to be sure that a research project is good
p.000022: enough to lead to new knowledge. Around the world public or open funders use reviewers to this end, in a process called
p.000022: peer review. Reviewers often work using templates containing clearly formulated criteria. The review always entails an
p.000022: evaluation of the scientific quality, often of the originality of the research question and sometimes also of how
p.000022: significant the question is from a specific, given perspective. This allows funding to be routed towards researchers
p.000022: who are judged to have the best design as well as the best ability to conduct their projects, but sometimes also to
p.000022: certain areas the funding body considers important.
p.000022:
p.000022:
p.000022:
...
p.000026: Thereafter, once the informant has had the opportunity to watch the video, he or she shall have the opportunity to give
p.000026: consent to the researcher to continue with the work of analysing it. Consent may also be given to show the video to
p.000026: persons named in advance, such as researchers, students, patient association, or similar.
p.000026: The informant shall confirm that he or she has received information that the consent to the researcher analysing, using
p.000026: and showing the video may be recalled at any time. The research records and the information to the informant shall
p.000026: state whether the video material will be destroyed or not, in the event the informant recalls his or her consent. If it
p.000026: states that the material shall be destroyed in the event consent is recalled, this shall be done, or else the video
p.000026: recording given to the informant, provide he or she is the sole person shown in the recording. If several persons
p.000026: appear in the video recording, the identity of the person who has recalled the consent shall be edited out, if
p.000026: possible.
p.000026: A video recording shall be stored in a secure manner, so that it is out of reach of unauthorised persons, and so that
p.000026: it is not destroyed through negligence. The researcher must ensure that only authorised persons can get
p.000026:
p.000026:
p.000026: GOOD RESEARCH PRACTICE
p.000027: 27
p.000027:
p.000027: access to the video recording. If it is a case of sensitive personal data, more comprehensive and considered protective
p.000027: measures are needed.
p.000027:
p.000027: 2.3.4 Sources of error and reliability
p.000027: When a scientific study starts to produce results, you are faced with the challenging task of evaluating their
p.000027: reliability. This is an integral part of the study, and an important aspect of the quality of the research. For
p.000027: example, a recent investigation of suspected research misconduct brought to the fore how important it is that the
p.000027: decision of how to represent decimals is well considered and clarified. A common, and tempting, mistake is to
p.000027: overestimate the significance of the results you have arrived at, and exaggerating their bearing power far beyond the
p.000027: area in which they have found to apply.
p.000027: Within most research traditions a careful error analysis is required, or at least a discussion of possible error
p.000027: sources and other conditions that might affect the soundness of the results. The challenge is to make realistic
p.000027: evaluations. It is ethically problematic, and damaging to research as such, if a researcher knowingly suppresses
p.000027: indications of significant sources of error. It could be a case of withholding certain data to be able to get an
p.000027: article published, or taking a chance that the results will hold in order to be the first to report a new discovery. At
p.000027: the same time, one also should not refrain from publishing results due to exaggerated caution. The most important thing
p.000027: is to be clear, critical and honest in evaluating sources of error.
p.000027: The evaluation of error sources is often limited by the research tradition and method a researcher is working within.
...
p.000030: issued with support of the Act.
p.000030:
p.000030:
p.000030:
p.000030: GOOD RESEARCH PRACTICE
p.000031: 31
p.000031:
p.000031: 3.1.2 Other approval
p.000031: Besides approval from an ethics review board, other approval can also be required for research involving humans.
p.000031: In clinical trials, except so-called non-intervention studies, it is a requirement that approval is obtained from the
p.000031: Swedish Medical Products Agency (see Chapter 7 Section 9 of the Medicinal Products Act SFS 2015:315). This also applies
p.000031: to trials of a drug for an approved indication, at an approved dosage and with an approved method of administration
p.000031: with the aim of further showing effect and/or safety. The Agency has issued detailed rules for how clinical trials of
p.000031: drugs for humans shall be conducted. Applications to the Swedish Medical Products Agency shall be made by the sponsor,
p.000031: i.e. the individual, company, institution or organisation that assumes responsibility for starting, organising and/or
p.000031: funding the clinical trial. More information on regulations and the steps of the application process can be found on
p.000031: the Agency’s website (www.lakemedelsverket.se.).
p.000031: Applications for clinical trials within the EU are registered in the database Eudra CT (European Clinical Trials
p.000031: Database). Currently, this database is only accessible to national medical products agencies, for instance the Swedish
p.000031: Medical Products Agency, the European Medicines Agency (EMA), and the Commission. As a step towards increasing the
p.000031: transparency within the EU, access to certain parts of the database’s content will soon be given to the general public
p.000031: via the website www.clinicaltrialsregister.eu. On this website, information on issues such as ethics committee
p.000031: decisions regarding clinical trials on children will be publicly accessible. In the US, the corresponding database is
p.000031: ClinicalTrials.gov.
p.000031: To conduct a research project involving the irradiation of research subjects with ionising radiation, the project must
p.000031: be approved by a local radiation protection committee. (See 22 § of the Swedish Radiation Safety Authority’s rules
p.000031: regarding general obligations in medical and odontological activities involving ionising radiation, SSMFS 2008:35). For
p.000031: multicentre studies, an application must be sent to all local radiation protection committees within the study’s scope.
p.000031:
p.000031: 3.2 Research on animals and laboratory animal ethics
p.000031:
p.000031: 3.2.1 The use of laboratory animals
p.000031: Laboratory animal ethics deals with the ethical issues that arise when animals are used in scientific experiments. In
p.000031: society, it is a common perception that animal experiments are needed for development and research within both human
p.000031: and veterinary medicine. Research using animals is thus conducted partly because it provides new knowledge, partly
p.000031: because it benefits humans, and not infrequently also for the sake of animals themselves.
...
p.000034: ethical evaluation. The following concepts (in italics) may help in highlighting important questions to ask when
p.000034: evaluating what is ethically defensible.
p.000034: A fundamental element to consider is who or what has moral relevance, that is who or what should be considered in the
p.000034: ethical deliberation. A distinction must be made between whether something or someone has moral relevance in itself –
p.000034: intrinsic value – or is relevant for the sake of someone or something else – instrumental value. Intrinsic value is
p.000034: often not measured in degrees, but is instead regarded as either existing in an individual (or a material entity), or
p.000034: not. On the other hand, the instrumental value of an individual or a material entity is possible to measure. Its value
p.000034: can differ, depending on the user or beholder.
p.000034: It is not unusual either for an individual to be considered as having both intrinsic and instrumental value. For
p.000034: example, a genetically modified mouse of a certain lineage can be a highly valuable instrument within a certain
p.000034: research project and at the same time be regarded as having intrinsic value, for instance because it is an experiencing
p.000034: individual, able to feel pain. A sibling mouse that does not express the desired genetic modification has a low
p.000034: instrumental value, but the same intrinsic value.
p.000034: Animal ethicists who argue that animals have rights usually base this on the idea that animals have intrinsic value.
p.000034: Individuals who have intrinsic value also have certain fundamental rights, such as those to food, water, a place for
p.000034: rest, protection from the elements and access to social contact.
p.000034: This reasoning does not necessarily lead to the conclusion that animals and people have the same rights, however.
p.000034: Perceptions of what rights animals are considered to have, and how far-reaching they are, differ among animal
p.000034: ethicists, but are often tied to the capacities of the species in question. A shrimp’s rights are less extensive than
p.000034: those of a mouse, which in its turn has a shorter list of rights than a primate. The point of rights is thus not to
p.000034: argue that “pigs should have the right to vote”, but rather that animals’ physical and social needs should be met, to
p.000034: the degree they exist.
p.000034:
p.000034:
p.000034:
p.000034: GOOD RESEARCH PRACTICE
p.000035: 35
p.000035:
p.000035: A highly central issue in animal ethics concerns the fact that humans are traditionally regarded as something special –
p.000035: as having a special dignity and integrity – and therefore enjoy an elevated level of protection. It is unrealistic to
p.000035: believe that we can arrive at one single reason that is valid for everybody why humans hold this exceptional position.
p.000035: Perhaps the philosophers are right when they say it is impossible to justify it in any other way than to say that
p.000035: someone born by a human thereby has the right to a certain moral protection that is not extended to other living
p.000035: beings. If this is indeed the case, then we have just as great a responsibility to contemplate what we should do with
p.000035: this special position.
p.000035: Our rationality and knowledge allow us to exercise power over other animals. But with power comes responsibility –
...
p.000037: Experiments and Clinical Trials: Systemic Review”. British Medical Journal, 2007, 334 (7586):197.
p.000037: 23. Personuppgiftslag (SFS 1998:204).
p.000037: 24. Personuppgiftsförordning (SFS 1998:1191).
p.000037: 25. Rodman, John, ”The Dolphin Papers”, The North American Review, spring 1974, 259:13-26 (page 18).
p.000037: 26. Statens Jordbruksverks författningssamling (SJVFS 2008:70).
p.000037: 27. Strålsäkerhetsmyndighetens föreskrifter om allmänna skyldigheter vid medicinsk och odontologisk verksamhet med
p.000037: joniserande strålning (SSMFS 2008:35).
p.000037: 28. World Medical Association. Declaration of Helsinki. Ethical Principles for Medical Research Involving Human
p.000037: Subjects, adopted by the 18th WMA General Assembly, Helsinki, Finland, June 1964, latest revision by the WMA General
p.000037: Assembly, Seoul 2013. Ferney-Voltaire, France, World Medical Association, 2013.
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037: GOOD RESEARCH PRACTICE
p.000038: 38
p.000038:
p.000038: 4 HANDLING OF RESEARCH MATERIAL
p.000038: - THINK FIRST
p.000038:
p.000038: This chapter, with the exception of Section 4.5, is the translation of a text that is virtually identical to that of
p.000038: Göran Hermerén’s article, “Hantering av integritetskänsligt material”.
p.000038:
p.000038: 4.1 Background and problems
p.000038: The fundamental openness in all public organisations is required by law and established constitutionally. Universities
p.000038: and individual researchers can therefore not take it upon themselves to weigh the interest of public access against
p.000038: other interests.
p.000038: The Declaration of Helsinki, adopted by the World Medical Association, is an important document for medical research
p.000038: ethics. The ethical principles stated in the Declaration are in part also applicable to other research, not least
p.000038: certain social medicine and social science research. This document has been updated a number of times, most recently in
p.000038: October 2013.
p.000038: However, the Declaration of Helsinki is not legally binding. This was reiterated by the Swedish Court of Appeal for
p.000038: Western Sweden in a case a number of years ago that received a great deal of attention; A view that was upheld by the
p.000038: European Court of Justice in 2010. The issue concerned a request that a researcher in Göteborg make public the research
p.000038: material from a controversial study on children with neuropsychiatric disabilities.
p.000038: Swedish law carries more weight than this international declaration in cases when they come into conflict.
p.000038: These issues have received attention in medical research, for instance in the debate and trials that have followed in
p.000038: the wake of the Göteborg case. But the issues have a more general and fundamental side as well, as they also arise in
p.000038: many other scientific areas, such as the humanities (integrity-sensitive information on famous politicians and authors)
p.000038: and social sciences (integrity-sensitive information on individuals and groups that may be revealed in studies).
p.000038: In these cases, the requirements for public access, openness and transparency sometimes come into conflict with the
p.000038: requirement to protect the integrity of research subjects and informants. These issues also carry a danger that current
p.000038: regulation systems increase the risk that studies will be performed outside the healthcare arena, where there is less
p.000038: transparency. It is thus important to have a general discussion on ethical issues in the handling of
p.000038: integrity-sensitive material. Awareness of both the rules and the problems needs to increase within the research
p.000038: community.
p.000038:
p.000038: 4.2 Interest considerations and various types of research
p.000038: In research, this means finding a reasonable way of weighing up many types of interests which are all legitimate, but
p.000038: which in some situations can conflict with each other: the researcher’s interest in obtaining new knowledge, the
p.000038: interest of participants and those affected by the research to have their integrity and private lives protected, and
p.000038: patients’ interest in information they have given their doctor remaining only between them.
p.000038: Funding bodies for basic research, such as the Swedish Research Council, have an interest in openness and transparency.
p.000038: Other funding bodies may have an interest, from a societal perspective, in material being reused or used by many groups
p.000038: – an important task in this case is to specify the conditions under which this can be done.
p.000038: How this weighing of interests is done depends on aspects such as the type of research is being conducted. A
p.000038: significant difference in this context is the distinction between research which is not being conducted in connection
...
p.000039: health and medical care, dental care and social services, for instance, must observe professional secrecy. This means
p.000039: that they are not allowed to discuss patients’ and clients’ health or personal situation with unauthorised individuals,
p.000039: or in any other way communicate this information. Similar standards for professional secrecy also apply to
p.000039: psychologists and clergy, for example. If a certain task is covered by secrecy, it means the person carrying out the
p.000039: task has a duty of professional secrecy.
p.000039: Anonymising or de-identifying involves eliminating the connection between samples or questionnaire answers and a
p.000039: certain individual, so that neither unauthorised persons nor the research group can re-establish it; no one should
p.000039: therefore be able to combine a certain piece of information with a specific person’s identity, for example. The code
p.000039: list is destroyed. Anonymity can also be achieved by collecting material without noting the identity of specific
p.000039: individuals.
p.000039: What is described above differs from a situation where the research group can use code keys to link information or
p.000039: samples to specific individuals (pseudo-anonymising) – which is usually necessary in longitudinal studies, for
p.000039: instance, or to enable auditing of the research. The question of who is and is not authorised, however, is not
p.000039: something for the researcher to determine ultimately. Disputes over this issue can be settled in court. Usually, it is
p.000039: a case of other researchers wishing to use the information in their research. In some cases, it can be stipulated that
p.000039: their research is ethically reviewed. Various reservations can be set in this context, for example that the researcher
p.000039: may have access to the information but is not allowed to contact the subjects studied.
p.000039: Confidentiality is a more general obligation not to communicate information given in confidence, and entails protection
p.000039: against unauthorised persons partaking of the information.
p.000039:
p.000039: 4.4 What can researchers promise?
p.000039: There are some things researchers cannot promise and yet do promise anyway – due to being poorly informed of applicable
p.000039: rules or because they confuse the four concepts discussed above.
p.000039:
p.000039: 4.4.1 Secrecy
p.000039: The basic principle is that public documents shall be publicly accessible and that information can be covered by
p.000039: secrecy only if falls under a specific provision of the Public Access to Information and Secrecy Act. The Act contains
p.000039: a chapter that specifically addresses secrecy to protect the individual in research (Chapter 24). But in addition, the
p.000039: Act contains many other provisions that the researcher may have to address, for instance regarding secrecy to protect
p.000039: the individual within health and medical care in Chapter 25.
p.000039: The principle of public access covers public activities, and those activities listed in the appendix to the Act. When a
p.000039: request for information from public documents is received, the authority where it is being stored (for example a
p.000039: university or a county council) is required to evaluate whether the information may be handed out, that is to say
p.000039: whether or not the information is covered by secrecy.
p.000039:
p.000039:
p.000039:
p.000039:
p.000039:
p.000039:
p.000039:
p.000039: GOOD RESEARCH PRACTICE
p.000040: 40
p.000040:
p.000040: 4.4.2 Professional secrecy
p.000040: Professional secrecy follows from secrecy to the extent that if certain information is covered by secrecy, then this
p.000040: also entails a requirement of professional secrecy about it. However, the opposite is not true.
p.000040: If professional secrecy applies for a certain activity, this does not necessarily mean that what is said during the
p.000040: activity is automatically covered by secrecy or that it that it falls under the Public Access to Information and
p.000040: Secrecy Act. Furthermore, it can happen that a researcher, through his or her work on a project, becomes aware of some
p.000040: circumstance that must be reported by law (such as child abuse or paedophilia). In such cases, the obligation to report
p.000040: outweighs the secrecy requirement.
p.000040:
p.000040: 4.4.3 Anonymity
p.000040: In some cases, the anonymising of information is a condition set by an ethics review board for its approval of a study.
p.000040: This can be done, for example, by removing personal information on completed questionnaires or samples, so that it is
p.000040: difficult or in practice impossible to link a certain answer or sample to a specific individual. In some types of
p.000040: studies, the identity of the individuals is not relevant, for instance studies on variations in attitudes towards a
p.000040: certain issue in a specific group over time. In such situations, researchers can promise anonymity.
p.000040: It should be noted, however, that this strategy has other drawbacks. Not only is it difficult or impossible to verify
p.000040: the researcher’s information, but it can also happen that an entire group is stigmatised or discriminated against due
p.000040: to the publication of certain research results, even if no individual person in the group can be identified.
p.000040:
p.000040: 4.4.4 Confidentiality
p.000040: The Declaration of Helsinki stresses the importance of confidentiality and of the researcher taking measures to protect
p.000040: the integrity of research subjects and their right to protection of their private lives. This is stated in the latest
p.000040: version of the Declaration from 2013, where it is stressed that:
p.000040:
p.000040: Every precaution must be taken to protect the privacy of the research subjects and the confidentiality of their
p.000040: personal information and to minimise the impact of the study on their physical, mental and social integrity.
p.000040:
p.000040: 4.4.5 Conclusions
p.000040: As just discussed, a researcher cannot promise that no one outside the research group will ever have access to the
p.000040: material or information collected in the course of the study. There are many situations in which access to research
p.000040: material is justified and necessary. For example, it could be a case of other researchers wanting to test the strength
p.000040: of scientific results, an opponent at a disputation requesting access to the basic data, or a report of suspected
p.000040: research misconduct, clinical trials (e.g. inspection), a court ruling or an ongoing court case.
p.000040: It also cannot be ruled out that research material may be handed over to other researchers in cases besides those
p.000040: referred to above. Research costs money, so it is also in society’s interest that material collected is used as much as
p.000040: possible in research. Two general conditions for this to be possible are that the new research project is ethically
p.000040: reviewed (if the law so requires), and that the new researchers adopt the previous researchers’ promise of
p.000040: confidentiality and safe storage of the material.
p.000040: Naturally, the researcher can and should describe to the research subjects the measures taken to prevent, or reduce,
p.000040: the risk that sensitive personal information will be disseminated. The researcher should also explain the conditions
p.000040: under which these protective measures can be enforced. These measures can include the use of code keys, the encryption
p.000040: of certain information, etc.
p.000040: There is of course a risk that some persons will not want to participate in a study if the researchers truthfully
p.000040: explain what they are able to promise, based on the rules that apply. But as a rule, people are willing to participate
p.000040: in medical research if they are asked, informed according to the principles in the Declaration of Helsinki and are told
p.000040: why and to whom the research is important. Of course, it is easier and cheaper to do things right from the beginning.
p.000040: In research that is not conducted in connection with healthcare one can, for example, use a code key and record coded
p.000040: information directly in the research journals, even though there is a certain extra cost involved. This makes it
p.000040: possible to give other researchers access to the information on
p.000040:
p.000040:
p.000040: GOOD RESEARCH PRACTICE
p.000041: 41
p.000041:
p.000041: condition that they assume or take over the professional secrecy promised by the previous researchers. The new
p.000041: researchers then become the personal data controllers.
p.000041: It is not only names that can be replaced with code numbers. Other information in the material that could identify
p.000041: individual subjects can also be disguised in this way (see Chapter 9). The ethics review boards should be able to
p.000041: determine the level of encryption required.
p.000041: Costs can be significantly higher if material that will be shown to other researchers is not collected using codes and
p.000041: code keys, especially if a project is conducted over a prolonged period of time. But it is neither ethical nor legally
p.000041: acceptable for an individual researcher or research group to breach the rules applicable with reference to such costs.
p.000041:
p.000041: What would you do in the following situation?
p.000041: A researcher, Adam, collects data from a specific group of adult informants. He promises that no one outside his
p.000041: research group will have access to the data. Later, his findings are questioned by two other researchers, Brian and
p.000041: Cecilia, who request access to his source data. Adam refuses to hand them over, referring to his promise to his
p.000041: informants. The case reaches an unexpected conclusion when colleagues of Adam’s say they have destroyed the source data
p.000041: on their own initiative.
p.000041: Is the action taken by Adam’s colleagues ethically defensible? Is it compatible with existing legislation? Has Adam
p.000041: promised more than he can deliver?
p.000041:
p.000041: 4.5 Documentation
p.000041: Data collected for a research project is called source data. Sometimes, researchers consider source data to be their
p.000041: own individual property. This might possibly be the case if the research is privately funded and conducted by
p.000041: individuals not associated with normal research environments, and the data does not include personal data.
p.000041: But when the research is conducted at a university or other research institution, or when it is funded with public
p.000041: funds through grants from a research council or foundation, it is the organisation where the research is conducted that
p.000041: owns the material. The researcher or research group can thus not do whatever they want with it, for instance take it
p.000041: with them upon changing jobs, without agreements and special arrangements. Source data and material that documents the
p.000041: research process and the project’s various steps should instead be regarded as documents (submitted, upheld) belonging
p.000041: to the organisation and fall under the Public Access to Information and Secrecy Act and the Archives Act.
p.000041: The material from a completed research project should therefore be stored and archived, with subsequent preservation
...
p.000041: For instance, it must be possible to verify research results6, or the material might be requested in the investigation
p.000041: of an accusation of research misconduct. It can also happen that the researcher who obtained the results, or other
p.000041: researchers, wish to reuse the material in another project. As a rule, this type of reuse requires a new ethics review.
p.000041: The material may also be of great value in itself, for example if it documents current societal conditions, in which
p.000041: future generations may have an interest.
p.000041: Whether, when and how an organisation may sort material is addressed in the Archives Act. If material is considered
p.000041: valuable, for instance for the way in which current society will be regarded in the future, it should be saved by the
p.000041: institution. The National Archives should be consulted as to how to proceed.
p.000041: It is important that research institutions and similar establish procedures for documentation, archiving and sorting,
p.000041: and that these procedures are known and observed by their researchers.
p.000041: Making data material collected available to other researchers contributes to facilitating both the scrutiny and the
p.000041: development and application of research. Digitally stored data can today be uploaded onto platforms where it becomes
p.000041: available to other researchers. The conditions under which this may be done are shown in the Open Science Framework
p.000041: (www.osf.io).
p.000041:
p.000041:
p.000041:
p.000041:
p.000041: 6 The importance of other researchers being able to verify the results naturally also applies to publication, including
p.000041: the increasingly common requirement of open access; this is discussed in Chapter 6.
p.000041:
p.000041:
p.000041: GOOD RESEARCH PRACTICE
p.000042: 42
p.000042:
p.000042: References
p.000042: 1. Arkivförordning (SFS 1991:441). Arkivlag (SFS 1990:782).
p.000042: 2. Bohlin, Alf, Offentlighet & sekretess i myndighets forskningsverksamhet. Riksarkivet, 1997:2. Those interested
p.000042: can read more about public access and secrecy issues in the Uppsala University handbook “Hantering av allmänna
p.000042: handlingar vid universitetet” (3 uppl. 2009), which can be downloaded from Uppsala University’s website (regler.uu.se,
p.000042: search for handling of public documents at universities).
p.000042: 3. Hermerén, Göran, Hanteringen av integritetskänsligt forskningsmaterial. Vetenskapsrådet, 2007.
p.000042: 4. Justitiedepartementet, Offentlighet och sekretess hos det allmänna. 2009.
p.000042: 5. Offentlighets- och sekretesslag (SFS 2009:400).
p.000042: 6. Riksarkivet, Om gallring – från utredning till beslut. Rapport, 1999:1.
p.000042: 7. Riksarkivet. Riksarkivets föreskrifter och allmänna råd om gallring av handlingar i statliga myndigheters
p.000042: forskningsverksamhet. Riksarkivets författningssamling, RA-FS, 1999:1.
p.000042: 8. Sveriges universitets- och högskoleförbund (SUHF), Övergripande principer för offentlighet och sekretess i
p.000042: integritetskänslig forskning. SUHF, 2006.
p.000042: 9. Tryckfrihetsförordning (SFS 1949:105).
p.000042: 10. Uppsala universitet, Hantering av allmänna handlingar vid universitetet. Tredje upplagan, 2009.
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p.000042: GOOD RESEARCH PRACTICE
p.000043: 43
p.000043:
p.000043: 5 RESEARCH COLLABORATION
p.000043:
p.000043: 5.1 Introduction
p.000043: Research is an activity that involves the creation and accumulation of significant amounts of knowledge, and its
p.000043: results can be of lasting value for many people. This means that research can be very rewarding activity for an
p.000043: individual to be involved in, but it also means that it can never be a purely private matter, least of all when paid
p.000043: for out of public funds. Research projects are often collaborative endeavours, with a large number of stakeholders.
p.000043: In fields of research where large-scale projects need to be undertaken – perhaps involving heavy investments in
p.000043: instrumentation, large computer programs, detailed interview surveys, questionnaires sent to thousands of informants or
p.000043: clinical studies – extensive collaboration is a practical necessity. Today, much research is conducted by large teams
p.000043: that sometimes include hundreds of researchers scattered across the globe. Such collaborative projects do not come
p.000043: about by themselves.
p.000043: Administration and project management are important in making the research functional. If they are to be concluded,
p.000043: moreover, purposeful efforts are needed and more or less clearly stated rules have to be followed. The organisation of
p.000043: projects of this kind, and the collaboration that occurs within them, raise particular problems.
p.000043:
p.000043: 5.2 Relations with fellow researchers
p.000043: A common reason for establishing scientific collaboration is to broaden the competency within the planned project, for
p.000043: example by involving a colleague who is a specialist in a method of analysis with which you yourself are not familiar.
p.000043: Another reason might be that a colleague has access to resources, such as an instrument, that is not available to you.
p.000043: Yet another could be that the project requires more working hours than you yourself are able to devote to it, or that
p.000043: you wish to complete the project in a shorter time by involving more people in it. It is also common, no doubt, simply
p.000043: to want to have other people to work with, to be part of a team. Collaborations can also arise naturally when
p.000043: researchers supervise students within the framework of their own projects.
p.000043: Whatever the motives for collaboration, it is crucial to form a clear idea at an early stage, and to make it clear to
p.000043: your fellow researchers, what you expect of each other, and not least what you yourself are able to contribute. It is
p.000043: important to establish a time plan for the various parts of the project, even if it has to be updated from time to
p.000043: time. Like all joint ventures, scientific collaboration requires a certain degree of reliability in keeping to agreed
p.000043: timetables.
p.000043: It is still possible to see examples of scientific collaboration in which the participants take such responsibilities
p.000043: quite lightly. Collaborators contribute to the common undertaking “when the spirit moves them”. If the project involves
p.000043: postgraduate students or researchers in the early stages of their careers, this is totally unacceptable. They are so
p.000043: dependent on being able to produce a track record of publications and other results in order to be able to continue at
p.000043: all, that collaborative projects in which they participate must involve a realistic sharing of the workload and a
p.000043: viable and quite strictly regulated time plan.
p.000043: In many collaborations, a modified division of labour gradually crystallises out, with some researchers not
...
p.000043: already possess, but also to learn new skills. This is particularly true of research students and other young
p.000043: researchers; senior members of a group have a special responsibility to ensure that their younger colleagues’ interests
p.000043: in this respect are provided for.
p.000043:
p.000043:
p.000043: GOOD RESEARCH PRACTICE
p.000044: 44
p.000044:
p.000044: It is a good idea to broach the subject of publications and their authorship early on, at the planning stage. These
p.000044: issues should be discussed again if the division of labour changes, or the project develops along new lines. It may be
p.000044: tempting to put off crossing that bridge until you come to it, but experience tells us that, by then, it may be too
p.000044: late. Plain speaking about what rewards different individuals expect and lay claim to in terms of publication credit
p.000044: greatly reduces the risk of conflicts later.
p.000044: When the project and its results are presented in more informal settings too, for example in papers at international
p.000044: conferences, care should be taken to give a correct picture of the contributions of the various participants. In such
p.000044: contexts, the results presented are commonly perceived chiefly as the speaker’s own, and precisely for that reason
p.000044: emphasis should be placed on the contributions of one’s colleagues.
p.000044: A large research group often generates a sizeable and valuable common database of experimental data, computer software,
p.000044: etc. Who owns such material? This question is sometimes raised, not least when doctoral students or postdocs from the
p.000044: group move to other centres to continue their careers. Will they then have free access to the database? This cannot be
p.000044: taken for granted, especially if the researchers in the group have not yet completed and published their analysis of
p.000044: the data. It is important to discuss such questions when the database is created, or at any rate before doctoral
p.000044: students and other collaborators leave the group.
p.000044:
p.000044: 5.3 Interaction with funding and commissioning bodies
p.000044: Major collaborative projects may involve or affect dozens of research groups in as many countries. They may be
p.000044: supported by a large number of funding bodies, often national research councils. An honest and open attitude to these
p.000044: funding agencies is important and, in the long run, beneficial to the research undertaken.
p.000044: In an international project, there may be a temptation to describe your own national involvement as more advanced or
p.000044: extensive than it really is. This can occur both in your direct dealings with the funding body, for example when you
p.000044: apply for grants; and more indirectly, in your dealings with the media: differently targeted press releases may perhaps
p.000044: be written for the media of the various participating countries, lending exaggerated prominence to each individual
p.000044: country’s own researchers.
p.000044: In the case of large-scale projects in particular, funding agencies quite justifiably wish to monitor progress. It is
p.000044: therefore important for project managers and participating researchers to develop appropriate ways of keeping them
p.000044: regularly informed. It is particularly important to give ample warning of forthcoming decisions within the project
p.000044: which will have far-reaching financial consequences. The agencies’ experts, who will usually have introduced the
p.000044: original proposal to the relevant review panel, are often colleagues of the researchers who make up the project
...
p.000051: The individual articles may have several authors, but the introduction should be the work of the doctoral student
p.000051: alone.
p.000051: In the humanities and social sciences, the monograph – a single, coherent text, written by the doctoral student alone –
p.000051: is currently the normal form of publication used for doctoral theses. After completing their doctorates, too,
p.000051: researchers in these fields often publish their results in book form and as sole authors.
p.000051: Publication serves several purposes. Only if the results are made public does the research conducted contribute
p.000051: effectively to the dissemination of new knowledge to the wider society. What is more, publication is often essential if
p.000051: others are to build on the researcher’s ideas or to develop practical applications. But it is also necessary to enable
p.000051: the scientific community to scrutinise and discuss the results achieved. The report that the researcher presents
p.000051: consequently has to meet a number of quality standards.
p.000051: In addition, publication serves as an announcement of what the researcher (or group of researchers) concerned has
p.000051: accomplished. The work published is thus of importance when it comes to assessing the worth of a contributing
p.000051: researcher, for example when he or she is applying for a position. The citation of published work nowadays also
p.000051: influences the distribution of governmental research funding to different universities and colleges.
p.000051: When projects are funded by public agencies, researchers are required to make their results available to others (open
p.000051: access). According to the Swedish Research Council general rules for research grants, a researcher may currently not
p.000051: allow an agreement with a commercial actor or other stakeholder to delay publication of results for more than two
p.000051: months, unless a patent application is planned, in which case publication may be delayed by up to four months.
p.000051:
p.000051: 6.2 Disclosure of financial and scientific dependence
p.000051: A researcher publishing results must clearly disclose any ties or dependencies that may exist. Details should also be
p.000051: given of any individuals or bodies providing financial support for the work, and if the research is commissioned, the
p.000051: commissioning organisation should be named.
p.000051: A researcher often builds on other people’s results, uses ideas, concepts, theories and methods drawn from their work,
p.000051: or develops his or her arguments in dialogue with others. It is important to describe such relationships too, to make
p.000051: clear what the researcher’s (research group’s) own contribution is.
p.000051:
p.000051: 6.3 Background, materials and conclusions
p.000051: When a researcher publishes research results, he or she must fulfil a number of crucial requirements. If these are not
p.000051: met, other researchers will not be able to scrutinise the results, and the research community will not be able to
p.000051: assess the quality of the project or the significance of the results.
p.000051: An honest and clear account of the background to the study should always be included in the published report, which
p.000051: will involve quoting and referring to relevant earlier publications. Materials and methods must be described with
p.000051: sufficient clarity and detail to allow a reasonably well-informed reader to assess the scientific quality or
p.000051: significance of the results.
p.000051:
...
p.000052: discussing topical scientific issues brought up in the general news flow, and in societal debate. Keeping things secret
p.000052: or remaining silent fosters misunderstanding and suspicion.
p.000052: However, preliminary and unverified results should not be made public, even if they may make for interesting news. If,
p.000052: at a later date, and on closer scrutiny, the results announced prove incorrect, then misgivings or false hopes will
p.000052: have been raised among the various people directly or indirectly affected by the study, for instance patients or
p.000052: relatives of patients with the disease being studied. Well-founded alerts to newly discovered problems should of course
p.000052: be published as soon as possible, but the researcher must guard against exaggeration, for example by securing
p.000052: independent peer review of the results.
p.000052:
p.000052: What would you do in the following situation?
p.000052: In a science programme on the radio, your professor gets his facts wrong, and not for the first time. He expresses
p.000052: himself, with great self-assurance, on matters far beyond his field of expertise. You raise the matter with him (again,
p.000052: not for the first time), but this time he does not simply shrug his shoulders, but tells you to get in touch with the
p.000052: producers to do a piece of your own and “have the fight out in the open”. Next term he will be deciding on an extension
p.000052: of your postdoctoral fellowship.
p.000052: What do you do? Would things be different if he didn’t have a say in your situation – or if it was the first time this
p.000052: had happened? Does it depend on what type of issue he talked about?
p.000052:
p.000052:
p.000052:
p.000052:
p.000052:
p.000052:
p.000052:
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p.000053: 53
p.000053:
p.000053: 6.5 Open access
p.000053: Open access to scientific publications has a number of advantages. For researchers, it is an excellent way of rapidly
p.000053: presenting their findings, and making their texts easily accessible. This makes work available to researchers, whose
p.000053: departments cannot afford to subscribe to scientific journals, and to students and teachers who can use them freely for
p.000053: educational purposes. The more readers a text has, the greater the chance is that it will be of benefit. The OECD, the
p.000053: European Commission and other organisations have stressed that scientific work financed by public funds should also be
p.000053: openly accessible to all. The disadvantage, to the individual author, of the additional costs of making a research
p.000053: article openly accessible must be weighed against the advantage of avoiding expensive subscription fees.
p.000053: Many actors in Sweden – among them the Swedish Research Council and the Association of Swedish Higher Education –
p.000053: follow the 2003 Berlin Declaration on open access to scientific knowledge. The signatories to this declaration intend
p.000053: to encourage researchers to publish their results on the Internet, to develop methods for safeguarding the quality of
p.000053: online publication, and to work towards open publication being counted as a merit in the evaluation and recruitment of
p.000053: researchers.
p.000053: Since 2010, researchers granted funding from the Swedish Research Council are obliged to publish their results
p.000053: according to the principle of open access (open access journal, hybrid or self archiving; the concepts are explained in
p.000053: the next section). Research articles lodged shall be made openly accessible within six months. For researchers with
p.000053: grants within educational sciences or humanities and social sciences, open access has to be made available within
p.000053: twelve months. The Swedish Research Council’s rules concerning open access currently only apply to scientifically
p.000053: reviewed texts in journals and conference reports, and not monographs or book chapters.
p.000053: Journals often publish material electronically, but it is important to remember that this does not automatically entail
p.000053: that it becomes openly accessible. In order to publish according to the requirements for open access, there are three
p.000053: options:
p.000053:
p.000053: 1) In an open-access journal – these, just like traditional scientific journals, use peer review to assess the
p.000053: quality of the research articles.
p.000053: 2) Hybrid publication – the research article is published in a subscription-based journal, which offers the author
p.000053: the choice of open access, against a fee.
p.000053: 3) Self archiving – which means that the researcher, in addition to publishing the research article in a
p.000053: subscription based scientific journal, also deposits it at the time of publication in an open repository, and is made
p.000053: openly accessible within six or twelve months.
p.000053:
p.000053: The legal room surrounding self archiving is dependent on the policy of the journal/publisher. To help researchers in
p.000053: handling rights issues, the EU Commission’s framework programme for research and innovation, Horizon 2020, has produced
p.000053: an appendix to the publication agreement. This appendix guarantees that the researcher retains the right to deposit the
p.000053: work in an open archive, and thus make it freely accessible. An accompanying letter that researchers can use in their
p.000053: contacts with publishers has also been produced, see the website sparcopen.org Despite this, self archiving is
p.000053: regarded as complicated, and for this reason the major journal publishers are offering the option of hybrid
p.000053: publication, which replaces the need for an appendix to the publication agreement and avoids the risk of several
p.000053: different versions of the work being published.
p.000053: Developments in technology have entailed a fundamental change within the area of scientific publication area. To follow
p.000053: this development, see for example the website kb.se/openaccess, which has information on current developments and a
p.000053: discussion forum. A discussion is also in progress on the existence of a so-called “copyright teacher exemption”, which
p.000053: would give the university both the right to use and a certain right to process educational materials.
p.000053:
...
p.000056: he or she should request clarifications of methods, results or interpretations, for example, if they seem unclear.
p.000056: Alongside the author, who obviously has the main responsibility, the editor is also responsible for making sure a
p.000056: published article provides accurate references to relevant earlier research, and that the choice of references is not
p.000056: improperly influenced by rivalry or a conflict of interest. The editor should also provide space in the journal for
p.000056: debate about published manuscripts.
p.000056: Researchers have found that it can be difficult to get negative results published. But what constitutes a negative
p.000056: result depends on how the hypothesis is framed. The editor should ensure that it is also possible to publish articles
p.000056: showing that a certain hypothesis does not have scientific support. If the hypothesis is one that is currently under
p.000056: debate, then such negative findings are important and space should be made available for them.
p.000056:
p.000056: What would you do in the following situation?
p.000056: As a journal editor, you have received a manuscript from a very well-known, older researcher. You see that he has
p.000056: published over 50 articles in your journal, long before you became its editor, and that many of them are now classics.
p.000056: But his new article seems to be mostly a rehash of old material, and is also quite poorly structured. The referee
p.000056: recommends rejection. You are considering giving him special treatment by going through his paper carefully and
p.000056: suggesting a number of specific changes.
p.000056: Would you do this?
p.000056:
p.000056:
p.000056: GOOD RESEARCH PRACTICE
p.000057: 57
p.000057:
p.000057:
p.000057:
p.000057: References
p.000057: 1. Berlin Declaration on Open Access to Knowledge in the Sciences and Humanities. Berlin, 2003,
p.000057: https://openaccess.mpg.de/Berlin-Declaration.
p.000057: 2. Helgesson, Gert & Eriksson, Stefan, Publiceringsetik. Studentlitteratur, 2013.
p.000057: 3. Horizon 2020, http://ec.europa.eu/research/participants/data/ref/h2020/grants_manual/hi/oa_pilot/h2020-
p.000057: hi-oa-pilot-guide_en.pdf
p.000057: 4. Högskolelag (SFS 1992:1434).
p.000057: 5. International Committee of Medical Journal Editors (ICMJE), Uniform Requirements for Manuscripts Submitted to
p.000057: Biomedical Journals, (Vancouver Rules), ICMJE, updated 2010.
p.000057: 6. Organisation for Economic Co-operation and Development (OECD). OECD Principles and Guidelines for Access to
p.000057: Research Data from Public Funding. Paris, OECD, 2007.
p.000057:
p.000057:
p.000057:
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p.000057:
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p.000057:
p.000057:
p.000057:
p.000057:
p.000057:
p.000057:
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p.000057:
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p.000057:
p.000057:
p.000057:
p.000057:
p.000057:
p.000057:
p.000057:
p.000057:
p.000057:
p.000057:
p.000057:
p.000057:
p.000057:
p.000057:
p.000057:
p.000057:
p.000057:
p.000057:
p.000057:
p.000057:
p.000057:
p.000057:
p.000057: GOOD RESEARCH PRACTICE
p.000058: 58
p.000058:
p.000058: 7 OTHER ROLES OF THE RESEARCHER
p.000058:
p.000058: The requirements on quality and integrity are also relevant to discuss in connection with tasks associated with the
p.000058: researcher role. This relates to the roles of supervisor, teacher, expert and reviewer.
p.000058:
p.000058: 7.1 The supervisor and postgraduate supervision
p.000058:
p.000058: 7.1.1 The tasks of the supervisor
p.000058: There are many ways of being a good supervisor. In general, someone who is appointed as a supervisor has a
p.000058: responsibility to create conditions that will help to develop the doctoral student’s knowledge and skills.
p.000058: Through discussions, teaching and their own example, good supervisors transfer knowledge, skills and experience to
p.000058: their doctoral students, and guide the research which they are undertaking.
p.000058: One important task is to work with the research student to define a suitable thesis project, and to draw up an
p.000058: individual plan of study consistent with the general guidelines laid down by the faculty and the department. The extent
...
p.000059: should disclose this to the party requesting your participation. Provisions relating to conflict of interest are
p.000059: included in the Administrative Procedure Act (for national public authorities) and in the Local Government Act (for
p.000059: municipalities). To help in the interpretation of conflict of interest rules in research funding, the Swedish Research
p.000059: Council has produced a policy on conflicts of interest (2014).
p.000059: It is also important to base assessments of this nature on an objective and careful analysis of the documents and
p.000059: qualifications presented, and to maintain a critical stance towards unfounded claims and opinions aired by others. It
p.000059: should go without saying that the analysis in any assessment should be well founded.
p.000059:
p.000059:
p.000059:
p.000059:
p.000059: GOOD RESEARCH PRACTICE
p.000060: 60
p.000060:
p.000060: 7.4 Reviewing manuscripts for publication
p.000060: Another situation where ethics may be tested is when a researcher reviews an article or a larger manuscript submitted
p.000060: to a journal or publishers for publication. It is very common in the academic world for a researcher’s work to be
p.000060: assessed by his or her colleagues. Since such assessments presuppose expert knowledge in the field concerned, there are
p.000060: few alternatives to this system, which is generally referred to as “peer review”. Thus, clear rules to counteract
p.000060: various types of conflict of interest are crucial.
p.000060: One reason the system has been challenged is a number of flagrant cases of peer reviewers abusing the trust which being
p.000060: given access to a colleague’s work to assess it entails. Such abuses have included reviewers stealing ideas from
p.000060: submitted manuscripts (this is addressed in Chapter 8), “sitting on” manuscripts for a long time to enable researchers
p.000060: in their own groups to publish their results first, or trying without just cause to prevent the publication of
p.000060: colleagues’ work.
p.000060: Often, the journal reviewers know the identity of the authors, while the authors do not know the identity of the
p.000060: reviewers. Temptations to abuse the system in conjunction with such tasks could be reduced if the system was either
p.000060: entirely open, or else double-blind.
p.000060: Another important reason why the peer review system has been questioned is that the volume of manuscripts submitted to
p.000060: journals is now so great that it can be difficult to find willing and competent reviewers. There is good reason to
p.000060: consider awarding greater merit than is given today for the arduous work of reviewing texts (not only when it comes to
p.000060: journal publication, but also in advisory groups and in the case of thesis defence and the awarding of positions).
p.000060: For the system of peer review to continue working, as referred to above, at least three criteria must be met: reviewers
p.000060: must submit their reports as quickly as possible, they must not use information in the manuscript for their own
p.000060: purposes without referring to the source – and if they do wish to use it, they must first contact the author and ask
p.000060: whether he or she has any objection – and they must be guided only by objective reasons in deciding whether or not to
p.000060: recommend publication.
...
p.000064: presented as such through the use of quotation marks, indentation or the like. When a researcher uses the ideas,
p.000064: hypotheses, distinctions, concepts, etc. of others, it usually suffices to state from whom the material has been
p.000064: borrowed to avoid accusations of plagiarism, But, if it is crucial to the context, its origin should also be supplied.
p.000064: This can apply to a conversation, presentation, article, book, etc.
p.000064: However, there are ideas – theories, methods, concepts – that are so widely known that mentioning them hardly runs a
p.000064: risk of creating misunderstanding. In such cases, it is not necessary to point out that they are not an author’s own
p.000064: material. Sometimes it is no longer known who coined an expression, for instance; thus, using the formulation does not
p.000064: risk misleading the reader. Using such a formulation cannot mislead the reader in this case. Additionally, it is common
p.000064: practice within a number of subject areas to use standardised formulations in a text’s method section, and this is done
p.000064: without the use of quotation marks. Different opinions can be expressed on this practice, but the main point is that
p.000064: this is such a well-known approach that no one draws benefit from it, and no one is misled.
p.000064:
p.000064:
p.000064:
p.000064:
p.000064: GOOD RESEARCH PRACTICE
p.000065: 65
p.000065:
p.000065: 8.5 Unpublished material and self-plagiarism
p.000065: In the research community, researchers partake of others’ results and ideas in various ways. Publication means that a
p.000065: text is available to the general public and can thus be used legitimately by others. However, a researcher may also
p.000065: have access to material before its publication, for instance through lectures, presentations, congresses and other
p.000065: meetings, or in conversations with other researchers. Before a researcher uses someone else’s material that was
p.000065: accessed in such a way, he or she should think about the situation in which access was provided.
p.000065: As a guideline, one can say that lectures given at major conferences, or by established researchers, can be regarded as
p.000065: published, and that their content may be used in accordance with the rules presented above.
p.000065: However, one should be more careful with presentations or lectures at small conferences, seminars and the like, as well
p.000065: as lectures given by doctoral students. Doctoral students often talk about their own projects, which are as yet not
p.000065: completed, and normally participate in conferences to get feedback to improve their ongoing work. It is not a given
p.000065: that such a lecture should be regarded as a publication – often, it should not. To avoid causing any harm to the
p.000065: doctoral student, interested parties should contact him or her directly and ask whether specific ideas or other aspects
p.000065: of the lecture may be used, naturally citing the source, or if this should wait until the material has been published
p.000065: in a journal or in connection with the student’s thesis defence.
p.000065: If someone has access to material in the role of external assessor, for example reviewing a manuscript for possible
p.000065: publication in a journal, or as a member of an examining committee or a faculty opponent, this material should be
p.000065: considered confidential until it has been published. Using parts or ideas from it or publishing it without supplying
p.000065: the source is not only plagiarism, but also theft of material, and places the entire evaluation system at risk.
p.000065: It is very common for a researcher to refer to his or her earlier results or mention problems previously dealt with. If
p.000065: the purpose is to confirm or repeat previous results, the earlier account should be presented to the reader. It also
p.000065: happens that researchers want to reuse earlier formulations. Nothing prevents this, but it is actually a quotation from
p.000065: the researcher’s previous work and should be presented as such. It is also completely acceptable to use complete
p.000065: sections of text, for instance a whole chapter from a book, as long as the researcher states that that text has
p.000065: appeared in an earlier context. This can easily be done in a preface or a note in the chapter itself. Neglecting to
p.000065: take these precautions is called self-plagiarism. There is currently a debate in the scientific community concerning
p.000065: whether this concept is accurate, or if it should instead be called double publication (see also Chapter 6). At any
p.000065: rate, it is a violation of good publication practice.
p.000065:
p.000065: 8.6 Establishing plagiarism
p.000065: How, then, can it be established that plagiarism has been committed? First of all, a very clear congruence between the
p.000065: work in question and the suspected source must exist. In texts, this can be a congruence between formulations, perhaps
p.000065: even partly verbatim congruence. It can also be a case of detailed agreement when it comes to arrangement, structure,
p.000065: terminology or concept formation. In certain types of texts, formulation congruence can now be established using the
p.000065: Internet or databases created for this purpose. Here, however, one should beware of false congruence. There are only so
p.000065: many ways to express something, and some degree phrasing congruence can nearly always be found.
p.000065: As regards plagiarism of ideas, the congruence should not only exist in the actual content of the idea but also in the
p.000065: argument for it. However, considerations of similarities between a work and a suspected source can never serve as the
p.000065: sole evidence of plagiarism; even extensive congruence can be coincidental. It can be natural to present certain
p.000065: premises within a given field, and it can happen that two researchers do so independently of each other. The history
p.000065: of science provides many examples of the “same” discovery being made by different researchers at approximately the same
p.000065: time, without their having had anything to do with each other, and with no possibility of plagiarism.
p.000065: Therefore, it is necessary to evaluate how likely it is that the suspected source actually is a source. An assessment
p.000065: must be made of whether it could have been available at all to the accused researcher, as well as of how likely it is
p.000065: that he or she in that case would have known of it, and had access to it. For instance, is there anything that suggests
p.000065: the researcher might have owned, read or spoken of the suspected source? Was the source published in a journal that
p.000065: those in the researcher’s field usually read? Plagiarism of an idea can possibly be established if there is a high
p.000065: probability of determining that the source was available to the researcher, and if there is a great deal of congruence
p.000065: between a text and a suspected source. In an actual investigation, it is
p.000065:
p.000065:
p.000065: GOOD RESEARCH PRACTICE
p.000066: 66
p.000066:
p.000066: naturally important to consider the researcher’s own explanation for the similarities, and of his or her relationship
p.000066: to the suspected source.
p.000066:
p.000066: What would you do in the following situation?
p.000066: A doctoral student, Eric, sends his thesis to fellow postgraduate Nicole at another university to get her feedback.
p.000066: They work in the same field and have previously met at a seminar, at which they got on well. Nicole uses some of the
p.000066: data and ideas from Eric’s work in her own thesis, which she presents before Eric completes his. Eric is accused of
p.000066: plagiarism.
p.000066: What should the doctoral students, their supervisors, heads of department, vice-chancellors and their colleagues do?
p.000066:
p.000066: 8.7 Prevention
p.000066: Researchers operate in a highly competitive environment. Publications are the most essential merit for applicants to
p.000066: university positions – there is often talk of a “publish or perish” culture. This can tempt researchers to strive for
p.000066: quantity rather than quality; and the same applies in the system of research funding.
p.000066: If the results of a US study can be applied to a Swedish context, there is mistrust of the career system among
...
p.000073: whether it involves any infringement of human rights or hard-to-capture concept of human dignity. An assessment is also
p.000073: made of the relationship between the value of the project and any burdens or risks which it might entail for the
p.000073: subjects of the research. Its value must be judged to outweigh the risks. Great importance is placed on an assessment
p.000073: of how the issue of informed consent has been handled. Regional ethics boards are also able to issue advisory
p.000073: statements on research involving human subjects in the event the research is not covered by the Act (SFS 2003:460)
p.000073: concerning the Ethical Review of Research Involving Humans. Such statements are sometimes required in order to obtain
p.000073: financial support, or to enable publication of results in certain international journals. Reviews by the regional
p.000073: boards are subject to a fee and shall be undertaken within 60 days from receipt of application. More information is
p.000073: available on (epn.se).
p.000073:
p.000073: 9.3 Secrecy
p.000073: Researchers need to know whether the data handled within the research they carry out is covered by secrecy, and if so,
p.000073: what the secrecy parameters are. A significant factor when determining the secrecy parameters for a task is who is
p.000073: carrying out the activity.
p.000073:
p.000073: 9.3.1 Public principal
p.000073: The Freedom of the Press Act contains regulations for public documents stored by public authorities. The starting point
p.000073: is that public documents are open to the general public, and that the general public’s access to these may only be
p.000073: limited for the purposes listed in Chapter 2 Section 2 of the Act. One of the purposes is the protection of the
p.000073: personal or financial circumstances of individuals. The issue of when data may be covered by secrecy under this
p.000073: exception is regulated in particular in the Public Access to Information and Secrecy Act (SFS 2009:400). This Act
p.000073: contains provisions that apply to the handling of personal data within the framework of health and medical care, in
p.000073: research activities and other activities carried on by public agencies.
p.000073: The regulations in the Act also entail that those who work at a public agency are automatically covered by professional
p.000073: secrecy rules. It is important to remember that employees have an obligation of professional secrecy under the Act, but
p.000073: cannot have a more comprehensive obligation imposed. That means that if data is covered by secrecy under the Act, it
p.000073: must not be disclosed, at the same time that data that is public must be disclosed on demand.
p.000073:
p.000073:
p.000073:
p.000073:
p.000073:
p.000073:
p.000073:
p.000073: GOOD RESEARCH PRACTICE
p.000074: 74
p.000074:
p.000074: 9.3.2 Private principal
p.000074: Private actors have no obligation to disclose data, or keep data secret, unless this follows from special legislation
p.000074: covering their activities. Such regulations exist, for example for private caregivers, in Chapter 6 of the Patient
p.000074: Safety Act. If there are no particular regulation, private actors may themselves decide on the secrecy protection that
p.000074: shall apply for a certain task.
...
p.000075: Organization (WHO), published Ethical Guidelines for Biomedical Research Involving Human Subjects, addressing issues of
p.000075: safety and informed consent. Through this document, the Council attempts to apply the principles of the Declaration of
p.000075: Helsinki while acknowledging important differences between the countries of the world. The guidelines contain special
p.000075: sections on research on weaker groups and women. CIOMS has also published guidelines on epidemiological research which
p.000075: are widely referred to.
p.000075:
p.000075: 9.10 Center for Open Science
p.000075: Recently, researchers have taken the initiative to encourage better research practice. The currently best established
p.000075: and comprehensive initiative is the Center for Open Science, which provides resources to increase openness, integrity
p.000075: and reproducibility. (https://cos.io/)
p.000075:
p.000075: 9.11 Publication ethics and questions of misconduct
p.000075: Some important documents on research ethics, such as the Declaration of Helsinki, address aspects of publishing ethics.
p.000075: As the Swedish Research Council has signed the Berlin Declaration (the Berlin Declaration
p.000075:
p.000075:
p.000075:
p.000075: GOOD RESEARCH PRACTICE
p.000076: 76
p.000076:
p.000076: on Open Access to Knowledge in the Sciences and Humanities), the Council has since 2010 included a requirement for open
p.000076: access publication in its calls for grant applications.
p.000076: Two international documents are of particular relevance in this context: one being, the Editorial Policy Statements of
p.000076: the Council of Science Editors (CSE), and the other – and most important – the “Vancouver Rules”, published by the
p.000076: International Committee of Medical Journal Editors (ICMJE) under the title of Uniform Requirements for Manuscripts
p.000076: Submitted to Biomedical Journals. A point emphasised in both these documents is the clear link between the right to be
p.000076: credited as an author and the obligation to assume responsibility for and have contributed to the intellectual content
p.000076: of the publication.
p.000076: Shared authorship is addressed in the CSE’s Recommendations for Group- Author Articles in Scientific Journals and
p.000076: Bibliometric Databases. Many journals today also refer to the ethical guidelines launched by the British Committee on
p.000076: Publication Ethics (COPE).
p.000076: Constant departures from these standards have led other actors to intensify their work with publication ethics. Not
p.000076: least, publishing companies themselves have started formulating rules and guidelines. Groups of researchers, editors
p.000076: and funding bodies have also collaborated in drawing up a number of standards, such as CONSORT, STARD, STROBE and
p.000076: STREGA, for how various types of studies should be presented in journals. These and other documents can be found on the
p.000076: CODEX website’s page on publication ethics.
p.000076: As regards research misconduct in general, perhaps the most important initiative in recent time is the OECD’s Best
p.000076: Practices for Ensuring Scientific Integrity and Preventing Misconduct, and another one produced by ALLEA, the European
p.000076: Code of Conduct for Research Integrity Revised Edition. The US federal guidelines,
p.000076: U.S. Federal Policy on Research Misconduct, have also received a great deal of attention. The European Science
p.000076: Foundation’s contribution is a discussion of Research Integrity in its Briefing no. 30. In Sweden, the Association of
p.000076: Swedish Higher Education has presented guidelines for the handling of questions of research misconduct by universities
p.000076: and higher education institutions in its Riktlinjer för hantering vid universitet och högskolor av frågor om
p.000076: vetenskaplig ohederlighet.
p.000076: The most recent contribution to the documents on misconduct, the Singapore Statement on Research Integrity, was drawn
p.000076: up at the 2nd World Conference on Research Integrity.
p.000076:
p.000076: References
p.000076: 1. 2nd World Conference on Research Integrity. Singapore Statement on Research Integrity. Singapore, 2010.
p.000076: Arkivförordning (SFS 1991:446).
p.000076: 2. Arkivlag (SFS 1990:782).
p.000076: 3. Berlin Declaration on Open Access to Knowledge in the Sciences and Humanities. Berlin, 2003.
p.000076: 4. Commission Directive 2005/28/EC of 8 April 2005 laying down principles and detailed guidelines for good
p.000076: clinical practice as regards investigational medicinal products for human use, as well as the requirements for
p.000076: authorisation of the manufacturing or importation of such products. European Community, Brussels, 2005.
p.000076: 5. Council of Europe. Convention for the Protection of Human Rights and Dignity of the Human Being with regard to
p.000076: the Application of Biology and Medicine: Convention on Human Rights and Biomedicine, (Oviedo Convention), European
p.000076: Treaty Series No 164, Strasbourg, 1997.
p.000076: 6. Council of Science Editors. Editorial Policy Statements, Wheat Ridge, CO, 2010.
p.000076: 7. Council for International Organizations of Medical Sciences (CIOMS). International ethical guidelines for
p.000076: biomedical research involving human subjects. Geneva, CIOMS, 2002.
p.000076: 8. Council for International Organizations of Medical Sciences (CIOMS). International ethical guidelines for
p.000076: epidemiological studies. Geneva, CIOMS, 2008.
p.000076: 9. Djurskyddsförordning (SFS 1988:539).
p.000076: 10. Djurskyddslag (SFS 1988:534).
p.000076: 11. European Code of Conduct for Research Integrity Revised Edition. ALLEA, All European Academies, Berlin 2017.
p.000076: 12. European Science Foundation. Research Integrity: global responsibility to foster common standards. ORI-ESF
p.000076: Science Policy Briefing 30, Strasbourg, 2007.
...
p.000079: animals used for scientific purposes.
p.000079: 6. Förordning om etikprövning av forskning som avser människor (SFS 2003:615).
p.000079: 7. Förordning om utsättning av genetiskt modifierade organismer i miljön (SFS 2002:1086).
p.000079: 8. Förordning om innesluten användning av genetiskt modifierade organismer (SFS 2000:271).
p.000079: 9. Förordning med instruktion för regionala etikprövningsnämnder (SFS 2007:1069).
p.000079: 10. Förordning med instruktion för Centrala etikprövningsnämnden (SFS 2007:1068).
p.000079: 11. Lag om biobanker i hälso- och sjukvården med mera (SFS 2002:297). Förordning (2002:746) om biobanker i hälso-
p.000079: och sjukvården med mera.
p.000079: 12. Lag om etikprövning av forskning som avser människor (SFS 2003:460).
p.000079: 13. Lag om genetisk integritet med mera (SFS 2006:351).
p.000079: 14. Läkemedelslag (SFS 2015:315).
p.000079: 15. Offentlighets- och sekretesslag (SFS 2009:400).
p.000079: 16. Patientdatalag (SFS 2008:355).
p.000079: 17. Personuppgiftslag (SFS 1998:204).
p.000079: 18. Personuppgiftsförordning (SFS 1998:1191).
p.000079: 19. Ändring i Centrala försöksdjursnämndens föreskrifter (LSFS 1988:45) om den etiska prövningen av användningen av
p.000079: djur för vetenskapliga ändamål med mera (SJVFS 2008:70).
p.000079: 20. Strålsäkerhetsmyndighetens föreskrifter om allmänna skyldigheter vid medicinsk och odontologisk verksamhet med
p.000079: joniserande strålning (SSMFS 2008:35).
p.000079: 21. Tryckfrihetsförordning (SFS 1949:105).
p.000079:
p.000079: Declarations, guidelines, reports
p.000079: 1. 2nd World Conference on Research Integrity. Singapore Statement on Research Integrity, Singapore, 2010.
p.000079: 2. Berlin Declaration on Open Access to Knowledge in the Sciences and Humanities. Berlin, 2003. Bohlin, Alf,
p.000079: Offentlighet & sekretess i myndighetsforskningsverksamhet. Riksarkivet, 1997:2.
p.000079:
p.000079:
p.000079: GOOD RESEARCH PRACTICE
p.000080: 80
p.000080:
p.000080: 3. Brambell, Rogers, F.W. (Chairman), Report of the Technical Committee to enquire into the Welfare
p.000080: 4. of Animals kept under Intensive Livestock Husbandry Systems, London, HMSO, 1965.
p.000080: 5. Centrala försöksdjursnämnden, Författningar, allmänna råd och anvisningar om användningen av djur för
p.000080: vetenskapliga ändamål. Stockholm, CFN:s skriftserie: 45, 2002.
p.000080: 6. Council of Europe. Convention for the Protection of Human Rights and Dignity of the Human Being with regard to
p.000080: the Application of Biology and Medicine: Convention on Human Rights and Biomedicine, (Oviedo Convention), European
p.000080: Treaty Series No 164, Strasbourg, 1997.
p.000080: 7. Council for International Organizations of Medical Sciences (CIOMS). International ethical guidelines for
p.000080: biomedical research involving human subjects. Geneva, CIOMS, 2002.
p.000080: 8. Council for International Organizations of Medical Sciences (CIOMS). International ethical guidelines for
p.000080: epidemiological studies. Geneva, CIOMS, 2008.
p.000080: 9. Council of Science Editors. Editorial Policy Statements, Wheat Ridge, CO, Council of Science Editors, 2010.
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p.000080: 15. European Science Foundation. Research Integrity: global responsibility to foster common standards. ORI-ESF
p.000080: Science Policy Briefing 30, Strasbourg, 2007.
p.000080: 16. Forsman, Birgitta, Begrepp om forskningsfusk, rapport till Vetenskapsrådet, 2007.
p.000080: 17. Hermerén, Göran, Hanteringen av integritetskänsligt forskningsmaterial, Vetenskapsrådet, 2007. International
p.000080: Committee of Medical Journal Editors (ICMJE). Uniform Requirements for Manuscripts Submitted to Biomedical Journals,
p.000080: (Vancouver Rules), ICMJE, updated 2010.
p.000080: 18. Jordbruksverket, Användningen av försöksdjur i Sverige under 2008. Rapport, Dnr: 31-502/09.
p.000080: 19. Justitiedepartementet, Offentlighet och sekretess hos det allmänna, 2009.
p.000080: 20. Livsmedelsverket, Läkemedelsförmånsnämnden, Läkemedelsverket, Statens beredning för medicinsk utvärdering,
p.000080: Smittskyddsinstitutet, Socialstyrelsen och Statens folkhälsoinstitut, Hantering av jäv, intressekonflikter och
p.000080: bindningar när externa experter anlitas, 2008.
p.000080: 21. National Science Foundation (NSF), Research Misconduct Regulation, Key Regulations 45 CFR 689, 1982.
p.000080: 22. Office of Research Integrity (ORI), ORI Annual Report 2007, Rockville, ORI, 2008.
p.000080: 23. Office of Research Integrity (ORI), ORI sample policy and procedures for responding to research misconduct
p.000080: allegations, Rockville, U.S. Department of Health and Human Services, 2009.
p.000080: 24. Office of Research Integrity (ORI), Federal Research Misconduct Policy. Federal Register: December 6, 2000,
p.000080: Volume 65, Number 235, Notices, Page 76260–76264.
p.000080: 25. Organisation for Economic Co-operation and Development (OECD). OECD Principles and Guidelines for Access to
p.000080: Research Data from Public Funding. Paris, OECD, 2007.
p.000080: 26. Organisation for Economic Co-operation and Development (OECD), Investigating research misconduct allegations in
p.000080: international collaborative research projects. A practical guide, Paris, OECD, 2009.
p.000080: 27. Riksarkivet, Om gallring – från utredning till beslut. Rapport, 1999:1.
p.000080: 28. Sveriges universitets- och högskoleförbund (SUHF), Riktlinjer för hantering vid universitet och högskolor av
p.000080: frågor om vetenskaplig ohederlighet. Stockholm, SUHF, 1997.
p.000080: 29. Sveriges universitets- och högskoleförbund (SUHF), Övergripande principer för offentlighet och sekretess i
p.000080: integritetskänslig forskning. SUHF, 2006.
p.000080:
p.000080:
p.000080: GOOD RESEARCH PRACTICE
p.000081: 81
p.000081:
p.000081: 30. Sveriges universitetslärarförbund (SULF), Etiska riktlinjer för universitetslärare, 2005.
p.000081: 31. The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for
p.000081: Human Use (ICH). E6(R1): Good clinical practice: consolidated guideline, adopted by CPMP, July 1996, issued as
p.000081: CPMP/ICH/135/95/Step5, Geneva, 1996.
p.000081: 32. Uppsala universitet, Hantering av allmänna handlingar vid universitetet. Tredje upplagan, 2009.
p.000081: 33. Vetenskapsrådet, Jävspolicy för Vetenskapsrådet, 2014.
p.000081: 34. World Medical Association. Declaration of Helsinki. Ethical Principles for Medical Research Involving Human
p.000081: Subjects, adopted by the 18th WMA General Assembly, Helsinki, Finland, June 1964, latest revision by the WMA General
p.000081: Assembly, Seoul 2013. Ferney-Voltaire, France, World Medical Association, 2013.
p.000081:
p.000081:
p.000081:
p.000081:
p.000081:
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Searching for indicator accessXtoXinformation:
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p.000038: transparency. It is thus important to have a general discussion on ethical issues in the handling of
p.000038: integrity-sensitive material. Awareness of both the rules and the problems needs to increase within the research
p.000038: community.
p.000038:
p.000038: 4.2 Interest considerations and various types of research
p.000038: In research, this means finding a reasonable way of weighing up many types of interests which are all legitimate, but
p.000038: which in some situations can conflict with each other: the researcher’s interest in obtaining new knowledge, the
p.000038: interest of participants and those affected by the research to have their integrity and private lives protected, and
p.000038: patients’ interest in information they have given their doctor remaining only between them.
p.000038: Funding bodies for basic research, such as the Swedish Research Council, have an interest in openness and transparency.
p.000038: Other funding bodies may have an interest, from a societal perspective, in material being reused or used by many groups
p.000038: – an important task in this case is to specify the conditions under which this can be done.
p.000038: How this weighing of interests is done depends on aspects such as the type of research is being conducted. A
p.000038: significant difference in this context is the distinction between research which is not being conducted in connection
p.000038: with healthcare, and that which is. This distinction is important, as different regulations apply in the two cases.
p.000038: If research is combined with healthcare, for example, the Patient Data Act and the provisions applicable to healthcare
p.000038: operations in the Public Access to Information and Secrecy Act apply. It is therefore important to keep several types
p.000038: of journals – both on the patient/treatment being provided, and on the research itself. The patient/treatment journals
p.000038: should only contain information that is necessary for the patient to receive good and
p.000038:
p.000038:
p.000038:
p.000038: GOOD RESEARCH PRACTICE
p.000039: 39
p.000039:
p.000039: safe treatment. Information required for the research project should be reserved for the research journals. The same
p.000039: applies in retrospective studies, especially if they deal with integrity-sensitive questions.
p.000039: But in any type of research, the material collected is not the private property of the researcher or research group,
p.000039: something they own and can do with as they wish. It must be stored and archived according to the general regulations
p.000039: issued by each authority in question.
p.000039:
p.000039: 4.3 Four concepts
p.000039: Four important concepts in the debate that are sometimes confused with each other or used synonymously are secrecy,
p.000039: professional secrecy, anonymity and confidentiality.
p.000039: Information can be covered by secrecy only if it is stated in law, normally the Public Access to Information and
p.000039: Secrecy Act.
p.000039: Standards for professional secrecy apply to some professions by law, as well as by ethics rules. All personnel in
p.000039: health and medical care, dental care and social services, for instance, must observe professional secrecy. This means
p.000039: that they are not allowed to discuss patients’ and clients’ health or personal situation with unauthorised individuals,
p.000039: or in any other way communicate this information. Similar standards for professional secrecy also apply to
p.000039: psychologists and clergy, for example. If a certain task is covered by secrecy, it means the person carrying out the
p.000039: task has a duty of professional secrecy.
p.000039: Anonymising or de-identifying involves eliminating the connection between samples or questionnaire answers and a
p.000039: certain individual, so that neither unauthorised persons nor the research group can re-establish it; no one should
p.000039: therefore be able to combine a certain piece of information with a specific person’s identity, for example. The code
p.000039: list is destroyed. Anonymity can also be achieved by collecting material without noting the identity of specific
p.000039: individuals.
p.000039: What is described above differs from a situation where the research group can use code keys to link information or
p.000039: samples to specific individuals (pseudo-anonymising) – which is usually necessary in longitudinal studies, for
p.000039: instance, or to enable auditing of the research. The question of who is and is not authorised, however, is not
p.000039: something for the researcher to determine ultimately. Disputes over this issue can be settled in court. Usually, it is
p.000039: a case of other researchers wishing to use the information in their research. In some cases, it can be stipulated that
p.000039: their research is ethically reviewed. Various reservations can be set in this context, for example that the researcher
p.000039: may have access to the information but is not allowed to contact the subjects studied.
p.000039: Confidentiality is a more general obligation not to communicate information given in confidence, and entails protection
p.000039: against unauthorised persons partaking of the information.
p.000039:
p.000039: 4.4 What can researchers promise?
p.000039: There are some things researchers cannot promise and yet do promise anyway – due to being poorly informed of applicable
p.000039: rules or because they confuse the four concepts discussed above.
p.000039:
p.000039: 4.4.1 Secrecy
p.000039: The basic principle is that public documents shall be publicly accessible and that information can be covered by
p.000039: secrecy only if falls under a specific provision of the Public Access to Information and Secrecy Act. The Act contains
p.000039: a chapter that specifically addresses secrecy to protect the individual in research (Chapter 24). But in addition, the
p.000039: Act contains many other provisions that the researcher may have to address, for instance regarding secrecy to protect
p.000039: the individual within health and medical care in Chapter 25.
p.000039: The principle of public access covers public activities, and those activities listed in the appendix to the Act. When a
p.000039: request for information from public documents is received, the authority where it is being stored (for example a
p.000039: university or a county council) is required to evaluate whether the information may be handed out, that is to say
p.000039: whether or not the information is covered by secrecy.
p.000039:
p.000039:
p.000039:
p.000039:
p.000039:
p.000039:
p.000039:
p.000039: GOOD RESEARCH PRACTICE
p.000040: 40
p.000040:
p.000040: 4.4.2 Professional secrecy
p.000040: Professional secrecy follows from secrecy to the extent that if certain information is covered by secrecy, then this
p.000040: also entails a requirement of professional secrecy about it. However, the opposite is not true.
p.000040: If professional secrecy applies for a certain activity, this does not necessarily mean that what is said during the
p.000040: activity is automatically covered by secrecy or that it that it falls under the Public Access to Information and
p.000040: Secrecy Act. Furthermore, it can happen that a researcher, through his or her work on a project, becomes aware of some
p.000040: circumstance that must be reported by law (such as child abuse or paedophilia). In such cases, the obligation to report
p.000040: outweighs the secrecy requirement.
p.000040:
p.000040: 4.4.3 Anonymity
p.000040: In some cases, the anonymising of information is a condition set by an ethics review board for its approval of a study.
p.000040: This can be done, for example, by removing personal information on completed questionnaires or samples, so that it is
p.000040: difficult or in practice impossible to link a certain answer or sample to a specific individual. In some types of
p.000040: studies, the identity of the individuals is not relevant, for instance studies on variations in attitudes towards a
p.000040: certain issue in a specific group over time. In such situations, researchers can promise anonymity.
p.000040: It should be noted, however, that this strategy has other drawbacks. Not only is it difficult or impossible to verify
p.000040: the researcher’s information, but it can also happen that an entire group is stigmatised or discriminated against due
p.000040: to the publication of certain research results, even if no individual person in the group can be identified.
p.000040:
p.000040: 4.4.4 Confidentiality
p.000040: The Declaration of Helsinki stresses the importance of confidentiality and of the researcher taking measures to protect
...
p.000041: research group will have access to the data. Later, his findings are questioned by two other researchers, Brian and
p.000041: Cecilia, who request access to his source data. Adam refuses to hand them over, referring to his promise to his
p.000041: informants. The case reaches an unexpected conclusion when colleagues of Adam’s say they have destroyed the source data
p.000041: on their own initiative.
p.000041: Is the action taken by Adam’s colleagues ethically defensible? Is it compatible with existing legislation? Has Adam
p.000041: promised more than he can deliver?
p.000041:
p.000041: 4.5 Documentation
p.000041: Data collected for a research project is called source data. Sometimes, researchers consider source data to be their
p.000041: own individual property. This might possibly be the case if the research is privately funded and conducted by
p.000041: individuals not associated with normal research environments, and the data does not include personal data.
p.000041: But when the research is conducted at a university or other research institution, or when it is funded with public
p.000041: funds through grants from a research council or foundation, it is the organisation where the research is conducted that
p.000041: owns the material. The researcher or research group can thus not do whatever they want with it, for instance take it
p.000041: with them upon changing jobs, without agreements and special arrangements. Source data and material that documents the
p.000041: research process and the project’s various steps should instead be regarded as documents (submitted, upheld) belonging
p.000041: to the organisation and fall under the Public Access to Information and Secrecy Act and the Archives Act.
p.000041: The material from a completed research project should therefore be stored and archived, with subsequent preservation
p.000041: and occasional sorting. If it is integrity-sensitive, there are also specific requirements for how it should be stored.
p.000041: Information on this is provided by the Data Inspection Board, among others. There are many reasons to keep material.
p.000041: For instance, it must be possible to verify research results6, or the material might be requested in the investigation
p.000041: of an accusation of research misconduct. It can also happen that the researcher who obtained the results, or other
p.000041: researchers, wish to reuse the material in another project. As a rule, this type of reuse requires a new ethics review.
p.000041: The material may also be of great value in itself, for example if it documents current societal conditions, in which
p.000041: future generations may have an interest.
p.000041: Whether, when and how an organisation may sort material is addressed in the Archives Act. If material is considered
p.000041: valuable, for instance for the way in which current society will be regarded in the future, it should be saved by the
p.000041: institution. The National Archives should be consulted as to how to proceed.
p.000041: It is important that research institutions and similar establish procedures for documentation, archiving and sorting,
p.000041: and that these procedures are known and observed by their researchers.
p.000041: Making data material collected available to other researchers contributes to facilitating both the scrutiny and the
p.000041: development and application of research. Digitally stored data can today be uploaded onto platforms where it becomes
...
p.000073: of how the issue of informed consent has been handled. Regional ethics boards are also able to issue advisory
p.000073: statements on research involving human subjects in the event the research is not covered by the Act (SFS 2003:460)
p.000073: concerning the Ethical Review of Research Involving Humans. Such statements are sometimes required in order to obtain
p.000073: financial support, or to enable publication of results in certain international journals. Reviews by the regional
p.000073: boards are subject to a fee and shall be undertaken within 60 days from receipt of application. More information is
p.000073: available on (epn.se).
p.000073:
p.000073: 9.3 Secrecy
p.000073: Researchers need to know whether the data handled within the research they carry out is covered by secrecy, and if so,
p.000073: what the secrecy parameters are. A significant factor when determining the secrecy parameters for a task is who is
p.000073: carrying out the activity.
p.000073:
p.000073: 9.3.1 Public principal
p.000073: The Freedom of the Press Act contains regulations for public documents stored by public authorities. The starting point
p.000073: is that public documents are open to the general public, and that the general public’s access to these may only be
p.000073: limited for the purposes listed in Chapter 2 Section 2 of the Act. One of the purposes is the protection of the
p.000073: personal or financial circumstances of individuals. The issue of when data may be covered by secrecy under this
p.000073: exception is regulated in particular in the Public Access to Information and Secrecy Act (SFS 2009:400). This Act
p.000073: contains provisions that apply to the handling of personal data within the framework of health and medical care, in
p.000073: research activities and other activities carried on by public agencies.
p.000073: The regulations in the Act also entail that those who work at a public agency are automatically covered by professional
p.000073: secrecy rules. It is important to remember that employees have an obligation of professional secrecy under the Act, but
p.000073: cannot have a more comprehensive obligation imposed. That means that if data is covered by secrecy under the Act, it
p.000073: must not be disclosed, at the same time that data that is public must be disclosed on demand.
p.000073:
p.000073:
p.000073:
p.000073:
p.000073:
p.000073:
p.000073:
p.000073: GOOD RESEARCH PRACTICE
p.000074: 74
p.000074:
p.000074: 9.3.2 Private principal
p.000074: Private actors have no obligation to disclose data, or keep data secret, unless this follows from special legislation
p.000074: covering their activities. Such regulations exist, for example for private caregivers, in Chapter 6 of the Patient
p.000074: Safety Act. If there are no particular regulation, private actors may themselves decide on the secrecy protection that
p.000074: shall apply for a certain task.
p.000074: This also means that employees of private employers do not have any statutory obligation of secrecy, unless this
p.000074: follows from special regulations, such as those in the Patient Data Act. This must instead be regulated between the
p.000074: employee and the employer in such a way that the private employer ensures that data that shall not be disseminated are
p.000074: kept secret.
...
Social / Child
Searching for indicator child:
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p.000026: Overt observation studies, in which participants know research is being conducted, are used, for example, to study the
p.000026: work within different organisations, or at an emergency room or a school. The observations should be performed
p.000026: systematically using observation schedules, notes, etc. The researcher should strive for objectivity and try not to
p.000026: influence research subjects or events.
p.000026: Ethical considerations are very important in participant observation. The researcher is responsible for preventing any
p.000026: damage, and for ensuring the identities of those observed will not be revealed. Although this requirement may be
p.000026: difficult to fulfil, it is necessary.
p.000026: One way to observe human beings is through video recording. Research using a video can intrude on the private lives and
p.000026: integrity of individuals, as it is possible to identify them. Video recording should therefore only be used when it is
p.000026: impossible to achieve the same results with the help of other data collection methods. For example, masked photographs
p.000026: can be used instead of video if it is not necessary to study the subjects’ movements, facial expressions or
p.000026: interaction/communication.
p.000026: It is important that the recording is done in a respectful and responsible way. Individual integrity must be respected.
p.000026: If underage subjects are to be video recorded, the same special rules apply as for other research involving children.
p.000026: This means that if the child is less than 15 years old, both guardians and the child must have consented to the
p.000026: participation. The information should be written in such a way that the child too can understand it (according to the
p.000026: Act concerning the Ethical Review of Research Involving Humans).
p.000026: Just as for other research, the video recording shall be preceded by detailed information and consent be given
p.000026: afterwards. This information should describe the purpose of the research, and emphasise that participation is
p.000026: voluntary. Those asked to participate shall also be informed of exactly what the researchers intends to analyse in the
p.000026: video recording, and why other forms of registration have not been considered suitable or sufficient. As it is a
p.000026: question of personal data being handled, the personal data controller for the handling shall also be named.
p.000026: The information (which should be both oral and written) to the informants shall also include more detailed information
p.000026: on the following:
p.000026:
p.000026: • Whether any editing of the recording will be done, for example to disguise the face and/or voice
p.000026: • Whether the video recording will be copied, and if so how many copies will be made
p.000026: • Whether the recording will also be used for any other purpose than for research, for example educational purposes
p.000026: • Whether any other analysis will be carried out in addition to those first stated – if so, both the regional ethics
p.000026: review board and the informant must be asked
p.000026: • The informant is probably entitled to demand a copy of the recording as a registry excerpts under Section 26 of the
p.000026: Personal Data Act
p.000026: • That any links between the recording and other personal data will be encoded
p.000026: • How and where the recording will be stored, and for how long it will be saved
p.000026:
...
p.000039: Act contains many other provisions that the researcher may have to address, for instance regarding secrecy to protect
p.000039: the individual within health and medical care in Chapter 25.
p.000039: The principle of public access covers public activities, and those activities listed in the appendix to the Act. When a
p.000039: request for information from public documents is received, the authority where it is being stored (for example a
p.000039: university or a county council) is required to evaluate whether the information may be handed out, that is to say
p.000039: whether or not the information is covered by secrecy.
p.000039:
p.000039:
p.000039:
p.000039:
p.000039:
p.000039:
p.000039:
p.000039: GOOD RESEARCH PRACTICE
p.000040: 40
p.000040:
p.000040: 4.4.2 Professional secrecy
p.000040: Professional secrecy follows from secrecy to the extent that if certain information is covered by secrecy, then this
p.000040: also entails a requirement of professional secrecy about it. However, the opposite is not true.
p.000040: If professional secrecy applies for a certain activity, this does not necessarily mean that what is said during the
p.000040: activity is automatically covered by secrecy or that it that it falls under the Public Access to Information and
p.000040: Secrecy Act. Furthermore, it can happen that a researcher, through his or her work on a project, becomes aware of some
p.000040: circumstance that must be reported by law (such as child abuse or paedophilia). In such cases, the obligation to report
p.000040: outweighs the secrecy requirement.
p.000040:
p.000040: 4.4.3 Anonymity
p.000040: In some cases, the anonymising of information is a condition set by an ethics review board for its approval of a study.
p.000040: This can be done, for example, by removing personal information on completed questionnaires or samples, so that it is
p.000040: difficult or in practice impossible to link a certain answer or sample to a specific individual. In some types of
p.000040: studies, the identity of the individuals is not relevant, for instance studies on variations in attitudes towards a
p.000040: certain issue in a specific group over time. In such situations, researchers can promise anonymity.
p.000040: It should be noted, however, that this strategy has other drawbacks. Not only is it difficult or impossible to verify
p.000040: the researcher’s information, but it can also happen that an entire group is stigmatised or discriminated against due
p.000040: to the publication of certain research results, even if no individual person in the group can be identified.
p.000040:
p.000040: 4.4.4 Confidentiality
p.000040: The Declaration of Helsinki stresses the importance of confidentiality and of the researcher taking measures to protect
p.000040: the integrity of research subjects and their right to protection of their private lives. This is stated in the latest
p.000040: version of the Declaration from 2013, where it is stressed that:
p.000040:
...
Searching for indicator children:
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p.000019: asked. The question should preferably also be important and its answer clearly and strictly formulated. If a study does
p.000019: not answer its question, it should not be conducted in its current design.
p.000019: When you decide to begin a research project, you should choose a method with the fewest imaginable harmful consequences
p.000019: on the people and/or animals involved, if the methods are otherwise somewhat equal. Additionally, the benefit of the
p.000019: planned research and the scientific value of its expected results should always be weighed against its harmful
p.000019: consequences. This is discussed further in Chapter 3.
p.000019: An example can illustrate how important is it to think about whether a certain study might provide an answer to the
p.000019: question you have decided to study. Assume that you want to determine who has power in a certain community. First, you
p.000019: have to specify what you mean by power. It is one thing to have the power to keep certain issues from being brought up
p.000019: on the agenda of meetings of political deciding making bodies, and quite another to have a reputation as powerful and
p.000019: influential. The latter phenomenon can be studied through interviews and questionnaires in which people are asked who
p.000019: they believe has power in certain issues, but it is doubtful that this method would help in answering the first
p.000019: question. Neither could the first question be studied by looking at who is the most successful in pushing their
p.000019: proposals through in political deciding bodies at various levels.
p.000019: Another example: Determining whether there is a difference in the effect and safety of a flu vaccination between
p.000019: children who have not previously had the vaccination and those who have is a reasonable and interesting task. To study
p.000019: this, you should be able to conduct a controlled study of these two groups of children and examine whether there is any
p.000019: statistically significant difference. But if you want to answer the question by comparing to children previously
p.000019: vaccinated for something else, for instance hepatitis, it becomes unclear what function the control group has and what
p.000019: question is being answered.
p.000019:
p.000019:
p.000019:
p.000019: GOOD RESEARCH PRACTICE
p.000020: 20
p.000020:
p.000020: 2.1.4 Who bears the responsibility?
p.000020: When it comes to how research should be conducted and who has the responsibility for its being conducted in a
p.000020: satisfactory way scientifically and ethically, it can help to distinguish between the respective responsibilities of
p.000020: the individual researcher, the project leader, the department head and the research principal, even if the borders
p.000020: between them are not always sharp. In certain types of research another aspect also arises: the responsibility of the
p.000020: commissioning party or funding body.
p.000020: An issue for the individual researcher to consider is the choice of research question. This choice can be between, for
p.000020: example, a well-defined problem that can give relatively quick publishable results but does not seem to have any
p.000020: greater significance for society on the one hand and a more diffuse or less meritable project of substantial societal
p.000020: significance. This choice must be made by the individual researcher.
p.000020: Within all disciplines the researcher also chooses among the various subject areas, focuses and problems. For instance,
p.000020: within history a researcher can take an interest in the history of individuals, groups or countries from many
p.000020: perspectives, including mentality, political, legal, economic and/or others.
...
p.000025: is being conducted. It can happen that the research environment at a department is so focused on a certain method that
p.000025: alternatives are not discussed or even considered. In such a case, it can be beneficial to consciously seek out
p.000025: alternatives and – possibly in collaboration with researchers within other method traditions – conduct parallel studies
p.000025: using different methods.
p.000025: In science, method issues are a hot topic and are linked to criteria for scientific quality. This is also the case in
p.000025: the humanities and social sciences. There is thus not only a practical difference between studies on people that are
p.000025: based on measurements, e.g. of reaction times or response frequency in schematic questionnaire surveys on the one hand,
p.000025: and on the other hand studies in which people’s views are interpreted – as in letter collections or interviews. In
p.000025: discussions, the generalisability and more or less claimed objectivity of the results can end up being in opposition to
p.000025: the interest and “depth” of the scientific claims. This does not mean that research collaboration combining different
p.000025: methods cannot be fruitful, however.
p.000025: Method choice also has an ethical aspect. In studies of the first type mentioned above, the researcher’s relation to
p.000025: the people being studied is often more distant, while in the second type it is more involved. In both cases, the
p.000025: researcher’s position can entail ethical complications or risks.
p.000025: The choice of method can present many other important ethical considerations, for example whether animal subjects can
p.000025: be completely or partially replaced by tissue samples. Or there could be a question of how an interview study on
p.000025: children of abused mothers should be limited, to what degree violent tendencies or intelligence should be measured in
p.000025: studies on the socialisation of different ethnic groups, etc. At international level in particular, discussions are
p.000025: being held on the research ethics of so-called participant observation, a method used in the fields of social and
p.000025: behavioural science, among others.
p.000025:
p.000025: 2.3.3 Observational studies conducted through participating, observing and recording
p.000025: For some research questions participant observation may be used, but this research method is associated with a large
p.000025: number of ethical problems.
p.000025: The methods of participating, observing and/or recording can be used in several situations. A researcher may want to
p.000025: actually be in the research subjects’/informants’ environment and observe what happens, hear what is said and follow
p.000025: the persons’ interactions. In some situations, covert participant observation is used. This type of secret or disguised
p.000025: research is rare, however, and should be the exception rather than the rule.
p.000025: The ideal situation is always that those to whom the research applies should be informed that they are the subject of
p.000025: research, and should normally also have given their written consent. If the research includes handling any personal
p.000025: data, the Personal Data Act applies. If the personal data is also so-called “sensitive personal data”
p.000025:
p.000025:
p.000025: GOOD RESEARCH PRACTICE
p.000026: 26
p.000026:
p.000026: (see Chapter 3), then approval from an ethics review board must also be obtained. It is worth mentioning in this
p.000026: context that recording of sound from and/or images of persons constitutes handling of personal data (see Chapter 9).
p.000026: Overt observation studies, in which participants know research is being conducted, are used, for example, to study the
p.000026: work within different organisations, or at an emergency room or a school. The observations should be performed
p.000026: systematically using observation schedules, notes, etc. The researcher should strive for objectivity and try not to
p.000026: influence research subjects or events.
p.000026: Ethical considerations are very important in participant observation. The researcher is responsible for preventing any
p.000026: damage, and for ensuring the identities of those observed will not be revealed. Although this requirement may be
p.000026: difficult to fulfil, it is necessary.
p.000026: One way to observe human beings is through video recording. Research using a video can intrude on the private lives and
p.000026: integrity of individuals, as it is possible to identify them. Video recording should therefore only be used when it is
p.000026: impossible to achieve the same results with the help of other data collection methods. For example, masked photographs
p.000026: can be used instead of video if it is not necessary to study the subjects’ movements, facial expressions or
p.000026: interaction/communication.
p.000026: It is important that the recording is done in a respectful and responsible way. Individual integrity must be respected.
p.000026: If underage subjects are to be video recorded, the same special rules apply as for other research involving children.
p.000026: This means that if the child is less than 15 years old, both guardians and the child must have consented to the
p.000026: participation. The information should be written in such a way that the child too can understand it (according to the
p.000026: Act concerning the Ethical Review of Research Involving Humans).
p.000026: Just as for other research, the video recording shall be preceded by detailed information and consent be given
p.000026: afterwards. This information should describe the purpose of the research, and emphasise that participation is
p.000026: voluntary. Those asked to participate shall also be informed of exactly what the researchers intends to analyse in the
p.000026: video recording, and why other forms of registration have not been considered suitable or sufficient. As it is a
p.000026: question of personal data being handled, the personal data controller for the handling shall also be named.
p.000026: The information (which should be both oral and written) to the informants shall also include more detailed information
p.000026: on the following:
p.000026:
p.000026: • Whether any editing of the recording will be done, for example to disguise the face and/or voice
p.000026: • Whether the video recording will be copied, and if so how many copies will be made
p.000026: • Whether the recording will also be used for any other purpose than for research, for example educational purposes
...
p.000031: In clinical trials, except so-called non-intervention studies, it is a requirement that approval is obtained from the
p.000031: Swedish Medical Products Agency (see Chapter 7 Section 9 of the Medicinal Products Act SFS 2015:315). This also applies
p.000031: to trials of a drug for an approved indication, at an approved dosage and with an approved method of administration
p.000031: with the aim of further showing effect and/or safety. The Agency has issued detailed rules for how clinical trials of
p.000031: drugs for humans shall be conducted. Applications to the Swedish Medical Products Agency shall be made by the sponsor,
p.000031: i.e. the individual, company, institution or organisation that assumes responsibility for starting, organising and/or
p.000031: funding the clinical trial. More information on regulations and the steps of the application process can be found on
p.000031: the Agency’s website (www.lakemedelsverket.se.).
p.000031: Applications for clinical trials within the EU are registered in the database Eudra CT (European Clinical Trials
p.000031: Database). Currently, this database is only accessible to national medical products agencies, for instance the Swedish
p.000031: Medical Products Agency, the European Medicines Agency (EMA), and the Commission. As a step towards increasing the
p.000031: transparency within the EU, access to certain parts of the database’s content will soon be given to the general public
p.000031: via the website www.clinicaltrialsregister.eu. On this website, information on issues such as ethics committee
p.000031: decisions regarding clinical trials on children will be publicly accessible. In the US, the corresponding database is
p.000031: ClinicalTrials.gov.
p.000031: To conduct a research project involving the irradiation of research subjects with ionising radiation, the project must
p.000031: be approved by a local radiation protection committee. (See 22 § of the Swedish Radiation Safety Authority’s rules
p.000031: regarding general obligations in medical and odontological activities involving ionising radiation, SSMFS 2008:35). For
p.000031: multicentre studies, an application must be sent to all local radiation protection committees within the study’s scope.
p.000031:
p.000031: 3.2 Research on animals and laboratory animal ethics
p.000031:
p.000031: 3.2.1 The use of laboratory animals
p.000031: Laboratory animal ethics deals with the ethical issues that arise when animals are used in scientific experiments. In
p.000031: society, it is a common perception that animal experiments are needed for development and research within both human
p.000031: and veterinary medicine. Research using animals is thus conducted partly because it provides new knowledge, partly
p.000031: because it benefits humans, and not infrequently also for the sake of animals themselves.
p.000031: The production of new medicines is highly dependent on animal experiments. A long line of medical advances that have
p.000031: saved many human lives were possible thanks to the use of animals. The law does not allow the testing of medicinal
p.000031: preparations on humans, and even less their being used in treatment, before they have been tested on animals or through
...
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037: GOOD RESEARCH PRACTICE
p.000038: 38
p.000038:
p.000038: 4 HANDLING OF RESEARCH MATERIAL
p.000038: - THINK FIRST
p.000038:
p.000038: This chapter, with the exception of Section 4.5, is the translation of a text that is virtually identical to that of
p.000038: Göran Hermerén’s article, “Hantering av integritetskänsligt material”.
p.000038:
p.000038: 4.1 Background and problems
p.000038: The fundamental openness in all public organisations is required by law and established constitutionally. Universities
p.000038: and individual researchers can therefore not take it upon themselves to weigh the interest of public access against
p.000038: other interests.
p.000038: The Declaration of Helsinki, adopted by the World Medical Association, is an important document for medical research
p.000038: ethics. The ethical principles stated in the Declaration are in part also applicable to other research, not least
p.000038: certain social medicine and social science research. This document has been updated a number of times, most recently in
p.000038: October 2013.
p.000038: However, the Declaration of Helsinki is not legally binding. This was reiterated by the Swedish Court of Appeal for
p.000038: Western Sweden in a case a number of years ago that received a great deal of attention; A view that was upheld by the
p.000038: European Court of Justice in 2010. The issue concerned a request that a researcher in Göteborg make public the research
p.000038: material from a controversial study on children with neuropsychiatric disabilities.
p.000038: Swedish law carries more weight than this international declaration in cases when they come into conflict.
p.000038: These issues have received attention in medical research, for instance in the debate and trials that have followed in
p.000038: the wake of the Göteborg case. But the issues have a more general and fundamental side as well, as they also arise in
p.000038: many other scientific areas, such as the humanities (integrity-sensitive information on famous politicians and authors)
p.000038: and social sciences (integrity-sensitive information on individuals and groups that may be revealed in studies).
p.000038: In these cases, the requirements for public access, openness and transparency sometimes come into conflict with the
p.000038: requirement to protect the integrity of research subjects and informants. These issues also carry a danger that current
p.000038: regulation systems increase the risk that studies will be performed outside the healthcare arena, where there is less
p.000038: transparency. It is thus important to have a general discussion on ethical issues in the handling of
p.000038: integrity-sensitive material. Awareness of both the rules and the problems needs to increase within the research
p.000038: community.
p.000038:
p.000038: 4.2 Interest considerations and various types of research
p.000038: In research, this means finding a reasonable way of weighing up many types of interests which are all legitimate, but
...
p.000077: 2007.
p.000077: 17. Görman, Ulf & Andrén, Carl-Gustaf & Hermerén, Göran, Att forma vår framtid: bioteknikens möjligheter och
p.000077: problem. Lund, Nordic Academic Press, 2009.
p.000077:
p.000077:
p.000077: GOOD RESEARCH PRACTICE
p.000078: 78
p.000078:
p.000078: 18. Hansson, Mats G., Integritet. I spänningen mellan avskildhet och delaktighet, Stockholm, Carlsson Bokförlag,
p.000078: 2006.
p.000078: 19. Helgesson, Gert, Forskningsetik för medicinare och naturvetare, Lund, Studentlitteratur, 2006.
p.000078: 20. Hermerén, Göran, Kunskapens pris: forskningsetiska problem och principer i humaniora och samhällsvetenskap.
p.000078: Stockholm, Swedish Science Press & HSFR, 1986, andra upplagan 1996.
p.000078: 21. Hermerén, Göran, ”Vi kommer aldrig att ha forskat färdigt kring de etiska problemen”. Praktik & Teori, 2007,
p.000078: 2:44–51.
p.000078: 22. Hermerén, Göran, ”Challenges in the Evaluation of Nanoscale Research: Ethical Aspects”. Nano Ethics, 2007,
p.000078: 1:223–237.
p.000078: 23. Hermerén, Göran, Hug, Kristina (red). Translational Stem Cell Research: Issues Beyond the Debate on the Moral
p.000078: Status of the Human Embryo. New York, Springer, 2010.
p.000078: 24. Karlsson, Fredrik, Weighing Animal Lives – a Critical Assessment of Justification and Prioritization in
p.000078: Animal-Rights Theories. Uppsala, Acta Universitatis Upsaliensis, 2009.
p.000078: 25. Klareskog, Lars & Rönnelid, Johan & Lundberg, Karin & Padyukov, Leonid & Alfredsson, Lars, ”Immunity to
p.000078: citrullinated proteins in rheumatoid arthritis.” Annual Review of Immunology, 2008, 26:651–675.
p.000078: 26. Kodish, Eric (ed), Ethics and research with children. A case-based approach. Oxford & New York, Oxford
p.000078: University Press, 2005.
p.000078: 27. Kuhn, Thomas S., De vetenskapliga revolutionernas struktur (1962). Stockholm, Thales, andra upplagan, 2009.
p.000078: 28. Loue, Sana, Textbook of research ethics. Theory and practice. Dordrecht, Kluwer, 2000.
p.000078: 29. Lynøe, Niels, Mellan cowboyetik och scoutmoral: medicinsk forskningsetik i praktiken. Stockholm, Liber, 1999.
p.000078: 30. Lynøe, Niels & Juth, Niklas, Medicinska etikens ABZ. Stockholm, Liber, 2009.
p.000078: 31. Macklin, Ruth, Double standards in medical research in developing countries. Cambridge, Cambridge University
p.000078: Press, 2004.
p.000078: 32. Merton, Robert, ”The Normative Structure of Science” (1942), in Merton, R., The Sociology of Science: University
p.000078: of Chicago Press, 1973.
p.000078: 33. Murphy, Timothy, F., Case Studies in Biomedical Research Ethics. Cambridge, Mass., MIT Press, 2004.
p.000078: 34. Myrdal, Janken, Spelets regler i vetenskapens hantverk: Om humanvetenskap och naturvetenskap. Stockholm, Natur &
p.000078: Kultur, 2009.
p.000078: 35. Newman, W. Lawrence, Social Research Methods, Qualitative and Quantitative Approaches. 5th edition. Boston etc,
p.000078: Pearson Education, 2003.
p.000078: 36. Pence, Gregory E., Classic Cases in Medical Ethics. New York, McGraw Hill, 2000.
p.000078: 37. Perel, Pablo, & Roberts, Ian & Sena, Emily & Wheble, Philipa & Briscoe, Catherine & Sandercock, Peter & Macleod,
p.000078: Malcolm & Mignini, Luciano E. & Jayaram, Pradeep & Khan, Khalid S., ”Comparison of Treatment Effects between Animal
...
Social / Ethnicity
Searching for indicator ethnic:
(return to top)
p.000025: alternatives and – possibly in collaboration with researchers within other method traditions – conduct parallel studies
p.000025: using different methods.
p.000025: In science, method issues are a hot topic and are linked to criteria for scientific quality. This is also the case in
p.000025: the humanities and social sciences. There is thus not only a practical difference between studies on people that are
p.000025: based on measurements, e.g. of reaction times or response frequency in schematic questionnaire surveys on the one hand,
p.000025: and on the other hand studies in which people’s views are interpreted – as in letter collections or interviews. In
p.000025: discussions, the generalisability and more or less claimed objectivity of the results can end up being in opposition to
p.000025: the interest and “depth” of the scientific claims. This does not mean that research collaboration combining different
p.000025: methods cannot be fruitful, however.
p.000025: Method choice also has an ethical aspect. In studies of the first type mentioned above, the researcher’s relation to
p.000025: the people being studied is often more distant, while in the second type it is more involved. In both cases, the
p.000025: researcher’s position can entail ethical complications or risks.
p.000025: The choice of method can present many other important ethical considerations, for example whether animal subjects can
p.000025: be completely or partially replaced by tissue samples. Or there could be a question of how an interview study on
p.000025: children of abused mothers should be limited, to what degree violent tendencies or intelligence should be measured in
p.000025: studies on the socialisation of different ethnic groups, etc. At international level in particular, discussions are
p.000025: being held on the research ethics of so-called participant observation, a method used in the fields of social and
p.000025: behavioural science, among others.
p.000025:
p.000025: 2.3.3 Observational studies conducted through participating, observing and recording
p.000025: For some research questions participant observation may be used, but this research method is associated with a large
p.000025: number of ethical problems.
p.000025: The methods of participating, observing and/or recording can be used in several situations. A researcher may want to
p.000025: actually be in the research subjects’/informants’ environment and observe what happens, hear what is said and follow
p.000025: the persons’ interactions. In some situations, covert participant observation is used. This type of secret or disguised
p.000025: research is rare, however, and should be the exception rather than the rule.
p.000025: The ideal situation is always that those to whom the research applies should be informed that they are the subject of
p.000025: research, and should normally also have given their written consent. If the research includes handling any personal
p.000025: data, the Personal Data Act applies. If the personal data is also so-called “sensitive personal data”
p.000025:
p.000025:
p.000025: GOOD RESEARCH PRACTICE
p.000026: 26
p.000026:
p.000026: (see Chapter 3), then approval from an ethics review board must also be obtained. It is worth mentioning in this
p.000026: context that recording of sound from and/or images of persons constitutes handling of personal data (see Chapter 9).
...
p.000029: A research project falls within the scope of the Act concerning the Ethical Review of Research Involving Humans because
p.000029: of its content. What is to be reviewed therefore has nothing to do with how the project is funded. Also, research that
p.000029: is not funded by external bodies, but is carried out within a position at an institution, shall therefore be reviewed
p.000029: if the content so requires.
p.000029: A research project shall be reviewed by an ethics review board if any of the following conditions exist.
p.000029: Namely, if the project (A)
p.000029:
p.000029: • entails physical encroachment on the research subject
p.000029: • will be conducted using a method aiming to affect the research subject physically or psychologically, or that
p.000029: carries an obvious risk of physical or psychological harm to the research subject
p.000029: • entails studies on biological material taken from a living human being and can be traced to this person
p.000029: • entails physical encroachment on a deceased human being
p.000029: • entails studies on biological material taken for medical purposes from a deceased human being and can be traced to
p.000029: this person. Act (SFS 2008:192).
p.000029:
p.000029: A research project shall also be reviewed if it (B)
p.000029:
p.000029: • entails the handling of sensitive personal data according to Section 13 of the Personal Data Act (SFS 1998:204),
p.000029: including information on race, ethnic origin, political views or religious conviction, or personal
p.000029:
p.000029:
p.000029:
p.000029:
p.000029: 3The research principal is the government authority or the physical or legal entity within whose organisation the
p.000029: research is conducted. A researcher employed at a university or a county council has the same as his or her research
p.000029: principal. The research principal, through its internal work or delegation order or through power of attorney,
p.000029: determines who is authorised to represent the research principal. The research principal always has ultimate
p.000029: responsibility for the research.
p.000029:
p.000029:
p.000029: GOOD RESEARCH PRACTICE
p.000030: 30
p.000030:
p.000030: data according to Section 21 of the Personal Data Act, including information on judgements in criminal cases.
p.000030:
p.000030: Condition (B) thus means that all research dealing with sensitive personal data shall be ethically reviewed, regardless
p.000030: of how the data has been collected and whether or not the researcher has obtained the participants’ consent.
p.000030: When an ethics review board evaluates a project, it has a number of aspects to note and consider. Generally, the
p.000030: research in question can be approved only if it can be conducted with respect for human dignity. In the review, the
p.000030: board should also evaluate how the human rights and basic freedoms of those involved are treated in relation to the
...
p.000054: before the next application round, or the Germans beat you to it, the livelihoods of a postdoc scholarship holder and a
p.000054: postdoctoral research fellow funded from your council grant will be put in jeopardy.
p.000054: What do you do?
p.000054:
p.000054: 6.7 The author
p.000054: The author is responsible for the contents of a book or article presenting his or her research. That includes
p.000054: everything related to the actual project – methods, validity and reliability of the results, etc. – but also the
p.000054: quality of the manuscript. It is also the author’s responsibility to check a journal’s or publisher’s terms regarding
p.000054: parallel publishing before one and the same manuscript is simultaneously submitted to or published in several different
p.000054: journals. Another responsibility is of course to make sure that the references and quotations in the text are correct.
p.000054: In the case of research based on statistical analysis, a scientific interpretation has to be undertaken, taking careful
p.000054: account of all the basic assumptions and limitations of the procedure used to test the hypothesis. The results also
p.000054: have to be interpreted in the light of previously published findings, and other investigators’ results cited where
p.000054: relevant.
p.000054: Researchers studying, for example, the links between gender and absence from the workplace, the incidence of crime in
p.000054: different groups in the community, or the economic situation, genetics and dietary habits of
p.000054:
p.000054:
p.000054:
p.000054: GOOD RESEARCH PRACTICE
p.000055: 55
p.000055:
p.000055: different ethnic groups, must make sure they present their statistical interpretation of the data, in relation to
p.000055: their scientific hypotheses, and explain what that interpretation shows and what underlying assumptions have been made,
p.000055: not least when the results are published outside traditional academic circles. If the author foresees a risk of
p.000055: over-interpretation in the media, he or she has a responsibility to try to preclude or prevent that risk, especially if
p.000055: it might cause harm to the research subjects or any third parties.
p.000055: A good scientific presentation will include an active discussion of the results by the author. This means that the
p.000055: author should not only cite or refer to works which support the proposition advanced. It is also necessary to present
p.000055: possible arguments against it, and try to respond to them in the text.
p.000055:
p.000055: 6.8 Multiple authors – responsibility – publication rules
p.000055: Why is the question of authorship important?
p.000055: One reason is that the authors’ names are, rightly or wrongly, seen by colleagues in their field as an indication of
p.000055: the quality of a publication. Consequently, it is important to know who actually did the work, so as to be able to
p.000055: evaluate the results. A second reason is that researchers applying for positions are assessed to a large degree on the
p.000055: basis of their publications. Obviously, therefore, it is important that no one is listed as an author who should not
p.000055: be, and that no one who should be so listed is omitted. A third reason is that it must be apparent who bears the
p.000055: responsibility in the event of an investigation into research misconduct.
...
Searching for indicator ethnicity:
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p.000015: Nevertheless, it is important to remember that the concept of scientific quality is used in a broader sense as well. In
p.000015: such cases this entails an overall judgement from which it is not possible to single out individual criteria. When the
p.000015: total quality of the research is evaluated, no single quality can be ignored. The quality is evaluated based on the
p.000015: collective qualities of originality, external and internal validity, precision and ethics. The requirement of good
p.000015: research ethics is thus included here; therefore, there can be no conflict between the demands for good research ethics
p.000015: and good scientific quality. A research report exhibits poor research ethics if it contains scientific shortcomings in
p.000015: the precision of its questions, uses incorrect methods (or uses established methods incorrectly), systematically
p.000015: excludes observations that do not support the author’s hypothesis, handles the problem of dropout in a statistically
p.000015: unacceptable way, or uses a study design that does not allow for the research question to be answered. People’s time
p.000015: has been used needlessly, and they may have been exposed to not only a certain amount of inconvenience or discomfort,
p.000015: but sometimes even suffering. In any case, resources that could have been used in a better way have been wasted. It is
p.000015: also quite easy to find examples of studies that, through superficial correlations between ethnicity, criminality,
p.000015: intelligence, education, etc., have led to the discrimination or stigmatisation of individuals and groups.
p.000015: Unfortunately, there are also examples of cheating in studies on methods for treating breast cancer or links between
p.000015: vaccination and autism. Here, poor scientific quality and poor ethics overlap, leading to the possibility that people
p.000015: can be harmed when the results of the research are applied in practice.
p.000015:
p.000015:
p.000015:
p.000015:
p.000015: GOOD RESEARCH PRACTICE
p.000016: 16
p.000016:
p.000016: There can sometimes also be economic and time frames that tempt researchers to take shortcuts, which can cause the
p.000016: research to fail in meeting both scientific and ethical quality criteria. If the problem is due solely to these
p.000016: factors, there is no fundamental opposition between the two; with other time frames or better economic resources, the
p.000016: problem would not surface. We thereby find ourselves back in a situation of type (1), in which there is no fundamental
p.000016: opposition between the diverse types of quality criteria. Against this background it is reasonable to regard work to
p.000016: improve the ethical aspects of the research as a quality issue.
p.000016:
p.000016: Stanley Milgram conducted experiments with volunteer subjects. The subjects were informed that they, as “teachers”,
p.000016: were to give an electric shock to “students” when they answered incorrectly, and that they were to increase the
p.000016: strength of the shock with each successive wrong answer. The students then simulated great pain. Everything was
...
Social / Incarcerated
Searching for indicator liberty:
(return to top)
p.000072: administration, planning, follow-up, evaluation and supervision of the activities, or to produce statistics relating to
p.000072: health and medical care; see Chapter 2 Section 4 of the Patient Data Act. The aim of stating purposes is to establish
p.000072: an outer-most limit for when personal data may be collected and then processed. The starting point is thus that only
p.000072: such personal data handling may take place as is covered by one or several of the stated purposes, see Govt. Bill
p.000072: 2007/08:126 p. 228.
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072: GOOD RESEARCH PRACTICE
p.000073: 73
p.000073:
p.000073: 9.2.2 The Act concerning the Ethical Review of Research Involving Humans
p.000073: Since 1 January 2004, the Act concerning the Ethical Review of Research Involving Humans has been in force. It covers
p.000073: research involving living persons, but also research involving deceased persons and biological material from humans,
p.000073: and also research involving the handling of sensitive personal data. The purpose of the Act is to protect the
p.000073: individual person and ensure respect for human dignity in research.
p.000073: The Act (SFS 2003:460) concerning the Ethical Review of Research Involving Humans shall apply to research involving
p.000073: sensitive personal data under Section 13 of the Personal Data Act, or personal data on breaches of the law that
p.000073: includes statutory offences, judgements in criminal cases, criminal procedural coercive measures or administrative
p.000073: deprivation of liberty according to Section 21 of the Personal Data Act. The Act is also applicable to research that
p.000073: involves physical encroachment on a research subject, that is carried out using a method aimed at influencing the
p.000073: research subject physically or mentally, or that entails a clear risk of physical or mental harm to the research
p.000073: subject, that relates to studies of biological material taken from a living person that can be attributed to this
p.000073: person, that involves a physical encroachment on a deceased person, or relates to studies of biological material taken
p.000073: for medical purposes from a deceased person that can be attributed to this person.
p.000073: By means of the ethics review procedure, support can be created for personal data handling in research projects that
p.000073: are carried out without consent, but the Act gives no support for personal data handling carried out before the actual
p.000073: research process begins.
p.000073: The Act applies to all such research, regardless of in what institutional setting it is carried out, or how it is
p.000073: funded. The regional ethics review board’s review involves an examination of the project description to establish
p.000073: whether it involves any infringement of human rights or hard-to-capture concept of human dignity. An assessment is also
p.000073: made of the relationship between the value of the project and any burdens or risks which it might entail for the
...
Searching for indicator restricted:
(return to top)
p.000006: used and when new materials are analysed. The early focus of research ethics was on protecting patients and research
p.000006: subjects against encroachments in the name of science. Through the development of epidemiologic research and register
p.000006: data research, other issues have to some extent become central. In recent years, stem cell research and nano technology
p.000006: research have attracted great interest, as has the commercialisation of research, and the effects of research on the
p.000006: environment and society in a more global perspective.
p.000006: Ethical considerations in research are largely a matter of finding a reasonable balance between various interests that
p.000006: are all legitimate. The quest for knowledge is one such interest. New knowledge is valuable in several ways, and can
p.000006: contribute to the development of the individual and of society. Individual privacy interests as well as protection
p.000006: against various forms of harm or risk of harm are other legitimate interests. But sometimes, new knowledge can only be
p.000006: obtained if research subjects and participants are exposed to a certain amount of risk. This is clear not least in
p.000006: medical research. If the risk is to be non-existent, the opportunities for finding advances will be heavily restricted
p.000006: – which impacts on various groups of patients.
p.000006: The harm and the risks this might involve varies considerably from one area of science to another. For this reason,
p.000006: research of different types also brings up distinct types of considerations. The risk/benefit analysis is done in
p.000006: varying ways, and the guidelines – which aim both to promote the search for knowledge and to safeguard the interests of
p.000006: participants – are not quite the same either. Ethical problems were acknowledged early on by medical researchers and
p.000006: psychologists, and others have since followed.
p.000006: This book is a revision of the book Good Research Practice, published by the Swedish Research Council in January 2011.
p.000006: The previous book was produced during the period when Göran Hermerén chaired the expert group on ethics.
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p.000006: GOOD RESEARCH PRACTICE
p.000007: 7
p.000007:
p.000007: SAMMANFATTNING
p.000007:
p.000007: Forskningen har en viktig position i dagens samhälle och stora förväntningar ställs på den. Men därmed riktas också
p.000007: fokus mot forskarna. De har ett särskilt ansvar gentemot de människor och djur som medverkar i forskningen, men också
p.000007: mot alla dem som indirekt kan påverkas av forskningen och gagnas av forskningsresultaten. Forskaren förväntas göra sitt
...
Social / Linguistic Proficiency
Searching for indicator language:
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p.000010: Council’s Expert Group on Ethics considers to be of particular importance.
p.000010: In research, there are demands on both the quality of the work and the integrity of the researcher. A properly
p.000010: considered ethical approach to the researcher’s various roles is therefore fundamental. To flesh out what this means,
p.000010: the text provides a number of examples of research, many of which have been borrowed from the previous book Good
p.000010: Research Practice – What Is It? It adds some new examples as well. The examples are fictitious, but realistic. One of
p.000010: the aims is to show that good research conduct, in practice, may involve difficult choices between different courses of
p.000010: action. The question is how one should act in a complex reality in which different principles and interests sometimes
p.000010: come into conflict with one another.
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p.000010: GOOD RESEARCH PRACTICE
p.000011: 11
p.000011:
p.000011: 1 WHAT ETHICS DICTATES AND THE LAW DEMANDS
p.000011:
p.000011: 1.1 Ethics and morals
p.000011: In many contexts in which “ethics and morals” are discussed, no distinction is made between the two concepts. Everyday
p.000011: language is also unclear in this area, even though we can surely sense a difference in meaning between “Kant’s Ethics”
p.000011: and “Kant’s Morals”. There are established uses of the concepts that do make a distinction, however, and there is good
p.000011: reason to maintain such a distinction here.
p.000011: It is reasonable to assume that everyone carries a set of morals, which manifest themselves in a person’s behaviour,
p.000011: especially towards other people. The person does not need to be aware of his or her moral positions and does not need
p.000011: to reflect on them. The specific values and positions these morals can be assumed to consist of need also not be
p.000011: particularly consistent with each other. They do not need to exhibit any systematics whatsoever, and the person does
p.000011: not need to be able justify him or herself in any way. Every person, after all, has morals, be they more or less
p.000011: well-developed. Through choices and actions, a person shows what his or her morals are.
p.000011: On the other hand, we cannot have ethics without being conscious of them, or without having reflected on them. When we
p.000011: use the term “ethics”, we mean a type of theory on the area of morals. We want precisely formulated norms, as general
p.000011: as possible, for which we can find good arguments. We want to justify our position. A set of ethics cannot be
p.000011: arbitrary. We also want our formulations to be able to work together and form a system. A set of ethics should also be
p.000011: able to be formulated in words.
...
p.000021: research project’s benefit from a comparative international perspective.
p.000021:
p.000021:
p.000021: GOOD RESEARCH PRACTICE
p.000022: 22
p.000022:
p.000022: Some facts on chance
p.000022: Penicillin was discovered in 1928 by Alexander Fleming. After having accidentally left his staphylococci cultures in
p.000022: his laboratory for a longer time, he noticed that the mould growing on some of them had killed the surrounding
p.000022: bacteria.
p.000022: Teflon was invented by chance by Roy Plunkett when he was trying to make the gas tetrafluoroethylene work as a
p.000022: refrigerator cooling agent. A bottle of the gas was left overnight and polymerised into polytetrafluoroethylene, a very
p.000022: slick plastic. Eventually it came to be used to coat fishing line and frying pans, and was also used on spacecraft
p.000022: because it does not react to UV light, ozone or oxygen and tolerates temperatures from -200 to over 200 °C.
p.000022: Dark energy became a concept in 1998 when scientists were studying gravitation and cosmic acceleration. It suddenly
p.000022: became evident to them that we can only see around 30% of the universe – the other 70% is called dark energy.
p.000022: A perhaps not completely comparable, but revolutionary, discovery from the humanities is Linear B, a script found on
p.000022: clay tablets at an archaeological dig at Knossos on Crete in 1900. The script was long indecipherable. Then a British
p.000022: architect, Michael Ventris, who first thought the scripts were Etruscan, made a guess that they might instead be Greek.
p.000022: With the help of Linear B findings from the Greek mainland, which did not contain certain words found in the texts from
p.000022: Crete, he guessed that these words might be Cretan place names. This allowed him, in 1951, to decipher Europe’s first
p.000022: written language.
p.000022:
p.000022: 2.2.2 Research funding and collaboration
p.000022: All research requires resources: time, place and equipment. Funding can be obtained through a position a researcher
p.000022: holds at a company, in which the research aspect is part of his or her duties. In such cases it can be the employer who
p.000022: formulates the research question. Research can also be conducted as an assignment the researcher has received, in
p.000022: competition with others or not. Finally, funding can also be obtained through grants from a funding body in the
p.000022: governmental or private sphere, or some other party.
p.000022: You could say that there are two types of funders: those who do not have a direct interest in the results and those who
p.000022: do. The first group includes the government in the form of various foundations or research councils, as well as
p.000022: research foundations, based on collections and private donations with a specific focus, for instance the Swedish Cancer
p.000022: Society and the Heart-Lung Foundation. The second group includes commercial, non- profit and public actors who need
p.000022: research to develop their activities and, in some cases, to earn money.
p.000022: External funding creates opportunities for research that otherwise might not have been conducted, but the ties and
p.000022: control it can entail are not without risk. This is illustrated in the many conflicts over publishing, access to data
p.000022: and the interpretation of results that are often debated in the media.
p.000022:
p.000022: What would you do in the following situation?
p.000022: You are researching the effectiveness of different toothpastes in a study commissioned by one of the larger
...
p.000027: With the development of epidemiological research and register data research of diverse types, some other issues have
p.000027: now come to the fore. The persons who are subject to such research, where data about them is collected and analysed,
p.000027: participate in a different way than those who take part directly in clinical trials of new medicines, for instance.
p.000027: Those who contribute to a register study do not need to be aware that they are part of the study and thereby a subject
p.000027: of research. Meanwhile, this type of research can be sensitive from an integrity perspective, and the knowledge that
p.000027: information, which the people in question may not even know has been recorded, can be gathered and analysed can be
p.000027: cause for concern. The study design and the presentation of results are essential elements in alleviating unfounded (or
p.000027: well-founded) worry over discrimination and stigmatisation. The likely value of new knowledge must thus be weighed
p.000027: against the risk that subjects’ integrity will be compromised and the need to protect individuals’ right to privacy.
p.000027: New methods, and/or those coming into more frequent use, in humanities and social science research, such as
p.000027: video-recording and participant observation, have raised new issues in research ethics. With questionnaires and
p.000027: interviews, the requirement that the participants’ identities are protected is met through the use of code keys and by
p.000027: masking and de-personalising answers. However, this is not possible with videos, for instance, in which the interplay
p.000027: between body language and verbal communication is studied. In participant observation, the researcher is sometimes not
p.000027: able to obtain informed consent in advance without making it impossible to conduct the research. This presents new
p.000027: challenges to researchers and ethics review boards.
p.000027: In recent years, stem cell research and nano technology research have attracted great interest, as has the
p.000027: commercialisation of research, and the effects of research on the environment and society in a more global perspective.
p.000027: Besides traditional research ethics issues regarding informed consent and risk-benefit analysis,
p.000027:
p.000027:
p.000027: GOOD RESEARCH PRACTICE
p.000028: 28
p.000028:
p.000028: some types of stem cell research bring up specific issues regarding both the research object and the methods being
p.000028: used. These concern the moral status of fertilised eggs, and, for instance, whether methods such as nucleus transfer
p.000028: from one cell to another are ethically acceptable. The existence of gaps in knowledge and uncertainty, such as about
p.000028: what happens when nano particles enter the body, is highlighted when results from nano research are applied within new
p.000028: areas, such as the automobile industry, medicine, cosmetics, etc. Limited toxicological studies have been conducted,
p.000028: but the gaps in knowledge make it difficult to perform a meaningful risk-benefit analysis and points to the need for
p.000028: method development in this area.
...
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p.000053: GOOD RESEARCH PRACTICE
p.000054: 54
p.000054:
p.000054: m
p.000054:
p.000054: 6.6 Publication as a measure of worth
p.000054: Since the number of published works play a major role when the merits are compared, for example in recruitment, there
p.000054: is a temptation to break research results down into “smallest publishable units”, to enable a larger number of titles
p.000054: to be presented. Such a proceeding is contrary to good research practice. It makes it more difficult to check the
p.000054: results of the research, with each individual article only providing some of the information that a more comprehensive
p.000054: one could convey.
p.000054: Research has shown that this can lead to misleading results. Readers could get the wrong impression that results
p.000054: presented in a number of different publications come from different studies, when they were actually obtained in a
p.000054: single study. In overview articles they will then be added up, with misleading consequences.
p.000054: Generally speaking, a complete presentation of the results should be given, and published reports should not be
p.000054: fragmented in such a way that subsets of results from the same study are presented in different publications. If this
p.000054: nevertheless occurs, there must be clear reasons for it, and cross-references must be given to where other results from
p.000054: the same or very closely related studies are published.
p.000054: Duplicate publication, i.e. the publishing of articles very similar in content, perhaps with different titles, should
p.000054: also be avoided. If there is good reason to do this, however, for instance when an article is included in an anthology
p.000054: or translated into a more internationally accessible language, it should be stated that it is a case of duplicate
p.000054: publication and a reference to the previous publication should be included.
p.000054: In peer reviews, it should be the quality of the research that is evaluated. Various publication tricks are easily
p.000054: spotted, with the likely consequence that the author’s credibility is called into question. The number of a
p.000054: researcher’s publications in itself also has no significance in the bibliometric model that is used in the distribution
p.000054: of some governmental funds to universities; instead, it is the number of citations that is decisive.
p.000054: Here, a distinction must of course be made between own citations and citations by other authors. A publication with no
p.000054: citations has no value whatsoever in the bibliometric model.
p.000054: In summary, a merit list is not necessarily better simply because it contains a large number of publications.
p.000054:
p.000054: What would you do in the following situation?
p.000054: For far too long now, in your applications to the research council and at various international conferences, you have
p.000054: been talking about a major work that is soon to be finished, and of which you are rightly proud. Now you are finally
p.000054: going to publish it – and not before time, because you have heard that a group in Hamburg has a similar publication in
p.000054: the pipeline.
p.000054: Then one of your colleagues discovers an irritating error in one of your computer programs. It is probably of no
p.000054: significance, but it will take at least six months to fully investigate the consequences. If your work is not published
p.000054: before the next application round, or the Germans beat you to it, the livelihoods of a postdoc scholarship holder and a
p.000054: postdoctoral research fellow funded from your council grant will be put in jeopardy.
p.000054: What do you do?
p.000054:
...
Searching for indicator linguistic:
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p.000062: community that others are acting dishonestly, or bending the rules (de Vries et al. 2006, “Scientists’ Perceptions of
p.000062: organizational justice and self-reported misbehaviors”).
p.000062:
p.000062: What would you do in the following situation?
p.000062: A doctor carried out a study to establish whether high-dose chemotherapy followed by bone marrow transplantation could
p.000062: improve the survival rate of a certain group of patients with breast cancer. The results were questioned, however, and
p.000062: the doctor was unable to produce the patient records and source data to confirm them. Other researchers then tried to
p.000062: repeat the results, without success. It is one person’s word against another’s, but primary data that could clear the
p.000062: doctor’s name are not available.
p.000062: What should the next step be? Who should do what?
p.000062:
p.000062: 8.2 Questions of definition and scope
p.000062: What is research misconduct? It can be defined in several ways. In a narrow sense, it refers to obvious violations
p.000062: involving the theft of other people’s ideas and data, manipulation (or falsification) of data, and plagiarism of other
p.000062: people’s texts. In a wider sense, it also includes other forms of reprehensible behaviour, such as dishonesty towards
p.000062: funding bodies, exaggeration of one’s qualifications in applications, publication of
p.000062:
p.000062:
p.000062:
p.000062: GOOD RESEARCH PRACTICE
p.000063: 63
p.000063:
p.000063: the same study in multiple contexts, sexual harassment, defamation of colleagues, sabotage of colleagues’ work and so
p.000063: on.
p.000063: The choice between wide and narrow definitions is not only a matter of linguistic usage. It also has consequences, for
p.000063: example, when it comes to applying rules on sanctions for research misconduct. With a narrow definition, only certain
p.000063: phenomena can be acted on; with a wider one, others can as well. The requirements of due process suggest that we should
p.000063: concentrate on central, reasonably well-defined transgressions such as plagiarism, fraud (falsification, invented data)
p.000063: and manipulation of data, and deal with other forms of inappropriate behaviour in other contexts and under other
p.000063: headings.
p.000063: Another problem that is not always easy to handle is how to distinguish between intentional fraudulent behaviour on the
p.000063: one hand, and carelessness, rushed work and incompetence on the other. Research misconduct can be intentional
p.000063: behaviour, or as something that can also be perceived as being independent of the researcher’s intention, that is to
p.000063: say something that can be established without any need to speculate on whether the author intended to deceive.
p.000063: The definition of research misconduct used by the Swedish Research Council was formulated by Birgitta Forsman (2007),
p.000063: and uses the current terminology of the scientific community. It states that
p.000063:
p.000063: Research misconduct entails actions or omissions in research, which – consciously or through carelessness – lead to
p.000063: falsified or manipulated results or give misleading information about someone’s contribution to the research.
p.000063:
p.000063: This definition thus limits itself to the narrower concept of research misconduct, in which it directly concerns the
p.000063: scientific work. Sexual harassment, defamation of colleagues and the like are not included here, even though they are
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Social / Marital Status
Searching for indicator single:
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p.000015: principally interesting problem.
p.000015: The problem must be clearly defined, however; the answer to the questions above also depends on how the key concepts
p.000015: are defined. For sake of simplicity, let us say that the criteria for good research ethics are reasonably met if the
p.000015: researcher has followed the principles described in this book. Good research ethics quality thus requires compliance
p.000015: with basic research ethics principles. The criteria for good scientific quality, on the other hand, can have both broad
p.000015: and narrow interpretations. In a narrow interpretation, these criteria are met by research that provides new knowledge,
p.000015: reveals conditions not previously known or sheds new light on previously known phenomena and relationships – it gives
p.000015: us more reliable knowledge maps to navigate by than we have had in the past.
p.000015: With this narrow interpretation, the content of the criteria for good scientific quality is not completely unequivocal,
p.000015: as research can meet many of these criteria to higher and lower degrees. The criteria of stringency, representativity,
p.000015: generalisability, transferability, reproducibility, transparency, etc. can be interpreted and applied in somewhat
p.000015: diverse ways within various research areas, such as history, social sciences, medicine and technical and natural
p.000015: sciences.
p.000015: Nevertheless, it is important to remember that the concept of scientific quality is used in a broader sense as well. In
p.000015: such cases this entails an overall judgement from which it is not possible to single out individual criteria. When the
p.000015: total quality of the research is evaluated, no single quality can be ignored. The quality is evaluated based on the
p.000015: collective qualities of originality, external and internal validity, precision and ethics. The requirement of good
p.000015: research ethics is thus included here; therefore, there can be no conflict between the demands for good research ethics
p.000015: and good scientific quality. A research report exhibits poor research ethics if it contains scientific shortcomings in
p.000015: the precision of its questions, uses incorrect methods (or uses established methods incorrectly), systematically
p.000015: excludes observations that do not support the author’s hypothesis, handles the problem of dropout in a statistically
p.000015: unacceptable way, or uses a study design that does not allow for the research question to be answered. People’s time
p.000015: has been used needlessly, and they may have been exposed to not only a certain amount of inconvenience or discomfort,
p.000015: but sometimes even suffering. In any case, resources that could have been used in a better way have been wasted. It is
p.000015: also quite easy to find examples of studies that, through superficial correlations between ethnicity, criminality,
p.000015: intelligence, education, etc., have led to the discrimination or stigmatisation of individuals and groups.
p.000015: Unfortunately, there are also examples of cheating in studies on methods for treating breast cancer or links between
...
p.000032: (jordbruksverket.se).
p.000032:
p.000032: 3.2.2 Laboratory animal ethics
p.000032: Work using laboratory animals raises a number of difficult ethical issues. Positions on these issues have a great deal
p.000032: to do with fundamental ideas concerning views on humankind, that is to say the essence, function and task of human
p.000032: beings, and not least their position in relation to other living beings. In addition, ethical notions regarding animal
p.000032: experiments are influenced by our general moral convictions.
p.000032: Anyone considering conducting research using animals in order to better understand how the human body works, or to
p.000032: contribute to improvements to human medicine, faces difficult ethical challenges. Similar challenges arise in other
p.000032: fields of research as well. This is clearly demonstrated in the so-called paradox of animal experimentation, which
p.000032: summarises the dilemma that animal experimentation entails: we use (nonhuman) animals in experiments, because they are
p.000032: sufficiently like us (to achieve relevant results) – and since they are sufficiently different from us (to allow us to
p.000032: justify the suffering we cause).
p.000032: This paradox is not new; it has existed as long as animal experiments have been conducted, or at least since ancient
p.000032: times. Humans have always had a relationship with all other animals, but differing notions of how humans should relate
p.000032: to animals have been dominant at various times, and have reflected the norms and values of those times and cultures. It
p.000032: cannot be assumed that one unified view exists of what this human-animal relationship should be like within one single
p.000032: era and culture.
p.000032: Even today, there are a number of differing views of how the responsibility of humans to animals should manifest
p.000032: itself. The discussion itself on how this responsibility should be exercised, and its limits, can enrich our
p.000032: self-understanding, and contribute to changes in how animals are treated in research. Within the subject of animal
p.000032: ethics, this relationship is highlighted through an analysis of views of the moral status and intrinsic value of
p.000032: animals, as well as of the responsibility of humans. Animal ethics also involves the study of theories on the rights of
p.000032: and obligations towards humans and animals, for both present and future generations.
p.000032:
p.000032: 3.2.3 The ethics committees on animal experiments: organisation and task
p.000032: Experiments using animals can only be conducted at a facility approved by the Swedish Board of Agriculture, where there
p.000032: is an approved supervisor, an approved veterinarian and personnel with sufficient competence.
p.000032: Review by an ethics committee on animal experiments is obligatory.
p.000032: In Sweden, the legal requirement of the advisory ethics review of animal experiments was introduced in 1979. Since
p.000032: 1988, the ethics committees on animal experiments have had the task of approving or rejecting applications, and since
p.000032: 1998 their ruling has been legally binding. In total, around 1,700 applications are reviewed each year.
...
p.000034: individual, able to feel pain. A sibling mouse that does not express the desired genetic modification has a low
p.000034: instrumental value, but the same intrinsic value.
p.000034: Animal ethicists who argue that animals have rights usually base this on the idea that animals have intrinsic value.
p.000034: Individuals who have intrinsic value also have certain fundamental rights, such as those to food, water, a place for
p.000034: rest, protection from the elements and access to social contact.
p.000034: This reasoning does not necessarily lead to the conclusion that animals and people have the same rights, however.
p.000034: Perceptions of what rights animals are considered to have, and how far-reaching they are, differ among animal
p.000034: ethicists, but are often tied to the capacities of the species in question. A shrimp’s rights are less extensive than
p.000034: those of a mouse, which in its turn has a shorter list of rights than a primate. The point of rights is thus not to
p.000034: argue that “pigs should have the right to vote”, but rather that animals’ physical and social needs should be met, to
p.000034: the degree they exist.
p.000034:
p.000034:
p.000034:
p.000034: GOOD RESEARCH PRACTICE
p.000035: 35
p.000035:
p.000035: A highly central issue in animal ethics concerns the fact that humans are traditionally regarded as something special –
p.000035: as having a special dignity and integrity – and therefore enjoy an elevated level of protection. It is unrealistic to
p.000035: believe that we can arrive at one single reason that is valid for everybody why humans hold this exceptional position.
p.000035: Perhaps the philosophers are right when they say it is impossible to justify it in any other way than to say that
p.000035: someone born by a human thereby has the right to a certain moral protection that is not extended to other living
p.000035: beings. If this is indeed the case, then we have just as great a responsibility to contemplate what we should do with
p.000035: this special position.
p.000035: Our rationality and knowledge allow us to exercise power over other animals. But with power comes responsibility –
p.000035: power over the animals’ situation and power over what issues we choose to research, for both the sake of the people who
p.000035: put their hopes in science and the sake of the animals whose lives are used to this end.
p.000035:
p.000035: What would you do in the following situation?
p.000035: Millions of people today have HIV and risk contracting AIDS if they do not receive effective inhibitor medications. A
p.000035: great deal of research is being conducted to find a cure for HIV/AIDS using chimpanzees which, besides humans, are the
p.000035: only animals that can get HIV/AIDS.
p.000035: You are a member of an ethics committee on animal experiments that is to ethically evaluate a research project aiming
p.000035: to test the effectiveness of a potential vaccine. The researchers inform the committee that the vaccine’s effect needs
...
p.000048: 48
p.000048:
p.000048: It might be sensible to clarify carefully the responsibility of persons further down in the hierarchy as well. This may
p.000048: encourage openness, which is healthy and contributes to increased clarity and transparency in the research. It can also
p.000048: help to reduce the risk of various forms of power abuse; but to say this is not to suggest that it is necessary to
p.000048: reduce the leadership capacity of international and national research directors.
p.000048:
p.000048: What would you do in the following situation?
p.000048: An investigation reveals that a researcher has broken international regulations and thereby proven herself unsuitable
p.000048: to continue as research director and supervisor. However, the vice-chancellor of the university where the researcher
p.000048: works chooses to ignore this, and lets her continue in as research director and supervisor. A number of colleagues who
p.000048: question this are themselves subjected to an investigation and other reprisals. Silence spreads among those working at
p.000048: the university.
p.000048: What do you do? Do you remain silent and thereby support and defend the vice-chancellor?
p.000048:
p.000048: Quite a lot of inquiry and legislation work of importance to good research practice is currently in progress. Briefly
p.000048: can be mentioned Ds 2016:46, En ny organisation for etikprövning av forskning (“A new organisation for ethical review
p.000048: of research”). This report presents a proposal for re-organisation that entails the current regional ethics review
p.000048: boards being converted into a single unified public authority, the Ethics Review Authority. According to its directives
p.000048: (Dir 2016:65), the inquiry into the ethics review system shall also carry out a review of the regulatory frameworks for
p.000048: research ethics and the borderline area between clinical research and health and medical care (SOU 2017:50). The
p.000048: research data inquiry (Dir 2016:65) will be analysing the adaptations necessary to the Act concerning the Ethical
p.000048: Review of Research Involving Humans (SFS 2003:460) based on the new EU regulation governing personal data handling.
p.000048: Of particular importance to the handling of personal data for research purposes is the General Data Protection
p.000048: Regulation adopted by the EU (EU 2016/679), which comes into force on 25 May 2018. In general, this reinforces the
p.000048: protection of integrity via the various requirements set by the Regulation to ensure the personal data handling is
p.000048: legal. It applies to areas such as the obligation to inform, and technical and organisational protective measures, etc.
p.000048: At the same time as the new regulatory framework is comprehensive and complicated, it should be noted that research
p.000048: receives favourable treatment in several different respects, such as the issues of handling sensitive personal data. In
...
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p.000050: GOOD RESEARCH PRACTICE
p.000051: 51
p.000051:
p.000051: 6 PUBLISHING RESEARCH RESULTS
p.000051:
p.000051: 6.1 Why publish?
p.000051: Researchers are generally considered to have a duty to publish their results. Not withholding their findings from
p.000051: society and other scientists is a fundamental principle, stressed already by Robert Merton (see Chapter 1).
p.000051: Publication is an integral and essential part of the research endeavour. Researchers must therefore be careful, as
p.000051: discussed earlier (see Chapters 2 and 5), when accepting commissioned work, to make no undertakings to refrain from
p.000051: publishing their results, to restrict their publication or to publish them only if a particular outcome is obtained.
p.000051: Research results are normally reported in writing, either in book form or as articles in scientific journals. In many
p.000051: fields of research, such as medicine and the natural sciences, it is now common for a doctoral student to present a
p.000051: thesis incorporating a number of such articles. Where this format is chosen, the articles are preceded by an
p.000051: introductory narrative, which provides a background and summary and shows how the articles are related to one another.
p.000051: The individual articles may have several authors, but the introduction should be the work of the doctoral student
p.000051: alone.
p.000051: In the humanities and social sciences, the monograph – a single, coherent text, written by the doctoral student alone –
p.000051: is currently the normal form of publication used for doctoral theses. After completing their doctorates, too,
p.000051: researchers in these fields often publish their results in book form and as sole authors.
p.000051: Publication serves several purposes. Only if the results are made public does the research conducted contribute
p.000051: effectively to the dissemination of new knowledge to the wider society. What is more, publication is often essential if
p.000051: others are to build on the researcher’s ideas or to develop practical applications. But it is also necessary to enable
p.000051: the scientific community to scrutinise and discuss the results achieved. The report that the researcher presents
p.000051: consequently has to meet a number of quality standards.
p.000051: In addition, publication serves as an announcement of what the researcher (or group of researchers) concerned has
p.000051: accomplished. The work published is thus of importance when it comes to assessing the worth of a contributing
p.000051: researcher, for example when he or she is applying for a position. The citation of published work nowadays also
p.000051: influences the distribution of governmental research funding to different universities and colleges.
p.000051: When projects are funded by public agencies, researchers are required to make their results available to others (open
p.000051: access). According to the Swedish Research Council general rules for research grants, a researcher may currently not
p.000051: allow an agreement with a commercial actor or other stakeholder to delay publication of results for more than two
p.000051: months, unless a patent application is planned, in which case publication may be delayed by up to four months.
p.000051:
...
p.000053: publication, which replaces the need for an appendix to the publication agreement and avoids the risk of several
p.000053: different versions of the work being published.
p.000053: Developments in technology have entailed a fundamental change within the area of scientific publication area. To follow
p.000053: this development, see for example the website kb.se/openaccess, which has information on current developments and a
p.000053: discussion forum. A discussion is also in progress on the existence of a so-called “copyright teacher exemption”, which
p.000053: would give the university both the right to use and a certain right to process educational materials.
p.000053:
p.000053:
p.000053:
p.000053:
p.000053:
p.000053:
p.000053:
p.000053:
p.000053:
p.000053:
p.000053: GOOD RESEARCH PRACTICE
p.000054: 54
p.000054:
p.000054: m
p.000054:
p.000054: 6.6 Publication as a measure of worth
p.000054: Since the number of published works play a major role when the merits are compared, for example in recruitment, there
p.000054: is a temptation to break research results down into “smallest publishable units”, to enable a larger number of titles
p.000054: to be presented. Such a proceeding is contrary to good research practice. It makes it more difficult to check the
p.000054: results of the research, with each individual article only providing some of the information that a more comprehensive
p.000054: one could convey.
p.000054: Research has shown that this can lead to misleading results. Readers could get the wrong impression that results
p.000054: presented in a number of different publications come from different studies, when they were actually obtained in a
p.000054: single study. In overview articles they will then be added up, with misleading consequences.
p.000054: Generally speaking, a complete presentation of the results should be given, and published reports should not be
p.000054: fragmented in such a way that subsets of results from the same study are presented in different publications. If this
p.000054: nevertheless occurs, there must be clear reasons for it, and cross-references must be given to where other results from
p.000054: the same or very closely related studies are published.
p.000054: Duplicate publication, i.e. the publishing of articles very similar in content, perhaps with different titles, should
p.000054: also be avoided. If there is good reason to do this, however, for instance when an article is included in an anthology
p.000054: or translated into a more internationally accessible language, it should be stated that it is a case of duplicate
p.000054: publication and a reference to the previous publication should be included.
p.000054: In peer reviews, it should be the quality of the research that is evaluated. Various publication tricks are easily
p.000054: spotted, with the likely consequence that the author’s credibility is called into question. The number of a
p.000054: researcher’s publications in itself also has no significance in the bibliometric model that is used in the distribution
p.000054: of some governmental funds to universities; instead, it is the number of citations that is decisive.
p.000054: Here, a distinction must of course be made between own citations and citations by other authors. A publication with no
p.000054: citations has no value whatsoever in the bibliometric model.
p.000054: In summary, a merit list is not necessarily better simply because it contains a large number of publications.
p.000054:
p.000054: What would you do in the following situation?
...
Social / Mothers
Searching for indicator mothers:
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p.000025: is being conducted. It can happen that the research environment at a department is so focused on a certain method that
p.000025: alternatives are not discussed or even considered. In such a case, it can be beneficial to consciously seek out
p.000025: alternatives and – possibly in collaboration with researchers within other method traditions – conduct parallel studies
p.000025: using different methods.
p.000025: In science, method issues are a hot topic and are linked to criteria for scientific quality. This is also the case in
p.000025: the humanities and social sciences. There is thus not only a practical difference between studies on people that are
p.000025: based on measurements, e.g. of reaction times or response frequency in schematic questionnaire surveys on the one hand,
p.000025: and on the other hand studies in which people’s views are interpreted – as in letter collections or interviews. In
p.000025: discussions, the generalisability and more or less claimed objectivity of the results can end up being in opposition to
p.000025: the interest and “depth” of the scientific claims. This does not mean that research collaboration combining different
p.000025: methods cannot be fruitful, however.
p.000025: Method choice also has an ethical aspect. In studies of the first type mentioned above, the researcher’s relation to
p.000025: the people being studied is often more distant, while in the second type it is more involved. In both cases, the
p.000025: researcher’s position can entail ethical complications or risks.
p.000025: The choice of method can present many other important ethical considerations, for example whether animal subjects can
p.000025: be completely or partially replaced by tissue samples. Or there could be a question of how an interview study on
p.000025: children of abused mothers should be limited, to what degree violent tendencies or intelligence should be measured in
p.000025: studies on the socialisation of different ethnic groups, etc. At international level in particular, discussions are
p.000025: being held on the research ethics of so-called participant observation, a method used in the fields of social and
p.000025: behavioural science, among others.
p.000025:
p.000025: 2.3.3 Observational studies conducted through participating, observing and recording
p.000025: For some research questions participant observation may be used, but this research method is associated with a large
p.000025: number of ethical problems.
p.000025: The methods of participating, observing and/or recording can be used in several situations. A researcher may want to
p.000025: actually be in the research subjects’/informants’ environment and observe what happens, hear what is said and follow
p.000025: the persons’ interactions. In some situations, covert participant observation is used. This type of secret or disguised
p.000025: research is rare, however, and should be the exception rather than the rule.
p.000025: The ideal situation is always that those to whom the research applies should be informed that they are the subject of
p.000025: research, and should normally also have given their written consent. If the research includes handling any personal
p.000025: data, the Personal Data Act applies. If the personal data is also so-called “sensitive personal data”
p.000025:
p.000025:
p.000025: GOOD RESEARCH PRACTICE
p.000026: 26
p.000026:
...
Social / Occupation
Searching for indicator job:
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p.000012: The norm of communism, or communalism (C), means that the research community and society as a whole have the right to
p.000012: be informed of the results of research. New knowledge should not be kept secret and concealed. Scientific advances are
p.000012: regarded as a result of collaboration within and between generations of researchers; after all, the researcher does not
p.000012: work in a vacuum. Thus, according to Merton, there is no such thing as intellectual property, owned by the researcher.
p.000012: Merton’s norm of universalism (U) requires scientific work to be evaluated with reference to scientific criteria alone.
p.000012: When assessing the validity of the results, we are to take no account, for example, of the researcher’s race, gender or
p.000012: position in society. The norm of disinterestedness (D) means that the researcher must have no other motive for his or
p.000012: her research than a desire to contribute new knowledge. The fourth norm, organised scepticism (OS), requires the
p.000012: researcher to constantly question and scrutinise, but also to refrain from expressing an assessment until he or she has
p.000012: sufficient evidence on which to base it.
p.000012: Since these principles were put forward, the position of the researcher, or at least the general perception of it, has
p.000012: changed in many respects. Being a researcher can no doubt colour an individual’s whole way of being and thinking, but
p.000012: these days it is quite a common professional role, and researchers are employed specifically as researchers. They, too,
p.000012: are expected to be loyal to organisations and superiors, and have to take financial factors and their own job security
p.000012: into account.
p.000012: In many cases, therefore, Merton’s norms will be difficult to live up to in reality. His requirement for
p.000012: disinterestedness, which says that the researcher’s main reason for doing research should be to contribute new
p.000012: knowledge, is a case in point. Researchers must surely be allowed to have other motives as well, such as promoting
p.000012: their prospects of employment through the work they do. The important thing, rather, is that motives of this kind do
p.000012: not influence the researcher in such a way that he or she arrives at interpretations or conclusions for which there is
p.000012: no scientific basis, or withholds findings for which evidence does exist.
p.000012: Merton’s strict requirement of communism is also difficult to live up to in many types of research and in certain
p.000012: research environments, for example in an industrial setting, although the importance of publishing results and
p.000012: communicating them to society and to other researchers will nevertheless often be acknowledged in such environments as
p.000012: well. However, when it comes to publicly funded research, the requirement of openness is clear.
p.000012: There are various problems with Merton’s other norms, too. The ideals expressed in the CUDOS norms nevertheless provide
p.000012: one of the cornerstones for the present-day discussion about research misconduct (see Chapter 8). They are also
p.000012: reflected in the requirements of honesty and openness that were formulated in our introduction.
p.000012:
p.000012: 1.4 Ethics codes
p.000012: While individuals participating in research should be protected from harms or wrongs (the criterion of protection of
...
p.000018: clinical diagnostics and treatment in medicine, or be applied in practice in the production or improvement of products,
p.000018: in planning and decision-making, for example in changes to organisations and communication strategies, etc. Besides
p.000018: providing knowledge about a specific area, all types of research provide methodological education and training in
p.000018: critical thinking. Thus, research can contribute in many ways to the development of both individuals and society.
p.000018: Today, scientific research is a crucial element of society. The value of new knowledge is underlined in many different
p.000018: contexts. So, what is it that makes research valuable? Scientific knowledge has a value not only as an instrument, in
p.000018: other words as a means of achieving something else we value. Knowledge is also worth something in its own right – has
p.000018: its own value – regardless of how it might be used.
p.000018: People need to make sense of the world, be able to explain and understand. This is true even when we do not directly
p.000018: seek a use or an application. Basic research is often justified in this way. The results of it might also later prove
p.000018: to be good instruments for promoting something we consider useful and beneficial to society; but the nature of research
p.000018: prevents us from knowing entirely in advance where its results will lead us. The desire to know and understand is very
p.000018: often sufficient justification for research.
p.000018: When the benefits of research are discussed, this concept should be considered in a broad sense. It is not only a case
p.000018: of creating conditions to produce more and new products, or increasing society’s industrial competitiveness, or even of
p.000018: creating more job opportunities. It also concerns promoting other values that have to do with critical thinking,
p.000018: better quality of life and a revitalised public discourse.
p.000018: Meanwhile, history shows that the planned reasons for research sometimes do not coincide with its actual effects.
p.000018: Research that can facilitate developing new and stronger materials or more effective medicines can also have undesired
p.000018: and unexpected effects, or be used for negative purposes by countries, terrorists or others. The
p.000018:
p.000018:
p.000018:
p.000018: GOOD RESEARCH PRACTICE
p.000019: 19
p.000019:
p.000019: challenge is therefore to optimise the opportunities of using the positive effects of research, and to minimise the
p.000019: negative ones. A vibrant ethics discourse is an essential element of these attempts.
p.000019: The task of higher education institutions not only includes cooperating with the world around it and providing
p.000019: information about their activities, but now also includes “working towards research results obtained at the higher
p.000019: education institution being of benefit” (“verka för att forskningsresultat tillkomna vid högskolan kommer till nytta”,
p.000019: Chapter 1, Section 2 of the Higher Education Act, [SFS 2009:45]). There are undeniably many examples of research
p.000019: discoveries improving conditions for many people. Vaccines, the production of new materials and developments in
p.000019: telecommunications are examples of research results being further developed into products that have made life easier
p.000019: and improved the quality of life for many.
...
Social / Property Ownership
Searching for indicator home:
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p.000035:
p.000035:
p.000035:
p.000035:
p.000035: GOOD RESEARCH PRACTICE
p.000036: 36
p.000036:
p.000036: Sweden participate and Swedish funding bodies contribute money. Ethical standards that appear self-evident in Sweden
p.000036: can then be difficult to find support for in international research environments.
p.000036: It is especially worrying if researchers perform their work in countries with lower ethical standards, just to take
p.000036: advantage of this. It can, for example, be easier to find research subjects, easier to get permission to use primates
p.000036: in research, cheaper to conduct studies, or involve less extensive application procedures. If these advantages come at
p.000036: the cost of the integrity of the research, it will in many cases involve a breach of the standards in the Declaration
p.000036: of Helsinki:
p.000036:
p.000036: Physicians should consider the ethical, legal and regulatory norms and standards for research involving human subjects
p.000036: in their own countries as well as applicable international norms and standards. No national or international ethical,
p.000036: legal or regulatory requirement should reduce or eliminate any of the protections for research subjects set forth in
p.000036: this Declaration.
p.000036:
p.000036: It is unacceptable for studies to violate this principle. The Norwegian National Committee for Research Ethics in
p.000036: Science and Technology states precise and necessary requirements, namely that
p.000036:
p.000036: a researcher is not to conduct parts of his or her research in another country simply because it has lower ethical or
p.000036: safety standards than at home;
p.000036:
p.000036: and that researchers shall inform funding bodies of divergent ethical or safety standards in the country or countries
p.000036: where their research is being conducted.
p.000036:
p.000036: Another problem is that the most fundamental protection for research subjects – that the research project must be
p.000036: ethically reviewed before it can begin – is not always self-evident in other countries. The Declaration of Helsinki
p.000036: requires this review for all medical research performed on humans, and this requirement is held by many funding bodies
p.000036: and journals.
p.000036: Here, the Swedish legal requirement of ethics review is less comprehensive. However, as mentioned earlier, in Sweden
p.000036: there is the option to request an advisory statement from an ethics review board regarding a project that does not
p.000036: formally need to be reviewed. It is good research practice to request a statement in the event research collaborations
p.000036: in other countries are expected to present ethical difficulties for the researchers.
p.000036: The ethics review boards have no obligation to issue these advisory statements however, just the right to do so. If the
p.000036: regional ethics review board refuses to issue such a statement, however, this may cause profound consequences for the
p.000036: researchers’ chances of obtaining further funding and being published.
...
p.000070: Data Act. This means that the handling of personal data must be supported either by the Personal Data Act or by another
p.000070: law or ordinance that regulates the handling.
p.000070:
p.000070: 9.1.2 International regulations
p.000070: Sweden has undertaken to safeguard the respect of fundamental freedoms and rights in an international context,
p.000070: including the right to personal integrity in the handling of personal data. Below follows a brief description of some
p.000070: of the most important ones. The aim is to provide a background to the principles encompassed by the Swedish regulations
p.000070: within the area. Some of the central principles are that personal data may only be collected for one or several stated
p.000070: purposes, that they shall be fit for purpose, relevant, necessary for the purposes for which they are handled, and not
p.000070: be stored for longer than necessary.
p.000070:
p.000070:
p.000070:
p.000070:
p.000070:
p.000070:
p.000070:
p.000070: 7 Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural
p.000070: persons with regard to the processing of personal data and on the free movement of such data, and repealing Directive
p.000070: 95/46/EC (General Data Protection Regulation), EUT L 119, 4.5.2016, p. 1.
p.000070:
p.000070:
p.000070: GOOD RESEARCH PRACTICE
p.000071: 71
p.000071:
p.000071: 9.1.3 The UN’s Universal Declaration of Human Rights, etc.
p.000071: Article 12 of the United Nations’ Universal Declaration of Human Rights, etc. establishes that “No one shall be
p.000071: subjected to arbitrary interference with his privacy, family, home or correspondence, nor to attacks upon his honour
p.000071: and reputation. Everyone has the right to the protection of the law against such interference or attacks.” Article 29
p.000071: Item 2 further states that “In the exercise of his rights and freedoms, everyone shall be subject only to such
p.000071: limitations as are determined by law solely for the purpose of securing due recognition and respect for the rights and
p.000071: freedoms of others and of meeting the just requirements of morality, public order and the general welfare in a
p.000071: democratic society.”
p.000071: The Universal Declaration is not binding upon member states, but may be seen as an expression of common law rules
p.000071: within the area.
p.000071:
p.000071: 9.1.4 The European Convention on Human Rights
p.000071: The Convention for the Protection of Human Rights and Fundamental Freedoms of 4 November 1950 (“European Convention on
p.000071: Human Rights”) was incorporated into Swedish law on 1 January 1995, and has since then applied as law in Sweden.
p.000071: Article 8 of the European Convention on Human Rights states that “Everyone has the right to respect for his private and
p.000071: family life, his home and his correspondence”. It further states that “There shall be no interference by a public
p.000071: authority with the exercise of this right except such as is in accordance with the law and is necessary in a democratic
p.000071: society in the interests of national security, public safety or the economic well-being of the country, for the
p.000071: prevention of disorder or crime, for the protection of health or morals, or for the protection of the rights and
p.000071: freedoms of others”. The European Court of Human Rights was established to monitor that the obligations under the
p.000071: European Court of Human Rights are fulfilled.
p.000071:
p.000071: 9.1.5 The Council of Europe’s Data Protection Convention
p.000071: In 1981, the Committee of Ministers of the Council of Europe adopted the Convention for the Protection of Individuals
p.000071: with regard to Automatic Processing of Personal Data. The Convention came into force on 1 October 1985. All EU member
p.000071: states have ratified the Convention. The Convention is binding on the countries who have ratified it. The Convention is
p.000071: associated with a number of recommendations on how personal data should be handled in various areas. The
p.000071: recommendations are not directly binding.
p.000071: According to Article 1, the Convention aims “to secure in the territory of each Party for every individual, whatever
p.000071: his nationality or residence, respect for his rights and fundamental freedoms, and in particular his right to privacy,
...
p.000071: legislation. Sweden has adopted these recommendations, and by this means undertaken to follow the Guidelines. The
p.000071: Guidelines are minimum rules, which means that protection in the countries that have undertaken to follow the
p.000071: Guidelines may be made more comprehensive than the protection given by the Guidelines. The Guidelines include eight
p.000071: fundamental principles to protect personal integrity; for
p.000071:
p.000071:
p.000071: GOOD RESEARCH PRACTICE
p.000072: 72
p.000072:
p.000072: example, they state that personal data shall be collected for specific purposes, be relevant to the purpose for which
p.000072: they are intended, and shall be correct, complete and up-to-date.
p.000072:
p.000072: 9.1.7 The European Union’s Charter of Fundamental Rights
p.000072: The European Union’s Charter of Fundamental Rights was adopted at the meeting of the Council of Europe in Nice in 2000
p.000072: (the “EU Charter”). The EU Charter states the fundamental rights under six headings: Dignity, Freedoms, Equality,
p.000072: Solidarity, Citizens' Rights, and Justice.
p.000072: In terms of protection of personal integrity, it states that everyone has the right to physical and mental integrity
p.000072: (Article 3). Everyone has the right to respect for his or her private and family life, home and communications (Article
p.000072: 7), and to the protection of personal data concerning him or her (Article 8). Article 8 also states that personal data
p.000072: shall be processed fairly for specified purposes and on the basis of the consent of the person concerned or some other
p.000072: legitimate basis. The EU Charter is now legally binding through the Lisbon Treaty when EU institutions and EU member
p.000072: states apply the EU’s laws and regulations.
p.000072:
p.000072: 9.1.8 The Data Protection Directive
p.000072: On 24 October 1995, the EU adopted a Directive on the protection of natural persons with regard to the processing of
p.000072: personal data and on the free movement of such data, the Data Protection Directive. The provisions of the Data
p.000072: Protection Directive set the framework for what is possible to do in Sweden in terms of handling personal data. It is
p.000072: therefore not possible to create Swedish legal provisions that are not compatible with the Directive.
p.000072: The Data Protection Directive includes a number of fundamental requirements that must be fulfilled in the handling of
p.000072: personal data. These rules are largely represented in the Swedish Personal Data Act. As mentioned in Section 9.1, the
p.000072: Data Protection Directive will be replaced by a new EU Regulation on data protection.
p.000072:
p.000072: 9.2 Two important Swedish laws
...
Searching for indicator property:
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p.000011: behaviour in various roles, of responsibility in connection with publication, and of so-called research misconduct
p.000011: belong to this category. Many of the questions in this book are thus of the professional ethics type. It is also
p.000011: possible to distinguish between external and internal research ethics, with professional ethics corresponding to the
p.000011: latter.
p.000011:
p.000011:
p.000011: GOOD RESEARCH PRACTICE
p.000012: 12
p.000012:
p.000012: 1.3 Merton’s CUDOS norms
p.000012: In the 1940s, the American sociologist Robert Merton formulated four principles which he believed constituted a “moral
p.000012: consensus” in science, and these have had a significant impact on the discussion around professional ethics. Commonly
p.000012: referred to as the CUDOS (Communism/Communalism, Universalism, Disinterestedness and Organised Scepticism) norms, they
p.000012: have since been both modified and questioned but nonetheless merit attention as one starting point for a discussion
p.000012: about what constitutes good research practice.
p.000012: The norm of communism, or communalism (C), means that the research community and society as a whole have the right to
p.000012: be informed of the results of research. New knowledge should not be kept secret and concealed. Scientific advances are
p.000012: regarded as a result of collaboration within and between generations of researchers; after all, the researcher does not
p.000012: work in a vacuum. Thus, according to Merton, there is no such thing as intellectual property, owned by the researcher.
p.000012: Merton’s norm of universalism (U) requires scientific work to be evaluated with reference to scientific criteria alone.
p.000012: When assessing the validity of the results, we are to take no account, for example, of the researcher’s race, gender or
p.000012: position in society. The norm of disinterestedness (D) means that the researcher must have no other motive for his or
p.000012: her research than a desire to contribute new knowledge. The fourth norm, organised scepticism (OS), requires the
p.000012: researcher to constantly question and scrutinise, but also to refrain from expressing an assessment until he or she has
p.000012: sufficient evidence on which to base it.
p.000012: Since these principles were put forward, the position of the researcher, or at least the general perception of it, has
p.000012: changed in many respects. Being a researcher can no doubt colour an individual’s whole way of being and thinking, but
p.000012: these days it is quite a common professional role, and researchers are employed specifically as researchers. They, too,
p.000012: are expected to be loyal to organisations and superiors, and have to take financial factors and their own job security
p.000012: into account.
p.000012: In many cases, therefore, Merton’s norms will be difficult to live up to in reality. His requirement for
p.000012: disinterestedness, which says that the researcher’s main reason for doing research should be to contribute new
p.000012: knowledge, is a case in point. Researchers must surely be allowed to have other motives as well, such as promoting
p.000012: their prospects of employment through the work they do. The important thing, rather, is that motives of this kind do
...
p.000038: patients’ interest in information they have given their doctor remaining only between them.
p.000038: Funding bodies for basic research, such as the Swedish Research Council, have an interest in openness and transparency.
p.000038: Other funding bodies may have an interest, from a societal perspective, in material being reused or used by many groups
p.000038: – an important task in this case is to specify the conditions under which this can be done.
p.000038: How this weighing of interests is done depends on aspects such as the type of research is being conducted. A
p.000038: significant difference in this context is the distinction between research which is not being conducted in connection
p.000038: with healthcare, and that which is. This distinction is important, as different regulations apply in the two cases.
p.000038: If research is combined with healthcare, for example, the Patient Data Act and the provisions applicable to healthcare
p.000038: operations in the Public Access to Information and Secrecy Act apply. It is therefore important to keep several types
p.000038: of journals – both on the patient/treatment being provided, and on the research itself. The patient/treatment journals
p.000038: should only contain information that is necessary for the patient to receive good and
p.000038:
p.000038:
p.000038:
p.000038: GOOD RESEARCH PRACTICE
p.000039: 39
p.000039:
p.000039: safe treatment. Information required for the research project should be reserved for the research journals. The same
p.000039: applies in retrospective studies, especially if they deal with integrity-sensitive questions.
p.000039: But in any type of research, the material collected is not the private property of the researcher or research group,
p.000039: something they own and can do with as they wish. It must be stored and archived according to the general regulations
p.000039: issued by each authority in question.
p.000039:
p.000039: 4.3 Four concepts
p.000039: Four important concepts in the debate that are sometimes confused with each other or used synonymously are secrecy,
p.000039: professional secrecy, anonymity and confidentiality.
p.000039: Information can be covered by secrecy only if it is stated in law, normally the Public Access to Information and
p.000039: Secrecy Act.
p.000039: Standards for professional secrecy apply to some professions by law, as well as by ethics rules. All personnel in
p.000039: health and medical care, dental care and social services, for instance, must observe professional secrecy. This means
p.000039: that they are not allowed to discuss patients’ and clients’ health or personal situation with unauthorised individuals,
p.000039: or in any other way communicate this information. Similar standards for professional secrecy also apply to
p.000039: psychologists and clergy, for example. If a certain task is covered by secrecy, it means the person carrying out the
p.000039: task has a duty of professional secrecy.
p.000039: Anonymising or de-identifying involves eliminating the connection between samples or questionnaire answers and a
p.000039: certain individual, so that neither unauthorised persons nor the research group can re-establish it; no one should
p.000039: therefore be able to combine a certain piece of information with a specific person’s identity, for example. The code
p.000039: list is destroyed. Anonymity can also be achieved by collecting material without noting the identity of specific
...
p.000041: researchers then become the personal data controllers.
p.000041: It is not only names that can be replaced with code numbers. Other information in the material that could identify
p.000041: individual subjects can also be disguised in this way (see Chapter 9). The ethics review boards should be able to
p.000041: determine the level of encryption required.
p.000041: Costs can be significantly higher if material that will be shown to other researchers is not collected using codes and
p.000041: code keys, especially if a project is conducted over a prolonged period of time. But it is neither ethical nor legally
p.000041: acceptable for an individual researcher or research group to breach the rules applicable with reference to such costs.
p.000041:
p.000041: What would you do in the following situation?
p.000041: A researcher, Adam, collects data from a specific group of adult informants. He promises that no one outside his
p.000041: research group will have access to the data. Later, his findings are questioned by two other researchers, Brian and
p.000041: Cecilia, who request access to his source data. Adam refuses to hand them over, referring to his promise to his
p.000041: informants. The case reaches an unexpected conclusion when colleagues of Adam’s say they have destroyed the source data
p.000041: on their own initiative.
p.000041: Is the action taken by Adam’s colleagues ethically defensible? Is it compatible with existing legislation? Has Adam
p.000041: promised more than he can deliver?
p.000041:
p.000041: 4.5 Documentation
p.000041: Data collected for a research project is called source data. Sometimes, researchers consider source data to be their
p.000041: own individual property. This might possibly be the case if the research is privately funded and conducted by
p.000041: individuals not associated with normal research environments, and the data does not include personal data.
p.000041: But when the research is conducted at a university or other research institution, or when it is funded with public
p.000041: funds through grants from a research council or foundation, it is the organisation where the research is conducted that
p.000041: owns the material. The researcher or research group can thus not do whatever they want with it, for instance take it
p.000041: with them upon changing jobs, without agreements and special arrangements. Source data and material that documents the
p.000041: research process and the project’s various steps should instead be regarded as documents (submitted, upheld) belonging
p.000041: to the organisation and fall under the Public Access to Information and Secrecy Act and the Archives Act.
p.000041: The material from a completed research project should therefore be stored and archived, with subsequent preservation
p.000041: and occasional sorting. If it is integrity-sensitive, there are also specific requirements for how it should be stored.
p.000041: Information on this is provided by the Data Inspection Board, among others. There are many reasons to keep material.
p.000041: For instance, it must be possible to verify research results6, or the material might be requested in the investigation
p.000041: of an accusation of research misconduct. It can also happen that the researcher who obtained the results, or other
p.000041: researchers, wish to reuse the material in another project. As a rule, this type of reuse requires a new ethics review.
...
p.000058: could be devastating.
p.000058: Although supervisor and doctoral student often work very closely together and it is natural for them to see each other
p.000058: as friends, it is important that the professional relationship takes precedence. The supervisor has a responsibility to
p.000058: ensure that no circumstances arise that could jeopardise this relationship. If this happens, the supervisor may have to
p.000058: hand over the task to someone else.
p.000058:
p.000058: 7.1.2 Whose ideas?
p.000058: In discussions between the supervisor and doctoral student, different arguments and approaches are tested, and views
p.000058: and ideas exchanged. Sometimes it is also important in such discussions to consider how justice can best be done to the
p.000058: contributor’s input as the work continues and the results are published. In the thesis, the doctoral student should
p.000058: account for any contributions by others, including his or her supervisor.
p.000058: But it is also important that, if the supervisor uses or develops ideas originating from the student, this is done in
p.000058: consultation with the student and no attempt is made to conceal their origins. Ideas that the supervisor suggests to
p.000058: the doctoral student for further investigation, however, do not thereby become the latter’s property. The supervisor,
p.000058: too, must be able to continue to work on these ideas in his or her own research without jeopardising the student’s
p.000058: research work.
p.000058:
p.000058: 7.1.3 The thesis and its presentation
p.000058: The ultimate goal of the doctoral student’s research is to produce knowledge, formulated in a scholarly dissertation
p.000058: and reviewed at presentation. The supervisor decides, in consultation with the student and the examiner, when the work
p.000058: can be considered complete and its public defence arranged. A host of different factors will be considered in reaching
p.000058: this decision, including purely financial considerations, the future prospects of the student, undertakings regarding
p.000058: completion time, and the personal wishes of the student.
p.000058:
p.000058:
p.000058: GOOD RESEARCH PRACTICE
p.000059: 59
p.000059:
p.000059: But the supervisor’s personal wishes, for example to see a postgraduate gain his or her doctorate as soon as possible,
p.000059: can also figure. The primary considerations in this context, however, must be the student and the research programme
p.000059: undertaken. It is unethical to force the pace of completion, for example to collect “PhD points” for the department.
p.000059:
p.000059: 7.1.4 Responsibility for ethical and legal compliance
p.000059: Ethical and legal rules vary depending on the kind of research being conducted. As the leader of the specific research
...
Social / Racial Minority
Searching for indicator race:
(return to top)
p.000011: possible to distinguish between external and internal research ethics, with professional ethics corresponding to the
p.000011: latter.
p.000011:
p.000011:
p.000011: GOOD RESEARCH PRACTICE
p.000012: 12
p.000012:
p.000012: 1.3 Merton’s CUDOS norms
p.000012: In the 1940s, the American sociologist Robert Merton formulated four principles which he believed constituted a “moral
p.000012: consensus” in science, and these have had a significant impact on the discussion around professional ethics. Commonly
p.000012: referred to as the CUDOS (Communism/Communalism, Universalism, Disinterestedness and Organised Scepticism) norms, they
p.000012: have since been both modified and questioned but nonetheless merit attention as one starting point for a discussion
p.000012: about what constitutes good research practice.
p.000012: The norm of communism, or communalism (C), means that the research community and society as a whole have the right to
p.000012: be informed of the results of research. New knowledge should not be kept secret and concealed. Scientific advances are
p.000012: regarded as a result of collaboration within and between generations of researchers; after all, the researcher does not
p.000012: work in a vacuum. Thus, according to Merton, there is no such thing as intellectual property, owned by the researcher.
p.000012: Merton’s norm of universalism (U) requires scientific work to be evaluated with reference to scientific criteria alone.
p.000012: When assessing the validity of the results, we are to take no account, for example, of the researcher’s race, gender or
p.000012: position in society. The norm of disinterestedness (D) means that the researcher must have no other motive for his or
p.000012: her research than a desire to contribute new knowledge. The fourth norm, organised scepticism (OS), requires the
p.000012: researcher to constantly question and scrutinise, but also to refrain from expressing an assessment until he or she has
p.000012: sufficient evidence on which to base it.
p.000012: Since these principles were put forward, the position of the researcher, or at least the general perception of it, has
p.000012: changed in many respects. Being a researcher can no doubt colour an individual’s whole way of being and thinking, but
p.000012: these days it is quite a common professional role, and researchers are employed specifically as researchers. They, too,
p.000012: are expected to be loyal to organisations and superiors, and have to take financial factors and their own job security
p.000012: into account.
p.000012: In many cases, therefore, Merton’s norms will be difficult to live up to in reality. His requirement for
p.000012: disinterestedness, which says that the researcher’s main reason for doing research should be to contribute new
p.000012: knowledge, is a case in point. Researchers must surely be allowed to have other motives as well, such as promoting
p.000012: their prospects of employment through the work they do. The important thing, rather, is that motives of this kind do
p.000012: not influence the researcher in such a way that he or she arrives at interpretations or conclusions for which there is
p.000012: no scientific basis, or withholds findings for which evidence does exist.
...
p.000029: A research project falls within the scope of the Act concerning the Ethical Review of Research Involving Humans because
p.000029: of its content. What is to be reviewed therefore has nothing to do with how the project is funded. Also, research that
p.000029: is not funded by external bodies, but is carried out within a position at an institution, shall therefore be reviewed
p.000029: if the content so requires.
p.000029: A research project shall be reviewed by an ethics review board if any of the following conditions exist.
p.000029: Namely, if the project (A)
p.000029:
p.000029: • entails physical encroachment on the research subject
p.000029: • will be conducted using a method aiming to affect the research subject physically or psychologically, or that
p.000029: carries an obvious risk of physical or psychological harm to the research subject
p.000029: • entails studies on biological material taken from a living human being and can be traced to this person
p.000029: • entails physical encroachment on a deceased human being
p.000029: • entails studies on biological material taken for medical purposes from a deceased human being and can be traced to
p.000029: this person. Act (SFS 2008:192).
p.000029:
p.000029: A research project shall also be reviewed if it (B)
p.000029:
p.000029: • entails the handling of sensitive personal data according to Section 13 of the Personal Data Act (SFS 1998:204),
p.000029: including information on race, ethnic origin, political views or religious conviction, or personal
p.000029:
p.000029:
p.000029:
p.000029:
p.000029: 3The research principal is the government authority or the physical or legal entity within whose organisation the
p.000029: research is conducted. A researcher employed at a university or a county council has the same as his or her research
p.000029: principal. The research principal, through its internal work or delegation order or through power of attorney,
p.000029: determines who is authorised to represent the research principal. The research principal always has ultimate
p.000029: responsibility for the research.
p.000029:
p.000029:
p.000029: GOOD RESEARCH PRACTICE
p.000030: 30
p.000030:
p.000030: data according to Section 21 of the Personal Data Act, including information on judgements in criminal cases.
p.000030:
p.000030: Condition (B) thus means that all research dealing with sensitive personal data shall be ethically reviewed, regardless
p.000030: of how the data has been collected and whether or not the researcher has obtained the participants’ consent.
p.000030: When an ethics review board evaluates a project, it has a number of aspects to note and consider. Generally, the
p.000030: research in question can be approved only if it can be conducted with respect for human dignity. In the review, the
...
Searching for indicator racial:
(return to top)
p.000071: with regard to Automatic Processing of Personal Data. The Convention came into force on 1 October 1985. All EU member
p.000071: states have ratified the Convention. The Convention is binding on the countries who have ratified it. The Convention is
p.000071: associated with a number of recommendations on how personal data should be handled in various areas. The
p.000071: recommendations are not directly binding.
p.000071: According to Article 1, the Convention aims “to secure in the territory of each Party for every individual, whatever
p.000071: his nationality or residence, respect for his rights and fundamental freedoms, and in particular his right to privacy,
p.000071: with regard to automatic processing of personal data relating to him ("data protection”)”. According to Article 2, the
p.000071: Convention’s area of application is "automated data files" and "automatic processing" of personal data in public and
p.000071: private activities. Each Convention state may, however, introduce certain general restrictions or expansions of the
p.000071: area of implementation. The central part of the Convention is Chapter II (Articles 4–11), which comprise the
p.000071: fundamental principles for data protection. They include requirements that personal data that is processed
p.000071: automatically shall be “obtained and processed fairly and lawfully”, “adequate, relevant and not excessive in relation
p.000071: to the purposes for which they are stored” and “preserved ... for no longer than is required” (Article 5). Personal
p.000071: data “revealing racial origin, political opinions ... health or sexual life”, as well as “personal data relating to
p.000071: criminal convictions” “may not be processed automatically unless domestic law provides appropriate safeguards” (Article
p.000071: 6). The Convention also includes provisions governing requirements on safety measures and information to those whose
p.000071: data is being processed.
p.000071:
p.000071: 9.1.6 OECD’s Guidelines
p.000071: The Organisation for Economic Cooperation and Development (OECD) has produced Guidelines Governing the Protection of
p.000071: Privacy and Transborder Flows of Personal Data. These Guidelines were adopted by the OECD Council in 1980,
p.000071: simultaneously with a recommendation to the governments of the member countries to consider the Guidelines in national
p.000071: legislation. Sweden has adopted these recommendations, and by this means undertaken to follow the Guidelines. The
p.000071: Guidelines are minimum rules, which means that protection in the countries that have undertaken to follow the
p.000071: Guidelines may be made more comprehensive than the protection given by the Guidelines. The Guidelines include eight
p.000071: fundamental principles to protect personal integrity; for
p.000071:
p.000071:
p.000071: GOOD RESEARCH PRACTICE
p.000072: 72
p.000072:
p.000072: example, they state that personal data shall be collected for specific purposes, be relevant to the purpose for which
p.000072: they are intended, and shall be correct, complete and up-to-date.
p.000072:
...
Social / Religion
Searching for indicator belief:
(return to top)
p.000018:
p.000018:
p.000018: 2.1 Starting points for research
p.000018:
p.000018: 2.1.1 Some types of research
p.000018: There are diverse types of research. Distinctions can be drawn between hypothesis-generating and hypothesis- testing
p.000018: research, and between research using qualitative and quantitative methods. One can also distinguish between research
p.000018: that tries to explain why something has happened by showing that it can be subsumed under a natural law and research
p.000018: that that tries to increase and deepen our knowledge about events, processes or texts. From a research ethics
p.000018: perspective, another distinction is interesting. One usually distinguishes between three forms of research: basic,
p.000018: applied and commissioned (there are also other terminologies and distinctions).
p.000018: Basic research entails the researcher seeking new knowledge without a particular application in mind, and can lead to
p.000018: unexpected and ground-breaking discoveries. Applied and commissioned research both have a particular aim. They are
p.000018: aimed at being of use to the party who initiated or ordered the research.
p.000018: Commissioned research is more directly and clearly driven by the commissioning party than applied research is.
p.000018: As opposed to other knowledge-seeking activities, research entails a systematic search for knowledge. This knowledge
p.000018: must also be new, not simply a compilation of what is already known. However, attempting to replicate previously
p.000018: published (and thus not new) results with the aim of confirming them is also research. If the results can be
p.000018: replicated, this increases our belief in the soundness of the conclusions, and we learn something we did not know
p.000018: before. A systematic-critical review and compilation of previous results in a certain area can also raise knowledge
p.000018: levels, and can therefore also be regarded as research.
p.000018:
p.000018: 2.1.2 Why conduct research?
p.000018: The reasons for research vary, partly depending on the type of research. Basic research is conducted to develop new
p.000018: knowledge, which can be valuable in its own right – but can sometimes also lead to valuable consequences, for instance
p.000018: new products. Applied research, on the other hand, primarily aims to develop knowledge that can lead to improved
p.000018: clinical diagnostics and treatment in medicine, or be applied in practice in the production or improvement of products,
p.000018: in planning and decision-making, for example in changes to organisations and communication strategies, etc. Besides
p.000018: providing knowledge about a specific area, all types of research provide methodological education and training in
p.000018: critical thinking. Thus, research can contribute in many ways to the development of both individuals and society.
p.000018: Today, scientific research is a crucial element of society. The value of new knowledge is underlined in many different
p.000018: contexts. So, what is it that makes research valuable? Scientific knowledge has a value not only as an instrument, in
p.000018: other words as a means of achieving something else we value. Knowledge is also worth something in its own right – has
p.000018: its own value – regardless of how it might be used.
p.000018: People need to make sense of the world, be able to explain and understand. This is true even when we do not directly
...
Searching for indicator conviction:
(return to top)
p.000013: like “As from 1 July, it will be morally right to tell the truth” is absurd.
p.000013: Morals can also not be assumed to have a limited geographical reach in the same way as a law does. Even when I am in
p.000013: Denmark, I have to hold that I should avoid harming my fellow humans just as I would in Sweden.
p.000013: Another difference between morals and the law is that morals have no explicit system of sanctions. A breach of morals
p.000013: is of course followed by sanctions, but what these might be and how they are applied vary greatly.
p.000013: That laws and morals are different is also directly observable in our everyday experiences. There are many situations
p.000013: in life when a law has nothing to say but our morals prescribe or forbid action. On the other hand, the law can in turn
p.000013: regulate conditions that from a moral perspective are completely neutral, for instance certain traffic legislation.
p.000013: There are also conditions that a certain law prescribes or allows, but cause us to ask ourselves: Is it morally right
p.000013: to do that? Certain behaviour is allowed in business law – thus no laws are broken
p.000013: – but should one really act in that way? This is another question, and one that is asked often. Answering the legal
p.000013: question is one thing, while answering the moral question is another.
p.000013: What morals prescribe and forbid thus needs to be analysed and interpreted. But are there given answers, or are morals
p.000013: relative? It is reasonable to assume that certain fundamental values can be shared by all people, while others can vary
p.000013: from person to person and between cultures or traditions. Whatever the case is concerning this relativity, however, it
p.000013: is clear that a moral conviction or principle is different from a legal rule.
p.000013:
p.000013:
p.000013:
p.000013: GOOD RESEARCH PRACTICE
p.000014: 14
p.000014:
p.000014: If we take the moral premises set forth in the Declaration of Helsinki, for example, these are premises that
p.000014: researchers around the world – not only those in the West – can relate to and apply in their research. Below, the
p.000014: mention of “common” ethical criteria for research refers to such premises, for example those formulated in the
p.000014: Declaration of Helsinki.
p.000014:
p.000014: 1.6 The law and morals in the area of research
p.000014: It is important for the researcher to know what the various laws dictate concerning research, as well as what the
p.000014: various codes prescribe. The Swedish Research Council, like many other funding bodies, also places specific ethics
p.000014: requirements in conjunction with an application for funding. It is important to note the difference between these
p.000014: distinct types of requirements. Legislation in the area of research ethics, both historically and content-wise, has its
p.000014: starting point in ethical convictions, for instance as they are expressed in ethical codes. But legislation only
p.000014: addresses certain specific situations and certain specific conditions.
p.000014: On 1 January 2004, the Act (SFS 2003:460) concerning the Ethical Review of Research Involving Humans came into force
p.000014: (riksdagen.se/sv/dokument-lagar/dokument/svensk-forfattningssamling/lag-2003460-om-
p.000014: etikprovning-av-forskning-som_sfs-2003-460). The purpose of the Act is to protect the individual person and ensure
...
p.000029: is not funded by external bodies, but is carried out within a position at an institution, shall therefore be reviewed
p.000029: if the content so requires.
p.000029: A research project shall be reviewed by an ethics review board if any of the following conditions exist.
p.000029: Namely, if the project (A)
p.000029:
p.000029: • entails physical encroachment on the research subject
p.000029: • will be conducted using a method aiming to affect the research subject physically or psychologically, or that
p.000029: carries an obvious risk of physical or psychological harm to the research subject
p.000029: • entails studies on biological material taken from a living human being and can be traced to this person
p.000029: • entails physical encroachment on a deceased human being
p.000029: • entails studies on biological material taken for medical purposes from a deceased human being and can be traced to
p.000029: this person. Act (SFS 2008:192).
p.000029:
p.000029: A research project shall also be reviewed if it (B)
p.000029:
p.000029: • entails the handling of sensitive personal data according to Section 13 of the Personal Data Act (SFS 1998:204),
p.000029: including information on race, ethnic origin, political views or religious conviction, or personal
p.000029:
p.000029:
p.000029:
p.000029:
p.000029: 3The research principal is the government authority or the physical or legal entity within whose organisation the
p.000029: research is conducted. A researcher employed at a university or a county council has the same as his or her research
p.000029: principal. The research principal, through its internal work or delegation order or through power of attorney,
p.000029: determines who is authorised to represent the research principal. The research principal always has ultimate
p.000029: responsibility for the research.
p.000029:
p.000029:
p.000029: GOOD RESEARCH PRACTICE
p.000030: 30
p.000030:
p.000030: data according to Section 21 of the Personal Data Act, including information on judgements in criminal cases.
p.000030:
p.000030: Condition (B) thus means that all research dealing with sensitive personal data shall be ethically reviewed, regardless
p.000030: of how the data has been collected and whether or not the researcher has obtained the participants’ consent.
p.000030: When an ethics review board evaluates a project, it has a number of aspects to note and consider. Generally, the
p.000030: research in question can be approved only if it can be conducted with respect for human dignity. In the review, the
p.000030: board should also evaluate how the human rights and basic freedoms of those involved are treated in relation to the
p.000030: value of the research. The welfare of human beings should be placed before the needs of society and science, and the
...
Searching for indicator religious:
(return to top)
p.000029: of its content. What is to be reviewed therefore has nothing to do with how the project is funded. Also, research that
p.000029: is not funded by external bodies, but is carried out within a position at an institution, shall therefore be reviewed
p.000029: if the content so requires.
p.000029: A research project shall be reviewed by an ethics review board if any of the following conditions exist.
p.000029: Namely, if the project (A)
p.000029:
p.000029: • entails physical encroachment on the research subject
p.000029: • will be conducted using a method aiming to affect the research subject physically or psychologically, or that
p.000029: carries an obvious risk of physical or psychological harm to the research subject
p.000029: • entails studies on biological material taken from a living human being and can be traced to this person
p.000029: • entails physical encroachment on a deceased human being
p.000029: • entails studies on biological material taken for medical purposes from a deceased human being and can be traced to
p.000029: this person. Act (SFS 2008:192).
p.000029:
p.000029: A research project shall also be reviewed if it (B)
p.000029:
p.000029: • entails the handling of sensitive personal data according to Section 13 of the Personal Data Act (SFS 1998:204),
p.000029: including information on race, ethnic origin, political views or religious conviction, or personal
p.000029:
p.000029:
p.000029:
p.000029:
p.000029: 3The research principal is the government authority or the physical or legal entity within whose organisation the
p.000029: research is conducted. A researcher employed at a university or a county council has the same as his or her research
p.000029: principal. The research principal, through its internal work or delegation order or through power of attorney,
p.000029: determines who is authorised to represent the research principal. The research principal always has ultimate
p.000029: responsibility for the research.
p.000029:
p.000029:
p.000029: GOOD RESEARCH PRACTICE
p.000030: 30
p.000030:
p.000030: data according to Section 21 of the Personal Data Act, including information on judgements in criminal cases.
p.000030:
p.000030: Condition (B) thus means that all research dealing with sensitive personal data shall be ethically reviewed, regardless
p.000030: of how the data has been collected and whether or not the researcher has obtained the participants’ consent.
p.000030: When an ethics review board evaluates a project, it has a number of aspects to note and consider. Generally, the
p.000030: research in question can be approved only if it can be conducted with respect for human dignity. In the review, the
p.000030: board should also evaluate how the human rights and basic freedoms of those involved are treated in relation to the
...
Social / Student
Searching for indicator student:
(return to top)
p.000019: vaccinated for something else, for instance hepatitis, it becomes unclear what function the control group has and what
p.000019: question is being answered.
p.000019:
p.000019:
p.000019:
p.000019: GOOD RESEARCH PRACTICE
p.000020: 20
p.000020:
p.000020: 2.1.4 Who bears the responsibility?
p.000020: When it comes to how research should be conducted and who has the responsibility for its being conducted in a
p.000020: satisfactory way scientifically and ethically, it can help to distinguish between the respective responsibilities of
p.000020: the individual researcher, the project leader, the department head and the research principal, even if the borders
p.000020: between them are not always sharp. In certain types of research another aspect also arises: the responsibility of the
p.000020: commissioning party or funding body.
p.000020: An issue for the individual researcher to consider is the choice of research question. This choice can be between, for
p.000020: example, a well-defined problem that can give relatively quick publishable results but does not seem to have any
p.000020: greater significance for society on the one hand and a more diffuse or less meritable project of substantial societal
p.000020: significance. This choice must be made by the individual researcher.
p.000020: Within all disciplines the researcher also chooses among the various subject areas, focuses and problems. For instance,
p.000020: within history a researcher can take an interest in the history of individuals, groups or countries from many
p.000020: perspectives, including mentality, political, legal, economic and/or others.
p.000020: A task of the supervisor is to monitor the doctoral student’s choices. Those responsible for the academic merit system
p.000020: should give the right signals so that a researcher can avoid the temptation of defining his or her research task based
p.000020: more on the merit possibilities instead of on the importance of the research question.
p.000020: Today, a great many studies are conducted that do not allow conclusions to be drawn – and “unnecessary” research is
p.000020: also conducted, in the sense that its questions have already been answered. This has been shown, for example, in
p.000020: systematic reviews by the Swedish Council on Health Technology Assessment (SBU) carried out in various medical fields.
p.000020: Funding bodies naturally have an interest in their resources leading to research of high quality. The evaluation of a
p.000020: project proposal is often based on the weighing of a number of different criteria, listed, for example, in the Swedish
p.000020: Research Council’s instructions to grant applicants and reviewers (see www.vr.se). Besides the scientific quality and
p.000020: the researcher’s or research group’s competence to conduct the project, originality, significance and in some cases
p.000020: also some form of benefit aspect may be considered.
p.000020: The researcher is responsible for seeing to it that the research subjects 1 have satisfactory insurance coverage.
p.000020: Patient insurance covers injury in connection with research or treatment, as well as injury caused by treatment given
p.000020: due to an incorrect diagnosis. However, it does not cover injury or side effects caused by medication, or side effects
p.000020: of medication, which are instead covered by pharmaceutical insurance. Patient insurance applies within Swedish
p.000020: healthcare, public as well as private. Pharmaceutical insurance was established through an agreement between most of
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p.000028: Status of the Human Embryo. New York, Springer, 2010.
p.000028: 7. Högskolelag (SFS 1992:1434).
p.000028: 8. Rydén, Lars (red), Etik för forskare. En antologi med utgångspunkt i arbetet med Uppsala- kodexen. Stockholm,
p.000028: UHÄ, 1990.
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p.000028: GOOD RESEARCH PRACTICE
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p.000029: 3 ETHICS REVIEW AND OTHER PERMIT REVIEW
p.000029:
p.000029:
p.000029: To be allowed to conduct certain types of research, it is necessary to obtain a permit. This applies especially to
p.000029: research that involves humans or entails experiments on animals, but also to some other types of research.
p.000029:
p.000029: 3.1 Ethics review and other permit review of research involving humans
p.000029:
p.000029: 3.1.1 Approval according to the Act concerning the Ethical Review of Research Involving Humans, etc.
p.000029: As mentioned above, the Act (SFS 2003:460) concerning the Ethical Review of Research Involving Humans came into effect
p.000029: as from 1 January 2004.
p.000029: The Act states what types of research projects must be reviewed. It also lists factors and conditions that should be
p.000029: addressed in order for a research project to be approved, as well as how the review bodies – the ethics review boards –
p.000029: should be composed.
p.000029: It is the researcher (or the supervisor of a doctoral student project) who, together with the research principal 3
p.000029: applies for an ethics review, when the research falls within the scope of the law. Simply starting or completing a
p.000029: research project that falls within the scope of the law without approval from an ethics review board is a breach of
p.000029: law and is punishable.
p.000029: Ethics review carries a fee, which varies depending on the type of project (one or multiple principals) and the type of
p.000029: application (new project or supplementary application). For concrete information on how to apply and who should apply,
p.000029: etc., please see the Central Ethics Review Board’s website on epn.se or the CODEX website at codex.vr.se.
p.000029: A research project falls within the scope of the Act concerning the Ethical Review of Research Involving Humans because
p.000029: of its content. What is to be reviewed therefore has nothing to do with how the project is funded. Also, research that
p.000029: is not funded by external bodies, but is carried out within a position at an institution, shall therefore be reviewed
p.000029: if the content so requires.
p.000029: A research project shall be reviewed by an ethics review board if any of the following conditions exist.
p.000029: Namely, if the project (A)
p.000029:
p.000029: • entails physical encroachment on the research subject
p.000029: • will be conducted using a method aiming to affect the research subject physically or psychologically, or that
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p.000044: management. They, too, should be kept posted on how the work is progressing. In principle, researchers should show the
p.000044: same openness to non-public commissioning and funding bodies as to public ones.
p.000044: Of particular interest in this context, of course, are private companies. It is not uncommon for the researchers
p.000044: involved in a project to have partly different motives from the companies that have commissioned and supported it. This
p.000044: is not something that should be denied or hushed up – on the contrary, once again openness is to be recommended. But
p.000044: these differences in motives may very well resurface in new ways, not least when a strategy is to be adopted for the
p.000044: way ahead in the light of results necessitating a reappraisal of the project design. In such circumstances, researchers
p.000044: should make it clear where they stand, and not try to negotiate with hidden agendas.
p.000044:
p.000044: What would you do in the following situation?
p.000044: In the course of a research project, you discover that a classic problem of applied psychology, which you and others
p.000044: have long been working on, has in fact been wrongly formulated. With your deeper insight, you now realise that a number
p.000044: of earlier contributions in this field are irrelevant. Certain chemotherapeutic methods which seemed promising will
p.000044: probably not work. On the other hand, completely new possibilities have now opened up, though hardly of a kind that can
p.000044: be turned into commercial therapeutic products in the foreseeable future.
p.000044: You have an annually renewable contract with a company to develop the originally envisaged chemotherapeutic methods
p.000044: into commercial products. That grant provides funding for a PhD student who needs another three years to complete her
p.000044: doctorate.
p.000044: How do you act? Does the situation influence your eagerness to publish the new results without delay, results which you
p.000044: are almost certainly the only group in the world to have arrived at?
p.000044:
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p.000044: GOOD RESEARCH PRACTICE
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p.000045:
p.000045:
p.000045: The biggest collaborative scientific projects are funded by international research organisations. Sweden is often
p.000045: represented on the governing bodies of such organisations by researchers or officials, appointed by central government
p.000045: agencies. It is important that researchers selected for such positions do not simply regard their appointment as a
p.000045: personal distinction, but also see themselves as representatives of the country’s research agencies and its research
p.000045: community. This entails, among other things, ensuring that the positions which they adopt on important issues enjoy
p.000045: broad support from the relevant agencies and community, and regularly reporting back to their constituencies on what is
p.000045: happening in the organisations concerned.
p.000045:
p.000045: 5.4 Commercial aspects
p.000045: A growing proportion of Swedish research is paid for by external funding organisations, some of which provide their
p.000045: support in pursuit of commercial goals. Such research is often directly commissioned by the companies concerned, and to
p.000045: a certain extent they may temporarily reserve an exclusive right to make use of the results by deferring publication. A
p.000045: reason for this is that patent rights must be secured before a decision can be made regarding larger investments in
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p.000045: central government generally pays part of the bill for such research projects. According to the Swedish Research
p.000045: Council’s current rules, an agreement with a commercial actor or other stakeholder may not limit the opportunity to
p.000045: publish the results of research carried out with a grant from the Swedish Research Council. Nor may such an agreement
p.000045: delay publication by more than two months. However, the delay may amount to at most four months if the purpose is to
p.000045: enable a patent application based, wholly or partly, on the research results referred to above. Many public funding
p.000045: bodies have similar rules.
p.000045: The largest international database for the registration of clinical trials is currently the US-based
p.000045: ClinicalTrials.gov, developed by the National Institutes of Health (NIH) in collaboration with the Food and Drug
p.000045: Administration (FDA). There are rules stating the conditions under which ongoing studies are to be reported to and
p.000045: registered in the database, one reason being to reduce the risk of the unnecessary duplication of work. Many prominent
p.000045: medical journals currently require that a study be registered in a database of ongoing clinical studies for it to be
p.000045: considered for publication.
p.000045: Matters become especially complicated in projects co-funded by commercial organisations when, as often happens, they
p.000045: involve doctoral students, or assume the form of major international collaborations. A doctoral thesis is fundamentally
p.000045: a public document – the whole point of it is that it should be open to public scrutiny by critics. But if the doctoral
p.000045: student’s work has been funded by an industrial company that wishes to use the results in product development and
p.000045: therefore wants to defer publication, problems can arise.
p.000045:
p.000045: What would you do in the following situation?
p.000045: A company is funding a series of drug studies. Your research group has been given a large grant for such a study, in
p.000045: which you are comparing the company’s products with similar products from other manufacturers, under varying conditions
p.000045: and on different target groups. The company has views on the publication, and tries to influence it so that the studies
p.000045: with the results most positive to the company are published first, the less positive ones much later, and the negative
p.000045: ones not at all. You protest at this.
p.000045: What action do you take?
p.000045:
p.000045: When commercial aspects arise in an international project, the diverging regulatory frameworks of different countries
p.000045: can cause particular problems. In Sweden, the “teacher exemption” allows research results arrived at during working
p.000045: hours, for example at a university department, nevertheless to be patented by the individual researcher concerned,
p.000045: resulting in private financial gain. In other countries, such as the United States, patent rights shall instead be
p.000045: assigned (either wholly or partially) to the university where the work was done. The question of ownership of the
p.000045: results of an international collaborative study can be extremely complex, and can easily poison the atmosphere in such
p.000045: a project.
p.000045: Issues of this kind, including purely practical aspects of how any commercially exploitable results are to be handled,
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p.000050: CPMP/ICH/135/95/Step5, Geneva, 1996.
p.000050: 9. World Medical Association. Declaration of Helsinki. Ethical Principles for Medical Research Involving Human
p.000050: Subjects, adopted by the 18th WMA General Assembly, Helsinki, Finland, June 1964, latest revision by the WMA General
p.000050: Assembly, Seoul 2013. Ferney-Voltaire, France, World Medical Association, 2013.
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p.000051:
p.000051: 6 PUBLISHING RESEARCH RESULTS
p.000051:
p.000051: 6.1 Why publish?
p.000051: Researchers are generally considered to have a duty to publish their results. Not withholding their findings from
p.000051: society and other scientists is a fundamental principle, stressed already by Robert Merton (see Chapter 1).
p.000051: Publication is an integral and essential part of the research endeavour. Researchers must therefore be careful, as
p.000051: discussed earlier (see Chapters 2 and 5), when accepting commissioned work, to make no undertakings to refrain from
p.000051: publishing their results, to restrict their publication or to publish them only if a particular outcome is obtained.
p.000051: Research results are normally reported in writing, either in book form or as articles in scientific journals. In many
p.000051: fields of research, such as medicine and the natural sciences, it is now common for a doctoral student to present a
p.000051: thesis incorporating a number of such articles. Where this format is chosen, the articles are preceded by an
p.000051: introductory narrative, which provides a background and summary and shows how the articles are related to one another.
p.000051: The individual articles may have several authors, but the introduction should be the work of the doctoral student
p.000051: alone.
p.000051: In the humanities and social sciences, the monograph – a single, coherent text, written by the doctoral student alone –
p.000051: is currently the normal form of publication used for doctoral theses. After completing their doctorates, too,
p.000051: researchers in these fields often publish their results in book form and as sole authors.
p.000051: Publication serves several purposes. Only if the results are made public does the research conducted contribute
p.000051: effectively to the dissemination of new knowledge to the wider society. What is more, publication is often essential if
p.000051: others are to build on the researcher’s ideas or to develop practical applications. But it is also necessary to enable
p.000051: the scientific community to scrutinise and discuss the results achieved. The report that the researcher presents
p.000051: consequently has to meet a number of quality standards.
p.000051: In addition, publication serves as an announcement of what the researcher (or group of researchers) concerned has
p.000051: accomplished. The work published is thus of importance when it comes to assessing the worth of a contributing
p.000051: researcher, for example when he or she is applying for a position. The citation of published work nowadays also
p.000051: influences the distribution of governmental research funding to different universities and colleges.
p.000051: When projects are funded by public agencies, researchers are required to make their results available to others (open
p.000051: access). According to the Swedish Research Council general rules for research grants, a researcher may currently not
p.000051: allow an agreement with a commercial actor or other stakeholder to delay publication of results for more than two
p.000051: months, unless a patent application is planned, in which case publication may be delayed by up to four months.
p.000051:
...
p.000057: 3. Horizon 2020, http://ec.europa.eu/research/participants/data/ref/h2020/grants_manual/hi/oa_pilot/h2020-
p.000057: hi-oa-pilot-guide_en.pdf
p.000057: 4. Högskolelag (SFS 1992:1434).
p.000057: 5. International Committee of Medical Journal Editors (ICMJE), Uniform Requirements for Manuscripts Submitted to
p.000057: Biomedical Journals, (Vancouver Rules), ICMJE, updated 2010.
p.000057: 6. Organisation for Economic Co-operation and Development (OECD). OECD Principles and Guidelines for Access to
p.000057: Research Data from Public Funding. Paris, OECD, 2007.
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p.000057: GOOD RESEARCH PRACTICE
p.000058: 58
p.000058:
p.000058: 7 OTHER ROLES OF THE RESEARCHER
p.000058:
p.000058: The requirements on quality and integrity are also relevant to discuss in connection with tasks associated with the
p.000058: researcher role. This relates to the roles of supervisor, teacher, expert and reviewer.
p.000058:
p.000058: 7.1 The supervisor and postgraduate supervision
p.000058:
p.000058: 7.1.1 The tasks of the supervisor
p.000058: There are many ways of being a good supervisor. In general, someone who is appointed as a supervisor has a
p.000058: responsibility to create conditions that will help to develop the doctoral student’s knowledge and skills.
p.000058: Through discussions, teaching and their own example, good supervisors transfer knowledge, skills and experience to
p.000058: their doctoral students, and guide the research which they are undertaking.
p.000058: One important task is to work with the research student to define a suitable thesis project, and to draw up an
p.000058: individual plan of study consistent with the general guidelines laid down by the faculty and the department. The extent
p.000058: to which doctoral students are able to choose and shape their research topics can vary, however. In some research
p.000058: areas, research students will often be offered a place in an existing project group, where the problems to be
p.000058: investigated will already essentially have been formulated, whereas in other areas they will have more opportunity to
p.000058: influence their research tasks. It is therefore important for the supervisor to discuss the basic prerequisites for the
p.000058: research work with the doctoral student before a topic is chosen. Where more than one supervisor is appointed, the
p.000058: different supervisors’ functions and relationships to the research student should be clearly defined from the outset.
p.000058: In the supervision, the supervisor serves as a support, a contributor of ideas, a critic and a discussion partner.
p.000058: The supervisor is the person the doctoral student can test his or her ideas on, the person who provides encouragement,
p.000058: but also the person who reads with a critical eye the texts that the student produces. The supervisor has to give
p.000058: opinions on methodology issues, as well as on questions of interpretation and results, and thus acts as both adviser
p.000058: and critic. The role of constructive critic is both important and difficult. Criticism on a scientific point must not
p.000058: be withheld out of a misguided concern not to hurt feelings; the consequences for the doctoral student at a later stage
p.000058: could be devastating.
p.000058: Although supervisor and doctoral student often work very closely together and it is natural for them to see each other
p.000058: as friends, it is important that the professional relationship takes precedence. The supervisor has a responsibility to
p.000058: ensure that no circumstances arise that could jeopardise this relationship. If this happens, the supervisor may have to
p.000058: hand over the task to someone else.
p.000058:
p.000058: 7.1.2 Whose ideas?
p.000058: In discussions between the supervisor and doctoral student, different arguments and approaches are tested, and views
p.000058: and ideas exchanged. Sometimes it is also important in such discussions to consider how justice can best be done to the
p.000058: contributor’s input as the work continues and the results are published. In the thesis, the doctoral student should
p.000058: account for any contributions by others, including his or her supervisor.
p.000058: But it is also important that, if the supervisor uses or develops ideas originating from the student, this is done in
p.000058: consultation with the student and no attempt is made to conceal their origins. Ideas that the supervisor suggests to
p.000058: the doctoral student for further investigation, however, do not thereby become the latter’s property. The supervisor,
p.000058: too, must be able to continue to work on these ideas in his or her own research without jeopardising the student’s
p.000058: research work.
p.000058:
p.000058: 7.1.3 The thesis and its presentation
p.000058: The ultimate goal of the doctoral student’s research is to produce knowledge, formulated in a scholarly dissertation
p.000058: and reviewed at presentation. The supervisor decides, in consultation with the student and the examiner, when the work
p.000058: can be considered complete and its public defence arranged. A host of different factors will be considered in reaching
p.000058: this decision, including purely financial considerations, the future prospects of the student, undertakings regarding
p.000058: completion time, and the personal wishes of the student.
p.000058:
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p.000058: GOOD RESEARCH PRACTICE
p.000059: 59
p.000059:
p.000059: But the supervisor’s personal wishes, for example to see a postgraduate gain his or her doctorate as soon as possible,
p.000059: can also figure. The primary considerations in this context, however, must be the student and the research programme
p.000059: undertaken. It is unethical to force the pace of completion, for example to collect “PhD points” for the department.
p.000059:
p.000059: 7.1.4 Responsibility for ethical and legal compliance
p.000059: Ethical and legal rules vary depending on the kind of research being conducted. As the leader of the specific research
p.000059: project on which the doctoral student is working, the supervisor is responsible for ensuring that the necessary
p.000059: approvals have been obtained and that the project complies with the ethical standards relevant to the type of research
p.000059: involved.
p.000059: He or she must consequently keep abreast of the basic documents setting out the fundamental rules and guidelines for
p.000059: research ethics that may be topical. The supervisor should discuss the relevant documents with the doctoral student,
p.000059: and try to create an awareness of what their application entails in specific situations and, in particular, in the
p.000059: student’s own research. Examples of documents that apply in various situations are discussed in Chapter 9.
p.000059: Since the responsibility for the ethical aspects of the doctoral student’s project rests with the supervisor, it is the
p.000059: supervisor who has to ensure, for instance, that experiments in medical research are terminated if patients or healthy
p.000059: subjects suffer unexpected harm. The same applies if the ratio of risk to benefit is not consistent with the
p.000059: risk-benefit assessment arrived at when the research was planned and approved by the regional ethics review board, or
p.000059: if other undesirable complications are reported.
p.000059:
p.000059: 7.2 The teacher
p.000059: A role often combined with academic research is that of teaching. The role of teacher carries special responsibilities,
p.000059: towards the students and towards the department offering the courses. An academic teacher may be obliged to teach on a
p.000059: broad spectrum of courses.
p.000059: Students have a right to set high standards for their teachers to be competent and to stay informed on developments
p.000059: within their field. To uphold good quality, a teacher must not only maintain his or her knowledge and skills, but also
p.000059: seek to broaden them. Teaching staff should not – at least not without declaring their limitations – address problems
p.000059: in their lectures and classes which do not fall within their field of expertise.
p.000059: Basically, these standards are no different from those placed on many other occupations. For instance, who wants to see
p.000059: a doctor or hire a computer consultant who hasn’t kept up with current developments since graduation?
p.000059: It is important to be aware that the teacher is in a position of power in relation to the students; a position which
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p.000064: this is such a well-known approach that no one draws benefit from it, and no one is misled.
p.000064:
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p.000064: GOOD RESEARCH PRACTICE
p.000065: 65
p.000065:
p.000065: 8.5 Unpublished material and self-plagiarism
p.000065: In the research community, researchers partake of others’ results and ideas in various ways. Publication means that a
p.000065: text is available to the general public and can thus be used legitimately by others. However, a researcher may also
p.000065: have access to material before its publication, for instance through lectures, presentations, congresses and other
p.000065: meetings, or in conversations with other researchers. Before a researcher uses someone else’s material that was
p.000065: accessed in such a way, he or she should think about the situation in which access was provided.
p.000065: As a guideline, one can say that lectures given at major conferences, or by established researchers, can be regarded as
p.000065: published, and that their content may be used in accordance with the rules presented above.
p.000065: However, one should be more careful with presentations or lectures at small conferences, seminars and the like, as well
p.000065: as lectures given by doctoral students. Doctoral students often talk about their own projects, which are as yet not
p.000065: completed, and normally participate in conferences to get feedback to improve their ongoing work. It is not a given
p.000065: that such a lecture should be regarded as a publication – often, it should not. To avoid causing any harm to the
p.000065: doctoral student, interested parties should contact him or her directly and ask whether specific ideas or other aspects
p.000065: of the lecture may be used, naturally citing the source, or if this should wait until the material has been published
p.000065: in a journal or in connection with the student’s thesis defence.
p.000065: If someone has access to material in the role of external assessor, for example reviewing a manuscript for possible
p.000065: publication in a journal, or as a member of an examining committee or a faculty opponent, this material should be
p.000065: considered confidential until it has been published. Using parts or ideas from it or publishing it without supplying
p.000065: the source is not only plagiarism, but also theft of material, and places the entire evaluation system at risk.
p.000065: It is very common for a researcher to refer to his or her earlier results or mention problems previously dealt with. If
p.000065: the purpose is to confirm or repeat previous results, the earlier account should be presented to the reader. It also
p.000065: happens that researchers want to reuse earlier formulations. Nothing prevents this, but it is actually a quotation from
p.000065: the researcher’s previous work and should be presented as such. It is also completely acceptable to use complete
p.000065: sections of text, for instance a whole chapter from a book, as long as the researcher states that that text has
p.000065: appeared in an earlier context. This can easily be done in a preface or a note in the chapter itself. Neglecting to
p.000065: take these precautions is called self-plagiarism. There is currently a debate in the scientific community concerning
p.000065: whether this concept is accurate, or if it should instead be called double publication (see also Chapter 6). At any
p.000065: rate, it is a violation of good publication practice.
p.000065:
p.000065: 8.6 Establishing plagiarism
p.000065: How, then, can it be established that plagiarism has been committed? First of all, a very clear congruence between the
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p.000065: argument for it. However, considerations of similarities between a work and a suspected source can never serve as the
p.000065: sole evidence of plagiarism; even extensive congruence can be coincidental. It can be natural to present certain
p.000065: premises within a given field, and it can happen that two researchers do so independently of each other. The history
p.000065: of science provides many examples of the “same” discovery being made by different researchers at approximately the same
p.000065: time, without their having had anything to do with each other, and with no possibility of plagiarism.
p.000065: Therefore, it is necessary to evaluate how likely it is that the suspected source actually is a source. An assessment
p.000065: must be made of whether it could have been available at all to the accused researcher, as well as of how likely it is
p.000065: that he or she in that case would have known of it, and had access to it. For instance, is there anything that suggests
p.000065: the researcher might have owned, read or spoken of the suspected source? Was the source published in a journal that
p.000065: those in the researcher’s field usually read? Plagiarism of an idea can possibly be established if there is a high
p.000065: probability of determining that the source was available to the researcher, and if there is a great deal of congruence
p.000065: between a text and a suspected source. In an actual investigation, it is
p.000065:
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p.000065: GOOD RESEARCH PRACTICE
p.000066: 66
p.000066:
p.000066: naturally important to consider the researcher’s own explanation for the similarities, and of his or her relationship
p.000066: to the suspected source.
p.000066:
p.000066: What would you do in the following situation?
p.000066: A doctoral student, Eric, sends his thesis to fellow postgraduate Nicole at another university to get her feedback.
p.000066: They work in the same field and have previously met at a seminar, at which they got on well. Nicole uses some of the
p.000066: data and ideas from Eric’s work in her own thesis, which she presents before Eric completes his. Eric is accused of
p.000066: plagiarism.
p.000066: What should the doctoral students, their supervisors, heads of department, vice-chancellors and their colleagues do?
p.000066:
p.000066: 8.7 Prevention
p.000066: Researchers operate in a highly competitive environment. Publications are the most essential merit for applicants to
p.000066: university positions – there is often talk of a “publish or perish” culture. This can tempt researchers to strive for
p.000066: quantity rather than quality; and the same applies in the system of research funding.
p.000066: If the results of a US study can be applied to a Swedish context, there is mistrust of the career system among
p.000066: researchers in Sweden as well. In the US study, nearly four of five researchers asked felt that the most successful
p.000066: members of their field had achieved their positions by successfully “working the system” (de Vries et al. 2006, Normal
p.000066: Misbehavior...).
p.000066: What can or should be done to counteract and prevent research misconduct? The discussion above suggests a number of
p.000066: possible long-term changes. But right now, there is a need to address research misconduct within the merit and career
p.000066: systems in place today. The most crucial issue is to work to create a good research environment, characterised by a
p.000066: culture that does not tolerate research misconduct and that nurtures good practice. The individual researcher, as well
p.000066: as department and faculty heads, can contribute to creating such an environment (see ALLEAS’s European Code of Conduct
...
Social / Trade Union Membership
Searching for indicator union:
(return to top)
p.000058: 7 OTHER ROLES OF THE RESEARCHER
p.000059: 59
p.000059: 7.1 The supervisor and postgraduate supervision
p.000059: 59
p.000059: 7.1.1 The tasks of the supervisor
p.000059: 59
p.000059: 7.1.2 Whose ideas?
p.000059: 59
p.000059: 7.1.3 The thesis and its presentation
p.000059: 59
p.000059: 7.1.4 Responsibility for ethical and legal compliance
p.000060: 60
p.000060: 7.2 The teacher
p.000060: 60
p.000060: 7.3 Assessing applications and proposals
p.000060: 60
p.000060: 7.4 Reviewing manuscripts for publication
p.000061: 61
p.000061: 7.5 Committee work
p.000061: 61
p.000061: References
p.000062: 62
p.000062: 8 RESEARCH MISCONDUCT
p.000063: 63
p.000063: 8.1 Introduction
p.000063: 63
p.000063: 8.2 Questions of definition and scope
p.000063: 63
p.000063: 8.3 Fabrication and falsification
p.000064: 64
p.000064: 8.4 Plagiarism
p.000065: 65
p.000065: 8.5 Unpublished material and self-plagiarism
p.000066: 66
p.000066: 8.6 Establishing plagiarism
p.000066: 66
p.000066: 8.7 Prevention
p.000067: 67
p.000067: 8.8 Sanctions for misconduct
p.000068: 68
p.000068: 8.9 Addressing issues of misconduct
p.000068: 68
p.000068: 8.10 A broader perspective
p.000069: 69
p.000069: References
p.000070: 70
p.000070: 9. KEY LEGISLATION AND OTHER REGULATIONS WITH WHICH RESEARCHERS SHOULD BE FAMILIAR
p.000071: 71
p.000071: 9.1 Personal data handling
p.000071: 71
p.000071: 9.1.1 Legal support for personal data handling
p.000071: 71
p.000071: 9.1.2 International regulations
p.000071: 71
p.000071: 9.1.3 The UN’s Universal Declaration of Human Rights, etc
p.000072: 72
p.000072: 9.1.4 The European Convention on Human Rights
p.000072: 72
p.000072: 9.1.5 The Council of Europe’s Data Protection Convention
p.000072: 72
p.000072: 9.1.6 OECD’s Guidelines
p.000072: 72
p.000072: 9.1.7 The European Union’s Charter of Fundamental Rights
p.000073: 73
p.000073: 9.1.8 The Data Protection Directive
p.000073: 73
p.000073: 9.2 Two important Swedish laws
p.000073: 73
p.000073: 9.2.1 The Patient Data Act
p.000073: 73
p.000073: 9.2.2 The Act concerning the Ethical Review of Research Involving Humans 74
p.000073: 9.3 Secrecy
p.000074: 74
p.000074: 9.3.1 Public principal
p.000074: 74
p.000074: 9.3.2 Private principal
p.000075: 75
p.000075: 9.4 Examples of other legislation
p.000075: 75
p.000075: 9.5 The CODEX website
p.000075: 75
p.000075: 9.6 The Declaration of Helsinki
p.000075: 75
p.000075: GOOD RESEARCH PRACTICE
p.000005: 5
p.000005:
p.000005: 9.7 Guidelines for Good Clinical Practice (GCP)
p.000076: 76
p.000076: 9.8 The Council of Europe’s Convention for the Protection of Human Rights and biomedicine 76
p.000076: 9.9 The CIOMS guidelines for research
p.000076: 76
p.000076: 9.10 Center for Open Science
p.000076: 76
p.000076: 9.11 Publication ethics and questions of misconduct
p.000076: 76
p.000076: References
p.000077: 77
p.000077: Reading tips
p.000078: 78
p.000078: Laws, ordinances, directives
p.000080: 80
p.000080: Declarations, guidelines, reports
p.000080: 80
p.000080:
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p.000080:
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...
p.000071: criminal convictions” “may not be processed automatically unless domestic law provides appropriate safeguards” (Article
p.000071: 6). The Convention also includes provisions governing requirements on safety measures and information to those whose
p.000071: data is being processed.
p.000071:
p.000071: 9.1.6 OECD’s Guidelines
p.000071: The Organisation for Economic Cooperation and Development (OECD) has produced Guidelines Governing the Protection of
p.000071: Privacy and Transborder Flows of Personal Data. These Guidelines were adopted by the OECD Council in 1980,
p.000071: simultaneously with a recommendation to the governments of the member countries to consider the Guidelines in national
p.000071: legislation. Sweden has adopted these recommendations, and by this means undertaken to follow the Guidelines. The
p.000071: Guidelines are minimum rules, which means that protection in the countries that have undertaken to follow the
p.000071: Guidelines may be made more comprehensive than the protection given by the Guidelines. The Guidelines include eight
p.000071: fundamental principles to protect personal integrity; for
p.000071:
p.000071:
p.000071: GOOD RESEARCH PRACTICE
p.000072: 72
p.000072:
p.000072: example, they state that personal data shall be collected for specific purposes, be relevant to the purpose for which
p.000072: they are intended, and shall be correct, complete and up-to-date.
p.000072:
p.000072: 9.1.7 The European Union’s Charter of Fundamental Rights
p.000072: The European Union’s Charter of Fundamental Rights was adopted at the meeting of the Council of Europe in Nice in 2000
p.000072: (the “EU Charter”). The EU Charter states the fundamental rights under six headings: Dignity, Freedoms, Equality,
p.000072: Solidarity, Citizens' Rights, and Justice.
p.000072: In terms of protection of personal integrity, it states that everyone has the right to physical and mental integrity
p.000072: (Article 3). Everyone has the right to respect for his or her private and family life, home and communications (Article
p.000072: 7), and to the protection of personal data concerning him or her (Article 8). Article 8 also states that personal data
p.000072: shall be processed fairly for specified purposes and on the basis of the consent of the person concerned or some other
p.000072: legitimate basis. The EU Charter is now legally binding through the Lisbon Treaty when EU institutions and EU member
p.000072: states apply the EU’s laws and regulations.
p.000072:
p.000072: 9.1.8 The Data Protection Directive
p.000072: On 24 October 1995, the EU adopted a Directive on the protection of natural persons with regard to the processing of
p.000072: personal data and on the free movement of such data, the Data Protection Directive. The provisions of the Data
...
p.000080: 6. Council of Europe. Convention for the Protection of Human Rights and Dignity of the Human Being with regard to
p.000080: the Application of Biology and Medicine: Convention on Human Rights and Biomedicine, (Oviedo Convention), European
p.000080: Treaty Series No 164, Strasbourg, 1997.
p.000080: 7. Council for International Organizations of Medical Sciences (CIOMS). International ethical guidelines for
p.000080: biomedical research involving human subjects. Geneva, CIOMS, 2002.
p.000080: 8. Council for International Organizations of Medical Sciences (CIOMS). International ethical guidelines for
p.000080: epidemiological studies. Geneva, CIOMS, 2008.
p.000080: 9. Council of Science Editors. Editorial Policy Statements, Wheat Ridge, CO, Council of Science Editors, 2010.
p.000080: 10. Danish Committees on Scientific Dishonesty, Annual Report. Copenhagen, Danish Research Agency, 1993–.
p.000080: 11. Den nasjonale forskningsetiske komité for naturvitenskap og teknologi (NENT), Forskningsetiske retningslinjer
p.000080: for naturvitenskaplig teknologi. Oslo, 2007.
p.000080: 12. Djurförsöksetiska utredningen, Etisk prövning av djurförsök: delbetänkande (SOU 2002:86). Stockholm, Fritzes
p.000080: offentliga publikationer, 2002.
p.000080: 13. European Commission, European Research Area, Science in Society, European Textbook on Ethics in Research. EUR
p.000080: 24452 EN, Luxembourg Publication Office of the European Union 2010.
p.000080: 14. European Commission, European Research Area, Science in Society, Syllabus on Ethics in Research, Addendum to the
p.000080: European Textbook on Ethics in Research. EUR 24451 EN, Luxembourg Publication Office of the European Union 2010.
p.000080: 15. European Science Foundation. Research Integrity: global responsibility to foster common standards. ORI-ESF
p.000080: Science Policy Briefing 30, Strasbourg, 2007.
p.000080: 16. Forsman, Birgitta, Begrepp om forskningsfusk, rapport till Vetenskapsrådet, 2007.
p.000080: 17. Hermerén, Göran, Hanteringen av integritetskänsligt forskningsmaterial, Vetenskapsrådet, 2007. International
p.000080: Committee of Medical Journal Editors (ICMJE). Uniform Requirements for Manuscripts Submitted to Biomedical Journals,
p.000080: (Vancouver Rules), ICMJE, updated 2010.
p.000080: 18. Jordbruksverket, Användningen av försöksdjur i Sverige under 2008. Rapport, Dnr: 31-502/09.
p.000080: 19. Justitiedepartementet, Offentlighet och sekretess hos det allmänna, 2009.
p.000080: 20. Livsmedelsverket, Läkemedelsförmånsnämnden, Läkemedelsverket, Statens beredning för medicinsk utvärdering,
p.000080: Smittskyddsinstitutet, Socialstyrelsen och Statens folkhälsoinstitut, Hantering av jäv, intressekonflikter och
p.000080: bindningar när externa experter anlitas, 2008.
p.000080: 21. National Science Foundation (NSF), Research Misconduct Regulation, Key Regulations 45 CFR 689, 1982.
p.000080: 22. Office of Research Integrity (ORI), ORI Annual Report 2007, Rockville, ORI, 2008.
p.000080: 23. Office of Research Integrity (ORI), ORI sample policy and procedures for responding to research misconduct
p.000080: allegations, Rockville, U.S. Department of Health and Human Services, 2009.
p.000080: 24. Office of Research Integrity (ORI), Federal Research Misconduct Policy. Federal Register: December 6, 2000,
p.000080: Volume 65, Number 235, Notices, Page 76260–76264.
p.000080: 25. Organisation for Economic Co-operation and Development (OECD). OECD Principles and Guidelines for Access to
p.000080: Research Data from Public Funding. Paris, OECD, 2007.
...
Social / Victim of Abuse
Searching for indicator abuse:
(return to top)
p.000039: Act contains many other provisions that the researcher may have to address, for instance regarding secrecy to protect
p.000039: the individual within health and medical care in Chapter 25.
p.000039: The principle of public access covers public activities, and those activities listed in the appendix to the Act. When a
p.000039: request for information from public documents is received, the authority where it is being stored (for example a
p.000039: university or a county council) is required to evaluate whether the information may be handed out, that is to say
p.000039: whether or not the information is covered by secrecy.
p.000039:
p.000039:
p.000039:
p.000039:
p.000039:
p.000039:
p.000039:
p.000039: GOOD RESEARCH PRACTICE
p.000040: 40
p.000040:
p.000040: 4.4.2 Professional secrecy
p.000040: Professional secrecy follows from secrecy to the extent that if certain information is covered by secrecy, then this
p.000040: also entails a requirement of professional secrecy about it. However, the opposite is not true.
p.000040: If professional secrecy applies for a certain activity, this does not necessarily mean that what is said during the
p.000040: activity is automatically covered by secrecy or that it that it falls under the Public Access to Information and
p.000040: Secrecy Act. Furthermore, it can happen that a researcher, through his or her work on a project, becomes aware of some
p.000040: circumstance that must be reported by law (such as child abuse or paedophilia). In such cases, the obligation to report
p.000040: outweighs the secrecy requirement.
p.000040:
p.000040: 4.4.3 Anonymity
p.000040: In some cases, the anonymising of information is a condition set by an ethics review board for its approval of a study.
p.000040: This can be done, for example, by removing personal information on completed questionnaires or samples, so that it is
p.000040: difficult or in practice impossible to link a certain answer or sample to a specific individual. In some types of
p.000040: studies, the identity of the individuals is not relevant, for instance studies on variations in attitudes towards a
p.000040: certain issue in a specific group over time. In such situations, researchers can promise anonymity.
p.000040: It should be noted, however, that this strategy has other drawbacks. Not only is it difficult or impossible to verify
p.000040: the researcher’s information, but it can also happen that an entire group is stigmatised or discriminated against due
p.000040: to the publication of certain research results, even if no individual person in the group can be identified.
p.000040:
p.000040: 4.4.4 Confidentiality
p.000040: The Declaration of Helsinki stresses the importance of confidentiality and of the researcher taking measures to protect
p.000040: the integrity of research subjects and their right to protection of their private lives. This is stated in the latest
p.000040: version of the Declaration from 2013, where it is stressed that:
p.000040:
p.000040: Every precaution must be taken to protect the privacy of the research subjects and the confidentiality of their
...
p.000047: accountable must be able to influence or prevent things for which he or she is held responsible.
p.000047: Predictability standards refer to the aspect that he or she should be able to predict what might happen.
p.000047: Causal conditions for responsibility should at times be supplemented with other conditions. In some cases, it is not
p.000047: sufficient that a person is held accountable for something that has happened by means of the fact that he or she has
p.000047: influenced or neglected to influence the events. It is also a requirement that he or she had realised the consequences
p.000047: of these actions. Knowledge and intent clauses can thus sometimes be needed as a complement to causal conditions.
p.000047: Normative clauses on negligence may also be necessary in such a situation, based on the point that it was actually a
p.000047: person who influenced what happened. Suppose a research director created conditions for misconduct by neglecting to act
p.000047: to prevent it, though he or she neither realised he or she was doing so, nor intended to do it. But he or she should
p.000047: have realised this. In this case, a negligence clause can be cited.
p.000047:
p.000047:
p.000047:
p.000047: GOOD RESEARCH PRACTICE
p.000048: 48
p.000048:
p.000048: It might be sensible to clarify carefully the responsibility of persons further down in the hierarchy as well. This may
p.000048: encourage openness, which is healthy and contributes to increased clarity and transparency in the research. It can also
p.000048: help to reduce the risk of various forms of power abuse; but to say this is not to suggest that it is necessary to
p.000048: reduce the leadership capacity of international and national research directors.
p.000048:
p.000048: What would you do in the following situation?
p.000048: An investigation reveals that a researcher has broken international regulations and thereby proven herself unsuitable
p.000048: to continue as research director and supervisor. However, the vice-chancellor of the university where the researcher
p.000048: works chooses to ignore this, and lets her continue in as research director and supervisor. A number of colleagues who
p.000048: question this are themselves subjected to an investigation and other reprisals. Silence spreads among those working at
p.000048: the university.
p.000048: What do you do? Do you remain silent and thereby support and defend the vice-chancellor?
p.000048:
p.000048: Quite a lot of inquiry and legislation work of importance to good research practice is currently in progress. Briefly
p.000048: can be mentioned Ds 2016:46, En ny organisation for etikprövning av forskning (“A new organisation for ethical review
p.000048: of research”). This report presents a proposal for re-organisation that entails the current regional ethics review
p.000048: boards being converted into a single unified public authority, the Ethics Review Authority. According to its directives
p.000048: (Dir 2016:65), the inquiry into the ethics review system shall also carry out a review of the regulatory frameworks for
...
p.000059: It is also important to base assessments of this nature on an objective and careful analysis of the documents and
p.000059: qualifications presented, and to maintain a critical stance towards unfounded claims and opinions aired by others. It
p.000059: should go without saying that the analysis in any assessment should be well founded.
p.000059:
p.000059:
p.000059:
p.000059:
p.000059: GOOD RESEARCH PRACTICE
p.000060: 60
p.000060:
p.000060: 7.4 Reviewing manuscripts for publication
p.000060: Another situation where ethics may be tested is when a researcher reviews an article or a larger manuscript submitted
p.000060: to a journal or publishers for publication. It is very common in the academic world for a researcher’s work to be
p.000060: assessed by his or her colleagues. Since such assessments presuppose expert knowledge in the field concerned, there are
p.000060: few alternatives to this system, which is generally referred to as “peer review”. Thus, clear rules to counteract
p.000060: various types of conflict of interest are crucial.
p.000060: One reason the system has been challenged is a number of flagrant cases of peer reviewers abusing the trust which being
p.000060: given access to a colleague’s work to assess it entails. Such abuses have included reviewers stealing ideas from
p.000060: submitted manuscripts (this is addressed in Chapter 8), “sitting on” manuscripts for a long time to enable researchers
p.000060: in their own groups to publish their results first, or trying without just cause to prevent the publication of
p.000060: colleagues’ work.
p.000060: Often, the journal reviewers know the identity of the authors, while the authors do not know the identity of the
p.000060: reviewers. Temptations to abuse the system in conjunction with such tasks could be reduced if the system was either
p.000060: entirely open, or else double-blind.
p.000060: Another important reason why the peer review system has been questioned is that the volume of manuscripts submitted to
p.000060: journals is now so great that it can be difficult to find willing and competent reviewers. There is good reason to
p.000060: consider awarding greater merit than is given today for the arduous work of reviewing texts (not only when it comes to
p.000060: journal publication, but also in advisory groups and in the case of thesis defence and the awarding of positions).
p.000060: For the system of peer review to continue working, as referred to above, at least three criteria must be met: reviewers
p.000060: must submit their reports as quickly as possible, they must not use information in the manuscript for their own
p.000060: purposes without referring to the source – and if they do wish to use it, they must first contact the author and ask
p.000060: whether he or she has any objection – and they must be guided only by objective reasons in deciding whether or not to
p.000060: recommend publication.
p.000060: The system of peer review is used also in other contexts, such as when awarding positions and allocating grants.
p.000060:
p.000060: What would you do in the following situation?
p.000060: You are reviewing an article and discover that the authors have made a major issue of a discovery that you yourself
p.000060: made 20 years ago, but never wrote clearly about at the time – only a parenthesis buried in a long article. Now they
p.000060: are claiming credit for the discovery. However, you currently have an article of your own at the proof stage, and are
p.000060: now considering adding a section about your old discovery to underline your ownership of it.
p.000060: Would it be right to do so?
...
Social / Women
Searching for indicator women:
(return to top)
p.000075: and Medicine of 1997 (also known as the Oviedo Convention) comprises a number of articles that directly or indirectly
p.000075: relate to biomedical research. It deals in particular with the protection of individuals undergoing research and with
p.000075: the conduct of research on persons with reduced capacity to give free and informed consent. One article deals with
p.000075: research on embryos in vitro.
p.000075: This document, together with the EU Directive on Good Clinical Practice in the member states, has directly prompted the
p.000075: Swedish Act concerning the Ethical Review of Research Involving Humans. Sweden has signed this convention but has not
p.000075: yet ratified it. In practice, however, it has served as a guidepost for Swedish regulations since its establishment.
p.000075:
p.000075: 9.9 The CIOMS guidelines for research
p.000075: The Council for International Organizations of Medical Sciences (CIOMS) has, in collaboration with the World Health
p.000075: Organization (WHO), published Ethical Guidelines for Biomedical Research Involving Human Subjects, addressing issues of
p.000075: safety and informed consent. Through this document, the Council attempts to apply the principles of the Declaration of
p.000075: Helsinki while acknowledging important differences between the countries of the world. The guidelines contain special
p.000075: sections on research on weaker groups and women. CIOMS has also published guidelines on epidemiological research which
p.000075: are widely referred to.
p.000075:
p.000075: 9.10 Center for Open Science
p.000075: Recently, researchers have taken the initiative to encourage better research practice. The currently best established
p.000075: and comprehensive initiative is the Center for Open Science, which provides resources to increase openness, integrity
p.000075: and reproducibility. (https://cos.io/)
p.000075:
p.000075: 9.11 Publication ethics and questions of misconduct
p.000075: Some important documents on research ethics, such as the Declaration of Helsinki, address aspects of publishing ethics.
p.000075: As the Swedish Research Council has signed the Berlin Declaration (the Berlin Declaration
p.000075:
p.000075:
p.000075:
p.000075: GOOD RESEARCH PRACTICE
p.000076: 76
p.000076:
p.000076: on Open Access to Knowledge in the Sciences and Humanities), the Council has since 2010 included a requirement for open
p.000076: access publication in its calls for grant applications.
p.000076: Two international documents are of particular relevance in this context: one being, the Editorial Policy Statements of
p.000076: the Council of Science Editors (CSE), and the other – and most important – the “Vancouver Rules”, published by the
p.000076: International Committee of Medical Journal Editors (ICMJE) under the title of Uniform Requirements for Manuscripts
...
Social / Youth/Minors
Searching for indicator minor:
(return to top)
p.000067: therefore a delicate task to take a stand and state that something has come about through research misconduct. Many
p.000067: components must be investigated and clarified.
p.000067: If it is established that misconduct has occurred, it is important that this is made known: that it has happened, how
p.000067: it happened and where it happened. Going public with established cases of misconduct is also a crucial discouraging
p.000067: factor. Departments and other research environments do not want to be associated with such cases any more than
p.000067: researchers themselves or research principals do.
p.000067: It is also important that established misconduct be followed by sanctions, to mark that a violation of research ethics
p.000067: is a serious matter. If it is discovered, for instance, that someone has committed plagiarism and nothing happens, it
p.000067: can be interpreted that plagiarism is not a particularly serious offence. There are labour law measures that employers
p.000067: can take in the event of established misconduct.
p.000067: Research misconduct shall simply not occur in research. As part of this effort, the Swedish Research Council wants to
p.000067: stimulate departments, higher education institutions and universities to develop into such excellent environments as
p.000067: described above. The Swedish Research Council is government agency that awards grants to research following careful
p.000067: quality control. Payment of a grant may be stopped if any misconduct is established.
p.000067:
p.000067: What would you do in the following situation?
p.000067: You discover that one of your older colleagues in the department has falsified a series of measurements in a minor
p.000067: publication, with no very sensational results. He is close to retirement. When you raise the matter with him, he breaks
p.000067: down crying and blames the head of department’s demand for “at least one paper a year”. If he fails to meet that
p.000067: target, he will not get a share of the “special research resource” and will have to teach 400 hours a year. The man is
p.000067: in poor health and has no great talent for teaching.
p.000067: What do you do?
p.000067:
p.000067: 8.9 Addressing issues of misconduct
p.000067: According to the Higher Education Ordinance (SFS 1993:100), it is mandatory for universities and higher education
p.000067: institutions to investigate any suspected research misconduct. No equivalent requirement exists for research conducted
p.000067: outside academia. The Ordinance does not, however, regulate how investigations should be conducted; this is up to each
p.000067: higher education institution.
p.000067: It is common practice that suspicions of research misconduct are reported to the organisation – the department,
p.000067: university, etc. – where the suspected researcher works. For instance, if someone discovers that a colleague has
p.000067: committed plagiarism, this person must report this to the department head or the dean of the university, who should in
p.000067: turn report this to the vice-chancellor. The vice-chancellor is under obligation to process the report and ensure that
p.000067: the case is investigated, and, if the accused researcher is found guilty of research misconduct, determine the labour
p.000067: law sanctions to be imposed. It is thus primarily the learning institution itself that investigates and decides on the
...
Social / education
Searching for indicator education:
(return to top)
p.000015: such cases this entails an overall judgement from which it is not possible to single out individual criteria. When the
p.000015: total quality of the research is evaluated, no single quality can be ignored. The quality is evaluated based on the
p.000015: collective qualities of originality, external and internal validity, precision and ethics. The requirement of good
p.000015: research ethics is thus included here; therefore, there can be no conflict between the demands for good research ethics
p.000015: and good scientific quality. A research report exhibits poor research ethics if it contains scientific shortcomings in
p.000015: the precision of its questions, uses incorrect methods (or uses established methods incorrectly), systematically
p.000015: excludes observations that do not support the author’s hypothesis, handles the problem of dropout in a statistically
p.000015: unacceptable way, or uses a study design that does not allow for the research question to be answered. People’s time
p.000015: has been used needlessly, and they may have been exposed to not only a certain amount of inconvenience or discomfort,
p.000015: but sometimes even suffering. In any case, resources that could have been used in a better way have been wasted. It is
p.000015: also quite easy to find examples of studies that, through superficial correlations between ethnicity, criminality,
p.000015: intelligence, education, etc., have led to the discrimination or stigmatisation of individuals and groups.
p.000015: Unfortunately, there are also examples of cheating in studies on methods for treating breast cancer or links between
p.000015: vaccination and autism. Here, poor scientific quality and poor ethics overlap, leading to the possibility that people
p.000015: can be harmed when the results of the research are applied in practice.
p.000015:
p.000015:
p.000015:
p.000015:
p.000015: GOOD RESEARCH PRACTICE
p.000016: 16
p.000016:
p.000016: There can sometimes also be economic and time frames that tempt researchers to take shortcuts, which can cause the
p.000016: research to fail in meeting both scientific and ethical quality criteria. If the problem is due solely to these
p.000016: factors, there is no fundamental opposition between the two; with other time frames or better economic resources, the
p.000016: problem would not surface. We thereby find ourselves back in a situation of type (1), in which there is no fundamental
p.000016: opposition between the diverse types of quality criteria. Against this background it is reasonable to regard work to
p.000016: improve the ethical aspects of the research as a quality issue.
p.000016:
p.000016: Stanley Milgram conducted experiments with volunteer subjects. The subjects were informed that they, as “teachers”,
p.000016: were to give an electric shock to “students” when they answered incorrectly, and that they were to increase the
p.000016: strength of the shock with each successive wrong answer. The students then simulated great pain. Everything was
p.000016: simulated, and everyone except the subjects knew this. Most of the subjects followed the instructions.
...
p.000018: aimed at being of use to the party who initiated or ordered the research.
p.000018: Commissioned research is more directly and clearly driven by the commissioning party than applied research is.
p.000018: As opposed to other knowledge-seeking activities, research entails a systematic search for knowledge. This knowledge
p.000018: must also be new, not simply a compilation of what is already known. However, attempting to replicate previously
p.000018: published (and thus not new) results with the aim of confirming them is also research. If the results can be
p.000018: replicated, this increases our belief in the soundness of the conclusions, and we learn something we did not know
p.000018: before. A systematic-critical review and compilation of previous results in a certain area can also raise knowledge
p.000018: levels, and can therefore also be regarded as research.
p.000018:
p.000018: 2.1.2 Why conduct research?
p.000018: The reasons for research vary, partly depending on the type of research. Basic research is conducted to develop new
p.000018: knowledge, which can be valuable in its own right – but can sometimes also lead to valuable consequences, for instance
p.000018: new products. Applied research, on the other hand, primarily aims to develop knowledge that can lead to improved
p.000018: clinical diagnostics and treatment in medicine, or be applied in practice in the production or improvement of products,
p.000018: in planning and decision-making, for example in changes to organisations and communication strategies, etc. Besides
p.000018: providing knowledge about a specific area, all types of research provide methodological education and training in
p.000018: critical thinking. Thus, research can contribute in many ways to the development of both individuals and society.
p.000018: Today, scientific research is a crucial element of society. The value of new knowledge is underlined in many different
p.000018: contexts. So, what is it that makes research valuable? Scientific knowledge has a value not only as an instrument, in
p.000018: other words as a means of achieving something else we value. Knowledge is also worth something in its own right – has
p.000018: its own value – regardless of how it might be used.
p.000018: People need to make sense of the world, be able to explain and understand. This is true even when we do not directly
p.000018: seek a use or an application. Basic research is often justified in this way. The results of it might also later prove
p.000018: to be good instruments for promoting something we consider useful and beneficial to society; but the nature of research
p.000018: prevents us from knowing entirely in advance where its results will lead us. The desire to know and understand is very
p.000018: often sufficient justification for research.
p.000018: When the benefits of research are discussed, this concept should be considered in a broad sense. It is not only a case
p.000018: of creating conditions to produce more and new products, or increasing society’s industrial competitiveness, or even of
p.000018: creating more job opportunities. It also concerns promoting other values that have to do with critical thinking,
p.000018: better quality of life and a revitalised public discourse.
p.000018: Meanwhile, history shows that the planned reasons for research sometimes do not coincide with its actual effects.
p.000018: Research that can facilitate developing new and stronger materials or more effective medicines can also have undesired
p.000018: and unexpected effects, or be used for negative purposes by countries, terrorists or others. The
p.000018:
p.000018:
p.000018:
p.000018: GOOD RESEARCH PRACTICE
p.000019: 19
p.000019:
p.000019: challenge is therefore to optimise the opportunities of using the positive effects of research, and to minimise the
p.000019: negative ones. A vibrant ethics discourse is an essential element of these attempts.
p.000019: The task of higher education institutions not only includes cooperating with the world around it and providing
p.000019: information about their activities, but now also includes “working towards research results obtained at the higher
p.000019: education institution being of benefit” (“verka för att forskningsresultat tillkomna vid högskolan kommer till nytta”,
p.000019: Chapter 1, Section 2 of the Higher Education Act, [SFS 2009:45]). There are undeniably many examples of research
p.000019: discoveries improving conditions for many people. Vaccines, the production of new materials and developments in
p.000019: telecommunications are examples of research results being further developed into products that have made life easier
p.000019: and improved the quality of life for many.
p.000019: For the individual researcher, the purpose of research may be more personal, such as curiosity or a desire to solve a
p.000019: problem, contribute to the solution of some problem in society, build a career, or increase his or her income through
p.000019: inventions and patents. The attitude in the research community should be generous when it comes to the personal
p.000019: motivation of researchers.
p.000019: The motivation for research can end up characterising the research environment, and the focus of the research. In an
p.000019: environment where the importance of commercialisation and patents is uniformly stressed, the space for more basic
p.000019: research-oriented researchers can be limited. On the other hand, an environment where the value of basic research is
p.000019: instead placed above, anything else risks being perceived as isolated and elitist. This type of goal conflict often
p.000019: integral to certain types of research, such as clinical research.
p.000019: The risks involved with goal conflicts are reduced when the researcher is in an environment where the discourse is
p.000019: lively and where an open and generous view of the researchers’ motivations is maintained. The key factor is that, not
p.000019: why, someone wants to contribute to research, and that the significance different motivations have for the research
p.000019: environment and for the focus of the research is discussed openly within research groups, departments and faculties.
p.000019:
p.000019: 2.1.3 How is research conducted?
...
p.000052:
p.000052: Where research is based on empirical data and statistical methods, for example, any dropout and excluded observations
p.000052: must be reported, along with the reasons for the latter. The statistical analysis must be clear and adequate for the
p.000052: method used. Experimental studies must also be presented in such a way that their reproducibility can be tested. The
p.000052: researcher should report all variables and conditions included in the study, and the deliberations carried out in order
p.000052: to determine the sample size. in empirical, non-experimental studies, for instance within the historical disciplines,
p.000052: source material and support for any claims made must be presented. These standards have to be met if it is to be
p.000052: possible for other researchers to check the results and assess the quality of the research and the significance of the
p.000052: results.
p.000052: It is important that the presentation of the results and conclusions is balanced and fair. When publishing research
p.000052: findings, issues such as the underlying assumptions for the conclusions drawn, the limitations of those conclusions and
p.000052: the area in which they apply, and a discussion of possible objections are crucial quality factors.
p.000052: Several scientific journals are open to researchers pre-registering their studies. This means that before the study is
p.000052: carried out, the journal approves the background and the question addressed, the design and analysis of the research,
p.000052: and also guarantee publication, whatever the outcome.
p.000052: Several scientific journals also require that the study plan is registered in a public database before any research
p.000052: subjects are included.
p.000052:
p.000052: 6.4 The third task and the media
p.000052: According to Chapter 1 Section 2 of the Swedish Higher Education Act (SFS 1992:1434), one of the main tasks of the
p.000052: country’s universities is to cooperate with society and inform the general public about research. This usually is
p.000052: called the “third task”, and is often achieved through the media.
p.000052: It is important for researchers to understand that the task of the media is to discover and transmit what goes on,
p.000052: openly or below the surface, or what is under development. An urge to be the first to report things that could
p.000052: challenge the established wisdom and a tendency to stress the dramatic are part of the basic strategy in most media.
p.000052: Some researchers may be put off by the media and what can be felt to be a blunt and oversimplified way of presenting
p.000052: important research problems, while others may be tempted to succumb to this media pressure and announce results
p.000052: prematurely, or even to exaggerate their importance. Both these extremes can have harmful effects.
p.000052: The public’s trust in research is the very foundation for public funds being used to support research.
p.000052: Therefore, researchers should make it a point of informing the public about new research results, but also of
p.000052: discussing topical scientific issues brought up in the general news flow, and in societal debate. Keeping things secret
p.000052: or remaining silent fosters misunderstanding and suspicion.
p.000052: However, preliminary and unverified results should not be made public, even if they may make for interesting news. If,
p.000052: at a later date, and on closer scrutiny, the results announced prove incorrect, then misgivings or false hopes will
p.000052: have been raised among the various people directly or indirectly affected by the study, for instance patients or
p.000052: relatives of patients with the disease being studied. Well-founded alerts to newly discovered problems should of course
...
p.000052: not for the first time), but this time he does not simply shrug his shoulders, but tells you to get in touch with the
p.000052: producers to do a piece of your own and “have the fight out in the open”. Next term he will be deciding on an extension
p.000052: of your postdoctoral fellowship.
p.000052: What do you do? Would things be different if he didn’t have a say in your situation – or if it was the first time this
p.000052: had happened? Does it depend on what type of issue he talked about?
p.000052:
p.000052:
p.000052:
p.000052:
p.000052:
p.000052:
p.000052:
p.000052: GOOD RESEARCH PRACTICE
p.000053: 53
p.000053:
p.000053: 6.5 Open access
p.000053: Open access to scientific publications has a number of advantages. For researchers, it is an excellent way of rapidly
p.000053: presenting their findings, and making their texts easily accessible. This makes work available to researchers, whose
p.000053: departments cannot afford to subscribe to scientific journals, and to students and teachers who can use them freely for
p.000053: educational purposes. The more readers a text has, the greater the chance is that it will be of benefit. The OECD, the
p.000053: European Commission and other organisations have stressed that scientific work financed by public funds should also be
p.000053: openly accessible to all. The disadvantage, to the individual author, of the additional costs of making a research
p.000053: article openly accessible must be weighed against the advantage of avoiding expensive subscription fees.
p.000053: Many actors in Sweden – among them the Swedish Research Council and the Association of Swedish Higher Education –
p.000053: follow the 2003 Berlin Declaration on open access to scientific knowledge. The signatories to this declaration intend
p.000053: to encourage researchers to publish their results on the Internet, to develop methods for safeguarding the quality of
p.000053: online publication, and to work towards open publication being counted as a merit in the evaluation and recruitment of
p.000053: researchers.
p.000053: Since 2010, researchers granted funding from the Swedish Research Council are obliged to publish their results
p.000053: according to the principle of open access (open access journal, hybrid or self archiving; the concepts are explained in
p.000053: the next section). Research articles lodged shall be made openly accessible within six months. For researchers with
p.000053: grants within educational sciences or humanities and social sciences, open access has to be made available within
p.000053: twelve months. The Swedish Research Council’s rules concerning open access currently only apply to scientifically
p.000053: reviewed texts in journals and conference reports, and not monographs or book chapters.
p.000053: Journals often publish material electronically, but it is important to remember that this does not automatically entail
p.000053: that it becomes openly accessible. In order to publish according to the requirements for open access, there are three
p.000053: options:
p.000053:
...
p.000061: diminishing or concealing.
p.000061:
p.000061: References
p.000061: 1. Vetenskapsrådet, Jävspolicy för Vetenskapsrådet, 2014.
p.000061: 2. Sveriges universitetslärarförbund (SULF), Etiska riktlinjer för universitetslärare, 2005.
p.000061: 3. Livsmedelsverket, Läkemedelsförmånsnämnden, Läkemedelsverket, Statens beredning för medicinsk utvärdering,
p.000061: Smittskyddsinstitutet, Socialstyrelsen och Statens folkhälsoinstitut, Hantering av jäv, intressekonflikter och
p.000061: bindningar när externa experter anlitas, 2008.
p.000061:
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p.000061:
p.000061:
p.000061: GOOD RESEARCH PRACTICE
p.000062: 62
p.000062:
p.000062: 8 RESEARCH MISCONDUCT
p.000062:
p.000062: 8.1 Introduction
p.000062: The occurrence of research (or scientific) misconduct undermines confidence in published scientific results, in the
p.000062: research community as well as in society at large. It also risks eroding the trust between researchers, providers of
p.000062: funding and the people who participate in research, for example as subjects.
p.000062: In many types of research, there is another angle as well. Research findings are used to make choices in the treatment
p.000062: of patients, to select construction methods for tunnels, bridges or aircraft, as an input into the planning of health
p.000062: care, social work, road safety or education. If those findings are based on research misconduct, people could suffer
p.000062: harm as a result of poorer treatment, collapsing bridges and tunnels, and incompetent planning.
p.000062: Research misconduct also has negative consequences on the academic merit system. A researcher who presents falsified
p.000062: merits, for example producing work containing undetected elements of plagiarism, or through another form of misconduct,
p.000062: can cause other applicants to be passed over. Misconduct thus causes injustice in the research community, often
p.000062: resulting in lower quality research when a fraudulent researcher is chosen over better ones.
p.000062: If research misconduct occurred on a regular basis, researchers’ trust in the merit system would also diminish and
p.000062: become completely useless for determining who is most competent. It is also likely that researchers, knowing or having
p.000062: the impression that others do not take good research practice seriously, can themselves be tempted to turn to such
p.000062: methods. The toleration of plagiarism and other types of misconduct would be devastating to research in the long run.
p.000062: It is difficult to say how common research misconduct is; the answer depends, of course, on how it is defined. There
p.000062: are no large, thorough studies on the subject, although some statistics and interesting yet limited studies can be
p.000062: found. However, these are based on somewhat different definitions of misconduct. At any rate, few reports of suspicion
p.000062: result in action being taken, for instance the retraction of journal articles. In the USA during the period 1994-2006,
p.000062: the Office of Research Integrity received a total of 3,571 reports. Misconduct – there, defined as fabrication,
...
p.000066: plagiarism.
p.000066: What should the doctoral students, their supervisors, heads of department, vice-chancellors and their colleagues do?
p.000066:
p.000066: 8.7 Prevention
p.000066: Researchers operate in a highly competitive environment. Publications are the most essential merit for applicants to
p.000066: university positions – there is often talk of a “publish or perish” culture. This can tempt researchers to strive for
p.000066: quantity rather than quality; and the same applies in the system of research funding.
p.000066: If the results of a US study can be applied to a Swedish context, there is mistrust of the career system among
p.000066: researchers in Sweden as well. In the US study, nearly four of five researchers asked felt that the most successful
p.000066: members of their field had achieved their positions by successfully “working the system” (de Vries et al. 2006, Normal
p.000066: Misbehavior...).
p.000066: What can or should be done to counteract and prevent research misconduct? The discussion above suggests a number of
p.000066: possible long-term changes. But right now, there is a need to address research misconduct within the merit and career
p.000066: systems in place today. The most crucial issue is to work to create a good research environment, characterised by a
p.000066: culture that does not tolerate research misconduct and that nurtures good practice. The individual researcher, as well
p.000066: as department and faculty heads, can contribute to creating such an environment (see ALLEAS’s European Code of Conduct
p.000066: for Research Integrity Revised Edition).
p.000066: A university’s vice-chancellor has a special responsibility to ensure that ethics awareness is kept at a high level
p.000066: amongst its researchers. According to Chapter 1 Section 16 of the Higher Education Ordinance (SFS 1993:100), a
p.000066: university, which through a report or in some other way is made aware of suspicions of misconduct in research, artistic
p.000066: work or other development work at the university, must investigate these suspicions. The vice-chancellor is ultimately
p.000066: responsible for all activities at a higher education institution, and is thereby also ultimately responsible for
p.000066: investigating suspicions of misconduct. The equivalent applies to research conducted outside universities, for instance
p.000066: at a county council or an independent research institute, or within industry. Here too, the person who is ultimately
p.000066: responsible for the organisation’s activities has a special responsibility to see to it that a high level of research
p.000066: ethics is maintained.
p.000066: A good research environment is open to and encourages the discussion of issues around good research practice. Cases of
p.000066: misconduct that are revealed nationally or internationally can be followed and discussed. How could the misconduct have
p.000066: been prevented or discovered sooner? The supervisor is responsible for ensuring that the young researcher is familiar
p.000066: with correct practice, and has thought about what this means in his or her own work. The supervisor should also serve
p.000066: as a good example of how to behave.
p.000066: Recurring discussions and information at a department are a way of creating and maintaining good research ethics. For
p.000066: doctoral students, the supervisor’s input can be supplemented with classes in research ethics and professional ethics
p.000066: that address issues of research misconduct in its various forms. Already during undergraduate studies, issues of at
p.000066: least plagiarism should be brought up, as these problems already exist at this level, for instance in connection with
p.000066: students’ essay work.
p.000066: In addition to preventive work and creating a good environment, something else that can discourage research misconduct
...
p.000067: department or work closely in some other way. It has also happened that faculty opponents, in preparation for an
p.000067: upcoming thesis defence, have found that large parts of the thesis text have been taken from others’ work. Others who
p.000067: may discover research misconduct in similar ways include reviewers at journals and experts working with applications
p.000067: for positions in academia.
p.000067:
p.000067: 8.8 Sanctions for misconduct
p.000067: An accusation of research misconduct is very serious and can have grave consequences for the researcher. It is
p.000067: therefore a delicate task to take a stand and state that something has come about through research misconduct. Many
p.000067: components must be investigated and clarified.
p.000067: If it is established that misconduct has occurred, it is important that this is made known: that it has happened, how
p.000067: it happened and where it happened. Going public with established cases of misconduct is also a crucial discouraging
p.000067: factor. Departments and other research environments do not want to be associated with such cases any more than
p.000067: researchers themselves or research principals do.
p.000067: It is also important that established misconduct be followed by sanctions, to mark that a violation of research ethics
p.000067: is a serious matter. If it is discovered, for instance, that someone has committed plagiarism and nothing happens, it
p.000067: can be interpreted that plagiarism is not a particularly serious offence. There are labour law measures that employers
p.000067: can take in the event of established misconduct.
p.000067: Research misconduct shall simply not occur in research. As part of this effort, the Swedish Research Council wants to
p.000067: stimulate departments, higher education institutions and universities to develop into such excellent environments as
p.000067: described above. The Swedish Research Council is government agency that awards grants to research following careful
p.000067: quality control. Payment of a grant may be stopped if any misconduct is established.
p.000067:
p.000067: What would you do in the following situation?
p.000067: You discover that one of your older colleagues in the department has falsified a series of measurements in a minor
p.000067: publication, with no very sensational results. He is close to retirement. When you raise the matter with him, he breaks
p.000067: down crying and blames the head of department’s demand for “at least one paper a year”. If he fails to meet that
p.000067: target, he will not get a share of the “special research resource” and will have to teach 400 hours a year. The man is
p.000067: in poor health and has no great talent for teaching.
p.000067: What do you do?
p.000067:
p.000067: 8.9 Addressing issues of misconduct
p.000067: According to the Higher Education Ordinance (SFS 1993:100), it is mandatory for universities and higher education
p.000067: institutions to investigate any suspected research misconduct. No equivalent requirement exists for research conducted
p.000067: outside academia. The Ordinance does not, however, regulate how investigations should be conducted; this is up to each
p.000067: higher education institution.
p.000067: It is common practice that suspicions of research misconduct are reported to the organisation – the department,
p.000067: university, etc. – where the suspected researcher works. For instance, if someone discovers that a colleague has
p.000067: committed plagiarism, this person must report this to the department head or the dean of the university, who should in
p.000067: turn report this to the vice-chancellor. The vice-chancellor is under obligation to process the report and ensure that
p.000067: the case is investigated, and, if the accused researcher is found guilty of research misconduct, determine the labour
p.000067: law sanctions to be imposed. It is thus primarily the learning institution itself that investigates and decides on the
p.000067: case.
p.000067:
p.000067:
p.000067:
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p.000067: GOOD RESEARCH PRACTICE
p.000068: 68
p.000068:
p.000068: However, the vice-chancellor does have the possibility to get an external statement. Since 1 January 2010, the CEPN
p.000068: has had an expert group on research misconduct, which on request can provide assistance in these matters. The group is
p.000068: completely independent, with no ties to universities or other research institutions. This ensures an impartial
p.000068: evaluation; something that is sometimes called into question when a university investigates an internal matter itself.
p.000068: The individual – either the person who submitted the report or the reported person – can also submit a request to the
p.000068: vice-chancellor that the expert group handle the investigation. If the person who reported the suspicion of misconduct,
p.000068: or the person suspected of misconduct so request, the university shall obtain such a statement. However, no statement
p.000068: needs to be obtained if the university decides it is clearly unnecessary. The expert group thus investigates whether
...
p.000076: credited as an author and the obligation to assume responsibility for and have contributed to the intellectual content
p.000076: of the publication.
p.000076: Shared authorship is addressed in the CSE’s Recommendations for Group- Author Articles in Scientific Journals and
p.000076: Bibliometric Databases. Many journals today also refer to the ethical guidelines launched by the British Committee on
p.000076: Publication Ethics (COPE).
p.000076: Constant departures from these standards have led other actors to intensify their work with publication ethics. Not
p.000076: least, publishing companies themselves have started formulating rules and guidelines. Groups of researchers, editors
p.000076: and funding bodies have also collaborated in drawing up a number of standards, such as CONSORT, STARD, STROBE and
p.000076: STREGA, for how various types of studies should be presented in journals. These and other documents can be found on the
p.000076: CODEX website’s page on publication ethics.
p.000076: As regards research misconduct in general, perhaps the most important initiative in recent time is the OECD’s Best
p.000076: Practices for Ensuring Scientific Integrity and Preventing Misconduct, and another one produced by ALLEA, the European
p.000076: Code of Conduct for Research Integrity Revised Edition. The US federal guidelines,
p.000076: U.S. Federal Policy on Research Misconduct, have also received a great deal of attention. The European Science
p.000076: Foundation’s contribution is a discussion of Research Integrity in its Briefing no. 30. In Sweden, the Association of
p.000076: Swedish Higher Education has presented guidelines for the handling of questions of research misconduct by universities
p.000076: and higher education institutions in its Riktlinjer för hantering vid universitet och högskolor av frågor om
p.000076: vetenskaplig ohederlighet.
p.000076: The most recent contribution to the documents on misconduct, the Singapore Statement on Research Integrity, was drawn
p.000076: up at the 2nd World Conference on Research Integrity.
p.000076:
p.000076: References
p.000076: 1. 2nd World Conference on Research Integrity. Singapore Statement on Research Integrity. Singapore, 2010.
p.000076: Arkivförordning (SFS 1991:446).
p.000076: 2. Arkivlag (SFS 1990:782).
p.000076: 3. Berlin Declaration on Open Access to Knowledge in the Sciences and Humanities. Berlin, 2003.
p.000076: 4. Commission Directive 2005/28/EC of 8 April 2005 laying down principles and detailed guidelines for good
p.000076: clinical practice as regards investigational medicinal products for human use, as well as the requirements for
p.000076: authorisation of the manufacturing or importation of such products. European Community, Brussels, 2005.
p.000076: 5. Council of Europe. Convention for the Protection of Human Rights and Dignity of the Human Being with regard to
p.000076: the Application of Biology and Medicine: Convention on Human Rights and Biomedicine, (Oviedo Convention), European
p.000076: Treaty Series No 164, Strasbourg, 1997.
p.000076: 6. Council of Science Editors. Editorial Policy Statements, Wheat Ridge, CO, 2010.
p.000076: 7. Council for International Organizations of Medical Sciences (CIOMS). International ethical guidelines for
p.000076: biomedical research involving human subjects. Geneva, CIOMS, 2002.
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p.000078: 25. Klareskog, Lars & Rönnelid, Johan & Lundberg, Karin & Padyukov, Leonid & Alfredsson, Lars, ”Immunity to
p.000078: citrullinated proteins in rheumatoid arthritis.” Annual Review of Immunology, 2008, 26:651–675.
p.000078: 26. Kodish, Eric (ed), Ethics and research with children. A case-based approach. Oxford & New York, Oxford
p.000078: University Press, 2005.
p.000078: 27. Kuhn, Thomas S., De vetenskapliga revolutionernas struktur (1962). Stockholm, Thales, andra upplagan, 2009.
p.000078: 28. Loue, Sana, Textbook of research ethics. Theory and practice. Dordrecht, Kluwer, 2000.
p.000078: 29. Lynøe, Niels, Mellan cowboyetik och scoutmoral: medicinsk forskningsetik i praktiken. Stockholm, Liber, 1999.
p.000078: 30. Lynøe, Niels & Juth, Niklas, Medicinska etikens ABZ. Stockholm, Liber, 2009.
p.000078: 31. Macklin, Ruth, Double standards in medical research in developing countries. Cambridge, Cambridge University
p.000078: Press, 2004.
p.000078: 32. Merton, Robert, ”The Normative Structure of Science” (1942), in Merton, R., The Sociology of Science: University
p.000078: of Chicago Press, 1973.
p.000078: 33. Murphy, Timothy, F., Case Studies in Biomedical Research Ethics. Cambridge, Mass., MIT Press, 2004.
p.000078: 34. Myrdal, Janken, Spelets regler i vetenskapens hantverk: Om humanvetenskap och naturvetenskap. Stockholm, Natur &
p.000078: Kultur, 2009.
p.000078: 35. Newman, W. Lawrence, Social Research Methods, Qualitative and Quantitative Approaches. 5th edition. Boston etc,
p.000078: Pearson Education, 2003.
p.000078: 36. Pence, Gregory E., Classic Cases in Medical Ethics. New York, McGraw Hill, 2000.
p.000078: 37. Perel, Pablo, & Roberts, Ian & Sena, Emily & Wheble, Philipa & Briscoe, Catherine & Sandercock, Peter & Macleod,
p.000078: Malcolm & Mignini, Luciano E. & Jayaram, Pradeep & Khan, Khalid S., ”Comparison of Treatment Effects between Animal
p.000078: Experiments and Clinical Trials: Systemic Review”. British Medical Journal, 2007, 334 (7586):197.
p.000078: 38. Petersson, Bo, Forskning och etiska koder. Nora, Nya Doxa, 1994.
p.000078: 39. Petersson, Bo, Forskningsetisk vägning. Forskningens värde, Linköping, Centrum för tillämpad etik, 1999.
p.000078: 40. Popper, Karl, Conjectures and refutations: The growth of scientific knowledge (1934), London, Routledge, 2002.
p.000078: 41. Pryor, Erica R. & Habermann, Barbara & Broome, Marion E.,”Scientific Misconduct from the Perspective of Research
p.000078: Coordinators: A National Survey”. Journal of Medical Ethics, 2007, 33; 6:365– 369.
p.000078: 42. Rydén, Lars (red), Etik för forskare. En antologi med utgångspunkt i arbetet med Uppsalakodexen. Stockholm, UHÄ,
p.000078: 1990.
p.000078: 43. Snyder, Peter J. & Mayes, Linda C. & Spencer, Dennis D., Science and the media: Delgado’s brave bulls and the
p.000078: ethics of scientific disclosure. London, Academic Press, Elsevier, 2009.
p.000078:
p.000078:
p.000078:
p.000078: GOOD RESEARCH PRACTICE
p.000079: 79
p.000079:
p.000079: 44. de Vries, Raymond & Anderson, Melissa S. & Martinson, Brian C., ”Normal misbehavior: Scientists talk about the
...
Searching for indicator educational:
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p.000026: If underage subjects are to be video recorded, the same special rules apply as for other research involving children.
p.000026: This means that if the child is less than 15 years old, both guardians and the child must have consented to the
p.000026: participation. The information should be written in such a way that the child too can understand it (according to the
p.000026: Act concerning the Ethical Review of Research Involving Humans).
p.000026: Just as for other research, the video recording shall be preceded by detailed information and consent be given
p.000026: afterwards. This information should describe the purpose of the research, and emphasise that participation is
p.000026: voluntary. Those asked to participate shall also be informed of exactly what the researchers intends to analyse in the
p.000026: video recording, and why other forms of registration have not been considered suitable or sufficient. As it is a
p.000026: question of personal data being handled, the personal data controller for the handling shall also be named.
p.000026: The information (which should be both oral and written) to the informants shall also include more detailed information
p.000026: on the following:
p.000026:
p.000026: • Whether any editing of the recording will be done, for example to disguise the face and/or voice
p.000026: • Whether the video recording will be copied, and if so how many copies will be made
p.000026: • Whether the recording will also be used for any other purpose than for research, for example educational purposes
p.000026: • Whether any other analysis will be carried out in addition to those first stated – if so, both the regional ethics
p.000026: review board and the informant must be asked
p.000026: • The informant is probably entitled to demand a copy of the recording as a registry excerpts under Section 26 of the
p.000026: Personal Data Act
p.000026: • That any links between the recording and other personal data will be encoded
p.000026: • How and where the recording will be stored, and for how long it will be saved
p.000026:
p.000026: Once the informant has received detailed information as per above, consent must be requested, normally in writing. It
p.000026: is the practice in some fields of research, but not all, that consent is given in two stages. In these cases, the
p.000026: information must first decide and possibly give his or her consent to the video recording itself.
p.000026: Thereafter, once the informant has had the opportunity to watch the video, he or she shall have the opportunity to give
p.000026: consent to the researcher to continue with the work of analysing it. Consent may also be given to show the video to
p.000026: persons named in advance, such as researchers, students, patient association, or similar.
p.000026: The informant shall confirm that he or she has received information that the consent to the researcher analysing, using
p.000026: and showing the video may be recalled at any time. The research records and the information to the informant shall
...
p.000052: relatives of patients with the disease being studied. Well-founded alerts to newly discovered problems should of course
p.000052: be published as soon as possible, but the researcher must guard against exaggeration, for example by securing
p.000052: independent peer review of the results.
p.000052:
p.000052: What would you do in the following situation?
p.000052: In a science programme on the radio, your professor gets his facts wrong, and not for the first time. He expresses
p.000052: himself, with great self-assurance, on matters far beyond his field of expertise. You raise the matter with him (again,
p.000052: not for the first time), but this time he does not simply shrug his shoulders, but tells you to get in touch with the
p.000052: producers to do a piece of your own and “have the fight out in the open”. Next term he will be deciding on an extension
p.000052: of your postdoctoral fellowship.
p.000052: What do you do? Would things be different if he didn’t have a say in your situation – or if it was the first time this
p.000052: had happened? Does it depend on what type of issue he talked about?
p.000052:
p.000052:
p.000052:
p.000052:
p.000052:
p.000052:
p.000052:
p.000052: GOOD RESEARCH PRACTICE
p.000053: 53
p.000053:
p.000053: 6.5 Open access
p.000053: Open access to scientific publications has a number of advantages. For researchers, it is an excellent way of rapidly
p.000053: presenting their findings, and making their texts easily accessible. This makes work available to researchers, whose
p.000053: departments cannot afford to subscribe to scientific journals, and to students and teachers who can use them freely for
p.000053: educational purposes. The more readers a text has, the greater the chance is that it will be of benefit. The OECD, the
p.000053: European Commission and other organisations have stressed that scientific work financed by public funds should also be
p.000053: openly accessible to all. The disadvantage, to the individual author, of the additional costs of making a research
p.000053: article openly accessible must be weighed against the advantage of avoiding expensive subscription fees.
p.000053: Many actors in Sweden – among them the Swedish Research Council and the Association of Swedish Higher Education –
p.000053: follow the 2003 Berlin Declaration on open access to scientific knowledge. The signatories to this declaration intend
p.000053: to encourage researchers to publish their results on the Internet, to develop methods for safeguarding the quality of
p.000053: online publication, and to work towards open publication being counted as a merit in the evaluation and recruitment of
p.000053: researchers.
p.000053: Since 2010, researchers granted funding from the Swedish Research Council are obliged to publish their results
p.000053: according to the principle of open access (open access journal, hybrid or self archiving; the concepts are explained in
p.000053: the next section). Research articles lodged shall be made openly accessible within six months. For researchers with
p.000053: grants within educational sciences or humanities and social sciences, open access has to be made available within
p.000053: twelve months. The Swedish Research Council’s rules concerning open access currently only apply to scientifically
p.000053: reviewed texts in journals and conference reports, and not monographs or book chapters.
p.000053: Journals often publish material electronically, but it is important to remember that this does not automatically entail
p.000053: that it becomes openly accessible. In order to publish according to the requirements for open access, there are three
p.000053: options:
p.000053:
p.000053: 1) In an open-access journal – these, just like traditional scientific journals, use peer review to assess the
p.000053: quality of the research articles.
p.000053: 2) Hybrid publication – the research article is published in a subscription-based journal, which offers the author
p.000053: the choice of open access, against a fee.
p.000053: 3) Self archiving – which means that the researcher, in addition to publishing the research article in a
p.000053: subscription based scientific journal, also deposits it at the time of publication in an open repository, and is made
p.000053: openly accessible within six or twelve months.
p.000053:
p.000053: The legal room surrounding self archiving is dependent on the policy of the journal/publisher. To help researchers in
p.000053: handling rights issues, the EU Commission’s framework programme for research and innovation, Horizon 2020, has produced
p.000053: an appendix to the publication agreement. This appendix guarantees that the researcher retains the right to deposit the
p.000053: work in an open archive, and thus make it freely accessible. An accompanying letter that researchers can use in their
p.000053: contacts with publishers has also been produced, see the website sparcopen.org Despite this, self archiving is
p.000053: regarded as complicated, and for this reason the major journal publishers are offering the option of hybrid
p.000053: publication, which replaces the need for an appendix to the publication agreement and avoids the risk of several
p.000053: different versions of the work being published.
p.000053: Developments in technology have entailed a fundamental change within the area of scientific publication area. To follow
p.000053: this development, see for example the website kb.se/openaccess, which has information on current developments and a
p.000053: discussion forum. A discussion is also in progress on the existence of a so-called “copyright teacher exemption”, which
p.000053: would give the university both the right to use and a certain right to process educational materials.
p.000053:
p.000053:
p.000053:
p.000053:
p.000053:
p.000053:
p.000053:
p.000053:
p.000053:
p.000053:
p.000053: GOOD RESEARCH PRACTICE
p.000054: 54
p.000054:
p.000054: m
p.000054:
p.000054: 6.6 Publication as a measure of worth
p.000054: Since the number of published works play a major role when the merits are compared, for example in recruitment, there
p.000054: is a temptation to break research results down into “smallest publishable units”, to enable a larger number of titles
p.000054: to be presented. Such a proceeding is contrary to good research practice. It makes it more difficult to check the
p.000054: results of the research, with each individual article only providing some of the information that a more comprehensive
p.000054: one could convey.
p.000054: Research has shown that this can lead to misleading results. Readers could get the wrong impression that results
p.000054: presented in a number of different publications come from different studies, when they were actually obtained in a
p.000054: single study. In overview articles they will then be added up, with misleading consequences.
p.000054: Generally speaking, a complete presentation of the results should be given, and published reports should not be
p.000054: fragmented in such a way that subsets of results from the same study are presented in different publications. If this
p.000054: nevertheless occurs, there must be clear reasons for it, and cross-references must be given to where other results from
p.000054: the same or very closely related studies are published.
p.000054: Duplicate publication, i.e. the publishing of articles very similar in content, perhaps with different titles, should
p.000054: also be avoided. If there is good reason to do this, however, for instance when an article is included in an anthology
...
Social / embryo
Searching for indicator embryo:
(return to top)
p.000028: example, the requirement of informed consent can be interpreted and applied as a requirement of individual informed
p.000028: consent in liberal, western societies. But in cultures where the family, group, clan or village elder gives consent,
p.000028: this requirement must be interpreted slightly differently. Research ethics are thereby placed in a cultural and social
p.000028: context. Some values reflect technical and economic development, while others are slower to change and are based on
p.000028: more basic human needs.
p.000028:
p.000028: References
p.000028: 1. Chalmers, Alan F., Vad är vetenskap egentligen? Nora, Nya Doxa, 2003.
p.000028: 2. Föllesdal, Dagfinn & Wallöe, Lars & Elster, Jon, Argumentationsanalys, språk och vetenskapsfilosofi. Stockholm,
p.000028: Thales, 2001.
p.000028: 3. Gilje, Nils & Grimen, Harald, Samhällsvetenskapernas förutsättningar. Göteborg, Daidalos, 1993, tredje upplagan
p.000028: 2007.
p.000028: 4. Hermerén, Göran, Kunskapens pris: forskningsetiska problem och principer i humaniora och samhällsvetenskap.
p.000028: Stockholm, Swedish Science Press & HSFR, 1986, andra upplagan, 1996.
p.000028: 5. Hermerén, Göran,” Challenges in the Evaluation of Nanoscale Research: Ethical Aspects”. NanoEthics, 2007,
p.000028: 1:223–237.
p.000028: 6. Hermerén, Göran & Hug, Kristina (red). Translational Stem Cell Research: Issues Beyond the Debate on the Moral
p.000028: Status of the Human Embryo. New York, Springer, 2010.
p.000028: 7. Högskolelag (SFS 1992:1434).
p.000028: 8. Rydén, Lars (red), Etik för forskare. En antologi med utgångspunkt i arbetet med Uppsala- kodexen. Stockholm,
p.000028: UHÄ, 1990.
p.000028:
p.000028:
p.000028:
p.000028:
p.000028:
p.000028:
p.000028:
p.000028:
p.000028:
p.000028:
p.000028:
p.000028:
p.000028:
p.000028:
p.000028:
p.000028:
p.000028:
p.000028: GOOD RESEARCH PRACTICE
p.000029: 29
p.000029:
p.000029: 3 ETHICS REVIEW AND OTHER PERMIT REVIEW
p.000029:
p.000029:
p.000029: To be allowed to conduct certain types of research, it is necessary to obtain a permit. This applies especially to
p.000029: research that involves humans or entails experiments on animals, but also to some other types of research.
p.000029:
p.000029: 3.1 Ethics review and other permit review of research involving humans
p.000029:
p.000029: 3.1.1 Approval according to the Act concerning the Ethical Review of Research Involving Humans, etc.
p.000029: As mentioned above, the Act (SFS 2003:460) concerning the Ethical Review of Research Involving Humans came into effect
p.000029: as from 1 January 2004.
p.000029: The Act states what types of research projects must be reviewed. It also lists factors and conditions that should be
p.000029: addressed in order for a research project to be approved, as well as how the review bodies – the ethics review boards –
p.000029: should be composed.
p.000029: It is the researcher (or the supervisor of a doctoral student project) who, together with the research principal 3
...
p.000077: 13. Forsman, Birgitta, Etik i biomedicinsk forskning: En orientering. Lund, Studentlitteratur, 2005. Forsman,
p.000077: Birgitta, Forskningsfusk och vetenskaplig oredlighet. Lund, Enheten för medicinsk etik, 2006.
p.000077: 14. Forsman, Birgitta, Forskares frihet: Om makt och moral. Lund, Studentlitteratur, 2009.
p.000077: 15. Föllesdal, Dagfinn & Wallöe, Lars & Elster, Jon, Argumentationsanalys, språk och vetenskaps- filosofi.
p.000077: Stockholm, Thales, 2001.
p.000077: 16. Gilje, Nils & Grimen, Harald, Samhällsvetenskapernas förutsättningar. Göteborg, Daidalos, 1993, tredje upplagan
p.000077: 2007.
p.000077: 17. Görman, Ulf & Andrén, Carl-Gustaf & Hermerén, Göran, Att forma vår framtid: bioteknikens möjligheter och
p.000077: problem. Lund, Nordic Academic Press, 2009.
p.000077:
p.000077:
p.000077: GOOD RESEARCH PRACTICE
p.000078: 78
p.000078:
p.000078: 18. Hansson, Mats G., Integritet. I spänningen mellan avskildhet och delaktighet, Stockholm, Carlsson Bokförlag,
p.000078: 2006.
p.000078: 19. Helgesson, Gert, Forskningsetik för medicinare och naturvetare, Lund, Studentlitteratur, 2006.
p.000078: 20. Hermerén, Göran, Kunskapens pris: forskningsetiska problem och principer i humaniora och samhällsvetenskap.
p.000078: Stockholm, Swedish Science Press & HSFR, 1986, andra upplagan 1996.
p.000078: 21. Hermerén, Göran, ”Vi kommer aldrig att ha forskat färdigt kring de etiska problemen”. Praktik & Teori, 2007,
p.000078: 2:44–51.
p.000078: 22. Hermerén, Göran, ”Challenges in the Evaluation of Nanoscale Research: Ethical Aspects”. Nano Ethics, 2007,
p.000078: 1:223–237.
p.000078: 23. Hermerén, Göran, Hug, Kristina (red). Translational Stem Cell Research: Issues Beyond the Debate on the Moral
p.000078: Status of the Human Embryo. New York, Springer, 2010.
p.000078: 24. Karlsson, Fredrik, Weighing Animal Lives – a Critical Assessment of Justification and Prioritization in
p.000078: Animal-Rights Theories. Uppsala, Acta Universitatis Upsaliensis, 2009.
p.000078: 25. Klareskog, Lars & Rönnelid, Johan & Lundberg, Karin & Padyukov, Leonid & Alfredsson, Lars, ”Immunity to
p.000078: citrullinated proteins in rheumatoid arthritis.” Annual Review of Immunology, 2008, 26:651–675.
p.000078: 26. Kodish, Eric (ed), Ethics and research with children. A case-based approach. Oxford & New York, Oxford
p.000078: University Press, 2005.
p.000078: 27. Kuhn, Thomas S., De vetenskapliga revolutionernas struktur (1962). Stockholm, Thales, andra upplagan, 2009.
p.000078: 28. Loue, Sana, Textbook of research ethics. Theory and practice. Dordrecht, Kluwer, 2000.
p.000078: 29. Lynøe, Niels, Mellan cowboyetik och scoutmoral: medicinsk forskningsetik i praktiken. Stockholm, Liber, 1999.
p.000078: 30. Lynøe, Niels & Juth, Niklas, Medicinska etikens ABZ. Stockholm, Liber, 2009.
p.000078: 31. Macklin, Ruth, Double standards in medical research in developing countries. Cambridge, Cambridge University
p.000078: Press, 2004.
p.000078: 32. Merton, Robert, ”The Normative Structure of Science” (1942), in Merton, R., The Sociology of Science: University
p.000078: of Chicago Press, 1973.
p.000078: 33. Murphy, Timothy, F., Case Studies in Biomedical Research Ethics. Cambridge, Mass., MIT Press, 2004.
p.000078: 34. Myrdal, Janken, Spelets regler i vetenskapens hantverk: Om humanvetenskap och naturvetenskap. Stockholm, Natur &
p.000078: Kultur, 2009.
...
Social / employees
Searching for indicator employees:
(return to top)
p.000073: financial support, or to enable publication of results in certain international journals. Reviews by the regional
p.000073: boards are subject to a fee and shall be undertaken within 60 days from receipt of application. More information is
p.000073: available on (epn.se).
p.000073:
p.000073: 9.3 Secrecy
p.000073: Researchers need to know whether the data handled within the research they carry out is covered by secrecy, and if so,
p.000073: what the secrecy parameters are. A significant factor when determining the secrecy parameters for a task is who is
p.000073: carrying out the activity.
p.000073:
p.000073: 9.3.1 Public principal
p.000073: The Freedom of the Press Act contains regulations for public documents stored by public authorities. The starting point
p.000073: is that public documents are open to the general public, and that the general public’s access to these may only be
p.000073: limited for the purposes listed in Chapter 2 Section 2 of the Act. One of the purposes is the protection of the
p.000073: personal or financial circumstances of individuals. The issue of when data may be covered by secrecy under this
p.000073: exception is regulated in particular in the Public Access to Information and Secrecy Act (SFS 2009:400). This Act
p.000073: contains provisions that apply to the handling of personal data within the framework of health and medical care, in
p.000073: research activities and other activities carried on by public agencies.
p.000073: The regulations in the Act also entail that those who work at a public agency are automatically covered by professional
p.000073: secrecy rules. It is important to remember that employees have an obligation of professional secrecy under the Act, but
p.000073: cannot have a more comprehensive obligation imposed. That means that if data is covered by secrecy under the Act, it
p.000073: must not be disclosed, at the same time that data that is public must be disclosed on demand.
p.000073:
p.000073:
p.000073:
p.000073:
p.000073:
p.000073:
p.000073:
p.000073: GOOD RESEARCH PRACTICE
p.000074: 74
p.000074:
p.000074: 9.3.2 Private principal
p.000074: Private actors have no obligation to disclose data, or keep data secret, unless this follows from special legislation
p.000074: covering their activities. Such regulations exist, for example for private caregivers, in Chapter 6 of the Patient
p.000074: Safety Act. If there are no particular regulation, private actors may themselves decide on the secrecy protection that
p.000074: shall apply for a certain task.
p.000074: This also means that employees of private employers do not have any statutory obligation of secrecy, unless this
p.000074: follows from special regulations, such as those in the Patient Data Act. This must instead be regulated between the
p.000074: employee and the employer in such a way that the private employer ensures that data that shall not be disseminated are
p.000074: kept secret.
p.000074: If the data is held by a private principal, there is also no right for the general public, including research
p.000074: principals, to partake of data in the system under the Freedom of the Press Act. There is thus greater freedom for a
p.000074: private principal to decide who may partake of data.
p.000074:
p.000074: 9.4 Examples of other legislation
p.000074: The Animal Welfare Act (SFS 1988:534) and Animal Welfare Ordinance (SFS 1988:539) apply to research on animals. The
p.000074: Swedish Board of Agriculture provides supplementary guidelines and general advice.
p.000074:
p.000074: 9.5 The CODEX website
p.000074: The Swedish Research Council maintains a website in collaboration with the Centre for Research Ethics and Bioethics at
p.000074: Uppsala University on which the great majority of documents that may be relevant to the researcher can be found. The
p.000074: site thus includes legislation with a bearing on research.
p.000074: Also to be found here are various directives and conventions of an international character, adopted for example by the
p.000074: UN, UNESCO, the EU and the Council of Europe. The site also features the full texts of codes of research ethics for
p.000074: different disciplines and fields of research, along with introductions to specific challenges in research, such as
...
Social / gender
Searching for indicator gender:
(return to top)
p.000011: possible to distinguish between external and internal research ethics, with professional ethics corresponding to the
p.000011: latter.
p.000011:
p.000011:
p.000011: GOOD RESEARCH PRACTICE
p.000012: 12
p.000012:
p.000012: 1.3 Merton’s CUDOS norms
p.000012: In the 1940s, the American sociologist Robert Merton formulated four principles which he believed constituted a “moral
p.000012: consensus” in science, and these have had a significant impact on the discussion around professional ethics. Commonly
p.000012: referred to as the CUDOS (Communism/Communalism, Universalism, Disinterestedness and Organised Scepticism) norms, they
p.000012: have since been both modified and questioned but nonetheless merit attention as one starting point for a discussion
p.000012: about what constitutes good research practice.
p.000012: The norm of communism, or communalism (C), means that the research community and society as a whole have the right to
p.000012: be informed of the results of research. New knowledge should not be kept secret and concealed. Scientific advances are
p.000012: regarded as a result of collaboration within and between generations of researchers; after all, the researcher does not
p.000012: work in a vacuum. Thus, according to Merton, there is no such thing as intellectual property, owned by the researcher.
p.000012: Merton’s norm of universalism (U) requires scientific work to be evaluated with reference to scientific criteria alone.
p.000012: When assessing the validity of the results, we are to take no account, for example, of the researcher’s race, gender or
p.000012: position in society. The norm of disinterestedness (D) means that the researcher must have no other motive for his or
p.000012: her research than a desire to contribute new knowledge. The fourth norm, organised scepticism (OS), requires the
p.000012: researcher to constantly question and scrutinise, but also to refrain from expressing an assessment until he or she has
p.000012: sufficient evidence on which to base it.
p.000012: Since these principles were put forward, the position of the researcher, or at least the general perception of it, has
p.000012: changed in many respects. Being a researcher can no doubt colour an individual’s whole way of being and thinking, but
p.000012: these days it is quite a common professional role, and researchers are employed specifically as researchers. They, too,
p.000012: are expected to be loyal to organisations and superiors, and have to take financial factors and their own job security
p.000012: into account.
p.000012: In many cases, therefore, Merton’s norms will be difficult to live up to in reality. His requirement for
p.000012: disinterestedness, which says that the researcher’s main reason for doing research should be to contribute new
p.000012: knowledge, is a case in point. Researchers must surely be allowed to have other motives as well, such as promoting
p.000012: their prospects of employment through the work they do. The important thing, rather, is that motives of this kind do
p.000012: not influence the researcher in such a way that he or she arrives at interpretations or conclusions for which there is
p.000012: no scientific basis, or withholds findings for which evidence does exist.
p.000012: Merton’s strict requirement of communism is also difficult to live up to in many types of research and in certain
...
p.000054: going to publish it – and not before time, because you have heard that a group in Hamburg has a similar publication in
p.000054: the pipeline.
p.000054: Then one of your colleagues discovers an irritating error in one of your computer programs. It is probably of no
p.000054: significance, but it will take at least six months to fully investigate the consequences. If your work is not published
p.000054: before the next application round, or the Germans beat you to it, the livelihoods of a postdoc scholarship holder and a
p.000054: postdoctoral research fellow funded from your council grant will be put in jeopardy.
p.000054: What do you do?
p.000054:
p.000054: 6.7 The author
p.000054: The author is responsible for the contents of a book or article presenting his or her research. That includes
p.000054: everything related to the actual project – methods, validity and reliability of the results, etc. – but also the
p.000054: quality of the manuscript. It is also the author’s responsibility to check a journal’s or publisher’s terms regarding
p.000054: parallel publishing before one and the same manuscript is simultaneously submitted to or published in several different
p.000054: journals. Another responsibility is of course to make sure that the references and quotations in the text are correct.
p.000054: In the case of research based on statistical analysis, a scientific interpretation has to be undertaken, taking careful
p.000054: account of all the basic assumptions and limitations of the procedure used to test the hypothesis. The results also
p.000054: have to be interpreted in the light of previously published findings, and other investigators’ results cited where
p.000054: relevant.
p.000054: Researchers studying, for example, the links between gender and absence from the workplace, the incidence of crime in
p.000054: different groups in the community, or the economic situation, genetics and dietary habits of
p.000054:
p.000054:
p.000054:
p.000054: GOOD RESEARCH PRACTICE
p.000055: 55
p.000055:
p.000055: different ethnic groups, must make sure they present their statistical interpretation of the data, in relation to
p.000055: their scientific hypotheses, and explain what that interpretation shows and what underlying assumptions have been made,
p.000055: not least when the results are published outside traditional academic circles. If the author foresees a risk of
p.000055: over-interpretation in the media, he or she has a responsibility to try to preclude or prevent that risk, especially if
p.000055: it might cause harm to the research subjects or any third parties.
p.000055: A good scientific presentation will include an active discussion of the results by the author. This means that the
p.000055: author should not only cite or refer to works which support the proposition advanced. It is also necessary to present
p.000055: possible arguments against it, and try to respond to them in the text.
p.000055:
p.000055: 6.8 Multiple authors – responsibility – publication rules
p.000055: Why is the question of authorship important?
p.000055: One reason is that the authors’ names are, rightly or wrongly, seen by colleagues in their field as an indication of
p.000055: the quality of a publication. Consequently, it is important to know who actually did the work, so as to be able to
...
Social / parents
Searching for indicator parent:
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p.000034: the latter instance is studies aimed at developing methods for treating rheumatoid arthritis by studying patients’
p.000034: tissue samples. Here we can see two of the reasons for not using animals: arthritis is a painful disease even for the
p.000034: animals serving as disease models, and only humans and primates have the central receptors the treatment involves. This
p.000034: means that experiments on mice and rats would have lower relevance.
p.000034: Computer programs are also sometimes used instead of animal experiments, for example to evaluate and calculate side
p.000034: effects of various treatment methods. Cell models can also be used to test, at cell level, the impact of certain
p.000034: chemicals or to study the effects of medication.
p.000034: In Sweden, there is governmental support for research grants for alternative methods to animal experimentation
p.000034: according to the 3R principle, i.e. methods that refine, reduce and replace animal experiments, which can be applied
p.000034: for through the Swedish Research Council. Alternative methods refer to methods that refine, limit and/or replace
p.000034: experiments on animals. It is also possible to apply for research grants from the Swedish Fund for Research Without
p.000034: Animal Experiments (forskautandjurforsok.se). The EU has a centre for the coordination, development and evaluation of
p.000034: alternatives to animal experimentation, ECVAM (the European Centre for the Validation of Alternative Methods), located
p.000034: near Milan, Italy. Since April 2010, there is also an industry-funded centre for alternative methods, CAAT-EU (the
p.000034: Center for Alternatives to Animal Testing Europe) at the University of Konstanz in Germany. Its parent organisation in
p.000034: the US was established in the 1980s.
p.000034: Together with a number of universities, the Swedish Research Council is responsible for providing information to
p.000034: researchers and the general public via the website www.djurforsok.info.
p.000034:
p.000034: 3.2.6 Evaluating the ethics of animal experiments
p.000034: A researcher who uses laboratory animals, as well as the majority of the members of the ethics committees on animal
p.000034: experiments who have the task of determining what is ethically acceptable, have all reached the fundamental conclusion
p.000034: that there are animal experiments that are ethically defensible. Every experiment, however, must be preceded by an
p.000034: ethical evaluation. The following concepts (in italics) may help in highlighting important questions to ask when
p.000034: evaluating what is ethically defensible.
p.000034: A fundamental element to consider is who or what has moral relevance, that is who or what should be considered in the
p.000034: ethical deliberation. A distinction must be made between whether something or someone has moral relevance in itself –
p.000034: intrinsic value – or is relevant for the sake of someone or something else – instrumental value. Intrinsic value is
p.000034: often not measured in degrees, but is instead regarded as either existing in an individual (or a material entity), or
p.000034: not. On the other hand, the instrumental value of an individual or a material entity is possible to measure. Its value
p.000034: can differ, depending on the user or beholder.
p.000034: It is not unusual either for an individual to be considered as having both intrinsic and instrumental value. For
p.000034: example, a genetically modified mouse of a certain lineage can be a highly valuable instrument within a certain
...
Social / philosophical differences/differences of opinion
Searching for indicator opinion:
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p.000020: terminated.
p.000020: If a researcher realises that he or she is working with research that has or can have dangerous consequences, an
p.000020: important problem arises. While it is certainly very difficult to make such a judgement, the researcher in question is
p.000020: often just the person in society who has the best ability to do so. However, even researchers can sometimes be
p.000020: blinkered or short-sighted, looking after their own interests in conducting a certain research project.
p.000020: The so-called Uppsala Code discusses this ethical issue. This ethical code, developed by researchers at Uppsala
p.000020: University during the 1980s, has received a great deal of attention. It appeals to researchers to avoid
p.000020:
p.000020:
p.000020:
p.000020:
p.000020:
p.000020: 1In the Act concerning the Ethical Review of Research Involving Humans, a research subject refers to a “living person
p.000020: observed for the purposes of research”. Other typical expressions are subject, interview subject, etc. This covers, for
p.000020: example, persons who participate in experiments, are the subject of observations in studies, or provide information
p.000020: used in research.
p.000020:
p.000020:
p.000020: GOOD RESEARCH PRACTICE
p.000021: 21
p.000021:
p.000021: research that can lead to ecological harm or the development of weapons, or that is in conflict with basic human
p.000021: rights.
p.000021: The Uppsala Code is intended to be used by the researcher to evaluate his or her own research or that of colleagues. A
p.000021: researcher who determines that current or planned research will breach the Code is encouraged not to participate in it,
p.000021: and to make his or her opinion publicly known. The Code also states that colleagues and the research community should
p.000021: support such a researcher. A decision like this is difficult to make, not least for younger researchers just beginning
p.000021: their careers or still completing their studies. And, as a rule, it is easier and more reasonable to regulate the use
p.000021: of knowledge than to direct the quest for knowledge itself.
p.000021:
p.000021:
p.000021: What would you do in the following situation?
p.000021: You are the leader of a research group in the process of synthesising a virus that caused a lethal epidemic a long time
p.000021: ago. You realise that the results – if published – can easily be used by terrorists for biological warfare.
p.000021: Do you publish the results? How do you respond to objections?
p.000021:
p.000021:
p.000021: Meanwhile, it is also important that a researcher be loyal to his or her research task. With a decision to terminate,
p.000021: you should also consider the fact that other researchers may be depending on the work’s completion. Loyalty to the
p.000021: research task, diligence and an ability to concentrate are therefore important qualities for a researcher as well as a
p.000021: research environment to have. Most research projects demand a great work effort and a high level of concentration. As a
p.000021: rule, the time it takes from the first ideas to results is both long and uncertain. Most research work certainly
p.000021: contains creative elements, but there are often long, laborious periods of routine and transition in between.
p.000021: A researcher can have several reasons for leaving a project he or she has undertaken. Ethical reasons can include the
p.000021: research risking violating people’s integrity or the published results being misused. Scientific reasons can include
p.000021: new discoveries making the purpose of the research no longer fruitful.
p.000021:
...
p.000032:
p.000032:
p.000032:
p.000032:
p.000032:
p.000032:
p.000032:
p.000032: 4A summary of its development is given in the Swedish Board of Agriculture’s regulations on change in the Central
p.000032: Laboratory Animals Board’s regulations from 1988; see the Board of Agriculture’s Code of Statutes 2008:70 as well as
p.000032: Borgström 2009.
p.000032: 5http://ec.europa.eu/environment/chemicals/lab_animals/index_en.htm
p.000032:
p.000032:
p.000032: GOOD RESEARCH PRACTICE
p.000033: 33
p.000033:
p.000033: Some facts
p.000033: The chair and vice chair of the ethics committees on animal experiments are lawyers with experience of court work. Of
p.000033: the other twelve members, one half are scientists or staff who work with laboratory animals and other half are laymen,
p.000033: of whom at least one represents an animal welfare organisation. It is a stated political goal that the laymen should
p.000033: represent the general public to the greatest degree possible. The composition of the research group should be such that
p.000033: the committee as a whole has broad competence.
p.000033:
p.000033: 3.2.4 Ethics review
p.000033: The main task of an ethics committee on animal experiments is to weigh the purpose of the experiment against the
p.000033: suffering that may be inflicted on the animals, and determine whether the purpose is sufficiently important to justify
p.000033: the animals’ expected suffering. This is a challenging task. It is important that the application be clear and
p.000033: informative, so that the committee can form an opinion on how important the experiment is, and how the animals may be
p.000033: affected.
p.000033: Central questions that must be answered by the applicant to enable the committee to make an adequate assessment are:
p.000033: the purpose of the research, whether this can be achieved using another method than animal experimentation or with
p.000033: another type of animal, whether the animals will be subjected to greater suffering than is absolutely necessary,
p.000033: whether anaesthesia or painkillers will be required, and whether the experiment is an unnecessary repetition of an
p.000033: earlier one.
p.000033: A report on the ethics review of animal experiments (Etisk prövning av djurförsök, SOU 2002:86) contains a
p.000033: well/structured suggestion for discussion subjects that highlight which ethical aspects need to be stressed in
p.000033: connection with each application.
p.000033: A researcher who wishes to make a sound decision in the question of whether or not an animal experiment is justified
p.000033: must, just like the ethics committees on animal experiments, consider the purpose of the research by weighing the
p.000033: expected benefit of the experiment against the expected suffering of the animals. The fundamental principle in all
p.000033: research, weighing benefit against possible harm, was touched on earlier. Here, a number of factors determine the
p.000033: outcome.
p.000033: As regards benefit, the researcher should consider the importance of the knowledge gain or possible application, for
p.000033: society in general as well as for the research itself. He or she must think about whether, for example, it applies to a
p.000033: considerable number of people – each suffering relatively little – or if it is a matter of only a small number of
p.000033: people, who each suffer a great deal or have a disability that affects their everyday lives.
p.000033: The task of the committee is then to make its legally binding decision on the application and to ensure that only
p.000033: experiments that are relevant to the research and well-designed are conducted. Committee members representing the
p.000033: research community review the scientific stringency and methodical relevance of the application. The lay members’ task
p.000033: is to confirm the societal importance of the animal experimentation and to represent the general public’s observation
p.000033: and evaluation.
p.000033: The applicant must submit a complete application and describe the project in such a way that all committee members can
p.000033: understand and discuss it, based on the information it contains. As necessary, the committee may call the applicant to
p.000033: the meeting to provide clarification, or request an expert opinion. The committee may decide that a partial or pilot
p.000033: study should be conducted if a method must first be evaluated; the committee can also do this to reduce the number of
p.000033: animals used, before it has been determined to the best possible degree how the animals will feel or if their suffering
p.000033: is directly regarded as severe.
p.000033: To simplify the evaluation of the animals’ suffering and in the interest of achieving uniformity among the committees,
p.000033: a four-part categorisation has been introduced. Based on this, the applicant him or herself assesses whether the
p.000033: experiment in its entirety entails terminal, mild, moderate or severe suffering for the animal – this is the
p.000033: experiment’s so-called classification of severity. Here, both the researcher and committee may refer to the list of
p.000033: experiments according to degree of severity in the Board of Agriculture’s instructions. The committee must determine
p.000033: whether the applicant has made a reasonable evaluation and, when necessary, correct the information.
p.000033:
p.000033: 3.2.5 Alternatives to using laboratory animals
p.000033: Many researchers try to find animal-free methods that allow them to reach results that are equally dependable. There
p.000033: are several reasons for this. Reasons can include the researcher not wanting to inflict suffering on
p.000033:
p.000033:
p.000033: GOOD RESEARCH PRACTICE
p.000034: 34
p.000034:
p.000034: animals, or the fact that it is relatively costly to keep animals. A third reason, which is being discussed
p.000034: increasingly, is the uncertainty of how transferable results from medical experiments are; that is, how relevant
p.000034: results from experiments using animals are in the medical treatment of humans.
...
p.000045: assigned (either wholly or partially) to the university where the work was done. The question of ownership of the
p.000045: results of an international collaborative study can be extremely complex, and can easily poison the atmosphere in such
p.000045: a project.
p.000045: Issues of this kind, including purely practical aspects of how any commercially exploitable results are to be handled,
p.000045: must be discussed in detail by the research groups concerned – preferably before they become a
p.000045:
p.000045:
p.000045:
p.000045: GOOD RESEARCH PRACTICE
p.000046: 46
p.000046:
p.000046: pressing concern. All participants in the project, and not least any doctoral students involved, should be informed
p.000046: about what rules apply.
p.000046:
p.000046: 5.5 Responsibility for a collaborative project: general
p.000046: In certain contexts, it is necessary to identify the individual or individuals formally responsible for a joint
p.000046: project. If, for example, use is to be made of a major international research facility, such as CERN or ESO, a
p.000046: principal investigator (PI) must be designated. Preferably, this should be the initiator of the project or its
p.000046: administrative leader and coordinator.
p.000046: A PI also has to be identified in an application for ethics review.
p.000046: It is important not to fall for the temptation to choose a “high profile” name, if the person concerned cannot take on
p.000046: full responsibility for leading the project. In general, it is also advisable to refrain from naming celebrated
p.000046: researchers as co-applicants, members of reference groups etc., merely to give the project greater credibility. Such
p.000046: individuals can express their favourable opinion of the work in other ways, for instance by writing a letter of
p.000046: support.
p.000046: As part of a professional evaluation of project proposals, funding bodies will seek to clarify the real management
p.000046: structure of projects and the capabilities of those actively involved in them. It increases credibility if such matters
p.000046: are dealt with openly. When a project involves a large number of researchers at different stages in their careers,
p.000046: large quantities of unique equipment or very substantial funding, competent management and effective administrative
p.000046: arrangements are essential. Many research projects are wanting in precisely these respects, making the research
p.000046: inefficient and completion times unnecessarily unpredictable.
p.000046: For postgraduate or early-career researchers especially, such a situation creates difficulties. From the point of view
p.000046: of society at large, too, it is obviously unsatisfactory if resources made available are not put to efficient use. The
p.000046: bohemian charm often associated with creative environments does not excuse laid-back or incompetent leadership or
p.000046: careless management of funding. Public agencies and other funding bodies have a right to expect all researchers
p.000046: entrusted with public funds to make sure they are used in the best possible manner. Clearly this applies not least to
p.000046: major projects, where there are resources that can be devoted to this purpose. Resources must also be set aside for
p.000046: documentation.
p.000046: The special issues of responsibility that can arise in large multinational research projects are discussed in more
p.000046: detail in the next section.
p.000046:
p.000046: 5.6 Issues of responsibility in multinational research projects
p.000046:
p.000046: 5.6.1 Starting points
...
Economic / Economic/Poverty
Searching for indicator poor:
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p.000011: as possible, for which we can find good arguments. We want to justify our position. A set of ethics cannot be
p.000011: arbitrary. We also want our formulations to be able to work together and form a system. A set of ethics should also be
p.000011: able to be formulated in words.
p.000011: Perhaps you could say that ethics contain moral precepts that are conscious, reflected on and motivated, which one
p.000011: formulates as clearly as possible and are presented in a systematic way. In a way, ethics provide a theory for morals,
p.000011: which are their practical expression. But you can sometimes have a practice without a theory; this is why one speaks
p.000011: of research ethics and, on a much smaller scale, research morals. It is a question of norms (principles) that the
p.000011: research community has reflected on and has tried to formulate clearly and motivate. These norms are assumed to work
p.000011: well together and offer guidance. A code is a collection of research ethics rules, i.e. more specified norms concerning
p.000011: a certain research area or certain stages of research projects.
p.000011: Both ethics and morals contain normative assumptions that dictate what is good or bad and that recommend or forbid
p.000011: different behaviours. A distinction is usually made between statements about values, which attribute a value to
p.000011: something – “good”, “poor”, “bad”, “valuable”, “attractive”, “ugly”, etc. – and norms, which tell us what we ought to
p.000011: do, what our “duty” is or what is “right” or “wrong”; what we should do and what we should refrain from doing. As a
p.000011: rule, both ethics and morals contain degrees of assumption, and there is often a simple connection between them. For
p.000011: example, if we regard suffering as bad this also becomes a reason for us to maintain that we should not cause suffering
p.000011: and that actions that do cause it is wrong. By the same token, if knowledge is seen as valuable, we naturally embrace
p.000011: the norm that humans should seek knowledge.
p.000011:
p.000011: 1.2 Research ethics and professional ethics
p.000011: The area of research ethics is not a well-defined area, even though it is obvious that it entails questions regarding
p.000011: the relationship between research and ethics as well as ethical standards for the researcher and the aim and
p.000011: implementation of the research. It is difficult to summarise this in a simply formulated definition. New types of
p.000011: questions also arise as research moves into new areas or as new techniques or research methods appear.
p.000011: A crucial part of research ethics concerns questions of how people who participate in research as subjects or
p.000011: informants can be treated. It can seem self-evident that these people should be protected to the highest degree
p.000011: possible from harms or wrongs in connection with their participation in research. But how do you do this?
...
p.000015: and narrow interpretations. In a narrow interpretation, these criteria are met by research that provides new knowledge,
p.000015: reveals conditions not previously known or sheds new light on previously known phenomena and relationships – it gives
p.000015: us more reliable knowledge maps to navigate by than we have had in the past.
p.000015: With this narrow interpretation, the content of the criteria for good scientific quality is not completely unequivocal,
p.000015: as research can meet many of these criteria to higher and lower degrees. The criteria of stringency, representativity,
p.000015: generalisability, transferability, reproducibility, transparency, etc. can be interpreted and applied in somewhat
p.000015: diverse ways within various research areas, such as history, social sciences, medicine and technical and natural
p.000015: sciences.
p.000015: Nevertheless, it is important to remember that the concept of scientific quality is used in a broader sense as well. In
p.000015: such cases this entails an overall judgement from which it is not possible to single out individual criteria. When the
p.000015: total quality of the research is evaluated, no single quality can be ignored. The quality is evaluated based on the
p.000015: collective qualities of originality, external and internal validity, precision and ethics. The requirement of good
p.000015: research ethics is thus included here; therefore, there can be no conflict between the demands for good research ethics
p.000015: and good scientific quality. A research report exhibits poor research ethics if it contains scientific shortcomings in
p.000015: the precision of its questions, uses incorrect methods (or uses established methods incorrectly), systematically
p.000015: excludes observations that do not support the author’s hypothesis, handles the problem of dropout in a statistically
p.000015: unacceptable way, or uses a study design that does not allow for the research question to be answered. People’s time
p.000015: has been used needlessly, and they may have been exposed to not only a certain amount of inconvenience or discomfort,
p.000015: but sometimes even suffering. In any case, resources that could have been used in a better way have been wasted. It is
p.000015: also quite easy to find examples of studies that, through superficial correlations between ethnicity, criminality,
p.000015: intelligence, education, etc., have led to the discrimination or stigmatisation of individuals and groups.
p.000015: Unfortunately, there are also examples of cheating in studies on methods for treating breast cancer or links between
p.000015: vaccination and autism. Here, poor scientific quality and poor ethics overlap, leading to the possibility that people
p.000015: can be harmed when the results of the research are applied in practice.
p.000015:
p.000015:
p.000015:
p.000015:
p.000015: GOOD RESEARCH PRACTICE
p.000016: 16
p.000016:
p.000016: There can sometimes also be economic and time frames that tempt researchers to take shortcuts, which can cause the
p.000016: research to fail in meeting both scientific and ethical quality criteria. If the problem is due solely to these
p.000016: factors, there is no fundamental opposition between the two; with other time frames or better economic resources, the
p.000016: problem would not surface. We thereby find ourselves back in a situation of type (1), in which there is no fundamental
p.000016: opposition between the diverse types of quality criteria. Against this background it is reasonable to regard work to
p.000016: improve the ethical aspects of the research as a quality issue.
p.000016:
p.000016: Stanley Milgram conducted experiments with volunteer subjects. The subjects were informed that they, as “teachers”,
p.000016: were to give an electric shock to “students” when they answered incorrectly, and that they were to increase the
p.000016: strength of the shock with each successive wrong answer. The students then simulated great pain. Everything was
p.000016: simulated, and everyone except the subjects knew this. Most of the subjects followed the instructions.
p.000016: Milgram’s research provided important knowledge on subordination and the obedience of instructions from authorities –
p.000016: it revealed things about ourselves that we perhaps would rather not know, but that are important for the understanding
p.000016: of the success of Hitler and others like him – but Milgram’s research has also been criticised.
...
p.000033: animals used, before it has been determined to the best possible degree how the animals will feel or if their suffering
p.000033: is directly regarded as severe.
p.000033: To simplify the evaluation of the animals’ suffering and in the interest of achieving uniformity among the committees,
p.000033: a four-part categorisation has been introduced. Based on this, the applicant him or herself assesses whether the
p.000033: experiment in its entirety entails terminal, mild, moderate or severe suffering for the animal – this is the
p.000033: experiment’s so-called classification of severity. Here, both the researcher and committee may refer to the list of
p.000033: experiments according to degree of severity in the Board of Agriculture’s instructions. The committee must determine
p.000033: whether the applicant has made a reasonable evaluation and, when necessary, correct the information.
p.000033:
p.000033: 3.2.5 Alternatives to using laboratory animals
p.000033: Many researchers try to find animal-free methods that allow them to reach results that are equally dependable. There
p.000033: are several reasons for this. Reasons can include the researcher not wanting to inflict suffering on
p.000033:
p.000033:
p.000033: GOOD RESEARCH PRACTICE
p.000034: 34
p.000034:
p.000034: animals, or the fact that it is relatively costly to keep animals. A third reason, which is being discussed
p.000034: increasingly, is the uncertainty of how transferable results from medical experiments are; that is, how relevant
p.000034: results from experiments using animals are in the medical treatment of humans.
p.000034: For example, comparisons between treatment effects on animals and clinical trials using humans might show poor
p.000034: correspondence. This indicates both that animal experiments and clinical trials may need to be better coordinated, and
p.000034: also that animal experiments do not always provide meaningful information for the treatment of humans. An example of
p.000034: the latter instance is studies aimed at developing methods for treating rheumatoid arthritis by studying patients’
p.000034: tissue samples. Here we can see two of the reasons for not using animals: arthritis is a painful disease even for the
p.000034: animals serving as disease models, and only humans and primates have the central receptors the treatment involves. This
p.000034: means that experiments on mice and rats would have lower relevance.
p.000034: Computer programs are also sometimes used instead of animal experiments, for example to evaluate and calculate side
p.000034: effects of various treatment methods. Cell models can also be used to test, at cell level, the impact of certain
p.000034: chemicals or to study the effects of medication.
p.000034: In Sweden, there is governmental support for research grants for alternative methods to animal experimentation
p.000034: according to the 3R principle, i.e. methods that refine, reduce and replace animal experiments, which can be applied
p.000034: for through the Swedish Research Council. Alternative methods refer to methods that refine, limit and/or replace
p.000034: experiments on animals. It is also possible to apply for research grants from the Swedish Fund for Research Without
p.000034: Animal Experiments (forskautandjurforsok.se). The EU has a centre for the coordination, development and evaluation of
p.000034: alternatives to animal experimentation, ECVAM (the European Centre for the Validation of Alternative Methods), located
...
p.000035: Perhaps the philosophers are right when they say it is impossible to justify it in any other way than to say that
p.000035: someone born by a human thereby has the right to a certain moral protection that is not extended to other living
p.000035: beings. If this is indeed the case, then we have just as great a responsibility to contemplate what we should do with
p.000035: this special position.
p.000035: Our rationality and knowledge allow us to exercise power over other animals. But with power comes responsibility –
p.000035: power over the animals’ situation and power over what issues we choose to research, for both the sake of the people who
p.000035: put their hopes in science and the sake of the animals whose lives are used to this end.
p.000035:
p.000035: What would you do in the following situation?
p.000035: Millions of people today have HIV and risk contracting AIDS if they do not receive effective inhibitor medications. A
p.000035: great deal of research is being conducted to find a cure for HIV/AIDS using chimpanzees which, besides humans, are the
p.000035: only animals that can get HIV/AIDS.
p.000035: You are a member of an ethics committee on animal experiments that is to ethically evaluate a research project aiming
p.000035: to test the effectiveness of a potential vaccine. The researchers inform the committee that the vaccine’s effect needs
p.000035: to be tested on advanced AIDS, which means that the chimpanzees will be in very poor health when the actual
p.000035: experimenting begins.
p.000035: What ethically significant aspects to you feel should be considered to ethically evaluate whether this experiment
p.000035: should be approved? Consider the issue from both a researcher’s and a layman’s evaluation perspective.
p.000035:
p.000035: 3.3 Genetically modified organisms
p.000035: Basic research and applied research with genetically modified organisms, i.e. organisms whose genetic material has been
p.000035: changed in a way that does not occur naturally through mating or the natural recombination of genes, is covered by a
p.000035: detailed system of regulations. Supervisory responsibilities are divided between several authorities, including the
p.000035: Swedish Work Environment Authority, the Swedish Board of Agriculture, the Swedish Board of Fisheries and the Swedish
p.000035: Medical Products Agency. The different authorities’ areas of responsibility, as well as the applicable regulations, can
p.000035: be found at the web portal of the Swedish Gene Technology Advisory Board, (genteknik.se).
p.000035: For research involving the enclosed use of genetically modified organisms, for example the growing of cultures in
p.000035: tightly shut containers or cultivation in a greenhouse, to be conducted it is necessary either for the responsible
p.000035: authority to have given its approval, or for the research to have been reported to this authority. The research should
p.000035: always be preceded by an investigation that serves as a basis for a risk assessment, and the results of this assessment
p.000035: then determine what protective measures will be necessary.
...
p.000067: factor. Departments and other research environments do not want to be associated with such cases any more than
p.000067: researchers themselves or research principals do.
p.000067: It is also important that established misconduct be followed by sanctions, to mark that a violation of research ethics
p.000067: is a serious matter. If it is discovered, for instance, that someone has committed plagiarism and nothing happens, it
p.000067: can be interpreted that plagiarism is not a particularly serious offence. There are labour law measures that employers
p.000067: can take in the event of established misconduct.
p.000067: Research misconduct shall simply not occur in research. As part of this effort, the Swedish Research Council wants to
p.000067: stimulate departments, higher education institutions and universities to develop into such excellent environments as
p.000067: described above. The Swedish Research Council is government agency that awards grants to research following careful
p.000067: quality control. Payment of a grant may be stopped if any misconduct is established.
p.000067:
p.000067: What would you do in the following situation?
p.000067: You discover that one of your older colleagues in the department has falsified a series of measurements in a minor
p.000067: publication, with no very sensational results. He is close to retirement. When you raise the matter with him, he breaks
p.000067: down crying and blames the head of department’s demand for “at least one paper a year”. If he fails to meet that
p.000067: target, he will not get a share of the “special research resource” and will have to teach 400 hours a year. The man is
p.000067: in poor health and has no great talent for teaching.
p.000067: What do you do?
p.000067:
p.000067: 8.9 Addressing issues of misconduct
p.000067: According to the Higher Education Ordinance (SFS 1993:100), it is mandatory for universities and higher education
p.000067: institutions to investigate any suspected research misconduct. No equivalent requirement exists for research conducted
p.000067: outside academia. The Ordinance does not, however, regulate how investigations should be conducted; this is up to each
p.000067: higher education institution.
p.000067: It is common practice that suspicions of research misconduct are reported to the organisation – the department,
p.000067: university, etc. – where the suspected researcher works. For instance, if someone discovers that a colleague has
p.000067: committed plagiarism, this person must report this to the department head or the dean of the university, who should in
p.000067: turn report this to the vice-chancellor. The vice-chancellor is under obligation to process the report and ensure that
p.000067: the case is investigated, and, if the accused researcher is found guilty of research misconduct, determine the labour
p.000067: law sanctions to be imposed. It is thus primarily the learning institution itself that investigates and decides on the
p.000067: case.
p.000067:
p.000067:
p.000067:
p.000067:
p.000067: GOOD RESEARCH PRACTICE
p.000068: 68
p.000068:
p.000068: However, the vice-chancellor does have the possibility to get an external statement. Since 1 January 2010, the CEPN
p.000068: has had an expert group on research misconduct, which on request can provide assistance in these matters. The group is
...
Economic / Food Insecurity
Searching for indicator hunger:
(return to top)
p.000036: researchers’ chances of obtaining further funding and being published.
p.000036: There are issues concerning the withdrawal of consent that are problematic for research ethics. In biobank research,
p.000036: the research subject has the option of withdrawing consent. If this happens, it is the responsible party at the biobank
p.000036: who determines whether the biological material should be destroyed – which is likely to be the research subject’s wish
p.000036: – or only de-identified. In the latter case, the research subject can feel tricked. In research projects using video or
p.000036: audio recording, the research subject is often told he or she can withdraw consent after the recording and that the
p.000036: tape will be destroyed. However, this is in conflict with the regulations governing archiving and storage of research
p.000036: material, as well as with the rules regarding withdrawal of consent in the Act concerning the Ethical Review of
p.000036: Research Involving Humans.
p.000036:
p.000036: References
p.000036: 1. Alexius Borgström, Katarina, Djuren, läkarna och lagen: en rättslig studie om djurförsöksetik. Uppsala, Iustus
p.000036: förlag, 2009. Arkivlag (SFS 1990:782).
p.000036: 2. Brambell, Rogers, F.W. (Chairman), Report of the Technical Committee to enquire into the Welfare of Animals
p.000036: kept under Intensive Livestock Husbandry Systems, London, HMSO, 1965. This states five freedoms for farm animals:
p.000036: freedom from hunger and thirst, from discomfort in housing, from pain and injury, from fear and worry and the
p.000036: opportunity to exhibit natural behaviour.
p.000036: 3. Cavalieri, Paola & Singer, Peter (red.), The Great Ape Project: Equality Beyond Humanity. New York, St.
p.000036: Martin’s Press, 1994. A proclamation from 34 researchers and authors for three rights for certain primates: the right
p.000036: to life, the right to freedom and a prohibition against torture.
p.000036:
p.000036:
p.000036:
p.000036: GOOD RESEARCH PRACTICE
p.000037: 37
p.000037:
p.000037: 4. Centrala försöksdjursnämnden, Författningar, allmänna råd och anvisningar om användningen av djur för
p.000037: vetenskapliga ändamål. Stockholm, CFN:s skriftserie: 45, 2002.
p.000037: 5. Den nasjonale forskningsetiske komité for naturvitenskap og teknologi (NENT), Forsknings- etiske retningslinjer
p.000037: for naturvitenskap og teknologi. Oslo, 2007.
p.000037: 6. Djurförsöksetiska utredningen. Etisk prövning av djurförsök: delbetänkande (SOU 2002:86). Stockholm, Fritzes
p.000037: offentliga publikationer, 2002. Djurskyddslag (SFS 1988:534).
p.000037: 7. Egonsson, Dan, Filosofiska essäer om människovärde. Nora, Nya Doxa, 1999.
p.000037: 8. Förordning om etikprövning av forskning som avser människor (SFS 2003:615).
p.000037: 9. Förordning med instruktion för regionala etikprövningsnämnder (SFS 2007:1068)
p.000037: 10. Förordning med instruktion för Centrala etikprövningsnämnden (SFS 2007:1069).
p.000037: 11. Förordning om utsättning av genetiskt modifierade organismer i miljön (SFS 2002:1086).
p.000037: 12. Förordning om innesluten användning av genetiskt modifierade organismer (SFS 2000:271).
p.000037: 13. Jordbruksverket, Användningen av försöksdjur i Sverige under 2015. Rapport, Dnr: 5.2.17-5428/17.
...
General/Other / Dependent
Searching for indicator dependent:
(return to top)
p.000022: You could say that there are two types of funders: those who do not have a direct interest in the results and those who
p.000022: do. The first group includes the government in the form of various foundations or research councils, as well as
p.000022: research foundations, based on collections and private donations with a specific focus, for instance the Swedish Cancer
p.000022: Society and the Heart-Lung Foundation. The second group includes commercial, non- profit and public actors who need
p.000022: research to develop their activities and, in some cases, to earn money.
p.000022: External funding creates opportunities for research that otherwise might not have been conducted, but the ties and
p.000022: control it can entail are not without risk. This is illustrated in the many conflicts over publishing, access to data
p.000022: and the interpretation of results that are often debated in the media.
p.000022:
p.000022: What would you do in the following situation?
p.000022: You are researching the effectiveness of different toothpastes in a study commissioned by one of the larger
p.000022: manufacturers in this field. You design a comparative study in which the qualities and effects of different toothpastes
p.000022: from a number of aspects are compared.
p.000022: However, the results are not what the funding body had hoped for and they want to stop publication or at least divide
p.000022: the report into multiple studies, which would make it difficult or even impossible to draw any conclusions. When you
p.000022: object to this they threaten to revoke their grants for a number of projects on which your doctoral students are
p.000022: dependent.
p.000022: Do you go along with the funding body’s demand in order to save your students’ funding? Do you try to negotiate a
p.000022: compromise? Or...?
p.000022:
p.000022: Funding bodies, no matter who they are, want to see results. Everyone wants to be sure that a research project is good
p.000022: enough to lead to new knowledge. Around the world public or open funders use reviewers to this end, in a process called
p.000022: peer review. Reviewers often work using templates containing clearly formulated criteria. The review always entails an
p.000022: evaluation of the scientific quality, often of the originality of the research question and sometimes also of how
p.000022: significant the question is from a specific, given perspective. This allows funding to be routed towards researchers
p.000022: who are judged to have the best design as well as the best ability to conduct their projects, but sometimes also to
p.000022: certain areas the funding body considers important.
p.000022:
p.000022:
p.000022:
p.000022: GOOD RESEARCH PRACTICE
p.000023: 23
p.000023:
p.000023: For research results to be useful, it is normally necessary that they are developed further and that someone makes use
p.000023: of the new knowledge. Public institutions can have such an ambition, but it most often occurs through
p.000023: commercialisation. From society’s perspective, it is important that new findings come into use as soon as possible if
p.000023: they can be expected to be of benefit and carry no risk. How this should occur is the constant subject of debate. The
p.000023: goals of a commercial actor or a public institution can compete with the ambition to further raise knowledge levels.
p.000023: Research results or a discovery can mean profit for the author or someone who develops it further, but can also have
...
p.000027: Besides traditional research ethics issues regarding informed consent and risk-benefit analysis,
p.000027:
p.000027:
p.000027: GOOD RESEARCH PRACTICE
p.000028: 28
p.000028:
p.000028: some types of stem cell research bring up specific issues regarding both the research object and the methods being
p.000028: used. These concern the moral status of fertilised eggs, and, for instance, whether methods such as nucleus transfer
p.000028: from one cell to another are ethically acceptable. The existence of gaps in knowledge and uncertainty, such as about
p.000028: what happens when nano particles enter the body, is highlighted when results from nano research are applied within new
p.000028: areas, such as the automobile industry, medicine, cosmetics, etc. Limited toxicological studies have been conducted,
p.000028: but the gaps in knowledge make it difficult to perform a meaningful risk-benefit analysis and points to the need for
p.000028: method development in this area.
p.000028: Issues concerning the commercialisation of research and the effects of research on the environment and society from a
p.000028: more global perspective have recently attracted growing interest; these issues are discussed earlier in this chapter as
p.000028: well as in Chapter 5. The background is not only globalisation and the increased international collaboration between
p.000028: research groups in different countries, but also the fact that large-scale research demands significant resources and
p.000028: public funding is not sufficient. Research groups are therefore becoming increasingly dependent on collaboration with
p.000028: and financial contributions from non-public funding bodies. This enables research that might otherwise not have been
p.000028: possible to be conducted, but also brings to the fore issues of control, dependency and the supervision of research.
p.000028: Human rights are universal. To the extent research ethics principles are based on and protect these rights, they can be
p.000028: accepted in various cultures. At the same time, they then have to be formulated with a certain amount of vagueness. For
p.000028: example, the requirement of informed consent can be interpreted and applied as a requirement of individual informed
p.000028: consent in liberal, western societies. But in cultures where the family, group, clan or village elder gives consent,
p.000028: this requirement must be interpreted slightly differently. Research ethics are thereby placed in a cultural and social
p.000028: context. Some values reflect technical and economic development, while others are slower to change and are based on
p.000028: more basic human needs.
p.000028:
p.000028: References
p.000028: 1. Chalmers, Alan F., Vad är vetenskap egentligen? Nora, Nya Doxa, 2003.
p.000028: 2. Föllesdal, Dagfinn & Wallöe, Lars & Elster, Jon, Argumentationsanalys, språk och vetenskapsfilosofi. Stockholm,
p.000028: Thales, 2001.
...
p.000031: via the website www.clinicaltrialsregister.eu. On this website, information on issues such as ethics committee
p.000031: decisions regarding clinical trials on children will be publicly accessible. In the US, the corresponding database is
p.000031: ClinicalTrials.gov.
p.000031: To conduct a research project involving the irradiation of research subjects with ionising radiation, the project must
p.000031: be approved by a local radiation protection committee. (See 22 § of the Swedish Radiation Safety Authority’s rules
p.000031: regarding general obligations in medical and odontological activities involving ionising radiation, SSMFS 2008:35). For
p.000031: multicentre studies, an application must be sent to all local radiation protection committees within the study’s scope.
p.000031:
p.000031: 3.2 Research on animals and laboratory animal ethics
p.000031:
p.000031: 3.2.1 The use of laboratory animals
p.000031: Laboratory animal ethics deals with the ethical issues that arise when animals are used in scientific experiments. In
p.000031: society, it is a common perception that animal experiments are needed for development and research within both human
p.000031: and veterinary medicine. Research using animals is thus conducted partly because it provides new knowledge, partly
p.000031: because it benefits humans, and not infrequently also for the sake of animals themselves.
p.000031: The production of new medicines is highly dependent on animal experiments. A long line of medical advances that have
p.000031: saved many human lives were possible thanks to the use of animals. The law does not allow the testing of medicinal
p.000031: preparations on humans, and even less their being used in treatment, before they have been tested on animals or through
p.000031: another appropriate method to arrive at dependable research results.
p.000031: The EU’s definition of laboratory animals includes only those animals that are actually subjected to invasive
p.000031: procedures, at minimum a needle-prick. Based on this definition, the Swedish Board of Agriculture received reports that
p.000031: 258,403 laboratory animals had been used in Sweden in 2015. Sweden’s definition is considerably broader, however, and
p.000031: includes all animals used for scientific purposes. Based on the Swedish definition, the Board of Agriculture received
p.000031: reports that 16,373,330 laboratory animals were used in Sweden. The large difference is because Sweden includes the
p.000031: fish collected to evaluate or tag the fish population, which in 2015 amounted to 16,042,533 fish (the Swedish Board of
p.000031: Agriculture, Användningen av försöksdjur i Sverige under 2015, report Dnr: 5.2.17-5428/17).
p.000031: In recent years, a number of issues concerning laboratory animals have been raised in public debate, for instance the
p.000031: use of genetically modified animals as disease models. Also worth mention is the discussion of whether primates should
p.000031: be used in research on Hepatitis C and HIV, which only afflict humans and chimpanzees. Another debated issue is the
p.000031: EU’s REACH Regulation on the Registration, Evaluation, Authorisation and Restriction of Chemicals (ordinance EU
p.000031: 1907/2006). This has entailed increased requirements concerning the testing of chemicals on animals, with the aim of
...
p.000043:
p.000043: 5.2 Relations with fellow researchers
p.000043: A common reason for establishing scientific collaboration is to broaden the competency within the planned project, for
p.000043: example by involving a colleague who is a specialist in a method of analysis with which you yourself are not familiar.
p.000043: Another reason might be that a colleague has access to resources, such as an instrument, that is not available to you.
p.000043: Yet another could be that the project requires more working hours than you yourself are able to devote to it, or that
p.000043: you wish to complete the project in a shorter time by involving more people in it. It is also common, no doubt, simply
p.000043: to want to have other people to work with, to be part of a team. Collaborations can also arise naturally when
p.000043: researchers supervise students within the framework of their own projects.
p.000043: Whatever the motives for collaboration, it is crucial to form a clear idea at an early stage, and to make it clear to
p.000043: your fellow researchers, what you expect of each other, and not least what you yourself are able to contribute. It is
p.000043: important to establish a time plan for the various parts of the project, even if it has to be updated from time to
p.000043: time. Like all joint ventures, scientific collaboration requires a certain degree of reliability in keeping to agreed
p.000043: timetables.
p.000043: It is still possible to see examples of scientific collaboration in which the participants take such responsibilities
p.000043: quite lightly. Collaborators contribute to the common undertaking “when the spirit moves them”. If the project involves
p.000043: postgraduate students or researchers in the early stages of their careers, this is totally unacceptable. They are so
p.000043: dependent on being able to produce a track record of publications and other results in order to be able to continue at
p.000043: all, that collaborative projects in which they participate must involve a realistic sharing of the workload and a
p.000043: viable and quite strictly regulated time plan.
p.000043: In many collaborations, a modified division of labour gradually crystallises out, with some researchers not
p.000043: contributing in accordance to the original plan, while others fill the gap by doing more. Such adjustments are natural,
p.000043: but they should be openly discussed when they become apparent, and should be reflected in the authorship of the final
p.000043: publications. It causes a great deal of trouble and frustration if researchers who do not have time to participate as
p.000043: intended nevertheless continue to promise to contribute to the joint project, with no realistic chance, or perhaps even
p.000043: intention, of actually doing so.
p.000043: The distinct roles that various participants assume in a collaborative research project are not always what everyone
p.000043: would wish. Just as in other joint efforts – whether it be a matter of domestic chores or team sports – you can end up
p.000043: with certain people taking on responsibility for broader plans, or tricky details, while others look after routine
p.000043: tasks or maintain order. Preferably, of course, everyone should have the chance not only to use the abilities they
p.000043: already possess, but also to learn new skills. This is particularly true of research students and other young
p.000043: researchers; senior members of a group have a special responsibility to ensure that their younger colleagues’ interests
p.000043: in this respect are provided for.
p.000043:
p.000043:
p.000043: GOOD RESEARCH PRACTICE
p.000044: 44
p.000044:
...
p.000053: the next section). Research articles lodged shall be made openly accessible within six months. For researchers with
p.000053: grants within educational sciences or humanities and social sciences, open access has to be made available within
p.000053: twelve months. The Swedish Research Council’s rules concerning open access currently only apply to scientifically
p.000053: reviewed texts in journals and conference reports, and not monographs or book chapters.
p.000053: Journals often publish material electronically, but it is important to remember that this does not automatically entail
p.000053: that it becomes openly accessible. In order to publish according to the requirements for open access, there are three
p.000053: options:
p.000053:
p.000053: 1) In an open-access journal – these, just like traditional scientific journals, use peer review to assess the
p.000053: quality of the research articles.
p.000053: 2) Hybrid publication – the research article is published in a subscription-based journal, which offers the author
p.000053: the choice of open access, against a fee.
p.000053: 3) Self archiving – which means that the researcher, in addition to publishing the research article in a
p.000053: subscription based scientific journal, also deposits it at the time of publication in an open repository, and is made
p.000053: openly accessible within six or twelve months.
p.000053:
p.000053: The legal room surrounding self archiving is dependent on the policy of the journal/publisher. To help researchers in
p.000053: handling rights issues, the EU Commission’s framework programme for research and innovation, Horizon 2020, has produced
p.000053: an appendix to the publication agreement. This appendix guarantees that the researcher retains the right to deposit the
p.000053: work in an open archive, and thus make it freely accessible. An accompanying letter that researchers can use in their
p.000053: contacts with publishers has also been produced, see the website sparcopen.org Despite this, self archiving is
p.000053: regarded as complicated, and for this reason the major journal publishers are offering the option of hybrid
p.000053: publication, which replaces the need for an appendix to the publication agreement and avoids the risk of several
p.000053: different versions of the work being published.
p.000053: Developments in technology have entailed a fundamental change within the area of scientific publication area. To follow
p.000053: this development, see for example the website kb.se/openaccess, which has information on current developments and a
p.000053: discussion forum. A discussion is also in progress on the existence of a so-called “copyright teacher exemption”, which
p.000053: would give the university both the right to use and a certain right to process educational materials.
p.000053:
p.000053:
p.000053:
p.000053:
p.000053:
p.000053:
p.000053:
p.000053:
p.000053:
p.000053:
p.000053: GOOD RESEARCH PRACTICE
p.000054: 54
p.000054:
p.000054: m
p.000054:
p.000054: 6.6 Publication as a measure of worth
p.000054: Since the number of published works play a major role when the merits are compared, for example in recruitment, there
...
General/Other / Manipulable
Searching for indicator manipulate:
(return to top)
p.000063: encompasses fraud, the fabrication of data and plagiarism – that is, actions we regard as evidence of an intention to
p.000063: deceive; it also encompasses actions such as iterated carelessness, for example when a researcher would have been
p.000063: immediately able to realise that the results were distorted, or when his or her own contribution is described
p.000063: incorrectly.
p.000063: In order to enable a nuanced description of the situation, to avoid the juridification of research ethics and avoid one
p.000063: person’s word standing against another’s – and to avoid the matter therefore being dismissed due to lack of evidence –
p.000063: a proposal has been made to differentiate between parallel and disjunctive definitions. For parallel definitions, two
p.000063: main questions are asked: Has the author diverged from good research practice? Has the author intended to deceive or
p.000063: mislead his or her readers? One may exist without the other, and each of the two questions can be answered with “yes”,
p.000063: “no” or “unclear”. If the answers are combined, a more nuanced picture of the situation is obtained in each individual
p.000063: case.
p.000063:
p.000063: 8.3 Fabrication and falsification
p.000063: The most obvious case of research fraud would be a researcher simply fabricating data or results – making them up – and
p.000063: then representing them as genuine. Falsification, however, is a more multifaceted phenomenon. The concept comprises all
p.000063: the possible ways of manipulating the research process, equipment, material or data that make it impossible to present
p.000063: a research project in a trustworthy way. The same can happen if certain data or experiments are left out of the report.
p.000063: It is also possible to manipulate the research report itself, for instance through changing diagrams and other
p.000063: pictures. New technology has made manipulation increasingly easier.
p.000063: Another issue that has been discussed at length is whether “outliers” (notable individual deviations from the other
p.000063: results) should be included in the statistics the researcher presents, and when it can be justified to call them
p.000063: anomalies or mistakes, and therefore exclude them from the report.
p.000063: Manipulation of research – as opposed to cases of fabrication – can be the unintentional result of carelessness or
p.000063: ignorance, and it can be difficult to determine whether intentional misconduct has occurred. This further supports the
p.000063: need for the concept of research misconduct to encompass both intentional and unintentional behaviour.
p.000063:
p.000063:
p.000063:
p.000063:
p.000063:
p.000063:
p.000063:
p.000063: GOOD RESEARCH PRACTICE
p.000064: 64
p.000064:
p.000064: 8.4 Plagiarism
p.000064: Plagiarism is the form of scientific misconduct that, in the experience of the Swedish Research Council’s expert group
p.000064: on ethics, seems to be the most common. In the definition of scientific misconduct discussed above, it is the final
p.000064: mention of “misleading information about someone’s contribution to the research” that especially refers to plagiarism.
p.000064: The term plagiarism concerns a researcher presenting text excerpts, ideas, data, results, etc. in such a way that they
p.000064: appear to be his or her own, when they have in fact been created by someone else.
p.000064: Doing this is a form of lying, and in many cases is also considered theft. A definition of plagiarism can thus be
p.000064: formulated as follows:
p.000064:
...
Searching for indicator manipulated:
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p.000062:
p.000062:
p.000062:
p.000062: GOOD RESEARCH PRACTICE
p.000063: 63
p.000063:
p.000063: the same study in multiple contexts, sexual harassment, defamation of colleagues, sabotage of colleagues’ work and so
p.000063: on.
p.000063: The choice between wide and narrow definitions is not only a matter of linguistic usage. It also has consequences, for
p.000063: example, when it comes to applying rules on sanctions for research misconduct. With a narrow definition, only certain
p.000063: phenomena can be acted on; with a wider one, others can as well. The requirements of due process suggest that we should
p.000063: concentrate on central, reasonably well-defined transgressions such as plagiarism, fraud (falsification, invented data)
p.000063: and manipulation of data, and deal with other forms of inappropriate behaviour in other contexts and under other
p.000063: headings.
p.000063: Another problem that is not always easy to handle is how to distinguish between intentional fraudulent behaviour on the
p.000063: one hand, and carelessness, rushed work and incompetence on the other. Research misconduct can be intentional
p.000063: behaviour, or as something that can also be perceived as being independent of the researcher’s intention, that is to
p.000063: say something that can be established without any need to speculate on whether the author intended to deceive.
p.000063: The definition of research misconduct used by the Swedish Research Council was formulated by Birgitta Forsman (2007),
p.000063: and uses the current terminology of the scientific community. It states that
p.000063:
p.000063: Research misconduct entails actions or omissions in research, which – consciously or through carelessness – lead to
p.000063: falsified or manipulated results or give misleading information about someone’s contribution to the research.
p.000063:
p.000063: This definition thus limits itself to the narrower concept of research misconduct, in which it directly concerns the
p.000063: scientific work. Sexual harassment, defamation of colleagues and the like are not included here, even though they are
p.000063: unethical in other ways. The reference to “consciously or through carelessness” means that the definition not only
p.000063: encompasses fraud, the fabrication of data and plagiarism – that is, actions we regard as evidence of an intention to
p.000063: deceive; it also encompasses actions such as iterated carelessness, for example when a researcher would have been
p.000063: immediately able to realise that the results were distorted, or when his or her own contribution is described
p.000063: incorrectly.
p.000063: In order to enable a nuanced description of the situation, to avoid the juridification of research ethics and avoid one
p.000063: person’s word standing against another’s – and to avoid the matter therefore being dismissed due to lack of evidence –
p.000063: a proposal has been made to differentiate between parallel and disjunctive definitions. For parallel definitions, two
p.000063: main questions are asked: Has the author diverged from good research practice? Has the author intended to deceive or
p.000063: mislead his or her readers? One may exist without the other, and each of the two questions can be answered with “yes”,
p.000063: “no” or “unclear”. If the answers are combined, a more nuanced picture of the situation is obtained in each individual
p.000063: case.
p.000063:
p.000063: 8.3 Fabrication and falsification
p.000063: The most obvious case of research fraud would be a researcher simply fabricating data or results – making them up – and
...
General/Other / Other Country
Searching for indicator another country:
(return to top)
p.000035: always be preceded by an investigation that serves as a basis for a risk assessment, and the results of this assessment
p.000035: then determine what protective measures will be necessary.
p.000035: Research that involves the intentional exposure of genetically modified organisms, for instance field experiments using
p.000035: genetically modified plants or microorganisms, should always be preceded by an investigation so that the risk of harm
p.000035: can be assessed. Additionally, approval must be received from the proper supervisory authority; and approval can only
p.000035: be given if the research is ethically acceptable. A researcher who ignores the obligation to notify the proper
p.000035: authority or obtain approval can be found guilty of conducting unauthorised environmental work.
p.000035:
p.000035: 3.4 Examples of problems that are still unsolved
p.000035: The Swedish legislation and regulations concerning research are not comprehensive – and never can be (see Chapter 1 on
p.000035: the law and morals). However, there are currently a number of shortcomings that deserve attention, so that workable
p.000035: solutions can be discussed and, if possible, be implemented.
p.000035: First, there is the problem that Swedish legislation is only applicable in Swedish territory. This affects the ethics
p.000035: review of projects that will be conducted wholly or partly in another country, even if researchers from
p.000035:
p.000035:
p.000035:
p.000035:
p.000035: GOOD RESEARCH PRACTICE
p.000036: 36
p.000036:
p.000036: Sweden participate and Swedish funding bodies contribute money. Ethical standards that appear self-evident in Sweden
p.000036: can then be difficult to find support for in international research environments.
p.000036: It is especially worrying if researchers perform their work in countries with lower ethical standards, just to take
p.000036: advantage of this. It can, for example, be easier to find research subjects, easier to get permission to use primates
p.000036: in research, cheaper to conduct studies, or involve less extensive application procedures. If these advantages come at
p.000036: the cost of the integrity of the research, it will in many cases involve a breach of the standards in the Declaration
p.000036: of Helsinki:
p.000036:
p.000036: Physicians should consider the ethical, legal and regulatory norms and standards for research involving human subjects
p.000036: in their own countries as well as applicable international norms and standards. No national or international ethical,
p.000036: legal or regulatory requirement should reduce or eliminate any of the protections for research subjects set forth in
p.000036: this Declaration.
p.000036:
p.000036: It is unacceptable for studies to violate this principle. The Norwegian National Committee for Research Ethics in
p.000036: Science and Technology states precise and necessary requirements, namely that
p.000036:
p.000036: a researcher is not to conduct parts of his or her research in another country simply because it has lower ethical or
p.000036: safety standards than at home;
p.000036:
p.000036: and that researchers shall inform funding bodies of divergent ethical or safety standards in the country or countries
p.000036: where their research is being conducted.
p.000036:
p.000036: Another problem is that the most fundamental protection for research subjects – that the research project must be
p.000036: ethically reviewed before it can begin – is not always self-evident in other countries. The Declaration of Helsinki
p.000036: requires this review for all medical research performed on humans, and this requirement is held by many funding bodies
p.000036: and journals.
p.000036: Here, the Swedish legal requirement of ethics review is less comprehensive. However, as mentioned earlier, in Sweden
p.000036: there is the option to request an advisory statement from an ethics review board regarding a project that does not
p.000036: formally need to be reviewed. It is good research practice to request a statement in the event research collaborations
p.000036: in other countries are expected to present ethical difficulties for the researchers.
p.000036: The ethics review boards have no obligation to issue these advisory statements however, just the right to do so. If the
p.000036: regional ethics review board refuses to issue such a statement, however, this may cause profound consequences for the
p.000036: researchers’ chances of obtaining further funding and being published.
...
General/Other / Public Emergency
Searching for indicator emergency:
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p.000025: behavioural science, among others.
p.000025:
p.000025: 2.3.3 Observational studies conducted through participating, observing and recording
p.000025: For some research questions participant observation may be used, but this research method is associated with a large
p.000025: number of ethical problems.
p.000025: The methods of participating, observing and/or recording can be used in several situations. A researcher may want to
p.000025: actually be in the research subjects’/informants’ environment and observe what happens, hear what is said and follow
p.000025: the persons’ interactions. In some situations, covert participant observation is used. This type of secret or disguised
p.000025: research is rare, however, and should be the exception rather than the rule.
p.000025: The ideal situation is always that those to whom the research applies should be informed that they are the subject of
p.000025: research, and should normally also have given their written consent. If the research includes handling any personal
p.000025: data, the Personal Data Act applies. If the personal data is also so-called “sensitive personal data”
p.000025:
p.000025:
p.000025: GOOD RESEARCH PRACTICE
p.000026: 26
p.000026:
p.000026: (see Chapter 3), then approval from an ethics review board must also be obtained. It is worth mentioning in this
p.000026: context that recording of sound from and/or images of persons constitutes handling of personal data (see Chapter 9).
p.000026: Overt observation studies, in which participants know research is being conducted, are used, for example, to study the
p.000026: work within different organisations, or at an emergency room or a school. The observations should be performed
p.000026: systematically using observation schedules, notes, etc. The researcher should strive for objectivity and try not to
p.000026: influence research subjects or events.
p.000026: Ethical considerations are very important in participant observation. The researcher is responsible for preventing any
p.000026: damage, and for ensuring the identities of those observed will not be revealed. Although this requirement may be
p.000026: difficult to fulfil, it is necessary.
p.000026: One way to observe human beings is through video recording. Research using a video can intrude on the private lives and
p.000026: integrity of individuals, as it is possible to identify them. Video recording should therefore only be used when it is
p.000026: impossible to achieve the same results with the help of other data collection methods. For example, masked photographs
p.000026: can be used instead of video if it is not necessary to study the subjects’ movements, facial expressions or
p.000026: interaction/communication.
p.000026: It is important that the recording is done in a respectful and responsible way. Individual integrity must be respected.
p.000026: If underage subjects are to be video recorded, the same special rules apply as for other research involving children.
p.000026: This means that if the child is less than 15 years old, both guardians and the child must have consented to the
p.000026: participation. The information should be written in such a way that the child too can understand it (according to the
p.000026: Act concerning the Ethical Review of Research Involving Humans).
...
General/Other / Relationship to Authority
Searching for indicator authority:
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p.000016:
p.000016: 1.8 Review
p.000016: In summary, one must constantly distinguish between the law and morals and, when it comes to research, also between
p.000016: research ethics legislation and the rules found in research ethics codes. The ethical criteria can be more far-reaching
p.000016: than the legal requirements when their content is otherwise closely related. The ethical criteria can also address
p.000016: issues that do not appear in legislation at all. The collective ethical criteria on how good research should be
p.000016: conducted can be said to express what good research practice is.
p.000016: Researchers should follow good research practice. It can therefore not be said, for example, that the Act concerning
p.000016: the Ethical Review of Research Involving Humans, replaces codes like the Declaration of Helsinki or eliminates or
p.000016: reduces the significance of one’s own moral judgement. The researcher’s own reflections on his or her project must
p.000016: instead be based on both knowledge of the content of laws and codes, and on his or her own moral judgement.
p.000016:
p.000016: 1.9 Various regulatory systems
p.000016: Laws are made by Sweden’s Riksdag, its parliament, and are binding. Ordinances, issued by the Government, and
p.000016: regulations and directives, issued by public authorities (such as the National Board of Health and Welfare, or the
p.000016: Dental and Pharmaceutical Benefits Agency) with support from laws and ordinances, have the same legal character.
p.000016: Within the EU there are regulations, which have the same authority as Swedish law, and directives, which normally must
p.000016: be implemented in Swedish law to be binding. Also in the international context are conventions, which are binding for
p.000016: the countries who have agreed to follow them, such as the Council of Europe’s Oviedo Convention.
p.000016: Guidelines can be issued by authorities or different non-governmental organisations and assemblies. Though such
p.000016: documents are not legally binding, their content can be generally accepted. Supervisory authorities, such as the
p.000016: Central Ethical Review Board and the Swedish Data Protection Authority, produce guidelines, information brochures, etc.
p.000016: of importance to research.
p.000016: Declarations, resolutions and statements are also generally issued by organisations and assemblies, and entail that
p.000016: these groups declare a certain stance within their field. These documents usually consist of calls for certain ethical
p.000016: approaches, and can sometimes reach a status similar to that of international conventions. An excellent example of a
p.000016: declaration with extremely high status is the Declaration of Helsinki, which provides the foundation of the work of
p.000016: research ethics committees and their like around the world.
p.000016: Ethics codes usually have a pronounced voluntary character. They usually concern relations not regulated by law, and
p.000016: often concentrate on how those affected by the code conduct themselves in relation to their work, as well as the
p.000016: consequences the work can have for other people, the organisation, the environment, etc.
p.000016:
p.000016:
p.000016: GOOD RESEARCH PRACTICE
p.000017: 17
p.000017:
p.000017: References
p.000017: 1. Forsman, Birgitta, Forskningsetik: en introduktion. Lund, Studentlitteratur, 1997. Forsman, Birgitta, Vetenskap
p.000017: och moral. Nora, Nya Doxa, 2002.
p.000017: 2. Hermerén, Göran, Kunskapens pris: forskningsetiska problem och principer i humaniora och samhällsvetenskap.
p.000017: Stockholm, Swedish Science Press & HSFR, 1986, 2nd edition, 1996.
p.000017: 3. Lag om etikprövning av forskning som avser människor (SFS 2003:460).
p.000017: 4. Merton, Robert ”The Normative Structure of Science” (1942), in Merton, R., The Sociology of Science. University
p.000017: of Chicago Press, 1973.
...
p.000023: many obstacles along the way: amateurishness in the ability to convert research results into practical use, attitude
p.000023: problems of the various actors towards each other and structures involving slow publication processes, sluggish
p.000023: handling of patent applications and a lack of risk capital.
p.000023: Without the cooperation of the researcher, it is often difficult to convert academic research results into a benefit
p.000023: for society at large. Therefore, great demands must be placed on the individual researcher’s awareness and on the
p.000023: environment in he or she works when it comes to handling situations and contacts involving profit motive.
p.000023: In such cases, all researchers should carefully consider any agreements with other parties in order to maintain their
p.000023: personal integrity and scientific credibility. Two cornerstones in this stance are openness regarding ties and
p.000023: dependencies, as well as openness regarding all research results. This is important, regardless of whether the results
p.000023: meet or contradict a commissioning party’s expectations. Conflicts have often arisen between funding bodies and
p.000023: researchers over the publication and interpretation of results, sometimes leading the researcher to suppress
p.000023: “undesirable” results. A researcher should also not let him or herself be convinced to over-interpret results in a
p.000023: certain direction. Angled reports can cause a great deal of harm, irrespective of whether they have a commercial angle
p.000023: or are affected by the ambitions of a public authority.
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023: GOOD RESEARCH PRACTICE
p.000024: 24
p.000024:
p.000024: What would you do in the following situation?
p.000024: You are working with technical research on new light, strong materials. You see an opportunity to apply for a patent
p.000024: and have started a company along with some entrepreneurs to commercialise the products. However, the commercialisation
p.000024: takes longer than expected and the company starts having economic problems.
p.000024: A co-worker points out that fibres in the new material have qualities reminiscent of asbestos, and therefore suggests
p.000024: additional toxicological studies. But you want to speed up the development work.
p.000024: Do you choose to interrupt the development work and examine the health risks? If no, how do you respond to the
p.000024: criticism from your co-worker?
p.000024:
p.000024: 2.2.5 Openness is your guiding light
p.000024: Just like everyone else, a researcher has a legitimate need for appreciation. This can consist of economic
p.000024: compensation, honour and recognition or academic advancement, often in combination. But the way to attain recognition
p.000024: does not always follow the same path, and can be effective to different degrees at different points in time. Conflicts
p.000024: often arise. For instance, the individual researcher might be eager to quickly make his or her discovery publicly
p.000024: known, while the research group feels it is tactical or even necessary to withhold the information in anticipation of a
p.000024: patent application or further development.
p.000024: A fundamental rule in all research is that all researchers should openly account for any conflicts of interest when
p.000024: presenting their results in a scientific context. For the credibility of the research community, it is also crucial
...
p.000029: if the content so requires.
p.000029: A research project shall be reviewed by an ethics review board if any of the following conditions exist.
p.000029: Namely, if the project (A)
p.000029:
p.000029: • entails physical encroachment on the research subject
p.000029: • will be conducted using a method aiming to affect the research subject physically or psychologically, or that
p.000029: carries an obvious risk of physical or psychological harm to the research subject
p.000029: • entails studies on biological material taken from a living human being and can be traced to this person
p.000029: • entails physical encroachment on a deceased human being
p.000029: • entails studies on biological material taken for medical purposes from a deceased human being and can be traced to
p.000029: this person. Act (SFS 2008:192).
p.000029:
p.000029: A research project shall also be reviewed if it (B)
p.000029:
p.000029: • entails the handling of sensitive personal data according to Section 13 of the Personal Data Act (SFS 1998:204),
p.000029: including information on race, ethnic origin, political views or religious conviction, or personal
p.000029:
p.000029:
p.000029:
p.000029:
p.000029: 3The research principal is the government authority or the physical or legal entity within whose organisation the
p.000029: research is conducted. A researcher employed at a university or a county council has the same as his or her research
p.000029: principal. The research principal, through its internal work or delegation order or through power of attorney,
p.000029: determines who is authorised to represent the research principal. The research principal always has ultimate
p.000029: responsibility for the research.
p.000029:
p.000029:
p.000029: GOOD RESEARCH PRACTICE
p.000030: 30
p.000030:
p.000030: data according to Section 21 of the Personal Data Act, including information on judgements in criminal cases.
p.000030:
p.000030: Condition (B) thus means that all research dealing with sensitive personal data shall be ethically reviewed, regardless
p.000030: of how the data has been collected and whether or not the researcher has obtained the participants’ consent.
p.000030: When an ethics review board evaluates a project, it has a number of aspects to note and consider. Generally, the
p.000030: research in question can be approved only if it can be conducted with respect for human dignity. In the review, the
p.000030: board should also evaluate how the human rights and basic freedoms of those involved are treated in relation to the
p.000030: value of the research. The welfare of human beings should be placed before the needs of society and science, and the
p.000030: knowledge value of the research must be assessed as outweighing the risks. The research cannot be approved if the
...
p.000031: with the aim of further showing effect and/or safety. The Agency has issued detailed rules for how clinical trials of
p.000031: drugs for humans shall be conducted. Applications to the Swedish Medical Products Agency shall be made by the sponsor,
p.000031: i.e. the individual, company, institution or organisation that assumes responsibility for starting, organising and/or
p.000031: funding the clinical trial. More information on regulations and the steps of the application process can be found on
p.000031: the Agency’s website (www.lakemedelsverket.se.).
p.000031: Applications for clinical trials within the EU are registered in the database Eudra CT (European Clinical Trials
p.000031: Database). Currently, this database is only accessible to national medical products agencies, for instance the Swedish
p.000031: Medical Products Agency, the European Medicines Agency (EMA), and the Commission. As a step towards increasing the
p.000031: transparency within the EU, access to certain parts of the database’s content will soon be given to the general public
p.000031: via the website www.clinicaltrialsregister.eu. On this website, information on issues such as ethics committee
p.000031: decisions regarding clinical trials on children will be publicly accessible. In the US, the corresponding database is
p.000031: ClinicalTrials.gov.
p.000031: To conduct a research project involving the irradiation of research subjects with ionising radiation, the project must
p.000031: be approved by a local radiation protection committee. (See 22 § of the Swedish Radiation Safety Authority’s rules
p.000031: regarding general obligations in medical and odontological activities involving ionising radiation, SSMFS 2008:35). For
p.000031: multicentre studies, an application must be sent to all local radiation protection committees within the study’s scope.
p.000031:
p.000031: 3.2 Research on animals and laboratory animal ethics
p.000031:
p.000031: 3.2.1 The use of laboratory animals
p.000031: Laboratory animal ethics deals with the ethical issues that arise when animals are used in scientific experiments. In
p.000031: society, it is a common perception that animal experiments are needed for development and research within both human
p.000031: and veterinary medicine. Research using animals is thus conducted partly because it provides new knowledge, partly
p.000031: because it benefits humans, and not infrequently also for the sake of animals themselves.
p.000031: The production of new medicines is highly dependent on animal experiments. A long line of medical advances that have
p.000031: saved many human lives were possible thanks to the use of animals. The law does not allow the testing of medicinal
p.000031: preparations on humans, and even less their being used in treatment, before they have been tested on animals or through
p.000031: another appropriate method to arrive at dependable research results.
p.000031: The EU’s definition of laboratory animals includes only those animals that are actually subjected to invasive
p.000031: procedures, at minimum a needle-prick. Based on this definition, the Swedish Board of Agriculture received reports that
p.000031: 258,403 laboratory animals had been used in Sweden in 2015. Sweden’s definition is considerably broader, however, and
...
p.000035:
p.000035: What would you do in the following situation?
p.000035: Millions of people today have HIV and risk contracting AIDS if they do not receive effective inhibitor medications. A
p.000035: great deal of research is being conducted to find a cure for HIV/AIDS using chimpanzees which, besides humans, are the
p.000035: only animals that can get HIV/AIDS.
p.000035: You are a member of an ethics committee on animal experiments that is to ethically evaluate a research project aiming
p.000035: to test the effectiveness of a potential vaccine. The researchers inform the committee that the vaccine’s effect needs
p.000035: to be tested on advanced AIDS, which means that the chimpanzees will be in very poor health when the actual
p.000035: experimenting begins.
p.000035: What ethically significant aspects to you feel should be considered to ethically evaluate whether this experiment
p.000035: should be approved? Consider the issue from both a researcher’s and a layman’s evaluation perspective.
p.000035:
p.000035: 3.3 Genetically modified organisms
p.000035: Basic research and applied research with genetically modified organisms, i.e. organisms whose genetic material has been
p.000035: changed in a way that does not occur naturally through mating or the natural recombination of genes, is covered by a
p.000035: detailed system of regulations. Supervisory responsibilities are divided between several authorities, including the
p.000035: Swedish Work Environment Authority, the Swedish Board of Agriculture, the Swedish Board of Fisheries and the Swedish
p.000035: Medical Products Agency. The different authorities’ areas of responsibility, as well as the applicable regulations, can
p.000035: be found at the web portal of the Swedish Gene Technology Advisory Board, (genteknik.se).
p.000035: For research involving the enclosed use of genetically modified organisms, for example the growing of cultures in
p.000035: tightly shut containers or cultivation in a greenhouse, to be conducted it is necessary either for the responsible
p.000035: authority to have given its approval, or for the research to have been reported to this authority. The research should
p.000035: always be preceded by an investigation that serves as a basis for a risk assessment, and the results of this assessment
p.000035: then determine what protective measures will be necessary.
p.000035: Research that involves the intentional exposure of genetically modified organisms, for instance field experiments using
p.000035: genetically modified plants or microorganisms, should always be preceded by an investigation so that the risk of harm
p.000035: can be assessed. Additionally, approval must be received from the proper supervisory authority; and approval can only
p.000035: be given if the research is ethically acceptable. A researcher who ignores the obligation to notify the proper
p.000035: authority or obtain approval can be found guilty of conducting unauthorised environmental work.
p.000035:
p.000035: 3.4 Examples of problems that are still unsolved
p.000035: The Swedish legislation and regulations concerning research are not comprehensive – and never can be (see Chapter 1 on
p.000035: the law and morals). However, there are currently a number of shortcomings that deserve attention, so that workable
p.000035: solutions can be discussed and, if possible, be implemented.
p.000035: First, there is the problem that Swedish legislation is only applicable in Swedish territory. This affects the ethics
p.000035: review of projects that will be conducted wholly or partly in another country, even if researchers from
p.000035:
p.000035:
p.000035:
p.000035:
p.000035: GOOD RESEARCH PRACTICE
p.000036: 36
p.000036:
p.000036: Sweden participate and Swedish funding bodies contribute money. Ethical standards that appear self-evident in Sweden
p.000036: can then be difficult to find support for in international research environments.
p.000036: It is especially worrying if researchers perform their work in countries with lower ethical standards, just to take
p.000036: advantage of this. It can, for example, be easier to find research subjects, easier to get permission to use primates
p.000036: in research, cheaper to conduct studies, or involve less extensive application procedures. If these advantages come at
p.000036: the cost of the integrity of the research, it will in many cases involve a breach of the standards in the Declaration
p.000036: of Helsinki:
p.000036:
p.000036: Physicians should consider the ethical, legal and regulatory norms and standards for research involving human subjects
...
p.000038: Other funding bodies may have an interest, from a societal perspective, in material being reused or used by many groups
p.000038: – an important task in this case is to specify the conditions under which this can be done.
p.000038: How this weighing of interests is done depends on aspects such as the type of research is being conducted. A
p.000038: significant difference in this context is the distinction between research which is not being conducted in connection
p.000038: with healthcare, and that which is. This distinction is important, as different regulations apply in the two cases.
p.000038: If research is combined with healthcare, for example, the Patient Data Act and the provisions applicable to healthcare
p.000038: operations in the Public Access to Information and Secrecy Act apply. It is therefore important to keep several types
p.000038: of journals – both on the patient/treatment being provided, and on the research itself. The patient/treatment journals
p.000038: should only contain information that is necessary for the patient to receive good and
p.000038:
p.000038:
p.000038:
p.000038: GOOD RESEARCH PRACTICE
p.000039: 39
p.000039:
p.000039: safe treatment. Information required for the research project should be reserved for the research journals. The same
p.000039: applies in retrospective studies, especially if they deal with integrity-sensitive questions.
p.000039: But in any type of research, the material collected is not the private property of the researcher or research group,
p.000039: something they own and can do with as they wish. It must be stored and archived according to the general regulations
p.000039: issued by each authority in question.
p.000039:
p.000039: 4.3 Four concepts
p.000039: Four important concepts in the debate that are sometimes confused with each other or used synonymously are secrecy,
p.000039: professional secrecy, anonymity and confidentiality.
p.000039: Information can be covered by secrecy only if it is stated in law, normally the Public Access to Information and
p.000039: Secrecy Act.
p.000039: Standards for professional secrecy apply to some professions by law, as well as by ethics rules. All personnel in
p.000039: health and medical care, dental care and social services, for instance, must observe professional secrecy. This means
p.000039: that they are not allowed to discuss patients’ and clients’ health or personal situation with unauthorised individuals,
p.000039: or in any other way communicate this information. Similar standards for professional secrecy also apply to
p.000039: psychologists and clergy, for example. If a certain task is covered by secrecy, it means the person carrying out the
p.000039: task has a duty of professional secrecy.
p.000039: Anonymising or de-identifying involves eliminating the connection between samples or questionnaire answers and a
p.000039: certain individual, so that neither unauthorised persons nor the research group can re-establish it; no one should
p.000039: therefore be able to combine a certain piece of information with a specific person’s identity, for example. The code
p.000039: list is destroyed. Anonymity can also be achieved by collecting material without noting the identity of specific
p.000039: individuals.
p.000039: What is described above differs from a situation where the research group can use code keys to link information or
p.000039: samples to specific individuals (pseudo-anonymising) – which is usually necessary in longitudinal studies, for
...
p.000039: their research is ethically reviewed. Various reservations can be set in this context, for example that the researcher
p.000039: may have access to the information but is not allowed to contact the subjects studied.
p.000039: Confidentiality is a more general obligation not to communicate information given in confidence, and entails protection
p.000039: against unauthorised persons partaking of the information.
p.000039:
p.000039: 4.4 What can researchers promise?
p.000039: There are some things researchers cannot promise and yet do promise anyway – due to being poorly informed of applicable
p.000039: rules or because they confuse the four concepts discussed above.
p.000039:
p.000039: 4.4.1 Secrecy
p.000039: The basic principle is that public documents shall be publicly accessible and that information can be covered by
p.000039: secrecy only if falls under a specific provision of the Public Access to Information and Secrecy Act. The Act contains
p.000039: a chapter that specifically addresses secrecy to protect the individual in research (Chapter 24). But in addition, the
p.000039: Act contains many other provisions that the researcher may have to address, for instance regarding secrecy to protect
p.000039: the individual within health and medical care in Chapter 25.
p.000039: The principle of public access covers public activities, and those activities listed in the appendix to the Act. When a
p.000039: request for information from public documents is received, the authority where it is being stored (for example a
p.000039: university or a county council) is required to evaluate whether the information may be handed out, that is to say
p.000039: whether or not the information is covered by secrecy.
p.000039:
p.000039:
p.000039:
p.000039:
p.000039:
p.000039:
p.000039:
p.000039: GOOD RESEARCH PRACTICE
p.000040: 40
p.000040:
p.000040: 4.4.2 Professional secrecy
p.000040: Professional secrecy follows from secrecy to the extent that if certain information is covered by secrecy, then this
p.000040: also entails a requirement of professional secrecy about it. However, the opposite is not true.
p.000040: If professional secrecy applies for a certain activity, this does not necessarily mean that what is said during the
p.000040: activity is automatically covered by secrecy or that it that it falls under the Public Access to Information and
p.000040: Secrecy Act. Furthermore, it can happen that a researcher, through his or her work on a project, becomes aware of some
p.000040: circumstance that must be reported by law (such as child abuse or paedophilia). In such cases, the obligation to report
p.000040: outweighs the secrecy requirement.
p.000040:
p.000040: 4.4.3 Anonymity
p.000040: In some cases, the anonymising of information is a condition set by an ethics review board for its approval of a study.
p.000040: This can be done, for example, by removing personal information on completed questionnaires or samples, so that it is
p.000040: difficult or in practice impossible to link a certain answer or sample to a specific individual. In some types of
...
p.000048: encourage openness, which is healthy and contributes to increased clarity and transparency in the research. It can also
p.000048: help to reduce the risk of various forms of power abuse; but to say this is not to suggest that it is necessary to
p.000048: reduce the leadership capacity of international and national research directors.
p.000048:
p.000048: What would you do in the following situation?
p.000048: An investigation reveals that a researcher has broken international regulations and thereby proven herself unsuitable
p.000048: to continue as research director and supervisor. However, the vice-chancellor of the university where the researcher
p.000048: works chooses to ignore this, and lets her continue in as research director and supervisor. A number of colleagues who
p.000048: question this are themselves subjected to an investigation and other reprisals. Silence spreads among those working at
p.000048: the university.
p.000048: What do you do? Do you remain silent and thereby support and defend the vice-chancellor?
p.000048:
p.000048: Quite a lot of inquiry and legislation work of importance to good research practice is currently in progress. Briefly
p.000048: can be mentioned Ds 2016:46, En ny organisation for etikprövning av forskning (“A new organisation for ethical review
p.000048: of research”). This report presents a proposal for re-organisation that entails the current regional ethics review
p.000048: boards being converted into a single unified public authority, the Ethics Review Authority. According to its directives
p.000048: (Dir 2016:65), the inquiry into the ethics review system shall also carry out a review of the regulatory frameworks for
p.000048: research ethics and the borderline area between clinical research and health and medical care (SOU 2017:50). The
p.000048: research data inquiry (Dir 2016:65) will be analysing the adaptations necessary to the Act concerning the Ethical
p.000048: Review of Research Involving Humans (SFS 2003:460) based on the new EU regulation governing personal data handling.
p.000048: Of particular importance to the handling of personal data for research purposes is the General Data Protection
p.000048: Regulation adopted by the EU (EU 2016/679), which comes into force on 25 May 2018. In general, this reinforces the
p.000048: protection of integrity via the various requirements set by the Regulation to ensure the personal data handling is
p.000048: legal. It applies to areas such as the obligation to inform, and technical and organisational protective measures, etc.
p.000048: At the same time as the new regulatory framework is comprehensive and complicated, it should be noted that research
p.000048: receives favourable treatment in several different respects, such as the issues of handling sensitive personal data. In
p.000048: addition to the EU General Data Protection Regulation, which will apply with legal force in Sweden, work is in progress
p.000048: on national supplementary legislation, and a further special regulation focusing on the handling of research data.
...
p.000071: subjected to arbitrary interference with his privacy, family, home or correspondence, nor to attacks upon his honour
p.000071: and reputation. Everyone has the right to the protection of the law against such interference or attacks.” Article 29
p.000071: Item 2 further states that “In the exercise of his rights and freedoms, everyone shall be subject only to such
p.000071: limitations as are determined by law solely for the purpose of securing due recognition and respect for the rights and
p.000071: freedoms of others and of meeting the just requirements of morality, public order and the general welfare in a
p.000071: democratic society.”
p.000071: The Universal Declaration is not binding upon member states, but may be seen as an expression of common law rules
p.000071: within the area.
p.000071:
p.000071: 9.1.4 The European Convention on Human Rights
p.000071: The Convention for the Protection of Human Rights and Fundamental Freedoms of 4 November 1950 (“European Convention on
p.000071: Human Rights”) was incorporated into Swedish law on 1 January 1995, and has since then applied as law in Sweden.
p.000071: Article 8 of the European Convention on Human Rights states that “Everyone has the right to respect for his private and
p.000071: family life, his home and his correspondence”. It further states that “There shall be no interference by a public
p.000071: authority with the exercise of this right except such as is in accordance with the law and is necessary in a democratic
p.000071: society in the interests of national security, public safety or the economic well-being of the country, for the
p.000071: prevention of disorder or crime, for the protection of health or morals, or for the protection of the rights and
p.000071: freedoms of others”. The European Court of Human Rights was established to monitor that the obligations under the
p.000071: European Court of Human Rights are fulfilled.
p.000071:
p.000071: 9.1.5 The Council of Europe’s Data Protection Convention
p.000071: In 1981, the Committee of Ministers of the Council of Europe adopted the Convention for the Protection of Individuals
p.000071: with regard to Automatic Processing of Personal Data. The Convention came into force on 1 October 1985. All EU member
p.000071: states have ratified the Convention. The Convention is binding on the countries who have ratified it. The Convention is
p.000071: associated with a number of recommendations on how personal data should be handled in various areas. The
p.000071: recommendations are not directly binding.
p.000071: According to Article 1, the Convention aims “to secure in the territory of each Party for every individual, whatever
p.000071: his nationality or residence, respect for his rights and fundamental freedoms, and in particular his right to privacy,
p.000071: with regard to automatic processing of personal data relating to him ("data protection”)”. According to Article 2, the
...
General/Other / cioms guidelines
Searching for indicator cioms:
(return to top)
p.000068: 68
p.000068: 8.10 A broader perspective
p.000069: 69
p.000069: References
p.000070: 70
p.000070: 9. KEY LEGISLATION AND OTHER REGULATIONS WITH WHICH RESEARCHERS SHOULD BE FAMILIAR
p.000071: 71
p.000071: 9.1 Personal data handling
p.000071: 71
p.000071: 9.1.1 Legal support for personal data handling
p.000071: 71
p.000071: 9.1.2 International regulations
p.000071: 71
p.000071: 9.1.3 The UN’s Universal Declaration of Human Rights, etc
p.000072: 72
p.000072: 9.1.4 The European Convention on Human Rights
p.000072: 72
p.000072: 9.1.5 The Council of Europe’s Data Protection Convention
p.000072: 72
p.000072: 9.1.6 OECD’s Guidelines
p.000072: 72
p.000072: 9.1.7 The European Union’s Charter of Fundamental Rights
p.000073: 73
p.000073: 9.1.8 The Data Protection Directive
p.000073: 73
p.000073: 9.2 Two important Swedish laws
p.000073: 73
p.000073: 9.2.1 The Patient Data Act
p.000073: 73
p.000073: 9.2.2 The Act concerning the Ethical Review of Research Involving Humans 74
p.000073: 9.3 Secrecy
p.000074: 74
p.000074: 9.3.1 Public principal
p.000074: 74
p.000074: 9.3.2 Private principal
p.000075: 75
p.000075: 9.4 Examples of other legislation
p.000075: 75
p.000075: 9.5 The CODEX website
p.000075: 75
p.000075: 9.6 The Declaration of Helsinki
p.000075: 75
p.000075: GOOD RESEARCH PRACTICE
p.000005: 5
p.000005:
p.000005: 9.7 Guidelines for Good Clinical Practice (GCP)
p.000076: 76
p.000076: 9.8 The Council of Europe’s Convention for the Protection of Human Rights and biomedicine 76
p.000076: 9.9 The CIOMS guidelines for research
p.000076: 76
p.000076: 9.10 Center for Open Science
p.000076: 76
p.000076: 9.11 Publication ethics and questions of misconduct
p.000076: 76
p.000076: References
p.000077: 77
p.000077: Reading tips
p.000078: 78
p.000078: Laws, ordinances, directives
p.000080: 80
p.000080: Declarations, guidelines, reports
p.000080: 80
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p.000080:
p.000080: GOOD RESEARCH PRACTICE
p.000006: 6
p.000006:
p.000006: INTRODUCTION
p.000006:
p.000006: Research ethics is not static. New ethical problems arise when new scientific questions are asked, when new methods are
p.000006: used and when new materials are analysed. The early focus of research ethics was on protecting patients and research
p.000006: subjects against encroachments in the name of science. Through the development of epidemiologic research and register
p.000006: data research, other issues have to some extent become central. In recent years, stem cell research and nano technology
p.000006: research have attracted great interest, as has the commercialisation of research, and the effects of research on the
p.000006: environment and society in a more global perspective.
...
p.000048: it is primarily a matter of international and national legislation, for example the EU’s Clinical Trials Directive, the
p.000048: Medical Products Act and the Act concerning the Ethical Review of Research Involving Humans. These texts define or
p.000048: specify our legal responsibility – naturally along with other laws that may apply.
p.000048: Two important paragraphs in the Act concerning the Ethical Review of Research Involving Humans are Sections 11 and 11
p.000048: a, which state that research may only be approved if it is to be conducted by, or under the supervision of, a
p.000048: researcher who possesses the necessary scientific competence, and that during ethics review of clinical trials on
p.000048: humans of the characteristics of a medication (clinical medical trial), in addition to what follows from this Act,
p.000048: Chapter 7 Sections 6 and 7 of the Medical Products Act (SFS 2015:315) shall apply.
p.000048: Besides the moral and legal responsibilities, we have discussed thus far, there is a third category, based on ‘soft
p.000048: law’. This category includes international guidelines, which are not legally binding, but nonetheless carry moral
p.000048: weight and can be cited in legal contexts (see Chapters 1 and 9). Here, there is significantly less flexibility than in
p.000048: the case of views on one’s personal moral responsibility. Important documents in this context
p.000048:
p.000048:
p.000048: GOOD RESEARCH PRACTICE
p.000049: 49
p.000049:
p.000049: are the Declaration of Helsinki, as well as the research ethical guidelines the ICH (International Conference on
p.000049: Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Beings) and CIOMS (Council for
p.000049: International Organizations of Medical Sciences) have adopted.
p.000049:
p.000049: 5.6.4 The extent of responsibility
p.000049: In a research project, a distinction can be made between a number of stages, such as planning the research and
p.000049: conducting the project – which includes collecting, interpreting and analysing data – as well as testing or generating
p.000049: hypotheses, publishing the research results and applying them. Collecting and analysing data is different from drawing
p.000049: conclusions based on them, writing a research report or publishing the report.
p.000049: The coordinating research director has a comprehensive responsibility that covers all these aspects. During the
p.000049: planning phase, this responsibility is obvious. If a research group claims to have equipment or competence it later
p.000049: turns out to lack, it can be reproached both legally and morally. But the coordinating research director is responsible
p.000049: for choosing the research group and ensuring that its members have understood what is required of them. He or she can
p.000049: therefore also not escape reproach (at least morally, and perhaps even legally), if crucial information turns out to be
p.000049: wrong.
p.000049: For projects that entail research on human embryonic stem cells, for example, the EU requires that information be
p.000049: provided on where the stem cell lines come from, when they were created, etc. It is not reasonable to require that
p.000049: these details or similar information be verified by the coordinating research director; in principle, one must be able
p.000049: to assume that the information provided is correct. However, it can be reasonable to require research directors to
p.000049: choose to work with researchers they know they can depend on – who they have good reason to believe are trustworthy.
...
p.000049: and everyone affected by it needs to understand what they are responsible for. However, such a delegation does not
p.000049: absolve the coordinating research director from ultimate responsibility. He or she must speak up if there are
p.000049: indications that the division of responsibility is not working as intended, and ensure that the shortcomings are
p.000049: corrected.
p.000049: Within a research group, everyone has a certain degree of responsibility to make sure that certain things happen (or do
p.000049: not happen). Experimental researchers in a group should use logbooks of the same type and use the same principles to
p.000049: record information in them on the experiments they conduct and the data they obtain.
p.000049: Coordinating research directors at national and international levels are responsible for presenting the potential
p.000049: problems that can arise, and for taking action to hinder or prevent them through clear instructions. A clear division
p.000049: of responsibility is necessary to avoid problems, and preventive work to this end should be encouraged.
p.000049:
p.000049: What would you do in the following situation?
p.000049: An investigation reveals that a researcher has in many ways proven himself unsuitable to continue as research director
p.000049: and supervisor. Can he be removed from these positions?
p.000049: What do you do, if you have the possibility to influence the case? How do you justify your decision? Is there common
p.000049: practice or some rule you believe you can cite?
p.000049:
p.000049:
p.000049:
p.000049:
p.000049:
p.000049:
p.000049:
p.000049: GOOD RESEARCH PRACTICE
p.000050: 50
p.000050:
p.000050: References
p.000050: 1. Council for International Organizations of Medical Sciences (CIOMS). International ethical guidelines for
p.000050: biomedical research involving human subjects. Geneva, CIOMS, 2002.
p.000050: 2. Council of Europe. Convention for the Protection of Human Rights and Dignity of the Human Being with regard to
p.000050: the Application of Biology and Medicine: Convention on Human Rights and Biomedicine, (Oviedo Convention), European
p.000050: Treaty Series No 164, Strasbourg, 1997.
p.000050: 3. European Code of Conduct for Research Integrity Revised Edition. ALLEA, All European Academies, Berlin 2017
p.000050: 4. Directive 2001/20/EC of 4 April 2001, of the European Parliament and of the Council on the approximation of the
p.000050: laws, regulations and administrative provisions of the Member States relating to implementation of good clinical
p.000050: practice in the conduct of clinical trials on medicinal products for human use.
p.000050: 5. International Committee of Medical Journal Editors (ICMJE). Uniform Requirements for Manuscripts Submitted to
p.000050: Biomedical Journals, (Vancouver Rules), ICMJE, updated 2010.
p.000050: 6. Lag om etikprövning av forskning som avser människor (SFS 2003:460).
p.000050: 7. Läkemedelsverkets föreskrifter om kliniska läkemedelsprövningar på människor (LVFS 2011:19).
p.000050: 8. The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for
p.000050: Human Use (ICH). E6(R1): Good clinical practice: consolidated guideline, adopted by CPMP, July 1996, issued as
p.000050: CPMP/ICH/135/95/Step5, Geneva, 1996.
p.000050: 9. World Medical Association. Declaration of Helsinki. Ethical Principles for Medical Research Involving Human
...
p.000075: Declaration of Helsinki but are much more comprehensive, addressing everything from planning and conducting clinical
p.000075: studies to how they should be documented and reported.
p.000075:
p.000075: 9.8 The Council of Europe’s Convention for the Protection of Human Rights and biomedicine
p.000075: The Council of Europe is an organisation that works to uphold human rights in its member countries. The Council’s
p.000075: Convention for the Protection of Human Rights and Dignity of the Human Being with Regard to the Application of Biology
p.000075: and Medicine of 1997 (also known as the Oviedo Convention) comprises a number of articles that directly or indirectly
p.000075: relate to biomedical research. It deals in particular with the protection of individuals undergoing research and with
p.000075: the conduct of research on persons with reduced capacity to give free and informed consent. One article deals with
p.000075: research on embryos in vitro.
p.000075: This document, together with the EU Directive on Good Clinical Practice in the member states, has directly prompted the
p.000075: Swedish Act concerning the Ethical Review of Research Involving Humans. Sweden has signed this convention but has not
p.000075: yet ratified it. In practice, however, it has served as a guidepost for Swedish regulations since its establishment.
p.000075:
p.000075: 9.9 The CIOMS guidelines for research
p.000075: The Council for International Organizations of Medical Sciences (CIOMS) has, in collaboration with the World Health
p.000075: Organization (WHO), published Ethical Guidelines for Biomedical Research Involving Human Subjects, addressing issues of
p.000075: safety and informed consent. Through this document, the Council attempts to apply the principles of the Declaration of
p.000075: Helsinki while acknowledging important differences between the countries of the world. The guidelines contain special
p.000075: sections on research on weaker groups and women. CIOMS has also published guidelines on epidemiological research which
p.000075: are widely referred to.
p.000075:
p.000075: 9.10 Center for Open Science
p.000075: Recently, researchers have taken the initiative to encourage better research practice. The currently best established
p.000075: and comprehensive initiative is the Center for Open Science, which provides resources to increase openness, integrity
p.000075: and reproducibility. (https://cos.io/)
p.000075:
p.000075: 9.11 Publication ethics and questions of misconduct
p.000075: Some important documents on research ethics, such as the Declaration of Helsinki, address aspects of publishing ethics.
p.000075: As the Swedish Research Council has signed the Berlin Declaration (the Berlin Declaration
p.000075:
p.000075:
p.000075:
p.000075: GOOD RESEARCH PRACTICE
p.000076: 76
p.000076:
p.000076: on Open Access to Knowledge in the Sciences and Humanities), the Council has since 2010 included a requirement for open
p.000076: access publication in its calls for grant applications.
p.000076: Two international documents are of particular relevance in this context: one being, the Editorial Policy Statements of
p.000076: the Council of Science Editors (CSE), and the other – and most important – the “Vancouver Rules”, published by the
p.000076: International Committee of Medical Journal Editors (ICMJE) under the title of Uniform Requirements for Manuscripts
p.000076: Submitted to Biomedical Journals. A point emphasised in both these documents is the clear link between the right to be
...
p.000076: and higher education institutions in its Riktlinjer för hantering vid universitet och högskolor av frågor om
p.000076: vetenskaplig ohederlighet.
p.000076: The most recent contribution to the documents on misconduct, the Singapore Statement on Research Integrity, was drawn
p.000076: up at the 2nd World Conference on Research Integrity.
p.000076:
p.000076: References
p.000076: 1. 2nd World Conference on Research Integrity. Singapore Statement on Research Integrity. Singapore, 2010.
p.000076: Arkivförordning (SFS 1991:446).
p.000076: 2. Arkivlag (SFS 1990:782).
p.000076: 3. Berlin Declaration on Open Access to Knowledge in the Sciences and Humanities. Berlin, 2003.
p.000076: 4. Commission Directive 2005/28/EC of 8 April 2005 laying down principles and detailed guidelines for good
p.000076: clinical practice as regards investigational medicinal products for human use, as well as the requirements for
p.000076: authorisation of the manufacturing or importation of such products. European Community, Brussels, 2005.
p.000076: 5. Council of Europe. Convention for the Protection of Human Rights and Dignity of the Human Being with regard to
p.000076: the Application of Biology and Medicine: Convention on Human Rights and Biomedicine, (Oviedo Convention), European
p.000076: Treaty Series No 164, Strasbourg, 1997.
p.000076: 6. Council of Science Editors. Editorial Policy Statements, Wheat Ridge, CO, 2010.
p.000076: 7. Council for International Organizations of Medical Sciences (CIOMS). International ethical guidelines for
p.000076: biomedical research involving human subjects. Geneva, CIOMS, 2002.
p.000076: 8. Council for International Organizations of Medical Sciences (CIOMS). International ethical guidelines for
p.000076: epidemiological studies. Geneva, CIOMS, 2008.
p.000076: 9. Djurskyddsförordning (SFS 1988:539).
p.000076: 10. Djurskyddslag (SFS 1988:534).
p.000076: 11. European Code of Conduct for Research Integrity Revised Edition. ALLEA, All European Academies, Berlin 2017.
p.000076: 12. European Science Foundation. Research Integrity: global responsibility to foster common standards. ORI-ESF
p.000076: Science Policy Briefing 30, Strasbourg, 2007.
p.000076: 13. Hälso- och sjukvårdslag (SFS 1982:763).
p.000076: 14. Lag om biobanker i hälso- och sjukvården med mera (SFS 2002:297).
p.000076:
p.000076:
p.000076: GOOD RESEARCH PRACTICE
p.000077: 77
p.000077:
p.000077: 15. Lag om etikprövning av forskning som avser människor (SFS 2003:460).
p.000077: 16. Lag om genetisk integritet med mera (SFS 2006:351).
p.000077: 17. Läkemedelsverkets föreskrifter om kliniska läkemedelsprövningar på människor (LVFS 2011:19).
p.000077: 18. Offentlighets- och sekretesslag (SFS 2009:400).
p.000077: 19. Office of Research Integrity (ORI). Federal Research Misconduct Policy. Federal Register: December 6, 2000,
p.000077: Volume 65, Number 235, Notices, Page 76260–76264.
p.000077: 20. Organisation for Economic Co-operation and Development (OECD). Best Practices for Ensuring Scientific Integrity
p.000077: and Preventing Misconduct. Paris, OECD, 2007.
p.000077: 21. Patientdatalag (SFS 2008:355).
p.000077: 22. Personuppgiftslag (SFS 1998:204).
p.000077: 23. Sveriges universitets- och högskoleförbund (SUHF), Riktlinjer för hantering vid universitet och högskolor av
p.000077: frågor om vetenskaplig ohederlighet. Stockholm, SUHF, 1997.
p.000077: 24. The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for
p.000077: Human Use (ICH). E6(R1): Good clinical practice: consolidated guideline, adopted by CPMP, July 1996, issued as
p.000077: CPMP/ICH/135/95/Step5, Geneva, 1996.
...
p.000079: djur för vetenskapliga ändamål med mera (SJVFS 2008:70).
p.000079: 20. Strålsäkerhetsmyndighetens föreskrifter om allmänna skyldigheter vid medicinsk och odontologisk verksamhet med
p.000079: joniserande strålning (SSMFS 2008:35).
p.000079: 21. Tryckfrihetsförordning (SFS 1949:105).
p.000079:
p.000079: Declarations, guidelines, reports
p.000079: 1. 2nd World Conference on Research Integrity. Singapore Statement on Research Integrity, Singapore, 2010.
p.000079: 2. Berlin Declaration on Open Access to Knowledge in the Sciences and Humanities. Berlin, 2003. Bohlin, Alf,
p.000079: Offentlighet & sekretess i myndighetsforskningsverksamhet. Riksarkivet, 1997:2.
p.000079:
p.000079:
p.000079: GOOD RESEARCH PRACTICE
p.000080: 80
p.000080:
p.000080: 3. Brambell, Rogers, F.W. (Chairman), Report of the Technical Committee to enquire into the Welfare
p.000080: 4. of Animals kept under Intensive Livestock Husbandry Systems, London, HMSO, 1965.
p.000080: 5. Centrala försöksdjursnämnden, Författningar, allmänna råd och anvisningar om användningen av djur för
p.000080: vetenskapliga ändamål. Stockholm, CFN:s skriftserie: 45, 2002.
p.000080: 6. Council of Europe. Convention for the Protection of Human Rights and Dignity of the Human Being with regard to
p.000080: the Application of Biology and Medicine: Convention on Human Rights and Biomedicine, (Oviedo Convention), European
p.000080: Treaty Series No 164, Strasbourg, 1997.
p.000080: 7. Council for International Organizations of Medical Sciences (CIOMS). International ethical guidelines for
p.000080: biomedical research involving human subjects. Geneva, CIOMS, 2002.
p.000080: 8. Council for International Organizations of Medical Sciences (CIOMS). International ethical guidelines for
p.000080: epidemiological studies. Geneva, CIOMS, 2008.
p.000080: 9. Council of Science Editors. Editorial Policy Statements, Wheat Ridge, CO, Council of Science Editors, 2010.
p.000080: 10. Danish Committees on Scientific Dishonesty, Annual Report. Copenhagen, Danish Research Agency, 1993–.
p.000080: 11. Den nasjonale forskningsetiske komité for naturvitenskap og teknologi (NENT), Forskningsetiske retningslinjer
p.000080: for naturvitenskaplig teknologi. Oslo, 2007.
p.000080: 12. Djurförsöksetiska utredningen, Etisk prövning av djurförsök: delbetänkande (SOU 2002:86). Stockholm, Fritzes
p.000080: offentliga publikationer, 2002.
p.000080: 13. European Commission, European Research Area, Science in Society, European Textbook on Ethics in Research. EUR
p.000080: 24452 EN, Luxembourg Publication Office of the European Union 2010.
p.000080: 14. European Commission, European Research Area, Science in Society, Syllabus on Ethics in Research, Addendum to the
p.000080: European Textbook on Ethics in Research. EUR 24451 EN, Luxembourg Publication Office of the European Union 2010.
p.000080: 15. European Science Foundation. Research Integrity: global responsibility to foster common standards. ORI-ESF
p.000080: Science Policy Briefing 30, Strasbourg, 2007.
p.000080: 16. Forsman, Birgitta, Begrepp om forskningsfusk, rapport till Vetenskapsrådet, 2007.
p.000080: 17. Hermerén, Göran, Hanteringen av integritetskänsligt forskningsmaterial, Vetenskapsrådet, 2007. International
p.000080: Committee of Medical Journal Editors (ICMJE). Uniform Requirements for Manuscripts Submitted to Biomedical Journals,
p.000080: (Vancouver Rules), ICMJE, updated 2010.
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p.000063: 63
p.000063: 8.3 Fabrication and falsification
p.000064: 64
p.000064: 8.4 Plagiarism
p.000065: 65
p.000065: 8.5 Unpublished material and self-plagiarism
p.000066: 66
p.000066: 8.6 Establishing plagiarism
p.000066: 66
p.000066: 8.7 Prevention
p.000067: 67
p.000067: 8.8 Sanctions for misconduct
p.000068: 68
p.000068: 8.9 Addressing issues of misconduct
p.000068: 68
p.000068: 8.10 A broader perspective
p.000069: 69
p.000069: References
p.000070: 70
p.000070: 9. KEY LEGISLATION AND OTHER REGULATIONS WITH WHICH RESEARCHERS SHOULD BE FAMILIAR
p.000071: 71
p.000071: 9.1 Personal data handling
p.000071: 71
p.000071: 9.1.1 Legal support for personal data handling
p.000071: 71
p.000071: 9.1.2 International regulations
p.000071: 71
p.000071: 9.1.3 The UN’s Universal Declaration of Human Rights, etc
p.000072: 72
p.000072: 9.1.4 The European Convention on Human Rights
p.000072: 72
p.000072: 9.1.5 The Council of Europe’s Data Protection Convention
p.000072: 72
p.000072: 9.1.6 OECD’s Guidelines
p.000072: 72
p.000072: 9.1.7 The European Union’s Charter of Fundamental Rights
p.000073: 73
p.000073: 9.1.8 The Data Protection Directive
p.000073: 73
p.000073: 9.2 Two important Swedish laws
p.000073: 73
p.000073: 9.2.1 The Patient Data Act
p.000073: 73
p.000073: 9.2.2 The Act concerning the Ethical Review of Research Involving Humans 74
p.000073: 9.3 Secrecy
p.000074: 74
p.000074: 9.3.1 Public principal
p.000074: 74
p.000074: 9.3.2 Private principal
p.000075: 75
p.000075: 9.4 Examples of other legislation
p.000075: 75
p.000075: 9.5 The CODEX website
p.000075: 75
p.000075: 9.6 The Declaration of Helsinki
p.000075: 75
p.000075: GOOD RESEARCH PRACTICE
p.000005: 5
p.000005:
p.000005: 9.7 Guidelines for Good Clinical Practice (GCP)
p.000076: 76
p.000076: 9.8 The Council of Europe’s Convention for the Protection of Human Rights and biomedicine 76
p.000076: 9.9 The CIOMS guidelines for research
p.000076: 76
p.000076: 9.10 Center for Open Science
p.000076: 76
p.000076: 9.11 Publication ethics and questions of misconduct
p.000076: 76
p.000076: References
p.000077: 77
p.000077: Reading tips
p.000078: 78
p.000078: Laws, ordinances, directives
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p.000080: Declarations, guidelines, reports
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p.000080: GOOD RESEARCH PRACTICE
p.000006: 6
p.000006:
p.000006: INTRODUCTION
p.000006:
p.000006: Research ethics is not static. New ethical problems arise when new scientific questions are asked, when new methods are
p.000006: used and when new materials are analysed. The early focus of research ethics was on protecting patients and research
p.000006: subjects against encroachments in the name of science. Through the development of epidemiologic research and register
...
p.000012: can bring about. In addition to their benefits, research results are often valuable in their own right. You could say
p.000012: that there is an ethically motivated imperative to conduct research: the research criterion.
p.000012: Many problems in research ethics can therefore be described as achieving a balance between these two criteria. We are
p.000012: to conduct qualitatively good research with an important purpose, and at the same time protect those individuals taking
p.000012: part in the research. How this is balanced and achieved depends on what type of research (questions, methods,
p.000012: participants etc.) is conducted.
p.000012: The discussion on research ethics issues took off after World War II. Research ethics codes, collections of rules
p.000012: attempting to clarify how the researcher should act towards research subjects in an ethically sound way, were developed
p.000012: for various research areas. The codes stated what the researcher should do before conducting the research (information,
p.000012: consent), during the research (avoidance of risks, design issues) and after the
p.000012:
p.000012:
p.000012: GOOD RESEARCH PRACTICE
p.000013: 13
p.000013:
p.000013: research (publication, retention and archiving of material). A number of ethical issues within research thus received
p.000013: attention, and the codes greatly contributed to creating a praxis and increasing awareness of possible ethical problems
p.000013: in research.
p.000013: By far the most significant code is the medical Declaration of Helsinki, which has been adopted by the World Medical
p.000013: Association. The Declaration appeared its earliest version in 1964 and has undergone several revisions, most recently
p.000013: in 2013. Rules as well as concepts from the Declaration of Helsinki have proven to be useful in other research areas as
p.000013: well, which has contributed to the code’s central position within research ethics in general.
p.000013: A code is thus a collection of ethical rules. Through these rules, someone (a research group, a research funding body,
p.000013: an organisation of researchers or research institutions, etc.) attempts to interpret and formulate what morals in
p.000013: certain situations demand of the researcher in relation to the informant, and sometimes also in relation to other
p.000013: interested parties. However, a code is not a legal document.
p.000013: With time, however, legislation has entered the area of research ethics. Clear examples of this are the Act concerning
p.000013: the Ethical Review of Research Involving Humans and the Animal Welfare Act. However, although the legislation in these
p.000013: cases has entered a specific area of ethics, this does not mean that ethics and the law have entirely converged.
p.000013:
p.000013: 1.5 The law and morals
p.000013: Many differences between the law and morals can be noticed even at a glance. As a rule, that which is legally right,
p.000013: what a certain law prescribes, is very clearly and precisely formulated.
p.000013: The law has also come to be through an established decision as a result of a special procedure. It is only when a
p.000013: decision has been reached in this way that a law is created. A law can also be abolished through a corresponding
p.000013: process; it is thus in effect between two points in time.
...
p.000013: Denmark, I have to hold that I should avoid harming my fellow humans just as I would in Sweden.
p.000013: Another difference between morals and the law is that morals have no explicit system of sanctions. A breach of morals
p.000013: is of course followed by sanctions, but what these might be and how they are applied vary greatly.
p.000013: That laws and morals are different is also directly observable in our everyday experiences. There are many situations
p.000013: in life when a law has nothing to say but our morals prescribe or forbid action. On the other hand, the law can in turn
p.000013: regulate conditions that from a moral perspective are completely neutral, for instance certain traffic legislation.
p.000013: There are also conditions that a certain law prescribes or allows, but cause us to ask ourselves: Is it morally right
p.000013: to do that? Certain behaviour is allowed in business law – thus no laws are broken
p.000013: – but should one really act in that way? This is another question, and one that is asked often. Answering the legal
p.000013: question is one thing, while answering the moral question is another.
p.000013: What morals prescribe and forbid thus needs to be analysed and interpreted. But are there given answers, or are morals
p.000013: relative? It is reasonable to assume that certain fundamental values can be shared by all people, while others can vary
p.000013: from person to person and between cultures or traditions. Whatever the case is concerning this relativity, however, it
p.000013: is clear that a moral conviction or principle is different from a legal rule.
p.000013:
p.000013:
p.000013:
p.000013: GOOD RESEARCH PRACTICE
p.000014: 14
p.000014:
p.000014: If we take the moral premises set forth in the Declaration of Helsinki, for example, these are premises that
p.000014: researchers around the world – not only those in the West – can relate to and apply in their research. Below, the
p.000014: mention of “common” ethical criteria for research refers to such premises, for example those formulated in the
p.000014: Declaration of Helsinki.
p.000014:
p.000014: 1.6 The law and morals in the area of research
p.000014: It is important for the researcher to know what the various laws dictate concerning research, as well as what the
p.000014: various codes prescribe. The Swedish Research Council, like many other funding bodies, also places specific ethics
p.000014: requirements in conjunction with an application for funding. It is important to note the difference between these
p.000014: distinct types of requirements. Legislation in the area of research ethics, both historically and content-wise, has its
p.000014: starting point in ethical convictions, for instance as they are expressed in ethical codes. But legislation only
p.000014: addresses certain specific situations and certain specific conditions.
p.000014: On 1 January 2004, the Act (SFS 2003:460) concerning the Ethical Review of Research Involving Humans came into force
p.000014: (riksdagen.se/sv/dokument-lagar/dokument/svensk-forfattningssamling/lag-2003460-om-
p.000014: etikprovning-av-forskning-som_sfs-2003-460). The purpose of the Act is to protect the individual person and ensure
p.000014: respect for human dignity in research, and it is limited to certain aspects of research; professional ethics are not
p.000014: addressed.
p.000014: This legislation has been complemented with the establishment of legal agencies – ethics review boards – which review
p.000014: research projects and decide whether they merit approval. The Act therefore also states (1) which projects must be
p.000014: board reviewed, (2) what parts of these projects are to be reviewed and what warrants approval, and (3) how the boards
...
p.000016: were to give an electric shock to “students” when they answered incorrectly, and that they were to increase the
p.000016: strength of the shock with each successive wrong answer. The students then simulated great pain. Everything was
p.000016: simulated, and everyone except the subjects knew this. Most of the subjects followed the instructions.
p.000016: Milgram’s research provided important knowledge on subordination and the obedience of instructions from authorities –
p.000016: it revealed things about ourselves that we perhaps would rather not know, but that are important for the understanding
p.000016: of the success of Hitler and others like him – but Milgram’s research has also been criticised.
p.000016: What ethical issues does this research bring to the fore? Is there a conflict here between scientific and ethical
p.000016: quality criteria? In what way? How do you feel this conflict should be handled?
p.000016:
p.000016: 1.8 Review
p.000016: In summary, one must constantly distinguish between the law and morals and, when it comes to research, also between
p.000016: research ethics legislation and the rules found in research ethics codes. The ethical criteria can be more far-reaching
p.000016: than the legal requirements when their content is otherwise closely related. The ethical criteria can also address
p.000016: issues that do not appear in legislation at all. The collective ethical criteria on how good research should be
p.000016: conducted can be said to express what good research practice is.
p.000016: Researchers should follow good research practice. It can therefore not be said, for example, that the Act concerning
p.000016: the Ethical Review of Research Involving Humans, replaces codes like the Declaration of Helsinki or eliminates or
p.000016: reduces the significance of one’s own moral judgement. The researcher’s own reflections on his or her project must
p.000016: instead be based on both knowledge of the content of laws and codes, and on his or her own moral judgement.
p.000016:
p.000016: 1.9 Various regulatory systems
p.000016: Laws are made by Sweden’s Riksdag, its parliament, and are binding. Ordinances, issued by the Government, and
p.000016: regulations and directives, issued by public authorities (such as the National Board of Health and Welfare, or the
p.000016: Dental and Pharmaceutical Benefits Agency) with support from laws and ordinances, have the same legal character.
p.000016: Within the EU there are regulations, which have the same authority as Swedish law, and directives, which normally must
p.000016: be implemented in Swedish law to be binding. Also in the international context are conventions, which are binding for
p.000016: the countries who have agreed to follow them, such as the Council of Europe’s Oviedo Convention.
p.000016: Guidelines can be issued by authorities or different non-governmental organisations and assemblies. Though such
p.000016: documents are not legally binding, their content can be generally accepted. Supervisory authorities, such as the
p.000016: Central Ethical Review Board and the Swedish Data Protection Authority, produce guidelines, information brochures, etc.
p.000016: of importance to research.
p.000016: Declarations, resolutions and statements are also generally issued by organisations and assemblies, and entail that
p.000016: these groups declare a certain stance within their field. These documents usually consist of calls for certain ethical
p.000016: approaches, and can sometimes reach a status similar to that of international conventions. An excellent example of a
p.000016: declaration with extremely high status is the Declaration of Helsinki, which provides the foundation of the work of
p.000016: research ethics committees and their like around the world.
p.000016: Ethics codes usually have a pronounced voluntary character. They usually concern relations not regulated by law, and
p.000016: often concentrate on how those affected by the code conduct themselves in relation to their work, as well as the
p.000016: consequences the work can have for other people, the organisation, the environment, etc.
p.000016:
p.000016:
p.000016: GOOD RESEARCH PRACTICE
p.000017: 17
p.000017:
p.000017: References
p.000017: 1. Forsman, Birgitta, Forskningsetik: en introduktion. Lund, Studentlitteratur, 1997. Forsman, Birgitta, Vetenskap
p.000017: och moral. Nora, Nya Doxa, 2002.
p.000017: 2. Hermerén, Göran, Kunskapens pris: forskningsetiska problem och principer i humaniora och samhällsvetenskap.
p.000017: Stockholm, Swedish Science Press & HSFR, 1986, 2nd edition, 1996.
p.000017: 3. Lag om etikprövning av forskning som avser människor (SFS 2003:460).
p.000017: 4. Merton, Robert ”The Normative Structure of Science” (1942), in Merton, R., The Sociology of Science. University
p.000017: of Chicago Press, 1973.
p.000017: 5. Petersson, Bo, Forskning och etiska koder. Nora, Nya Doxa, 1994.
p.000017: 6. World Medical Association. Declaration of Helsinki. Ethical Principles for Medical Research Involving Human
p.000017: Subjects, adopted by the 18th WMA General Assembly, Helsinki, Finland, June 1964, latest revision by the WMA General
p.000017: Assembly, Seoul 2013. Ferney-Voltaire, France, World Medical Association, 2013.
p.000017:
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p.000017:
p.000017:
p.000017: GOOD RESEARCH PRACTICE
p.000018: 18
p.000018:
p.000018: 2 ABOUT RESEARCH – WHAT, WHY, HOW AND FOR WHOM?
p.000018:
p.000018:
p.000018: 2.1 Starting points for research
p.000018:
p.000018: 2.1.1 Some types of research
p.000018: There are diverse types of research. Distinctions can be drawn between hypothesis-generating and hypothesis- testing
p.000018: research, and between research using qualitative and quantitative methods. One can also distinguish between research
p.000018: that tries to explain why something has happened by showing that it can be subsumed under a natural law and research
p.000018: that that tries to increase and deepen our knowledge about events, processes or texts. From a research ethics
p.000018: perspective, another distinction is interesting. One usually distinguishes between three forms of research: basic,
p.000018: applied and commissioned (there are also other terminologies and distinctions).
p.000018: Basic research entails the researcher seeking new knowledge without a particular application in mind, and can lead to
p.000018: unexpected and ground-breaking discoveries. Applied and commissioned research both have a particular aim. They are
...
p.000027: article published, or taking a chance that the results will hold in order to be the first to report a new discovery. At
p.000027: the same time, one also should not refrain from publishing results due to exaggerated caution. The most important thing
p.000027: is to be clear, critical and honest in evaluating sources of error.
p.000027: The evaluation of error sources is often limited by the research tradition and method a researcher is working within.
p.000027: Some sources of error do not “show” if one performs the analysis based on a certain theoretical standpoint or model. It
p.000027: is thus important in the error analysis not to limit yourself to the possible “internal errors” within the frame of
p.000027: your chosen viewpoint, but rather to allow the analysis to broaden the perspective to show other, alternative
p.000027: viewpoints. This can be very difficult, however. One is often forced to lower the level of ambition, but in such cases,
p.000027: it is all the more important to be accurate in explaining the basis for the analysis and its limitations.
p.000027:
p.000027: 2.4 Research ethics from a dynamic perspective
p.000027: The landscape of research ethics is changing. When researchers ask new questions, use new methods and work with new
p.000027: materials, new research ethics issues arise. Early on, the purpose of research ethics was to keep researchers from
p.000027: harming or violating patients and research subjects in numerous ways in the name of science. This was the overarching
p.000027: purpose of the Declaration of Helsinki, against a background of events including the research that had been conducted
p.000027: on prisoners in concentration camps and jails. Therefore, the Declaration stressed standards for informed consent and
p.000027: risk-benefit analysis, as well as that the interests of science and society not being allowed to carry more weight than
p.000027: the protection of the individual’s well-being and safety.
p.000027: With the development of epidemiological research and register data research of diverse types, some other issues have
p.000027: now come to the fore. The persons who are subject to such research, where data about them is collected and analysed,
p.000027: participate in a different way than those who take part directly in clinical trials of new medicines, for instance.
p.000027: Those who contribute to a register study do not need to be aware that they are part of the study and thereby a subject
p.000027: of research. Meanwhile, this type of research can be sensitive from an integrity perspective, and the knowledge that
p.000027: information, which the people in question may not even know has been recorded, can be gathered and analysed can be
p.000027: cause for concern. The study design and the presentation of results are essential elements in alleviating unfounded (or
p.000027: well-founded) worry over discrimination and stigmatisation. The likely value of new knowledge must thus be weighed
p.000027: against the risk that subjects’ integrity will be compromised and the need to protect individuals’ right to privacy.
...
p.000035: be given if the research is ethically acceptable. A researcher who ignores the obligation to notify the proper
p.000035: authority or obtain approval can be found guilty of conducting unauthorised environmental work.
p.000035:
p.000035: 3.4 Examples of problems that are still unsolved
p.000035: The Swedish legislation and regulations concerning research are not comprehensive – and never can be (see Chapter 1 on
p.000035: the law and morals). However, there are currently a number of shortcomings that deserve attention, so that workable
p.000035: solutions can be discussed and, if possible, be implemented.
p.000035: First, there is the problem that Swedish legislation is only applicable in Swedish territory. This affects the ethics
p.000035: review of projects that will be conducted wholly or partly in another country, even if researchers from
p.000035:
p.000035:
p.000035:
p.000035:
p.000035: GOOD RESEARCH PRACTICE
p.000036: 36
p.000036:
p.000036: Sweden participate and Swedish funding bodies contribute money. Ethical standards that appear self-evident in Sweden
p.000036: can then be difficult to find support for in international research environments.
p.000036: It is especially worrying if researchers perform their work in countries with lower ethical standards, just to take
p.000036: advantage of this. It can, for example, be easier to find research subjects, easier to get permission to use primates
p.000036: in research, cheaper to conduct studies, or involve less extensive application procedures. If these advantages come at
p.000036: the cost of the integrity of the research, it will in many cases involve a breach of the standards in the Declaration
p.000036: of Helsinki:
p.000036:
p.000036: Physicians should consider the ethical, legal and regulatory norms and standards for research involving human subjects
p.000036: in their own countries as well as applicable international norms and standards. No national or international ethical,
p.000036: legal or regulatory requirement should reduce or eliminate any of the protections for research subjects set forth in
p.000036: this Declaration.
p.000036:
p.000036: It is unacceptable for studies to violate this principle. The Norwegian National Committee for Research Ethics in
p.000036: Science and Technology states precise and necessary requirements, namely that
p.000036:
p.000036: a researcher is not to conduct parts of his or her research in another country simply because it has lower ethical or
p.000036: safety standards than at home;
p.000036:
p.000036: and that researchers shall inform funding bodies of divergent ethical or safety standards in the country or countries
p.000036: where their research is being conducted.
p.000036:
p.000036: Another problem is that the most fundamental protection for research subjects – that the research project must be
p.000036: ethically reviewed before it can begin – is not always self-evident in other countries. The Declaration of Helsinki
p.000036: requires this review for all medical research performed on humans, and this requirement is held by many funding bodies
p.000036: and journals.
p.000036: Here, the Swedish legal requirement of ethics review is less comprehensive. However, as mentioned earlier, in Sweden
p.000036: there is the option to request an advisory statement from an ethics review board regarding a project that does not
p.000036: formally need to be reviewed. It is good research practice to request a statement in the event research collaborations
p.000036: in other countries are expected to present ethical difficulties for the researchers.
p.000036: The ethics review boards have no obligation to issue these advisory statements however, just the right to do so. If the
p.000036: regional ethics review board refuses to issue such a statement, however, this may cause profound consequences for the
p.000036: researchers’ chances of obtaining further funding and being published.
p.000036: There are issues concerning the withdrawal of consent that are problematic for research ethics. In biobank research,
p.000036: the research subject has the option of withdrawing consent. If this happens, it is the responsible party at the biobank
p.000036: who determines whether the biological material should be destroyed – which is likely to be the research subject’s wish
p.000036: – or only de-identified. In the latter case, the research subject can feel tricked. In research projects using video or
...
p.000037: Regen Med, 2017. 12(1): p. 25-36.
p.000037: 15. Hug, K., G. Hermeren, and M. Johansson, Withdrawal from biobank research: considerations and the way forward.
p.000037: Stem Cell Rev, 2012. 8(4): p. 1056-65.
p.000037: 16. Karlsson, Fredrik, Weighing Animal Lives – a Critical Assessment of Justification and Prioritization in
p.000037: Animal-Rights Theories. Uppsala, Acta Universitatis Upsaliensis, 2009.
p.000037: 17. Klareskog, Lars & Rönnelid, Johan & Lundberg, Karin & Padyukov, Leonid & Alfredsson, Lars ”Immunity to
p.000037: citrullinated proteins in rheumatoid arthritis.” Annual Review of Immunology, 2008, 26:651–675.
p.000037: 18. Lag om etikprövning av forskning som avser människor (SFS 2003:460).
p.000037: 19. Lag om biobanker i hälso- och sjukvården med mera (SFS 2002:297).
p.000037: 20. Läkemedelslag (SFS 2015:315).
p.000037: 21. Läkemedelsverkets föreskrifter om kliniska läkemedelsprövningar på människor (LVFS 2011:19).
p.000037: 22. Perel, Pablo, & Roberts, Ian & Sena, Emily & Wheble, Philipa & Briscoe, Catherine & Sandercock, Peter & Macleod,
p.000037: Malcolm & Mignini, Luciano E. & Jayaram, Pradeep & Khan Khalid S.,”Comparison of Treatment Effects between Animal
p.000037: Experiments and Clinical Trials: Systemic Review”. British Medical Journal, 2007, 334 (7586):197.
p.000037: 23. Personuppgiftslag (SFS 1998:204).
p.000037: 24. Personuppgiftsförordning (SFS 1998:1191).
p.000037: 25. Rodman, John, ”The Dolphin Papers”, The North American Review, spring 1974, 259:13-26 (page 18).
p.000037: 26. Statens Jordbruksverks författningssamling (SJVFS 2008:70).
p.000037: 27. Strålsäkerhetsmyndighetens föreskrifter om allmänna skyldigheter vid medicinsk och odontologisk verksamhet med
p.000037: joniserande strålning (SSMFS 2008:35).
p.000037: 28. World Medical Association. Declaration of Helsinki. Ethical Principles for Medical Research Involving Human
p.000037: Subjects, adopted by the 18th WMA General Assembly, Helsinki, Finland, June 1964, latest revision by the WMA General
p.000037: Assembly, Seoul 2013. Ferney-Voltaire, France, World Medical Association, 2013.
p.000037:
p.000037:
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p.000037: GOOD RESEARCH PRACTICE
p.000038: 38
p.000038:
p.000038: 4 HANDLING OF RESEARCH MATERIAL
p.000038: - THINK FIRST
p.000038:
p.000038: This chapter, with the exception of Section 4.5, is the translation of a text that is virtually identical to that of
p.000038: Göran Hermerén’s article, “Hantering av integritetskänsligt material”.
p.000038:
p.000038: 4.1 Background and problems
p.000038: The fundamental openness in all public organisations is required by law and established constitutionally. Universities
p.000038: and individual researchers can therefore not take it upon themselves to weigh the interest of public access against
p.000038: other interests.
p.000038: The Declaration of Helsinki, adopted by the World Medical Association, is an important document for medical research
p.000038: ethics. The ethical principles stated in the Declaration are in part also applicable to other research, not least
p.000038: certain social medicine and social science research. This document has been updated a number of times, most recently in
p.000038: October 2013.
p.000038: However, the Declaration of Helsinki is not legally binding. This was reiterated by the Swedish Court of Appeal for
p.000038: Western Sweden in a case a number of years ago that received a great deal of attention; A view that was upheld by the
p.000038: European Court of Justice in 2010. The issue concerned a request that a researcher in Göteborg make public the research
p.000038: material from a controversial study on children with neuropsychiatric disabilities.
p.000038: Swedish law carries more weight than this international declaration in cases when they come into conflict.
p.000038: These issues have received attention in medical research, for instance in the debate and trials that have followed in
p.000038: the wake of the Göteborg case. But the issues have a more general and fundamental side as well, as they also arise in
p.000038: many other scientific areas, such as the humanities (integrity-sensitive information on famous politicians and authors)
p.000038: and social sciences (integrity-sensitive information on individuals and groups that may be revealed in studies).
p.000038: In these cases, the requirements for public access, openness and transparency sometimes come into conflict with the
p.000038: requirement to protect the integrity of research subjects and informants. These issues also carry a danger that current
p.000038: regulation systems increase the risk that studies will be performed outside the healthcare arena, where there is less
p.000038: transparency. It is thus important to have a general discussion on ethical issues in the handling of
...
p.000040: If professional secrecy applies for a certain activity, this does not necessarily mean that what is said during the
p.000040: activity is automatically covered by secrecy or that it that it falls under the Public Access to Information and
p.000040: Secrecy Act. Furthermore, it can happen that a researcher, through his or her work on a project, becomes aware of some
p.000040: circumstance that must be reported by law (such as child abuse or paedophilia). In such cases, the obligation to report
p.000040: outweighs the secrecy requirement.
p.000040:
p.000040: 4.4.3 Anonymity
p.000040: In some cases, the anonymising of information is a condition set by an ethics review board for its approval of a study.
p.000040: This can be done, for example, by removing personal information on completed questionnaires or samples, so that it is
p.000040: difficult or in practice impossible to link a certain answer or sample to a specific individual. In some types of
p.000040: studies, the identity of the individuals is not relevant, for instance studies on variations in attitudes towards a
p.000040: certain issue in a specific group over time. In such situations, researchers can promise anonymity.
p.000040: It should be noted, however, that this strategy has other drawbacks. Not only is it difficult or impossible to verify
p.000040: the researcher’s information, but it can also happen that an entire group is stigmatised or discriminated against due
p.000040: to the publication of certain research results, even if no individual person in the group can be identified.
p.000040:
p.000040: 4.4.4 Confidentiality
p.000040: The Declaration of Helsinki stresses the importance of confidentiality and of the researcher taking measures to protect
p.000040: the integrity of research subjects and their right to protection of their private lives. This is stated in the latest
p.000040: version of the Declaration from 2013, where it is stressed that:
p.000040:
p.000040: Every precaution must be taken to protect the privacy of the research subjects and the confidentiality of their
p.000040: personal information and to minimise the impact of the study on their physical, mental and social integrity.
p.000040:
p.000040: 4.4.5 Conclusions
p.000040: As just discussed, a researcher cannot promise that no one outside the research group will ever have access to the
p.000040: material or information collected in the course of the study. There are many situations in which access to research
p.000040: material is justified and necessary. For example, it could be a case of other researchers wanting to test the strength
p.000040: of scientific results, an opponent at a disputation requesting access to the basic data, or a report of suspected
p.000040: research misconduct, clinical trials (e.g. inspection), a court ruling or an ongoing court case.
p.000040: It also cannot be ruled out that research material may be handed over to other researchers in cases besides those
p.000040: referred to above. Research costs money, so it is also in society’s interest that material collected is used as much as
p.000040: possible in research. Two general conditions for this to be possible are that the new research project is ethically
p.000040: reviewed (if the law so requires), and that the new researchers adopt the previous researchers’ promise of
p.000040: confidentiality and safe storage of the material.
p.000040: Naturally, the researcher can and should describe to the research subjects the measures taken to prevent, or reduce,
p.000040: the risk that sensitive personal information will be disseminated. The researcher should also explain the conditions
p.000040: under which these protective measures can be enforced. These measures can include the use of code keys, the encryption
p.000040: of certain information, etc.
p.000040: There is of course a risk that some persons will not want to participate in a study if the researchers truthfully
p.000040: explain what they are able to promise, based on the rules that apply. But as a rule, people are willing to participate
p.000040: in medical research if they are asked, informed according to the principles in the Declaration of Helsinki and are told
p.000040: why and to whom the research is important. Of course, it is easier and cheaper to do things right from the beginning.
p.000040: In research that is not conducted in connection with healthcare one can, for example, use a code key and record coded
p.000040: information directly in the research journals, even though there is a certain extra cost involved. This makes it
p.000040: possible to give other researchers access to the information on
p.000040:
p.000040:
p.000040: GOOD RESEARCH PRACTICE
p.000041: 41
p.000041:
p.000041: condition that they assume or take over the professional secrecy promised by the previous researchers. The new
p.000041: researchers then become the personal data controllers.
p.000041: It is not only names that can be replaced with code numbers. Other information in the material that could identify
p.000041: individual subjects can also be disguised in this way (see Chapter 9). The ethics review boards should be able to
p.000041: determine the level of encryption required.
p.000041: Costs can be significantly higher if material that will be shown to other researchers is not collected using codes and
p.000041: code keys, especially if a project is conducted over a prolonged period of time. But it is neither ethical nor legally
p.000041: acceptable for an individual researcher or research group to breach the rules applicable with reference to such costs.
p.000041:
p.000041: What would you do in the following situation?
p.000041: A researcher, Adam, collects data from a specific group of adult informants. He promises that no one outside his
p.000041: research group will have access to the data. Later, his findings are questioned by two other researchers, Brian and
...
p.000048: What rights and obligations do the various actors have, and what does current law have to say on the subject? To answer
p.000048: this question, one has to determine which legislation is applicable and how it should be interpreted. In this context,
p.000048: it is primarily a matter of international and national legislation, for example the EU’s Clinical Trials Directive, the
p.000048: Medical Products Act and the Act concerning the Ethical Review of Research Involving Humans. These texts define or
p.000048: specify our legal responsibility – naturally along with other laws that may apply.
p.000048: Two important paragraphs in the Act concerning the Ethical Review of Research Involving Humans are Sections 11 and 11
p.000048: a, which state that research may only be approved if it is to be conducted by, or under the supervision of, a
p.000048: researcher who possesses the necessary scientific competence, and that during ethics review of clinical trials on
p.000048: humans of the characteristics of a medication (clinical medical trial), in addition to what follows from this Act,
p.000048: Chapter 7 Sections 6 and 7 of the Medical Products Act (SFS 2015:315) shall apply.
p.000048: Besides the moral and legal responsibilities, we have discussed thus far, there is a third category, based on ‘soft
p.000048: law’. This category includes international guidelines, which are not legally binding, but nonetheless carry moral
p.000048: weight and can be cited in legal contexts (see Chapters 1 and 9). Here, there is significantly less flexibility than in
p.000048: the case of views on one’s personal moral responsibility. Important documents in this context
p.000048:
p.000048:
p.000048: GOOD RESEARCH PRACTICE
p.000049: 49
p.000049:
p.000049: are the Declaration of Helsinki, as well as the research ethical guidelines the ICH (International Conference on
p.000049: Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Beings) and CIOMS (Council for
p.000049: International Organizations of Medical Sciences) have adopted.
p.000049:
p.000049: 5.6.4 The extent of responsibility
p.000049: In a research project, a distinction can be made between a number of stages, such as planning the research and
p.000049: conducting the project – which includes collecting, interpreting and analysing data – as well as testing or generating
p.000049: hypotheses, publishing the research results and applying them. Collecting and analysing data is different from drawing
p.000049: conclusions based on them, writing a research report or publishing the report.
p.000049: The coordinating research director has a comprehensive responsibility that covers all these aspects. During the
p.000049: planning phase, this responsibility is obvious. If a research group claims to have equipment or competence it later
p.000049: turns out to lack, it can be reproached both legally and morally. But the coordinating research director is responsible
p.000049: for choosing the research group and ensuring that its members have understood what is required of them. He or she can
p.000049: therefore also not escape reproach (at least morally, and perhaps even legally), if crucial information turns out to be
p.000049: wrong.
p.000049: For projects that entail research on human embryonic stem cells, for example, the EU requires that information be
p.000049: provided on where the stem cell lines come from, when they were created, etc. It is not reasonable to require that
p.000049: these details or similar information be verified by the coordinating research director; in principle, one must be able
...
p.000050: biomedical research involving human subjects. Geneva, CIOMS, 2002.
p.000050: 2. Council of Europe. Convention for the Protection of Human Rights and Dignity of the Human Being with regard to
p.000050: the Application of Biology and Medicine: Convention on Human Rights and Biomedicine, (Oviedo Convention), European
p.000050: Treaty Series No 164, Strasbourg, 1997.
p.000050: 3. European Code of Conduct for Research Integrity Revised Edition. ALLEA, All European Academies, Berlin 2017
p.000050: 4. Directive 2001/20/EC of 4 April 2001, of the European Parliament and of the Council on the approximation of the
p.000050: laws, regulations and administrative provisions of the Member States relating to implementation of good clinical
p.000050: practice in the conduct of clinical trials on medicinal products for human use.
p.000050: 5. International Committee of Medical Journal Editors (ICMJE). Uniform Requirements for Manuscripts Submitted to
p.000050: Biomedical Journals, (Vancouver Rules), ICMJE, updated 2010.
p.000050: 6. Lag om etikprövning av forskning som avser människor (SFS 2003:460).
p.000050: 7. Läkemedelsverkets föreskrifter om kliniska läkemedelsprövningar på människor (LVFS 2011:19).
p.000050: 8. The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for
p.000050: Human Use (ICH). E6(R1): Good clinical practice: consolidated guideline, adopted by CPMP, July 1996, issued as
p.000050: CPMP/ICH/135/95/Step5, Geneva, 1996.
p.000050: 9. World Medical Association. Declaration of Helsinki. Ethical Principles for Medical Research Involving Human
p.000050: Subjects, adopted by the 18th WMA General Assembly, Helsinki, Finland, June 1964, latest revision by the WMA General
p.000050: Assembly, Seoul 2013. Ferney-Voltaire, France, World Medical Association, 2013.
p.000050:
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p.000050:
p.000050: GOOD RESEARCH PRACTICE
p.000051: 51
p.000051:
p.000051: 6 PUBLISHING RESEARCH RESULTS
p.000051:
p.000051: 6.1 Why publish?
p.000051: Researchers are generally considered to have a duty to publish their results. Not withholding their findings from
p.000051: society and other scientists is a fundamental principle, stressed already by Robert Merton (see Chapter 1).
p.000051: Publication is an integral and essential part of the research endeavour. Researchers must therefore be careful, as
p.000051: discussed earlier (see Chapters 2 and 5), when accepting commissioned work, to make no undertakings to refrain from
p.000051: publishing their results, to restrict their publication or to publish them only if a particular outcome is obtained.
p.000051: Research results are normally reported in writing, either in book form or as articles in scientific journals. In many
p.000051: fields of research, such as medicine and the natural sciences, it is now common for a doctoral student to present a
p.000051: thesis incorporating a number of such articles. Where this format is chosen, the articles are preceded by an
p.000051: introductory narrative, which provides a background and summary and shows how the articles are related to one another.
...
p.000074: Swedish Board of Agriculture provides supplementary guidelines and general advice.
p.000074:
p.000074: 9.5 The CODEX website
p.000074: The Swedish Research Council maintains a website in collaboration with the Centre for Research Ethics and Bioethics at
p.000074: Uppsala University on which the great majority of documents that may be relevant to the researcher can be found. The
p.000074: site thus includes legislation with a bearing on research.
p.000074: Also to be found here are various directives and conventions of an international character, adopted for example by the
p.000074: UN, UNESCO, the EU and the Council of Europe. The site also features the full texts of codes of research ethics for
p.000074: different disciplines and fields of research, along with introductions to specific challenges in research, such as
p.000074: informed consent or publication. In addition, there is a section on the use of animals in research. CODEX can be found
p.000074: at www.codex.vr.se.
p.000074: Note that CODEX is a site that provides information on research ethics; the material presented there does not
p.000074: necessarily reflect the Swedish Research Council’s opinions on research ethics issues.
p.000074: Below, some documents that are central to research in Sweden are commented on briefly. The complete texts can all be
p.000074: found in CODEX, together with many other significant and valuable questions. They are arranged here from the most
p.000074: binding to the more voluntary.
p.000074:
p.000074: 9.6 The Declaration of Helsinki
p.000074: The Declaration of Helsinki is a central guideline for research ethics adopted by the World Medical Association in
p.000074: 1964. The Declaration contains ethical principles for doctors and other participants in medical research.
p.000074: The Declaration of Helsinki is not legally binding, but has had major impact on national legislation. Since 2000, it
p.000074: refers explicitly to research using identifiable samples and data. One of the fundamental principles of the Declaration
p.000074: is that concern for the individual must always take precedence over the interests of science and society.
p.000074: Furthermore, the principles state that informed consent must be obtained for research that uses identifiable samples
p.000074: and data – for collection, analysis, storage and use for new purposes. It establishes, however, that situations may
p.000074: exist where it is impossible or unsuitable to obtain consent. In such cases, research may only be carried out if an
p.000074: ethics review board has approved the research project.
p.000074: The principles further establish that all conceivable safety measures must be undertaken to respect the private lives
p.000074: of participants, and to treat patient information confidentially, and to minimise the impact the study may have on the
p.000074: participants’ physical and mental integrity and personality.
p.000074: The Declaration of Helsinki is mentioned in the preambles of both the Act concerning the Ethical Review of Research
p.000074: Involving Humans and the Biobanks in Medical Care Act (2002:297). The above-mentioned instruction from the Swedish
p.000074: Medical Products Agency states that it shall be followed in clinical trials. It is often a requirement that a medical
p.000074: research project has been carried out in accordance with the requirements of
p.000074:
p.000074:
p.000074:
p.000074: GOOD RESEARCH PRACTICE
p.000075: 75
p.000075:
p.000075: the Declaration of Helsinki in order to receive research grants or be published. The Declaration has been updated
p.000075: regularly with various new formulations and additions. The current version was adopted in 2013.
p.000075: The Declaration stated a number of principles that apply, such as a competency requirement on the researcher, a
p.000075: requirement for a balance between the value of the research (benefit) and risks, where the well- being of the patient
p.000075: shall take precedence. It also includes requirements for the informed consent; what the information shall contain, how
p.000075: the consent is given, by whom it is given, and to whom it is given. The Declaration of Helsinki also covers a number of
p.000075: rules that apply when medical research is combined with care.
p.000075:
p.000075: 9.7 Guidelines for Good Clinical Practice (GCP)
p.000075: For clinical trials of drugs, the relevant guideline is Good Clinical Practice (GCP). This guideline applies in the EU,
p.000075: the United States, Japan and Australia, and is included in Swedish law through the Swedish Medical Products Agency’s
p.000075: rules and general recommendations (LVS 2011:19) regarding clinical trials using human subjects. It contains a large
p.000075: number of detailed principles, together with a glossary defining relevant concepts.
p.000075: To aid European research ethics committees, the European Forum for Good Clinical Practice has produced a number of
p.000075: documents that serve as guides when using GCP (www.efgcp.eu). These documents are intended to harmonise with the
p.000075: Declaration of Helsinki but are much more comprehensive, addressing everything from planning and conducting clinical
p.000075: studies to how they should be documented and reported.
p.000075:
p.000075: 9.8 The Council of Europe’s Convention for the Protection of Human Rights and biomedicine
p.000075: The Council of Europe is an organisation that works to uphold human rights in its member countries. The Council’s
p.000075: Convention for the Protection of Human Rights and Dignity of the Human Being with Regard to the Application of Biology
p.000075: and Medicine of 1997 (also known as the Oviedo Convention) comprises a number of articles that directly or indirectly
p.000075: relate to biomedical research. It deals in particular with the protection of individuals undergoing research and with
p.000075: the conduct of research on persons with reduced capacity to give free and informed consent. One article deals with
p.000075: research on embryos in vitro.
p.000075: This document, together with the EU Directive on Good Clinical Practice in the member states, has directly prompted the
p.000075: Swedish Act concerning the Ethical Review of Research Involving Humans. Sweden has signed this convention but has not
p.000075: yet ratified it. In practice, however, it has served as a guidepost for Swedish regulations since its establishment.
p.000075:
p.000075: 9.9 The CIOMS guidelines for research
p.000075: The Council for International Organizations of Medical Sciences (CIOMS) has, in collaboration with the World Health
p.000075: Organization (WHO), published Ethical Guidelines for Biomedical Research Involving Human Subjects, addressing issues of
p.000075: safety and informed consent. Through this document, the Council attempts to apply the principles of the Declaration of
p.000075: Helsinki while acknowledging important differences between the countries of the world. The guidelines contain special
p.000075: sections on research on weaker groups and women. CIOMS has also published guidelines on epidemiological research which
p.000075: are widely referred to.
p.000075:
p.000075: 9.10 Center for Open Science
p.000075: Recently, researchers have taken the initiative to encourage better research practice. The currently best established
p.000075: and comprehensive initiative is the Center for Open Science, which provides resources to increase openness, integrity
p.000075: and reproducibility. (https://cos.io/)
p.000075:
p.000075: 9.11 Publication ethics and questions of misconduct
p.000075: Some important documents on research ethics, such as the Declaration of Helsinki, address aspects of publishing ethics.
p.000075: As the Swedish Research Council has signed the Berlin Declaration (the Berlin Declaration
p.000075:
p.000075:
p.000075:
p.000075: GOOD RESEARCH PRACTICE
p.000076: 76
p.000076:
p.000076: on Open Access to Knowledge in the Sciences and Humanities), the Council has since 2010 included a requirement for open
p.000076: access publication in its calls for grant applications.
p.000076: Two international documents are of particular relevance in this context: one being, the Editorial Policy Statements of
p.000076: the Council of Science Editors (CSE), and the other – and most important – the “Vancouver Rules”, published by the
p.000076: International Committee of Medical Journal Editors (ICMJE) under the title of Uniform Requirements for Manuscripts
p.000076: Submitted to Biomedical Journals. A point emphasised in both these documents is the clear link between the right to be
p.000076: credited as an author and the obligation to assume responsibility for and have contributed to the intellectual content
p.000076: of the publication.
p.000076: Shared authorship is addressed in the CSE’s Recommendations for Group- Author Articles in Scientific Journals and
p.000076: Bibliometric Databases. Many journals today also refer to the ethical guidelines launched by the British Committee on
p.000076: Publication Ethics (COPE).
p.000076: Constant departures from these standards have led other actors to intensify their work with publication ethics. Not
p.000076: least, publishing companies themselves have started formulating rules and guidelines. Groups of researchers, editors
...
p.000076: 12. European Science Foundation. Research Integrity: global responsibility to foster common standards. ORI-ESF
p.000076: Science Policy Briefing 30, Strasbourg, 2007.
p.000076: 13. Hälso- och sjukvårdslag (SFS 1982:763).
p.000076: 14. Lag om biobanker i hälso- och sjukvården med mera (SFS 2002:297).
p.000076:
p.000076:
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p.000077: 77
p.000077:
p.000077: 15. Lag om etikprövning av forskning som avser människor (SFS 2003:460).
p.000077: 16. Lag om genetisk integritet med mera (SFS 2006:351).
p.000077: 17. Läkemedelsverkets föreskrifter om kliniska läkemedelsprövningar på människor (LVFS 2011:19).
p.000077: 18. Offentlighets- och sekretesslag (SFS 2009:400).
p.000077: 19. Office of Research Integrity (ORI). Federal Research Misconduct Policy. Federal Register: December 6, 2000,
p.000077: Volume 65, Number 235, Notices, Page 76260–76264.
p.000077: 20. Organisation for Economic Co-operation and Development (OECD). Best Practices for Ensuring Scientific Integrity
p.000077: and Preventing Misconduct. Paris, OECD, 2007.
p.000077: 21. Patientdatalag (SFS 2008:355).
p.000077: 22. Personuppgiftslag (SFS 1998:204).
p.000077: 23. Sveriges universitets- och högskoleförbund (SUHF), Riktlinjer för hantering vid universitet och högskolor av
p.000077: frågor om vetenskaplig ohederlighet. Stockholm, SUHF, 1997.
p.000077: 24. The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for
p.000077: Human Use (ICH). E6(R1): Good clinical practice: consolidated guideline, adopted by CPMP, July 1996, issued as
p.000077: CPMP/ICH/135/95/Step5, Geneva, 1996.
p.000077: 25. Tryckfrihetsförordning (SFS 1949:105).
p.000077: 26. World Medical Association. Declaration of Helsinki. Ethical Principles for Medical Research Involving Human
p.000077: Subjects, adopted by the 18th WMA General Assembly, Helsinki, Finland, June 1964, latest revision by the WMA General
p.000077: Assembly, Seoul 2013. Ferney-Voltaire, France, World Medical Association, 2013.
p.000077:
p.000077: Reading tips
p.000077: 1. Alexius Borgström, Katarina, Djuren, läkarna och lagen: en rättslig studie om djurförsöksetik. Uppsala, Iustus
p.000077: förlag, 2009.
p.000077: 2. Baggni, Julian & Fosl, Peter S., The ethics toolkit. A compendium of ethical concepts and methods. Oxford,
p.000077: Blackwell, 2007.
p.000077: 3. Beauchamp, Tom L. & Childress, James F., Principles of biomedical ethics. Oxford & New York, Oxford University
p.000077: Press, (1979), Sixth Edition, 2008.
p.000077: 4. Bühler, Axel, (ed) Hermeneutik. Heidelberg, Synchron, 2003.
p.000077: 5. Cavalieri, Paola & Singer, Peter (eds.) The Great Ape Project: Equality Beyond Humanity. New York, St. Martin’s
p.000077: Press, 1994.
p.000077: 6. Chalmers, Alan F., Vad är vetenskap egentligen? Nora, Nya Doxa, 2003.
p.000077: 7. Coughlin, Steven S. & Beauchamp, Tom L. & Weed, Douglas L. (eds), Ethics and epidemiology. Oxford & New York,
p.000077: Oxford University Press, 2009.
p.000077: 8. Egonsson, Dan, Filosofiska essäer om människovärde. Falun, Nya Doxa, 1999.
p.000077: 9. Emanuel, Ezekiel J., et al., The Oxford textbook of clinical research ethics. Oxford & New York, Oxford
p.000077: University Press, 2008.
p.000077: 10. Fleischhauer, Kurt & Hermerén, Göran, Goals of Medicine in the Course of History and Today. A&W International,
p.000077: Stockholm, 2006.
p.000077: 11. Forsman, Birgitta, Forskningsetik: en introduktion. Lund, Studentlitteratur, 1997.
...
p.000080: 24. Office of Research Integrity (ORI), Federal Research Misconduct Policy. Federal Register: December 6, 2000,
p.000080: Volume 65, Number 235, Notices, Page 76260–76264.
p.000080: 25. Organisation for Economic Co-operation and Development (OECD). OECD Principles and Guidelines for Access to
p.000080: Research Data from Public Funding. Paris, OECD, 2007.
p.000080: 26. Organisation for Economic Co-operation and Development (OECD), Investigating research misconduct allegations in
p.000080: international collaborative research projects. A practical guide, Paris, OECD, 2009.
p.000080: 27. Riksarkivet, Om gallring – från utredning till beslut. Rapport, 1999:1.
p.000080: 28. Sveriges universitets- och högskoleförbund (SUHF), Riktlinjer för hantering vid universitet och högskolor av
p.000080: frågor om vetenskaplig ohederlighet. Stockholm, SUHF, 1997.
p.000080: 29. Sveriges universitets- och högskoleförbund (SUHF), Övergripande principer för offentlighet och sekretess i
p.000080: integritetskänslig forskning. SUHF, 2006.
p.000080:
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p.000081: 30. Sveriges universitetslärarförbund (SULF), Etiska riktlinjer för universitetslärare, 2005.
p.000081: 31. The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for
p.000081: Human Use (ICH). E6(R1): Good clinical practice: consolidated guideline, adopted by CPMP, July 1996, issued as
p.000081: CPMP/ICH/135/95/Step5, Geneva, 1996.
p.000081: 32. Uppsala universitet, Hantering av allmänna handlingar vid universitetet. Tredje upplagan, 2009.
p.000081: 33. Vetenskapsrådet, Jävspolicy för Vetenskapsrådet, 2014.
p.000081: 34. World Medical Association. Declaration of Helsinki. Ethical Principles for Medical Research Involving Human
p.000081: Subjects, adopted by the 18th WMA General Assembly, Helsinki, Finland, June 1964, latest revision by the WMA General
p.000081: Assembly, Seoul 2013. Ferney-Voltaire, France, World Medical Association, 2013.
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p.000082: GOOD RESEARCH PRACTICE
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p.000082:
p.000082: Research ethics is not static, neither as a discipline nor as a practice. When the scientific landscape changes,
p.000082: sometimes the debate about research ethics shifts as well. New principles may be added, and old ones may need to be
p.000082: reinterpreted or applied differently.
p.000082:
p.000082: Ethical considerations in research are largely a matter of finding a reasonable balance between various interests that
p.000082: are all legitimate. The quest for knowledge is one such interest. Individual privacy interests as well as protection
...
General/Other / oviedo
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p.000016: than the legal requirements when their content is otherwise closely related. The ethical criteria can also address
p.000016: issues that do not appear in legislation at all. The collective ethical criteria on how good research should be
p.000016: conducted can be said to express what good research practice is.
p.000016: Researchers should follow good research practice. It can therefore not be said, for example, that the Act concerning
p.000016: the Ethical Review of Research Involving Humans, replaces codes like the Declaration of Helsinki or eliminates or
p.000016: reduces the significance of one’s own moral judgement. The researcher’s own reflections on his or her project must
p.000016: instead be based on both knowledge of the content of laws and codes, and on his or her own moral judgement.
p.000016:
p.000016: 1.9 Various regulatory systems
p.000016: Laws are made by Sweden’s Riksdag, its parliament, and are binding. Ordinances, issued by the Government, and
p.000016: regulations and directives, issued by public authorities (such as the National Board of Health and Welfare, or the
p.000016: Dental and Pharmaceutical Benefits Agency) with support from laws and ordinances, have the same legal character.
p.000016: Within the EU there are regulations, which have the same authority as Swedish law, and directives, which normally must
p.000016: be implemented in Swedish law to be binding. Also in the international context are conventions, which are binding for
p.000016: the countries who have agreed to follow them, such as the Council of Europe’s Oviedo Convention.
p.000016: Guidelines can be issued by authorities or different non-governmental organisations and assemblies. Though such
p.000016: documents are not legally binding, their content can be generally accepted. Supervisory authorities, such as the
p.000016: Central Ethical Review Board and the Swedish Data Protection Authority, produce guidelines, information brochures, etc.
p.000016: of importance to research.
p.000016: Declarations, resolutions and statements are also generally issued by organisations and assemblies, and entail that
p.000016: these groups declare a certain stance within their field. These documents usually consist of calls for certain ethical
p.000016: approaches, and can sometimes reach a status similar to that of international conventions. An excellent example of a
p.000016: declaration with extremely high status is the Declaration of Helsinki, which provides the foundation of the work of
p.000016: research ethics committees and their like around the world.
p.000016: Ethics codes usually have a pronounced voluntary character. They usually concern relations not regulated by law, and
p.000016: often concentrate on how those affected by the code conduct themselves in relation to their work, as well as the
p.000016: consequences the work can have for other people, the organisation, the environment, etc.
p.000016:
p.000016:
p.000016: GOOD RESEARCH PRACTICE
p.000017: 17
p.000017:
p.000017: References
p.000017: 1. Forsman, Birgitta, Forskningsetik: en introduktion. Lund, Studentlitteratur, 1997. Forsman, Birgitta, Vetenskap
p.000017: och moral. Nora, Nya Doxa, 2002.
...
p.000049: not happen). Experimental researchers in a group should use logbooks of the same type and use the same principles to
p.000049: record information in them on the experiments they conduct and the data they obtain.
p.000049: Coordinating research directors at national and international levels are responsible for presenting the potential
p.000049: problems that can arise, and for taking action to hinder or prevent them through clear instructions. A clear division
p.000049: of responsibility is necessary to avoid problems, and preventive work to this end should be encouraged.
p.000049:
p.000049: What would you do in the following situation?
p.000049: An investigation reveals that a researcher has in many ways proven himself unsuitable to continue as research director
p.000049: and supervisor. Can he be removed from these positions?
p.000049: What do you do, if you have the possibility to influence the case? How do you justify your decision? Is there common
p.000049: practice or some rule you believe you can cite?
p.000049:
p.000049:
p.000049:
p.000049:
p.000049:
p.000049:
p.000049:
p.000049: GOOD RESEARCH PRACTICE
p.000050: 50
p.000050:
p.000050: References
p.000050: 1. Council for International Organizations of Medical Sciences (CIOMS). International ethical guidelines for
p.000050: biomedical research involving human subjects. Geneva, CIOMS, 2002.
p.000050: 2. Council of Europe. Convention for the Protection of Human Rights and Dignity of the Human Being with regard to
p.000050: the Application of Biology and Medicine: Convention on Human Rights and Biomedicine, (Oviedo Convention), European
p.000050: Treaty Series No 164, Strasbourg, 1997.
p.000050: 3. European Code of Conduct for Research Integrity Revised Edition. ALLEA, All European Academies, Berlin 2017
p.000050: 4. Directive 2001/20/EC of 4 April 2001, of the European Parliament and of the Council on the approximation of the
p.000050: laws, regulations and administrative provisions of the Member States relating to implementation of good clinical
p.000050: practice in the conduct of clinical trials on medicinal products for human use.
p.000050: 5. International Committee of Medical Journal Editors (ICMJE). Uniform Requirements for Manuscripts Submitted to
p.000050: Biomedical Journals, (Vancouver Rules), ICMJE, updated 2010.
p.000050: 6. Lag om etikprövning av forskning som avser människor (SFS 2003:460).
p.000050: 7. Läkemedelsverkets föreskrifter om kliniska läkemedelsprövningar på människor (LVFS 2011:19).
p.000050: 8. The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for
p.000050: Human Use (ICH). E6(R1): Good clinical practice: consolidated guideline, adopted by CPMP, July 1996, issued as
p.000050: CPMP/ICH/135/95/Step5, Geneva, 1996.
p.000050: 9. World Medical Association. Declaration of Helsinki. Ethical Principles for Medical Research Involving Human
p.000050: Subjects, adopted by the 18th WMA General Assembly, Helsinki, Finland, June 1964, latest revision by the WMA General
p.000050: Assembly, Seoul 2013. Ferney-Voltaire, France, World Medical Association, 2013.
p.000050:
p.000050:
p.000050:
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p.000050:
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p.000075: rules that apply when medical research is combined with care.
p.000075:
p.000075: 9.7 Guidelines for Good Clinical Practice (GCP)
p.000075: For clinical trials of drugs, the relevant guideline is Good Clinical Practice (GCP). This guideline applies in the EU,
p.000075: the United States, Japan and Australia, and is included in Swedish law through the Swedish Medical Products Agency’s
p.000075: rules and general recommendations (LVS 2011:19) regarding clinical trials using human subjects. It contains a large
p.000075: number of detailed principles, together with a glossary defining relevant concepts.
p.000075: To aid European research ethics committees, the European Forum for Good Clinical Practice has produced a number of
p.000075: documents that serve as guides when using GCP (www.efgcp.eu). These documents are intended to harmonise with the
p.000075: Declaration of Helsinki but are much more comprehensive, addressing everything from planning and conducting clinical
p.000075: studies to how they should be documented and reported.
p.000075:
p.000075: 9.8 The Council of Europe’s Convention for the Protection of Human Rights and biomedicine
p.000075: The Council of Europe is an organisation that works to uphold human rights in its member countries. The Council’s
p.000075: Convention for the Protection of Human Rights and Dignity of the Human Being with Regard to the Application of Biology
p.000075: and Medicine of 1997 (also known as the Oviedo Convention) comprises a number of articles that directly or indirectly
p.000075: relate to biomedical research. It deals in particular with the protection of individuals undergoing research and with
p.000075: the conduct of research on persons with reduced capacity to give free and informed consent. One article deals with
p.000075: research on embryos in vitro.
p.000075: This document, together with the EU Directive on Good Clinical Practice in the member states, has directly prompted the
p.000075: Swedish Act concerning the Ethical Review of Research Involving Humans. Sweden has signed this convention but has not
p.000075: yet ratified it. In practice, however, it has served as a guidepost for Swedish regulations since its establishment.
p.000075:
p.000075: 9.9 The CIOMS guidelines for research
p.000075: The Council for International Organizations of Medical Sciences (CIOMS) has, in collaboration with the World Health
p.000075: Organization (WHO), published Ethical Guidelines for Biomedical Research Involving Human Subjects, addressing issues of
p.000075: safety and informed consent. Through this document, the Council attempts to apply the principles of the Declaration of
p.000075: Helsinki while acknowledging important differences between the countries of the world. The guidelines contain special
...
p.000076: U.S. Federal Policy on Research Misconduct, have also received a great deal of attention. The European Science
p.000076: Foundation’s contribution is a discussion of Research Integrity in its Briefing no. 30. In Sweden, the Association of
p.000076: Swedish Higher Education has presented guidelines for the handling of questions of research misconduct by universities
p.000076: and higher education institutions in its Riktlinjer för hantering vid universitet och högskolor av frågor om
p.000076: vetenskaplig ohederlighet.
p.000076: The most recent contribution to the documents on misconduct, the Singapore Statement on Research Integrity, was drawn
p.000076: up at the 2nd World Conference on Research Integrity.
p.000076:
p.000076: References
p.000076: 1. 2nd World Conference on Research Integrity. Singapore Statement on Research Integrity. Singapore, 2010.
p.000076: Arkivförordning (SFS 1991:446).
p.000076: 2. Arkivlag (SFS 1990:782).
p.000076: 3. Berlin Declaration on Open Access to Knowledge in the Sciences and Humanities. Berlin, 2003.
p.000076: 4. Commission Directive 2005/28/EC of 8 April 2005 laying down principles and detailed guidelines for good
p.000076: clinical practice as regards investigational medicinal products for human use, as well as the requirements for
p.000076: authorisation of the manufacturing or importation of such products. European Community, Brussels, 2005.
p.000076: 5. Council of Europe. Convention for the Protection of Human Rights and Dignity of the Human Being with regard to
p.000076: the Application of Biology and Medicine: Convention on Human Rights and Biomedicine, (Oviedo Convention), European
p.000076: Treaty Series No 164, Strasbourg, 1997.
p.000076: 6. Council of Science Editors. Editorial Policy Statements, Wheat Ridge, CO, 2010.
p.000076: 7. Council for International Organizations of Medical Sciences (CIOMS). International ethical guidelines for
p.000076: biomedical research involving human subjects. Geneva, CIOMS, 2002.
p.000076: 8. Council for International Organizations of Medical Sciences (CIOMS). International ethical guidelines for
p.000076: epidemiological studies. Geneva, CIOMS, 2008.
p.000076: 9. Djurskyddsförordning (SFS 1988:539).
p.000076: 10. Djurskyddslag (SFS 1988:534).
p.000076: 11. European Code of Conduct for Research Integrity Revised Edition. ALLEA, All European Academies, Berlin 2017.
p.000076: 12. European Science Foundation. Research Integrity: global responsibility to foster common standards. ORI-ESF
p.000076: Science Policy Briefing 30, Strasbourg, 2007.
p.000076: 13. Hälso- och sjukvårdslag (SFS 1982:763).
p.000076: 14. Lag om biobanker i hälso- och sjukvården med mera (SFS 2002:297).
p.000076:
p.000076:
p.000076: GOOD RESEARCH PRACTICE
p.000077: 77
p.000077:
p.000077: 15. Lag om etikprövning av forskning som avser människor (SFS 2003:460).
p.000077: 16. Lag om genetisk integritet med mera (SFS 2006:351).
p.000077: 17. Läkemedelsverkets föreskrifter om kliniska läkemedelsprövningar på människor (LVFS 2011:19).
p.000077: 18. Offentlighets- och sekretesslag (SFS 2009:400).
p.000077: 19. Office of Research Integrity (ORI). Federal Research Misconduct Policy. Federal Register: December 6, 2000,
p.000077: Volume 65, Number 235, Notices, Page 76260–76264.
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p.000079: 16. Patientdatalag (SFS 2008:355).
p.000079: 17. Personuppgiftslag (SFS 1998:204).
p.000079: 18. Personuppgiftsförordning (SFS 1998:1191).
p.000079: 19. Ändring i Centrala försöksdjursnämndens föreskrifter (LSFS 1988:45) om den etiska prövningen av användningen av
p.000079: djur för vetenskapliga ändamål med mera (SJVFS 2008:70).
p.000079: 20. Strålsäkerhetsmyndighetens föreskrifter om allmänna skyldigheter vid medicinsk och odontologisk verksamhet med
p.000079: joniserande strålning (SSMFS 2008:35).
p.000079: 21. Tryckfrihetsförordning (SFS 1949:105).
p.000079:
p.000079: Declarations, guidelines, reports
p.000079: 1. 2nd World Conference on Research Integrity. Singapore Statement on Research Integrity, Singapore, 2010.
p.000079: 2. Berlin Declaration on Open Access to Knowledge in the Sciences and Humanities. Berlin, 2003. Bohlin, Alf,
p.000079: Offentlighet & sekretess i myndighetsforskningsverksamhet. Riksarkivet, 1997:2.
p.000079:
p.000079:
p.000079: GOOD RESEARCH PRACTICE
p.000080: 80
p.000080:
p.000080: 3. Brambell, Rogers, F.W. (Chairman), Report of the Technical Committee to enquire into the Welfare
p.000080: 4. of Animals kept under Intensive Livestock Husbandry Systems, London, HMSO, 1965.
p.000080: 5. Centrala försöksdjursnämnden, Författningar, allmänna råd och anvisningar om användningen av djur för
p.000080: vetenskapliga ändamål. Stockholm, CFN:s skriftserie: 45, 2002.
p.000080: 6. Council of Europe. Convention for the Protection of Human Rights and Dignity of the Human Being with regard to
p.000080: the Application of Biology and Medicine: Convention on Human Rights and Biomedicine, (Oviedo Convention), European
p.000080: Treaty Series No 164, Strasbourg, 1997.
p.000080: 7. Council for International Organizations of Medical Sciences (CIOMS). International ethical guidelines for
p.000080: biomedical research involving human subjects. Geneva, CIOMS, 2002.
p.000080: 8. Council for International Organizations of Medical Sciences (CIOMS). International ethical guidelines for
p.000080: epidemiological studies. Geneva, CIOMS, 2008.
p.000080: 9. Council of Science Editors. Editorial Policy Statements, Wheat Ridge, CO, Council of Science Editors, 2010.
p.000080: 10. Danish Committees on Scientific Dishonesty, Annual Report. Copenhagen, Danish Research Agency, 1993–.
p.000080: 11. Den nasjonale forskningsetiske komité for naturvitenskap og teknologi (NENT), Forskningsetiske retningslinjer
p.000080: for naturvitenskaplig teknologi. Oslo, 2007.
p.000080: 12. Djurförsöksetiska utredningen, Etisk prövning av djurförsök: delbetänkande (SOU 2002:86). Stockholm, Fritzes
p.000080: offentliga publikationer, 2002.
p.000080: 13. European Commission, European Research Area, Science in Society, European Textbook on Ethics in Research. EUR
p.000080: 24452 EN, Luxembourg Publication Office of the European Union 2010.
p.000080: 14. European Commission, European Research Area, Science in Society, Syllabus on Ethics in Research, Addendum to the
...
General/Other / participants in a control group
Searching for indicator control group:
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p.000019: An example can illustrate how important is it to think about whether a certain study might provide an answer to the
p.000019: question you have decided to study. Assume that you want to determine who has power in a certain community. First, you
p.000019: have to specify what you mean by power. It is one thing to have the power to keep certain issues from being brought up
p.000019: on the agenda of meetings of political deciding making bodies, and quite another to have a reputation as powerful and
p.000019: influential. The latter phenomenon can be studied through interviews and questionnaires in which people are asked who
p.000019: they believe has power in certain issues, but it is doubtful that this method would help in answering the first
p.000019: question. Neither could the first question be studied by looking at who is the most successful in pushing their
p.000019: proposals through in political deciding bodies at various levels.
p.000019: Another example: Determining whether there is a difference in the effect and safety of a flu vaccination between
p.000019: children who have not previously had the vaccination and those who have is a reasonable and interesting task. To study
p.000019: this, you should be able to conduct a controlled study of these two groups of children and examine whether there is any
p.000019: statistically significant difference. But if you want to answer the question by comparing to children previously
p.000019: vaccinated for something else, for instance hepatitis, it becomes unclear what function the control group has and what
p.000019: question is being answered.
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p.000019: GOOD RESEARCH PRACTICE
p.000020: 20
p.000020:
p.000020: 2.1.4 Who bears the responsibility?
p.000020: When it comes to how research should be conducted and who has the responsibility for its being conducted in a
p.000020: satisfactory way scientifically and ethically, it can help to distinguish between the respective responsibilities of
p.000020: the individual researcher, the project leader, the department head and the research principal, even if the borders
p.000020: between them are not always sharp. In certain types of research another aspect also arises: the responsibility of the
p.000020: commissioning party or funding body.
p.000020: An issue for the individual researcher to consider is the choice of research question. This choice can be between, for
p.000020: example, a well-defined problem that can give relatively quick publishable results but does not seem to have any
p.000020: greater significance for society on the one hand and a more diffuse or less meritable project of substantial societal
p.000020: significance. This choice must be made by the individual researcher.
p.000020: Within all disciplines the researcher also chooses among the various subject areas, focuses and problems. For instance,
p.000020: within history a researcher can take an interest in the history of individuals, groups or countries from many
p.000020: perspectives, including mentality, political, legal, economic and/or others.
p.000020: A task of the supervisor is to monitor the doctoral student’s choices. Those responsible for the academic merit system
...
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p.000052: 52
p.000052: 6.2 Disclosure of financial and scientific dependence
p.000052: 52
p.000052: 6.3 Background, materials and conclusions
p.000052: 52
p.000052: 6.4 The third task and the media
p.000053: 53
p.000053: 6.5 Open access
p.000054: 54
p.000054: 6.6 Publication as a measure of worth
p.000055: 55
p.000055: 6.7 The author
p.000055: 55
p.000055: 6.8 Multiple authors – responsibility – publication rules
p.000056: 56
p.000056: 6.9 The responsible publisher and the editor
p.000057: 57
p.000057: GOOD RESEARCH PRACTICE
p.000004: 4
p.000004:
p.000004: References
p.000058: 58
p.000058: 7 OTHER ROLES OF THE RESEARCHER
p.000059: 59
p.000059: 7.1 The supervisor and postgraduate supervision
p.000059: 59
p.000059: 7.1.1 The tasks of the supervisor
p.000059: 59
p.000059: 7.1.2 Whose ideas?
p.000059: 59
p.000059: 7.1.3 The thesis and its presentation
p.000059: 59
p.000059: 7.1.4 Responsibility for ethical and legal compliance
p.000060: 60
p.000060: 7.2 The teacher
p.000060: 60
p.000060: 7.3 Assessing applications and proposals
p.000060: 60
p.000060: 7.4 Reviewing manuscripts for publication
p.000061: 61
p.000061: 7.5 Committee work
p.000061: 61
p.000061: References
p.000062: 62
p.000062: 8 RESEARCH MISCONDUCT
p.000063: 63
p.000063: 8.1 Introduction
p.000063: 63
p.000063: 8.2 Questions of definition and scope
p.000063: 63
p.000063: 8.3 Fabrication and falsification
p.000064: 64
p.000064: 8.4 Plagiarism
p.000065: 65
p.000065: 8.5 Unpublished material and self-plagiarism
p.000066: 66
p.000066: 8.6 Establishing plagiarism
p.000066: 66
p.000066: 8.7 Prevention
p.000067: 67
p.000067: 8.8 Sanctions for misconduct
p.000068: 68
p.000068: 8.9 Addressing issues of misconduct
p.000068: 68
p.000068: 8.10 A broader perspective
p.000069: 69
p.000069: References
p.000070: 70
p.000070: 9. KEY LEGISLATION AND OTHER REGULATIONS WITH WHICH RESEARCHERS SHOULD BE FAMILIAR
p.000071: 71
p.000071: 9.1 Personal data handling
p.000071: 71
p.000071: 9.1.1 Legal support for personal data handling
p.000071: 71
p.000071: 9.1.2 International regulations
p.000071: 71
p.000071: 9.1.3 The UN’s Universal Declaration of Human Rights, etc
p.000072: 72
p.000072: 9.1.4 The European Convention on Human Rights
p.000072: 72
p.000072: 9.1.5 The Council of Europe’s Data Protection Convention
p.000072: 72
p.000072: 9.1.6 OECD’s Guidelines
p.000072: 72
p.000072: 9.1.7 The European Union’s Charter of Fundamental Rights
p.000073: 73
p.000073: 9.1.8 The Data Protection Directive
p.000073: 73
p.000073: 9.2 Two important Swedish laws
p.000073: 73
p.000073: 9.2.1 The Patient Data Act
p.000073: 73
p.000073: 9.2.2 The Act concerning the Ethical Review of Research Involving Humans 74
p.000073: 9.3 Secrecy
p.000074: 74
p.000074: 9.3.1 Public principal
p.000074: 74
p.000074: 9.3.2 Private principal
p.000075: 75
p.000075: 9.4 Examples of other legislation
p.000075: 75
p.000075: 9.5 The CODEX website
p.000075: 75
p.000075: 9.6 The Declaration of Helsinki
p.000075: 75
p.000075: GOOD RESEARCH PRACTICE
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p.000005:
p.000005: 9.7 Guidelines for Good Clinical Practice (GCP)
p.000076: 76
p.000076: 9.8 The Council of Europe’s Convention for the Protection of Human Rights and biomedicine 76
p.000076: 9.9 The CIOMS guidelines for research
p.000076: 76
p.000076: 9.10 Center for Open Science
p.000076: 76
p.000076: 9.11 Publication ethics and questions of misconduct
p.000076: 76
p.000076: References
p.000077: 77
p.000077: Reading tips
p.000078: 78
p.000078: Laws, ordinances, directives
p.000080: 80
p.000080: Declarations, guidelines, reports
p.000080: 80
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p.000080: GOOD RESEARCH PRACTICE
p.000006: 6
p.000006:
p.000006: INTRODUCTION
p.000006:
p.000006: Research ethics is not static. New ethical problems arise when new scientific questions are asked, when new methods are
p.000006: used and when new materials are analysed. The early focus of research ethics was on protecting patients and research
p.000006: subjects against encroachments in the name of science. Through the development of epidemiologic research and register
p.000006: data research, other issues have to some extent become central. In recent years, stem cell research and nano technology
p.000006: research have attracted great interest, as has the commercialisation of research, and the effects of research on the
p.000006: environment and society in a more global perspective.
p.000006: Ethical considerations in research are largely a matter of finding a reasonable balance between various interests that
p.000006: are all legitimate. The quest for knowledge is one such interest. New knowledge is valuable in several ways, and can
p.000006: contribute to the development of the individual and of society. Individual privacy interests as well as protection
p.000006: against various forms of harm or risk of harm are other legitimate interests. But sometimes, new knowledge can only be
p.000006: obtained if research subjects and participants are exposed to a certain amount of risk. This is clear not least in
p.000006: medical research. If the risk is to be non-existent, the opportunities for finding advances will be heavily restricted
p.000006: – which impacts on various groups of patients.
p.000006: The harm and the risks this might involve varies considerably from one area of science to another. For this reason,
p.000006: research of different types also brings up distinct types of considerations. The risk/benefit analysis is done in
p.000006: varying ways, and the guidelines – which aim both to promote the search for knowledge and to safeguard the interests of
p.000006: participants – are not quite the same either. Ethical problems were acknowledged early on by medical researchers and
p.000006: psychologists, and others have since followed.
p.000006: This book is a revision of the book Good Research Practice, published by the Swedish Research Council in January 2011.
p.000006: The previous book was produced during the period when Göran Hermerén chaired the expert group on ethics.
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p.000006: GOOD RESEARCH PRACTICE
p.000007: 7
p.000007:
p.000007: SAMMANFATTNING
p.000007:
p.000007: Forskningen har en viktig position i dagens samhälle och stora förväntningar ställs på den. Men därmed riktas också
p.000007: fokus mot forskarna. De har ett särskilt ansvar gentemot de människor och djur som medverkar i forskningen, men också
p.000007: mot alla dem som indirekt kan påverkas av forskningen och gagnas av forskningsresultaten. Forskaren förväntas göra sitt
p.000007: bästa för att genomföra forskning av hög kvalitet. Forskaren ska också stå fri från yttre påverkan och manipulering och
p.000007: inte heller gå egna privata eller vissa intressenters ärenden. Ett välgrundat förtroende i samhället för forskarna och
p.000007: forskningen är en förutsättning för forskningens framtid.
p.000007: De olika uppförandekrav som ställs på en forskare hör ihop med forskarrollen, så som den uppfattas idag. De ligger
p.000007: inbyggda i forskningsprocessen. Men kraven har ändå sin förankring i samhällets vanliga etiska normer och värderingar.
p.000007: Den som läser de rekommendationer som presenteras i denna skrift upptäcker att mycket av det som sägs kan sammanfattas
p.000007: i några allmänna regler som alla svarar mot mer generella levnadsregler:
p.000007:
p.000007: 1) Du ska tala sanning om din forskning.
p.000007: 2) Du ska medvetet granska och redovisa utgångspunkterna för dina studier.
p.000007: 3) Du ska öppet redovisa metoder och resultat.
p.000007: 4) Du ska öppet redovisa kommersiella intressen och andra bindningar.
p.000007: 5) Du ska inte stjäla forskningsresultat från andra.
p.000007: 6) Du ska hålla god ordning i din forskning, bland annat genom dokumentation och arkivering.
p.000007: 7) Du ska sträva efter att bedriva din forskning utan att skada människor, djur eller miljö.
p.000007: 8) Du ska vara rättvis i din bedömning av andras forskning.
p.000007:
p.000007: Denna skrift ger en kortfattad och översiktlig framställning av det forskningsetiska området. Den bör därför
p.000007: kompletteras med annan läsning om man vill fördjupa sig i ämnet. Vissa dokument redovisas i texten men framför allt
p.000007: hänvisas till webbplatsen ”CODEX – regler och riktlinjer för forskning”, codex.vr.se. Här finns inte bara regler och
p.000007: riktlinjer samlade utan också korta forskningsetiska introduktioner till olika frågor, länkar till nationella och
p.000007: internationella dokument och dessutom en nyhetsbevakning.
p.000007: Kännedom om både relevant lagstiftning och forskningsetiska kodexar krävs för att forskaren ska kunna reflektera över
p.000007: sitt projekt. Behovet av forskningsetik diskuteras inledningsvis under rubriken Vad etiken föreskriver och lagen kräver
p.000007: i kapitel 1.
p.000007: I kapitel 2 Om forskning – vad, varför, hur och för vem? aktualiseras en rad frågor av forskningsetisk betydelse. De
p.000007: handlar om kunskapens värde, om tillvägagångssätt, om ansvar, om intressekonflikter, om metoder och om
p.000007: tillförlitlighet.
p.000007: För att få genomföra viss forskning krävs tillstånd. Det gäller forskning som avser människor, forskning som innefattar
p.000007: djurförsök, men också vissa andra typer av forskning. I kapitel 3, Etikprövning och annan tillståndsprövning, beskrivs
p.000007: viss lagstiftning och formerna för tillståndsprövningen. Här diskuteras även etiska problem och överväganden i samband
p.000007: med försöksdjursverksamhet samt vid forskning i annat land.
p.000007: Vid Hantering av integritetskänsligt forskningsmaterial är det viktigt att redan i ett tidigt skede fundera över olika
p.000007: intressen (forskarens, medverkande personers, andra forskares osv.), vad forskaren kan lova de medverkande, vem som
p.000007: äger ett forskningsmaterial etc. Vilka regler gäller? Dessa frågor har under de senaste åren ställts så ofta och av så
p.000007: många att vi valt att ägna kapitel 4 i denna bok åt dem.
p.000007: I den pågående förändringen av forskningens organisering och villkor, nationellt och internationellt, ställs nya
p.000007: forskningsetiska frågor, medan andra ges en ny vinkling och prioritet. Ansvarsfrågor i multicenterstudier och stora
p.000007: internationella projekt är exempel som behandlas i kapitel 5 om Forskningssamarbete.
p.000007: Publicering av forskningsresultat, diskuterad i kapitel 6, är en förutsättning för att forskningsresultat ska kunna
p.000007: komma till nytta, endera för omedelbar tillämpning eller för att ingå som en pusselbit i det fortsatta
p.000007: kunskapssökandet. Vem eller vilka som står som författare är inte bara av betydelse vid meritvärdering utan också för
p.000007: ansvarsfrågor. Rollen som granskare, ansvarig utgivare och redaktör reser särskilda etiska frågor. Det gäller också
p.000007: forskarens roll som handledare, som lärare och som sakkunnig. Dessa frågor berörs under rubriken Forskaren och
p.000007: uppdragen i kapitel 7.
p.000007: Ett forskningsetiskt problem som ofta uppmärksammas, också i medierna, rör Vetenskaplig oredlighet och behandlas i
p.000007: kapitel 8. Det kan röra uppenbara övertramp som fabrikat, plagiat, fusk och frisering av data, men
p.000007:
p.000007:
p.000007: GOOD RESEARCH PRACTICE
p.000008: 8
p.000008:
p.000008: också förtal, sabotage, missvisande framställning av egna meriter i samband med bidrags- eller tjänsteansökan etc. En
p.000008: rättssäker hantering vid misstankar om oredlighet är grundläggande, liksom ett tydligt och enhetligt sanktionssystem.
p.000008: Det forskningsetiska fältet är stort. Det finns många olika lagar, direktiv, riktlinjer och forskningsetiska och
p.000008: yrkesetiska kodexar som forskaren bör känna till och beakta i sitt arbete för att detta ska kunna utföras på ett både
p.000008: lagligt och etiskt genomtänkt sätt. Vilken lagstiftning som är tillämplig varierar dock med vilken forskning som
p.000008: bedrivs och hur den bedrivs. Under rubriken Några viktiga lagar och andra regler som forskaren bör känna till, nämns i
p.000008: kapitel 9 ett urval som Vetenskapsrådets expertgrupp för etik anser vara särskilt viktiga att uppmärksamma.
p.000008: I forskning ställs krav såväl på kvalitet i arbetet som på integritet hos forskaren. Ett reflekterat etiskt
p.000008: förhållningssätt och agerande i forskarens olika roller är därvid grundläggande. För att konkretisera har
p.000008: framställningen kompletterats med ett antal exempel från forskarlivet, många tillvaratagna från den tidigare boken God
p.000008: forskningssed?, andra nytillkomna. Exemplen är fiktiva men inte orealistiska. En av avsikterna med exemplen är att visa
p.000008: att god forskningssed i praktiken kan innebära svåra val mellan olika handlingsalternativ. Frågan är hur man bör handla
p.000008: i en komplicerad verklighet, där olika principer och intressen kan stå mot varandra.
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p.000008: GOOD RESEARCH PRACTICE
p.000009: 9
p.000009:
p.000009: SUMMARY
p.000009:
p.000009: Research occupies a prominent position in today’s society and much is expected of it. This places a focus on
p.000009: researchers, who have a specific responsibility not only towards the people and animals participating in their
p.000009: research, but also towards all those who may be affected indirectly, positively or negatively, by their results.
p.000009: Researchers are expected to strive to conduct research of high quality. Accordingly, their work must be free of
...
p.000011: In many contexts in which “ethics and morals” are discussed, no distinction is made between the two concepts. Everyday
p.000011: language is also unclear in this area, even though we can surely sense a difference in meaning between “Kant’s Ethics”
p.000011: and “Kant’s Morals”. There are established uses of the concepts that do make a distinction, however, and there is good
p.000011: reason to maintain such a distinction here.
p.000011: It is reasonable to assume that everyone carries a set of morals, which manifest themselves in a person’s behaviour,
p.000011: especially towards other people. The person does not need to be aware of his or her moral positions and does not need
p.000011: to reflect on them. The specific values and positions these morals can be assumed to consist of need also not be
p.000011: particularly consistent with each other. They do not need to exhibit any systematics whatsoever, and the person does
p.000011: not need to be able justify him or herself in any way. Every person, after all, has morals, be they more or less
p.000011: well-developed. Through choices and actions, a person shows what his or her morals are.
p.000011: On the other hand, we cannot have ethics without being conscious of them, or without having reflected on them. When we
p.000011: use the term “ethics”, we mean a type of theory on the area of morals. We want precisely formulated norms, as general
p.000011: as possible, for which we can find good arguments. We want to justify our position. A set of ethics cannot be
p.000011: arbitrary. We also want our formulations to be able to work together and form a system. A set of ethics should also be
p.000011: able to be formulated in words.
p.000011: Perhaps you could say that ethics contain moral precepts that are conscious, reflected on and motivated, which one
p.000011: formulates as clearly as possible and are presented in a systematic way. In a way, ethics provide a theory for morals,
p.000011: which are their practical expression. But you can sometimes have a practice without a theory; this is why one speaks
p.000011: of research ethics and, on a much smaller scale, research morals. It is a question of norms (principles) that the
p.000011: research community has reflected on and has tried to formulate clearly and motivate. These norms are assumed to work
p.000011: well together and offer guidance. A code is a collection of research ethics rules, i.e. more specified norms concerning
p.000011: a certain research area or certain stages of research projects.
p.000011: Both ethics and morals contain normative assumptions that dictate what is good or bad and that recommend or forbid
p.000011: different behaviours. A distinction is usually made between statements about values, which attribute a value to
...
p.000012: work in a vacuum. Thus, according to Merton, there is no such thing as intellectual property, owned by the researcher.
p.000012: Merton’s norm of universalism (U) requires scientific work to be evaluated with reference to scientific criteria alone.
p.000012: When assessing the validity of the results, we are to take no account, for example, of the researcher’s race, gender or
p.000012: position in society. The norm of disinterestedness (D) means that the researcher must have no other motive for his or
p.000012: her research than a desire to contribute new knowledge. The fourth norm, organised scepticism (OS), requires the
p.000012: researcher to constantly question and scrutinise, but also to refrain from expressing an assessment until he or she has
p.000012: sufficient evidence on which to base it.
p.000012: Since these principles were put forward, the position of the researcher, or at least the general perception of it, has
p.000012: changed in many respects. Being a researcher can no doubt colour an individual’s whole way of being and thinking, but
p.000012: these days it is quite a common professional role, and researchers are employed specifically as researchers. They, too,
p.000012: are expected to be loyal to organisations and superiors, and have to take financial factors and their own job security
p.000012: into account.
p.000012: In many cases, therefore, Merton’s norms will be difficult to live up to in reality. His requirement for
p.000012: disinterestedness, which says that the researcher’s main reason for doing research should be to contribute new
p.000012: knowledge, is a case in point. Researchers must surely be allowed to have other motives as well, such as promoting
p.000012: their prospects of employment through the work they do. The important thing, rather, is that motives of this kind do
p.000012: not influence the researcher in such a way that he or she arrives at interpretations or conclusions for which there is
p.000012: no scientific basis, or withholds findings for which evidence does exist.
p.000012: Merton’s strict requirement of communism is also difficult to live up to in many types of research and in certain
p.000012: research environments, for example in an industrial setting, although the importance of publishing results and
p.000012: communicating them to society and to other researchers will nevertheless often be acknowledged in such environments as
p.000012: well. However, when it comes to publicly funded research, the requirement of openness is clear.
p.000012: There are various problems with Merton’s other norms, too. The ideals expressed in the CUDOS norms nevertheless provide
p.000012: one of the cornerstones for the present-day discussion about research misconduct (see Chapter 8). They are also
p.000012: reflected in the requirements of honesty and openness that were formulated in our introduction.
p.000012:
p.000012: 1.4 Ethics codes
p.000012: While individuals participating in research should be protected from harms or wrongs (the criterion of protection of
p.000012: the individual), it is not reasonable for a trivial amount of harm to hinder important research. Research is important
p.000012: for both society and citizens due to the improvements in areas such as health, the environment and quality of life it
p.000012: can bring about. In addition to their benefits, research results are often valuable in their own right. You could say
p.000012: that there is an ethically motivated imperative to conduct research: the research criterion.
p.000012: Many problems in research ethics can therefore be described as achieving a balance between these two criteria. We are
p.000012: to conduct qualitatively good research with an important purpose, and at the same time protect those individuals taking
p.000012: part in the research. How this is balanced and achieved depends on what type of research (questions, methods,
p.000012: participants etc.) is conducted.
p.000012: The discussion on research ethics issues took off after World War II. Research ethics codes, collections of rules
p.000012: attempting to clarify how the researcher should act towards research subjects in an ethically sound way, were developed
p.000012: for various research areas. The codes stated what the researcher should do before conducting the research (information,
p.000012: consent), during the research (avoidance of risks, design issues) and after the
p.000012:
p.000012:
p.000012: GOOD RESEARCH PRACTICE
p.000013: 13
p.000013:
p.000013: research (publication, retention and archiving of material). A number of ethical issues within research thus received
p.000013: attention, and the codes greatly contributed to creating a praxis and increasing awareness of possible ethical problems
p.000013: in research.
p.000013: By far the most significant code is the medical Declaration of Helsinki, which has been adopted by the World Medical
p.000013: Association. The Declaration appeared its earliest version in 1964 and has undergone several revisions, most recently
p.000013: in 2013. Rules as well as concepts from the Declaration of Helsinki have proven to be useful in other research areas as
p.000013: well, which has contributed to the code’s central position within research ethics in general.
p.000013: A code is thus a collection of ethical rules. Through these rules, someone (a research group, a research funding body,
p.000013: an organisation of researchers or research institutions, etc.) attempts to interpret and formulate what morals in
p.000013: certain situations demand of the researcher in relation to the informant, and sometimes also in relation to other
p.000013: interested parties. However, a code is not a legal document.
p.000013: With time, however, legislation has entered the area of research ethics. Clear examples of this are the Act concerning
p.000013: the Ethical Review of Research Involving Humans and the Animal Welfare Act. However, although the legislation in these
p.000013: cases has entered a specific area of ethics, this does not mean that ethics and the law have entirely converged.
p.000013:
p.000013: 1.5 The law and morals
p.000013: Many differences between the law and morals can be noticed even at a glance. As a rule, that which is legally right,
p.000013: what a certain law prescribes, is very clearly and precisely formulated.
p.000013: The law has also come to be through an established decision as a result of a special procedure. It is only when a
p.000013: decision has been reached in this way that a law is created. A law can also be abolished through a corresponding
p.000013: process; it is thus in effect between two points in time.
p.000013: A law can be created for various reasons and can have different purposes. A law is also valid within a certain
p.000013: territory. Swedish law applies in Sweden while Danish law applies in Denmark; and even if the content of two laws, one
p.000013: Swedish and one Danish, is similar, it is still a case of two different laws – two separate decisions and
p.000013: decision-making processes. Breaking a law entails established sanctions. Each country has its own organisation for
p.000013: detecting when the law has been broken, and for trying the lawbreaker and applying sanctions.
p.000013: What morals imply, on the other hand, is not always clear or precise. Instead, when facing a moral issue, we often must
p.000013: argue based on our own values to bring about a more precise moral criterion. The rules implied by, and the values
p.000013: connected with, morals are also not something we explicitly decide on or formally adopt. And, naturally, we cannot
p.000013: speak of any specific decision-making process either.
p.000013: It is more reasonable to say that our values go along with our feelings and needs, both physical and psychological, and
p.000013: with the fact that we both want to and have to cooperate and share our life with others. For example, that suffering is
p.000013: bad and should therefore be avoided is nothing we decide to believe. It is also absurd to assume that a moral rule
p.000013: should apply from a certain point in time and be able to be abolished at another, as is the case with laws. A statement
p.000013: like “As from 1 July, it will be morally right to tell the truth” is absurd.
p.000013: Morals can also not be assumed to have a limited geographical reach in the same way as a law does. Even when I am in
p.000013: Denmark, I have to hold that I should avoid harming my fellow humans just as I would in Sweden.
p.000013: Another difference between morals and the law is that morals have no explicit system of sanctions. A breach of morals
p.000013: is of course followed by sanctions, but what these might be and how they are applied vary greatly.
p.000013: That laws and morals are different is also directly observable in our everyday experiences. There are many situations
p.000013: in life when a law has nothing to say but our morals prescribe or forbid action. On the other hand, the law can in turn
p.000013: regulate conditions that from a moral perspective are completely neutral, for instance certain traffic legislation.
p.000013: There are also conditions that a certain law prescribes or allows, but cause us to ask ourselves: Is it morally right
p.000013: to do that? Certain behaviour is allowed in business law – thus no laws are broken
p.000013: – but should one really act in that way? This is another question, and one that is asked often. Answering the legal
p.000013: question is one thing, while answering the moral question is another.
p.000013: What morals prescribe and forbid thus needs to be analysed and interpreted. But are there given answers, or are morals
p.000013: relative? It is reasonable to assume that certain fundamental values can be shared by all people, while others can vary
p.000013: from person to person and between cultures or traditions. Whatever the case is concerning this relativity, however, it
p.000013: is clear that a moral conviction or principle is different from a legal rule.
p.000013:
p.000013:
p.000013:
p.000013: GOOD RESEARCH PRACTICE
p.000014: 14
p.000014:
p.000014: If we take the moral premises set forth in the Declaration of Helsinki, for example, these are premises that
p.000014: researchers around the world – not only those in the West – can relate to and apply in their research. Below, the
p.000014: mention of “common” ethical criteria for research refers to such premises, for example those formulated in the
p.000014: Declaration of Helsinki.
p.000014:
p.000014: 1.6 The law and morals in the area of research
p.000014: It is important for the researcher to know what the various laws dictate concerning research, as well as what the
p.000014: various codes prescribe. The Swedish Research Council, like many other funding bodies, also places specific ethics
p.000014: requirements in conjunction with an application for funding. It is important to note the difference between these
p.000014: distinct types of requirements. Legislation in the area of research ethics, both historically and content-wise, has its
p.000014: starting point in ethical convictions, for instance as they are expressed in ethical codes. But legislation only
p.000014: addresses certain specific situations and certain specific conditions.
p.000014: On 1 January 2004, the Act (SFS 2003:460) concerning the Ethical Review of Research Involving Humans came into force
p.000014: (riksdagen.se/sv/dokument-lagar/dokument/svensk-forfattningssamling/lag-2003460-om-
p.000014: etikprovning-av-forskning-som_sfs-2003-460). The purpose of the Act is to protect the individual person and ensure
p.000014: respect for human dignity in research, and it is limited to certain aspects of research; professional ethics are not
p.000014: addressed.
p.000014: This legislation has been complemented with the establishment of legal agencies – ethics review boards – which review
p.000014: research projects and decide whether they merit approval. The Act therefore also states (1) which projects must be
p.000014: board reviewed, (2) what parts of these projects are to be reviewed and what warrants approval, and (3) how the boards
p.000014: are to be composed.
p.000014: In both (1) and (2) it is important to note the difference between the law and morals. According to (1), only projects
p.000014: with a certain content are to be reviewed in concordance with the Act. However, a great deal of research falls outside
p.000014: this description; this cannot mean that all such research is ethically problem-free. It only means that the lawmaker,
p.000014: the Riksdag, has made a choice regarding what the boards should review. Research that does not use personally sensitive
p.000014: data (3 §) and does not entail physical encroachment, aim to affect subjects physically or psychologically, or entail
p.000014: an obvious risk of harming subjects (4 §) is not to be reviewed, according to the Act. But this does not mean that this
p.000014: research can be conducted without considering ethical aspects. The researcher should not simply perform this type of
p.000014: research without providing information and obtaining consent, or choose subjects arbitrarily. The subjects’ identities
p.000014: must not be revealed in the published work either.
p.000014: Research projects outside the scope described above may therefore be conducted without a legally based ethics review.
p.000014: However, the researcher must still observe the ethical criteria as cited in commonly used codes, as well as personally
p.000014: reflect on his or her project. The fact that the project does not fall under the law’s description does not provide an
p.000014: exemption from this.
p.000014: The first version of the Act came into effect in 2004, and it was revised in 2008, the most notable change being an
p.000014: increase in its scope. In the first version, a great deal of research – even though it could entail significant
...
p.000015: total quality of the research is evaluated, no single quality can be ignored. The quality is evaluated based on the
p.000015: collective qualities of originality, external and internal validity, precision and ethics. The requirement of good
p.000015: research ethics is thus included here; therefore, there can be no conflict between the demands for good research ethics
p.000015: and good scientific quality. A research report exhibits poor research ethics if it contains scientific shortcomings in
p.000015: the precision of its questions, uses incorrect methods (or uses established methods incorrectly), systematically
p.000015: excludes observations that do not support the author’s hypothesis, handles the problem of dropout in a statistically
p.000015: unacceptable way, or uses a study design that does not allow for the research question to be answered. People’s time
p.000015: has been used needlessly, and they may have been exposed to not only a certain amount of inconvenience or discomfort,
p.000015: but sometimes even suffering. In any case, resources that could have been used in a better way have been wasted. It is
p.000015: also quite easy to find examples of studies that, through superficial correlations between ethnicity, criminality,
p.000015: intelligence, education, etc., have led to the discrimination or stigmatisation of individuals and groups.
p.000015: Unfortunately, there are also examples of cheating in studies on methods for treating breast cancer or links between
p.000015: vaccination and autism. Here, poor scientific quality and poor ethics overlap, leading to the possibility that people
p.000015: can be harmed when the results of the research are applied in practice.
p.000015:
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p.000015:
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p.000015: GOOD RESEARCH PRACTICE
p.000016: 16
p.000016:
p.000016: There can sometimes also be economic and time frames that tempt researchers to take shortcuts, which can cause the
p.000016: research to fail in meeting both scientific and ethical quality criteria. If the problem is due solely to these
p.000016: factors, there is no fundamental opposition between the two; with other time frames or better economic resources, the
p.000016: problem would not surface. We thereby find ourselves back in a situation of type (1), in which there is no fundamental
p.000016: opposition between the diverse types of quality criteria. Against this background it is reasonable to regard work to
p.000016: improve the ethical aspects of the research as a quality issue.
p.000016:
p.000016: Stanley Milgram conducted experiments with volunteer subjects. The subjects were informed that they, as “teachers”,
p.000016: were to give an electric shock to “students” when they answered incorrectly, and that they were to increase the
p.000016: strength of the shock with each successive wrong answer. The students then simulated great pain. Everything was
p.000016: simulated, and everyone except the subjects knew this. Most of the subjects followed the instructions.
p.000016: Milgram’s research provided important knowledge on subordination and the obedience of instructions from authorities –
p.000016: it revealed things about ourselves that we perhaps would rather not know, but that are important for the understanding
p.000016: of the success of Hitler and others like him – but Milgram’s research has also been criticised.
p.000016: What ethical issues does this research bring to the fore? Is there a conflict here between scientific and ethical
p.000016: quality criteria? In what way? How do you feel this conflict should be handled?
p.000016:
p.000016: 1.8 Review
p.000016: In summary, one must constantly distinguish between the law and morals and, when it comes to research, also between
p.000016: research ethics legislation and the rules found in research ethics codes. The ethical criteria can be more far-reaching
p.000016: than the legal requirements when their content is otherwise closely related. The ethical criteria can also address
p.000016: issues that do not appear in legislation at all. The collective ethical criteria on how good research should be
p.000016: conducted can be said to express what good research practice is.
p.000016: Researchers should follow good research practice. It can therefore not be said, for example, that the Act concerning
p.000016: the Ethical Review of Research Involving Humans, replaces codes like the Declaration of Helsinki or eliminates or
p.000016: reduces the significance of one’s own moral judgement. The researcher’s own reflections on his or her project must
p.000016: instead be based on both knowledge of the content of laws and codes, and on his or her own moral judgement.
p.000016:
p.000016: 1.9 Various regulatory systems
p.000016: Laws are made by Sweden’s Riksdag, its parliament, and are binding. Ordinances, issued by the Government, and
p.000016: regulations and directives, issued by public authorities (such as the National Board of Health and Welfare, or the
p.000016: Dental and Pharmaceutical Benefits Agency) with support from laws and ordinances, have the same legal character.
p.000016: Within the EU there are regulations, which have the same authority as Swedish law, and directives, which normally must
p.000016: be implemented in Swedish law to be binding. Also in the international context are conventions, which are binding for
p.000016: the countries who have agreed to follow them, such as the Council of Europe’s Oviedo Convention.
p.000016: Guidelines can be issued by authorities or different non-governmental organisations and assemblies. Though such
p.000016: documents are not legally binding, their content can be generally accepted. Supervisory authorities, such as the
p.000016: Central Ethical Review Board and the Swedish Data Protection Authority, produce guidelines, information brochures, etc.
p.000016: of importance to research.
p.000016: Declarations, resolutions and statements are also generally issued by organisations and assemblies, and entail that
p.000016: these groups declare a certain stance within their field. These documents usually consist of calls for certain ethical
p.000016: approaches, and can sometimes reach a status similar to that of international conventions. An excellent example of a
p.000016: declaration with extremely high status is the Declaration of Helsinki, which provides the foundation of the work of
p.000016: research ethics committees and their like around the world.
p.000016: Ethics codes usually have a pronounced voluntary character. They usually concern relations not regulated by law, and
p.000016: often concentrate on how those affected by the code conduct themselves in relation to their work, as well as the
p.000016: consequences the work can have for other people, the organisation, the environment, etc.
p.000016:
p.000016:
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p.000017: 17
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p.000017: References
p.000017: 1. Forsman, Birgitta, Forskningsetik: en introduktion. Lund, Studentlitteratur, 1997. Forsman, Birgitta, Vetenskap
p.000017: och moral. Nora, Nya Doxa, 2002.
p.000017: 2. Hermerén, Göran, Kunskapens pris: forskningsetiska problem och principer i humaniora och samhällsvetenskap.
p.000017: Stockholm, Swedish Science Press & HSFR, 1986, 2nd edition, 1996.
p.000017: 3. Lag om etikprövning av forskning som avser människor (SFS 2003:460).
p.000017: 4. Merton, Robert ”The Normative Structure of Science” (1942), in Merton, R., The Sociology of Science. University
p.000017: of Chicago Press, 1973.
p.000017: 5. Petersson, Bo, Forskning och etiska koder. Nora, Nya Doxa, 1994.
p.000017: 6. World Medical Association. Declaration of Helsinki. Ethical Principles for Medical Research Involving Human
p.000017: Subjects, adopted by the 18th WMA General Assembly, Helsinki, Finland, June 1964, latest revision by the WMA General
p.000017: Assembly, Seoul 2013. Ferney-Voltaire, France, World Medical Association, 2013.
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p.000018:
p.000018: 2 ABOUT RESEARCH – WHAT, WHY, HOW AND FOR WHOM?
p.000018:
p.000018:
p.000018: 2.1 Starting points for research
p.000018:
p.000018: 2.1.1 Some types of research
p.000018: There are diverse types of research. Distinctions can be drawn between hypothesis-generating and hypothesis- testing
p.000018: research, and between research using qualitative and quantitative methods. One can also distinguish between research
p.000018: that tries to explain why something has happened by showing that it can be subsumed under a natural law and research
p.000018: that that tries to increase and deepen our knowledge about events, processes or texts. From a research ethics
p.000018: perspective, another distinction is interesting. One usually distinguishes between three forms of research: basic,
p.000018: applied and commissioned (there are also other terminologies and distinctions).
p.000018: Basic research entails the researcher seeking new knowledge without a particular application in mind, and can lead to
p.000018: unexpected and ground-breaking discoveries. Applied and commissioned research both have a particular aim. They are
p.000018: aimed at being of use to the party who initiated or ordered the research.
p.000018: Commissioned research is more directly and clearly driven by the commissioning party than applied research is.
p.000018: As opposed to other knowledge-seeking activities, research entails a systematic search for knowledge. This knowledge
p.000018: must also be new, not simply a compilation of what is already known. However, attempting to replicate previously
p.000018: published (and thus not new) results with the aim of confirming them is also research. If the results can be
p.000018: replicated, this increases our belief in the soundness of the conclusions, and we learn something we did not know
p.000018: before. A systematic-critical review and compilation of previous results in a certain area can also raise knowledge
p.000018: levels, and can therefore also be regarded as research.
p.000018:
p.000018: 2.1.2 Why conduct research?
p.000018: The reasons for research vary, partly depending on the type of research. Basic research is conducted to develop new
p.000018: knowledge, which can be valuable in its own right – but can sometimes also lead to valuable consequences, for instance
p.000018: new products. Applied research, on the other hand, primarily aims to develop knowledge that can lead to improved
p.000018: clinical diagnostics and treatment in medicine, or be applied in practice in the production or improvement of products,
p.000018: in planning and decision-making, for example in changes to organisations and communication strategies, etc. Besides
p.000018: providing knowledge about a specific area, all types of research provide methodological education and training in
p.000018: critical thinking. Thus, research can contribute in many ways to the development of both individuals and society.
p.000018: Today, scientific research is a crucial element of society. The value of new knowledge is underlined in many different
p.000018: contexts. So, what is it that makes research valuable? Scientific knowledge has a value not only as an instrument, in
p.000018: other words as a means of achieving something else we value. Knowledge is also worth something in its own right – has
p.000018: its own value – regardless of how it might be used.
p.000018: People need to make sense of the world, be able to explain and understand. This is true even when we do not directly
p.000018: seek a use or an application. Basic research is often justified in this way. The results of it might also later prove
p.000018: to be good instruments for promoting something we consider useful and beneficial to society; but the nature of research
p.000018: prevents us from knowing entirely in advance where its results will lead us. The desire to know and understand is very
p.000018: often sufficient justification for research.
p.000018: When the benefits of research are discussed, this concept should be considered in a broad sense. It is not only a case
p.000018: of creating conditions to produce more and new products, or increasing society’s industrial competitiveness, or even of
p.000018: creating more job opportunities. It also concerns promoting other values that have to do with critical thinking,
p.000018: better quality of life and a revitalised public discourse.
p.000018: Meanwhile, history shows that the planned reasons for research sometimes do not coincide with its actual effects.
p.000018: Research that can facilitate developing new and stronger materials or more effective medicines can also have undesired
p.000018: and unexpected effects, or be used for negative purposes by countries, terrorists or others. The
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p.000019:
p.000019: challenge is therefore to optimise the opportunities of using the positive effects of research, and to minimise the
p.000019: negative ones. A vibrant ethics discourse is an essential element of these attempts.
p.000019: The task of higher education institutions not only includes cooperating with the world around it and providing
p.000019: information about their activities, but now also includes “working towards research results obtained at the higher
p.000019: education institution being of benefit” (“verka för att forskningsresultat tillkomna vid högskolan kommer till nytta”,
p.000019: Chapter 1, Section 2 of the Higher Education Act, [SFS 2009:45]). There are undeniably many examples of research
p.000019: discoveries improving conditions for many people. Vaccines, the production of new materials and developments in
p.000019: telecommunications are examples of research results being further developed into products that have made life easier
p.000019: and improved the quality of life for many.
p.000019: For the individual researcher, the purpose of research may be more personal, such as curiosity or a desire to solve a
p.000019: problem, contribute to the solution of some problem in society, build a career, or increase his or her income through
p.000019: inventions and patents. The attitude in the research community should be generous when it comes to the personal
p.000019: motivation of researchers.
p.000019: The motivation for research can end up characterising the research environment, and the focus of the research. In an
p.000019: environment where the importance of commercialisation and patents is uniformly stressed, the space for more basic
p.000019: research-oriented researchers can be limited. On the other hand, an environment where the value of basic research is
p.000019: instead placed above, anything else risks being perceived as isolated and elitist. This type of goal conflict often
p.000019: integral to certain types of research, such as clinical research.
p.000019: The risks involved with goal conflicts are reduced when the researcher is in an environment where the discourse is
p.000019: lively and where an open and generous view of the researchers’ motivations is maintained. The key factor is that, not
p.000019: why, someone wants to contribute to research, and that the significance different motivations have for the research
p.000019: environment and for the focus of the research is discussed openly within research groups, departments and faculties.
p.000019:
p.000019: 2.1.3 How is research conducted?
p.000019: A central question in all scientific studies and in their evaluation concerns the relationship between question and
p.000019: method. Textbooks on theory of science discuss quantitative and qualitative methods, but the focus in this book is on
p.000019: research ethics.
p.000019: A fundamental question in a research ethics review concerns the balance between risk and benefit. This always starts as
p.000019: a negative value, as every study demands time of its participants and exposes them to a certain amount of risk, even if
p.000019: it is sometimes minimal. A necessary condition for a balance to be reached is that the method used answers the question
p.000019: asked. The question should preferably also be important and its answer clearly and strictly formulated. If a study does
p.000019: not answer its question, it should not be conducted in its current design.
p.000019: When you decide to begin a research project, you should choose a method with the fewest imaginable harmful consequences
p.000019: on the people and/or animals involved, if the methods are otherwise somewhat equal. Additionally, the benefit of the
p.000019: planned research and the scientific value of its expected results should always be weighed against its harmful
p.000019: consequences. This is discussed further in Chapter 3.
p.000019: An example can illustrate how important is it to think about whether a certain study might provide an answer to the
p.000019: question you have decided to study. Assume that you want to determine who has power in a certain community. First, you
p.000019: have to specify what you mean by power. It is one thing to have the power to keep certain issues from being brought up
p.000019: on the agenda of meetings of political deciding making bodies, and quite another to have a reputation as powerful and
p.000019: influential. The latter phenomenon can be studied through interviews and questionnaires in which people are asked who
p.000019: they believe has power in certain issues, but it is doubtful that this method would help in answering the first
p.000019: question. Neither could the first question be studied by looking at who is the most successful in pushing their
p.000019: proposals through in political deciding bodies at various levels.
p.000019: Another example: Determining whether there is a difference in the effect and safety of a flu vaccination between
p.000019: children who have not previously had the vaccination and those who have is a reasonable and interesting task. To study
p.000019: this, you should be able to conduct a controlled study of these two groups of children and examine whether there is any
p.000019: statistically significant difference. But if you want to answer the question by comparing to children previously
p.000019: vaccinated for something else, for instance hepatitis, it becomes unclear what function the controlXgroup has and what
p.000019: question is being answered.
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p.000020: 2.1.4 Who bears the responsibility?
p.000020: When it comes to how research should be conducted and who has the responsibility for its being conducted in a
p.000020: satisfactory way scientifically and ethically, it can help to distinguish between the respective responsibilities of
p.000020: the individual researcher, the project leader, the department head and the research principal, even if the borders
p.000020: between them are not always sharp. In certain types of research another aspect also arises: the responsibility of the
p.000020: commissioning party or funding body.
p.000020: An issue for the individual researcher to consider is the choice of research question. This choice can be between, for
p.000020: example, a well-defined problem that can give relatively quick publishable results but does not seem to have any
p.000020: greater significance for society on the one hand and a more diffuse or less meritable project of substantial societal
p.000020: significance. This choice must be made by the individual researcher.
p.000020: Within all disciplines the researcher also chooses among the various subject areas, focuses and problems. For instance,
p.000020: within history a researcher can take an interest in the history of individuals, groups or countries from many
p.000020: perspectives, including mentality, political, legal, economic and/or others.
p.000020: A task of the supervisor is to monitor the doctoral student’s choices. Those responsible for the academic merit system
...
p.000021: rights.
p.000021: The Uppsala Code is intended to be used by the researcher to evaluate his or her own research or that of colleagues. A
p.000021: researcher who determines that current or planned research will breach the Code is encouraged not to participate in it,
p.000021: and to make his or her opinion publicly known. The Code also states that colleagues and the research community should
p.000021: support such a researcher. A decision like this is difficult to make, not least for younger researchers just beginning
p.000021: their careers or still completing their studies. And, as a rule, it is easier and more reasonable to regulate the use
p.000021: of knowledge than to direct the quest for knowledge itself.
p.000021:
p.000021:
p.000021: What would you do in the following situation?
p.000021: You are the leader of a research group in the process of synthesising a virus that caused a lethal epidemic a long time
p.000021: ago. You realise that the results – if published – can easily be used by terrorists for biological warfare.
p.000021: Do you publish the results? How do you respond to objections?
p.000021:
p.000021:
p.000021: Meanwhile, it is also important that a researcher be loyal to his or her research task. With a decision to terminate,
p.000021: you should also consider the fact that other researchers may be depending on the work’s completion. Loyalty to the
p.000021: research task, diligence and an ability to concentrate are therefore important qualities for a researcher as well as a
p.000021: research environment to have. Most research projects demand a great work effort and a high level of concentration. As a
p.000021: rule, the time it takes from the first ideas to results is both long and uncertain. Most research work certainly
p.000021: contains creative elements, but there are often long, laborious periods of routine and transition in between.
p.000021: A researcher can have several reasons for leaving a project he or she has undertaken. Ethical reasons can include the
p.000021: research risking violating people’s integrity or the published results being misused. Scientific reasons can include
p.000021: new discoveries making the purpose of the research no longer fruitful.
p.000021:
p.000021: 2.2 Making research results useful
p.000021:
p.000021: 2.2.1 The elusive and multidimensional benefit2
p.000021: It is natural to connect the question of how research results will be made useful with the questions “Useful – in what
p.000021: sense?” and “For whom?”. This is true for the simple reason that something that is of use to one person is not always
p.000021: of use to another. A product or method can also benefit many people in diverse ways: some may increase their income,
p.000021: others may get treatment that increases their life expectancy, and still others may experience an improved quality of
p.000021: life.
p.000021: From a broader perspective, the concept can also include new knowledge that can lead to political decisions being made
p.000021: in a more insightful way or new unforeseen aspects arising and resulting in completely new considerations. For the
p.000021: researcher him or herself, or for other researchers, this new knowledge can lead to innovative ideas and hypotheses for
p.000021: future research.
p.000021: Many important discoveries have been unexpected, and have sometimes occurred in the search for something else
p.000021: (Teflon). They have occurred purely coincidentally (dark energy) or by mistake (penicillin). But it is obviously
p.000021: necessary that the researcher realises the significance of the effects this coincidence or mistake can lead to.
p.000021: The following examples show that research should not be driven all too strictly.
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p.000021:
p.000021:
p.000021: 2 In its upcoming report on future research strategies, the Swedish Research Council will address the question of a
p.000021: research project’s benefit from a comparative international perspective.
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p.000022:
p.000022: Some facts on chance
p.000022: Penicillin was discovered in 1928 by Alexander Fleming. After having accidentally left his staphylococci cultures in
p.000022: his laboratory for a longer time, he noticed that the mould growing on some of them had killed the surrounding
p.000022: bacteria.
p.000022: Teflon was invented by chance by Roy Plunkett when he was trying to make the gas tetrafluoroethylene work as a
p.000022: refrigerator cooling agent. A bottle of the gas was left overnight and polymerised into polytetrafluoroethylene, a very
p.000022: slick plastic. Eventually it came to be used to coat fishing line and frying pans, and was also used on spacecraft
p.000022: because it does not react to UV light, ozone or oxygen and tolerates temperatures from -200 to over 200 °C.
p.000022: Dark energy became a concept in 1998 when scientists were studying gravitation and cosmic acceleration. It suddenly
p.000022: became evident to them that we can only see around 30% of the universe – the other 70% is called dark energy.
p.000022: A perhaps not completely comparable, but revolutionary, discovery from the humanities is Linear B, a script found on
p.000022: clay tablets at an archaeological dig at Knossos on Crete in 1900. The script was long indecipherable. Then a British
p.000022: architect, Michael Ventris, who first thought the scripts were Etruscan, made a guess that they might instead be Greek.
p.000022: With the help of Linear B findings from the Greek mainland, which did not contain certain words found in the texts from
p.000022: Crete, he guessed that these words might be Cretan place names. This allowed him, in 1951, to decipher Europe’s first
p.000022: written language.
p.000022:
p.000022: 2.2.2 Research funding and collaboration
p.000022: All research requires resources: time, place and equipment. Funding can be obtained through a position a researcher
p.000022: holds at a company, in which the research aspect is part of his or her duties. In such cases it can be the employer who
p.000022: formulates the research question. Research can also be conducted as an assignment the researcher has received, in
p.000022: competition with others or not. Finally, funding can also be obtained through grants from a funding body in the
p.000022: governmental or private sphere, or some other party.
p.000022: You could say that there are two types of funders: those who do not have a direct interest in the results and those who
p.000022: do. The first group includes the government in the form of various foundations or research councils, as well as
p.000022: research foundations, based on collections and private donations with a specific focus, for instance the Swedish Cancer
p.000022: Society and the Heart-Lung Foundation. The second group includes commercial, non- profit and public actors who need
p.000022: research to develop their activities and, in some cases, to earn money.
p.000022: External funding creates opportunities for research that otherwise might not have been conducted, but the ties and
p.000022: control it can entail are not without risk. This is illustrated in the many conflicts over publishing, access to data
p.000022: and the interpretation of results that are often debated in the media.
p.000022:
p.000022: What would you do in the following situation?
p.000022: You are researching the effectiveness of different toothpastes in a study commissioned by one of the larger
p.000022: manufacturers in this field. You design a comparative study in which the qualities and effects of different toothpastes
p.000022: from a number of aspects are compared.
p.000022: However, the results are not what the funding body had hoped for and they want to stop publication or at least divide
p.000022: the report into multiple studies, which would make it difficult or even impossible to draw any conclusions. When you
p.000022: object to this they threaten to revoke their grants for a number of projects on which your doctoral students are
p.000022: dependent.
p.000022: Do you go along with the funding body’s demand in order to save your students’ funding? Do you try to negotiate a
p.000022: compromise? Or...?
p.000022:
p.000022: Funding bodies, no matter who they are, want to see results. Everyone wants to be sure that a research project is good
p.000022: enough to lead to new knowledge. Around the world public or open funders use reviewers to this end, in a process called
p.000022: peer review. Reviewers often work using templates containing clearly formulated criteria. The review always entails an
p.000022: evaluation of the scientific quality, often of the originality of the research question and sometimes also of how
p.000022: significant the question is from a specific, given perspective. This allows funding to be routed towards researchers
p.000022: who are judged to have the best design as well as the best ability to conduct their projects, but sometimes also to
p.000022: certain areas the funding body considers important.
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p.000023:
p.000023: For research results to be useful, it is normally necessary that they are developed further and that someone makes use
p.000023: of the new knowledge. Public institutions can have such an ambition, but it most often occurs through
p.000023: commercialisation. From society’s perspective, it is important that new findings come into use as soon as possible if
p.000023: they can be expected to be of benefit and carry no risk. How this should occur is the constant subject of debate. The
p.000023: goals of a commercial actor or a public institution can compete with the ambition to further raise knowledge levels.
p.000023: Research results or a discovery can mean profit for the author or someone who develops it further, but can also have
p.000023: harmful effects on a large group or on society. In this case, as in all others, every researcher should think through
p.000023: the possible consequences of his or her research.
p.000023:
p.000023: 2.2.3 Various forms of collaboration
p.000023: Collaboration between research and private or public funding bodies can occur in different forms. The researcher can be
p.000023: employed by a university only, and through his or her department collaborate with industry and other funding bodies,
p.000023: who reimburse the department for the researcher’s contribution. Some institutions even have a special organisation for
p.000023: commercialisation, with separate bookkeeping and accounting.
p.000023: Some researchers are employed within industry and are assigned with using scientific methods to develop new knowledge
p.000023: that is valuable to the employer’s development projects. These researchers are also expected to participate in the
p.000023: scientific community and collaborate with researchers within academia, who receive their funding largely through
p.000023: external grants.
p.000023: Some researchers choose to take an active part in development collaborations with industry, and some even prefer to
p.000023: participate in the development of companies in which they have proprietary interest. This type of engagement places
p.000023: great demands on the researcher, requiring that his or her actions in the scientific role are well thought out and
p.000023: appropriate, and that he or she does not allow the industrial engagement to undermine the scientific approach.
p.000023: Researchers working within academia who are considering collaborating with a commercial company should try to find out
p.000023: what role and responsibility the industrial researcher has in his or her organisation. Research in this context can be
p.000023: of many types: everything from ground-breaking research to research activities more closely connected to the company’s
p.000023: marketing. Researchers should be aware that this span exists to allow for positive and constructive collaboration with
p.000023: maintained integrity. The research community, for its part, should strive to take an open-minded position and evaluate
p.000023: each scientific contribution based on scientific quality and its own merits.
p.000023:
p.000023: 2.2.4 Problems and pitfalls
p.000023: Quick publication and transferral to practical use are important goals, which we have just discussed. But there are
p.000023: many obstacles along the way: amateurishness in the ability to convert research results into practical use, attitude
p.000023: problems of the various actors towards each other and structures involving slow publication processes, sluggish
p.000023: handling of patent applications and a lack of risk capital.
p.000023: Without the cooperation of the researcher, it is often difficult to convert academic research results into a benefit
p.000023: for society at large. Therefore, great demands must be placed on the individual researcher’s awareness and on the
p.000023: environment in he or she works when it comes to handling situations and contacts involving profit motive.
p.000023: In such cases, all researchers should carefully consider any agreements with other parties in order to maintain their
p.000023: personal integrity and scientific credibility. Two cornerstones in this stance are openness regarding ties and
p.000023: dependencies, as well as openness regarding all research results. This is important, regardless of whether the results
p.000023: meet or contradict a commissioning party’s expectations. Conflicts have often arisen between funding bodies and
p.000023: researchers over the publication and interpretation of results, sometimes leading the researcher to suppress
p.000023: “undesirable” results. A researcher should also not let him or herself be convinced to over-interpret results in a
p.000023: certain direction. Angled reports can cause a great deal of harm, irrespective of whether they have a commercial angle
p.000023: or are affected by the ambitions of a public authority.
p.000023:
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p.000024:
p.000024: What would you do in the following situation?
p.000024: You are working with technical research on new light, strong materials. You see an opportunity to apply for a patent
p.000024: and have started a company along with some entrepreneurs to commercialise the products. However, the commercialisation
p.000024: takes longer than expected and the company starts having economic problems.
p.000024: A co-worker points out that fibres in the new material have qualities reminiscent of asbestos, and therefore suggests
p.000024: additional toxicological studies. But you want to speed up the development work.
p.000024: Do you choose to interrupt the development work and examine the health risks? If no, how do you respond to the
p.000024: criticism from your co-worker?
p.000024:
p.000024: 2.2.5 Openness is your guiding light
p.000024: Just like everyone else, a researcher has a legitimate need for appreciation. This can consist of economic
p.000024: compensation, honour and recognition or academic advancement, often in combination. But the way to attain recognition
p.000024: does not always follow the same path, and can be effective to different degrees at different points in time. Conflicts
p.000024: often arise. For instance, the individual researcher might be eager to quickly make his or her discovery publicly
p.000024: known, while the research group feels it is tactical or even necessary to withhold the information in anticipation of a
p.000024: patent application or further development.
p.000024: A fundamental rule in all research is that all researchers should openly account for any conflicts of interest when
p.000024: presenting their results in a scientific context. For the credibility of the research community, it is also crucial
p.000024: that a researcher does not withhold new knowledge or postpone publication. Every researcher must also make it possible
p.000024: for other researchers to use – and check – his or her research results.
p.000024: It is important that the surrounding world is informed if a researcher has a private profit interest in a certain
p.000024: project, or that commercial ties, such as details about ownership shares or research grants, are openly accounted for.
p.000024: Openness also contributes to forcing the researcher to clarify for him or herself what motives and research role he or
p.000024: she has.
p.000024: The researcher’s integrity is important “currency” that must not be allowed to devaluate. If this should happen, it
p.000024: could cause the researcher to lose credibility for a long time to come. In projects of commercial importance, the
p.000024: integrity of the company will then also be called into question. It is thus in the interest of both the company and the
p.000024: researcher that commercial contacts are handled appropriately.
p.000024: Companies often seek a dialog with leading researchers to keep themselves well informed on research. Like other
p.000024: researchers, those who work in researching companies participate in open scientific meetings. In these contexts, all
p.000024: participants are expected to account for existing ties, in accordance with the basic principle of openness. Such an
p.000024: account should be given in the introduction of a scientific presentation, to inform the listeners before the results
p.000024: are presented.
p.000024:
p.000024: 2.3 Quality and reliability
p.000024:
p.000024: 2.3.1 General principles
p.000024: The requirement of quality in research can be clarified through a number of general principles that are also recognised
p.000024: within the research community. These principles have also been thoroughly discussed and argued for in theory of science
p.000024: and methodology books.
p.000024: The various prerequisites and focuses in a study must be clarified and justified. The project should have a clear aim
p.000024: to answer or highlight certain interesting questions, which should also be formulated clearly. Methods that are used
p.000024: should be able to be explained, and it should also be possible to show that using these methods should allow the
p.000024: researcher to answer the questions being asked. The methods should be handled correctly and competently.
p.000024: Projects based on empirical material should be characterised by systematic and critical analysis of carefully collected
p.000024: data. Possible sources of errors should be identified and discussed. The arguments should be formulated clearly and be
p.000024: relevant to the intended conclusion. The project as a whole, the documentation and the report should exhibit clarity,
p.000024: order and structure. But the quality aspect also entails things like scientific imagination and originality. If a
p.000024: project is creative and innovative in some respect, this greatly contributes to its quality. The quality aspect also
p.000024: covers well-designed studies that validate and/or reproduce research carried out earlier.
p.000024:
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p.000025: 25
p.000025:
p.000025: The criteria discussed above are by no means a complete list; nor can each individual requirement be regarded as a
p.000025: necessary condition for quality in a certain project. There must, for instance, be room for explorative studies without
p.000025: clear goals. The specification and application of these criteria are not the same in quantum mechanics and hermeneutics
p.000025: (interpretation theories), but if a project is lacking in many of the aspects discussed above, this is a clear warning
p.000025: signal.
p.000025:
p.000025: 2.3.2 Research question and method
p.000025: In many fields, the research group’s activities can be quite strongly method-oriented, based on a method developed
p.000025: within the group, which is the connecting link for various research efforts in which it is used. In such cases, the
p.000025: choice of research question can be driven by the method. This is in opposition to the schematic representation of the
p.000025: researcher as a problem-solver, first asking a question and then choosing a method to answer it. The research of
p.000025: method-based groups often becomes splintered, and many contributions can be rather superficial. On the other hand, a
p.000025: systematic study of the strengths of a newly developed method can be highly valuable.
p.000025: In general, it should also be mentioned that advances in modern natural science, from astronomy to brain research, must
p.000025: be regarded as being greatly due to developments in technology that have allowed the use of new methods. The
p.000025: development of methods within areas like mathematics, statistics and information science should also not be
p.000025: underestimated. There is every reason for researchers and research groups to acknowledge their dependence on these
p.000025: contributions and give them the credit they deserve.
p.000025: The choice of method for a research task is decisive for the value and character of the results. It is often difficult
p.000025: and requires a good deal of experience, often even boldness. Sometimes the method choice is based on existing knowledge
p.000025: and contributions, perhaps by previous generations in the same research group or at the department where the research
p.000025: is being conducted. It can happen that the research environment at a department is so focused on a certain method that
p.000025: alternatives are not discussed or even considered. In such a case, it can be beneficial to consciously seek out
p.000025: alternatives and – possibly in collaboration with researchers within other method traditions – conduct parallel studies
p.000025: using different methods.
p.000025: In science, method issues are a hot topic and are linked to criteria for scientific quality. This is also the case in
p.000025: the humanities and social sciences. There is thus not only a practical difference between studies on people that are
p.000025: based on measurements, e.g. of reaction times or response frequency in schematic questionnaire surveys on the one hand,
p.000025: and on the other hand studies in which people’s views are interpreted – as in letter collections or interviews. In
p.000025: discussions, the generalisability and more or less claimed objectivity of the results can end up being in opposition to
p.000025: the interest and “depth” of the scientific claims. This does not mean that research collaboration combining different
p.000025: methods cannot be fruitful, however.
p.000025: Method choice also has an ethical aspect. In studies of the first type mentioned above, the researcher’s relation to
p.000025: the people being studied is often more distant, while in the second type it is more involved. In both cases, the
p.000025: researcher’s position can entail ethical complications or risks.
p.000025: The choice of method can present many other important ethical considerations, for example whether animal subjects can
p.000025: be completely or partially replaced by tissue samples. Or there could be a question of how an interview study on
p.000025: children of abused mothers should be limited, to what degree violent tendencies or intelligence should be measured in
p.000025: studies on the socialisation of different ethnic groups, etc. At international level in particular, discussions are
p.000025: being held on the research ethics of so-called participant observation, a method used in the fields of social and
p.000025: behavioural science, among others.
p.000025:
p.000025: 2.3.3 Observational studies conducted through participating, observing and recording
p.000025: For some research questions participant observation may be used, but this research method is associated with a large
p.000025: number of ethical problems.
p.000025: The methods of participating, observing and/or recording can be used in several situations. A researcher may want to
p.000025: actually be in the research subjects’/informants’ environment and observe what happens, hear what is said and follow
p.000025: the persons’ interactions. In some situations, covert participant observation is used. This type of secret or disguised
p.000025: research is rare, however, and should be the exception rather than the rule.
p.000025: The ideal situation is always that those to whom the research applies should be informed that they are the subject of
p.000025: research, and should normally also have given their written consent. If the research includes handling any personal
p.000025: data, the Personal Data Act applies. If the personal data is also so-called “sensitive personal data”
p.000025:
p.000025:
p.000025: GOOD RESEARCH PRACTICE
p.000026: 26
p.000026:
p.000026: (see Chapter 3), then approval from an ethics review board must also be obtained. It is worth mentioning in this
p.000026: context that recording of sound from and/or images of persons constitutes handling of personal data (see Chapter 9).
p.000026: Overt observation studies, in which participants know research is being conducted, are used, for example, to study the
p.000026: work within different organisations, or at an emergency room or a school. The observations should be performed
p.000026: systematically using observation schedules, notes, etc. The researcher should strive for objectivity and try not to
p.000026: influence research subjects or events.
p.000026: Ethical considerations are very important in participant observation. The researcher is responsible for preventing any
p.000026: damage, and for ensuring the identities of those observed will not be revealed. Although this requirement may be
p.000026: difficult to fulfil, it is necessary.
p.000026: One way to observe human beings is through video recording. Research using a video can intrude on the private lives and
p.000026: integrity of individuals, as it is possible to identify them. Video recording should therefore only be used when it is
p.000026: impossible to achieve the same results with the help of other data collection methods. For example, masked photographs
p.000026: can be used instead of video if it is not necessary to study the subjects’ movements, facial expressions or
p.000026: interaction/communication.
p.000026: It is important that the recording is done in a respectful and responsible way. Individual integrity must be respected.
p.000026: If underage subjects are to be video recorded, the same special rules apply as for other research involving children.
p.000026: This means that if the child is less than 15 years old, both guardians and the child must have consented to the
p.000026: participation. The information should be written in such a way that the child too can understand it (according to the
p.000026: Act concerning the Ethical Review of Research Involving Humans).
p.000026: Just as for other research, the video recording shall be preceded by detailed information and consent be given
p.000026: afterwards. This information should describe the purpose of the research, and emphasise that participation is
p.000026: voluntary. Those asked to participate shall also be informed of exactly what the researchers intends to analyse in the
p.000026: video recording, and why other forms of registration have not been considered suitable or sufficient. As it is a
p.000026: question of personal data being handled, the personal data controller for the handling shall also be named.
p.000026: The information (which should be both oral and written) to the informants shall also include more detailed information
p.000026: on the following:
p.000026:
p.000026: • Whether any editing of the recording will be done, for example to disguise the face and/or voice
p.000026: • Whether the video recording will be copied, and if so how many copies will be made
p.000026: • Whether the recording will also be used for any other purpose than for research, for example educational purposes
p.000026: • Whether any other analysis will be carried out in addition to those first stated – if so, both the regional ethics
p.000026: review board and the informant must be asked
p.000026: • The informant is probably entitled to demand a copy of the recording as a registry excerpts under Section 26 of the
p.000026: Personal Data Act
p.000026: • That any links between the recording and other personal data will be encoded
p.000026: • How and where the recording will be stored, and for how long it will be saved
p.000026:
p.000026: Once the informant has received detailed information as per above, consent must be requested, normally in writing. It
p.000026: is the practice in some fields of research, but not all, that consent is given in two stages. In these cases, the
p.000026: information must first decide and possibly give his or her consent to the video recording itself.
p.000026: Thereafter, once the informant has had the opportunity to watch the video, he or she shall have the opportunity to give
p.000026: consent to the researcher to continue with the work of analysing it. Consent may also be given to show the video to
p.000026: persons named in advance, such as researchers, students, patient association, or similar.
p.000026: The informant shall confirm that he or she has received information that the consent to the researcher analysing, using
p.000026: and showing the video may be recalled at any time. The research records and the information to the informant shall
p.000026: state whether the video material will be destroyed or not, in the event the informant recalls his or her consent. If it
p.000026: states that the material shall be destroyed in the event consent is recalled, this shall be done, or else the video
p.000026: recording given to the informant, provide he or she is the sole person shown in the recording. If several persons
p.000026: appear in the video recording, the identity of the person who has recalled the consent shall be edited out, if
p.000026: possible.
p.000026: A video recording shall be stored in a secure manner, so that it is out of reach of unauthorised persons, and so that
p.000026: it is not destroyed through negligence. The researcher must ensure that only authorised persons can get
p.000026:
p.000026:
p.000026: GOOD RESEARCH PRACTICE
p.000027: 27
p.000027:
p.000027: access to the video recording. If it is a case of sensitive personal data, more comprehensive and considered protective
p.000027: measures are needed.
p.000027:
p.000027: 2.3.4 Sources of error and reliability
p.000027: When a scientific study starts to produce results, you are faced with the challenging task of evaluating their
p.000027: reliability. This is an integral part of the study, and an important aspect of the quality of the research. For
p.000027: example, a recent investigation of suspected research misconduct brought to the fore how important it is that the
p.000027: decision of how to represent decimals is well considered and clarified. A common, and tempting, mistake is to
p.000027: overestimate the significance of the results you have arrived at, and exaggerating their bearing power far beyond the
p.000027: area in which they have found to apply.
p.000027: Within most research traditions a careful error analysis is required, or at least a discussion of possible error
p.000027: sources and other conditions that might affect the soundness of the results. The challenge is to make realistic
p.000027: evaluations. It is ethically problematic, and damaging to research as such, if a researcher knowingly suppresses
p.000027: indications of significant sources of error. It could be a case of withholding certain data to be able to get an
p.000027: article published, or taking a chance that the results will hold in order to be the first to report a new discovery. At
p.000027: the same time, one also should not refrain from publishing results due to exaggerated caution. The most important thing
p.000027: is to be clear, critical and honest in evaluating sources of error.
p.000027: The evaluation of error sources is often limited by the research tradition and method a researcher is working within.
p.000027: Some sources of error do not “show” if one performs the analysis based on a certain theoretical standpoint or model. It
p.000027: is thus important in the error analysis not to limit yourself to the possible “internal errors” within the frame of
p.000027: your chosen viewpoint, but rather to allow the analysis to broaden the perspective to show other, alternative
p.000027: viewpoints. This can be very difficult, however. One is often forced to lower the level of ambition, but in such cases,
p.000027: it is all the more important to be accurate in explaining the basis for the analysis and its limitations.
p.000027:
p.000027: 2.4 Research ethics from a dynamic perspective
p.000027: The landscape of research ethics is changing. When researchers ask new questions, use new methods and work with new
p.000027: materials, new research ethics issues arise. Early on, the purpose of research ethics was to keep researchers from
p.000027: harming or violating patients and research subjects in numerous ways in the name of science. This was the overarching
p.000027: purpose of the Declaration of Helsinki, against a background of events including the research that had been conducted
p.000027: on prisoners in concentration camps and jails. Therefore, the Declaration stressed standards for informed consent and
p.000027: risk-benefit analysis, as well as that the interests of science and society not being allowed to carry more weight than
p.000027: the protection of the individual’s well-being and safety.
p.000027: With the development of epidemiological research and register data research of diverse types, some other issues have
p.000027: now come to the fore. The persons who are subject to such research, where data about them is collected and analysed,
p.000027: participate in a different way than those who take part directly in clinical trials of new medicines, for instance.
p.000027: Those who contribute to a register study do not need to be aware that they are part of the study and thereby a subject
p.000027: of research. Meanwhile, this type of research can be sensitive from an integrity perspective, and the knowledge that
p.000027: information, which the people in question may not even know has been recorded, can be gathered and analysed can be
p.000027: cause for concern. The study design and the presentation of results are essential elements in alleviating unfounded (or
p.000027: well-founded) worry over discrimination and stigmatisation. The likely value of new knowledge must thus be weighed
p.000027: against the risk that subjects’ integrity will be compromised and the need to protect individuals’ right to privacy.
p.000027: New methods, and/or those coming into more frequent use, in humanities and social science research, such as
p.000027: video-recording and participant observation, have raised new issues in research ethics. With questionnaires and
p.000027: interviews, the requirement that the participants’ identities are protected is met through the use of code keys and by
p.000027: masking and de-personalising answers. However, this is not possible with videos, for instance, in which the interplay
p.000027: between body language and verbal communication is studied. In participant observation, the researcher is sometimes not
p.000027: able to obtain informed consent in advance without making it impossible to conduct the research. This presents new
p.000027: challenges to researchers and ethics review boards.
p.000027: In recent years, stem cell research and nano technology research have attracted great interest, as has the
p.000027: commercialisation of research, and the effects of research on the environment and society in a more global perspective.
p.000027: Besides traditional research ethics issues regarding informed consent and risk-benefit analysis,
p.000027:
p.000027:
p.000027: GOOD RESEARCH PRACTICE
p.000028: 28
p.000028:
p.000028: some types of stem cell research bring up specific issues regarding both the research object and the methods being
p.000028: used. These concern the moral status of fertilised eggs, and, for instance, whether methods such as nucleus transfer
p.000028: from one cell to another are ethically acceptable. The existence of gaps in knowledge and uncertainty, such as about
p.000028: what happens when nano particles enter the body, is highlighted when results from nano research are applied within new
p.000028: areas, such as the automobile industry, medicine, cosmetics, etc. Limited toxicological studies have been conducted,
p.000028: but the gaps in knowledge make it difficult to perform a meaningful risk-benefit analysis and points to the need for
p.000028: method development in this area.
p.000028: Issues concerning the commercialisation of research and the effects of research on the environment and society from a
p.000028: more global perspective have recently attracted growing interest; these issues are discussed earlier in this chapter as
p.000028: well as in Chapter 5. The background is not only globalisation and the increased international collaboration between
p.000028: research groups in different countries, but also the fact that large-scale research demands significant resources and
p.000028: public funding is not sufficient. Research groups are therefore becoming increasingly dependent on collaboration with
p.000028: and financial contributions from non-public funding bodies. This enables research that might otherwise not have been
p.000028: possible to be conducted, but also brings to the fore issues of control, dependency and the supervision of research.
p.000028: Human rights are universal. To the extent research ethics principles are based on and protect these rights, they can be
p.000028: accepted in various cultures. At the same time, they then have to be formulated with a certain amount of vagueness. For
p.000028: example, the requirement of informed consent can be interpreted and applied as a requirement of individual informed
p.000028: consent in liberal, western societies. But in cultures where the family, group, clan or village elder gives consent,
p.000028: this requirement must be interpreted slightly differently. Research ethics are thereby placed in a cultural and social
p.000028: context. Some values reflect technical and economic development, while others are slower to change and are based on
p.000028: more basic human needs.
p.000028:
p.000028: References
p.000028: 1. Chalmers, Alan F., Vad är vetenskap egentligen? Nora, Nya Doxa, 2003.
p.000028: 2. Föllesdal, Dagfinn & Wallöe, Lars & Elster, Jon, Argumentationsanalys, språk och vetenskapsfilosofi. Stockholm,
p.000028: Thales, 2001.
p.000028: 3. Gilje, Nils & Grimen, Harald, Samhällsvetenskapernas förutsättningar. Göteborg, Daidalos, 1993, tredje upplagan
p.000028: 2007.
p.000028: 4. Hermerén, Göran, Kunskapens pris: forskningsetiska problem och principer i humaniora och samhällsvetenskap.
p.000028: Stockholm, Swedish Science Press & HSFR, 1986, andra upplagan, 1996.
p.000028: 5. Hermerén, Göran,” Challenges in the Evaluation of Nanoscale Research: Ethical Aspects”. NanoEthics, 2007,
p.000028: 1:223–237.
p.000028: 6. Hermerén, Göran & Hug, Kristina (red). Translational Stem Cell Research: Issues Beyond the Debate on the Moral
p.000028: Status of the Human Embryo. New York, Springer, 2010.
p.000028: 7. Högskolelag (SFS 1992:1434).
p.000028: 8. Rydén, Lars (red), Etik för forskare. En antologi med utgångspunkt i arbetet med Uppsala- kodexen. Stockholm,
p.000028: UHÄ, 1990.
p.000028:
p.000028:
p.000028:
p.000028:
p.000028:
p.000028:
p.000028:
p.000028:
p.000028:
p.000028:
p.000028:
p.000028:
p.000028:
p.000028:
p.000028:
p.000028:
p.000028:
p.000028: GOOD RESEARCH PRACTICE
p.000029: 29
p.000029:
p.000029: 3 ETHICS REVIEW AND OTHER PERMIT REVIEW
p.000029:
p.000029:
p.000029: To be allowed to conduct certain types of research, it is necessary to obtain a permit. This applies especially to
p.000029: research that involves humans or entails experiments on animals, but also to some other types of research.
p.000029:
p.000029: 3.1 Ethics review and other permit review of research involving humans
p.000029:
p.000029: 3.1.1 Approval according to the Act concerning the Ethical Review of Research Involving Humans, etc.
p.000029: As mentioned above, the Act (SFS 2003:460) concerning the Ethical Review of Research Involving Humans came into effect
p.000029: as from 1 January 2004.
p.000029: The Act states what types of research projects must be reviewed. It also lists factors and conditions that should be
p.000029: addressed in order for a research project to be approved, as well as how the review bodies – the ethics review boards –
p.000029: should be composed.
p.000029: It is the researcher (or the supervisor of a doctoral student project) who, together with the research principal 3
p.000029: applies for an ethics review, when the research falls within the scope of the law. Simply starting or completing a
p.000029: research project that falls within the scope of the law without approval from an ethics review board is a breach of
p.000029: law and is punishable.
p.000029: Ethics review carries a fee, which varies depending on the type of project (one or multiple principals) and the type of
p.000029: application (new project or supplementary application). For concrete information on how to apply and who should apply,
p.000029: etc., please see the Central Ethics Review Board’s website on epn.se or the CODEX website at codex.vr.se.
p.000029: A research project falls within the scope of the Act concerning the Ethical Review of Research Involving Humans because
p.000029: of its content. What is to be reviewed therefore has nothing to do with how the project is funded. Also, research that
p.000029: is not funded by external bodies, but is carried out within a position at an institution, shall therefore be reviewed
p.000029: if the content so requires.
p.000029: A research project shall be reviewed by an ethics review board if any of the following conditions exist.
p.000029: Namely, if the project (A)
p.000029:
p.000029: • entails physical encroachment on the research subject
p.000029: • will be conducted using a method aiming to affect the research subject physically or psychologically, or that
p.000029: carries an obvious risk of physical or psychological harm to the research subject
p.000029: • entails studies on biological material taken from a living human being and can be traced to this person
p.000029: • entails physical encroachment on a deceased human being
p.000029: • entails studies on biological material taken for medical purposes from a deceased human being and can be traced to
p.000029: this person. Act (SFS 2008:192).
p.000029:
p.000029: A research project shall also be reviewed if it (B)
p.000029:
p.000029: • entails the handling of sensitive personal data according to Section 13 of the Personal Data Act (SFS 1998:204),
p.000029: including information on race, ethnic origin, political views or religious conviction, or personal
p.000029:
p.000029:
p.000029:
p.000029:
p.000029: 3The research principal is the government authority or the physical or legal entity within whose organisation the
p.000029: research is conducted. A researcher employed at a university or a county council has the same as his or her research
p.000029: principal. The research principal, through its internal work or delegation order or through power of attorney,
p.000029: determines who is authorised to represent the research principal. The research principal always has ultimate
p.000029: responsibility for the research.
p.000029:
p.000029:
p.000029: GOOD RESEARCH PRACTICE
p.000030: 30
p.000030:
p.000030: data according to Section 21 of the Personal Data Act, including information on judgements in criminal cases.
p.000030:
p.000030: Condition (B) thus means that all research dealing with sensitive personal data shall be ethically reviewed, regardless
p.000030: of how the data has been collected and whether or not the researcher has obtained the participants’ consent.
p.000030: When an ethics review board evaluates a project, it has a number of aspects to note and consider. Generally, the
p.000030: research in question can be approved only if it can be conducted with respect for human dignity. In the review, the
p.000030: board should also evaluate how the human rights and basic freedoms of those involved are treated in relation to the
p.000030: value of the research. The welfare of human beings should be placed before the needs of society and science, and the
p.000030: knowledge value of the research must be assessed as outweighing the risks. The research cannot be approved if the
p.000030: expected results can be reached in another way that presents fewer risks, for instance using other categories of
p.000030: research subjects, or an alternative study design.
p.000030: For the board to be able to approve certain types of research, informed consent must have been obtained from the
p.000030: participants (research subjects, stakeholders). The law also briefly describes how this consent should be constituted,
p.000030: and from whom and how it may be obtained.
p.000030: The law requires informed consent in the first three types of projects in (A) above; that is, research entailing
...
p.000031: In clinical trials, except so-called non-intervention studies, it is a requirement that approval is obtained from the
p.000031: Swedish Medical Products Agency (see Chapter 7 Section 9 of the Medicinal Products Act SFS 2015:315). This also applies
p.000031: to trials of a drug for an approved indication, at an approved dosage and with an approved method of administration
p.000031: with the aim of further showing effect and/or safety. The Agency has issued detailed rules for how clinical trials of
p.000031: drugs for humans shall be conducted. Applications to the Swedish Medical Products Agency shall be made by the sponsor,
p.000031: i.e. the individual, company, institution or organisation that assumes responsibility for starting, organising and/or
p.000031: funding the clinical trial. More information on regulations and the steps of the application process can be found on
p.000031: the Agency’s website (www.lakemedelsverket.se.).
p.000031: Applications for clinical trials within the EU are registered in the database Eudra CT (European Clinical Trials
p.000031: Database). Currently, this database is only accessible to national medical products agencies, for instance the Swedish
p.000031: Medical Products Agency, the European Medicines Agency (EMA), and the Commission. As a step towards increasing the
p.000031: transparency within the EU, access to certain parts of the database’s content will soon be given to the general public
p.000031: via the website www.clinicaltrialsregister.eu. On this website, information on issues such as ethics committee
p.000031: decisions regarding clinical trials on children will be publicly accessible. In the US, the corresponding database is
p.000031: ClinicalTrials.gov.
p.000031: To conduct a research project involving the irradiation of research subjects with ionising radiation, the project must
p.000031: be approved by a local radiation protection committee. (See 22 § of the Swedish Radiation Safety Authority’s rules
p.000031: regarding general obligations in medical and odontological activities involving ionising radiation, SSMFS 2008:35). For
p.000031: multicentre studies, an application must be sent to all local radiation protection committees within the study’s scope.
p.000031:
p.000031: 3.2 Research on animals and laboratory animal ethics
p.000031:
p.000031: 3.2.1 The use of laboratory animals
p.000031: Laboratory animal ethics deals with the ethical issues that arise when animals are used in scientific experiments. In
p.000031: society, it is a common perception that animal experiments are needed for development and research within both human
p.000031: and veterinary medicine. Research using animals is thus conducted partly because it provides new knowledge, partly
p.000031: because it benefits humans, and not infrequently also for the sake of animals themselves.
p.000031: The production of new medicines is highly dependent on animal experiments. A long line of medical advances that have
p.000031: saved many human lives were possible thanks to the use of animals. The law does not allow the testing of medicinal
p.000031: preparations on humans, and even less their being used in treatment, before they have been tested on animals or through
p.000031: another appropriate method to arrive at dependable research results.
p.000031: The EU’s definition of laboratory animals includes only those animals that are actually subjected to invasive
p.000031: procedures, at minimum a needle-prick. Based on this definition, the Swedish Board of Agriculture received reports that
p.000031: 258,403 laboratory animals had been used in Sweden in 2015. Sweden’s definition is considerably broader, however, and
p.000031: includes all animals used for scientific purposes. Based on the Swedish definition, the Board of Agriculture received
p.000031: reports that 16,373,330 laboratory animals were used in Sweden. The large difference is because Sweden includes the
p.000031: fish collected to evaluate or tag the fish population, which in 2015 amounted to 16,042,533 fish (the Swedish Board of
p.000031: Agriculture, Användningen av försöksdjur i Sverige under 2015, report Dnr: 5.2.17-5428/17).
p.000031: In recent years, a number of issues concerning laboratory animals have been raised in public debate, for instance the
p.000031: use of genetically modified animals as disease models. Also worth mention is the discussion of whether primates should
p.000031: be used in research on Hepatitis C and HIV, which only afflict humans and chimpanzees. Another debated issue is the
p.000031: EU’s REACH Regulation on the Registration, Evaluation, Authorisation and Restriction of Chemicals (ordinance EU
p.000031: 1907/2006). This has entailed increased requirements concerning the testing of chemicals on animals, with the aim of
p.000031: protecting human health and the environment.
p.000031:
p.000031:
p.000031:
p.000031:
p.000031: GOOD RESEARCH PRACTICE
p.000032: 32
p.000032:
p.000032: Regulations on animal experiments can also be found in the Animal Welfare Act (SFS 1988:534), which has undergone a
p.000032: number of changes since it was passed. 4
p.000032: An EU directive on the welfare of laboratory animals and the ethics review of research on animals was recently passed
p.000032: (2010/63EU)5, aimed at harmonising existing laboratory animal welfare protection and establishing common minimum and
p.000032: maximum levels within the EU. The establishment of a maximum level means that member countries cannot legislate
p.000032: stricter rules themselves in the future; however, a country is allowed to have stricter rules if they were already in
p.000032: place before the directive went into effect. Further information can be found on the Board of Agriculture’s website
p.000032: (jordbruksverket.se).
p.000032:
p.000032: 3.2.2 Laboratory animal ethics
p.000032: Work using laboratory animals raises a number of difficult ethical issues. Positions on these issues have a great deal
p.000032: to do with fundamental ideas concerning views on humankind, that is to say the essence, function and task of human
p.000032: beings, and not least their position in relation to other living beings. In addition, ethical notions regarding animal
p.000032: experiments are influenced by our general moral convictions.
p.000032: Anyone considering conducting research using animals in order to better understand how the human body works, or to
p.000032: contribute to improvements to human medicine, faces difficult ethical challenges. Similar challenges arise in other
p.000032: fields of research as well. This is clearly demonstrated in the so-called paradox of animal experimentation, which
p.000032: summarises the dilemma that animal experimentation entails: we use (nonhuman) animals in experiments, because they are
p.000032: sufficiently like us (to achieve relevant results) – and since they are sufficiently different from us (to allow us to
p.000032: justify the suffering we cause).
p.000032: This paradox is not new; it has existed as long as animal experiments have been conducted, or at least since ancient
p.000032: times. Humans have always had a relationship with all other animals, but differing notions of how humans should relate
p.000032: to animals have been dominant at various times, and have reflected the norms and values of those times and cultures. It
p.000032: cannot be assumed that one unified view exists of what this human-animal relationship should be like within one single
p.000032: era and culture.
p.000032: Even today, there are a number of differing views of how the responsibility of humans to animals should manifest
p.000032: itself. The discussion itself on how this responsibility should be exercised, and its limits, can enrich our
p.000032: self-understanding, and contribute to changes in how animals are treated in research. Within the subject of animal
p.000032: ethics, this relationship is highlighted through an analysis of views of the moral status and intrinsic value of
p.000032: animals, as well as of the responsibility of humans. Animal ethics also involves the study of theories on the rights of
p.000032: and obligations towards humans and animals, for both present and future generations.
p.000032:
p.000032: 3.2.3 The ethics committees on animal experiments: organisation and task
p.000032: Experiments using animals can only be conducted at a facility approved by the Swedish Board of Agriculture, where there
p.000032: is an approved supervisor, an approved veterinarian and personnel with sufficient competence.
p.000032: Review by an ethics committee on animal experiments is obligatory.
p.000032: In Sweden, the legal requirement of the advisory ethics review of animal experiments was introduced in 1979. Since
p.000032: 1988, the ethics committees on animal experiments have had the task of approving or rejecting applications, and since
p.000032: 1998 their ruling has been legally binding. In total, around 1,700 applications are reviewed each year.
p.000032: The responsibility for the ethics committees on animal experiments and the review function rests on the Board of
p.000032: Agriculture since 2007.
p.000032: There are six ethics committees on animal experiments in Sweden, and each committee has fourteen members.
p.000032:
p.000032:
p.000032:
p.000032:
p.000032:
p.000032:
p.000032:
p.000032: 4A summary of its development is given in the Swedish Board of Agriculture’s regulations on change in the Central
p.000032: Laboratory Animals Board’s regulations from 1988; see the Board of Agriculture’s Code of Statutes 2008:70 as well as
p.000032: Borgström 2009.
p.000032: 5http://ec.europa.eu/environment/chemicals/lab_animals/index_en.htm
p.000032:
p.000032:
p.000032: GOOD RESEARCH PRACTICE
p.000033: 33
p.000033:
p.000033: Some facts
p.000033: The chair and vice chair of the ethics committees on animal experiments are lawyers with experience of court work. Of
p.000033: the other twelve members, one half are scientists or staff who work with laboratory animals and other half are laymen,
p.000033: of whom at least one represents an animal welfare organisation. It is a stated political goal that the laymen should
p.000033: represent the general public to the greatest degree possible. The composition of the research group should be such that
p.000033: the committee as a whole has broad competence.
p.000033:
p.000033: 3.2.4 Ethics review
p.000033: The main task of an ethics committee on animal experiments is to weigh the purpose of the experiment against the
p.000033: suffering that may be inflicted on the animals, and determine whether the purpose is sufficiently important to justify
p.000033: the animals’ expected suffering. This is a challenging task. It is important that the application be clear and
p.000033: informative, so that the committee can form an opinion on how important the experiment is, and how the animals may be
p.000033: affected.
p.000033: Central questions that must be answered by the applicant to enable the committee to make an adequate assessment are:
p.000033: the purpose of the research, whether this can be achieved using another method than animal experimentation or with
p.000033: another type of animal, whether the animals will be subjected to greater suffering than is absolutely necessary,
p.000033: whether anaesthesia or painkillers will be required, and whether the experiment is an unnecessary repetition of an
p.000033: earlier one.
p.000033: A report on the ethics review of animal experiments (Etisk prövning av djurförsök, SOU 2002:86) contains a
p.000033: well/structured suggestion for discussion subjects that highlight which ethical aspects need to be stressed in
p.000033: connection with each application.
p.000033: A researcher who wishes to make a sound decision in the question of whether or not an animal experiment is justified
p.000033: must, just like the ethics committees on animal experiments, consider the purpose of the research by weighing the
p.000033: expected benefit of the experiment against the expected suffering of the animals. The fundamental principle in all
p.000033: research, weighing benefit against possible harm, was touched on earlier. Here, a number of factors determine the
p.000033: outcome.
p.000033: As regards benefit, the researcher should consider the importance of the knowledge gain or possible application, for
p.000033: society in general as well as for the research itself. He or she must think about whether, for example, it applies to a
p.000033: considerable number of people – each suffering relatively little – or if it is a matter of only a small number of
p.000033: people, who each suffer a great deal or have a disability that affects their everyday lives.
p.000033: The task of the committee is then to make its legally binding decision on the application and to ensure that only
p.000033: experiments that are relevant to the research and well-designed are conducted. Committee members representing the
p.000033: research community review the scientific stringency and methodical relevance of the application. The lay members’ task
p.000033: is to confirm the societal importance of the animal experimentation and to represent the general public’s observation
p.000033: and evaluation.
p.000033: The applicant must submit a complete application and describe the project in such a way that all committee members can
p.000033: understand and discuss it, based on the information it contains. As necessary, the committee may call the applicant to
p.000033: the meeting to provide clarification, or request an expert opinion. The committee may decide that a partial or pilot
p.000033: study should be conducted if a method must first be evaluated; the committee can also do this to reduce the number of
p.000033: animals used, before it has been determined to the best possible degree how the animals will feel or if their suffering
p.000033: is directly regarded as severe.
p.000033: To simplify the evaluation of the animals’ suffering and in the interest of achieving uniformity among the committees,
p.000033: a four-part categorisation has been introduced. Based on this, the applicant him or herself assesses whether the
p.000033: experiment in its entirety entails terminal, mild, moderate or severe suffering for the animal – this is the
p.000033: experiment’s so-called classification of severity. Here, both the researcher and committee may refer to the list of
p.000033: experiments according to degree of severity in the Board of Agriculture’s instructions. The committee must determine
p.000033: whether the applicant has made a reasonable evaluation and, when necessary, correct the information.
p.000033:
p.000033: 3.2.5 Alternatives to using laboratory animals
p.000033: Many researchers try to find animal-free methods that allow them to reach results that are equally dependable. There
p.000033: are several reasons for this. Reasons can include the researcher not wanting to inflict suffering on
p.000033:
p.000033:
p.000033: GOOD RESEARCH PRACTICE
p.000034: 34
p.000034:
p.000034: animals, or the fact that it is relatively costly to keep animals. A third reason, which is being discussed
p.000034: increasingly, is the uncertainty of how transferable results from medical experiments are; that is, how relevant
p.000034: results from experiments using animals are in the medical treatment of humans.
p.000034: For example, comparisons between treatment effects on animals and clinical trials using humans might show poor
p.000034: correspondence. This indicates both that animal experiments and clinical trials may need to be better coordinated, and
p.000034: also that animal experiments do not always provide meaningful information for the treatment of humans. An example of
p.000034: the latter instance is studies aimed at developing methods for treating rheumatoid arthritis by studying patients’
p.000034: tissue samples. Here we can see two of the reasons for not using animals: arthritis is a painful disease even for the
p.000034: animals serving as disease models, and only humans and primates have the central receptors the treatment involves. This
p.000034: means that experiments on mice and rats would have lower relevance.
p.000034: Computer programs are also sometimes used instead of animal experiments, for example to evaluate and calculate side
p.000034: effects of various treatment methods. Cell models can also be used to test, at cell level, the impact of certain
p.000034: chemicals or to study the effects of medication.
p.000034: In Sweden, there is governmental support for research grants for alternative methods to animal experimentation
p.000034: according to the 3R principle, i.e. methods that refine, reduce and replace animal experiments, which can be applied
p.000034: for through the Swedish Research Council. Alternative methods refer to methods that refine, limit and/or replace
p.000034: experiments on animals. It is also possible to apply for research grants from the Swedish Fund for Research Without
p.000034: Animal Experiments (forskautandjurforsok.se). The EU has a centre for the coordination, development and evaluation of
p.000034: alternatives to animal experimentation, ECVAM (the European Centre for the Validation of Alternative Methods), located
p.000034: near Milan, Italy. Since April 2010, there is also an industry-funded centre for alternative methods, CAAT-EU (the
p.000034: Center for Alternatives to Animal Testing Europe) at the University of Konstanz in Germany. Its parent organisation in
p.000034: the US was established in the 1980s.
p.000034: Together with a number of universities, the Swedish Research Council is responsible for providing information to
p.000034: researchers and the general public via the website www.djurforsok.info.
p.000034:
p.000034: 3.2.6 Evaluating the ethics of animal experiments
p.000034: A researcher who uses laboratory animals, as well as the majority of the members of the ethics committees on animal
p.000034: experiments who have the task of determining what is ethically acceptable, have all reached the fundamental conclusion
p.000034: that there are animal experiments that are ethically defensible. Every experiment, however, must be preceded by an
p.000034: ethical evaluation. The following concepts (in italics) may help in highlighting important questions to ask when
p.000034: evaluating what is ethically defensible.
p.000034: A fundamental element to consider is who or what has moral relevance, that is who or what should be considered in the
p.000034: ethical deliberation. A distinction must be made between whether something or someone has moral relevance in itself –
p.000034: intrinsic value – or is relevant for the sake of someone or something else – instrumental value. Intrinsic value is
p.000034: often not measured in degrees, but is instead regarded as either existing in an individual (or a material entity), or
p.000034: not. On the other hand, the instrumental value of an individual or a material entity is possible to measure. Its value
p.000034: can differ, depending on the user or beholder.
p.000034: It is not unusual either for an individual to be considered as having both intrinsic and instrumental value. For
p.000034: example, a genetically modified mouse of a certain lineage can be a highly valuable instrument within a certain
p.000034: research project and at the same time be regarded as having intrinsic value, for instance because it is an experiencing
p.000034: individual, able to feel pain. A sibling mouse that does not express the desired genetic modification has a low
p.000034: instrumental value, but the same intrinsic value.
p.000034: Animal ethicists who argue that animals have rights usually base this on the idea that animals have intrinsic value.
p.000034: Individuals who have intrinsic value also have certain fundamental rights, such as those to food, water, a place for
p.000034: rest, protection from the elements and access to social contact.
p.000034: This reasoning does not necessarily lead to the conclusion that animals and people have the same rights, however.
p.000034: Perceptions of what rights animals are considered to have, and how far-reaching they are, differ among animal
p.000034: ethicists, but are often tied to the capacities of the species in question. A shrimp’s rights are less extensive than
p.000034: those of a mouse, which in its turn has a shorter list of rights than a primate. The point of rights is thus not to
p.000034: argue that “pigs should have the right to vote”, but rather that animals’ physical and social needs should be met, to
p.000034: the degree they exist.
p.000034:
p.000034:
p.000034:
p.000034: GOOD RESEARCH PRACTICE
p.000035: 35
p.000035:
p.000035: A highly central issue in animal ethics concerns the fact that humans are traditionally regarded as something special –
p.000035: as having a special dignity and integrity – and therefore enjoy an elevated level of protection. It is unrealistic to
p.000035: believe that we can arrive at one single reason that is valid for everybody why humans hold this exceptional position.
p.000035: Perhaps the philosophers are right when they say it is impossible to justify it in any other way than to say that
p.000035: someone born by a human thereby has the right to a certain moral protection that is not extended to other living
p.000035: beings. If this is indeed the case, then we have just as great a responsibility to contemplate what we should do with
p.000035: this special position.
p.000035: Our rationality and knowledge allow us to exercise power over other animals. But with power comes responsibility –
p.000035: power over the animals’ situation and power over what issues we choose to research, for both the sake of the people who
p.000035: put their hopes in science and the sake of the animals whose lives are used to this end.
p.000035:
p.000035: What would you do in the following situation?
p.000035: Millions of people today have HIV and risk contracting AIDS if they do not receive effective inhibitor medications. A
p.000035: great deal of research is being conducted to find a cure for HIV/AIDS using chimpanzees which, besides humans, are the
p.000035: only animals that can get HIV/AIDS.
p.000035: You are a member of an ethics committee on animal experiments that is to ethically evaluate a research project aiming
p.000035: to test the effectiveness of a potential vaccine. The researchers inform the committee that the vaccine’s effect needs
p.000035: to be tested on advanced AIDS, which means that the chimpanzees will be in very poor health when the actual
p.000035: experimenting begins.
p.000035: What ethically significant aspects to you feel should be considered to ethically evaluate whether this experiment
p.000035: should be approved? Consider the issue from both a researcher’s and a layman’s evaluation perspective.
p.000035:
p.000035: 3.3 Genetically modified organisms
p.000035: Basic research and applied research with genetically modified organisms, i.e. organisms whose genetic material has been
p.000035: changed in a way that does not occur naturally through mating or the natural recombination of genes, is covered by a
p.000035: detailed system of regulations. Supervisory responsibilities are divided between several authorities, including the
p.000035: Swedish Work Environment Authority, the Swedish Board of Agriculture, the Swedish Board of Fisheries and the Swedish
p.000035: Medical Products Agency. The different authorities’ areas of responsibility, as well as the applicable regulations, can
p.000035: be found at the web portal of the Swedish Gene Technology Advisory Board, (genteknik.se).
p.000035: For research involving the enclosed use of genetically modified organisms, for example the growing of cultures in
p.000035: tightly shut containers or cultivation in a greenhouse, to be conducted it is necessary either for the responsible
p.000035: authority to have given its approval, or for the research to have been reported to this authority. The research should
p.000035: always be preceded by an investigation that serves as a basis for a risk assessment, and the results of this assessment
p.000035: then determine what protective measures will be necessary.
p.000035: Research that involves the intentional exposure of genetically modified organisms, for instance field experiments using
p.000035: genetically modified plants or microorganisms, should always be preceded by an investigation so that the risk of harm
p.000035: can be assessed. Additionally, approval must be received from the proper supervisory authority; and approval can only
p.000035: be given if the research is ethically acceptable. A researcher who ignores the obligation to notify the proper
p.000035: authority or obtain approval can be found guilty of conducting unauthorised environmental work.
p.000035:
p.000035: 3.4 Examples of problems that are still unsolved
p.000035: The Swedish legislation and regulations concerning research are not comprehensive – and never can be (see Chapter 1 on
p.000035: the law and morals). However, there are currently a number of shortcomings that deserve attention, so that workable
p.000035: solutions can be discussed and, if possible, be implemented.
p.000035: First, there is the problem that Swedish legislation is only applicable in Swedish territory. This affects the ethics
p.000035: review of projects that will be conducted wholly or partly in anotherXcountry, even if researchers from
p.000035:
p.000035:
p.000035:
p.000035:
p.000035: GOOD RESEARCH PRACTICE
p.000036: 36
p.000036:
p.000036: Sweden participate and Swedish funding bodies contribute money. Ethical standards that appear self-evident in Sweden
p.000036: can then be difficult to find support for in international research environments.
p.000036: It is especially worrying if researchers perform their work in countries with lower ethical standards, just to take
p.000036: advantage of this. It can, for example, be easier to find research subjects, easier to get permission to use primates
p.000036: in research, cheaper to conduct studies, or involve less extensive application procedures. If these advantages come at
p.000036: the cost of the integrity of the research, it will in many cases involve a breach of the standards in the Declaration
p.000036: of Helsinki:
p.000036:
p.000036: Physicians should consider the ethical, legal and regulatory norms and standards for research involving human subjects
p.000036: in their own countries as well as applicable international norms and standards. No national or international ethical,
p.000036: legal or regulatory requirement should reduce or eliminate any of the protections for research subjects set forth in
p.000036: this Declaration.
p.000036:
p.000036: It is unacceptable for studies to violate this principle. The Norwegian National Committee for Research Ethics in
p.000036: Science and Technology states precise and necessary requirements, namely that
p.000036:
p.000036: a researcher is not to conduct parts of his or her research in anotherXcountry simply because it has lower ethical or
p.000036: safety standards than at home;
p.000036:
p.000036: and that researchers shall inform funding bodies of divergent ethical or safety standards in the country or countries
p.000036: where their research is being conducted.
p.000036:
p.000036: Another problem is that the most fundamental protection for research subjects – that the research project must be
p.000036: ethically reviewed before it can begin – is not always self-evident in other countries. The Declaration of Helsinki
p.000036: requires this review for all medical research performed on humans, and this requirement is held by many funding bodies
p.000036: and journals.
p.000036: Here, the Swedish legal requirement of ethics review is less comprehensive. However, as mentioned earlier, in Sweden
p.000036: there is the option to request an advisory statement from an ethics review board regarding a project that does not
p.000036: formally need to be reviewed. It is good research practice to request a statement in the event research collaborations
p.000036: in other countries are expected to present ethical difficulties for the researchers.
p.000036: The ethics review boards have no obligation to issue these advisory statements however, just the right to do so. If the
p.000036: regional ethics review board refuses to issue such a statement, however, this may cause profound consequences for the
p.000036: researchers’ chances of obtaining further funding and being published.
p.000036: There are issues concerning the withdrawal of consent that are problematic for research ethics. In biobank research,
p.000036: the research subject has the option of withdrawing consent. If this happens, it is the responsible party at the biobank
p.000036: who determines whether the biological material should be destroyed – which is likely to be the research subject’s wish
p.000036: – or only de-identified. In the latter case, the research subject can feel tricked. In research projects using video or
p.000036: audio recording, the research subject is often told he or she can withdraw consent after the recording and that the
p.000036: tape will be destroyed. However, this is in conflict with the regulations governing archiving and storage of research
p.000036: material, as well as with the rules regarding withdrawal of consent in the Act concerning the Ethical Review of
p.000036: Research Involving Humans.
p.000036:
p.000036: References
p.000036: 1. Alexius Borgström, Katarina, Djuren, läkarna och lagen: en rättslig studie om djurförsöksetik. Uppsala, Iustus
p.000036: förlag, 2009. Arkivlag (SFS 1990:782).
p.000036: 2. Brambell, Rogers, F.W. (Chairman), Report of the Technical Committee to enquire into the Welfare of Animals
p.000036: kept under Intensive Livestock Husbandry Systems, London, HMSO, 1965. This states five freedoms for farm animals:
p.000036: freedom from hunger and thirst, from discomfort in housing, from pain and injury, from fear and worry and the
p.000036: opportunity to exhibit natural behaviour.
p.000036: 3. Cavalieri, Paola & Singer, Peter (red.), The Great Ape Project: Equality Beyond Humanity. New York, St.
p.000036: Martin’s Press, 1994. A proclamation from 34 researchers and authors for three rights for certain primates: the right
p.000036: to life, the right to freedom and a prohibition against torture.
p.000036:
p.000036:
p.000036:
p.000036: GOOD RESEARCH PRACTICE
p.000037: 37
p.000037:
p.000037: 4. Centrala försöksdjursnämnden, Författningar, allmänna råd och anvisningar om användningen av djur för
p.000037: vetenskapliga ändamål. Stockholm, CFN:s skriftserie: 45, 2002.
p.000037: 5. Den nasjonale forskningsetiske komité for naturvitenskap og teknologi (NENT), Forsknings- etiske retningslinjer
p.000037: for naturvitenskap og teknologi. Oslo, 2007.
p.000037: 6. Djurförsöksetiska utredningen. Etisk prövning av djurförsök: delbetänkande (SOU 2002:86). Stockholm, Fritzes
p.000037: offentliga publikationer, 2002. Djurskyddslag (SFS 1988:534).
p.000037: 7. Egonsson, Dan, Filosofiska essäer om människovärde. Nora, Nya Doxa, 1999.
p.000037: 8. Förordning om etikprövning av forskning som avser människor (SFS 2003:615).
p.000037: 9. Förordning med instruktion för regionala etikprövningsnämnder (SFS 2007:1068)
p.000037: 10. Förordning med instruktion för Centrala etikprövningsnämnden (SFS 2007:1069).
p.000037: 11. Förordning om utsättning av genetiskt modifierade organismer i miljön (SFS 2002:1086).
p.000037: 12. Förordning om innesluten användning av genetiskt modifierade organismer (SFS 2000:271).
p.000037: 13. Jordbruksverket, Användningen av försöksdjur i Sverige under 2015. Rapport, Dnr: 5.2.17-5428/17.
p.000037: 14. Hug, K. and M. Johansson, The ethics of withdrawal: the case of follow-up from first-in-human clinical trials.
p.000037: Regen Med, 2017. 12(1): p. 25-36.
p.000037: 15. Hug, K., G. Hermeren, and M. Johansson, Withdrawal from biobank research: considerations and the way forward.
p.000037: Stem Cell Rev, 2012. 8(4): p. 1056-65.
p.000037: 16. Karlsson, Fredrik, Weighing Animal Lives – a Critical Assessment of Justification and Prioritization in
p.000037: Animal-Rights Theories. Uppsala, Acta Universitatis Upsaliensis, 2009.
p.000037: 17. Klareskog, Lars & Rönnelid, Johan & Lundberg, Karin & Padyukov, Leonid & Alfredsson, Lars ”Immunity to
p.000037: citrullinated proteins in rheumatoid arthritis.” Annual Review of Immunology, 2008, 26:651–675.
p.000037: 18. Lag om etikprövning av forskning som avser människor (SFS 2003:460).
p.000037: 19. Lag om biobanker i hälso- och sjukvården med mera (SFS 2002:297).
p.000037: 20. Läkemedelslag (SFS 2015:315).
p.000037: 21. Läkemedelsverkets föreskrifter om kliniska läkemedelsprövningar på människor (LVFS 2011:19).
p.000037: 22. Perel, Pablo, & Roberts, Ian & Sena, Emily & Wheble, Philipa & Briscoe, Catherine & Sandercock, Peter & Macleod,
p.000037: Malcolm & Mignini, Luciano E. & Jayaram, Pradeep & Khan Khalid S.,”Comparison of Treatment Effects between Animal
p.000037: Experiments and Clinical Trials: Systemic Review”. British Medical Journal, 2007, 334 (7586):197.
p.000037: 23. Personuppgiftslag (SFS 1998:204).
p.000037: 24. Personuppgiftsförordning (SFS 1998:1191).
p.000037: 25. Rodman, John, ”The Dolphin Papers”, The North American Review, spring 1974, 259:13-26 (page 18).
p.000037: 26. Statens Jordbruksverks författningssamling (SJVFS 2008:70).
p.000037: 27. Strålsäkerhetsmyndighetens föreskrifter om allmänna skyldigheter vid medicinsk och odontologisk verksamhet med
p.000037: joniserande strålning (SSMFS 2008:35).
p.000037: 28. World Medical Association. Declaration of Helsinki. Ethical Principles for Medical Research Involving Human
p.000037: Subjects, adopted by the 18th WMA General Assembly, Helsinki, Finland, June 1964, latest revision by the WMA General
p.000037: Assembly, Seoul 2013. Ferney-Voltaire, France, World Medical Association, 2013.
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037: GOOD RESEARCH PRACTICE
p.000038: 38
p.000038:
p.000038: 4 HANDLING OF RESEARCH MATERIAL
p.000038: - THINK FIRST
p.000038:
p.000038: This chapter, with the exception of Section 4.5, is the translation of a text that is virtually identical to that of
p.000038: Göran Hermerén’s article, “Hantering av integritetskänsligt material”.
p.000038:
p.000038: 4.1 Background and problems
p.000038: The fundamental openness in all public organisations is required by law and established constitutionally. Universities
p.000038: and individual researchers can therefore not take it upon themselves to weigh the interest of public access against
p.000038: other interests.
p.000038: The Declaration of Helsinki, adopted by the World Medical Association, is an important document for medical research
p.000038: ethics. The ethical principles stated in the Declaration are in part also applicable to other research, not least
p.000038: certain social medicine and social science research. This document has been updated a number of times, most recently in
p.000038: October 2013.
p.000038: However, the Declaration of Helsinki is not legally binding. This was reiterated by the Swedish Court of Appeal for
p.000038: Western Sweden in a case a number of years ago that received a great deal of attention; A view that was upheld by the
p.000038: European Court of Justice in 2010. The issue concerned a request that a researcher in Göteborg make public the research
p.000038: material from a controversial study on children with neuropsychiatric disabilities.
p.000038: Swedish law carries more weight than this international declaration in cases when they come into conflict.
p.000038: These issues have received attention in medical research, for instance in the debate and trials that have followed in
p.000038: the wake of the Göteborg case. But the issues have a more general and fundamental side as well, as they also arise in
p.000038: many other scientific areas, such as the humanities (integrity-sensitive information on famous politicians and authors)
p.000038: and social sciences (integrity-sensitive information on individuals and groups that may be revealed in studies).
p.000038: In these cases, the requirements for public access, openness and transparency sometimes come into conflict with the
p.000038: requirement to protect the integrity of research subjects and informants. These issues also carry a danger that current
p.000038: regulation systems increase the risk that studies will be performed outside the healthcare arena, where there is less
p.000038: transparency. It is thus important to have a general discussion on ethical issues in the handling of
p.000038: integrity-sensitive material. Awareness of both the rules and the problems needs to increase within the research
p.000038: community.
p.000038:
p.000038: 4.2 Interest considerations and various types of research
p.000038: In research, this means finding a reasonable way of weighing up many types of interests which are all legitimate, but
p.000038: which in some situations can conflict with each other: the researcher’s interest in obtaining new knowledge, the
p.000038: interest of participants and those affected by the research to have their integrity and private lives protected, and
p.000038: patients’ interest in information they have given their doctor remaining only between them.
p.000038: Funding bodies for basic research, such as the Swedish Research Council, have an interest in openness and transparency.
p.000038: Other funding bodies may have an interest, from a societal perspective, in material being reused or used by many groups
p.000038: – an important task in this case is to specify the conditions under which this can be done.
p.000038: How this weighing of interests is done depends on aspects such as the type of research is being conducted. A
p.000038: significant difference in this context is the distinction between research which is not being conducted in connection
p.000038: with healthcare, and that which is. This distinction is important, as different regulations apply in the two cases.
p.000038: If research is combined with healthcare, for example, the Patient Data Act and the provisions applicable to healthcare
p.000038: operations in the Public AccessXtoXInformation and Secrecy Act apply. It is therefore important to keep several types
p.000038: of journals – both on the patient/treatment being provided, and on the research itself. The patient/treatment journals
p.000038: should only contain information that is necessary for the patient to receive good and
p.000038:
p.000038:
p.000038:
p.000038: GOOD RESEARCH PRACTICE
p.000039: 39
p.000039:
p.000039: safe treatment. Information required for the research project should be reserved for the research journals. The same
p.000039: applies in retrospective studies, especially if they deal with integrity-sensitive questions.
p.000039: But in any type of research, the material collected is not the private property of the researcher or research group,
p.000039: something they own and can do with as they wish. It must be stored and archived according to the general regulations
p.000039: issued by each authority in question.
p.000039:
p.000039: 4.3 Four concepts
p.000039: Four important concepts in the debate that are sometimes confused with each other or used synonymously are secrecy,
p.000039: professional secrecy, anonymity and confidentiality.
p.000039: Information can be covered by secrecy only if it is stated in law, normally the Public AccessXtoXInformation and
p.000039: Secrecy Act.
p.000039: Standards for professional secrecy apply to some professions by law, as well as by ethics rules. All personnel in
p.000039: health and medical care, dental care and social services, for instance, must observe professional secrecy. This means
p.000039: that they are not allowed to discuss patients’ and clients’ health or personal situation with unauthorised individuals,
p.000039: or in any other way communicate this information. Similar standards for professional secrecy also apply to
p.000039: psychologists and clergy, for example. If a certain task is covered by secrecy, it means the person carrying out the
p.000039: task has a duty of professional secrecy.
p.000039: Anonymising or de-identifying involves eliminating the connection between samples or questionnaire answers and a
p.000039: certain individual, so that neither unauthorised persons nor the research group can re-establish it; no one should
p.000039: therefore be able to combine a certain piece of information with a specific person’s identity, for example. The code
p.000039: list is destroyed. Anonymity can also be achieved by collecting material without noting the identity of specific
p.000039: individuals.
p.000039: What is described above differs from a situation where the research group can use code keys to link information or
p.000039: samples to specific individuals (pseudo-anonymising) – which is usually necessary in longitudinal studies, for
p.000039: instance, or to enable auditing of the research. The question of who is and is not authorised, however, is not
p.000039: something for the researcher to determine ultimately. Disputes over this issue can be settled in court. Usually, it is
p.000039: a case of other researchers wishing to use the information in their research. In some cases, it can be stipulated that
p.000039: their research is ethically reviewed. Various reservations can be set in this context, for example that the researcher
p.000039: may have access to the information but is not allowed to contact the subjects studied.
p.000039: Confidentiality is a more general obligation not to communicate information given in confidence, and entails protection
p.000039: against unauthorised persons partaking of the information.
p.000039:
p.000039: 4.4 What can researchers promise?
p.000039: There are some things researchers cannot promise and yet do promise anyway – due to being poorly informed of applicable
p.000039: rules or because they confuse the four concepts discussed above.
p.000039:
p.000039: 4.4.1 Secrecy
p.000039: The basic principle is that public documents shall be publicly accessible and that information can be covered by
p.000039: secrecy only if falls under a specific provision of the Public AccessXtoXInformation and Secrecy Act. The Act contains
p.000039: a chapter that specifically addresses secrecy to protect the individual in research (Chapter 24). But in addition, the
p.000039: Act contains many other provisions that the researcher may have to address, for instance regarding secrecy to protect
p.000039: the individual within health and medical care in Chapter 25.
p.000039: The principle of public access covers public activities, and those activities listed in the appendix to the Act. When a
p.000039: request for information from public documents is received, the authority where it is being stored (for example a
p.000039: university or a county council) is required to evaluate whether the information may be handed out, that is to say
p.000039: whether or not the information is covered by secrecy.
p.000039:
p.000039:
p.000039:
p.000039:
p.000039:
p.000039:
p.000039:
p.000039: GOOD RESEARCH PRACTICE
p.000040: 40
p.000040:
p.000040: 4.4.2 Professional secrecy
p.000040: Professional secrecy follows from secrecy to the extent that if certain information is covered by secrecy, then this
p.000040: also entails a requirement of professional secrecy about it. However, the opposite is not true.
p.000040: If professional secrecy applies for a certain activity, this does not necessarily mean that what is said during the
p.000040: activity is automatically covered by secrecy or that it that it falls under the Public AccessXtoXInformation and
p.000040: Secrecy Act. Furthermore, it can happen that a researcher, through his or her work on a project, becomes aware of some
p.000040: circumstance that must be reported by law (such as child abuse or paedophilia). In such cases, the obligation to report
p.000040: outweighs the secrecy requirement.
p.000040:
p.000040: 4.4.3 Anonymity
p.000040: In some cases, the anonymising of information is a condition set by an ethics review board for its approval of a study.
p.000040: This can be done, for example, by removing personal information on completed questionnaires or samples, so that it is
p.000040: difficult or in practice impossible to link a certain answer or sample to a specific individual. In some types of
p.000040: studies, the identity of the individuals is not relevant, for instance studies on variations in attitudes towards a
p.000040: certain issue in a specific group over time. In such situations, researchers can promise anonymity.
p.000040: It should be noted, however, that this strategy has other drawbacks. Not only is it difficult or impossible to verify
p.000040: the researcher’s information, but it can also happen that an entire group is stigmatised or discriminated against due
p.000040: to the publication of certain research results, even if no individual person in the group can be identified.
p.000040:
p.000040: 4.4.4 Confidentiality
p.000040: The Declaration of Helsinki stresses the importance of confidentiality and of the researcher taking measures to protect
p.000040: the integrity of research subjects and their right to protection of their private lives. This is stated in the latest
p.000040: version of the Declaration from 2013, where it is stressed that:
p.000040:
p.000040: Every precaution must be taken to protect the privacy of the research subjects and the confidentiality of their
p.000040: personal information and to minimise the impact of the study on their physical, mental and social integrity.
p.000040:
p.000040: 4.4.5 Conclusions
p.000040: As just discussed, a researcher cannot promise that no one outside the research group will ever have access to the
p.000040: material or information collected in the course of the study. There are many situations in which access to research
p.000040: material is justified and necessary. For example, it could be a case of other researchers wanting to test the strength
p.000040: of scientific results, an opponent at a disputation requesting access to the basic data, or a report of suspected
p.000040: research misconduct, clinical trials (e.g. inspection), a court ruling or an ongoing court case.
p.000040: It also cannot be ruled out that research material may be handed over to other researchers in cases besides those
p.000040: referred to above. Research costs money, so it is also in society’s interest that material collected is used as much as
p.000040: possible in research. Two general conditions for this to be possible are that the new research project is ethically
p.000040: reviewed (if the law so requires), and that the new researchers adopt the previous researchers’ promise of
p.000040: confidentiality and safe storage of the material.
p.000040: Naturally, the researcher can and should describe to the research subjects the measures taken to prevent, or reduce,
p.000040: the risk that sensitive personal information will be disseminated. The researcher should also explain the conditions
p.000040: under which these protective measures can be enforced. These measures can include the use of code keys, the encryption
p.000040: of certain information, etc.
p.000040: There is of course a risk that some persons will not want to participate in a study if the researchers truthfully
p.000040: explain what they are able to promise, based on the rules that apply. But as a rule, people are willing to participate
p.000040: in medical research if they are asked, informed according to the principles in the Declaration of Helsinki and are told
p.000040: why and to whom the research is important. Of course, it is easier and cheaper to do things right from the beginning.
p.000040: In research that is not conducted in connection with healthcare one can, for example, use a code key and record coded
p.000040: information directly in the research journals, even though there is a certain extra cost involved. This makes it
p.000040: possible to give other researchers access to the information on
p.000040:
p.000040:
p.000040: GOOD RESEARCH PRACTICE
p.000041: 41
p.000041:
p.000041: condition that they assume or take over the professional secrecy promised by the previous researchers. The new
p.000041: researchers then become the personal data controllers.
p.000041: It is not only names that can be replaced with code numbers. Other information in the material that could identify
p.000041: individual subjects can also be disguised in this way (see Chapter 9). The ethics review boards should be able to
p.000041: determine the level of encryption required.
p.000041: Costs can be significantly higher if material that will be shown to other researchers is not collected using codes and
p.000041: code keys, especially if a project is conducted over a prolonged period of time. But it is neither ethical nor legally
p.000041: acceptable for an individual researcher or research group to breach the rules applicable with reference to such costs.
p.000041:
p.000041: What would you do in the following situation?
p.000041: A researcher, Adam, collects data from a specific group of adult informants. He promises that no one outside his
p.000041: research group will have access to the data. Later, his findings are questioned by two other researchers, Brian and
p.000041: Cecilia, who request access to his source data. Adam refuses to hand them over, referring to his promise to his
p.000041: informants. The case reaches an unexpected conclusion when colleagues of Adam’s say they have destroyed the source data
p.000041: on their own initiative.
p.000041: Is the action taken by Adam’s colleagues ethically defensible? Is it compatible with existing legislation? Has Adam
p.000041: promised more than he can deliver?
p.000041:
p.000041: 4.5 Documentation
p.000041: Data collected for a research project is called source data. Sometimes, researchers consider source data to be their
p.000041: own individual property. This might possibly be the case if the research is privately funded and conducted by
p.000041: individuals not associated with normal research environments, and the data does not include personal data.
p.000041: But when the research is conducted at a university or other research institution, or when it is funded with public
p.000041: funds through grants from a research council or foundation, it is the organisation where the research is conducted that
p.000041: owns the material. The researcher or research group can thus not do whatever they want with it, for instance take it
p.000041: with them upon changing jobs, without agreements and special arrangements. Source data and material that documents the
p.000041: research process and the project’s various steps should instead be regarded as documents (submitted, upheld) belonging
p.000041: to the organisation and fall under the Public AccessXtoXInformation and Secrecy Act and the Archives Act.
p.000041: The material from a completed research project should therefore be stored and archived, with subsequent preservation
p.000041: and occasional sorting. If it is integrity-sensitive, there are also specific requirements for how it should be stored.
p.000041: Information on this is provided by the Data Inspection Board, among others. There are many reasons to keep material.
p.000041: For instance, it must be possible to verify research results6, or the material might be requested in the investigation
p.000041: of an accusation of research misconduct. It can also happen that the researcher who obtained the results, or other
p.000041: researchers, wish to reuse the material in another project. As a rule, this type of reuse requires a new ethics review.
p.000041: The material may also be of great value in itself, for example if it documents current societal conditions, in which
p.000041: future generations may have an interest.
p.000041: Whether, when and how an organisation may sort material is addressed in the Archives Act. If material is considered
p.000041: valuable, for instance for the way in which current society will be regarded in the future, it should be saved by the
p.000041: institution. The National Archives should be consulted as to how to proceed.
p.000041: It is important that research institutions and similar establish procedures for documentation, archiving and sorting,
p.000041: and that these procedures are known and observed by their researchers.
p.000041: Making data material collected available to other researchers contributes to facilitating both the scrutiny and the
p.000041: development and application of research. Digitally stored data can today be uploaded onto platforms where it becomes
p.000041: available to other researchers. The conditions under which this may be done are shown in the Open Science Framework
p.000041: (www.osf.io).
p.000041:
p.000041:
p.000041:
p.000041:
p.000041: 6 The importance of other researchers being able to verify the results naturally also applies to publication, including
p.000041: the increasingly common requirement of open access; this is discussed in Chapter 6.
p.000041:
p.000041:
p.000041: GOOD RESEARCH PRACTICE
p.000042: 42
p.000042:
p.000042: References
p.000042: 1. Arkivförordning (SFS 1991:441). Arkivlag (SFS 1990:782).
p.000042: 2. Bohlin, Alf, Offentlighet & sekretess i myndighets forskningsverksamhet. Riksarkivet, 1997:2. Those interested
p.000042: can read more about public access and secrecy issues in the Uppsala University handbook “Hantering av allmänna
p.000042: handlingar vid universitetet” (3 uppl. 2009), which can be downloaded from Uppsala University’s website (regler.uu.se,
p.000042: search for handling of public documents at universities).
p.000042: 3. Hermerén, Göran, Hanteringen av integritetskänsligt forskningsmaterial. Vetenskapsrådet, 2007.
p.000042: 4. Justitiedepartementet, Offentlighet och sekretess hos det allmänna. 2009.
p.000042: 5. Offentlighets- och sekretesslag (SFS 2009:400).
p.000042: 6. Riksarkivet, Om gallring – från utredning till beslut. Rapport, 1999:1.
p.000042: 7. Riksarkivet. Riksarkivets föreskrifter och allmänna råd om gallring av handlingar i statliga myndigheters
p.000042: forskningsverksamhet. Riksarkivets författningssamling, RA-FS, 1999:1.
p.000042: 8. Sveriges universitets- och högskoleförbund (SUHF), Övergripande principer för offentlighet och sekretess i
p.000042: integritetskänslig forskning. SUHF, 2006.
p.000042: 9. Tryckfrihetsförordning (SFS 1949:105).
p.000042: 10. Uppsala universitet, Hantering av allmänna handlingar vid universitetet. Tredje upplagan, 2009.
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p.000042: GOOD RESEARCH PRACTICE
p.000043: 43
p.000043:
p.000043: 5 RESEARCH COLLABORATION
p.000043:
p.000043: 5.1 Introduction
p.000043: Research is an activity that involves the creation and accumulation of significant amounts of knowledge, and its
p.000043: results can be of lasting value for many people. This means that research can be very rewarding activity for an
p.000043: individual to be involved in, but it also means that it can never be a purely private matter, least of all when paid
p.000043: for out of public funds. Research projects are often collaborative endeavours, with a large number of stakeholders.
p.000043: In fields of research where large-scale projects need to be undertaken – perhaps involving heavy investments in
p.000043: instrumentation, large computer programs, detailed interview surveys, questionnaires sent to thousands of informants or
p.000043: clinical studies – extensive collaboration is a practical necessity. Today, much research is conducted by large teams
p.000043: that sometimes include hundreds of researchers scattered across the globe. Such collaborative projects do not come
p.000043: about by themselves.
p.000043: Administration and project management are important in making the research functional. If they are to be concluded,
p.000043: moreover, purposeful efforts are needed and more or less clearly stated rules have to be followed. The organisation of
p.000043: projects of this kind, and the collaboration that occurs within them, raise particular problems.
p.000043:
p.000043: 5.2 Relations with fellow researchers
p.000043: A common reason for establishing scientific collaboration is to broaden the competency within the planned project, for
p.000043: example by involving a colleague who is a specialist in a method of analysis with which you yourself are not familiar.
p.000043: Another reason might be that a colleague has access to resources, such as an instrument, that is not available to you.
p.000043: Yet another could be that the project requires more working hours than you yourself are able to devote to it, or that
p.000043: you wish to complete the project in a shorter time by involving more people in it. It is also common, no doubt, simply
p.000043: to want to have other people to work with, to be part of a team. Collaborations can also arise naturally when
p.000043: researchers supervise students within the framework of their own projects.
p.000043: Whatever the motives for collaboration, it is crucial to form a clear idea at an early stage, and to make it clear to
p.000043: your fellow researchers, what you expect of each other, and not least what you yourself are able to contribute. It is
p.000043: important to establish a time plan for the various parts of the project, even if it has to be updated from time to
p.000043: time. Like all joint ventures, scientific collaboration requires a certain degree of reliability in keeping to agreed
p.000043: timetables.
p.000043: It is still possible to see examples of scientific collaboration in which the participants take such responsibilities
p.000043: quite lightly. Collaborators contribute to the common undertaking “when the spirit moves them”. If the project involves
p.000043: postgraduate students or researchers in the early stages of their careers, this is totally unacceptable. They are so
p.000043: dependent on being able to produce a track record of publications and other results in order to be able to continue at
p.000043: all, that collaborative projects in which they participate must involve a realistic sharing of the workload and a
p.000043: viable and quite strictly regulated time plan.
p.000043: In many collaborations, a modified division of labour gradually crystallises out, with some researchers not
p.000043: contributing in accordance to the original plan, while others fill the gap by doing more. Such adjustments are natural,
p.000043: but they should be openly discussed when they become apparent, and should be reflected in the authorship of the final
p.000043: publications. It causes a great deal of trouble and frustration if researchers who do not have time to participate as
p.000043: intended nevertheless continue to promise to contribute to the joint project, with no realistic chance, or perhaps even
p.000043: intention, of actually doing so.
p.000043: The distinct roles that various participants assume in a collaborative research project are not always what everyone
p.000043: would wish. Just as in other joint efforts – whether it be a matter of domestic chores or team sports – you can end up
p.000043: with certain people taking on responsibility for broader plans, or tricky details, while others look after routine
p.000043: tasks or maintain order. Preferably, of course, everyone should have the chance not only to use the abilities they
p.000043: already possess, but also to learn new skills. This is particularly true of research students and other young
p.000043: researchers; senior members of a group have a special responsibility to ensure that their younger colleagues’ interests
p.000043: in this respect are provided for.
p.000043:
p.000043:
p.000043: GOOD RESEARCH PRACTICE
p.000044: 44
p.000044:
p.000044: It is a good idea to broach the subject of publications and their authorship early on, at the planning stage. These
p.000044: issues should be discussed again if the division of labour changes, or the project develops along new lines. It may be
p.000044: tempting to put off crossing that bridge until you come to it, but experience tells us that, by then, it may be too
p.000044: late. Plain speaking about what rewards different individuals expect and lay claim to in terms of publication credit
p.000044: greatly reduces the risk of conflicts later.
p.000044: When the project and its results are presented in more informal settings too, for example in papers at international
p.000044: conferences, care should be taken to give a correct picture of the contributions of the various participants. In such
p.000044: contexts, the results presented are commonly perceived chiefly as the speaker’s own, and precisely for that reason
p.000044: emphasis should be placed on the contributions of one’s colleagues.
p.000044: A large research group often generates a sizeable and valuable common database of experimental data, computer software,
p.000044: etc. Who owns such material? This question is sometimes raised, not least when doctoral students or postdocs from the
p.000044: group move to other centres to continue their careers. Will they then have free access to the database? This cannot be
p.000044: taken for granted, especially if the researchers in the group have not yet completed and published their analysis of
p.000044: the data. It is important to discuss such questions when the database is created, or at any rate before doctoral
p.000044: students and other collaborators leave the group.
p.000044:
p.000044: 5.3 Interaction with funding and commissioning bodies
p.000044: Major collaborative projects may involve or affect dozens of research groups in as many countries. They may be
p.000044: supported by a large number of funding bodies, often national research councils. An honest and open attitude to these
p.000044: funding agencies is important and, in the long run, beneficial to the research undertaken.
p.000044: In an international project, there may be a temptation to describe your own national involvement as more advanced or
p.000044: extensive than it really is. This can occur both in your direct dealings with the funding body, for example when you
p.000044: apply for grants; and more indirectly, in your dealings with the media: differently targeted press releases may perhaps
p.000044: be written for the media of the various participating countries, lending exaggerated prominence to each individual
p.000044: country’s own researchers.
p.000044: In the case of large-scale projects in particular, funding agencies quite justifiably wish to monitor progress. It is
p.000044: therefore important for project managers and participating researchers to develop appropriate ways of keeping them
p.000044: regularly informed. It is particularly important to give ample warning of forthcoming decisions within the project
p.000044: which will have far-reaching financial consequences. The agencies’ experts, who will usually have introduced the
p.000044: original proposal to the relevant review panel, are often colleagues of the researchers who make up the project
p.000044: management. They, too, should be kept posted on how the work is progressing. In principle, researchers should show the
p.000044: same openness to non-public commissioning and funding bodies as to public ones.
p.000044: Of particular interest in this context, of course, are private companies. It is not uncommon for the researchers
p.000044: involved in a project to have partly different motives from the companies that have commissioned and supported it. This
p.000044: is not something that should be denied or hushed up – on the contrary, once again openness is to be recommended. But
p.000044: these differences in motives may very well resurface in new ways, not least when a strategy is to be adopted for the
p.000044: way ahead in the light of results necessitating a reappraisal of the project design. In such circumstances, researchers
p.000044: should make it clear where they stand, and not try to negotiate with hidden agendas.
p.000044:
p.000044: What would you do in the following situation?
p.000044: In the course of a research project, you discover that a classic problem of applied psychology, which you and others
p.000044: have long been working on, has in fact been wrongly formulated. With your deeper insight, you now realise that a number
p.000044: of earlier contributions in this field are irrelevant. Certain chemotherapeutic methods which seemed promising will
p.000044: probably not work. On the other hand, completely new possibilities have now opened up, though hardly of a kind that can
p.000044: be turned into commercial therapeutic products in the foreseeable future.
p.000044: You have an annually renewable contract with a company to develop the originally envisaged chemotherapeutic methods
p.000044: into commercial products. That grant provides funding for a PhD student who needs another three years to complete her
p.000044: doctorate.
p.000044: How do you act? Does the situation influence your eagerness to publish the new results without delay, results which you
p.000044: are almost certainly the only group in the world to have arrived at?
p.000044:
p.000044:
p.000044: GOOD RESEARCH PRACTICE
p.000045: 45
p.000045:
p.000045:
p.000045: The biggest collaborative scientific projects are funded by international research organisations. Sweden is often
p.000045: represented on the governing bodies of such organisations by researchers or officials, appointed by central government
p.000045: agencies. It is important that researchers selected for such positions do not simply regard their appointment as a
p.000045: personal distinction, but also see themselves as representatives of the country’s research agencies and its research
p.000045: community. This entails, among other things, ensuring that the positions which they adopt on important issues enjoy
p.000045: broad support from the relevant agencies and community, and regularly reporting back to their constituencies on what is
p.000045: happening in the organisations concerned.
p.000045:
p.000045: 5.4 Commercial aspects
p.000045: A growing proportion of Swedish research is paid for by external funding organisations, some of which provide their
p.000045: support in pursuit of commercial goals. Such research is often directly commissioned by the companies concerned, and to
p.000045: a certain extent they may temporarily reserve an exclusive right to make use of the results by deferring publication. A
p.000045: reason for this is that patent rights must be secured before a decision can be made regarding larger investments in
p.000045: costly, risk-filled development projects. However, this gives rise to problems regarding the openness otherwise
p.000045: practised in international research today.
p.000045: In terms of the principles involved, these problems are accentuated by the fact that, when all is said and done,
p.000045: central government generally pays part of the bill for such research projects. According to the Swedish Research
p.000045: Council’s current rules, an agreement with a commercial actor or other stakeholder may not limit the opportunity to
p.000045: publish the results of research carried out with a grant from the Swedish Research Council. Nor may such an agreement
p.000045: delay publication by more than two months. However, the delay may amount to at most four months if the purpose is to
p.000045: enable a patent application based, wholly or partly, on the research results referred to above. Many public funding
p.000045: bodies have similar rules.
p.000045: The largest international database for the registration of clinical trials is currently the US-based
p.000045: ClinicalTrials.gov, developed by the National Institutes of Health (NIH) in collaboration with the Food and Drug
p.000045: Administration (FDA). There are rules stating the conditions under which ongoing studies are to be reported to and
p.000045: registered in the database, one reason being to reduce the risk of the unnecessary duplication of work. Many prominent
p.000045: medical journals currently require that a study be registered in a database of ongoing clinical studies for it to be
p.000045: considered for publication.
p.000045: Matters become especially complicated in projects co-funded by commercial organisations when, as often happens, they
p.000045: involve doctoral students, or assume the form of major international collaborations. A doctoral thesis is fundamentally
p.000045: a public document – the whole point of it is that it should be open to public scrutiny by critics. But if the doctoral
p.000045: student’s work has been funded by an industrial company that wishes to use the results in product development and
p.000045: therefore wants to defer publication, problems can arise.
p.000045:
p.000045: What would you do in the following situation?
p.000045: A company is funding a series of drug studies. Your research group has been given a large grant for such a study, in
p.000045: which you are comparing the company’s products with similar products from other manufacturers, under varying conditions
p.000045: and on different target groups. The company has views on the publication, and tries to influence it so that the studies
p.000045: with the results most positive to the company are published first, the less positive ones much later, and the negative
p.000045: ones not at all. You protest at this.
p.000045: What action do you take?
p.000045:
p.000045: When commercial aspects arise in an international project, the diverging regulatory frameworks of different countries
p.000045: can cause particular problems. In Sweden, the “teacher exemption” allows research results arrived at during working
p.000045: hours, for example at a university department, nevertheless to be patented by the individual researcher concerned,
p.000045: resulting in private financial gain. In other countries, such as the United States, patent rights shall instead be
p.000045: assigned (either wholly or partially) to the university where the work was done. The question of ownership of the
p.000045: results of an international collaborative study can be extremely complex, and can easily poison the atmosphere in such
p.000045: a project.
p.000045: Issues of this kind, including purely practical aspects of how any commercially exploitable results are to be handled,
p.000045: must be discussed in detail by the research groups concerned – preferably before they become a
p.000045:
p.000045:
p.000045:
p.000045: GOOD RESEARCH PRACTICE
p.000046: 46
p.000046:
p.000046: pressing concern. All participants in the project, and not least any doctoral students involved, should be informed
p.000046: about what rules apply.
p.000046:
p.000046: 5.5 Responsibility for a collaborative project: general
p.000046: In certain contexts, it is necessary to identify the individual or individuals formally responsible for a joint
p.000046: project. If, for example, use is to be made of a major international research facility, such as CERN or ESO, a
p.000046: principal investigator (PI) must be designated. Preferably, this should be the initiator of the project or its
p.000046: administrative leader and coordinator.
p.000046: A PI also has to be identified in an application for ethics review.
p.000046: It is important not to fall for the temptation to choose a “high profile” name, if the person concerned cannot take on
p.000046: full responsibility for leading the project. In general, it is also advisable to refrain from naming celebrated
p.000046: researchers as co-applicants, members of reference groups etc., merely to give the project greater credibility. Such
p.000046: individuals can express their favourable opinion of the work in other ways, for instance by writing a letter of
p.000046: support.
...
p.000047: country (suggested term: national coordinator)
p.000047: • the international research director – in EU terminology “the coordinator” (suggested term: coordinating research
p.000047: director or principal investigator, “PI”)
p.000047: • the project’s “board of directors”, which the coordinating research director usually chairs.
p.000047:
p.000047: A reasonable starting point is that each research director is responsible, at his or her individual level, for ensuring
p.000047: that the control mechanisms at this level are actually used. The task of supervision can be delegated to others – and,
p.000047: as regards quality management, is regulated by the EU’s Clinical Trials Directive.
p.000047: The coordinating research director should be the one who bears the overall responsibility for what happens within the
p.000047: project. This means that he or she is the one responsible for ensuring that everyone is qualified to perform their
p.000047: task, that they receive correct instructions and have had time to absorb them and, when applicable, that they have been
p.000047: able to practice their application.
p.000047: If a researcher consciously does something wrong, he or she is reproached. However, research directors at various
p.000047: levels can also be reproached, if their instructions have proven to be faulty. This fundamental aspect may need to be
p.000047: nuanced through a distinction between several specified terms of responsibility, types of responsibility (especially
p.000047: moral and legal) and responsibility for different issues.
p.000047:
p.000047: What would you do in the following situation?
p.000047: A large multinational research project, partly funded by a medical technology company, is testing a technology this
p.000047: company is marketing and is criticised for this in medical trade journals. It turns out that researchers in different
p.000047: countries have used different methods to round off numbers – in all cases to the benefit of the funding company.
p.000047: You suspect that someone has made a mistake, possibly unintentional, but perhaps to benefit certain interested parties.
p.000047: Should you report this? To whom? The project employs a considerable number of researchers at your department and has
p.000047: received a great deal of international attention.
p.000047: What do you do? If your report turns out to be unfounded, the careers of many researchers’ may be damaged. But if you
p.000047: do not report it, you could be contributing to the research being misleading and the medical technology device being
p.000047: used incorrectly and causing harm, or even risking people’s lives.
p.000047:
p.000047: 5.6.2 Conditions of responsibility
p.000047: What conditions must be met in order for responsibility to arise? This question can have both a descriptive and a
p.000047: normative sense. In the first case, it refers to the conditions that do apply in various contexts, while in the second,
p.000047: it refers to the conditions that should apply – perhaps with reference to the guidelines according to which the
p.000047: research is conducted.
p.000047: Points of departure for a discussion of this problem include varieties of causal conditions and predictability
p.000047: standards. According to the causal conditions, one of the conditions for responsibility is that the person who is held
p.000047: accountable must be able to influence or prevent things for which he or she is held responsible.
p.000047: Predictability standards refer to the aspect that he or she should be able to predict what might happen.
p.000047: Causal conditions for responsibility should at times be supplemented with other conditions. In some cases, it is not
p.000047: sufficient that a person is held accountable for something that has happened by means of the fact that he or she has
p.000047: influenced or neglected to influence the events. It is also a requirement that he or she had realised the consequences
p.000047: of these actions. Knowledge and intent clauses can thus sometimes be needed as a complement to causal conditions.
p.000047: Normative clauses on negligence may also be necessary in such a situation, based on the point that it was actually a
p.000047: person who influenced what happened. Suppose a research director created conditions for misconduct by neglecting to act
p.000047: to prevent it, though he or she neither realised he or she was doing so, nor intended to do it. But he or she should
p.000047: have realised this. In this case, a negligence clause can be cited.
p.000047:
p.000047:
p.000047:
p.000047: GOOD RESEARCH PRACTICE
p.000048: 48
p.000048:
p.000048: It might be sensible to clarify carefully the responsibility of persons further down in the hierarchy as well. This may
p.000048: encourage openness, which is healthy and contributes to increased clarity and transparency in the research. It can also
p.000048: help to reduce the risk of various forms of power abuse; but to say this is not to suggest that it is necessary to
p.000048: reduce the leadership capacity of international and national research directors.
p.000048:
p.000048: What would you do in the following situation?
p.000048: An investigation reveals that a researcher has broken international regulations and thereby proven herself unsuitable
p.000048: to continue as research director and supervisor. However, the vice-chancellor of the university where the researcher
p.000048: works chooses to ignore this, and lets her continue in as research director and supervisor. A number of colleagues who
p.000048: question this are themselves subjected to an investigation and other reprisals. Silence spreads among those working at
p.000048: the university.
p.000048: What do you do? Do you remain silent and thereby support and defend the vice-chancellor?
p.000048:
p.000048: Quite a lot of inquiry and legislation work of importance to good research practice is currently in progress. Briefly
p.000048: can be mentioned Ds 2016:46, En ny organisation for etikprövning av forskning (“A new organisation for ethical review
p.000048: of research”). This report presents a proposal for re-organisation that entails the current regional ethics review
p.000048: boards being converted into a single unified public authority, the Ethics Review Authority. According to its directives
p.000048: (Dir 2016:65), the inquiry into the ethics review system shall also carry out a review of the regulatory frameworks for
p.000048: research ethics and the borderline area between clinical research and health and medical care (SOU 2017:50). The
p.000048: research data inquiry (Dir 2016:65) will be analysing the adaptations necessary to the Act concerning the Ethical
p.000048: Review of Research Involving Humans (SFS 2003:460) based on the new EU regulation governing personal data handling.
p.000048: Of particular importance to the handling of personal data for research purposes is the General Data Protection
p.000048: Regulation adopted by the EU (EU 2016/679), which comes into force on 25 May 2018. In general, this reinforces the
p.000048: protection of integrity via the various requirements set by the Regulation to ensure the personal data handling is
p.000048: legal. It applies to areas such as the obligation to inform, and technical and organisational protective measures, etc.
p.000048: At the same time as the new regulatory framework is comprehensive and complicated, it should be noted that research
p.000048: receives favourable treatment in several different respects, such as the issues of handling sensitive personal data. In
p.000048: addition to the EU General Data Protection Regulation, which will apply with legal force in Sweden, work is in progress
p.000048: on national supplementary legislation, and a further special regulation focusing on the handling of research data.
p.000048: Ultimately, it concerns the requirements set for permitting personal data handling for research purposes.
p.000048:
p.000048: 5.6.3 Moral and legal responsibility
p.000048: Researchers’ moral responsibility is based on more or less general values within our culture. This allows for different
p.000048: interpretations among people with varied backgrounds and experiences. One person’s idea of how far- reaching our
p.000048: personal moral responsibility is can be significantly different from another’s. In addition to this moral
p.000048: responsibility, a legal responsibility may also sometimes arise or be required.
p.000048: What rights and obligations do the various actors have, and what does current law have to say on the subject? To answer
p.000048: this question, one has to determine which legislation is applicable and how it should be interpreted. In this context,
p.000048: it is primarily a matter of international and national legislation, for example the EU’s Clinical Trials Directive, the
p.000048: Medical Products Act and the Act concerning the Ethical Review of Research Involving Humans. These texts define or
p.000048: specify our legal responsibility – naturally along with other laws that may apply.
p.000048: Two important paragraphs in the Act concerning the Ethical Review of Research Involving Humans are Sections 11 and 11
p.000048: a, which state that research may only be approved if it is to be conducted by, or under the supervision of, a
p.000048: researcher who possesses the necessary scientific competence, and that during ethics review of clinical trials on
p.000048: humans of the characteristics of a medication (clinical medical trial), in addition to what follows from this Act,
p.000048: Chapter 7 Sections 6 and 7 of the Medical Products Act (SFS 2015:315) shall apply.
p.000048: Besides the moral and legal responsibilities, we have discussed thus far, there is a third category, based on ‘soft
p.000048: law’. This category includes international guidelines, which are not legally binding, but nonetheless carry moral
p.000048: weight and can be cited in legal contexts (see Chapters 1 and 9). Here, there is significantly less flexibility than in
p.000048: the case of views on one’s personal moral responsibility. Important documents in this context
p.000048:
p.000048:
p.000048: GOOD RESEARCH PRACTICE
p.000049: 49
p.000049:
p.000049: are the Declaration of Helsinki, as well as the research ethical guidelines the ICH (International Conference on
p.000049: Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Beings) and CIOMS (Council for
p.000049: International Organizations of Medical Sciences) have adopted.
p.000049:
p.000049: 5.6.4 The extent of responsibility
p.000049: In a research project, a distinction can be made between a number of stages, such as planning the research and
p.000049: conducting the project – which includes collecting, interpreting and analysing data – as well as testing or generating
p.000049: hypotheses, publishing the research results and applying them. Collecting and analysing data is different from drawing
p.000049: conclusions based on them, writing a research report or publishing the report.
p.000049: The coordinating research director has a comprehensive responsibility that covers all these aspects. During the
p.000049: planning phase, this responsibility is obvious. If a research group claims to have equipment or competence it later
p.000049: turns out to lack, it can be reproached both legally and morally. But the coordinating research director is responsible
p.000049: for choosing the research group and ensuring that its members have understood what is required of them. He or she can
p.000049: therefore also not escape reproach (at least morally, and perhaps even legally), if crucial information turns out to be
p.000049: wrong.
p.000049: For projects that entail research on human embryonic stemXcells, for example, the EU requires that information be
p.000049: provided on where the stem cell lines come from, when they were created, etc. It is not reasonable to require that
p.000049: these details or similar information be verified by the coordinating research director; in principle, one must be able
p.000049: to assume that the information provided is correct. However, it can be reasonable to require research directors to
p.000049: choose to work with researchers they know they can depend on – who they have good reason to believe are trustworthy.
p.000049: The coordinating research director is also responsible for organising meetings with the various research groups within
p.000049: the project on a regular basis, and for ensuring that the groups’ work is reported at these meetings, as well as
p.000049: providing the opportunity to discuss how data and results have been obtained, as well as how reliable they are.
p.000049: Alternative interpretations of conclusions and other questions of fact and method should also be addressed in such
p.000049: discussions.
p.000049: The same applies to the all-important publishing phase. There are a number of international guidelines to follow here,
p.000049: for example the Vancouver rules, the Uniform Requirements, which are discussed in other parts of this book. The
p.000049: coordinating research director has to ensure that there is agreement on which rules to follow, that they are made known
p.000049: to the research groups working on the project, and that any necessary agreements are established – to prevent future
p.000049: conflict and problems within and between research groups.
p.000049: If the responsibility for certain issues within a project is delegated, the division of responsibility must be clear,
p.000049: and everyone affected by it needs to understand what they are responsible for. However, such a delegation does not
p.000049: absolve the coordinating research director from ultimate responsibility. He or she must speak up if there are
p.000049: indications that the division of responsibility is not working as intended, and ensure that the shortcomings are
p.000049: corrected.
p.000049: Within a research group, everyone has a certain degree of responsibility to make sure that certain things happen (or do
p.000049: not happen). Experimental researchers in a group should use logbooks of the same type and use the same principles to
p.000049: record information in them on the experiments they conduct and the data they obtain.
p.000049: Coordinating research directors at national and international levels are responsible for presenting the potential
p.000049: problems that can arise, and for taking action to hinder or prevent them through clear instructions. A clear division
p.000049: of responsibility is necessary to avoid problems, and preventive work to this end should be encouraged.
p.000049:
p.000049: What would you do in the following situation?
p.000049: An investigation reveals that a researcher has in many ways proven himself unsuitable to continue as research director
p.000049: and supervisor. Can he be removed from these positions?
p.000049: What do you do, if you have the possibility to influence the case? How do you justify your decision? Is there common
p.000049: practice or some rule you believe you can cite?
p.000049:
p.000049:
p.000049:
p.000049:
p.000049:
p.000049:
p.000049:
p.000049: GOOD RESEARCH PRACTICE
p.000050: 50
p.000050:
p.000050: References
p.000050: 1. Council for International Organizations of Medical Sciences (CIOMS). International ethical guidelines for
p.000050: biomedical research involving human subjects. Geneva, CIOMS, 2002.
p.000050: 2. Council of Europe. Convention for the Protection of Human Rights and Dignity of the Human Being with regard to
p.000050: the Application of Biology and Medicine: Convention on Human Rights and Biomedicine, (Oviedo Convention), European
p.000050: Treaty Series No 164, Strasbourg, 1997.
p.000050: 3. European Code of Conduct for Research Integrity Revised Edition. ALLEA, All European Academies, Berlin 2017
p.000050: 4. Directive 2001/20/EC of 4 April 2001, of the European Parliament and of the Council on the approximation of the
p.000050: laws, regulations and administrative provisions of the Member States relating to implementation of good clinical
p.000050: practice in the conduct of clinical trials on medicinal products for human use.
p.000050: 5. International Committee of Medical Journal Editors (ICMJE). Uniform Requirements for Manuscripts Submitted to
p.000050: Biomedical Journals, (Vancouver Rules), ICMJE, updated 2010.
p.000050: 6. Lag om etikprövning av forskning som avser människor (SFS 2003:460).
p.000050: 7. Läkemedelsverkets föreskrifter om kliniska läkemedelsprövningar på människor (LVFS 2011:19).
p.000050: 8. The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for
p.000050: Human Use (ICH). E6(R1): Good clinical practice: consolidated guideline, adopted by CPMP, July 1996, issued as
p.000050: CPMP/ICH/135/95/Step5, Geneva, 1996.
p.000050: 9. World Medical Association. Declaration of Helsinki. Ethical Principles for Medical Research Involving Human
p.000050: Subjects, adopted by the 18th WMA General Assembly, Helsinki, Finland, June 1964, latest revision by the WMA General
p.000050: Assembly, Seoul 2013. Ferney-Voltaire, France, World Medical Association, 2013.
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p.000050: GOOD RESEARCH PRACTICE
p.000051: 51
p.000051:
p.000051: 6 PUBLISHING RESEARCH RESULTS
p.000051:
p.000051: 6.1 Why publish?
p.000051: Researchers are generally considered to have a duty to publish their results. Not withholding their findings from
p.000051: society and other scientists is a fundamental principle, stressed already by Robert Merton (see Chapter 1).
p.000051: Publication is an integral and essential part of the research endeavour. Researchers must therefore be careful, as
p.000051: discussed earlier (see Chapters 2 and 5), when accepting commissioned work, to make no undertakings to refrain from
p.000051: publishing their results, to restrict their publication or to publish them only if a particular outcome is obtained.
p.000051: Research results are normally reported in writing, either in book form or as articles in scientific journals. In many
p.000051: fields of research, such as medicine and the natural sciences, it is now common for a doctoral student to present a
p.000051: thesis incorporating a number of such articles. Where this format is chosen, the articles are preceded by an
p.000051: introductory narrative, which provides a background and summary and shows how the articles are related to one another.
p.000051: The individual articles may have several authors, but the introduction should be the work of the doctoral student
p.000051: alone.
p.000051: In the humanities and social sciences, the monograph – a single, coherent text, written by the doctoral student alone –
p.000051: is currently the normal form of publication used for doctoral theses. After completing their doctorates, too,
p.000051: researchers in these fields often publish their results in book form and as sole authors.
p.000051: Publication serves several purposes. Only if the results are made public does the research conducted contribute
p.000051: effectively to the dissemination of new knowledge to the wider society. What is more, publication is often essential if
p.000051: others are to build on the researcher’s ideas or to develop practical applications. But it is also necessary to enable
p.000051: the scientific community to scrutinise and discuss the results achieved. The report that the researcher presents
p.000051: consequently has to meet a number of quality standards.
p.000051: In addition, publication serves as an announcement of what the researcher (or group of researchers) concerned has
p.000051: accomplished. The work published is thus of importance when it comes to assessing the worth of a contributing
p.000051: researcher, for example when he or she is applying for a position. The citation of published work nowadays also
p.000051: influences the distribution of governmental research funding to different universities and colleges.
p.000051: When projects are funded by public agencies, researchers are required to make their results available to others (open
p.000051: access). According to the Swedish Research Council general rules for research grants, a researcher may currently not
p.000051: allow an agreement with a commercial actor or other stakeholder to delay publication of results for more than two
p.000051: months, unless a patent application is planned, in which case publication may be delayed by up to four months.
p.000051:
p.000051: 6.2 Disclosure of financial and scientific dependence
p.000051: A researcher publishing results must clearly disclose any ties or dependencies that may exist. Details should also be
p.000051: given of any individuals or bodies providing financial support for the work, and if the research is commissioned, the
p.000051: commissioning organisation should be named.
p.000051: A researcher often builds on other people’s results, uses ideas, concepts, theories and methods drawn from their work,
p.000051: or develops his or her arguments in dialogue with others. It is important to describe such relationships too, to make
p.000051: clear what the researcher’s (research group’s) own contribution is.
p.000051:
p.000051: 6.3 Background, materials and conclusions
p.000051: When a researcher publishes research results, he or she must fulfil a number of crucial requirements. If these are not
p.000051: met, other researchers will not be able to scrutinise the results, and the research community will not be able to
p.000051: assess the quality of the project or the significance of the results.
p.000051: An honest and clear account of the background to the study should always be included in the published report, which
p.000051: will involve quoting and referring to relevant earlier publications. Materials and methods must be described with
p.000051: sufficient clarity and detail to allow a reasonably well-informed reader to assess the scientific quality or
p.000051: significance of the results.
p.000051:
p.000051:
p.000051: GOOD RESEARCH PRACTICE
p.000052: 52
p.000052:
p.000052: Where research is based on empirical data and statistical methods, for example, any dropout and excluded observations
p.000052: must be reported, along with the reasons for the latter. The statistical analysis must be clear and adequate for the
p.000052: method used. Experimental studies must also be presented in such a way that their reproducibility can be tested. The
p.000052: researcher should report all variables and conditions included in the study, and the deliberations carried out in order
p.000052: to determine the sample size. in empirical, non-experimental studies, for instance within the historical disciplines,
p.000052: source material and support for any claims made must be presented. These standards have to be met if it is to be
p.000052: possible for other researchers to check the results and assess the quality of the research and the significance of the
p.000052: results.
p.000052: It is important that the presentation of the results and conclusions is balanced and fair. When publishing research
p.000052: findings, issues such as the underlying assumptions for the conclusions drawn, the limitations of those conclusions and
p.000052: the area in which they apply, and a discussion of possible objections are crucial quality factors.
p.000052: Several scientific journals are open to researchers pre-registering their studies. This means that before the study is
p.000052: carried out, the journal approves the background and the question addressed, the design and analysis of the research,
p.000052: and also guarantee publication, whatever the outcome.
p.000052: Several scientific journals also require that the study plan is registered in a public database before any research
p.000052: subjects are included.
p.000052:
p.000052: 6.4 The third task and the media
p.000052: According to Chapter 1 Section 2 of the Swedish Higher Education Act (SFS 1992:1434), one of the main tasks of the
p.000052: country’s universities is to cooperate with society and inform the general public about research. This usually is
p.000052: called the “third task”, and is often achieved through the media.
p.000052: It is important for researchers to understand that the task of the media is to discover and transmit what goes on,
p.000052: openly or below the surface, or what is under development. An urge to be the first to report things that could
p.000052: challenge the established wisdom and a tendency to stress the dramatic are part of the basic strategy in most media.
p.000052: Some researchers may be put off by the media and what can be felt to be a blunt and oversimplified way of presenting
p.000052: important research problems, while others may be tempted to succumb to this media pressure and announce results
p.000052: prematurely, or even to exaggerate their importance. Both these extremes can have harmful effects.
p.000052: The public’s trust in research is the very foundation for public funds being used to support research.
p.000052: Therefore, researchers should make it a point of informing the public about new research results, but also of
p.000052: discussing topical scientific issues brought up in the general news flow, and in societal debate. Keeping things secret
p.000052: or remaining silent fosters misunderstanding and suspicion.
p.000052: However, preliminary and unverified results should not be made public, even if they may make for interesting news. If,
p.000052: at a later date, and on closer scrutiny, the results announced prove incorrect, then misgivings or false hopes will
p.000052: have been raised among the various people directly or indirectly affected by the study, for instance patients or
p.000052: relatives of patients with the disease being studied. Well-founded alerts to newly discovered problems should of course
p.000052: be published as soon as possible, but the researcher must guard against exaggeration, for example by securing
p.000052: independent peer review of the results.
p.000052:
p.000052: What would you do in the following situation?
p.000052: In a science programme on the radio, your professor gets his facts wrong, and not for the first time. He expresses
p.000052: himself, with great self-assurance, on matters far beyond his field of expertise. You raise the matter with him (again,
p.000052: not for the first time), but this time he does not simply shrug his shoulders, but tells you to get in touch with the
p.000052: producers to do a piece of your own and “have the fight out in the open”. Next term he will be deciding on an extension
p.000052: of your postdoctoral fellowship.
p.000052: What do you do? Would things be different if he didn’t have a say in your situation – or if it was the first time this
p.000052: had happened? Does it depend on what type of issue he talked about?
p.000052:
p.000052:
p.000052:
p.000052:
p.000052:
p.000052:
p.000052:
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p.000053:
p.000053: 6.5 Open access
p.000053: Open access to scientific publications has a number of advantages. For researchers, it is an excellent way of rapidly
p.000053: presenting their findings, and making their texts easily accessible. This makes work available to researchers, whose
p.000053: departments cannot afford to subscribe to scientific journals, and to students and teachers who can use them freely for
p.000053: educational purposes. The more readers a text has, the greater the chance is that it will be of benefit. The OECD, the
p.000053: European Commission and other organisations have stressed that scientific work financed by public funds should also be
p.000053: openly accessible to all. The disadvantage, to the individual author, of the additional costs of making a research
p.000053: article openly accessible must be weighed against the advantage of avoiding expensive subscription fees.
p.000053: Many actors in Sweden – among them the Swedish Research Council and the Association of Swedish Higher Education –
p.000053: follow the 2003 Berlin Declaration on open access to scientific knowledge. The signatories to this declaration intend
p.000053: to encourage researchers to publish their results on the Internet, to develop methods for safeguarding the quality of
p.000053: online publication, and to work towards open publication being counted as a merit in the evaluation and recruitment of
p.000053: researchers.
p.000053: Since 2010, researchers granted funding from the Swedish Research Council are obliged to publish their results
p.000053: according to the principle of open access (open access journal, hybrid or self archiving; the concepts are explained in
p.000053: the next section). Research articles lodged shall be made openly accessible within six months. For researchers with
p.000053: grants within educational sciences or humanities and social sciences, open access has to be made available within
p.000053: twelve months. The Swedish Research Council’s rules concerning open access currently only apply to scientifically
p.000053: reviewed texts in journals and conference reports, and not monographs or book chapters.
p.000053: Journals often publish material electronically, but it is important to remember that this does not automatically entail
p.000053: that it becomes openly accessible. In order to publish according to the requirements for open access, there are three
p.000053: options:
p.000053:
p.000053: 1) In an open-access journal – these, just like traditional scientific journals, use peer review to assess the
p.000053: quality of the research articles.
p.000053: 2) Hybrid publication – the research article is published in a subscription-based journal, which offers the author
p.000053: the choice of open access, against a fee.
p.000053: 3) Self archiving – which means that the researcher, in addition to publishing the research article in a
p.000053: subscription based scientific journal, also deposits it at the time of publication in an open repository, and is made
p.000053: openly accessible within six or twelve months.
p.000053:
p.000053: The legal room surrounding self archiving is dependent on the policy of the journal/publisher. To help researchers in
p.000053: handling rights issues, the EU Commission’s framework programme for research and innovation, Horizon 2020, has produced
p.000053: an appendix to the publication agreement. This appendix guarantees that the researcher retains the right to deposit the
p.000053: work in an open archive, and thus make it freely accessible. An accompanying letter that researchers can use in their
p.000053: contacts with publishers has also been produced, see the website sparcopen.org Despite this, self archiving is
p.000053: regarded as complicated, and for this reason the major journal publishers are offering the option of hybrid
p.000053: publication, which replaces the need for an appendix to the publication agreement and avoids the risk of several
p.000053: different versions of the work being published.
p.000053: Developments in technology have entailed a fundamental change within the area of scientific publication area. To follow
p.000053: this development, see for example the website kb.se/openaccess, which has information on current developments and a
p.000053: discussion forum. A discussion is also in progress on the existence of a so-called “copyright teacher exemption”, which
p.000053: would give the university both the right to use and a certain right to process educational materials.
p.000053:
p.000053:
p.000053:
p.000053:
p.000053:
p.000053:
p.000053:
p.000053:
p.000053:
p.000053:
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p.000054: 54
p.000054:
p.000054: m
p.000054:
p.000054: 6.6 Publication as a measure of worth
p.000054: Since the number of published works play a major role when the merits are compared, for example in recruitment, there
p.000054: is a temptation to break research results down into “smallest publishable units”, to enable a larger number of titles
p.000054: to be presented. Such a proceeding is contrary to good research practice. It makes it more difficult to check the
p.000054: results of the research, with each individual article only providing some of the information that a more comprehensive
p.000054: one could convey.
p.000054: Research has shown that this can lead to misleading results. Readers could get the wrong impression that results
p.000054: presented in a number of different publications come from different studies, when they were actually obtained in a
p.000054: single study. In overview articles they will then be added up, with misleading consequences.
p.000054: Generally speaking, a complete presentation of the results should be given, and published reports should not be
p.000054: fragmented in such a way that subsets of results from the same study are presented in different publications. If this
p.000054: nevertheless occurs, there must be clear reasons for it, and cross-references must be given to where other results from
p.000054: the same or very closely related studies are published.
p.000054: Duplicate publication, i.e. the publishing of articles very similar in content, perhaps with different titles, should
p.000054: also be avoided. If there is good reason to do this, however, for instance when an article is included in an anthology
p.000054: or translated into a more internationally accessible language, it should be stated that it is a case of duplicate
p.000054: publication and a reference to the previous publication should be included.
p.000054: In peer reviews, it should be the quality of the research that is evaluated. Various publication tricks are easily
p.000054: spotted, with the likely consequence that the author’s credibility is called into question. The number of a
p.000054: researcher’s publications in itself also has no significance in the bibliometric model that is used in the distribution
p.000054: of some governmental funds to universities; instead, it is the number of citations that is decisive.
p.000054: Here, a distinction must of course be made between own citations and citations by other authors. A publication with no
p.000054: citations has no value whatsoever in the bibliometric model.
p.000054: In summary, a merit list is not necessarily better simply because it contains a large number of publications.
p.000054:
p.000054: What would you do in the following situation?
p.000054: For far too long now, in your applications to the research council and at various international conferences, you have
p.000054: been talking about a major work that is soon to be finished, and of which you are rightly proud. Now you are finally
p.000054: going to publish it – and not before time, because you have heard that a group in Hamburg has a similar publication in
p.000054: the pipeline.
p.000054: Then one of your colleagues discovers an irritating error in one of your computer programs. It is probably of no
p.000054: significance, but it will take at least six months to fully investigate the consequences. If your work is not published
p.000054: before the next application round, or the Germans beat you to it, the livelihoods of a postdoc scholarship holder and a
p.000054: postdoctoral research fellow funded from your council grant will be put in jeopardy.
p.000054: What do you do?
p.000054:
p.000054: 6.7 The author
p.000054: The author is responsible for the contents of a book or article presenting his or her research. That includes
p.000054: everything related to the actual project – methods, validity and reliability of the results, etc. – but also the
p.000054: quality of the manuscript. It is also the author’s responsibility to check a journal’s or publisher’s terms regarding
p.000054: parallel publishing before one and the same manuscript is simultaneously submitted to or published in several different
p.000054: journals. Another responsibility is of course to make sure that the references and quotations in the text are correct.
p.000054: In the case of research based on statistical analysis, a scientific interpretation has to be undertaken, taking careful
p.000054: account of all the basic assumptions and limitations of the procedure used to test the hypothesis. The results also
p.000054: have to be interpreted in the light of previously published findings, and other investigators’ results cited where
p.000054: relevant.
p.000054: Researchers studying, for example, the links between gender and absence from the workplace, the incidence of crime in
p.000054: different groups in the community, or the economic situation, genetics and dietary habits of
p.000054:
p.000054:
p.000054:
p.000054: GOOD RESEARCH PRACTICE
p.000055: 55
p.000055:
p.000055: different ethnic groups, must make sure they present their statistical interpretation of the data, in relation to
p.000055: their scientific hypotheses, and explain what that interpretation shows and what underlying assumptions have been made,
p.000055: not least when the results are published outside traditional academic circles. If the author foresees a risk of
p.000055: over-interpretation in the media, he or she has a responsibility to try to preclude or prevent that risk, especially if
p.000055: it might cause harm to the research subjects or any third parties.
p.000055: A good scientific presentation will include an active discussion of the results by the author. This means that the
p.000055: author should not only cite or refer to works which support the proposition advanced. It is also necessary to present
p.000055: possible arguments against it, and try to respond to them in the text.
p.000055:
p.000055: 6.8 Multiple authors – responsibility – publication rules
p.000055: Why is the question of authorship important?
p.000055: One reason is that the authors’ names are, rightly or wrongly, seen by colleagues in their field as an indication of
p.000055: the quality of a publication. Consequently, it is important to know who actually did the work, so as to be able to
p.000055: evaluate the results. A second reason is that researchers applying for positions are assessed to a large degree on the
p.000055: basis of their publications. Obviously, therefore, it is important that no one is listed as an author who should not
p.000055: be, and that no one who should be so listed is omitted. A third reason is that it must be apparent who bears the
p.000055: responsibility in the event of an investigation into research misconduct.
p.000055: Two questions thus need to be asked:
p.000055:
p.000055: • Who should be designated as the author or authors of an article?
p.000055: • In what order should multiple authors be listed?
p.000055:
p.000055: The first question has been discussed at length internationally. An influential group of journal editors decided to
p.000055: attempt to draw up general guidelines on co-authorship. The result was a set of criteria described in the Uniform
p.000055: Requirements for Manuscripts Submitted to Biomedical Journals, the Vancouver Rules, mentioned in Chapter 9. An
p.000055: increasing number of influential journals in more and more research areas are adopting these rules, which, among other
p.000055: things, state:
p.000055:
p.000055: Authorship credit should be based on 1) substantial contributions to conception and design, acquisition of data, or
p.000055: analysis and interpretation of data; 2) drafting the article or revising it critically for important intellectual
p.000055: content; and 3) final approval of the version to be published. Authors should meet conditions 1, 2, and 3.
p.000055:
p.000055: To be credited as an author according to these criteria, it is not sufficient, for example, to collect patient data or
p.000055: provide a limited input – such contributions can be acknowledged in other ways, for example in notes or a preface. Such
p.000055: an acknowledgement should, however, be approved in advance by the person in question.
p.000055: An alternative to the approach just described is simply to list everyone who has been involved in the work in some way
p.000055: and to state what they have done, roughly in the manner of the closing credits of a film or television programme. Some
p.000055: journals have moved in this direction as a complementary practice. If the aim is to reduce the number of people listed
p.000055: as authors, the Uniform Requirements criteria are to be preferred; but if the goal is a system that reflects what
p.000055: contribution everyone has in fact made, the second approach is better.
p.000055: As regards the order of authorship, too, practices vary. One common tradition is to list the authors in alphabetical
p.000055: order, unless one of them has had a clearly dominant responsibility for the work presented. If the order is other than
p.000055: alphabetical, the first author will generally have made the most important contribution.
p.000055: Appearing first in the list will then carry most credit (assuming it is a good article). Names that come later in the
p.000055: list will often carry descending credit reflected by their distance from the first name, except for the author listed
p.000055: last, who is often the one who bears overall responsibility.
p.000055: Some journals allow a statement on a text’s title page that all authors have “contributed equally”. It should be
p.000055: noted, however, that measures of worth based on bibliometric methods often do not consider the order of the author
p.000055: list; as practices vary depending on research area, this is not possible. Thus, differences between the contributions
p.000055: of the various authors are not taken into account either. If the trend of using bibliometric evaluation systems
p.000055: continues, the order of the author list and different authors’ respective contributions will likely become less
p.000055: important.
p.000055:
p.000055:
p.000055: GOOD RESEARCH PRACTICE
p.000056: 56
p.000056:
p.000056: The basic principles are that every person listed as an author of a scientific text should meet the requirements for
p.000056: inclusion, and that no one who meets these requirements should be excluded.
p.000056: Another problem can arise when someone makes a significant contribution to the work effort during the research itself,
p.000056: but is not given the option of being included on the author list. It is even more problematic when someone contributes
p.000056: a great deal, not only to the research but also to the writing, and yet is not given the option of approving the final
p.000056: version of the text. This means that he or she does not meet the authorship requirements and can thus, according to the
p.000056: rules, be left off the author list.
p.000056: Should the principle be that everyone who contributes to the research to any significant degree should also contribute
p.000056: to the writing? This is not a given, but it seems that in most cases the two aspects should go together. If a person is
p.000056: not allowed to be included on the author list due to personal conflict with the research director, this is of course
p.000056: not ethically acceptable. If, on the other hand, it is because his or her contribution is deemed to be too
p.000056: insignificant, and it is a case of one person’s word against the other’s, it is hard to come up with proof. This again
p.000056: highlights the importance of clear agreements about the conditions for authorship. Such agreements should not be
p.000056: jeopardised by personal conflict; if this happens, it is a violation of good research practice.
p.000056:
p.000056: What would you do in the following situation?
p.000056: Prior to a meeting of a PhD examining committee, one of the members discovers that three of the articles making up the
p.000056: thesis have a co-author who died three and a half years ago. The articles concerned were published this year, or have
p.000056: recently been submitted. In other words, the author in question had been dead for at least two years before the papers
p.000056: were completed. The data were collected around five years ago, however.
p.000056: Thus, the person concerned may have had a hand in planning the project and collecting the data, but hardly in their
p.000056: analysis and interpretation. Still less could this co-author have been in a position to influence the drafting of the
p.000056: articles, to have accepted the contents or the final versions of the articles.
p.000056: Is it right for the deceased researcher to be listed as a co-author? What arguments could be advanced for and against
p.000056: his inclusion? What course of action could have been chosen instead?
p.000056:
p.000056: 6.9 The responsible publisher and the editor
p.000056: The responsible publisher of a scholarly journal has a responsibility to ensure that existing rules in the area of
p.000056: research ethics and current legislation relating to research are followed. Leading international journals now insist on
p.000056: review of a project by an ethics committee or the equivalent as a condition for publishing the results. This is
p.000056: something that every scientific journal in a field involving research on humans or animal experimentation should
p.000056: require (see Chapter 3).
p.000056: The editor of a journal has the overall responsibility for its scientific quality. That means, among other things, that
p.000056: he or she should request clarifications of methods, results or interpretations, for example, if they seem unclear.
p.000056: Alongside the author, who obviously has the main responsibility, the editor is also responsible for making sure a
p.000056: published article provides accurate references to relevant earlier research, and that the choice of references is not
p.000056: improperly influenced by rivalry or a conflict of interest. The editor should also provide space in the journal for
p.000056: debate about published manuscripts.
p.000056: Researchers have found that it can be difficult to get negative results published. But what constitutes a negative
p.000056: result depends on how the hypothesis is framed. The editor should ensure that it is also possible to publish articles
p.000056: showing that a certain hypothesis does not have scientific support. If the hypothesis is one that is currently under
p.000056: debate, then such negative findings are important and space should be made available for them.
p.000056:
p.000056: What would you do in the following situation?
p.000056: As a journal editor, you have received a manuscript from a very well-known, older researcher. You see that he has
p.000056: published over 50 articles in your journal, long before you became its editor, and that many of them are now classics.
p.000056: But his new article seems to be mostly a rehash of old material, and is also quite poorly structured. The referee
p.000056: recommends rejection. You are considering giving him special treatment by going through his paper carefully and
p.000056: suggesting a number of specific changes.
p.000056: Would you do this?
p.000056:
p.000056:
p.000056: GOOD RESEARCH PRACTICE
p.000057: 57
p.000057:
p.000057:
p.000057:
p.000057: References
p.000057: 1. Berlin Declaration on Open Access to Knowledge in the Sciences and Humanities. Berlin, 2003,
p.000057: https://openaccess.mpg.de/Berlin-Declaration.
p.000057: 2. Helgesson, Gert & Eriksson, Stefan, Publiceringsetik. Studentlitteratur, 2013.
p.000057: 3. Horizon 2020, http://ec.europa.eu/research/participants/data/ref/h2020/grants_manual/hi/oa_pilot/h2020-
p.000057: hi-oa-pilot-guide_en.pdf
p.000057: 4. Högskolelag (SFS 1992:1434).
p.000057: 5. International Committee of Medical Journal Editors (ICMJE), Uniform Requirements for Manuscripts Submitted to
p.000057: Biomedical Journals, (Vancouver Rules), ICMJE, updated 2010.
p.000057: 6. Organisation for Economic Co-operation and Development (OECD). OECD Principles and Guidelines for Access to
p.000057: Research Data from Public Funding. Paris, OECD, 2007.
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p.000058: 58
p.000058:
p.000058: 7 OTHER ROLES OF THE RESEARCHER
p.000058:
p.000058: The requirements on quality and integrity are also relevant to discuss in connection with tasks associated with the
p.000058: researcher role. This relates to the roles of supervisor, teacher, expert and reviewer.
p.000058:
p.000058: 7.1 The supervisor and postgraduate supervision
p.000058:
p.000058: 7.1.1 The tasks of the supervisor
p.000058: There are many ways of being a good supervisor. In general, someone who is appointed as a supervisor has a
p.000058: responsibility to create conditions that will help to develop the doctoral student’s knowledge and skills.
p.000058: Through discussions, teaching and their own example, good supervisors transfer knowledge, skills and experience to
p.000058: their doctoral students, and guide the research which they are undertaking.
p.000058: One important task is to work with the research student to define a suitable thesis project, and to draw up an
p.000058: individual plan of study consistent with the general guidelines laid down by the faculty and the department. The extent
p.000058: to which doctoral students are able to choose and shape their research topics can vary, however. In some research
p.000058: areas, research students will often be offered a place in an existing project group, where the problems to be
p.000058: investigated will already essentially have been formulated, whereas in other areas they will have more opportunity to
p.000058: influence their research tasks. It is therefore important for the supervisor to discuss the basic prerequisites for the
p.000058: research work with the doctoral student before a topic is chosen. Where more than one supervisor is appointed, the
p.000058: different supervisors’ functions and relationships to the research student should be clearly defined from the outset.
p.000058: In the supervision, the supervisor serves as a support, a contributor of ideas, a critic and a discussion partner.
p.000058: The supervisor is the person the doctoral student can test his or her ideas on, the person who provides encouragement,
p.000058: but also the person who reads with a critical eye the texts that the student produces. The supervisor has to give
p.000058: opinions on methodology issues, as well as on questions of interpretation and results, and thus acts as both adviser
p.000058: and critic. The role of constructive critic is both important and difficult. Criticism on a scientific point must not
p.000058: be withheld out of a misguided concern not to hurt feelings; the consequences for the doctoral student at a later stage
p.000058: could be devastating.
p.000058: Although supervisor and doctoral student often work very closely together and it is natural for them to see each other
p.000058: as friends, it is important that the professional relationship takes precedence. The supervisor has a responsibility to
p.000058: ensure that no circumstances arise that could jeopardise this relationship. If this happens, the supervisor may have to
p.000058: hand over the task to someone else.
p.000058:
p.000058: 7.1.2 Whose ideas?
p.000058: In discussions between the supervisor and doctoral student, different arguments and approaches are tested, and views
p.000058: and ideas exchanged. Sometimes it is also important in such discussions to consider how justice can best be done to the
p.000058: contributor’s input as the work continues and the results are published. In the thesis, the doctoral student should
p.000058: account for any contributions by others, including his or her supervisor.
p.000058: But it is also important that, if the supervisor uses or develops ideas originating from the student, this is done in
p.000058: consultation with the student and no attempt is made to conceal their origins. Ideas that the supervisor suggests to
p.000058: the doctoral student for further investigation, however, do not thereby become the latter’s property. The supervisor,
p.000058: too, must be able to continue to work on these ideas in his or her own research without jeopardising the student’s
p.000058: research work.
p.000058:
p.000058: 7.1.3 The thesis and its presentation
p.000058: The ultimate goal of the doctoral student’s research is to produce knowledge, formulated in a scholarly dissertation
p.000058: and reviewed at presentation. The supervisor decides, in consultation with the student and the examiner, when the work
p.000058: can be considered complete and its public defence arranged. A host of different factors will be considered in reaching
p.000058: this decision, including purely financial considerations, the future prospects of the student, undertakings regarding
p.000058: completion time, and the personal wishes of the student.
p.000058:
p.000058:
p.000058: GOOD RESEARCH PRACTICE
p.000059: 59
p.000059:
p.000059: But the supervisor’s personal wishes, for example to see a postgraduate gain his or her doctorate as soon as possible,
p.000059: can also figure. The primary considerations in this context, however, must be the student and the research programme
p.000059: undertaken. It is unethical to force the pace of completion, for example to collect “PhD points” for the department.
p.000059:
p.000059: 7.1.4 Responsibility for ethical and legal compliance
p.000059: Ethical and legal rules vary depending on the kind of research being conducted. As the leader of the specific research
p.000059: project on which the doctoral student is working, the supervisor is responsible for ensuring that the necessary
p.000059: approvals have been obtained and that the project complies with the ethical standards relevant to the type of research
p.000059: involved.
p.000059: He or she must consequently keep abreast of the basic documents setting out the fundamental rules and guidelines for
p.000059: research ethics that may be topical. The supervisor should discuss the relevant documents with the doctoral student,
p.000059: and try to create an awareness of what their application entails in specific situations and, in particular, in the
p.000059: student’s own research. Examples of documents that apply in various situations are discussed in Chapter 9.
p.000059: Since the responsibility for the ethical aspects of the doctoral student’s project rests with the supervisor, it is the
p.000059: supervisor who has to ensure, for instance, that experiments in medical research are terminated if patients or healthy
p.000059: subjects suffer unexpected harm. The same applies if the ratio of risk to benefit is not consistent with the
p.000059: risk-benefit assessment arrived at when the research was planned and approved by the regional ethics review board, or
p.000059: if other undesirable complications are reported.
p.000059:
p.000059: 7.2 The teacher
p.000059: A role often combined with academic research is that of teaching. The role of teacher carries special responsibilities,
p.000059: towards the students and towards the department offering the courses. An academic teacher may be obliged to teach on a
p.000059: broad spectrum of courses.
p.000059: Students have a right to set high standards for their teachers to be competent and to stay informed on developments
p.000059: within their field. To uphold good quality, a teacher must not only maintain his or her knowledge and skills, but also
p.000059: seek to broaden them. Teaching staff should not – at least not without declaring their limitations – address problems
p.000059: in their lectures and classes which do not fall within their field of expertise.
p.000059: Basically, these standards are no different from those placed on many other occupations. For instance, who wants to see
p.000059: a doctor or hire a computer consultant who hasn’t kept up with current developments since graduation?
p.000059: It is important to be aware that the teacher is in a position of power in relation to the students; a position which
p.000059: must not be abused. Certain departments and other course providers have special ethical rules for teachers. In
p.000059: addition, the Swedish Association of University Teachers (SULF) has adopted ethical guidelines for university teaching
p.000059: staff (Etiska riktlinjer för universitetslärare, 2005). Those working as teachers should be familiar with and seek to
p.000059: comply with such documents.
p.000059:
p.000059: 7.3 Assessing applications and proposals
p.000059: Researchers are frequently called upon to review colleagues’ research proposals or to act as external assessors in
p.000059: conjunction with appointments. It is important in such contexts to decline invitations to provide an assessment when a
p.000059: conflict of interest might arise. It is sufficient that a circumstance exists that, seen from outside, may reduce the
p.000059: confidence that the researchers will make an objective assessment. If you are uncertain whether a conflict exists, you
p.000059: should disclose this to the party requesting your participation. Provisions relating to conflict of interest are
p.000059: included in the Administrative Procedure Act (for national public authorities) and in the Local Government Act (for
p.000059: municipalities). To help in the interpretation of conflict of interest rules in research funding, the Swedish Research
p.000059: Council has produced a policy on conflicts of interest (2014).
p.000059: It is also important to base assessments of this nature on an objective and careful analysis of the documents and
p.000059: qualifications presented, and to maintain a critical stance towards unfounded claims and opinions aired by others. It
p.000059: should go without saying that the analysis in any assessment should be well founded.
p.000059:
p.000059:
p.000059:
p.000059:
p.000059: GOOD RESEARCH PRACTICE
p.000060: 60
p.000060:
p.000060: 7.4 Reviewing manuscripts for publication
p.000060: Another situation where ethics may be tested is when a researcher reviews an article or a larger manuscript submitted
p.000060: to a journal or publishers for publication. It is very common in the academic world for a researcher’s work to be
p.000060: assessed by his or her colleagues. Since such assessments presuppose expert knowledge in the field concerned, there are
p.000060: few alternatives to this system, which is generally referred to as “peer review”. Thus, clear rules to counteract
p.000060: various types of conflict of interest are crucial.
p.000060: One reason the system has been challenged is a number of flagrant cases of peer reviewers abusing the trust which being
p.000060: given access to a colleague’s work to assess it entails. Such abuses have included reviewers stealing ideas from
p.000060: submitted manuscripts (this is addressed in Chapter 8), “sitting on” manuscripts for a long time to enable researchers
p.000060: in their own groups to publish their results first, or trying without just cause to prevent the publication of
p.000060: colleagues’ work.
p.000060: Often, the journal reviewers know the identity of the authors, while the authors do not know the identity of the
p.000060: reviewers. Temptations to abuse the system in conjunction with such tasks could be reduced if the system was either
p.000060: entirely open, or else double-blind.
p.000060: Another important reason why the peer review system has been questioned is that the volume of manuscripts submitted to
p.000060: journals is now so great that it can be difficult to find willing and competent reviewers. There is good reason to
p.000060: consider awarding greater merit than is given today for the arduous work of reviewing texts (not only when it comes to
p.000060: journal publication, but also in advisory groups and in the case of thesis defence and the awarding of positions).
p.000060: For the system of peer review to continue working, as referred to above, at least three criteria must be met: reviewers
p.000060: must submit their reports as quickly as possible, they must not use information in the manuscript for their own
p.000060: purposes without referring to the source – and if they do wish to use it, they must first contact the author and ask
p.000060: whether he or she has any objection – and they must be guided only by objective reasons in deciding whether or not to
p.000060: recommend publication.
p.000060: The system of peer review is used also in other contexts, such as when awarding positions and allocating grants.
p.000060:
p.000060: What would you do in the following situation?
p.000060: You are reviewing an article and discover that the authors have made a major issue of a discovery that you yourself
p.000060: made 20 years ago, but never wrote clearly about at the time – only a parenthesis buried in a long article. Now they
p.000060: are claiming credit for the discovery. However, you currently have an article of your own at the proof stage, and are
p.000060: now considering adding a section about your old discovery to underline your ownership of it.
p.000060: Would it be right to do so?
p.000060:
p.000060: 7.5 Committee work
p.000060: Researchers may also be appointed to serve on various committees or boards. It is perhaps appropriate to distinguish
p.000060: between memberships related to research councils, research foundations and the like, and those of a more commercial
p.000060: nature, such as a position on the board of directors of a company.
p.000060: Researchers serving on committees and boards within the research community are subject to very similar ethical
p.000060: standards to those acting as reviewers or external assessors. They are all involved in decisions and appraisals
p.000060: concerning other people’s research. To maintain the research community’s confidence in these decisions and appraisals,
p.000060: it is particularly important that committee members make every effort to be independent of their own research community
p.000060: and affiliations, to avoid showing special favour to their own discipline, university or department, colleagues or
p.000060: students. In practice, this can be very difficult, not least because they may be seen by their close colleagues in the
p.000060: research community as “the representative of their discipline” on the body concerned. The research community needs to
p.000060: have an open discussion about what membership of a given committee or board entails; that the member represents the
p.000060: entire research community if no other terms have been specified. Appointments to committees of this kind are to be
p.000060: regarded as positions of trust. When the members of a decision-making committee with a research council is involved in
p.000060: making a decision, their decision-making must comply with the rules that apply for such decisions, such as the
p.000060:
p.000060:
p.000060:
p.000060: GOOD RESEARCH PRACTICE
p.000061: 61
p.000061:
p.000061: Administrative Procedures Act, the Government Agencies Ordinance and the Government’s Instruction to the research
p.000061: council.
p.000061: As a member of a board or committee outside the research community, it is important to realise that, whether you like
p.000061: it or not, in this context it is in fact the research community you are representing. You will usually have been
p.000061: appointed because you represent a certain desired area of expertise. Consequently, here too the researcher has a
p.000061: special responsibility. Your membership should not result in you lending scientific legitimacy to a company’s
p.000061: operations or production, for example, when the scientific evidence is in fact unclear or points in the opposite
p.000061: direction. Your task, rather, is to communicate the results and possibilities of research, without exaggerating,
p.000061: diminishing or concealing.
p.000061:
p.000061: References
p.000061: 1. Vetenskapsrådet, Jävspolicy för Vetenskapsrådet, 2014.
p.000061: 2. Sveriges universitetslärarförbund (SULF), Etiska riktlinjer för universitetslärare, 2005.
p.000061: 3. Livsmedelsverket, Läkemedelsförmånsnämnden, Läkemedelsverket, Statens beredning för medicinsk utvärdering,
p.000061: Smittskyddsinstitutet, Socialstyrelsen och Statens folkhälsoinstitut, Hantering av jäv, intressekonflikter och
p.000061: bindningar när externa experter anlitas, 2008.
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p.000062:
p.000062: 8 RESEARCH MISCONDUCT
p.000062:
p.000062: 8.1 Introduction
p.000062: The occurrence of research (or scientific) misconduct undermines confidence in published scientific results, in the
p.000062: research community as well as in society at large. It also risks eroding the trust between researchers, providers of
p.000062: funding and the people who participate in research, for example as subjects.
p.000062: In many types of research, there is another angle as well. Research findings are used to make choices in the treatment
p.000062: of patients, to select construction methods for tunnels, bridges or aircraft, as an input into the planning of health
p.000062: care, social work, road safety or education. If those findings are based on research misconduct, people could suffer
p.000062: harm as a result of poorer treatment, collapsing bridges and tunnels, and incompetent planning.
p.000062: Research misconduct also has negative consequences on the academic merit system. A researcher who presents falsified
p.000062: merits, for example producing work containing undetected elements of plagiarism, or through another form of misconduct,
p.000062: can cause other applicants to be passed over. Misconduct thus causes injustice in the research community, often
p.000062: resulting in lower quality research when a fraudulent researcher is chosen over better ones.
p.000062: If research misconduct occurred on a regular basis, researchers’ trust in the merit system would also diminish and
p.000062: become completely useless for determining who is most competent. It is also likely that researchers, knowing or having
p.000062: the impression that others do not take good research practice seriously, can themselves be tempted to turn to such
p.000062: methods. The toleration of plagiarism and other types of misconduct would be devastating to research in the long run.
p.000062: It is difficult to say how common research misconduct is; the answer depends, of course, on how it is defined. There
p.000062: are no large, thorough studies on the subject, although some statistics and interesting yet limited studies can be
p.000062: found. However, these are based on somewhat different definitions of misconduct. At any rate, few reports of suspicion
p.000062: result in action being taken, for instance the retraction of journal articles. In the USA during the period 1994-2006,
p.000062: the Office of Research Integrity received a total of 3,571 reports. Misconduct – there, defined as fabrication,
p.000062: falsification or plagiarism – was demonstrated in only 165 of these cases (Office of Research Integrity, ORI, Annual
p.000062: Report 2007).
p.000062: Various surveys indicate, however, that the number of cases reported are just the tip of an iceberg. In a study from
p.000062: 2007, for example, 18 per cent of participating US research project leaders (a total of 1,645 individuals) said that
p.000062: they had had direct experience of misconduct in the latest year (Pryor et al. 2007). In another study, 20 per cent of
p.000062: practicing researchers who were asked answered that they had consciously changed the design, method or results of a
p.000062: project when pressed to do so by their funding body (de Vries et al. 2006, “Normal Misbehavior: Scientists talk about
p.000062: the ethics of research”). What has also become evident is that there is a widespread perception in the research
p.000062: community that others are acting dishonestly, or bending the rules (de Vries et al. 2006, “Scientists’ Perceptions of
p.000062: organizational justice and self-reported misbehaviors”).
p.000062:
p.000062: What would you do in the following situation?
p.000062: A doctor carried out a study to establish whether high-dose chemotherapy followed by bone marrow transplantation could
p.000062: improve the survival rate of a certain group of patients with breast cancer. The results were questioned, however, and
p.000062: the doctor was unable to produce the patient records and source data to confirm them. Other researchers then tried to
p.000062: repeat the results, without success. It is one person’s word against another’s, but primary data that could clear the
p.000062: doctor’s name are not available.
p.000062: What should the next step be? Who should do what?
p.000062:
p.000062: 8.2 Questions of definition and scope
p.000062: What is research misconduct? It can be defined in several ways. In a narrow sense, it refers to obvious violations
p.000062: involving the theft of other people’s ideas and data, manipulation (or falsification) of data, and plagiarism of other
p.000062: people’s texts. In a wider sense, it also includes other forms of reprehensible behaviour, such as dishonesty towards
p.000062: funding bodies, exaggeration of one’s qualifications in applications, publication of
p.000062:
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p.000063: 63
p.000063:
p.000063: the same study in multiple contexts, sexual harassment, defamation of colleagues, sabotage of colleagues’ work and so
p.000063: on.
p.000063: The choice between wide and narrow definitions is not only a matter of linguistic usage. It also has consequences, for
p.000063: example, when it comes to applying rules on sanctions for research misconduct. With a narrow definition, only certain
p.000063: phenomena can be acted on; with a wider one, others can as well. The requirements of due process suggest that we should
p.000063: concentrate on central, reasonably well-defined transgressions such as plagiarism, fraud (falsification, invented data)
p.000063: and manipulation of data, and deal with other forms of inappropriate behaviour in other contexts and under other
p.000063: headings.
p.000063: Another problem that is not always easy to handle is how to distinguish between intentional fraudulent behaviour on the
p.000063: one hand, and carelessness, rushed work and incompetence on the other. Research misconduct can be intentional
p.000063: behaviour, or as something that can also be perceived as being independent of the researcher’s intention, that is to
p.000063: say something that can be established without any need to speculate on whether the author intended to deceive.
p.000063: The definition of research misconduct used by the Swedish Research Council was formulated by Birgitta Forsman (2007),
p.000063: and uses the current terminology of the scientific community. It states that
p.000063:
p.000063: Research misconduct entails actions or omissions in research, which – consciously or through carelessness – lead to
p.000063: falsified or manipulated results or give misleading information about someone’s contribution to the research.
p.000063:
p.000063: This definition thus limits itself to the narrower concept of research misconduct, in which it directly concerns the
p.000063: scientific work. Sexual harassment, defamation of colleagues and the like are not included here, even though they are
p.000063: unethical in other ways. The reference to “consciously or through carelessness” means that the definition not only
p.000063: encompasses fraud, the fabrication of data and plagiarism – that is, actions we regard as evidence of an intention to
p.000063: deceive; it also encompasses actions such as iterated carelessness, for example when a researcher would have been
p.000063: immediately able to realise that the results were distorted, or when his or her own contribution is described
p.000063: incorrectly.
p.000063: In order to enable a nuanced description of the situation, to avoid the juridification of research ethics and avoid one
p.000063: person’s word standing against another’s – and to avoid the matter therefore being dismissed due to lack of evidence –
p.000063: a proposal has been made to differentiate between parallel and disjunctive definitions. For parallel definitions, two
p.000063: main questions are asked: Has the author diverged from good research practice? Has the author intended to deceive or
p.000063: mislead his or her readers? One may exist without the other, and each of the two questions can be answered with “yes”,
p.000063: “no” or “unclear”. If the answers are combined, a more nuanced picture of the situation is obtained in each individual
p.000063: case.
p.000063:
p.000063: 8.3 Fabrication and falsification
p.000063: The most obvious case of research fraud would be a researcher simply fabricating data or results – making them up – and
p.000063: then representing them as genuine. Falsification, however, is a more multifaceted phenomenon. The concept comprises all
p.000063: the possible ways of manipulating the research process, equipment, material or data that make it impossible to present
p.000063: a research project in a trustworthy way. The same can happen if certain data or experiments are left out of the report.
p.000063: It is also possible to manipulate the research report itself, for instance through changing diagrams and other
p.000063: pictures. New technology has made manipulation increasingly easier.
p.000063: Another issue that has been discussed at length is whether “outliers” (notable individual deviations from the other
p.000063: results) should be included in the statistics the researcher presents, and when it can be justified to call them
p.000063: anomalies or mistakes, and therefore exclude them from the report.
p.000063: Manipulation of research – as opposed to cases of fabrication – can be the unintentional result of carelessness or
p.000063: ignorance, and it can be difficult to determine whether intentional misconduct has occurred. This further supports the
p.000063: need for the concept of research misconduct to encompass both intentional and unintentional behaviour.
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p.000064:
p.000064: 8.4 Plagiarism
p.000064: Plagiarism is the form of scientific misconduct that, in the experience of the Swedish Research Council’s expert group
p.000064: on ethics, seems to be the most common. In the definition of scientific misconduct discussed above, it is the final
p.000064: mention of “misleading information about someone’s contribution to the research” that especially refers to plagiarism.
p.000064: The term plagiarism concerns a researcher presenting text excerpts, ideas, data, results, etc. in such a way that they
p.000064: appear to be his or her own, when they have in fact been created by someone else.
p.000064: Doing this is a form of lying, and in many cases is also considered theft. A definition of plagiarism can thus be
p.000064: formulated as follows:
p.000064:
p.000064: Plagiarism in research entails a researcher using material (texts, ideas, hypotheses, “designs”, methods, data, results
p.000064: or conclusions) – consciously or through carelessness – in such a way that it presents a misleading picture of the
p.000064: researcher’s contribution to the project at hand.
p.000064:
p.000064: Thus, plagiarism can concern various aspects of research and its contents, and is not limited to the copying of text.
p.000064: Normally, it is a case of a researcher (or a research group) plagiarising someone else; but, according to the
p.000064: definition, it can also happen that a researcher uses his or her own material in a misleading way.
p.000064: It is not until stolen material is presented by a researcher as his or her own that it is a matter of plagiarism. If a
p.000064: researcher steals data from another researcher and then publishes them as his or her own, it is not the theft of the
p.000064: data that makes it plagiarism but rather the fact that the researcher, through publication, has claimed that they are
p.000064: his or her own product. Stealing someone’s data is of course unethical and a violation of good scientific practice, but
p.000064: plagiarism doesn’t come into the picture until these data are presented in a way that hides their origin. Thus, a
p.000064: researcher’s presentation in an article, report or conference paper, for instance, is especially interesting when
p.000064: questions of plagiarism arise.
p.000064: Research often involves the researcher building further on the results, ideas and methods of others. The researcher
p.000064: bases his or her work on knowledge that already exists and uses available data – his or her own or others – and borrows
p.000064: useful concepts and theories, or looks at them with a critical eye. Therefore, it is crucial that the researcher
p.000064: clarifies who has done what. See also the discussion of Merton’s CUDOS norms in Chapter 1.
p.000064: Publication should also not be delayed. As the researcher has no control over the material after publication, it is
p.000064: important that its origin is still made known. It is important to have one’s contribution acknowledged, not only for a
p.000064: researcher personally, but also for the research community, and to ensure the academic merit system continues to work.
p.000064: A published line of reasoning, a certain formulation of words, etc. is regarded as the author’s own if nothing else is
p.000064: specified. Therefore, an author who uses material from other authors must make the reader aware that the idea or
p.000064: formulation is not his or her own. Avoiding plagiarism is normally very simple. In general, a person using another
p.000064: author’s data, methods, ideas or formulations should state the author and usually also the printed source, if a
p.000064: specific text is used.
p.000064: Good conduct in this area dictates that the following basic principles be observed: When using other authors’ texts, be
p.000064: it in the form of paraphrase, summary, reference or quotation, one should always name the author and refer to the
p.000064: original text. In the case of a quotation, a detailed source reference must be included, and the quotation must be
p.000064: presented as such through the use of quotation marks, indentation or the like. When a researcher uses the ideas,
p.000064: hypotheses, distinctions, concepts, etc. of others, it usually suffices to state from whom the material has been
p.000064: borrowed to avoid accusations of plagiarism, But, if it is crucial to the context, its origin should also be supplied.
p.000064: This can apply to a conversation, presentation, article, book, etc.
p.000064: However, there are ideas – theories, methods, concepts – that are so widely known that mentioning them hardly runs a
p.000064: risk of creating misunderstanding. In such cases, it is not necessary to point out that they are not an author’s own
p.000064: material. Sometimes it is no longer known who coined an expression, for instance; thus, using the formulation does not
p.000064: risk misleading the reader. Using such a formulation cannot mislead the reader in this case. Additionally, it is common
p.000064: practice within a number of subject areas to use standardised formulations in a text’s method section, and this is done
p.000064: without the use of quotation marks. Different opinions can be expressed on this practice, but the main point is that
p.000064: this is such a well-known approach that no one draws benefit from it, and no one is misled.
p.000064:
p.000064:
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p.000065: 65
p.000065:
p.000065: 8.5 Unpublished material and self-plagiarism
p.000065: In the research community, researchers partake of others’ results and ideas in various ways. Publication means that a
p.000065: text is available to the general public and can thus be used legitimately by others. However, a researcher may also
p.000065: have access to material before its publication, for instance through lectures, presentations, congresses and other
p.000065: meetings, or in conversations with other researchers. Before a researcher uses someone else’s material that was
p.000065: accessed in such a way, he or she should think about the situation in which access was provided.
p.000065: As a guideline, one can say that lectures given at major conferences, or by established researchers, can be regarded as
p.000065: published, and that their content may be used in accordance with the rules presented above.
p.000065: However, one should be more careful with presentations or lectures at small conferences, seminars and the like, as well
p.000065: as lectures given by doctoral students. Doctoral students often talk about their own projects, which are as yet not
p.000065: completed, and normally participate in conferences to get feedback to improve their ongoing work. It is not a given
p.000065: that such a lecture should be regarded as a publication – often, it should not. To avoid causing any harm to the
p.000065: doctoral student, interested parties should contact him or her directly and ask whether specific ideas or other aspects
p.000065: of the lecture may be used, naturally citing the source, or if this should wait until the material has been published
p.000065: in a journal or in connection with the student’s thesis defence.
p.000065: If someone has access to material in the role of external assessor, for example reviewing a manuscript for possible
p.000065: publication in a journal, or as a member of an examining committee or a faculty opponent, this material should be
p.000065: considered confidential until it has been published. Using parts or ideas from it or publishing it without supplying
p.000065: the source is not only plagiarism, but also theft of material, and places the entire evaluation system at risk.
p.000065: It is very common for a researcher to refer to his or her earlier results or mention problems previously dealt with. If
p.000065: the purpose is to confirm or repeat previous results, the earlier account should be presented to the reader. It also
p.000065: happens that researchers want to reuse earlier formulations. Nothing prevents this, but it is actually a quotation from
p.000065: the researcher’s previous work and should be presented as such. It is also completely acceptable to use complete
p.000065: sections of text, for instance a whole chapter from a book, as long as the researcher states that that text has
p.000065: appeared in an earlier context. This can easily be done in a preface or a note in the chapter itself. Neglecting to
p.000065: take these precautions is called self-plagiarism. There is currently a debate in the scientific community concerning
p.000065: whether this concept is accurate, or if it should instead be called double publication (see also Chapter 6). At any
p.000065: rate, it is a violation of good publication practice.
p.000065:
p.000065: 8.6 Establishing plagiarism
p.000065: How, then, can it be established that plagiarism has been committed? First of all, a very clear congruence between the
p.000065: work in question and the suspected source must exist. In texts, this can be a congruence between formulations, perhaps
p.000065: even partly verbatim congruence. It can also be a case of detailed agreement when it comes to arrangement, structure,
p.000065: terminology or concept formation. In certain types of texts, formulation congruence can now be established using the
p.000065: Internet or databases created for this purpose. Here, however, one should beware of false congruence. There are only so
p.000065: many ways to express something, and some degree phrasing congruence can nearly always be found.
p.000065: As regards plagiarism of ideas, the congruence should not only exist in the actual content of the idea but also in the
p.000065: argument for it. However, considerations of similarities between a work and a suspected source can never serve as the
p.000065: sole evidence of plagiarism; even extensive congruence can be coincidental. It can be natural to present certain
p.000065: premises within a given field, and it can happen that two researchers do so independently of each other. The history
p.000065: of science provides many examples of the “same” discovery being made by different researchers at approximately the same
p.000065: time, without their having had anything to do with each other, and with no possibility of plagiarism.
p.000065: Therefore, it is necessary to evaluate how likely it is that the suspected source actually is a source. An assessment
p.000065: must be made of whether it could have been available at all to the accused researcher, as well as of how likely it is
p.000065: that he or she in that case would have known of it, and had access to it. For instance, is there anything that suggests
p.000065: the researcher might have owned, read or spoken of the suspected source? Was the source published in a journal that
p.000065: those in the researcher’s field usually read? Plagiarism of an idea can possibly be established if there is a high
p.000065: probability of determining that the source was available to the researcher, and if there is a great deal of congruence
p.000065: between a text and a suspected source. In an actual investigation, it is
p.000065:
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p.000066: 66
p.000066:
p.000066: naturally important to consider the researcher’s own explanation for the similarities, and of his or her relationship
p.000066: to the suspected source.
p.000066:
p.000066: What would you do in the following situation?
p.000066: A doctoral student, Eric, sends his thesis to fellow postgraduate Nicole at another university to get her feedback.
p.000066: They work in the same field and have previously met at a seminar, at which they got on well. Nicole uses some of the
p.000066: data and ideas from Eric’s work in her own thesis, which she presents before Eric completes his. Eric is accused of
p.000066: plagiarism.
p.000066: What should the doctoral students, their supervisors, heads of department, vice-chancellors and their colleagues do?
p.000066:
p.000066: 8.7 Prevention
p.000066: Researchers operate in a highly competitive environment. Publications are the most essential merit for applicants to
p.000066: university positions – there is often talk of a “publish or perish” culture. This can tempt researchers to strive for
p.000066: quantity rather than quality; and the same applies in the system of research funding.
p.000066: If the results of a US study can be applied to a Swedish context, there is mistrust of the career system among
p.000066: researchers in Sweden as well. In the US study, nearly four of five researchers asked felt that the most successful
p.000066: members of their field had achieved their positions by successfully “working the system” (de Vries et al. 2006, Normal
p.000066: Misbehavior...).
p.000066: What can or should be done to counteract and prevent research misconduct? The discussion above suggests a number of
p.000066: possible long-term changes. But right now, there is a need to address research misconduct within the merit and career
p.000066: systems in place today. The most crucial issue is to work to create a good research environment, characterised by a
p.000066: culture that does not tolerate research misconduct and that nurtures good practice. The individual researcher, as well
p.000066: as department and faculty heads, can contribute to creating such an environment (see ALLEAS’s European Code of Conduct
p.000066: for Research Integrity Revised Edition).
p.000066: A university’s vice-chancellor has a special responsibility to ensure that ethics awareness is kept at a high level
p.000066: amongst its researchers. According to Chapter 1 Section 16 of the Higher Education Ordinance (SFS 1993:100), a
p.000066: university, which through a report or in some other way is made aware of suspicions of misconduct in research, artistic
p.000066: work or other development work at the university, must investigate these suspicions. The vice-chancellor is ultimately
p.000066: responsible for all activities at a higher education institution, and is thereby also ultimately responsible for
...
p.000067: it happened and where it happened. Going public with established cases of misconduct is also a crucial discouraging
p.000067: factor. Departments and other research environments do not want to be associated with such cases any more than
p.000067: researchers themselves or research principals do.
p.000067: It is also important that established misconduct be followed by sanctions, to mark that a violation of research ethics
p.000067: is a serious matter. If it is discovered, for instance, that someone has committed plagiarism and nothing happens, it
p.000067: can be interpreted that plagiarism is not a particularly serious offence. There are labour law measures that employers
p.000067: can take in the event of established misconduct.
p.000067: Research misconduct shall simply not occur in research. As part of this effort, the Swedish Research Council wants to
p.000067: stimulate departments, higher education institutions and universities to develop into such excellent environments as
p.000067: described above. The Swedish Research Council is government agency that awards grants to research following careful
p.000067: quality control. Payment of a grant may be stopped if any misconduct is established.
p.000067:
p.000067: What would you do in the following situation?
p.000067: You discover that one of your older colleagues in the department has falsified a series of measurements in a minor
p.000067: publication, with no very sensational results. He is close to retirement. When you raise the matter with him, he breaks
p.000067: down crying and blames the head of department’s demand for “at least one paper a year”. If he fails to meet that
p.000067: target, he will not get a share of the “special research resource” and will have to teach 400 hours a year. The man is
p.000067: in poor health and has no great talent for teaching.
p.000067: What do you do?
p.000067:
p.000067: 8.9 Addressing issues of misconduct
p.000067: According to the Higher Education Ordinance (SFS 1993:100), it is mandatory for universities and higher education
p.000067: institutions to investigate any suspected research misconduct. No equivalent requirement exists for research conducted
p.000067: outside academia. The Ordinance does not, however, regulate how investigations should be conducted; this is up to each
p.000067: higher education institution.
p.000067: It is common practice that suspicions of research misconduct are reported to the organisation – the department,
p.000067: university, etc. – where the suspected researcher works. For instance, if someone discovers that a colleague has
p.000067: committed plagiarism, this person must report this to the department head or the dean of the university, who should in
p.000067: turn report this to the vice-chancellor. The vice-chancellor is under obligation to process the report and ensure that
p.000067: the case is investigated, and, if the accused researcher is found guilty of research misconduct, determine the labour
p.000067: law sanctions to be imposed. It is thus primarily the learning institution itself that investigates and decides on the
p.000067: case.
p.000067:
p.000067:
p.000067:
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p.000068: 68
p.000068:
p.000068: However, the vice-chancellor does have the possibility to get an external statement. Since 1 January 2010, the CEPN
p.000068: has had an expert group on research misconduct, which on request can provide assistance in these matters. The group is
p.000068: completely independent, with no ties to universities or other research institutions. This ensures an impartial
p.000068: evaluation; something that is sometimes called into question when a university investigates an internal matter itself.
p.000068: The individual – either the person who submitted the report or the reported person – can also submit a request to the
p.000068: vice-chancellor that the expert group handle the investigation. If the person who reported the suspicion of misconduct,
p.000068: or the person suspected of misconduct so request, the university shall obtain such a statement. However, no statement
p.000068: needs to be obtained if the university decides it is clearly unnecessary. The expert group thus investigates whether
p.000068: research misconduct has been committed, or not. The CEPN does not suggest consequences, however; this is the
p.000068: responsibility of the vice-chancellor as the employer.
...
p.000069: ALLEA underlines the importance of research not being improperly influenced by ideologies, political pressure or
p.000069: financial interests. ALLEA also emphasises our obligations as researchers to give guidance on these issues to future
p.000069: generations, and to monitor them collegially, which for example includes taking measures against all forms of
p.000069: harassment.
p.000069: In a report from 2016, Science Europe has moved in the same direction; that is to say emphasising the importance of
p.000069: researchers receiving good instruction in research ethics and researcher ethics, and that the values mentioned above
p.000069: are discussed and taught. This research and researcher ethics training shall start already during the first cycle, and
p.000069: the knowledge shall then be updated and expanded in width and depth throughout the career.
p.000069: The European Code of Conduct for Research Integrity (2017) is an important document that clearly indicates a code of
p.000069: conduct in a wider sense than the more narrow definition of misconduct emphasised by Good Research Practice. If
p.000069: researchers complied with this code, a large proportion of the current misconduct would probably be avoided. The few
p.000069: pathological cases of misconduct would not be prevented through this type of code of conduct, for which severe
p.000069: sanctions would instead be required. However, this entails a problem: if issues of research ethics are dealt with in
p.000069: legislation, and the concept becomes too comprehensive or multi- dimensional, the legal codification will be difficult
...
p.000070:
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p.000071:
p.000071: 9.1.3 The UN’s Universal Declaration of Human Rights, etc.
p.000071: Article 12 of the United Nations’ Universal Declaration of Human Rights, etc. establishes that “No one shall be
p.000071: subjected to arbitrary interference with his privacy, family, home or correspondence, nor to attacks upon his honour
p.000071: and reputation. Everyone has the right to the protection of the law against such interference or attacks.” Article 29
p.000071: Item 2 further states that “In the exercise of his rights and freedoms, everyone shall be subject only to such
p.000071: limitations as are determined by law solely for the purpose of securing due recognition and respect for the rights and
p.000071: freedoms of others and of meeting the just requirements of morality, public order and the general welfare in a
p.000071: democratic society.”
p.000071: The Universal Declaration is not binding upon member states, but may be seen as an expression of common law rules
p.000071: within the area.
p.000071:
p.000071: 9.1.4 The European Convention on Human Rights
p.000071: The Convention for the Protection of Human Rights and Fundamental Freedoms of 4 November 1950 (“European Convention on
p.000071: Human Rights”) was incorporated into Swedish law on 1 January 1995, and has since then applied as law in Sweden.
p.000071: Article 8 of the European Convention on Human Rights states that “Everyone has the right to respect for his private and
p.000071: family life, his home and his correspondence”. It further states that “There shall be no interference by a public
p.000071: authority with the exercise of this right except such as is in accordance with the law and is necessary in a democratic
p.000071: society in the interests of national security, public safety or the economic well-being of the country, for the
p.000071: prevention of disorder or crime, for the protection of health or morals, or for the protection of the rights and
p.000071: freedoms of others”. The European Court of Human Rights was established to monitor that the obligations under the
p.000071: European Court of Human Rights are fulfilled.
p.000071:
p.000071: 9.1.5 The Council of Europe’s Data Protection Convention
p.000071: In 1981, the Committee of Ministers of the Council of Europe adopted the Convention for the Protection of Individuals
p.000071: with regard to Automatic Processing of Personal Data. The Convention came into force on 1 October 1985. All EU member
p.000071: states have ratified the Convention. The Convention is binding on the countries who have ratified it. The Convention is
p.000071: associated with a number of recommendations on how personal data should be handled in various areas. The
p.000071: recommendations are not directly binding.
p.000071: According to Article 1, the Convention aims “to secure in the territory of each Party for every individual, whatever
p.000071: his nationality or residence, respect for his rights and fundamental freedoms, and in particular his right to privacy,
p.000071: with regard to automatic processing of personal data relating to him ("data protection”)”. According to Article 2, the
p.000071: Convention’s area of application is "automated data files" and "automatic processing" of personal data in public and
p.000071: private activities. Each Convention state may, however, introduce certain general restrictions or expansions of the
p.000071: area of implementation. The central part of the Convention is Chapter II (Articles 4–11), which comprise the
p.000071: fundamental principles for data protection. They include requirements that personal data that is processed
p.000071: automatically shall be “obtained and processed fairly and lawfully”, “adequate, relevant and not excessive in relation
p.000071: to the purposes for which they are stored” and “preserved ... for no longer than is required” (Article 5). Personal
p.000071: data “revealing racial origin, political opinions ... health or sexual life”, as well as “personal data relating to
p.000071: criminal convictions” “may not be processed automatically unless domestic law provides appropriate safeguards” (Article
p.000071: 6). The Convention also includes provisions governing requirements on safety measures and information to those whose
p.000071: data is being processed.
p.000071:
p.000071: 9.1.6 OECD’s Guidelines
p.000071: The Organisation for Economic Cooperation and Development (OECD) has produced Guidelines Governing the Protection of
p.000071: Privacy and Transborder Flows of Personal Data. These Guidelines were adopted by the OECD Council in 1980,
p.000071: simultaneously with a recommendation to the governments of the member countries to consider the Guidelines in national
p.000071: legislation. Sweden has adopted these recommendations, and by this means undertaken to follow the Guidelines. The
p.000071: Guidelines are minimum rules, which means that protection in the countries that have undertaken to follow the
p.000071: Guidelines may be made more comprehensive than the protection given by the Guidelines. The Guidelines include eight
p.000071: fundamental principles to protect personal integrity; for
p.000071:
p.000071:
p.000071: GOOD RESEARCH PRACTICE
p.000072: 72
p.000072:
p.000072: example, they state that personal data shall be collected for specific purposes, be relevant to the purpose for which
p.000072: they are intended, and shall be correct, complete and up-to-date.
p.000072:
p.000072: 9.1.7 The European Union’s Charter of Fundamental Rights
p.000072: The European Union’s Charter of Fundamental Rights was adopted at the meeting of the Council of Europe in Nice in 2000
p.000072: (the “EU Charter”). The EU Charter states the fundamental rights under six headings: Dignity, Freedoms, Equality,
p.000072: Solidarity, Citizens' Rights, and Justice.
p.000072: In terms of protection of personal integrity, it states that everyone has the right to physical and mental integrity
...
p.000072: an outer-most limit for when personal data may be collected and then processed. The starting point is thus that only
p.000072: such personal data handling may take place as is covered by one or several of the stated purposes, see Govt. Bill
p.000072: 2007/08:126 p. 228.
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
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p.000073: 73
p.000073:
p.000073: 9.2.2 The Act concerning the Ethical Review of Research Involving Humans
p.000073: Since 1 January 2004, the Act concerning the Ethical Review of Research Involving Humans has been in force. It covers
p.000073: research involving living persons, but also research involving deceased persons and biological material from humans,
p.000073: and also research involving the handling of sensitive personal data. The purpose of the Act is to protect the
p.000073: individual person and ensure respect for human dignity in research.
p.000073: The Act (SFS 2003:460) concerning the Ethical Review of Research Involving Humans shall apply to research involving
p.000073: sensitive personal data under Section 13 of the Personal Data Act, or personal data on breaches of the law that
p.000073: includes statutory offences, judgements in criminal cases, criminal procedural coercive measures or administrative
p.000073: deprivation of liberty according to Section 21 of the Personal Data Act. The Act is also applicable to research that
p.000073: involves physical encroachment on a research subject, that is carried out using a method aimed at influencing the
p.000073: research subject physically or mentally, or that entails a clear risk of physical or mental harm to the research
p.000073: subject, that relates to studies of biological material taken from a living person that can be attributed to this
p.000073: person, that involves a physical encroachment on a deceased person, or relates to studies of biological material taken
p.000073: for medical purposes from a deceased person that can be attributed to this person.
p.000073: By means of the ethics review procedure, support can be created for personal data handling in research projects that
p.000073: are carried out without consent, but the Act gives no support for personal data handling carried out before the actual
p.000073: research process begins.
p.000073: The Act applies to all such research, regardless of in what institutional setting it is carried out, or how it is
p.000073: funded. The regional ethics review board’s review involves an examination of the project description to establish
p.000073: whether it involves any infringement of human rights or hard-to-capture concept of human dignity. An assessment is also
p.000073: made of the relationship between the value of the project and any burdens or risks which it might entail for the
p.000073: subjects of the research. Its value must be judged to outweigh the risks. Great importance is placed on an assessment
p.000073: of how the issue of informed consent has been handled. Regional ethics boards are also able to issue advisory
p.000073: statements on research involving human subjects in the event the research is not covered by the Act (SFS 2003:460)
p.000073: concerning the Ethical Review of Research Involving Humans. Such statements are sometimes required in order to obtain
p.000073: financial support, or to enable publication of results in certain international journals. Reviews by the regional
p.000073: boards are subject to a fee and shall be undertaken within 60 days from receipt of application. More information is
p.000073: available on (epn.se).
p.000073:
p.000073: 9.3 Secrecy
p.000073: Researchers need to know whether the data handled within the research they carry out is covered by secrecy, and if so,
p.000073: what the secrecy parameters are. A significant factor when determining the secrecy parameters for a task is who is
p.000073: carrying out the activity.
p.000073:
p.000073: 9.3.1 Public principal
p.000073: The Freedom of the Press Act contains regulations for public documents stored by public authorities. The starting point
p.000073: is that public documents are open to the general public, and that the general public’s access to these may only be
p.000073: limited for the purposes listed in Chapter 2 Section 2 of the Act. One of the purposes is the protection of the
p.000073: personal or financial circumstances of individuals. The issue of when data may be covered by secrecy under this
p.000073: exception is regulated in particular in the Public AccessXtoXInformation and Secrecy Act (SFS 2009:400). This Act
p.000073: contains provisions that apply to the handling of personal data within the framework of health and medical care, in
p.000073: research activities and other activities carried on by public agencies.
p.000073: The regulations in the Act also entail that those who work at a public agency are automatically covered by professional
p.000073: secrecy rules. It is important to remember that employees have an obligation of professional secrecy under the Act, but
p.000073: cannot have a more comprehensive obligation imposed. That means that if data is covered by secrecy under the Act, it
p.000073: must not be disclosed, at the same time that data that is public must be disclosed on demand.
p.000073:
p.000073:
p.000073:
p.000073:
p.000073:
p.000073:
p.000073:
p.000073: GOOD RESEARCH PRACTICE
p.000074: 74
p.000074:
p.000074: 9.3.2 Private principal
p.000074: Private actors have no obligation to disclose data, or keep data secret, unless this follows from special legislation
p.000074: covering their activities. Such regulations exist, for example for private caregivers, in Chapter 6 of the Patient
p.000074: Safety Act. If there are no particular regulation, private actors may themselves decide on the secrecy protection that
p.000074: shall apply for a certain task.
p.000074: This also means that employees of private employers do not have any statutory obligation of secrecy, unless this
p.000074: follows from special regulations, such as those in the Patient Data Act. This must instead be regulated between the
p.000074: employee and the employer in such a way that the private employer ensures that data that shall not be disseminated are
p.000074: kept secret.
p.000074: If the data is held by a private principal, there is also no right for the general public, including research
p.000074: principals, to partake of data in the system under the Freedom of the Press Act. There is thus greater freedom for a
p.000074: private principal to decide who may partake of data.
p.000074:
p.000074: 9.4 Examples of other legislation
p.000074: The Animal Welfare Act (SFS 1988:534) and Animal Welfare Ordinance (SFS 1988:539) apply to research on animals. The
p.000074: Swedish Board of Agriculture provides supplementary guidelines and general advice.
p.000074:
p.000074: 9.5 The CODEX website
p.000074: The Swedish Research Council maintains a website in collaboration with the Centre for Research Ethics and Bioethics at
p.000074: Uppsala University on which the great majority of documents that may be relevant to the researcher can be found. The
p.000074: site thus includes legislation with a bearing on research.
p.000074: Also to be found here are various directives and conventions of an international character, adopted for example by the
p.000074: UN, UNESCO, the EU and the Council of Europe. The site also features the full texts of codes of research ethics for
p.000074: different disciplines and fields of research, along with introductions to specific challenges in research, such as
p.000074: informed consent or publication. In addition, there is a section on the use of animals in research. CODEX can be found
p.000074: at www.codex.vr.se.
p.000074: Note that CODEX is a site that provides information on research ethics; the material presented there does not
p.000074: necessarily reflect the Swedish Research Council’s opinions on research ethics issues.
p.000074: Below, some documents that are central to research in Sweden are commented on briefly. The complete texts can all be
p.000074: found in CODEX, together with many other significant and valuable questions. They are arranged here from the most
p.000074: binding to the more voluntary.
p.000074:
p.000074: 9.6 The Declaration of Helsinki
p.000074: The Declaration of Helsinki is a central guideline for research ethics adopted by the World Medical Association in
p.000074: 1964. The Declaration contains ethical principles for doctors and other participants in medical research.
p.000074: The Declaration of Helsinki is not legally binding, but has had major impact on national legislation. Since 2000, it
p.000074: refers explicitly to research using identifiable samples and data. One of the fundamental principles of the Declaration
p.000074: is that concern for the individual must always take precedence over the interests of science and society.
p.000074: Furthermore, the principles state that informed consent must be obtained for research that uses identifiable samples
p.000074: and data – for collection, analysis, storage and use for new purposes. It establishes, however, that situations may
p.000074: exist where it is impossible or unsuitable to obtain consent. In such cases, research may only be carried out if an
p.000074: ethics review board has approved the research project.
p.000074: The principles further establish that all conceivable safety measures must be undertaken to respect the private lives
p.000074: of participants, and to treat patient information confidentially, and to minimise the impact the study may have on the
p.000074: participants’ physical and mental integrity and personality.
p.000074: The Declaration of Helsinki is mentioned in the preambles of both the Act concerning the Ethical Review of Research
p.000074: Involving Humans and the Biobanks in Medical Care Act (2002:297). The above-mentioned instruction from the Swedish
p.000074: Medical Products Agency states that it shall be followed in clinical trials. It is often a requirement that a medical
p.000074: research project has been carried out in accordance with the requirements of
p.000074:
p.000074:
p.000074:
p.000074: GOOD RESEARCH PRACTICE
p.000075: 75
p.000075:
p.000075: the Declaration of Helsinki in order to receive research grants or be published. The Declaration has been updated
p.000075: regularly with various new formulations and additions. The current version was adopted in 2013.
p.000075: The Declaration stated a number of principles that apply, such as a competency requirement on the researcher, a
p.000075: requirement for a balance between the value of the research (benefit) and risks, where the well- being of the patient
p.000075: shall take precedence. It also includes requirements for the informed consent; what the information shall contain, how
p.000075: the consent is given, by whom it is given, and to whom it is given. The Declaration of Helsinki also covers a number of
p.000075: rules that apply when medical research is combined with care.
p.000075:
p.000075: 9.7 Guidelines for Good Clinical Practice (GCP)
p.000075: For clinical trials of drugs, the relevant guideline is Good Clinical Practice (GCP). This guideline applies in the EU,
p.000075: the United States, Japan and Australia, and is included in Swedish law through the Swedish Medical Products Agency’s
p.000075: rules and general recommendations (LVS 2011:19) regarding clinical trials using human subjects. It contains a large
p.000075: number of detailed principles, together with a glossary defining relevant concepts.
p.000075: To aid European research ethics committees, the European Forum for Good Clinical Practice has produced a number of
p.000075: documents that serve as guides when using GCP (www.efgcp.eu). These documents are intended to harmonise with the
p.000075: Declaration of Helsinki but are much more comprehensive, addressing everything from planning and conducting clinical
p.000075: studies to how they should be documented and reported.
p.000075:
p.000075: 9.8 The Council of Europe’s Convention for the Protection of Human Rights and biomedicine
p.000075: The Council of Europe is an organisation that works to uphold human rights in its member countries. The Council’s
p.000075: Convention for the Protection of Human Rights and Dignity of the Human Being with Regard to the Application of Biology
p.000075: and Medicine of 1997 (also known as the Oviedo Convention) comprises a number of articles that directly or indirectly
p.000075: relate to biomedical research. It deals in particular with the protection of individuals undergoing research and with
p.000075: the conduct of research on persons with reduced capacity to give free and informed consent. One article deals with
p.000075: research on embryos in vitro.
p.000075: This document, together with the EU Directive on Good Clinical Practice in the member states, has directly prompted the
p.000075: Swedish Act concerning the Ethical Review of Research Involving Humans. Sweden has signed this convention but has not
p.000075: yet ratified it. In practice, however, it has served as a guidepost for Swedish regulations since its establishment.
p.000075:
p.000075: 9.9 The CIOMS guidelines for research
p.000075: The Council for International Organizations of Medical Sciences (CIOMS) has, in collaboration with the World Health
p.000075: Organization (WHO), published Ethical Guidelines for Biomedical Research Involving Human Subjects, addressing issues of
p.000075: safety and informed consent. Through this document, the Council attempts to apply the principles of the Declaration of
p.000075: Helsinki while acknowledging important differences between the countries of the world. The guidelines contain special
p.000075: sections on research on weaker groups and women. CIOMS has also published guidelines on epidemiological research which
p.000075: are widely referred to.
p.000075:
p.000075: 9.10 Center for Open Science
p.000075: Recently, researchers have taken the initiative to encourage better research practice. The currently best established
p.000075: and comprehensive initiative is the Center for Open Science, which provides resources to increase openness, integrity
p.000075: and reproducibility. (https://cos.io/)
p.000075:
p.000075: 9.11 Publication ethics and questions of misconduct
p.000075: Some important documents on research ethics, such as the Declaration of Helsinki, address aspects of publishing ethics.
p.000075: As the Swedish Research Council has signed the Berlin Declaration (the Berlin Declaration
p.000075:
p.000075:
p.000075:
p.000075: GOOD RESEARCH PRACTICE
p.000076: 76
p.000076:
p.000076: on Open Access to Knowledge in the Sciences and Humanities), the Council has since 2010 included a requirement for open
p.000076: access publication in its calls for grant applications.
p.000076: Two international documents are of particular relevance in this context: one being, the Editorial Policy Statements of
p.000076: the Council of Science Editors (CSE), and the other – and most important – the “Vancouver Rules”, published by the
p.000076: International Committee of Medical Journal Editors (ICMJE) under the title of Uniform Requirements for Manuscripts
p.000076: Submitted to Biomedical Journals. A point emphasised in both these documents is the clear link between the right to be
p.000076: credited as an author and the obligation to assume responsibility for and have contributed to the intellectual content
p.000076: of the publication.
p.000076: Shared authorship is addressed in the CSE’s Recommendations for Group- Author Articles in Scientific Journals and
p.000076: Bibliometric Databases. Many journals today also refer to the ethical guidelines launched by the British Committee on
p.000076: Publication Ethics (COPE).
p.000076: Constant departures from these standards have led other actors to intensify their work with publication ethics. Not
p.000076: least, publishing companies themselves have started formulating rules and guidelines. Groups of researchers, editors
p.000076: and funding bodies have also collaborated in drawing up a number of standards, such as CONSORT, STARD, STROBE and
p.000076: STREGA, for how various types of studies should be presented in journals. These and other documents can be found on the
p.000076: CODEX website’s page on publication ethics.
p.000076: As regards research misconduct in general, perhaps the most important initiative in recent time is the OECD’s Best
p.000076: Practices for Ensuring Scientific Integrity and Preventing Misconduct, and another one produced by ALLEA, the European
p.000076: Code of Conduct for Research Integrity Revised Edition. The US federal guidelines,
p.000076: U.S. Federal Policy on Research Misconduct, have also received a great deal of attention. The European Science
p.000076: Foundation’s contribution is a discussion of Research Integrity in its Briefing no. 30. In Sweden, the Association of
p.000076: Swedish Higher Education has presented guidelines for the handling of questions of research misconduct by universities
p.000076: and higher education institutions in its Riktlinjer för hantering vid universitet och högskolor av frågor om
p.000076: vetenskaplig ohederlighet.
p.000076: The most recent contribution to the documents on misconduct, the Singapore Statement on Research Integrity, was drawn
p.000076: up at the 2nd World Conference on Research Integrity.
p.000076:
p.000076: References
p.000076: 1. 2nd World Conference on Research Integrity. Singapore Statement on Research Integrity. Singapore, 2010.
p.000076: Arkivförordning (SFS 1991:446).
p.000076: 2. Arkivlag (SFS 1990:782).
p.000076: 3. Berlin Declaration on Open Access to Knowledge in the Sciences and Humanities. Berlin, 2003.
p.000076: 4. Commission Directive 2005/28/EC of 8 April 2005 laying down principles and detailed guidelines for good
p.000076: clinical practice as regards investigational medicinal products for human use, as well as the requirements for
p.000076: authorisation of the manufacturing or importation of such products. European Community, Brussels, 2005.
p.000076: 5. Council of Europe. Convention for the Protection of Human Rights and Dignity of the Human Being with regard to
p.000076: the Application of Biology and Medicine: Convention on Human Rights and Biomedicine, (Oviedo Convention), European
p.000076: Treaty Series No 164, Strasbourg, 1997.
p.000076: 6. Council of Science Editors. Editorial Policy Statements, Wheat Ridge, CO, 2010.
p.000076: 7. Council for International Organizations of Medical Sciences (CIOMS). International ethical guidelines for
p.000076: biomedical research involving human subjects. Geneva, CIOMS, 2002.
p.000076: 8. Council for International Organizations of Medical Sciences (CIOMS). International ethical guidelines for
p.000076: epidemiological studies. Geneva, CIOMS, 2008.
p.000076: 9. Djurskyddsförordning (SFS 1988:539).
p.000076: 10. Djurskyddslag (SFS 1988:534).
p.000076: 11. European Code of Conduct for Research Integrity Revised Edition. ALLEA, All European Academies, Berlin 2017.
p.000076: 12. European Science Foundation. Research Integrity: global responsibility to foster common standards. ORI-ESF
p.000076: Science Policy Briefing 30, Strasbourg, 2007.
p.000076: 13. Hälso- och sjukvårdslag (SFS 1982:763).
p.000076: 14. Lag om biobanker i hälso- och sjukvården med mera (SFS 2002:297).
p.000076:
p.000076:
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p.000077: 77
p.000077:
p.000077: 15. Lag om etikprövning av forskning som avser människor (SFS 2003:460).
p.000077: 16. Lag om genetisk integritet med mera (SFS 2006:351).
p.000077: 17. Läkemedelsverkets föreskrifter om kliniska läkemedelsprövningar på människor (LVFS 2011:19).
p.000077: 18. Offentlighets- och sekretesslag (SFS 2009:400).
p.000077: 19. Office of Research Integrity (ORI). Federal Research Misconduct Policy. Federal Register: December 6, 2000,
p.000077: Volume 65, Number 235, Notices, Page 76260–76264.
p.000077: 20. Organisation for Economic Co-operation and Development (OECD). Best Practices for Ensuring Scientific Integrity
p.000077: and Preventing Misconduct. Paris, OECD, 2007.
p.000077: 21. Patientdatalag (SFS 2008:355).
p.000077: 22. Personuppgiftslag (SFS 1998:204).
p.000077: 23. Sveriges universitets- och högskoleförbund (SUHF), Riktlinjer för hantering vid universitet och högskolor av
p.000077: frågor om vetenskaplig ohederlighet. Stockholm, SUHF, 1997.
p.000077: 24. The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for
p.000077: Human Use (ICH). E6(R1): Good clinical practice: consolidated guideline, adopted by CPMP, July 1996, issued as
p.000077: CPMP/ICH/135/95/Step5, Geneva, 1996.
p.000077: 25. Tryckfrihetsförordning (SFS 1949:105).
p.000077: 26. World Medical Association. Declaration of Helsinki. Ethical Principles for Medical Research Involving Human
p.000077: Subjects, adopted by the 18th WMA General Assembly, Helsinki, Finland, June 1964, latest revision by the WMA General
p.000077: Assembly, Seoul 2013. Ferney-Voltaire, France, World Medical Association, 2013.
p.000077:
p.000077: Reading tips
p.000077: 1. Alexius Borgström, Katarina, Djuren, läkarna och lagen: en rättslig studie om djurförsöksetik. Uppsala, Iustus
p.000077: förlag, 2009.
p.000077: 2. Baggni, Julian & Fosl, Peter S., The ethics toolkit. A compendium of ethical concepts and methods. Oxford,
p.000077: Blackwell, 2007.
p.000077: 3. Beauchamp, Tom L. & Childress, James F., Principles of biomedical ethics. Oxford & New York, Oxford University
p.000077: Press, (1979), Sixth Edition, 2008.
p.000077: 4. Bühler, Axel, (ed) Hermeneutik. Heidelberg, Synchron, 2003.
p.000077: 5. Cavalieri, Paola & Singer, Peter (eds.) The Great Ape Project: Equality Beyond Humanity. New York, St. Martin’s
p.000077: Press, 1994.
p.000077: 6. Chalmers, Alan F., Vad är vetenskap egentligen? Nora, Nya Doxa, 2003.
p.000077: 7. Coughlin, Steven S. & Beauchamp, Tom L. & Weed, Douglas L. (eds), Ethics and epidemiology. Oxford & New York,
p.000077: Oxford University Press, 2009.
p.000077: 8. Egonsson, Dan, Filosofiska essäer om människovärde. Falun, Nya Doxa, 1999.
p.000077: 9. Emanuel, Ezekiel J., et al., The Oxford textbook of clinical research ethics. Oxford & New York, Oxford
p.000077: University Press, 2008.
p.000077: 10. Fleischhauer, Kurt & Hermerén, Göran, Goals of Medicine in the Course of History and Today. A&W International,
p.000077: Stockholm, 2006.
p.000077: 11. Forsman, Birgitta, Forskningsetik: en introduktion. Lund, Studentlitteratur, 1997.
p.000077: 12. Forsman, Birgitta, Vetenskap och moral. Nora, Nya Doxa, 2002.
p.000077: 13. Forsman, Birgitta, Etik i biomedicinsk forskning: En orientering. Lund, Studentlitteratur, 2005. Forsman,
p.000077: Birgitta, Forskningsfusk och vetenskaplig oredlighet. Lund, Enheten för medicinsk etik, 2006.
p.000077: 14. Forsman, Birgitta, Forskares frihet: Om makt och moral. Lund, Studentlitteratur, 2009.
p.000077: 15. Föllesdal, Dagfinn & Wallöe, Lars & Elster, Jon, Argumentationsanalys, språk och vetenskaps- filosofi.
p.000077: Stockholm, Thales, 2001.
p.000077: 16. Gilje, Nils & Grimen, Harald, Samhällsvetenskapernas förutsättningar. Göteborg, Daidalos, 1993, tredje upplagan
p.000077: 2007.
p.000077: 17. Görman, Ulf & Andrén, Carl-Gustaf & Hermerén, Göran, Att forma vår framtid: bioteknikens möjligheter och
p.000077: problem. Lund, Nordic Academic Press, 2009.
p.000077:
p.000077:
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p.000078:
p.000078: 18. Hansson, Mats G., Integritet. I spänningen mellan avskildhet och delaktighet, Stockholm, Carlsson Bokförlag,
p.000078: 2006.
p.000078: 19. Helgesson, Gert, Forskningsetik för medicinare och naturvetare, Lund, Studentlitteratur, 2006.
p.000078: 20. Hermerén, Göran, Kunskapens pris: forskningsetiska problem och principer i humaniora och samhällsvetenskap.
p.000078: Stockholm, Swedish Science Press & HSFR, 1986, andra upplagan 1996.
p.000078: 21. Hermerén, Göran, ”Vi kommer aldrig att ha forskat färdigt kring de etiska problemen”. Praktik & Teori, 2007,
p.000078: 2:44–51.
p.000078: 22. Hermerén, Göran, ”Challenges in the Evaluation of Nanoscale Research: Ethical Aspects”. Nano Ethics, 2007,
p.000078: 1:223–237.
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...
Appendix
Indicator List
| Indicator | Vulnerability |
|---|
| HIV | HIV/AIDS |
| abuse | Victim of Abuse |
| access | Access to Social Goods |
| accessXtoXinformation | Access to information |
| another country | Other Country |
| authority | Relationship to Authority |
| belief | Religion |
| blind | visual impairment |
| child | Child |
| children | Child |
| cioms | cioms guidelines |
| control group | participants in a control group |
| conviction | Religion |
| crime | Illegal Activity |
| criminal | criminal |
| dependence | Drug Dependence |
| dependency | Drug Dependence |
| dependent | Dependent |
| disability | Mentally Disabled |
| drug | Drug Usage |
| education | education |
| educational | education |
| embryo | embryo |
| emergency | Public Emergency |
| employees | employees |
| ethnic | Ethnicity |
| ethnicity | Ethnicity |
| family | Motherhood/Family |
| gender | gender |
| helsinki | declaration of helsinki |
| hiv/aids | HIV/AIDS |
| home | Property Ownership |
| hunger | Food Insecurity |
| influence | Drug Usage |
| job | Occupation |
| language | Linguistic Proficiency |
| liberty | Incarcerated |
| linguistic | Linguistic Proficiency |
| manipulate | Manipulable |
| manipulated | Manipulable |
| mentally | Mentally Disabled |
| minor | Youth/Minors |
| mothers | Mothers |
| opinion | philosophical differences/differences of opinion |
| oviedo | oviedo |
| parent | parents |
| party | political affiliation |
| physically | Physically Disabled |
| political | political affiliation |
| poor | Economic/Poverty |
| prisoners | Criminal Convictions |
| property | Property Ownership |
| race | Racial Minority |
| racial | Racial Minority |
| religious | Religion |
| restricted | Incarcerated |
| single | Marital Status |
| stem cells | stem cells |
| student | Student |
| terminal | Terminally Ill |
| union | Trade Union Membership |
| usage | Drug Usage |
| women | Women |
Indicator Peers (Indicators in Same Vulnerability)
| Indicator | Peers |
|---|
| HIV | ['hiv/aids'] |
| belief | ['conviction', 'religious'] |
| child | ['children'] |
| children | ['child'] |
| conviction | ['belief', 'religious'] |
| dependence | ['dependency'] |
| dependency | ['dependence'] |
| disability | ['mentally'] |
| drug | ['influence', 'usage'] |
| education | ['educational'] |
| educational | ['education'] |
| ethnic | ['ethnicity'] |
| ethnicity | ['ethnic'] |
| hiv/aids | ['HIV'] |
| home | ['property'] |
| influence | ['drug', 'usage'] |
| language | ['linguistic'] |
| liberty | ['restricted'] |
| linguistic | ['language'] |
| manipulate | ['manipulated'] |
| manipulated | ['manipulate'] |
| mentally | ['disability'] |
| party | ['political'] |
| political | ['party'] |
| property | ['home'] |
| race | ['racial'] |
| racial | ['race'] |
| religious | ['belief', 'conviction'] |
| restricted | ['liberty'] |
| usage | ['drug', 'influence'] |
Trigger Words
capacity
consent
cultural
developing
ethics
harm
justice
protect
protection
risk
sensitive
volunteer
welfare
Applicable Type / Vulnerability / Indicator Overlay for this Input