79C3C34C52B45572883A05D425EB0F82
Medical Research Involving Adults Who Cannot Consent (2007)
https://mrc.ukri.org/documents/pdf/medical-research-involving-adults-who-cannot-consent/
http://leaux.net/URLS/ConvertAPI Text Files/30503BA9B5C859E2C3A946CB851D7B2B.en.txt
Examining the file media/Synopses/30503BA9B5C859E2C3A946CB851D7B2B.html:
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| 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 / person under arrest
Searching for indicator arrest:
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p.000030: purposes of the trial but
p.000030: • It is not practical to meet the conditions required for consultation and
p.000030: • The ethics review committee has approved the procedure for such recruitment.
p.000030:
p.000030: When designing such a study researchers should consider the arrangements that will be made. In the information provided
p.000030: to the REC it should be explained why it is necessary to include participants in the trial before consent can be sought
p.000030: from a legal representative.The researchers should also document what steps will be taken to obtain appropriate consent
p.000030: once a participant has been recruited and how they will address refusal of such consent.Two examples (H and I) are
p.000030: provided below.
p.000030:
p.000030:
p.000030:
p.000030:
p.000030:
p.000030:
p.000030:
p.000030:
p.000030:
p.000030: 44The Medicines for Human Use (Clinical Trials) Amendment (no.2) Regulations 2006. SI 2006 No. 2984.
p.000030:
p.000030: MRC ETHICS GUIDE
p.000030: Medical research involving adults who cannot consent 2007
p.000031: 31
p.000031:
p.000031:
p.000031: Examples of clinical trials requiring immediate recruitment
p.000031: H. A large multinational study is examining the effectiveness of pre-hospital thrombolysis for cardiac arrest45.The
p.000031: trial involves recruitment of participants before they arrive at hospital.The trial includes only patients who have
p.000031: suffered a cardiac arrest and so no participants are able to give consent to inclusion.
p.000031: I. A multicentre clinical trial is being set up to compare the effectiveness of two antiepileptic drugs in pregnant
p.000031: women with eclampsia. Many
p.000031: of these patients will be temporarily unable to consent due to their medical condition.They may be unaccompanied when
p.000031: they arrive at hospital and/or have an eclamptic fit.When designing the protocol, the researchers addressed the various
p.000031: possibilities for obtaining consent. This included discussing the trial with women at particular risk of eclampsia and
p.000031: obtaining consent prior to the condition occurring. Careful communication was important, as it can be difficult to
p.000031: identify which women may actually develop eclampsia – the researchers did not wish to unnecessarily alarm women who
p.000031: would not then require therapy.They also considered how consent would be obtained if a woman was enrolled in the study
p.000031: before she had consented, and decided that this could be through a relative before the woman regained capacity, or from
p.000031: the participant herself when she regained capacity.
p.000031:
...
Political / vulnerable
Searching for indicator vulnerable:
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p.000004: 4.3.1 Clinical trials in emergency situations (all of UK)
p.000004: 4.3.2 Other research in emergency situations (England and Wales)
p.000004: 4.3.3 Other research in emergency situations (Scotland)
p.000004: 4.3.4 Data Protection Act 1998 and research in emergency situations (all of UK)
p.000004:
p.000004: MRC ETHICS GUIDE
p.000004: Medical research involving adults who cannot consent 2007
p.000004: 4
p.000004:
p.000004: 1. Introduction
p.000004:
p.000004: Medical research involving adults who lack mental capacity to consent can lead to innovations in healthcare that can
p.000004: substantially improve their health and quality of life and that of others with similar conditions. It is therefore
p.000004: important that these adults are given the opportunity to participate in such research.To exclude them from any research
p.000004: would be discriminatory and would diminish their ability to participate as fully as possible in society. It would also
p.000004: prevent researchers making progress in the understanding of many disorders that can affect the brain, and in the care
p.000004: and treatment of those who have such disorders. However, such research requires special safeguards to ensure that this
p.000004: vulnerable group are protected when they do participate in medical research.
p.000004:
p.000004: The law relating to the conduct of research when the potential participants lack capacity to consent has developed
p.000004: considerably over the past years.These changes provide welcome clarification of the legal framework within which such
p.000004: research can be carried out. Specific legislation has been introduced in Scotland1 and England and Wales2 relating to
p.000004: adults with mental incapacity (or who may become incapacitated). In Northern Ireland the recommendations of a review of
p.000004: mental health legislation are currently
p.000004: being considered. Further guidance for this region will be issued once available. Other instruments, such as the
p.000004: Clinical Trials Regulations 2004, the Human Tissue Act 20043 and the Data Protection Act 1998, are also of relevance to
p.000004: research in this area.
p.000004:
p.000004: This guidance aims to set out the general principles for assessing whether individuals have the capacity to consent to
p.000004: participation in research. It will also discuss participation in research projects when such capacity is lacking.The
p.000004: guidance does not deal with determining capacity in children, which is discussed in a separate MRC publication4.The
...
p.000004:
p.000004: MRC ETHICS GUIDE
p.000004: Medical research involving adults who cannot consent 2007
p.000005: 5
p.000005:
p.000005: 2. Ethical principles
p.000005:
p.000005: 2.1 General principles
p.000005: As with any research, the need to respect the interests of an individual participant is more important than any
p.000005: potential benefits of the research to others6,7.
p.000005:
p.000005: All medical research studies, including those involving adults who lack mental capacity, should comply with accepted
p.000005: principles of good practice, including the Declaration of Helsinki and relevant European and UK legislation. In
p.000005: accordance with section 13 of the Declaration, the research protocol should be submitted to and approved by an
p.000005: independent research ethics committee (REC). Under UK
p.000005: legislation relating to research involving adults who lack the capacity to consent, this REC approval is a legal
p.000005: requirement8. Detailed guidance on applying for approval is available from the National Research Ethics Service9.
p.000005:
p.000005: 2.2 Specific principles
p.000005: Individuals unable to consent to participation in a research project due to a lack of mental capacity are a
p.000005: particularly vulnerable group.Their interests must therefore be protected.They should be given the same opportunities
p.000005: to participate in ethically designed research projects as those who do not lack capacity but must not be put at
p.000005: unwarranted risk.Their participation needs to be agreed by someone who is independent of the study and who can assess
p.000005: the potential participant’s interests in accordance with current legislation and guidance.This person may be a
p.000005: relative, a carer or an independent representative.
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005: 6Declaration of Helsinki, 2000: www.wma.net/e/policy/b3.htm.
p.000005: 7Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology
p.000005: and Medicine: Convention on Human Rights and Biomedicine Oviedo, 4.IV.1997 Chapter 1 article 2.
p.000005: 8Excluding, at present, Northern Ireland.
p.000005: 9National Research Ethics Service: www.nres.npsa.nhs.uk/applicants/help/guidance.htm#awi.
p.000005:
p.000005: MRC ETHICS GUIDE
p.000005: Medical research involving adults who cannot consent 2007
p.000006: 6
p.000006:
p.000006:
p.000006: If possible, the proposed study should also be discussed or communicated with the person themselves in a way
...
Health / Cognitive Impairment
Searching for indicator impaired:
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p.000010: or to indicate willingness to participate in a study for which they are eligible, this willingness should be respected
p.000010: as far as is practical in accordance with legal requirements. See Example B (page 12).
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010: 17MCA Code of Practice issued on 23 April 2007: www.dh.gov.uk/mentalcapacityact.
p.000010: 18Re C adult: refusal of medical treatment [1994] 1 All ER 819.
p.000010: 19General Medical Council: Consent at www.gmc-uk.org/guidance/library/consent.asp.
p.000010: 20Assessment of mental capacity: BMA/Law Society Guidance. 2nd ed 2004.
p.000010: 21MCA Code of Practice section 11.7 summarises these for England.
p.000010: 22MRC Code of Practice at 11.4.
p.000010:
p.000010: MRC ETHICS GUIDE
p.000010: Medical research involving adults who cannot consent 2007
p.000011: 11
p.000011:
p.000011:
p.000011: Table 3: How to decide whether an individual lacks the mental capacity to consent to research participation (based on
p.000011: MCA Code of Practice)
p.000011: Researchers should assume capacity is present unless it is shown to be absent.22
p.000011:
p.000011: Capacity is absent if, at the time of decision making:
p.000011: • The person in question has impaired functioning of their mind or brain.
p.000011: • This impairment makes the person unable to decide whether to participate in this particular research.
p.000011:
p.000011: A person is deemed unable to decide whether to take part in research if they cannot23:
p.000011: • Understand the information relevant to the decision (information should be given in a way that is appropriate to the
p.000011: particular person, this might include use of simplified information sheets, pictures or sign language).
p.000011: • Retain that information for long enough to make the decision (this may be for a relatively short time, but still
p.000011: long enough to enable decision making to occur).
p.000011: • Use or weigh that information as part of the process of making the decision (they need to understand the
p.000011: consequences of each option and of not making the decision).
p.000011: • Communicate their decision (whether by talking, using sign language or any other means).
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011: 22MCA Code of Practice at 11.4.
p.000011: 23Section 3 MCA 2005.
p.000011:
p.000011: MRC ETHICS GUIDE
p.000011: Medical research involving adults who cannot consent 2007
p.000012: 12
p.000012:
p.000012:
p.000012: Example B: assessment of capacity
p.000012: Mr B had taken early retirement from his career as head teacher of a large school following the diagnosis of Pick’s
...
p.000020: Medical research involving adults who cannot consent 2007
p.000021: 21
p.000021:
p.000021:
p.000021: 4.2.1 Clinical trials (all of the UK)
p.000021: Clinical trials that fall under the CT Regulations are defined above (section 4.1): In order to comply with the CT
p.000021: Regulations, a trial must be approved by a recognised research ethics committee (REC) and licensed by the MHRA. All
p.000021: clinical trials must comply with the Good Clinical Practice (GCP) guidelines issued by the International Conference on
p.000021: Harmonisation. In relation to adults who lack mental capacity to consent, the GCP guidelines have specific requirements
p.000021: that must be met.These are summarised here. Please note that there are separate requirements for research in emergency
p.000021: situations, which is discussed in section 4.3.
p.000021:
p.000021: Trial design
p.000021: • A clinical trial must relate directly to a life-threatening or debilitating clinical condition from which a
p.000021: potential participant suffers. (Note that this differs from the requirements for other types of research, which must be
p.000021: relevant to the condition or impairment causing the loss of capacity.) See Example F.
p.000021:
p.000021:
p.000021: Example F: clinical trials that relate directly to a participant’s condition
p.000021: 1. Researchers have designed a trial studying adults with head injury and impaired consciousness.They wish to assess
p.000021: the effects of a 48-hour infusion of corticosteroids on survival and neurological disability.
p.000021: This trial relates directly to the cause of the impaired consciousness in this group of patients.
p.000021:
p.000021: 2.A trial is underway comparing the efficacy of two different dietary plans on blood glucose control in late-onset
p.000021: diabetes. Mrs F has advanced dementia and diabetes. Her family have read about the trial and request that she be
p.000021: included.The researchers consult the REC as to whether they could approve an amendment to the protocol to allow
p.000021: incapacitated adults to be included. In this case the study (which is not a clinical trial of a medicinal product) does
p.000021: not relate to the cause of the impairment of Mrs F’s capacity – which is dementia.
p.000021: It would therefore not be possible for the REC to approve this amendment. However, if it were a clinical trial
p.000021: comparing oral and subcutaneous insulin Mrs F’s participation could be approved.This is because the study would then be
p.000021: a clinical trial of a medicinal product and would relate directly to a condition – diabetes
p.000021: – from which Mrs F suffers.
p.000021:
p.000021: MRC ETHICS GUIDE
p.000021: Medical research involving adults who cannot consent 2007
p.000022: 22
p.000022:
p.000022:
p.000022: • There must be grounds to expect that administering the medicinal product to be tested in the trial will produce a
p.000022: benefit to the participant that outweighs the risks (or will result in no risk at all).
p.000022:
p.000022: • The clinical trial is essential to validate data obtained:
...
p.000024: matter of law.
p.000024: But does not apply to:
p.000024: • Research that falls under the CT Regulations (see section 4.1).
p.000024: • Research carried out in Scotland (see section 4.2.3) or Northern Ireland (see section 4.2.4).
p.000024:
p.000024:
p.000024: Requirements of the MCA
p.000024: The requirements of this Act are discussed in its accompanying Code of Practice35.
p.000024: In order to comply with the MCA, the following requirements must be met by researchers:
p.000024: 1. REC approval (by a recognised committee).
p.000024: 2. Consulting relatives/carers/others.
p.000024: 3. Safeguards to protect participants.
p.000024:
p.000024: 1. Ethical approval for the project or study
p.000024: There are several questions set out in the MCA that must be considered before ethical approval can be granted.
p.000024: Researchers should ensure that they address these in their application for REC approval.The REC must be recognised by
p.000024: the
p.000024: Department of Health (England) or the Welsh Ministers for the purpose of approving research that falls under the Act.At
p.000024: the time of publication, all such committees are part of the National Health Service REC system – further guidance on
p.000024: recognised committees can be obtained from the National Research Ethics Service (NRES)36.
p.000024: • Is the research study related to the impairing condition or its treatment?
p.000024: Asdiscussed in section 3.1, an adult deemed to lack capacity to consent to take part in a research study must have
p.000024: impaired or disturbed functioning of their mind or brain.To be approved, the proposed research must be connected with a
p.000024: condition which may cause, contribute to or result from this impairment of function of the mind or brain or its
p.000024: treatment.This means that participation cannot be approved if the condition being investigated by the study is
p.000024: completely unrelated to the reason for mental incapacity. The link between the study and the reason for the potential
p.000024: participant’s lack of capacity should be explained in the application for ethical approval.
p.000024:
p.000024: 35MRC policy is that, as in other research, payment of legitimate expenses of participants or representatives directly
p.000024: related to participation in the trial is generally considered acceptable.
p.000024: 36National Research Ethics Service: www.nres.npsa.nhs.uk.
p.000024:
p.000024: MRC ETHICS GUIDE
p.000024: Medical research involving adults who cannot consent 2007
p.000025: 25
p.000025:
p.000025: • Could the study be done involving only adults with capacity to consent?
p.000025: Researchers should enrol participants who lack the capacity to consent to take part only if there is reason to believe
...
Searching for indicator impairment:
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p.000006: 6
p.000006:
p.000006:
p.000006: If possible, the proposed study should also be discussed or communicated with the person themselves in a way
p.000006: appropriate to their understanding. In an emergency setting, consultation with the representative or participant may
p.000006: not be immediately possible but should occur as soon as practical. (There is more information about emergency
p.000006: situations in section 4.3).
p.000006:
p.000006: Someone who lacks the mental capacity to consent to take part in research should not take part in a study if he or she
p.000006: does not seem in agreement with any intervention or part of the study, even if agreement has been given by another
p.000006: person. If this happens, researchers are expected to inform the individual’s independant representative that the
p.000006: individual will not be taking part despite the representative’s agreement, and tell them the reasons for this decision.
p.000006:
p.000006: The risks and benefits of participation in any research must always be weighed up so that potential direct benefits
p.000006: outweigh any risks. Any potential risks must be minimised through the study design. If no direct benefit is anticipated
p.000006: the risks must be negligible (see Table 1).
p.000006:
p.000006:
p.000006: Table 1: Key principles when considering the participation of adults who lack capacity in research
p.000006: • The interests of the individual must always outweigh those of science and society.
p.000006: • The research must relate to a condition or impairment that affects the individual or the treatment of this
p.000006: condition10.
p.000006: • It must not be possible to conduct equally effective research with adults who have the capacity to consent.
p.000006: • The potential benefits of the project should outweigh the risks: the level of acceptable risk depends partly on the
p.000006: possible benefit to the individual.
p.000006: • Views of those close to the participant should always be sought, unless this is not possible due to particular
p.000006: circumstances.
p.000006: • A participant who lacks capacity should only be included in a study when there are no indications that he or she
p.000006: objects to this.
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006: 10Under the Mental Capacity Act and Adults with Incapacity (Scotland) Act, this condition or impairment must relate to
p.000006: the reason for incapacity. Under the Clinical Trials Regulations this is not specified.
p.000006:
p.000006: MRC ETHICS GUIDE
p.000006: Medical research involving adults who cannot consent 2007
p.000007: 7
p.000007:
p.000007:
p.000007: 2.3 Risks and benefits
p.000007: Acceptable level of risk
p.000007: The extent to which the likely benefit of a research project affects the acceptable level of risk has been widely
p.000007: discussed.This debate is reflected in changes to the wording of the statutes in relation to the acceptable level of
p.000007: risk:
p.000007: • Adults with Incapacity (Scotland) Act: In relation to the level of acceptable risk, the Scottish Act does not
p.000007: differentiate between research that may potentially
p.000007: benefit participants and that which will not. Both must impose, at most, minimal foreseeable risk and minimal
p.000007: discomfort.
p.000007: • Mental Capacity Act: If research has the potential to benefit participants, the burdens imposed should not be
p.000007: disproportionate to that benefit. If there is no potential benefit then the risks to the patient should be
p.000007: ‘negligible’.The Code of Practice interprets ‘negligible’ as equivalent to ‘minimal’.
p.000007: • Clinical Trials Regulations: The trial should be expected to offer a benefit that outweighs the risks of
...
p.000008: when worn.When the project was reviewed by the REC, it was questioned whether the radiofrequencies used constituted a
p.000008: health hazard in this
p.000008: age group.A decision on whether the study might go ahead was deferred until the researchers provided an updated
p.000008: analysis of the literature on this issue, in light of new scientific evidence.This analysis suggested that the
p.000008: radiofrequency risk was similar to that of mobile telephones.The REC decided that this was equivalent to a risk
p.000008: encountered in normal daily life and approved the study.
p.000008:
p.000008:
p.000008:
p.000008: 15Royal College of Psychiatrists: www.rcpsych.ac.uk/publications/cr/council/cr82i.pdf 3.4. British Medical Association:
p.000008: www.bma.org.uk/ap.nsf/Content/consenttk2~10.
p.000008:
p.000008: MRC ETHICS GUIDE
p.000008: Medical research involving adults who cannot consent 2007
p.000009: 9
p.000009:
p.000009: 3. Key concepts
p.000009:
p.000009: 3.1 Capacity/competence
p.000009: A person is assumed to have the mental capacity to make a decision unless it is shown to be absent.This is a
p.000009: fundamental principle. Mental capacity is considered to be lacking if, in a specific circumstance, a person is unable
p.000009: to make a decision for him or herself because of an impairment or a disturbance in the functioning of
p.000009: their mind or brain16. In designing a study, researchers should consider whether it is likely that some or all
p.000009: participants could lack or could lose their capacity to consent to take part. In this case the information provided to
p.000009: potential participants should include options for their continued participation if they should lose capacity.
p.000009:
p.000009: Table 2: Defining incapacity – from the adults with Incapacity
p.000009: (Scotland) Act
p.000009: ‘Incapable’ means unable to:
p.000009: • act; or
p.000009: • make decisions; or
p.000009: • communicate decisions; or
p.000009: • understand decisions; or
p.000009: • retain the memory of decisions
p.000009: by reason of mental disorder or of inability to communicate because of physical disability.
p.000009:
p.000009:
p.000009: It should be noted that:
p.000009: • Capacity is specific to the matter in question and so a person could have mental capacity in relation to some
p.000009: matters but not to others.
p.000009: • Capacity can also vary in time, for example, in a patient who is temporarily unconscious or who has suffered a
p.000009: relapse in their psychiatric condition.
p.000009: • Capacity is present if the person only has a difficulty with communication that can be overcome with human or
p.000009: mechanical assistance.
p.000009:
p.000009:
p.000009:
p.000009:
p.000009:
p.000009: 16Section 2 Mental Capacity Act 2005:“A person lacks capacity in relation to a matter if at the material time he is
p.000009: unable to make a decision for himself in relation to the matter because of an impairment of or a disturbance in the
p.000009: functioning of the mind or brain.”
p.000009:
p.000009: MRC ETHICS GUIDE
p.000009: Medical research involving adults who cannot consent 2007
p.000010: 10
p.000010:
p.000010:
p.000010: Assessment of mental capacity
p.000010: The Mental Capacity Act (MCA) 2005 and its associated Code of Practice17 set out criteria for assessment of mental
p.000010: capacity.They build upon principles previously used in the courts18 and set out by bodies such as the General Medical
p.000010: Council19 and the British Medical Association20. Assessment of mental capacity is described
p.000010: in the MCA as a two-stage process. First, the person must be shown to have an impairment or disturbance of brain
p.000010: functioning and, second, it must be shown that this renders them unable to make a particular decision.
p.000010:
p.000010: In general, researchers must ask potential participants for consent to take part in a study21. In doing so they must
p.000010: consider whether the person approached has the capacity to make this judgement. In some cases the researcher may have
p.000010: the necessary expertise to make this decision, but often they will need to seek an
p.000010: opinion from the clinical team caring for the potential participant.There are several factors to be considered when
p.000010: deciding whether a person lacks the mental capacity to provide consent to participate in research.These are outlined in
p.000010: Table 3.
p.000010:
p.000010: If a researcher or clinician is uncertain as to whether a person has the mental capacity to consent to participation in
p.000010: research or does not have the skills to assess this, an independent assessment should be carried out. If doubt remains
p.000010: or there are differences of opinion, for example, between clinical staff and relatives or carers, a court could make a
p.000010: ruling on this. However, it is unlikely that such steps would be taken: if such uncertainty exists it may be better not
p.000010: to include the patient in the study. On the other hand, when an adult does have the ability to make a decision
p.000010: or to indicate willingness to participate in a study for which they are eligible, this willingness should be respected
p.000010: as far as is practical in accordance with legal requirements. See Example B (page 12).
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010: 17MCA Code of Practice issued on 23 April 2007: www.dh.gov.uk/mentalcapacityact.
p.000010: 18Re C adult: refusal of medical treatment [1994] 1 All ER 819.
p.000010: 19General Medical Council: Consent at www.gmc-uk.org/guidance/library/consent.asp.
p.000010: 20Assessment of mental capacity: BMA/Law Society Guidance. 2nd ed 2004.
p.000010: 21MCA Code of Practice section 11.7 summarises these for England.
p.000010: 22MRC Code of Practice at 11.4.
p.000010:
p.000010: MRC ETHICS GUIDE
p.000010: Medical research involving adults who cannot consent 2007
p.000011: 11
p.000011:
p.000011:
p.000011: Table 3: How to decide whether an individual lacks the mental capacity to consent to research participation (based on
p.000011: MCA Code of Practice)
p.000011: Researchers should assume capacity is present unless it is shown to be absent.22
p.000011:
p.000011: Capacity is absent if, at the time of decision making:
p.000011: • The person in question has impaired functioning of their mind or brain.
p.000011: • This impairment makes the person unable to decide whether to participate in this particular research.
p.000011:
p.000011: A person is deemed unable to decide whether to take part in research if they cannot23:
p.000011: • Understand the information relevant to the decision (information should be given in a way that is appropriate to the
p.000011: particular person, this might include use of simplified information sheets, pictures or sign language).
p.000011: • Retain that information for long enough to make the decision (this may be for a relatively short time, but still
p.000011: long enough to enable decision making to occur).
p.000011: • Use or weigh that information as part of the process of making the decision (they need to understand the
p.000011: consequences of each option and of not making the decision).
p.000011: • Communicate their decision (whether by talking, using sign language or any other means).
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011: 22MCA Code of Practice at 11.4.
p.000011: 23Section 3 MCA 2005.
p.000011:
p.000011: MRC ETHICS GUIDE
p.000011: Medical research involving adults who cannot consent 2007
p.000012: 12
p.000012:
p.000012:
p.000012: Example B: assessment of capacity
p.000012: Mr B had taken early retirement from his career as head teacher of a large school following the diagnosis of Pick’s
...
p.000020: 32 Of relevance, section (45) of the Human Tissue Act relating to DNA analysis also applies in Scotland. For further
p.000020: guidance on the use of human tissue in research, please refer to separate MRC publications.
p.000020: 33At the time of publication in October 2007, a draft Bill amending this Act was being prepared.
p.000020:
p.000020: MRC ETHICS GUIDE
p.000020: Medical research involving adults who cannot consent 2007
p.000021: 21
p.000021:
p.000021:
p.000021: 4.2.1 Clinical trials (all of the UK)
p.000021: Clinical trials that fall under the CT Regulations are defined above (section 4.1): In order to comply with the CT
p.000021: Regulations, a trial must be approved by a recognised research ethics committee (REC) and licensed by the MHRA. All
p.000021: clinical trials must comply with the Good Clinical Practice (GCP) guidelines issued by the International Conference on
p.000021: Harmonisation. In relation to adults who lack mental capacity to consent, the GCP guidelines have specific requirements
p.000021: that must be met.These are summarised here. Please note that there are separate requirements for research in emergency
p.000021: situations, which is discussed in section 4.3.
p.000021:
p.000021: Trial design
p.000021: • A clinical trial must relate directly to a life-threatening or debilitating clinical condition from which a
p.000021: potential participant suffers. (Note that this differs from the requirements for other types of research, which must be
p.000021: relevant to the condition or impairment causing the loss of capacity.) See Example F.
p.000021:
p.000021:
p.000021: Example F: clinical trials that relate directly to a participant’s condition
p.000021: 1. Researchers have designed a trial studying adults with head injury and impaired consciousness.They wish to assess
p.000021: the effects of a 48-hour infusion of corticosteroids on survival and neurological disability.
p.000021: This trial relates directly to the cause of the impaired consciousness in this group of patients.
p.000021:
p.000021: 2.A trial is underway comparing the efficacy of two different dietary plans on blood glucose control in late-onset
p.000021: diabetes. Mrs F has advanced dementia and diabetes. Her family have read about the trial and request that she be
p.000021: included.The researchers consult the REC as to whether they could approve an amendment to the protocol to allow
p.000021: incapacitated adults to be included. In this case the study (which is not a clinical trial of a medicinal product) does
p.000021: not relate to the cause of the impairment of Mrs F’s capacity – which is dementia.
p.000021: It would therefore not be possible for the REC to approve this amendment. However, if it were a clinical trial
p.000021: comparing oral and subcutaneous insulin Mrs F’s participation could be approved.This is because the study would then be
p.000021: a clinical trial of a medicinal product and would relate directly to a condition – diabetes
p.000021: – from which Mrs F suffers.
p.000021:
p.000021: MRC ETHICS GUIDE
p.000021: Medical research involving adults who cannot consent 2007
p.000022: 22
p.000022:
p.000022:
p.000022: • There must be grounds to expect that administering the medicinal product to be tested in the trial will produce a
p.000022: benefit to the participant that outweighs the risks (or will result in no risk at all).
p.000022:
p.000022: • The clinical trial is essential to validate data obtained:
p.000022: • in other clinical trials involving participants who are able to give informed consent, or
p.000022: • by other research methods.
p.000022:
p.000022: • No incentives or financial inducements may be given to a participant or their legal representative, except provision
p.000022: for compensation in the event of injury or loss34.
p.000022:
p.000022: Consent by legal representative
p.000022: • Consent by a legal representative is required if consent to participate was not
p.000022: given prior to the loss of capacity.
p.000022:
...
p.000024:
p.000024:
p.000024: Requirements of the MCA
p.000024: The requirements of this Act are discussed in its accompanying Code of Practice35.
p.000024: In order to comply with the MCA, the following requirements must be met by researchers:
p.000024: 1. REC approval (by a recognised committee).
p.000024: 2. Consulting relatives/carers/others.
p.000024: 3. Safeguards to protect participants.
p.000024:
p.000024: 1. Ethical approval for the project or study
p.000024: There are several questions set out in the MCA that must be considered before ethical approval can be granted.
p.000024: Researchers should ensure that they address these in their application for REC approval.The REC must be recognised by
p.000024: the
p.000024: Department of Health (England) or the Welsh Ministers for the purpose of approving research that falls under the Act.At
p.000024: the time of publication, all such committees are part of the National Health Service REC system – further guidance on
p.000024: recognised committees can be obtained from the National Research Ethics Service (NRES)36.
p.000024: • Is the research study related to the impairing condition or its treatment?
p.000024: Asdiscussed in section 3.1, an adult deemed to lack capacity to consent to take part in a research study must have
p.000024: impaired or disturbed functioning of their mind or brain.To be approved, the proposed research must be connected with a
p.000024: condition which may cause, contribute to or result from this impairment of function of the mind or brain or its
p.000024: treatment.This means that participation cannot be approved if the condition being investigated by the study is
p.000024: completely unrelated to the reason for mental incapacity. The link between the study and the reason for the potential
p.000024: participant’s lack of capacity should be explained in the application for ethical approval.
p.000024:
p.000024: 35MRC policy is that, as in other research, payment of legitimate expenses of participants or representatives directly
p.000024: related to participation in the trial is generally considered acceptable.
p.000024: 36National Research Ethics Service: www.nres.npsa.nhs.uk.
p.000024:
p.000024: MRC ETHICS GUIDE
p.000024: Medical research involving adults who cannot consent 2007
p.000025: 25
p.000025:
p.000025: • Could the study be done involving only adults with capacity to consent?
p.000025: Researchers should enrol participants who lack the capacity to consent to take part only if there is reason to believe
p.000025: that the study could not be done as effectively if it involved only adults who could give consent.This is illustrated
p.000025: in Example G below.
p.000025:
p.000025:
p.000025: Example G: studies where it is not necessary to include adults who lack capacity to consent
p.000025: Researchers wish to assess changes in blood levels of immune factors following insertion of an invasive monitoring
p.000025: device into an artery. The team are based in intensive care and so they are seeking REC approval to include in the
p.000025: study unconscious patients in the intensive care unit who will frequently require such venous access. However, the
p.000025: scientists consider that these patients will not be able to consent to take part in the study.They therefore decide to
p.000025: instead enrol patients who require the placement of such lines before elective surgery and from whom consent could be
p.000025: sought. This study is related to treatment for the condition causing the impairment of capacity, but it could be done
p.000025: as effectively in patients who are able to consent to participation.
p.000025:
p.000025:
p.000025: • Does the study have the potential to benefit the participant?
p.000025: Ifso, then the expected burden of taking part in the research should be proportionate to the possible benefits.
p.000025: Researchers should consider what will be required of participants, including any possible discomfort, restriction of
p.000025: mobility or use of their data or tissue.This should be weighed against the potential for the study to be of direct
p.000025: benefit to those taking part. Potential benefits are discussed further in the MCA Code of Practice37.
p.000025:
p.000025: • Is there unlikely to be any benefit to the participant?
p.000025: If so, the research must fulfil all of the following objectives:
p.000025: • It must be investigating the cause, treatment or care of people with similar conditions.
p.000025: • The risks of the project must be ‘negligible’ (see the discussion in section 2.2 on levels of risks).
p.000025: • The project must not significantly interfere with freedom of action or privacy.
p.000025: • The project must not be unduly invasive or restrictive.
p.000025:
p.000025:
p.000025:
p.000025: 37MCA Code of Practice 2005 at 11.14.
p.000025:
p.000025: MRC ETHICS GUIDE
p.000025: Medical research involving adults who cannot consent 2007
p.000026: 26
p.000026:
p.000026:
p.000026: The MCA Code of Practice states that “actions will not usually be classed as unduly invasive if they do not go beyond
p.000026: the experience of daily life, a routine medical examination or a psychological examination”38.
p.000026:
...
Health / Drug Usage
Searching for indicator drug:
(return to top)
p.000018:
p.000018: 29Medicinal products are defined by the MHRA as “substances or combinations of substances which either prevent or treat
p.000018: disease in human beings or are administered to human beings with a view to making a medical diagnosis or to restore,
p.000018: correct or modify physiological functions in humans.”
p.000018: A clinical trial is defined by the MHRA the as “an investigation in human subjects which is intended to discover or
p.000018: verify the clinical, pharmacological and/or other pharmacodynamic effects of one or more medicinal products, identify
p.000018: any adverse reactions or study the absorption, distribution, metabolism and excretion, with the object of ascertaining
p.000018: the safety and/or efficacy of those products.” This definition includes pharmacokinetic studies.
p.000018: www.mhra.gov.uk/home/idcplg?IdcService=SS_GET_PAGE&nodeId=723.
p.000018:
p.000018: MRC ETHICS GUIDE
p.000018: Medical research involving adults who cannot consent 2007
p.000019: 19
p.000019:
p.000019: Example E: clinical trial governed by the MCA or CT Regulations Researchers in an English teaching hospital aim to
p.000019: compare two different neurosurgical techniques for treating severe sub-arachnoid haemorrhage.
p.000019: Many of the potential participants will lack capacity to consent due to the effects of the haemorrhage.
p.000019: This will not be a clinical trial of a medicinal product and so would fall under the MCA.
p.000019:
p.000019: The same unit also wishes to perform a study comparing the effects of a new anti-fibrinolytic drug on outcome after
p.000019: sub-arachnoid haemorrhage. This research is a clinical trial of a medicinal product.
p.000019:
p.000019:
p.000019: 2.All other ‘intrusive’ research in England and Wales involving adults who lack mental capacity to consent falls under
p.000019: the MCA, which contains specific requirements for the conduct of such research. Intrusive research in this context is
p.000019: described as that where: “if a person taking part had capacity, the researcher would need to get consent to involve
p.000019: them”30. It specifically excludes research that falls under the CT Regulations.
p.000019:
p.000019: 3. Research in Scotland is governed by the AWIS.This contains requirements for “surgical, medical, nursing, dental or
p.000019: psychological research”31.The Act gives specific requirements which are broadly similar to the MCA but have some
p.000019: differences in their detail. Section 4.2.3 below summarises the position in Scotland.
p.000019:
p.000019: 4.Table 5 summarises the legislation relevant to research involving people in different parts of the UK.
p.000019:
p.000019:
p.000019:
p.000019:
p.000019:
p.000019:
p.000019:
p.000019:
p.000019:
p.000019:
p.000019:
p.000019:
p.000019:
p.000019: 30MCA Code pf Practice at 11.6.
p.000019: 31AWIS 2000 at 51(3).
p.000019:
p.000019: MRC ETHICS GUIDE
p.000019: Medical research involving adults who cannot consent 2007
p.000020: 20
p.000020:
p.000020:
p.000020: Table 5: Summary of relevant legislation
p.000020: England and Wales Scotland Northern Ireland
p.000020:
...
Searching for indicator usage:
(return to top)
p.000017:
p.000017: However, the family agreed that the data and samples already collected could continue to be used in the study, in
p.000017: accordance with Mr D’s previously expressed wishes.
p.000017:
p.000017: MRC ETHICS GUIDE
p.000017: Medical research involving adults who cannot consent 2007
p.000018: 18
p.000018:
p.000018: 4. Legal requirements for research
p.000018:
p.000018: 4.1 Legislation relevant to medical research
p.000018: The law in the UK now makes a distinction between two types of research involving people.These are (i) clinical trials
p.000018: of medicinal products and (ii) other research involving people. In relation to capacity, these studies are governed by
p.000018: three separate pieces of legislation. Clinical trials of medicinal products are governed by the Medicines for Human Use
p.000018: (Clinical Trials) Regulations 2004 (CT Regulations) while other research is governed by the Adults With Incapacity
p.000018: (Scotland) Act 2000 (AWIS) or the Mental Capacity Act 2005 (MCA).The CT Regulations implement a European Directive and
p.000018: apply to all of the UK.The AWIS applies only to Scotland and the MCA applies only to England and Wales.
p.000018:
p.000018: To ensure that research is conducted lawfully researchers must first determine into which category their proposed
p.000018: research falls. It is important to note that the legal definition of a ‘clinical trial’ (i.e. a study which falls under
p.000018: the CT Regulations) is tightly defined, whereas in wider usage the term can sometimes refer to other types of study.
p.000018: See Example E.
p.000018:
p.000018: 1. Clinical trials of medicinal products:These are regulated by the CT Regulations and defined as “interventional
p.000018: investigations or studies undertaken to ascertain the efficacy or safety of a medicinal product in human
p.000018: subjects”29.The CT Regulations contain requirements that apply if adults who lack capacity are to be included
p.000018: in such research. Further guidance on the regulation of clinical trials and how to determine if a study falls into this
p.000018: category is available at www.ct-toolkit.ac.uk. The Medicines and Healthcare products Regulatory Agency (MHRA) can
p.000018: provide advice on an individual basis about whether a proposed trial is covered by the CT Regulations. In addition, an
p.000018: algorithm to help decide whether research is a clinical trial of a medicinal product is available at
p.000018: http://ec.europa.eu/enterprise/ pharmaceuticals/pharmacos/docs/doc2006/04_2006/clinical_trial_ qa_april_2006.pdf.
p.000018:
p.000018: 29Medicinal products are defined by the MHRA as “substances or combinations of substances which either prevent or treat
p.000018: disease in human beings or are administered to human beings with a view to making a medical diagnosis or to restore,
p.000018: correct or modify physiological functions in humans.”
p.000018: A clinical trial is defined by the MHRA the as “an investigation in human subjects which is intended to discover or
p.000018: verify the clinical, pharmacological and/or other pharmacodynamic effects of one or more medicinal products, identify
p.000018: any adverse reactions or study the absorption, distribution, metabolism and excretion, with the object of ascertaining
p.000018: the safety and/or efficacy of those products.” This definition includes pharmacokinetic studies.
...
Health / Mentally Disabled
Searching for indicator mentally:
(return to top)
p.000004: guidance does not deal with determining capacity in children, which is discussed in a separate MRC publication4.The
p.000004: emphasis of this publication is on the legislation relating to mental capacity, including explanation of this
p.000004: legislation.The greater emphasis than in previous MRC guidance5 on the legal requirements for such research reflects
p.000004: the altered legal framework.
p.000004:
p.000004: It is hoped that this guidance will help scientists to ensure that research involving people who lack mental capacity
p.000004: is conducted in a legally and ethically acceptable manner. It
p.000004: is also intended to give confidence to researchers that adults with incapacity can be included in their studies so
p.000004: that, when appropriate, they will make the opportunity available, in accordance with the required and recommended
p.000004: safeguards described here.
p.000004:
p.000004:
p.000004: 1Adults with Incapacity Act 2000.
p.000004: 2Mental Capacity Act 2005.
p.000004: 3Medicines for Human Use (Clinical Trials) Regulations 2004. SI 2004 1031 (as amended).
p.000004: 4MRC Ethics Guide: Research involving children, 2004.
p.000004: 5The Ethical Conduct of Research in the Mentally Incapacitated. MRC 1991.
p.000004:
p.000004: MRC ETHICS GUIDE
p.000004: Medical research involving adults who cannot consent 2007
p.000005: 5
p.000005:
p.000005: 2. Ethical principles
p.000005:
p.000005: 2.1 General principles
p.000005: As with any research, the need to respect the interests of an individual participant is more important than any
p.000005: potential benefits of the research to others6,7.
p.000005:
p.000005: All medical research studies, including those involving adults who lack mental capacity, should comply with accepted
p.000005: principles of good practice, including the Declaration of Helsinki and relevant European and UK legislation. In
p.000005: accordance with section 13 of the Declaration, the research protocol should be submitted to and approved by an
p.000005: independent research ethics committee (REC). Under UK
p.000005: legislation relating to research involving adults who lack the capacity to consent, this REC approval is a legal
p.000005: requirement8. Detailed guidance on applying for approval is available from the National Research Ethics Service9.
p.000005:
p.000005: 2.2 Specific principles
p.000005: Individuals unable to consent to participation in a research project due to a lack of mental capacity are a
...
Searching for indicator disability:
(return to top)
p.000009: 9
p.000009:
p.000009: 3. Key concepts
p.000009:
p.000009: 3.1 Capacity/competence
p.000009: A person is assumed to have the mental capacity to make a decision unless it is shown to be absent.This is a
p.000009: fundamental principle. Mental capacity is considered to be lacking if, in a specific circumstance, a person is unable
p.000009: to make a decision for him or herself because of an impairment or a disturbance in the functioning of
p.000009: their mind or brain16. In designing a study, researchers should consider whether it is likely that some or all
p.000009: participants could lack or could lose their capacity to consent to take part. In this case the information provided to
p.000009: potential participants should include options for their continued participation if they should lose capacity.
p.000009:
p.000009: Table 2: Defining incapacity – from the adults with Incapacity
p.000009: (Scotland) Act
p.000009: ‘Incapable’ means unable to:
p.000009: • act; or
p.000009: • make decisions; or
p.000009: • communicate decisions; or
p.000009: • understand decisions; or
p.000009: • retain the memory of decisions
p.000009: by reason of mental disorder or of inability to communicate because of physical disability.
p.000009:
p.000009:
p.000009: It should be noted that:
p.000009: • Capacity is specific to the matter in question and so a person could have mental capacity in relation to some
p.000009: matters but not to others.
p.000009: • Capacity can also vary in time, for example, in a patient who is temporarily unconscious or who has suffered a
p.000009: relapse in their psychiatric condition.
p.000009: • Capacity is present if the person only has a difficulty with communication that can be overcome with human or
p.000009: mechanical assistance.
p.000009:
p.000009:
p.000009:
p.000009:
p.000009:
p.000009: 16Section 2 Mental Capacity Act 2005:“A person lacks capacity in relation to a matter if at the material time he is
p.000009: unable to make a decision for himself in relation to the matter because of an impairment of or a disturbance in the
p.000009: functioning of the mind or brain.”
p.000009:
p.000009: MRC ETHICS GUIDE
p.000009: Medical research involving adults who cannot consent 2007
p.000010: 10
p.000010:
p.000010:
p.000010: Assessment of mental capacity
p.000010: The Mental Capacity Act (MCA) 2005 and its associated Code of Practice17 set out criteria for assessment of mental
...
p.000012: with respect to their lifestyle, interests, needs, religious beliefs and priorities24. If someone is unable to provide
p.000012: consent for themselves due to a lack of mental capacity, the next step to consider is
p.000012:
p.000012: 24General Medical Council guidance
p.000012:
p.000012: MRC ETHICS GUIDE
p.000012: Medical research involving adults who cannot consent 2007
p.000013: 13
p.000013:
p.000013: whether the legal requirements and safeguards can be met if they are included without their own consent (for example,
p.000013: under section 30 of the MCA).
p.000013: Alternatively the researchers should consider not including the person in question in the research.
p.000013:
p.000013: Example C: materials for consent
p.000013: A team of researchers was carrying out a series of studies comparing the benefits of different types of physiotherapy
p.000013: for people with serious physical restrictions following a severe stroke.They began with the assumption that all
p.000013: potential recruits would have the capacity to consent.The first step was to
p.000013: talk with each person to establish their mental capacity, irrespective of physical disability, using picture cards to
p.000013: help show what the intervention involved.
p.000013: Among those they approached was Mrs C, who was only able to communicate by nodding her head slightly and through her
p.000013: facial expression. She seemed able to understand that the physiotherapy would benefit her and to indicate that she
p.000013: would like it.To check that she could retain the information they gave her, the researchers returned to discuss the
p.000013: project on a separate occasion and she responded in the same way.The researchers determined that she had capacity and
p.000013: discussed this with her GP who agreed.The reasons for believing she had capacity were documented in the study records.
p.000013:
p.000013: Mrs C’s daughter was her main carer. Using the same methods the researcher obtained Mrs C’s agreement to discuss the
p.000013: study with her daughter.
p.000013:
p.000013:
p.000013: 3.2.1 Giving consent on behalf of an adult who lacks capacity
p.000013: There are varying interpretations of the meaning of consent by others for an adult who cannot give their own consent to
p.000013: participate in a research study.The laws and regulations relating to medical research involving adults who lack
p.000013: capacity to consent do not use the ‘best interests’ test. Instead they set out the necessary criteria for the research
...
p.000021: 21
p.000021:
p.000021:
p.000021: 4.2.1 Clinical trials (all of the UK)
p.000021: Clinical trials that fall under the CT Regulations are defined above (section 4.1): In order to comply with the CT
p.000021: Regulations, a trial must be approved by a recognised research ethics committee (REC) and licensed by the MHRA. All
p.000021: clinical trials must comply with the Good Clinical Practice (GCP) guidelines issued by the International Conference on
p.000021: Harmonisation. In relation to adults who lack mental capacity to consent, the GCP guidelines have specific requirements
p.000021: that must be met.These are summarised here. Please note that there are separate requirements for research in emergency
p.000021: situations, which is discussed in section 4.3.
p.000021:
p.000021: Trial design
p.000021: • A clinical trial must relate directly to a life-threatening or debilitating clinical condition from which a
p.000021: potential participant suffers. (Note that this differs from the requirements for other types of research, which must be
p.000021: relevant to the condition or impairment causing the loss of capacity.) See Example F.
p.000021:
p.000021:
p.000021: Example F: clinical trials that relate directly to a participant’s condition
p.000021: 1. Researchers have designed a trial studying adults with head injury and impaired consciousness.They wish to assess
p.000021: the effects of a 48-hour infusion of corticosteroids on survival and neurological disability.
p.000021: This trial relates directly to the cause of the impaired consciousness in this group of patients.
p.000021:
p.000021: 2.A trial is underway comparing the efficacy of two different dietary plans on blood glucose control in late-onset
p.000021: diabetes. Mrs F has advanced dementia and diabetes. Her family have read about the trial and request that she be
p.000021: included.The researchers consult the REC as to whether they could approve an amendment to the protocol to allow
p.000021: incapacitated adults to be included. In this case the study (which is not a clinical trial of a medicinal product) does
p.000021: not relate to the cause of the impairment of Mrs F’s capacity – which is dementia.
p.000021: It would therefore not be possible for the REC to approve this amendment. However, if it were a clinical trial
p.000021: comparing oral and subcutaneous insulin Mrs F’s participation could be approved.This is because the study would then be
p.000021: a clinical trial of a medicinal product and would relate directly to a condition – diabetes
p.000021: – from which Mrs F suffers.
p.000021:
p.000021: MRC ETHICS GUIDE
p.000021: Medical research involving adults who cannot consent 2007
p.000022: 22
p.000022:
p.000022:
p.000022: • There must be grounds to expect that administering the medicinal product to be tested in the trial will produce a
p.000022: benefit to the participant that outweighs the risks (or will result in no risk at all).
p.000022:
...
Health / Mentally Incapacitated
Searching for indicator incapable:
(return to top)
p.000008:
p.000008:
p.000008:
p.000008: 15Royal College of Psychiatrists: www.rcpsych.ac.uk/publications/cr/council/cr82i.pdf 3.4. British Medical Association:
p.000008: www.bma.org.uk/ap.nsf/Content/consenttk2~10.
p.000008:
p.000008: MRC ETHICS GUIDE
p.000008: Medical research involving adults who cannot consent 2007
p.000009: 9
p.000009:
p.000009: 3. Key concepts
p.000009:
p.000009: 3.1 Capacity/competence
p.000009: A person is assumed to have the mental capacity to make a decision unless it is shown to be absent.This is a
p.000009: fundamental principle. Mental capacity is considered to be lacking if, in a specific circumstance, a person is unable
p.000009: to make a decision for him or herself because of an impairment or a disturbance in the functioning of
p.000009: their mind or brain16. In designing a study, researchers should consider whether it is likely that some or all
p.000009: participants could lack or could lose their capacity to consent to take part. In this case the information provided to
p.000009: potential participants should include options for their continued participation if they should lose capacity.
p.000009:
p.000009: Table 2: Defining incapacity – from the adults with Incapacity
p.000009: (Scotland) Act
p.000009: ‘Incapable’ means unable to:
p.000009: • act; or
p.000009: • make decisions; or
p.000009: • communicate decisions; or
p.000009: • understand decisions; or
p.000009: • retain the memory of decisions
p.000009: by reason of mental disorder or of inability to communicate because of physical disability.
p.000009:
p.000009:
p.000009: It should be noted that:
p.000009: • Capacity is specific to the matter in question and so a person could have mental capacity in relation to some
p.000009: matters but not to others.
p.000009: • Capacity can also vary in time, for example, in a patient who is temporarily unconscious or who has suffered a
p.000009: relapse in their psychiatric condition.
p.000009: • Capacity is present if the person only has a difficulty with communication that can be overcome with human or
p.000009: mechanical assistance.
p.000009:
p.000009:
p.000009:
p.000009:
p.000009:
p.000009: 16Section 2 Mental Capacity Act 2005:“A person lacks capacity in relation to a matter if at the material time he is
p.000009: unable to make a decision for himself in relation to the matter because of an impairment of or a disturbance in the
p.000009: functioning of the mind or brain.”
p.000009:
p.000009: MRC ETHICS GUIDE
p.000009: Medical research involving adults who cannot consent 2007
p.000010: 10
...
Health / Motherhood/Family
Searching for indicator family:
(return to top)
p.000017: previously.Aware of the devastating effects of the disease, he wanted to help find out more about it to help expand
p.000017: the options for future treatment and care. Mr D went on to develop Alzheimer’s in his late 60s and was now in an
p.000017: advanced stage of dementia.When signing up for the study, he had given consent to re-assessment at yearly intervals
p.000017: throughout his life and indicated that he would wish this to continue in the event that he lost capacity. He also
p.000017: consented to continued use of his data in the study in the event that he lost capacity or was withdrawn from the study.
p.000017: This meant that the researchers were able to continue to monitor him.
p.000017:
p.000017: For a long time, he had seemed perfectly happy with this arrangement and this was confirmed when the researchers
p.000017: checked annually with his
p.000017: carers. However when an important new test became available that would involve taking further blood samples from the
p.000017: entire study population it became necessary to ask each participant for their specific consent to the alteration in
p.000017: sampling practice.Although the researchers would have liked to keep Mr D in the study, he was no longer able to consent
p.000017: for himself and his prior wishes were unknown. Furthermore, his carers informed the
p.000017: researchers that he had recently been hospitalised with an infection and had subsequently developed a marked fear of
p.000017: needles.
p.000017:
p.000017: The researchers agreed with the family that Mr D should not be included in the next round of sampling as the outcome of
p.000017: the research would not be of any direct benefit to his own health. In addition, his present condition meant that he may
p.000017: have found the taking of blood samples distressing: this was deemed an unacceptable risk.
p.000017:
p.000017: However, the family agreed that the data and samples already collected could continue to be used in the study, in
p.000017: accordance with Mr D’s previously expressed wishes.
p.000017:
p.000017: MRC ETHICS GUIDE
p.000017: Medical research involving adults who cannot consent 2007
p.000018: 18
p.000018:
p.000018: 4. Legal requirements for research
p.000018:
p.000018: 4.1 Legislation relevant to medical research
p.000018: The law in the UK now makes a distinction between two types of research involving people.These are (i) clinical trials
p.000018: of medicinal products and (ii) other research involving people. In relation to capacity, these studies are governed by
p.000018: three separate pieces of legislation. Clinical trials of medicinal products are governed by the Medicines for Human Use
p.000018: (Clinical Trials) Regulations 2004 (CT Regulations) while other research is governed by the Adults With Incapacity
p.000018: (Scotland) Act 2000 (AWIS) or the Mental Capacity Act 2005 (MCA).The CT Regulations implement a European Directive and
p.000018: apply to all of the UK.The AWIS applies only to Scotland and the MCA applies only to England and Wales.
p.000018:
p.000018: To ensure that research is conducted lawfully researchers must first determine into which category their proposed
p.000018: research falls. It is important to note that the legal definition of a ‘clinical trial’ (i.e. a study which falls under
p.000018: the CT Regulations) is tightly defined, whereas in wider usage the term can sometimes refer to other types of study.
p.000018: See Example E.
p.000018:
...
p.000021: Harmonisation. In relation to adults who lack mental capacity to consent, the GCP guidelines have specific requirements
p.000021: that must be met.These are summarised here. Please note that there are separate requirements for research in emergency
p.000021: situations, which is discussed in section 4.3.
p.000021:
p.000021: Trial design
p.000021: • A clinical trial must relate directly to a life-threatening or debilitating clinical condition from which a
p.000021: potential participant suffers. (Note that this differs from the requirements for other types of research, which must be
p.000021: relevant to the condition or impairment causing the loss of capacity.) See Example F.
p.000021:
p.000021:
p.000021: Example F: clinical trials that relate directly to a participant’s condition
p.000021: 1. Researchers have designed a trial studying adults with head injury and impaired consciousness.They wish to assess
p.000021: the effects of a 48-hour infusion of corticosteroids on survival and neurological disability.
p.000021: This trial relates directly to the cause of the impaired consciousness in this group of patients.
p.000021:
p.000021: 2.A trial is underway comparing the efficacy of two different dietary plans on blood glucose control in late-onset
p.000021: diabetes. Mrs F has advanced dementia and diabetes. Her family have read about the trial and request that she be
p.000021: included.The researchers consult the REC as to whether they could approve an amendment to the protocol to allow
p.000021: incapacitated adults to be included. In this case the study (which is not a clinical trial of a medicinal product) does
p.000021: not relate to the cause of the impairment of Mrs F’s capacity – which is dementia.
p.000021: It would therefore not be possible for the REC to approve this amendment. However, if it were a clinical trial
p.000021: comparing oral and subcutaneous insulin Mrs F’s participation could be approved.This is because the study would then be
p.000021: a clinical trial of a medicinal product and would relate directly to a condition – diabetes
p.000021: – from which Mrs F suffers.
p.000021:
p.000021: MRC ETHICS GUIDE
p.000021: Medical research involving adults who cannot consent 2007
p.000022: 22
p.000022:
p.000022:
p.000022: • There must be grounds to expect that administering the medicinal product to be tested in the trial will produce a
p.000022: benefit to the participant that outweighs the risks (or will result in no risk at all).
p.000022:
p.000022: • The clinical trial is essential to validate data obtained:
p.000022: • in other clinical trials involving participants who are able to give informed consent, or
p.000022: • by other research methods.
p.000022:
p.000022: • No incentives or financial inducements may be given to a participant or their legal representative, except provision
...
Health / Pregnant
Searching for indicator pregnant:
(return to top)
p.000030:
p.000030: When designing such a study researchers should consider the arrangements that will be made. In the information provided
p.000030: to the REC it should be explained why it is necessary to include participants in the trial before consent can be sought
p.000030: from a legal representative.The researchers should also document what steps will be taken to obtain appropriate consent
p.000030: once a participant has been recruited and how they will address refusal of such consent.Two examples (H and I) are
p.000030: provided below.
p.000030:
p.000030:
p.000030:
p.000030:
p.000030:
p.000030:
p.000030:
p.000030:
p.000030:
p.000030: 44The Medicines for Human Use (Clinical Trials) Amendment (no.2) Regulations 2006. SI 2006 No. 2984.
p.000030:
p.000030: MRC ETHICS GUIDE
p.000030: Medical research involving adults who cannot consent 2007
p.000031: 31
p.000031:
p.000031:
p.000031: Examples of clinical trials requiring immediate recruitment
p.000031: H. A large multinational study is examining the effectiveness of pre-hospital thrombolysis for cardiac arrest45.The
p.000031: trial involves recruitment of participants before they arrive at hospital.The trial includes only patients who have
p.000031: suffered a cardiac arrest and so no participants are able to give consent to inclusion.
p.000031: I. A multicentre clinical trial is being set up to compare the effectiveness of two antiepileptic drugs in pregnant
p.000031: women with eclampsia. Many
p.000031: of these patients will be temporarily unable to consent due to their medical condition.They may be unaccompanied when
p.000031: they arrive at hospital and/or have an eclamptic fit.When designing the protocol, the researchers addressed the various
p.000031: possibilities for obtaining consent. This included discussing the trial with women at particular risk of eclampsia and
p.000031: obtaining consent prior to the condition occurring. Careful communication was important, as it can be difficult to
p.000031: identify which women may actually develop eclampsia – the researchers did not wish to unnecessarily alarm women who
p.000031: would not then require therapy.They also considered how consent would be obtained if a woman was enrolled in the study
p.000031: before she had consented, and decided that this could be through a relative before the woman regained capacity, or from
p.000031: the participant herself when she regained capacity.
p.000031:
p.000031: 4.3.2 Other research in emergency situations (England and Wales) The MCA allows patients to be recruited into research
...
Health / Unconscious People
Searching for indicator unconscious:
(return to top)
p.000009: to make a decision for him or herself because of an impairment or a disturbance in the functioning of
p.000009: their mind or brain16. In designing a study, researchers should consider whether it is likely that some or all
p.000009: participants could lack or could lose their capacity to consent to take part. In this case the information provided to
p.000009: potential participants should include options for their continued participation if they should lose capacity.
p.000009:
p.000009: Table 2: Defining incapacity – from the adults with Incapacity
p.000009: (Scotland) Act
p.000009: ‘Incapable’ means unable to:
p.000009: • act; or
p.000009: • make decisions; or
p.000009: • communicate decisions; or
p.000009: • understand decisions; or
p.000009: • retain the memory of decisions
p.000009: by reason of mental disorder or of inability to communicate because of physical disability.
p.000009:
p.000009:
p.000009: It should be noted that:
p.000009: • Capacity is specific to the matter in question and so a person could have mental capacity in relation to some
p.000009: matters but not to others.
p.000009: • Capacity can also vary in time, for example, in a patient who is temporarily unconscious or who has suffered a
p.000009: relapse in their psychiatric condition.
p.000009: • Capacity is present if the person only has a difficulty with communication that can be overcome with human or
p.000009: mechanical assistance.
p.000009:
p.000009:
p.000009:
p.000009:
p.000009:
p.000009: 16Section 2 Mental Capacity Act 2005:“A person lacks capacity in relation to a matter if at the material time he is
p.000009: unable to make a decision for himself in relation to the matter because of an impairment of or a disturbance in the
p.000009: functioning of the mind or brain.”
p.000009:
p.000009: MRC ETHICS GUIDE
p.000009: Medical research involving adults who cannot consent 2007
p.000010: 10
p.000010:
p.000010:
p.000010: Assessment of mental capacity
p.000010: The Mental Capacity Act (MCA) 2005 and its associated Code of Practice17 set out criteria for assessment of mental
p.000010: capacity.They build upon principles previously used in the courts18 and set out by bodies such as the General Medical
p.000010: Council19 and the British Medical Association20. Assessment of mental capacity is described
p.000010: in the MCA as a two-stage process. First, the person must be shown to have an impairment or disturbance of brain
...
p.000024:
p.000024: 35MRC policy is that, as in other research, payment of legitimate expenses of participants or representatives directly
p.000024: related to participation in the trial is generally considered acceptable.
p.000024: 36National Research Ethics Service: www.nres.npsa.nhs.uk.
p.000024:
p.000024: MRC ETHICS GUIDE
p.000024: Medical research involving adults who cannot consent 2007
p.000025: 25
p.000025:
p.000025: • Could the study be done involving only adults with capacity to consent?
p.000025: Researchers should enrol participants who lack the capacity to consent to take part only if there is reason to believe
p.000025: that the study could not be done as effectively if it involved only adults who could give consent.This is illustrated
p.000025: in Example G below.
p.000025:
p.000025:
p.000025: Example G: studies where it is not necessary to include adults who lack capacity to consent
p.000025: Researchers wish to assess changes in blood levels of immune factors following insertion of an invasive monitoring
p.000025: device into an artery. The team are based in intensive care and so they are seeking REC approval to include in the
p.000025: study unconscious patients in the intensive care unit who will frequently require such venous access. However, the
p.000025: scientists consider that these patients will not be able to consent to take part in the study.They therefore decide to
p.000025: instead enrol patients who require the placement of such lines before elective surgery and from whom consent could be
p.000025: sought. This study is related to treatment for the condition causing the impairment of capacity, but it could be done
p.000025: as effectively in patients who are able to consent to participation.
p.000025:
p.000025:
p.000025: • Does the study have the potential to benefit the participant?
p.000025: Ifso, then the expected burden of taking part in the research should be proportionate to the possible benefits.
p.000025: Researchers should consider what will be required of participants, including any possible discomfort, restriction of
p.000025: mobility or use of their data or tissue.This should be weighed against the potential for the study to be of direct
p.000025: benefit to those taking part. Potential benefits are discussed further in the MCA Code of Practice37.
p.000025:
p.000025: • Is there unlikely to be any benefit to the participant?
p.000025: If so, the research must fulfil all of the following objectives:
p.000025: • It must be investigating the cause, treatment or care of people with similar conditions.
p.000025: • The risks of the project must be ‘negligible’ (see the discussion in section 2.2 on levels of risks).
p.000025: • The project must not significantly interfere with freedom of action or privacy.
...
p.000031: the participant herself when she regained capacity.
p.000031:
p.000031: 4.3.2 Other research in emergency situations (England and Wales) The MCA allows patients to be recruited into research
p.000031: studies in an emergency without consultation with a relative or carer. However, recruitment in an emergency can only
p.000031: occur if treatment needs to be given to the patient as a matter of urgency and enrolment into the research also has to
p.000031: be done as a matter of urgency. If
p.000031: there is not time to consult, as described in section 4.2, the researcher should have agreement from a registered
p.000031: doctor who is independent of the project. If this is also impractical, recruitment into the study may occur if it is
p.000031: done in accordance with a protocol already agreed by an ethics committee. See Example J.
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031: 45European Journal of Clinical Investigation. 2005 May;35(5):315-23.
p.000031:
p.000031: MRC ETHICS GUIDE
p.000031: Medical research involving adults who cannot consent 2007
p.000032: 32
p.000032:
p.000032:
p.000032: Example J: Research in an emergencyXsituation
p.000032: A research study is proposed to examine the changes in certain inflammatory markers in acute trauma patients who are
p.000032: unconscious on admission to hospital.The study involves taking initial blood and urine samples on admission to
p.000032: intensive care and regular samples thereafter. When such patients are admitted there will often not be a relative
p.000032: immediately available with whom to discuss the study.The samples would be taken from intravenous lines inserted to
p.000032: manage the patients’ clinical condition. In the protocol the researchers propose that, where available, a consultant
p.000032: anaesthetist unconnected with the study will be consulted about inclusion of each patient.Where this is not possible,
p.000032: for instance at
p.000032: nights or weekends, the patients will be enrolled into the study and baseline and further blood tests and data
p.000032: collected. However, as soon as a relative or unpaid carer is available they will be consulted about the continued
p.000032: participation of the patient in the study. If and when the patient regains consciousness the research project will be
p.000032: fully explained and they will be able to choose whether their data should remain in the study cohort.The approved this
p.000032: protocol.
p.000032:
p.000032:
p.000032: 4.3.4 Other research in emergency situations (Scotland)
p.000032: At this time there is no provision for recruitment into non-clinical research in an emergency without the consultative
p.000032: steps described in section 4.3.This means that such research cannot be lawfully carried out in Scotland at present. If
p.000032: researchers believe that this may affect a study they are considering, they should seek further advice from the MRC or
p.000032: the Scotland A REC.
p.000032:
...
Health / hospitalized patients
Searching for indicator hospitalised:
(return to top)
p.000017: Mr D had enrolled in a long-term, REC-approved, population study of people at risk of dementia 20 years
p.000017: previously.Aware of the devastating effects of the disease, he wanted to help find out more about it to help expand
p.000017: the options for future treatment and care. Mr D went on to develop Alzheimer’s in his late 60s and was now in an
p.000017: advanced stage of dementia.When signing up for the study, he had given consent to re-assessment at yearly intervals
p.000017: throughout his life and indicated that he would wish this to continue in the event that he lost capacity. He also
p.000017: consented to continued use of his data in the study in the event that he lost capacity or was withdrawn from the study.
p.000017: This meant that the researchers were able to continue to monitor him.
p.000017:
p.000017: For a long time, he had seemed perfectly happy with this arrangement and this was confirmed when the researchers
p.000017: checked annually with his
p.000017: carers. However when an important new test became available that would involve taking further blood samples from the
p.000017: entire study population it became necessary to ask each participant for their specific consent to the alteration in
p.000017: sampling practice.Although the researchers would have liked to keep Mr D in the study, he was no longer able to consent
p.000017: for himself and his prior wishes were unknown. Furthermore, his carers informed the
p.000017: researchers that he had recently been hospitalised with an infection and had subsequently developed a marked fear of
p.000017: needles.
p.000017:
p.000017: The researchers agreed with the family that Mr D should not be included in the next round of sampling as the outcome of
p.000017: the research would not be of any direct benefit to his own health. In addition, his present condition meant that he may
p.000017: have found the taking of blood samples distressing: this was deemed an unacceptable risk.
p.000017:
p.000017: However, the family agreed that the data and samples already collected could continue to be used in the study, in
p.000017: accordance with Mr D’s previously expressed wishes.
p.000017:
p.000017: MRC ETHICS GUIDE
p.000017: Medical research involving adults who cannot consent 2007
p.000018: 18
p.000018:
p.000018: 4. Legal requirements for research
p.000018:
p.000018: 4.1 Legislation relevant to medical research
p.000018: The law in the UK now makes a distinction between two types of research involving people.These are (i) clinical trials
p.000018: of medicinal products and (ii) other research involving people. In relation to capacity, these studies are governed by
p.000018: three separate pieces of legislation. Clinical trials of medicinal products are governed by the Medicines for Human Use
p.000018: (Clinical Trials) Regulations 2004 (CT Regulations) while other research is governed by the Adults With Incapacity
...
Social / Access to Social Goods
Searching for indicator access:
(return to top)
p.000024:
p.000024: 35MRC policy is that, as in other research, payment of legitimate expenses of participants or representatives directly
p.000024: related to participation in the trial is generally considered acceptable.
p.000024: 36National Research Ethics Service: www.nres.npsa.nhs.uk.
p.000024:
p.000024: MRC ETHICS GUIDE
p.000024: Medical research involving adults who cannot consent 2007
p.000025: 25
p.000025:
p.000025: • Could the study be done involving only adults with capacity to consent?
p.000025: Researchers should enrol participants who lack the capacity to consent to take part only if there is reason to believe
p.000025: that the study could not be done as effectively if it involved only adults who could give consent.This is illustrated
p.000025: in Example G below.
p.000025:
p.000025:
p.000025: Example G: studies where it is not necessary to include adults who lack capacity to consent
p.000025: Researchers wish to assess changes in blood levels of immune factors following insertion of an invasive monitoring
p.000025: device into an artery. The team are based in intensive care and so they are seeking REC approval to include in the
p.000025: study unconscious patients in the intensive care unit who will frequently require such venous access. However, the
p.000025: scientists consider that these patients will not be able to consent to take part in the study.They therefore decide to
p.000025: instead enrol patients who require the placement of such lines before elective surgery and from whom consent could be
p.000025: sought. This study is related to treatment for the condition causing the impairment of capacity, but it could be done
p.000025: as effectively in patients who are able to consent to participation.
p.000025:
p.000025:
p.000025: • Does the study have the potential to benefit the participant?
p.000025: Ifso, then the expected burden of taking part in the research should be proportionate to the possible benefits.
p.000025: Researchers should consider what will be required of participants, including any possible discomfort, restriction of
p.000025: mobility or use of their data or tissue.This should be weighed against the potential for the study to be of direct
p.000025: benefit to those taking part. Potential benefits are discussed further in the MCA Code of Practice37.
p.000025:
p.000025: • Is there unlikely to be any benefit to the participant?
p.000025: If so, the research must fulfil all of the following objectives:
p.000025: • It must be investigating the cause, treatment or care of people with similar conditions.
p.000025: • The risks of the project must be ‘negligible’ (see the discussion in section 2.2 on levels of risks).
p.000025: • The project must not significantly interfere with freedom of action or privacy.
p.000025: • The project must not be unduly invasive or restrictive.
p.000025:
p.000025:
p.000025:
...
Social / Child
Searching for indicator child:
(return to top)
p.000007: temporary negative impact on the health of the person concerned”.The Council defines minimal burden on participants as
p.000007: that where it is “to be expected that the discomfort will be, at the most, temporary and very slight for the person
p.000007: concerned.”12
p.000007:
p.000007: Assessment of risk has been described in MRC guidance relating to medical research involving children13,which divides
p.000007: risk into minimal, low or high. Examples of minimal risk procedures include14:
p.000007: • Observing and measuring, provided this is done in a sensitive way and with respect for the participant’s autonomy
p.000007: and privacy.
p.000007: • Obtaining samples in a non-invasive manner, for example, urine collection.
p.000007:
p.000007:
p.000007:
p.000007: 11Additional protocol to the convention on human rights and biomedicine, concerning biomedical research. Council of
p.000007: Europe at article 17 (2). http://conventions.coe.int/Treaty/en/Treaties/Html/195.htm.
p.000007: 12Above article 17 (1).
p.000007: 13MRC Ethics Guide: Medical research involving children 2004.
p.000007: www.mrc.ac.uk/Utilities/Documentrecord/index.htm?d=MRC002430.
p.000007: 14MRC children guidance adapted from the Royal College of Paediatrics and Child Health. Guidelines for the ethical
p.000007: conduct of medical research involving children 2002.
p.000007:
p.000007: MRC ETHICS GUIDE
p.000007: Medical research involving adults who cannot consent 2007
p.000008: 8
p.000008:
p.000008:
p.000008: Potential benefits of participation
p.000008: The statutes discussed here distinguish between research projects which may directly benefit participants and those
p.000008: which will not.This reflects a previous division of research projects into ‘therapeutic’ and ‘non-therapeutic’ – a
p.000008: distinction which has been widely criticised15.
p.000008:
p.000008: Estimating the potential for direct benefit is an important part of weighing up the risks and benefits of taking part
p.000008: in a research project.There may be occasions, however, when it is difficult to determine the potential for benefit to
p.000008: the individual.This may occur, for example, if clinicians are divided in their views of a particular therapy or are in
p.000008: equipoise – such as when a randomised controlled trial is considered appropriate.
p.000008:
p.000008: It is up to a REC to decide whether the risks associated with a research project are acceptable in relation to the
p.000008: expected benefits. A careful assessment of this should therefore be provided by the researchers. (See Example A).
p.000008:
p.000008:
p.000008: Example A: assessment of risks and benefits
p.000008: The Blandfordshire REC was asked to review a proposal to study whether electronic tagging was beneficial to the care of
p.000008: older people with varying degrees of dementia who lived in residential homes.The hypothesis was that the tagging would
...
Searching for indicator children:
(return to top)
p.000004: vulnerable group are protected when they do participate in medical research.
p.000004:
p.000004: The law relating to the conduct of research when the potential participants lack capacity to consent has developed
p.000004: considerably over the past years.These changes provide welcome clarification of the legal framework within which such
p.000004: research can be carried out. Specific legislation has been introduced in Scotland1 and England and Wales2 relating to
p.000004: adults with mental incapacity (or who may become incapacitated). In Northern Ireland the recommendations of a review of
p.000004: mental health legislation are currently
p.000004: being considered. Further guidance for this region will be issued once available. Other instruments, such as the
p.000004: Clinical Trials Regulations 2004, the Human Tissue Act 20043 and the Data Protection Act 1998, are also of relevance to
p.000004: research in this area.
p.000004:
p.000004: This guidance aims to set out the general principles for assessing whether individuals have the capacity to consent to
p.000004: participation in research. It will also discuss participation in research projects when such capacity is lacking.The
p.000004: guidance does not deal with determining capacity in children, which is discussed in a separate MRC publication4.The
p.000004: emphasis of this publication is on the legislation relating to mental capacity, including explanation of this
p.000004: legislation.The greater emphasis than in previous MRC guidance5 on the legal requirements for such research reflects
p.000004: the altered legal framework.
p.000004:
p.000004: It is hoped that this guidance will help scientists to ensure that research involving people who lack mental capacity
p.000004: is conducted in a legally and ethically acceptable manner. It
p.000004: is also intended to give confidence to researchers that adults with incapacity can be included in their studies so
p.000004: that, when appropriate, they will make the opportunity available, in accordance with the required and recommended
p.000004: safeguards described here.
p.000004:
p.000004:
p.000004: 1Adults with Incapacity Act 2000.
p.000004: 2Mental Capacity Act 2005.
p.000004: 3Medicines for Human Use (Clinical Trials) Regulations 2004. SI 2004 1031 (as amended).
p.000004: 4MRC Ethics Guide: Research involving children, 2004.
p.000004: 5The Ethical Conduct of Research in the Mentally Incapacitated. MRC 1991.
p.000004:
p.000004: MRC ETHICS GUIDE
p.000004: Medical research involving adults who cannot consent 2007
p.000005: 5
p.000005:
p.000005: 2. Ethical principles
p.000005:
p.000005: 2.1 General principles
p.000005: As with any research, the need to respect the interests of an individual participant is more important than any
p.000005: potential benefits of the research to others6,7.
p.000005:
p.000005: All medical research studies, including those involving adults who lack mental capacity, should comply with accepted
p.000005: principles of good practice, including the Declaration of Helsinki and relevant European and UK legislation. In
p.000005: accordance with section 13 of the Declaration, the research protocol should be submitted to and approved by an
p.000005: independent research ethics committee (REC). Under UK
p.000005: legislation relating to research involving adults who lack the capacity to consent, this REC approval is a legal
p.000005: requirement8. Detailed guidance on applying for approval is available from the National Research Ethics Service9.
p.000005:
p.000005: 2.2 Specific principles
...
p.000007: benefits for participants are anticipated, risks should be at a minimal or negligible level.
p.000007:
p.000007: Minimal risk has been defined by the Council of Europe11 as a risk that “will result, at the most, in a very slight and
p.000007: temporary negative impact on the health of the person concerned”.The Council defines minimal burden on participants as
p.000007: that where it is “to be expected that the discomfort will be, at the most, temporary and very slight for the person
p.000007: concerned.”12
p.000007:
p.000007: Assessment of risk has been described in MRC guidance relating to medical research involving children13,which divides
p.000007: risk into minimal, low or high. Examples of minimal risk procedures include14:
p.000007: • Observing and measuring, provided this is done in a sensitive way and with respect for the participant’s autonomy
p.000007: and privacy.
p.000007: • Obtaining samples in a non-invasive manner, for example, urine collection.
p.000007:
p.000007:
p.000007:
p.000007: 11Additional protocol to the convention on human rights and biomedicine, concerning biomedical research. Council of
p.000007: Europe at article 17 (2). http://conventions.coe.int/Treaty/en/Treaties/Html/195.htm.
p.000007: 12Above article 17 (1).
p.000007: 13MRC Ethics Guide: Medical research involving children 2004.
p.000007: www.mrc.ac.uk/Utilities/Documentrecord/index.htm?d=MRC002430.
p.000007: 14MRC children guidance adapted from the Royal College of Paediatrics and Child Health. Guidelines for the ethical
p.000007: conduct of medical research involving children 2002.
p.000007:
p.000007: MRC ETHICS GUIDE
p.000007: Medical research involving adults who cannot consent 2007
p.000008: 8
p.000008:
p.000008:
p.000008: Potential benefits of participation
p.000008: The statutes discussed here distinguish between research projects which may directly benefit participants and those
p.000008: which will not.This reflects a previous division of research projects into ‘therapeutic’ and ‘non-therapeutic’ – a
p.000008: distinction which has been widely criticised15.
p.000008:
p.000008: Estimating the potential for direct benefit is an important part of weighing up the risks and benefits of taking part
p.000008: in a research project.There may be occasions, however, when it is difficult to determine the potential for benefit to
p.000008: the individual.This may occur, for example, if clinicians are divided in their views of a particular therapy or are in
p.000008: equipoise – such as when a randomised controlled trial is considered appropriate.
p.000008:
p.000008: It is up to a REC to decide whether the risks associated with a research project are acceptable in relation to the
p.000008: expected benefits. A careful assessment of this should therefore be provided by the researchers. (See Example A).
p.000008:
p.000008:
p.000008: Example A: assessment of risks and benefits
p.000008: The Blandfordshire REC was asked to review a proposal to study whether electronic tagging was beneficial to the care of
p.000008: older people with varying degrees of dementia who lived in residential homes.The hypothesis was that the tagging would
p.000008: allow the residents more freedom while minimising their risk of getting lost.There was some discussion about whether
...
Social / Incarcerated
Searching for indicator restricted:
(return to top)
p.000026:
p.000026: It is important that personal nominees appreciate that this is a voluntary role and that they are not under any
p.000026: pressure to agree to fill this position if they do not wish to do so.This should be made clear by the researchers.
p.000026:
p.000026:
p.000026:
p.000026: 38MCA Code of Practice at 11.19.
p.000026: 39The MCA 2005 allows an adult to assign power of attorney to another person prior to loss of capacity; the power
p.000026: assigned may extend to financial affairs and/or personal welfare.
p.000026:
p.000026: MRC ETHICS GUIDE
p.000026: Medical research involving adults who cannot consent 2007
p.000027: 27
p.000027:
p.000027: Regarding a nominated consultee, the MCA Code of Practice has a wide interpretation of what ‘connected to the project’
p.000027: means. It could exclude anyone connected with the actual project, members of the research team or anyone with a wider
p.000027: connection, for instance people with a direct link to the funding body or the ethics committee that approved the
p.000027: project. Further guidance is available from the Department of Health (England)40 and the Welsh Assembly Government41 as
p.000027: to how this person should be chosen.
p.000027:
p.000027: In practice, a person should be identified who can understand the project and take a view, as described in Table 7, on
p.000027: the intended participation.This may be, for example, another clinician or healthcare worker in the unit where the
p.000027: research is being undertaken (who
p.000027: is not connected with the research project). It need not be restricted to one person for each project but may be more
p.000027: appropriate to have several people available to give advice. Researchers should set out in the protocol and ethical
p.000027: approval application who they propose to consult in this category in the event that a suitable carer is not available.
p.000027:
p.000027: Table 7: Consultees: information requirements
p.000027: The consultee should be given the following information about the study:
p.000027: • Why they are being approached.
p.000027: • The role of a consultee.
p.000027: • Explanation that acting as a consultee is completely voluntary.
p.000027: • Details of the study (as would be given to a participant with capacity).
p.000027:
p.000027: The consultee should provide the following information:
p.000027: • Advice on whether the participant should take part in the study.
p.000027: • What, in their opinion, the participant’s views and feelings would have been on taking part in the project had they
p.000027: retained capacity.
p.000027:
p.000027: If the consultee advises that the person in question would not have wanted to take part in the project, that person
p.000027: must not be recruited. Similarly, the participant must be withdrawn from the project if at any time the consultee is of
p.000027: the opinion that the participant would not have wished to continue. An exception can be made if the participant is
p.000027: receiving treatment as part of the project and the researcher has reasonable grounds to think that withdrawal of this
p.000027: treatment would cause a significant risk to their health.To apply this exception, the researcher needs to give good
...
Social / Linguistic Proficiency
Searching for indicator language:
(return to top)
p.000010: 20Assessment of mental capacity: BMA/Law Society Guidance. 2nd ed 2004.
p.000010: 21MCA Code of Practice section 11.7 summarises these for England.
p.000010: 22MRC Code of Practice at 11.4.
p.000010:
p.000010: MRC ETHICS GUIDE
p.000010: Medical research involving adults who cannot consent 2007
p.000011: 11
p.000011:
p.000011:
p.000011: Table 3: How to decide whether an individual lacks the mental capacity to consent to research participation (based on
p.000011: MCA Code of Practice)
p.000011: Researchers should assume capacity is present unless it is shown to be absent.22
p.000011:
p.000011: Capacity is absent if, at the time of decision making:
p.000011: • The person in question has impaired functioning of their mind or brain.
p.000011: • This impairment makes the person unable to decide whether to participate in this particular research.
p.000011:
p.000011: A person is deemed unable to decide whether to take part in research if they cannot23:
p.000011: • Understand the information relevant to the decision (information should be given in a way that is appropriate to the
p.000011: particular person, this might include use of simplified information sheets, pictures or sign language).
p.000011: • Retain that information for long enough to make the decision (this may be for a relatively short time, but still
p.000011: long enough to enable decision making to occur).
p.000011: • Use or weigh that information as part of the process of making the decision (they need to understand the
p.000011: consequences of each option and of not making the decision).
p.000011: • Communicate their decision (whether by talking, using sign language or any other means).
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011: 22MCA Code of Practice at 11.4.
p.000011: 23Section 3 MCA 2005.
p.000011:
p.000011: MRC ETHICS GUIDE
p.000011: Medical research involving adults who cannot consent 2007
p.000012: 12
p.000012:
p.000012:
p.000012: Example B: assessment of capacity
p.000012: Mr B had taken early retirement from his career as head teacher of a large school following the diagnosis of Pick’s
p.000012: disease. His condition meant that he had problems with language. He often misunderstood what was said to him and he had
p.000012: trouble putting sentences together.This made him anxious and frustrated. However, his memory remained intact.The
p.000012: researchers wanted to track the progress of this form of disease to assess whether there
p.000012: were benefits from treatment with a new antidepressant. In their ethics application they had stated that they would
p.000012: only include adults with capacity to consent in this initial study. In seeking consent from Mr B, it was necessary to
p.000012: explain that the treatment might alleviate the anxiety he was feeling, but could not fundamentally alter the course of
p.000012: the disease.
p.000012:
p.000012: However, when talking to Mr B the researchers found that while he readily retained the information presented to him, he
p.000012: did not seem to understand that he would be a participant in a research study or that the treatment would be for
p.000012: symptoms only.The consultant neurologist leading the study decided that it would be more appropriate for Mr B to be
p.000012: treated by
p.000012: his clinical team rather than taking part in a research study, pending the outcome of studies in participants with less
p.000012: advanced Pick’s disease who did have the capacity to consent.
p.000012:
p.000012: • The principal investigator decided that Mr B lacked capacity to make this decision.
...
Social / Property Ownership
Searching for indicator home:
(return to top)
p.000018:
p.000018: 1. Clinical trials of medicinal products:These are regulated by the CT Regulations and defined as “interventional
p.000018: investigations or studies undertaken to ascertain the efficacy or safety of a medicinal product in human
p.000018: subjects”29.The CT Regulations contain requirements that apply if adults who lack capacity are to be included
p.000018: in such research. Further guidance on the regulation of clinical trials and how to determine if a study falls into this
p.000018: category is available at www.ct-toolkit.ac.uk. The Medicines and Healthcare products Regulatory Agency (MHRA) can
p.000018: provide advice on an individual basis about whether a proposed trial is covered by the CT Regulations. In addition, an
p.000018: algorithm to help decide whether research is a clinical trial of a medicinal product is available at
p.000018: http://ec.europa.eu/enterprise/ pharmaceuticals/pharmacos/docs/doc2006/04_2006/clinical_trial_ qa_april_2006.pdf.
p.000018:
p.000018: 29Medicinal products are defined by the MHRA as “substances or combinations of substances which either prevent or treat
p.000018: disease in human beings or are administered to human beings with a view to making a medical diagnosis or to restore,
p.000018: correct or modify physiological functions in humans.”
p.000018: A clinical trial is defined by the MHRA the as “an investigation in human subjects which is intended to discover or
p.000018: verify the clinical, pharmacological and/or other pharmacodynamic effects of one or more medicinal products, identify
p.000018: any adverse reactions or study the absorption, distribution, metabolism and excretion, with the object of ascertaining
p.000018: the safety and/or efficacy of those products.” This definition includes pharmacokinetic studies.
p.000018: www.mhra.gov.uk/home/idcplg?IdcService=SS_GET_PAGE&nodeId=723.
p.000018:
p.000018: MRC ETHICS GUIDE
p.000018: Medical research involving adults who cannot consent 2007
p.000019: 19
p.000019:
p.000019: Example E: clinical trial governed by the MCA or CT Regulations Researchers in an English teaching hospital aim to
p.000019: compare two different neurosurgical techniques for treating severe sub-arachnoid haemorrhage.
p.000019: Many of the potential participants will lack capacity to consent due to the effects of the haemorrhage.
p.000019: This will not be a clinical trial of a medicinal product and so would fall under the MCA.
p.000019:
p.000019: The same unit also wishes to perform a study comparing the effects of a new anti-fibrinolytic drug on outcome after
p.000019: sub-arachnoid haemorrhage. This research is a clinical trial of a medicinal product.
p.000019:
p.000019:
p.000019: 2.All other ‘intrusive’ research in England and Wales involving adults who lack mental capacity to consent falls under
p.000019: the MCA, which contains specific requirements for the conduct of such research. Intrusive research in this context is
p.000019: described as that where: “if a person taking part had capacity, the researcher would need to get consent to involve
p.000019: them”30. It specifically excludes research that falls under the CT Regulations.
p.000019:
...
Social / Religion
Searching for indicator religious:
(return to top)
p.000012: symptoms only.The consultant neurologist leading the study decided that it would be more appropriate for Mr B to be
p.000012: treated by
p.000012: his clinical team rather than taking part in a research study, pending the outcome of studies in participants with less
p.000012: advanced Pick’s disease who did have the capacity to consent.
p.000012:
p.000012: • The principal investigator decided that Mr B lacked capacity to make this decision.
p.000012: • The protocol submitted to the research ethics committee (REC) was for inclusion of adults who had capacity to
p.000012: consent only.
p.000012: • Mr B could be suitable for a different research study.As capacity is decision specific, his capacity to make a
p.000012: decision in relation to a future study would need to be reassessed.
p.000012: • If he lacked capacity in relation to making a decision to participate in another study, his participation would be
p.000012: subject to the steps of the relevant legislation being followed.
p.000012:
p.000012:
p.000012: 3.2 Consent
p.000012: When seeking consent, researchers should consider how to present the information about the study to each individual
p.000012: with respect to their lifestyle, interests, needs, religious beliefs and priorities24. If someone is unable to provide
p.000012: consent for themselves due to a lack of mental capacity, the next step to consider is
p.000012:
p.000012: 24General Medical Council guidance
p.000012:
p.000012: MRC ETHICS GUIDE
p.000012: Medical research involving adults who cannot consent 2007
p.000013: 13
p.000013:
p.000013: whether the legal requirements and safeguards can be met if they are included without their own consent (for example,
p.000013: under section 30 of the MCA).
p.000013: Alternatively the researchers should consider not including the person in question in the research.
p.000013:
p.000013: Example C: materials for consent
p.000013: A team of researchers was carrying out a series of studies comparing the benefits of different types of physiotherapy
p.000013: for people with serious physical restrictions following a severe stroke.They began with the assumption that all
p.000013: potential recruits would have the capacity to consent.The first step was to
p.000013: talk with each person to establish their mental capacity, irrespective of physical disability, using picture cards to
p.000013: help show what the intervention involved.
p.000013: Among those they approached was Mrs C, who was only able to communicate by nodding her head slightly and through her
...
Social / Victim of Abuse
Searching for indicator trauma:
(return to top)
p.000031: the participant herself when she regained capacity.
p.000031:
p.000031: 4.3.2 Other research in emergency situations (England and Wales) The MCA allows patients to be recruited into research
p.000031: studies in an emergency without consultation with a relative or carer. However, recruitment in an emergency can only
p.000031: occur if treatment needs to be given to the patient as a matter of urgency and enrolment into the research also has to
p.000031: be done as a matter of urgency. If
p.000031: there is not time to consult, as described in section 4.2, the researcher should have agreement from a registered
p.000031: doctor who is independent of the project. If this is also impractical, recruitment into the study may occur if it is
p.000031: done in accordance with a protocol already agreed by an ethics committee. See Example J.
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031: 45European Journal of Clinical Investigation. 2005 May;35(5):315-23.
p.000031:
p.000031: MRC ETHICS GUIDE
p.000031: Medical research involving adults who cannot consent 2007
p.000032: 32
p.000032:
p.000032:
p.000032: Example J: Research in an emergencyXsituation
p.000032: A research study is proposed to examine the changes in certain inflammatory markers in acute trauma patients who are
p.000032: unconscious on admission to hospital.The study involves taking initial blood and urine samples on admission to
p.000032: intensive care and regular samples thereafter. When such patients are admitted there will often not be a relative
p.000032: immediately available with whom to discuss the study.The samples would be taken from intravenous lines inserted to
p.000032: manage the patients’ clinical condition. In the protocol the researchers propose that, where available, a consultant
p.000032: anaesthetist unconnected with the study will be consulted about inclusion of each patient.Where this is not possible,
p.000032: for instance at
p.000032: nights or weekends, the patients will be enrolled into the study and baseline and further blood tests and data
p.000032: collected. However, as soon as a relative or unpaid carer is available they will be consulted about the continued
p.000032: participation of the patient in the study. If and when the patient regains consciousness the research project will be
p.000032: fully explained and they will be able to choose whether their data should remain in the study cohort.The approved this
p.000032: protocol.
p.000032:
p.000032:
p.000032: 4.3.4 Other research in emergency situations (Scotland)
p.000032: At this time there is no provision for recruitment into non-clinical research in an emergency without the consultative
p.000032: steps described in section 4.3.This means that such research cannot be lawfully carried out in Scotland at present. If
p.000032: researchers believe that this may affect a study they are considering, they should seek further advice from the MRC or
p.000032: the Scotland A REC.
p.000032:
...
Social / Women
Searching for indicator women:
(return to top)
p.000030: to the REC it should be explained why it is necessary to include participants in the trial before consent can be sought
p.000030: from a legal representative.The researchers should also document what steps will be taken to obtain appropriate consent
p.000030: once a participant has been recruited and how they will address refusal of such consent.Two examples (H and I) are
p.000030: provided below.
p.000030:
p.000030:
p.000030:
p.000030:
p.000030:
p.000030:
p.000030:
p.000030:
p.000030:
p.000030: 44The Medicines for Human Use (Clinical Trials) Amendment (no.2) Regulations 2006. SI 2006 No. 2984.
p.000030:
p.000030: MRC ETHICS GUIDE
p.000030: Medical research involving adults who cannot consent 2007
p.000031: 31
p.000031:
p.000031:
p.000031: Examples of clinical trials requiring immediate recruitment
p.000031: H. A large multinational study is examining the effectiveness of pre-hospital thrombolysis for cardiac arrest45.The
p.000031: trial involves recruitment of participants before they arrive at hospital.The trial includes only patients who have
p.000031: suffered a cardiac arrest and so no participants are able to give consent to inclusion.
p.000031: I. A multicentre clinical trial is being set up to compare the effectiveness of two antiepileptic drugs in pregnant
p.000031: women with eclampsia. Many
p.000031: of these patients will be temporarily unable to consent due to their medical condition.They may be unaccompanied when
p.000031: they arrive at hospital and/or have an eclamptic fit.When designing the protocol, the researchers addressed the various
p.000031: possibilities for obtaining consent. This included discussing the trial with women at particular risk of eclampsia and
p.000031: obtaining consent prior to the condition occurring. Careful communication was important, as it can be difficult to
p.000031: identify which women may actually develop eclampsia – the researchers did not wish to unnecessarily alarm women who
p.000031: would not then require therapy.They also considered how consent would be obtained if a woman was enrolled in the study
p.000031: before she had consented, and decided that this could be through a relative before the woman regained capacity, or from
p.000031: the participant herself when she regained capacity.
p.000031:
p.000031: 4.3.2 Other research in emergency situations (England and Wales) The MCA allows patients to be recruited into research
p.000031: studies in an emergency without consultation with a relative or carer. However, recruitment in an emergency can only
p.000031: occur if treatment needs to be given to the patient as a matter of urgency and enrolment into the research also has to
p.000031: be done as a matter of urgency. If
p.000031: there is not time to consult, as described in section 4.2, the researcher should have agreement from a registered
p.000031: doctor who is independent of the project. If this is also impractical, recruitment into the study may occur if it is
p.000031: done in accordance with a protocol already agreed by an ethics committee. See Example J.
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031: 45European Journal of Clinical Investigation. 2005 May;35(5):315-23.
p.000031:
p.000031: MRC ETHICS GUIDE
p.000031: Medical research involving adults who cannot consent 2007
p.000032: 32
p.000032:
p.000032:
...
Social / philosophical differences/differences of opinion
Searching for indicator opinion:
(return to top)
p.000009: unable to make a decision for himself in relation to the matter because of an impairment of or a disturbance in the
p.000009: functioning of the mind or brain.”
p.000009:
p.000009: MRC ETHICS GUIDE
p.000009: Medical research involving adults who cannot consent 2007
p.000010: 10
p.000010:
p.000010:
p.000010: Assessment of mental capacity
p.000010: The Mental Capacity Act (MCA) 2005 and its associated Code of Practice17 set out criteria for assessment of mental
p.000010: capacity.They build upon principles previously used in the courts18 and set out by bodies such as the General Medical
p.000010: Council19 and the British Medical Association20. Assessment of mental capacity is described
p.000010: in the MCA as a two-stage process. First, the person must be shown to have an impairment or disturbance of brain
p.000010: functioning and, second, it must be shown that this renders them unable to make a particular decision.
p.000010:
p.000010: In general, researchers must ask potential participants for consent to take part in a study21. In doing so they must
p.000010: consider whether the person approached has the capacity to make this judgement. In some cases the researcher may have
p.000010: the necessary expertise to make this decision, but often they will need to seek an
p.000010: opinion from the clinical team caring for the potential participant.There are several factors to be considered when
p.000010: deciding whether a person lacks the mental capacity to provide consent to participate in research.These are outlined in
p.000010: Table 3.
p.000010:
p.000010: If a researcher or clinician is uncertain as to whether a person has the mental capacity to consent to participation in
p.000010: research or does not have the skills to assess this, an independent assessment should be carried out. If doubt remains
p.000010: or there are differences of opinion, for example, between clinical staff and relatives or carers, a court could make a
p.000010: ruling on this. However, it is unlikely that such steps would be taken: if such uncertainty exists it may be better not
p.000010: to include the patient in the study. On the other hand, when an adult does have the ability to make a decision
p.000010: or to indicate willingness to participate in a study for which they are eligible, this willingness should be respected
p.000010: as far as is practical in accordance with legal requirements. See Example B (page 12).
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010: 17MCA Code of Practice issued on 23 April 2007: www.dh.gov.uk/mentalcapacityact.
p.000010: 18Re C adult: refusal of medical treatment [1994] 1 All ER 819.
p.000010: 19General Medical Council: Consent at www.gmc-uk.org/guidance/library/consent.asp.
p.000010: 20Assessment of mental capacity: BMA/Law Society Guidance. 2nd ed 2004.
p.000010: 21MCA Code of Practice section 11.7 summarises these for England.
p.000010: 22MRC Code of Practice at 11.4.
p.000010:
p.000010: MRC ETHICS GUIDE
p.000010: Medical research involving adults who cannot consent 2007
p.000011: 11
p.000011:
p.000011:
p.000011: Table 3: How to decide whether an individual lacks the mental capacity to consent to research participation (based on
p.000011: MCA Code of Practice)
...
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014: Clinical trial in Scotland
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014: Research which is not a clinical trial (England and Wales)
p.000014:
p.000014:
p.000014:
p.000014:
p.000014: Research which is not a clinical trial (Scotland)
p.000014: Who should be asked
p.000014:
p.000014:
p.000014: Legal representative:
p.000014: 1. Relative or person independent of trial and providing care or
p.000014: 2. Doctor primarily responsible for adult’s treatment, or another independent person nominated by healthcare provider
p.000014:
p.000014: Legal representative:
p.000014: 1. Guardian or welfare attorney authorised to take decisions re research or
p.000014: 2. Nearest relative or
p.000014: 3. Doctor primarily responsible for adult’s treatment, or another independent person nominated by healthcare provider
p.000014:
p.000014: Carer or consultee
p.000014: 1. Unpaid person with an interest in the welfare of the potential participant or
p.000014: 2. Person who is independent of project
p.000014:
p.000014: 1. Guardian or welfare attorney authorised to take decisions about the research or
p.000014: 2. Nearest relative
p.000014: What should they be asked
p.000014:
p.000014: Presumed will of participant
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014: Presumed will of participant
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014: Opinion on views and feelings of participant
p.000014:
p.000014:
p.000014:
p.000014: Their consent
p.000014: What is given?
p.000014:
p.000014:
p.000014: Informed consent
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014: Informed consent
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014: Advice as to whether participant
p.000014: would decline to take part if he or she had capacity
p.000014:
p.000014: Consent
p.000014:
p.000014: Note: Emergency recruitment to research projects has separate requirements which are summarised in section 4.3.
p.000014:
p.000014: MRC ETHICS GUIDE
p.000014: Medical research involving adults who cannot consent 2007
p.000015: 15
p.000015:
p.000015:
p.000015: 3.2.2 Loss of capacity during the course of the research
p.000015: (See separate guidance for transitional arrangements for studies already underway in England and Wales on 1 October
p.000015: 2007.)
p.000015:
p.000015: 1. Clinical Trials Regulations:
p.000015: In a clinical trial (as defined by the CT Regulations – see more details in section 4.1), consent from an adult to
...
p.000022: related to participation in the trial is generally considered acceptable.
p.000022:
p.000022: MRC ETHICS GUIDE
p.000022: Medical research involving adults who cannot consent 2007
p.000023: 23
p.000023:
p.000023:
p.000023: Or, if that person is not available:
p.000023: • The doctor responsible for the medical treatment of the patient if they are independent of the study, or a person
p.000023: nominated by the healthcare provider.
p.000023:
p.000023: • The legal representative should have an interview with a member of the investigating team, during which the
p.000023: following should be discussed or made available to them:
p.000023: • Objectives, risks and inconveniences of the trial and the conditions under which it is to be carried out.
p.000023: • Contact details for further information.
p.000023: • Their right to withdraw the participant from the trial at any time without detriment.
p.000023:
p.000023: • After such discussions, the legal representative may give their ‘informed consent’ for the person to participate in
p.000023: the clinical trial. In relation to clinical trials, this consent is taken by the CT Regulations to represent the
p.000023: ‘presumed will’ of the participant.
p.000023:
p.000023: Views of the participant
p.000023: • The potential participant should receive information about the trial and its risks and benefits according to his or
p.000023: her capacity to understand this information.
p.000023:
p.000023: • If the person in question is capable of assessing the information referred to above and forming an opinion about it,
p.000023: then an explicit wish to refuse participation or to withdraw from the clinical trial at any time must be given serious
p.000023: consideration by the investigator.
p.000023:
p.000023: • Although the law requires only ‘consideration’, it is good practice to comply with any such request.The only
p.000023: exception would be if not participating or withdrawing from the trial would be detrimental to the participant’s health.
p.000023: In this situation, researchers should also consider whether the objection is short-term or relating to factors that
p.000023: could be altered, such as the research environment. Researchers should discuss a decision to keep a participant in a
p.000023: study in this situation with the clinical team caring for the participant and with their legal representative.
p.000023:
p.000023: 4.2.2 Other research (England and Wales)
p.000023: In the UK excluding Scotland, ‘intrusive research’ that does not involve a clinical trial is governed by the MCA, which
p.000023: has specific requirements for such research (see Table 6).
p.000023:
p.000023: MRC ETHICS GUIDE
p.000023: Medical research involving adults who cannot consent 2007
p.000024: 24
p.000024:
p.000024:
p.000024: Table 6: When does the Mental Capacity Act 2005 apply?
p.000024: It applies to:
p.000024: ‘Intrusive research’, that is, any research project that would require consent from adults who have capacity as a
p.000024: matter of law.
p.000024: But does not apply to:
p.000024: • Research that falls under the CT Regulations (see section 4.1).
...
p.000027: means. It could exclude anyone connected with the actual project, members of the research team or anyone with a wider
p.000027: connection, for instance people with a direct link to the funding body or the ethics committee that approved the
p.000027: project. Further guidance is available from the Department of Health (England)40 and the Welsh Assembly Government41 as
p.000027: to how this person should be chosen.
p.000027:
p.000027: In practice, a person should be identified who can understand the project and take a view, as described in Table 7, on
p.000027: the intended participation.This may be, for example, another clinician or healthcare worker in the unit where the
p.000027: research is being undertaken (who
p.000027: is not connected with the research project). It need not be restricted to one person for each project but may be more
p.000027: appropriate to have several people available to give advice. Researchers should set out in the protocol and ethical
p.000027: approval application who they propose to consult in this category in the event that a suitable carer is not available.
p.000027:
p.000027: Table 7: Consultees: information requirements
p.000027: The consultee should be given the following information about the study:
p.000027: • Why they are being approached.
p.000027: • The role of a consultee.
p.000027: • Explanation that acting as a consultee is completely voluntary.
p.000027: • Details of the study (as would be given to a participant with capacity).
p.000027:
p.000027: The consultee should provide the following information:
p.000027: • Advice on whether the participant should take part in the study.
p.000027: • What, in their opinion, the participant’s views and feelings would have been on taking part in the project had they
p.000027: retained capacity.
p.000027:
p.000027: If the consultee advises that the person in question would not have wanted to take part in the project, that person
p.000027: must not be recruited. Similarly, the participant must be withdrawn from the project if at any time the consultee is of
p.000027: the opinion that the participant would not have wished to continue. An exception can be made if the participant is
p.000027: receiving treatment as part of the project and the researcher has reasonable grounds to think that withdrawal of this
p.000027: treatment would cause a significant risk to their health.To apply this exception, the researcher needs to give good
p.000027: reasons for the treatment to continue. Discussion with the medical team and the representative of the patient will be
p.000027: essential.
p.000027:
p.000027: 40Department of Health (England): www.dh.gov.uk.
p.000027: 41Welsh Assembly Government: www.word-wales.gov.uk/index.htm.
p.000027:
p.000027: MRC ETHICS GUIDE
p.000027: Medical research involving adults who cannot consent 2007
p.000028: 28
p.000028:
p.000028:
p.000028: 3. Safeguards to protect the interests of patients
p.000028: Once a participant is enrolled in a study, several measures must be taken to ensure protection of the participant’s
p.000028: interests:
p.000028: • Nothing should be done which the participant seems to object to (unless it is to protect them from harm).
p.000028: • Nothing should be done which would be contrary to an advance directive or any other statement by the participant.
p.000028: This only applies if the researcher is aware of such an expression of wishes. Researchers should find out from
p.000028: relatives and carers
...
General/Other / Impaired Autonomy
Searching for indicator autonomy:
(return to top)
p.000007: disproportionate to that benefit. If there is no potential benefit then the risks to the patient should be
p.000007: ‘negligible’.The Code of Practice interprets ‘negligible’ as equivalent to ‘minimal’.
p.000007: • Clinical Trials Regulations: The trial should be expected to offer a benefit that outweighs the risks of
p.000007: participation or involve ‘no risks at all’.
p.000007: In summary, although these various instruments differ slightly in their interpretation of acceptable risks, it is clear
p.000007: that any risks involved in a research project should, at most, be proportionate to any expected direct benefit. If no
p.000007: benefits for participants are anticipated, risks should be at a minimal or negligible level.
p.000007:
p.000007: Minimal risk has been defined by the Council of Europe11 as a risk that “will result, at the most, in a very slight and
p.000007: temporary negative impact on the health of the person concerned”.The Council defines minimal burden on participants as
p.000007: that where it is “to be expected that the discomfort will be, at the most, temporary and very slight for the person
p.000007: concerned.”12
p.000007:
p.000007: Assessment of risk has been described in MRC guidance relating to medical research involving children13,which divides
p.000007: risk into minimal, low or high. Examples of minimal risk procedures include14:
p.000007: • Observing and measuring, provided this is done in a sensitive way and with respect for the participant’s autonomy
p.000007: and privacy.
p.000007: • Obtaining samples in a non-invasive manner, for example, urine collection.
p.000007:
p.000007:
p.000007:
p.000007: 11Additional protocol to the convention on human rights and biomedicine, concerning biomedical research. Council of
p.000007: Europe at article 17 (2). http://conventions.coe.int/Treaty/en/Treaties/Html/195.htm.
p.000007: 12Above article 17 (1).
p.000007: 13MRC Ethics Guide: Medical research involving children 2004.
p.000007: www.mrc.ac.uk/Utilities/Documentrecord/index.htm?d=MRC002430.
p.000007: 14MRC children guidance adapted from the Royal College of Paediatrics and Child Health. Guidelines for the ethical
p.000007: conduct of medical research involving children 2002.
p.000007:
p.000007: MRC ETHICS GUIDE
p.000007: Medical research involving adults who cannot consent 2007
p.000008: 8
p.000008:
p.000008:
p.000008: Potential benefits of participation
p.000008: The statutes discussed here distinguish between research projects which may directly benefit participants and those
p.000008: which will not.This reflects a previous division of research projects into ‘therapeutic’ and ‘non-therapeutic’ – a
p.000008: distinction which has been widely criticised15.
p.000008:
p.000008: Estimating the potential for direct benefit is an important part of weighing up the risks and benefits of taking part
p.000008: in a research project.There may be occasions, however, when it is difficult to determine the potential for benefit to
...
General/Other / Incapacitated
Searching for indicator incapacitated:
(return to top)
p.000004: Medical research involving adults who cannot consent 2007
p.000004: 4
p.000004:
p.000004: 1. Introduction
p.000004:
p.000004: Medical research involving adults who lack mental capacity to consent can lead to innovations in healthcare that can
p.000004: substantially improve their health and quality of life and that of others with similar conditions. It is therefore
p.000004: important that these adults are given the opportunity to participate in such research.To exclude them from any research
p.000004: would be discriminatory and would diminish their ability to participate as fully as possible in society. It would also
p.000004: prevent researchers making progress in the understanding of many disorders that can affect the brain, and in the care
p.000004: and treatment of those who have such disorders. However, such research requires special safeguards to ensure that this
p.000004: vulnerable group are protected when they do participate in medical research.
p.000004:
p.000004: The law relating to the conduct of research when the potential participants lack capacity to consent has developed
p.000004: considerably over the past years.These changes provide welcome clarification of the legal framework within which such
p.000004: research can be carried out. Specific legislation has been introduced in Scotland1 and England and Wales2 relating to
p.000004: adults with mental incapacity (or who may become incapacitated). In Northern Ireland the recommendations of a review of
p.000004: mental health legislation are currently
p.000004: being considered. Further guidance for this region will be issued once available. Other instruments, such as the
p.000004: Clinical Trials Regulations 2004, the Human Tissue Act 20043 and the Data Protection Act 1998, are also of relevance to
p.000004: research in this area.
p.000004:
p.000004: This guidance aims to set out the general principles for assessing whether individuals have the capacity to consent to
p.000004: participation in research. It will also discuss participation in research projects when such capacity is lacking.The
p.000004: guidance does not deal with determining capacity in children, which is discussed in a separate MRC publication4.The
p.000004: emphasis of this publication is on the legislation relating to mental capacity, including explanation of this
p.000004: legislation.The greater emphasis than in previous MRC guidance5 on the legal requirements for such research reflects
p.000004: the altered legal framework.
p.000004:
p.000004: It is hoped that this guidance will help scientists to ensure that research involving people who lack mental capacity
p.000004: is conducted in a legally and ethically acceptable manner. It
p.000004: is also intended to give confidence to researchers that adults with incapacity can be included in their studies so
p.000004: that, when appropriate, they will make the opportunity available, in accordance with the required and recommended
p.000004: safeguards described here.
p.000004:
p.000004:
p.000004: 1Adults with Incapacity Act 2000.
p.000004: 2Mental Capacity Act 2005.
p.000004: 3Medicines for Human Use (Clinical Trials) Regulations 2004. SI 2004 1031 (as amended).
p.000004: 4MRC Ethics Guide: Research involving children, 2004.
p.000004: 5The Ethical Conduct of Research in the Mentally Incapacitated. MRC 1991.
p.000004:
p.000004: MRC ETHICS GUIDE
p.000004: Medical research involving adults who cannot consent 2007
p.000005: 5
p.000005:
p.000005: 2. Ethical principles
p.000005:
p.000005: 2.1 General principles
p.000005: As with any research, the need to respect the interests of an individual participant is more important than any
p.000005: potential benefits of the research to others6,7.
p.000005:
p.000005: All medical research studies, including those involving adults who lack mental capacity, should comply with accepted
p.000005: principles of good practice, including the Declaration of Helsinki and relevant European and UK legislation. In
p.000005: accordance with section 13 of the Declaration, the research protocol should be submitted to and approved by an
p.000005: independent research ethics committee (REC). Under UK
p.000005: legislation relating to research involving adults who lack the capacity to consent, this REC approval is a legal
p.000005: requirement8. Detailed guidance on applying for approval is available from the National Research Ethics Service9.
p.000005:
p.000005: 2.2 Specific principles
p.000005: Individuals unable to consent to participation in a research project due to a lack of mental capacity are a
...
p.000021: that must be met.These are summarised here. Please note that there are separate requirements for research in emergency
p.000021: situations, which is discussed in section 4.3.
p.000021:
p.000021: Trial design
p.000021: • A clinical trial must relate directly to a life-threatening or debilitating clinical condition from which a
p.000021: potential participant suffers. (Note that this differs from the requirements for other types of research, which must be
p.000021: relevant to the condition or impairment causing the loss of capacity.) See Example F.
p.000021:
p.000021:
p.000021: Example F: clinical trials that relate directly to a participant’s condition
p.000021: 1. Researchers have designed a trial studying adults with head injury and impaired consciousness.They wish to assess
p.000021: the effects of a 48-hour infusion of corticosteroids on survival and neurological disability.
p.000021: This trial relates directly to the cause of the impaired consciousness in this group of patients.
p.000021:
p.000021: 2.A trial is underway comparing the efficacy of two different dietary plans on blood glucose control in late-onset
p.000021: diabetes. Mrs F has advanced dementia and diabetes. Her family have read about the trial and request that she be
p.000021: included.The researchers consult the REC as to whether they could approve an amendment to the protocol to allow
p.000021: incapacitated adults to be included. In this case the study (which is not a clinical trial of a medicinal product) does
p.000021: not relate to the cause of the impairment of Mrs F’s capacity – which is dementia.
p.000021: It would therefore not be possible for the REC to approve this amendment. However, if it were a clinical trial
p.000021: comparing oral and subcutaneous insulin Mrs F’s participation could be approved.This is because the study would then be
p.000021: a clinical trial of a medicinal product and would relate directly to a condition – diabetes
p.000021: – from which Mrs F suffers.
p.000021:
p.000021: MRC ETHICS GUIDE
p.000021: Medical research involving adults who cannot consent 2007
p.000022: 22
p.000022:
p.000022:
p.000022: • There must be grounds to expect that administering the medicinal product to be tested in the trial will produce a
p.000022: benefit to the participant that outweighs the risks (or will result in no risk at all).
p.000022:
p.000022: • The clinical trial is essential to validate data obtained:
p.000022: • in other clinical trials involving participants who are able to give informed consent, or
p.000022: • by other research methods.
p.000022:
p.000022: • No incentives or financial inducements may be given to a participant or their legal representative, except provision
p.000022: for compensation in the event of injury or loss34.
p.000022:
p.000022: Consent by legal representative
...
p.000028: relatives and carers
p.000028: what the participant’s views were on relevant issues prior to loss of capacity.They should specifically ask whether any
p.000028: relevant advance directives or expressions of wish are available and, if so, keep a record of them.
p.000028: • The interests of the participant must always outweigh those of science and society.
p.000028: • The researcher must withdraw the participant if any of the conditions for his or her inclusion in the research
p.000028: project no longer apply.
p.000028: • The participant should be withdrawn from the study if he or she gives any indication of not wanting to continue to
p.000028: take part (unless the project involves treatment and it is considered that continuation of this is in the patient’s
p.000028: best interests).
p.000028:
p.000028: Research involving human tissue samples
p.000028: Research (outside Scotland) using human tissue must comply with the Human Tissue Act 2004.This generally requires
p.000028: consent for the use of tissue for research, subject to certain exemptions.The law allows adults without capacity to be
p.000028: included in such research, providing that the research is conducted in accordance with the CT Regulations or MCA as
p.000028: discussed in section 4.1.
p.000028:
p.000028: 4.2.3 Other research (Scotland)
p.000028: In Scotland, research that does not fall under the CT Regulations is governed by the Adults with Incapacity (Scotland)
p.000028: Act 2000 (AWIS).The Act regulates the
p.000028: involvement of incapacitated adults in research42. It has similar requirements to the MCA but has some differences. Its
p.000028: requirements are set out in full below. In order to comply with the AWIS, the following conditions must be met:
p.000028:
p.000028: 1. Nature of the research
p.000028: It must not be possible to carry out research of a similar nature on an adult
p.000028: who has capacity to consent, and the research must be into the causes, diagnosis, treatment or care of the adult’s
p.000028: incapacity; or the effect of any treatment or care given during his incapacity to the adult which relates to that
p.000028: incapacity.
p.000028:
p.000028:
p.000028: 42Adults With Incapacity (Scotland) Act 2000 section 51.
p.000028:
p.000028: MRC ETHICS GUIDE
p.000028: Medical research involving adults who cannot consent 2007
p.000029: 29
p.000029:
p.000029:
p.000029: 2. Risks of the research
p.000029: Participation entails no foreseeable risk, or only a minimal foreseeable risk and imposes no discomfort, or only
p.000029: minimal discomfort, on the adult.
p.000029:
p.000029: 3. Benefits of the research
...
p.000032: manage the patients’ clinical condition. In the protocol the researchers propose that, where available, a consultant
p.000032: anaesthetist unconnected with the study will be consulted about inclusion of each patient.Where this is not possible,
p.000032: for instance at
p.000032: nights or weekends, the patients will be enrolled into the study and baseline and further blood tests and data
p.000032: collected. However, as soon as a relative or unpaid carer is available they will be consulted about the continued
p.000032: participation of the patient in the study. If and when the patient regains consciousness the research project will be
p.000032: fully explained and they will be able to choose whether their data should remain in the study cohort.The approved this
p.000032: protocol.
p.000032:
p.000032:
p.000032: 4.3.4 Other research in emergency situations (Scotland)
p.000032: At this time there is no provision for recruitment into non-clinical research in an emergency without the consultative
p.000032: steps described in section 4.3.This means that such research cannot be lawfully carried out in Scotland at present. If
p.000032: researchers believe that this may affect a study they are considering, they should seek further advice from the MRC or
p.000032: the Scotland A REC.
p.000032:
p.000032: 4.3.5 Data Protection Act 1998 and research in emergency situations (all of UK)
p.000032: It has been established46 that data may be processed for research in emergency situations involving incapacitated
p.000032: adults providing information about this work is given to them on recovery of capacity. At this point they may refuse to
p.000032: participate in the research, including refusal to allow further processing of data already collected. This makes the
p.000032: use of data for research purposes in this situation acceptable in relation to the Data Protection Act. Any research
p.000032: must always also comply with any other legal requirements such as the MCA,AWIS or CT Regulations.
p.000032:
p.000032:
p.000032:
p.000032: 46Time to get our Acts together. Reid CL and Menon DK. BMJ: 355; 415.
p.000032:
p.000032: MRC ETHICS GUIDE
p.000032: Medical research involving adults who cannot consent 2007
p.000033: 33
p.000033:
p.000033: Glossary
p.000033:
p.000033: AWIS Adults with Incapacity (Scotland) Act 2000
p.000033: CT Regulations Medicines for Human Use (Clinical Trials) Regulations 2004
p.000033: HTA Human Tissue Authority
p.000033: HTAct Human Tissue Act 2004
p.000033: ICH GCP International Conference on Harmonisation: Good
p.000033: Clinical Practice
p.000033: MCA Mental Capacity Act 2005
p.000033: MHRA Medicines and Healthcare products Regulatory Agency
p.000033: NRES National Research Ethics Service (formerly COREC)
...
Searching for indicator incapacity:
(return to top)
p.000004:
p.000004: MRC ETHICS GUIDE
p.000004: Medical research involving adults who cannot consent 2007
p.000004: 4
p.000004:
p.000004: 1. Introduction
p.000004:
p.000004: Medical research involving adults who lack mental capacity to consent can lead to innovations in healthcare that can
p.000004: substantially improve their health and quality of life and that of others with similar conditions. It is therefore
p.000004: important that these adults are given the opportunity to participate in such research.To exclude them from any research
p.000004: would be discriminatory and would diminish their ability to participate as fully as possible in society. It would also
p.000004: prevent researchers making progress in the understanding of many disorders that can affect the brain, and in the care
p.000004: and treatment of those who have such disorders. However, such research requires special safeguards to ensure that this
p.000004: vulnerable group are protected when they do participate in medical research.
p.000004:
p.000004: The law relating to the conduct of research when the potential participants lack capacity to consent has developed
p.000004: considerably over the past years.These changes provide welcome clarification of the legal framework within which such
p.000004: research can be carried out. Specific legislation has been introduced in Scotland1 and England and Wales2 relating to
p.000004: adults with mental incapacity (or who may become incapacitated). In Northern Ireland the recommendations of a review of
p.000004: mental health legislation are currently
p.000004: being considered. Further guidance for this region will be issued once available. Other instruments, such as the
p.000004: Clinical Trials Regulations 2004, the Human Tissue Act 20043 and the Data Protection Act 1998, are also of relevance to
p.000004: research in this area.
p.000004:
p.000004: This guidance aims to set out the general principles for assessing whether individuals have the capacity to consent to
p.000004: participation in research. It will also discuss participation in research projects when such capacity is lacking.The
p.000004: guidance does not deal with determining capacity in children, which is discussed in a separate MRC publication4.The
p.000004: emphasis of this publication is on the legislation relating to mental capacity, including explanation of this
p.000004: legislation.The greater emphasis than in previous MRC guidance5 on the legal requirements for such research reflects
p.000004: the altered legal framework.
p.000004:
p.000004: It is hoped that this guidance will help scientists to ensure that research involving people who lack mental capacity
p.000004: is conducted in a legally and ethically acceptable manner. It
p.000004: is also intended to give confidence to researchers that adults with incapacity can be included in their studies so
p.000004: that, when appropriate, they will make the opportunity available, in accordance with the required and recommended
p.000004: safeguards described here.
p.000004:
p.000004:
p.000004: 1Adults with Incapacity Act 2000.
p.000004: 2Mental Capacity Act 2005.
p.000004: 3Medicines for Human Use (Clinical Trials) Regulations 2004. SI 2004 1031 (as amended).
p.000004: 4MRC Ethics Guide: Research involving children, 2004.
p.000004: 5The Ethical Conduct of Research in the Mentally Incapacitated. MRC 1991.
p.000004:
p.000004: MRC ETHICS GUIDE
p.000004: Medical research involving adults who cannot consent 2007
p.000005: 5
p.000005:
p.000005: 2. Ethical principles
p.000005:
p.000005: 2.1 General principles
p.000005: As with any research, the need to respect the interests of an individual participant is more important than any
p.000005: potential benefits of the research to others6,7.
p.000005:
p.000005: All medical research studies, including those involving adults who lack mental capacity, should comply with accepted
p.000005: principles of good practice, including the Declaration of Helsinki and relevant European and UK legislation. In
p.000005: accordance with section 13 of the Declaration, the research protocol should be submitted to and approved by an
p.000005: independent research ethics committee (REC). Under UK
...
p.000006:
p.000006: The risks and benefits of participation in any research must always be weighed up so that potential direct benefits
p.000006: outweigh any risks. Any potential risks must be minimised through the study design. If no direct benefit is anticipated
p.000006: the risks must be negligible (see Table 1).
p.000006:
p.000006:
p.000006: Table 1: Key principles when considering the participation of adults who lack capacity in research
p.000006: • The interests of the individual must always outweigh those of science and society.
p.000006: • The research must relate to a condition or impairment that affects the individual or the treatment of this
p.000006: condition10.
p.000006: • It must not be possible to conduct equally effective research with adults who have the capacity to consent.
p.000006: • The potential benefits of the project should outweigh the risks: the level of acceptable risk depends partly on the
p.000006: possible benefit to the individual.
p.000006: • Views of those close to the participant should always be sought, unless this is not possible due to particular
p.000006: circumstances.
p.000006: • A participant who lacks capacity should only be included in a study when there are no indications that he or she
p.000006: objects to this.
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006: 10Under the Mental Capacity Act and Adults with Incapacity (Scotland) Act, this condition or impairment must relate to
p.000006: the reason for incapacity. Under the Clinical Trials Regulations this is not specified.
p.000006:
p.000006: MRC ETHICS GUIDE
p.000006: Medical research involving adults who cannot consent 2007
p.000007: 7
p.000007:
p.000007:
p.000007: 2.3 Risks and benefits
p.000007: Acceptable level of risk
p.000007: The extent to which the likely benefit of a research project affects the acceptable level of risk has been widely
p.000007: discussed.This debate is reflected in changes to the wording of the statutes in relation to the acceptable level of
p.000007: risk:
p.000007: • Adults with Incapacity (Scotland) Act: In relation to the level of acceptable risk, the Scottish Act does not
p.000007: differentiate between research that may potentially
p.000007: benefit participants and that which will not. Both must impose, at most, minimal foreseeable risk and minimal
p.000007: discomfort.
p.000007: • Mental Capacity Act: If research has the potential to benefit participants, the burdens imposed should not be
p.000007: disproportionate to that benefit. If there is no potential benefit then the risks to the patient should be
p.000007: ‘negligible’.The Code of Practice interprets ‘negligible’ as equivalent to ‘minimal’.
p.000007: • Clinical Trials Regulations: The trial should be expected to offer a benefit that outweighs the risks of
p.000007: participation or involve ‘no risks at all’.
p.000007: In summary, although these various instruments differ slightly in their interpretation of acceptable risks, it is clear
p.000007: that any risks involved in a research project should, at most, be proportionate to any expected direct benefit. If no
p.000007: benefits for participants are anticipated, risks should be at a minimal or negligible level.
p.000007:
p.000007: Minimal risk has been defined by the Council of Europe11 as a risk that “will result, at the most, in a very slight and
p.000007: temporary negative impact on the health of the person concerned”.The Council defines minimal burden on participants as
p.000007: that where it is “to be expected that the discomfort will be, at the most, temporary and very slight for the person
p.000007: concerned.”12
p.000007:
...
p.000008: encountered in normal daily life and approved the study.
p.000008:
p.000008:
p.000008:
p.000008: 15Royal College of Psychiatrists: www.rcpsych.ac.uk/publications/cr/council/cr82i.pdf 3.4. British Medical Association:
p.000008: www.bma.org.uk/ap.nsf/Content/consenttk2~10.
p.000008:
p.000008: MRC ETHICS GUIDE
p.000008: Medical research involving adults who cannot consent 2007
p.000009: 9
p.000009:
p.000009: 3. Key concepts
p.000009:
p.000009: 3.1 Capacity/competence
p.000009: A person is assumed to have the mental capacity to make a decision unless it is shown to be absent.This is a
p.000009: fundamental principle. Mental capacity is considered to be lacking if, in a specific circumstance, a person is unable
p.000009: to make a decision for him or herself because of an impairment or a disturbance in the functioning of
p.000009: their mind or brain16. In designing a study, researchers should consider whether it is likely that some or all
p.000009: participants could lack or could lose their capacity to consent to take part. In this case the information provided to
p.000009: potential participants should include options for their continued participation if they should lose capacity.
p.000009:
p.000009: Table 2: Defining incapacity – from the adults with Incapacity
p.000009: (Scotland) Act
p.000009: ‘Incapable’ means unable to:
p.000009: • act; or
p.000009: • make decisions; or
p.000009: • communicate decisions; or
p.000009: • understand decisions; or
p.000009: • retain the memory of decisions
p.000009: by reason of mental disorder or of inability to communicate because of physical disability.
p.000009:
p.000009:
p.000009: It should be noted that:
p.000009: • Capacity is specific to the matter in question and so a person could have mental capacity in relation to some
p.000009: matters but not to others.
p.000009: • Capacity can also vary in time, for example, in a patient who is temporarily unconscious or who has suffered a
p.000009: relapse in their psychiatric condition.
p.000009: • Capacity is present if the person only has a difficulty with communication that can be overcome with human or
p.000009: mechanical assistance.
p.000009:
p.000009:
p.000009:
p.000009:
p.000009:
p.000009: 16Section 2 Mental Capacity Act 2005:“A person lacks capacity in relation to a matter if at the material time he is
p.000009: unable to make a decision for himself in relation to the matter because of an impairment of or a disturbance in the
p.000009: functioning of the mind or brain.”
p.000009:
p.000009: MRC ETHICS GUIDE
...
p.000015:
p.000015: MRC ETHICS GUIDE
p.000015: Medical research involving adults who cannot consent 2007
p.000016: 16
p.000016:
p.000016:
p.000016: If an individual has made a decision to participate in research and subsequently loses capacity, it is expected that
p.000016: this consent would be respected in most circumstances and so use of samples or data could continue. Procedures should
p.000016: be in place in any study to ensure that, where necessary, participants can withdraw or be withdrawn from the study at
p.000016: any time. If the participant loses capacity, a request by a representative for withdrawal from a study should be
p.000016: considered carefully to ensure that it reflects the wishes of a participant before loss of capacity, their current
p.000016: situation and any potential benefits or harm that could arise from continued participation in the research study.
p.000016:
p.000016: When designing studies, researchers should consider the risk of participants losing capacity during the course of a
p.000016: study and, where appropriate, should discuss this possibility with them.The consent form should include an option to
p.000016: consent to remain in the study in the event of incapacity.This consent would not be ‘absolute’, as continued
p.000016: participation will depend upon individual circumstances.
p.000016:
p.000016: The participant may continue to receive a treatment received during the research if withdrawal would create a
p.000016: significant risk to their health.
p.000016:
p.000016: 3. Adults with Incapacity (Scotland) Act:
p.000016: The Act does not refer to loss of capacity during a research study. It will be up to researchers and the REC to decide
p.000016: whether procedures need to be in place for such an eventuality.The MRC advises that the principles described above
p.000016: should be followed when considering existing consent and the potential for withdrawal from a study.
p.000016:
p.000016: 4. Human Tissue Act 2004:
p.000016: The Act and its associated regulations28 state that storage and use of human tissue for research must be done in
p.000016: accordance with the provisions of the MCA, unless the adult consented before losing capacity. In Northern Ireland
p.000016: approval is required from an REC to store and use tissue from adults who lack capacity to consent.
p.000016:
p.000016: Example D illustrates some of the issues that may arise when a person loses capacity during the course of research.
p.000016:
p.000016:
p.000016:
p.000016:
p.000016:
p.000016: 28Human Tissue Act 2004 (Persons who lack capacity to consent) Regulations 2006 at 3c and d and Human Tissue Act 2004
p.000016: at s6.
p.000016:
p.000016: MRC ETHICS GUIDE
p.000016: Medical research involving adults who cannot consent 2007
p.000017: 17
p.000017:
p.000017:
p.000017: Example D: consent for new samples in long-term study
...
p.000017: researchers that he had recently been hospitalised with an infection and had subsequently developed a marked fear of
p.000017: needles.
p.000017:
p.000017: The researchers agreed with the family that Mr D should not be included in the next round of sampling as the outcome of
p.000017: the research would not be of any direct benefit to his own health. In addition, his present condition meant that he may
p.000017: have found the taking of blood samples distressing: this was deemed an unacceptable risk.
p.000017:
p.000017: However, the family agreed that the data and samples already collected could continue to be used in the study, in
p.000017: accordance with Mr D’s previously expressed wishes.
p.000017:
p.000017: MRC ETHICS GUIDE
p.000017: Medical research involving adults who cannot consent 2007
p.000018: 18
p.000018:
p.000018: 4. Legal requirements for research
p.000018:
p.000018: 4.1 Legislation relevant to medical research
p.000018: The law in the UK now makes a distinction between two types of research involving people.These are (i) clinical trials
p.000018: of medicinal products and (ii) other research involving people. In relation to capacity, these studies are governed by
p.000018: three separate pieces of legislation. Clinical trials of medicinal products are governed by the Medicines for Human Use
p.000018: (Clinical Trials) Regulations 2004 (CT Regulations) while other research is governed by the Adults With Incapacity
p.000018: (Scotland) Act 2000 (AWIS) or the Mental Capacity Act 2005 (MCA).The CT Regulations implement a European Directive and
p.000018: apply to all of the UK.The AWIS applies only to Scotland and the MCA applies only to England and Wales.
p.000018:
p.000018: To ensure that research is conducted lawfully researchers must first determine into which category their proposed
p.000018: research falls. It is important to note that the legal definition of a ‘clinical trial’ (i.e. a study which falls under
p.000018: the CT Regulations) is tightly defined, whereas in wider usage the term can sometimes refer to other types of study.
p.000018: See Example E.
p.000018:
p.000018: 1. Clinical trials of medicinal products:These are regulated by the CT Regulations and defined as “interventional
p.000018: investigations or studies undertaken to ascertain the efficacy or safety of a medicinal product in human
p.000018: subjects”29.The CT Regulations contain requirements that apply if adults who lack capacity are to be included
p.000018: in such research. Further guidance on the regulation of clinical trials and how to determine if a study falls into this
p.000018: category is available at www.ct-toolkit.ac.uk. The Medicines and Healthcare products Regulatory Agency (MHRA) can
p.000018: provide advice on an individual basis about whether a proposed trial is covered by the CT Regulations. In addition, an
p.000018: algorithm to help decide whether research is a clinical trial of a medicinal product is available at
p.000018: http://ec.europa.eu/enterprise/ pharmaceuticals/pharmacos/docs/doc2006/04_2006/clinical_trial_ qa_april_2006.pdf.
p.000018:
...
p.000019: the MCA, which contains specific requirements for the conduct of such research. Intrusive research in this context is
p.000019: described as that where: “if a person taking part had capacity, the researcher would need to get consent to involve
p.000019: them”30. It specifically excludes research that falls under the CT Regulations.
p.000019:
p.000019: 3. Research in Scotland is governed by the AWIS.This contains requirements for “surgical, medical, nursing, dental or
p.000019: psychological research”31.The Act gives specific requirements which are broadly similar to the MCA but have some
p.000019: differences in their detail. Section 4.2.3 below summarises the position in Scotland.
p.000019:
p.000019: 4.Table 5 summarises the legislation relevant to research involving people in different parts of the UK.
p.000019:
p.000019:
p.000019:
p.000019:
p.000019:
p.000019:
p.000019:
p.000019:
p.000019:
p.000019:
p.000019:
p.000019:
p.000019:
p.000019: 30MCA Code pf Practice at 11.6.
p.000019: 31AWIS 2000 at 51(3).
p.000019:
p.000019: MRC ETHICS GUIDE
p.000019: Medical research involving adults who cannot consent 2007
p.000020: 20
p.000020:
p.000020:
p.000020: Table 5: Summary of relevant legislation
p.000020: England and Wales Scotland Northern Ireland
p.000020:
p.000020: The Medicines for Human Use (Clinical Trials) Regula- tions 2004 (CT Regulations)
p.000020: Adults With Incapacity (Scotland) 2000 (AWIS)
p.000020: Mental Capacity Act 2005 (MCA)
p.000020: Human Tissue Act 2004
p.000020:
p.000020: Human Tissue (Scotland) Act 2006
p.000020: Data Protection Act 1998
p.000020: Human Fertilisation and Embryology Act 199033
p.000020:
p.000020:
p.000020: yes no
p.000020: yes yes
p.000020:
p.000020:
p.000020: no yes
p.000020:
p.000020: yes
p.000020: yes yes no
p.000020: mostly no32
p.000020:
p.000020: yes yes
p.000020:
p.000020: yes
p.000020:
p.000020:
p.000020: yes no
p.000020: under review yes
p.000020:
p.000020:
p.000020: no yes
p.000020:
p.000020: yes
p.000020:
p.000020:
p.000020: 4.2. Requirements for research
p.000020: This section summarises the requirements of the different laws and regulations that apply to research involving adults
p.000020: who lack capacity to consent. In italics are points of good practice that are additional to the legal requirements. In
p.000020: order to refer to the correct section, the key questions are:
p.000020:
p.000020:
p.000020: Is this a clinical trial?
p.000020: no
p.000020: Is the research in Scotland?
p.000020: no
p.000020: Section 4.2.2
p.000020:
p.000020: yes
p.000020:
p.000020:
p.000020: yes
p.000020:
p.000020: 4.2.1
p.000020:
p.000020: 4.2.3
p.000020:
p.000020:
p.000020:
p.000020: 32 Of relevance, section (45) of the Human Tissue Act relating to DNA analysis also applies in Scotland. For further
p.000020: guidance on the use of human tissue in research, please refer to separate MRC publications.
p.000020: 33At the time of publication in October 2007, a draft Bill amending this Act was being prepared.
p.000020:
...
p.000024: 1. REC approval (by a recognised committee).
p.000024: 2. Consulting relatives/carers/others.
p.000024: 3. Safeguards to protect participants.
p.000024:
p.000024: 1. Ethical approval for the project or study
p.000024: There are several questions set out in the MCA that must be considered before ethical approval can be granted.
p.000024: Researchers should ensure that they address these in their application for REC approval.The REC must be recognised by
p.000024: the
p.000024: Department of Health (England) or the Welsh Ministers for the purpose of approving research that falls under the Act.At
p.000024: the time of publication, all such committees are part of the National Health Service REC system – further guidance on
p.000024: recognised committees can be obtained from the National Research Ethics Service (NRES)36.
p.000024: • Is the research study related to the impairing condition or its treatment?
p.000024: Asdiscussed in section 3.1, an adult deemed to lack capacity to consent to take part in a research study must have
p.000024: impaired or disturbed functioning of their mind or brain.To be approved, the proposed research must be connected with a
p.000024: condition which may cause, contribute to or result from this impairment of function of the mind or brain or its
p.000024: treatment.This means that participation cannot be approved if the condition being investigated by the study is
p.000024: completely unrelated to the reason for mental incapacity. The link between the study and the reason for the potential
p.000024: participant’s lack of capacity should be explained in the application for ethical approval.
p.000024:
p.000024: 35MRC policy is that, as in other research, payment of legitimate expenses of participants or representatives directly
p.000024: related to participation in the trial is generally considered acceptable.
p.000024: 36National Research Ethics Service: www.nres.npsa.nhs.uk.
p.000024:
p.000024: MRC ETHICS GUIDE
p.000024: Medical research involving adults who cannot consent 2007
p.000025: 25
p.000025:
p.000025: • Could the study be done involving only adults with capacity to consent?
p.000025: Researchers should enrol participants who lack the capacity to consent to take part only if there is reason to believe
p.000025: that the study could not be done as effectively if it involved only adults who could give consent.This is illustrated
p.000025: in Example G below.
p.000025:
p.000025:
p.000025: Example G: studies where it is not necessary to include adults who lack capacity to consent
p.000025: Researchers wish to assess changes in blood levels of immune factors following insertion of an invasive monitoring
p.000025: device into an artery. The team are based in intensive care and so they are seeking REC approval to include in the
...
p.000028: • Nothing should be done which would be contrary to an advance directive or any other statement by the participant.
p.000028: This only applies if the researcher is aware of such an expression of wishes. Researchers should find out from
p.000028: relatives and carers
p.000028: what the participant’s views were on relevant issues prior to loss of capacity.They should specifically ask whether any
p.000028: relevant advance directives or expressions of wish are available and, if so, keep a record of them.
p.000028: • The interests of the participant must always outweigh those of science and society.
p.000028: • The researcher must withdraw the participant if any of the conditions for his or her inclusion in the research
p.000028: project no longer apply.
p.000028: • The participant should be withdrawn from the study if he or she gives any indication of not wanting to continue to
p.000028: take part (unless the project involves treatment and it is considered that continuation of this is in the patient’s
p.000028: best interests).
p.000028:
p.000028: Research involving human tissue samples
p.000028: Research (outside Scotland) using human tissue must comply with the Human Tissue Act 2004.This generally requires
p.000028: consent for the use of tissue for research, subject to certain exemptions.The law allows adults without capacity to be
p.000028: included in such research, providing that the research is conducted in accordance with the CT Regulations or MCA as
p.000028: discussed in section 4.1.
p.000028:
p.000028: 4.2.3 Other research (Scotland)
p.000028: In Scotland, research that does not fall under the CT Regulations is governed by the Adults with Incapacity (Scotland)
p.000028: Act 2000 (AWIS).The Act regulates the
p.000028: involvement of incapacitated adults in research42. It has similar requirements to the MCA but has some differences. Its
p.000028: requirements are set out in full below. In order to comply with the AWIS, the following conditions must be met:
p.000028:
p.000028: 1. Nature of the research
p.000028: It must not be possible to carry out research of a similar nature on an adult
p.000028: who has capacity to consent, and the research must be into the causes, diagnosis, treatment or care of the adult’s
p.000028: incapacity; or the effect of any treatment or care given during his incapacity to the adult which relates to that
p.000028: incapacity.
p.000028:
p.000028:
p.000028: 42Adults With Incapacity (Scotland) Act 2000 section 51.
p.000028:
p.000028: MRC ETHICS GUIDE
p.000028: Medical research involving adults who cannot consent 2007
p.000029: 29
p.000029:
p.000029:
p.000029: 2. Risks of the research
p.000029: Participation entails no foreseeable risk, or only a minimal foreseeable risk and imposes no discomfort, or only
p.000029: minimal discomfort, on the adult.
p.000029:
p.000029: 3. Benefits of the research
p.000029: The research must either be of real and direct benefit to the participant or, where the research is not likely to
p.000029: produce real and direct benefit, it can be carried out if it will contribute significantly to scientific understanding
p.000029: of the adult’s incapacity and thus will benefit the participant directly, or benefit other people with the same
p.000029: incapacity.
p.000029:
p.000029: 4. Consent
p.000029: Consent must be obtained from any guardian or welfare attorney who has the power to consent to the adult’s
p.000029: participation in research or, where there is no such
p.000029: guardian or welfare attorney, from the adult’s nearest relative. In addition the potential participant must not
p.000029: indicate unwillingness or objection to participation in the research.
p.000029:
p.000029: 5. Ethical committee review
p.000029: All research must be approved by the REC stated under the AWIS regulations. At the time of publication, this committee
p.000029: was the Scotland A REC.The NRES Central Allocation System can direct applications appropriately.
p.000029:
p.000029: The ethics committee is required to consider43:
p.000029: • Objectives, design, methodology, statistical considerations and organisation of the research.
p.000029: • Relevance of the research and study design.
p.000029: • Justification of predictable risks and inconveniences weighed against the anticipated benefits for research
p.000029: participants and future participants.
p.000029: • Suitability of the lead researcher.
p.000029: • Adequacy of the written information and procedures for obtaining consent.
p.000029: • Arrangements for recruitment of participants.
p.000029:
p.000029:
p.000029:
p.000029:
p.000029:
p.000029:
p.000029:
p.000029:
p.000029:
p.000029:
p.000029: 43The Adults With Incapacity (Ethics Committee) (Scotland) Regulations 2002 No. 190.
p.000029:
p.000029: MRC ETHICS GUIDE
p.000029: Medical research involving adults who cannot consent 2007
p.000030: 30
p.000030:
p.000030:
p.000030: 4.2.4 Other research (Northern Ireland)
p.000030: As at October 2007, the recommendations from a review of mental health legislation in Northern Ireland were being
p.000030: considered. Further guidance relating to this region will be issued once available. At present, there is no specific
p.000030: legislation applicable to research involving adults who lack capacity.All research must be approved by an ethics
p.000030: committee and must comply with common law principles.
p.000030:
p.000030: 4.3 Requirements for research in emergency situations
p.000030: Specific allowance is made for research in emergency situations when it may not be possible to consult as required by
p.000030: the various laws.These allowances apply to research which fulfils the other requirements of the relevant legislation
p.000030: but
p.000030: where it is not possible to obtain the consent or agreement of a consultee before participation in a clinical trial or
p.000030: other study begins.This exception can only be relied upon until it is possible to consult or seek consent in the normal
p.000030: manner.
p.000030:
...
p.000032: steps described in section 4.3.This means that such research cannot be lawfully carried out in Scotland at present. If
p.000032: researchers believe that this may affect a study they are considering, they should seek further advice from the MRC or
p.000032: the Scotland A REC.
p.000032:
p.000032: 4.3.5 Data Protection Act 1998 and research in emergency situations (all of UK)
p.000032: It has been established46 that data may be processed for research in emergency situations involving incapacitated
p.000032: adults providing information about this work is given to them on recovery of capacity. At this point they may refuse to
p.000032: participate in the research, including refusal to allow further processing of data already collected. This makes the
p.000032: use of data for research purposes in this situation acceptable in relation to the Data Protection Act. Any research
p.000032: must always also comply with any other legal requirements such as the MCA,AWIS or CT Regulations.
p.000032:
p.000032:
p.000032:
p.000032: 46Time to get our Acts together. Reid CL and Menon DK. BMJ: 355; 415.
p.000032:
p.000032: MRC ETHICS GUIDE
p.000032: Medical research involving adults who cannot consent 2007
p.000033: 33
p.000033:
p.000033: Glossary
p.000033:
p.000033: AWIS Adults with Incapacity (Scotland) Act 2000
p.000033: CT Regulations Medicines for Human Use (Clinical Trials) Regulations 2004
p.000033: HTA Human Tissue Authority
p.000033: HTAct Human Tissue Act 2004
p.000033: ICH GCP International Conference on Harmonisation: Good
p.000033: Clinical Practice
p.000033: MCA Mental Capacity Act 2005
p.000033: MHRA Medicines and Healthcare products Regulatory Agency
p.000033: NRES National Research Ethics Service (formerly COREC)
p.000033: REC Research Ethics Committee
p.000033:
p.000033:
p.000033: MRC ETHICS GUIDE
p.000033: Medical research involving adults who cannot consent 2007
p.000034: 34
p.000034:
p.000034: Further Reading
p.000034:
p.000034: Mental Capacity Act Code of Practice:
p.000034: www.opsi.gov.uk/acts/acts2005/related/ukpgacop_20050009_en.pdf
p.000034:
p.000034: Department of Health (England) guidance: www.dh.gov.uk/en/Policyandguidance/Healthandsocialcaretopics/
p.000034: Socialcare/IMCA/MentalCapacityAct2005/index.htm
p.000034:
p.000034: National Research Ethics Service guidance:
p.000034: www.nres.npsa.nhs.uk/applicants/help/guidance.htm#awi
p.000034:
p.000034: Full text of Mental Capacity Act 2005:
p.000034: www.opsi.gov.uk/acts/acts2005/50009--b.htm#30
p.000034:
p.000034: Full text of Adults with Incapacity (Scotland) Act 2000:
p.000034: www.opsi.gov.uk/legislation/scotland/acts2000/20000004.htm
p.000034:
p.000034: Full text of Medicines for Human Use (Clinical Trial) Regulations 2004:
p.000034: www.opsi.gov.uk/si/si2004/20041031.htm
p.000034:
p.000034: Declaration of Helsinki:
p.000034: www.wma.net/e/policy/b3.htm
p.000034: (at the time of publication the World Medical Association was consulting on a revision of the Declaration)
p.000034:
p.000034: This MRC guidance is based upon the previous 1992 guidance and updated in October 2007 in light of subsequent
p.000034: legislation.
p.000034:
p.000034: Comments or questions should be addressed to Dr Catherine Elliott at: MRC Head Office
p.000034: 20 Park Crescent London
p.000034: W1B 1AL
p.000034: Email: catherine.elliott@headoffice.mrc.ac.uk
p.000034:
p.000034:
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p.000034:
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p.000034:
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p.000034:
p.000034:
...
General/Other / Natural Hazards
Searching for indicator hazard:
(return to top)
p.000008:
p.000008: Estimating the potential for direct benefit is an important part of weighing up the risks and benefits of taking part
p.000008: in a research project.There may be occasions, however, when it is difficult to determine the potential for benefit to
p.000008: the individual.This may occur, for example, if clinicians are divided in their views of a particular therapy or are in
p.000008: equipoise – such as when a randomised controlled trial is considered appropriate.
p.000008:
p.000008: It is up to a REC to decide whether the risks associated with a research project are acceptable in relation to the
p.000008: expected benefits. A careful assessment of this should therefore be provided by the researchers. (See Example A).
p.000008:
p.000008:
p.000008: Example A: assessment of risks and benefits
p.000008: The Blandfordshire REC was asked to review a proposal to study whether electronic tagging was beneficial to the care of
p.000008: older people with varying degrees of dementia who lived in residential homes.The hypothesis was that the tagging would
p.000008: allow the residents more freedom while minimising their risk of getting lost.There was some discussion about whether
p.000008: the tagging was an invasion of privacy when the individuals concerned were unable to provide informed consent. However,
p.000008: the results of an independent consultation, commissioned by the researchers, of relatives and carers suggested that the
p.000008: benefits to the residents were perceived to outweigh this concern.The tagging device was very small and not noticeable
p.000008: when worn.When the project was reviewed by the REC, it was questioned whether the radiofrequencies used constituted a
p.000008: health hazard in this
p.000008: age group.A decision on whether the study might go ahead was deferred until the researchers provided an updated
p.000008: analysis of the literature on this issue, in light of new scientific evidence.This analysis suggested that the
p.000008: radiofrequency risk was similar to that of mobile telephones.The REC decided that this was equivalent to a risk
p.000008: encountered in normal daily life and approved the study.
p.000008:
p.000008:
p.000008:
p.000008: 15Royal College of Psychiatrists: www.rcpsych.ac.uk/publications/cr/council/cr82i.pdf 3.4. British Medical Association:
p.000008: www.bma.org.uk/ap.nsf/Content/consenttk2~10.
p.000008:
p.000008: MRC ETHICS GUIDE
p.000008: Medical research involving adults who cannot consent 2007
p.000009: 9
p.000009:
p.000009: 3. Key concepts
p.000009:
p.000009: 3.1 Capacity/competence
p.000009: A person is assumed to have the mental capacity to make a decision unless it is shown to be absent.This is a
p.000009: fundamental principle. Mental capacity is considered to be lacking if, in a specific circumstance, a person is unable
p.000009: to make a decision for him or herself because of an impairment or a disturbance in the functioning of
p.000009: their mind or brain16. In designing a study, researchers should consider whether it is likely that some or all
...
General/Other / Public Emergency
Searching for indicator emergency:
(return to top)
p.000004:
p.000004:
p.000004: MRC ETHICS GUIDE 2007
p.000004: Medical research involving adults who cannot consent
p.000004:
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p.000004:
p.000004:
p.000004:
p.000004:
p.000004:
p.000004:
p.000004: Contents
p.000004:
p.000004: 1. Introduction
p.000004:
p.000004: 2. Ethical principles
p.000004: 2.1 General principles
p.000004: 2.2 Specific principles
p.000004: 2.3 Risks and benefits
p.000004:
p.000004: 3. Key concepts
p.000004: 3.1 Capacity/competence
p.000004: 3.2 Consent
p.000004: 3.2.1 Giving consent on behalf of an adult who lacks capacity
p.000004: 3.2.2 Loss of capacity during the course of the research
p.000004:
p.000004: 4. Legal requirements for research
p.000004: 4.1 Legislation relevant to medical research
p.000004: 4.2 Requirements for research
p.000004: 4.2.1 Clinical trials (all of UK)
p.000004: 4.2.2 Other research (England and Wales)
p.000004: 4.2.3 Other research (Scotland)
p.000004: 4.2.4 Other research (Northern Ireland)
p.000004: 4.3 Requirements for research in emergency situations
p.000004: 4.3.1 Clinical trials in emergency situations (all of UK)
p.000004: 4.3.2 Other research in emergency situations (England and Wales)
p.000004: 4.3.3 Other research in emergency situations (Scotland)
p.000004: 4.3.4 Data Protection Act 1998 and research in emergency situations (all of UK)
p.000004:
p.000004: MRC ETHICS GUIDE
p.000004: Medical research involving adults who cannot consent 2007
p.000004: 4
p.000004:
p.000004: 1. Introduction
p.000004:
p.000004: Medical research involving adults who lack mental capacity to consent can lead to innovations in healthcare that can
p.000004: substantially improve their health and quality of life and that of others with similar conditions. It is therefore
p.000004: important that these adults are given the opportunity to participate in such research.To exclude them from any research
p.000004: would be discriminatory and would diminish their ability to participate as fully as possible in society. It would also
p.000004: prevent researchers making progress in the understanding of many disorders that can affect the brain, and in the care
p.000004: and treatment of those who have such disorders. However, such research requires special safeguards to ensure that this
p.000004: vulnerable group are protected when they do participate in medical research.
p.000004:
p.000004: The law relating to the conduct of research when the potential participants lack capacity to consent has developed
p.000004: considerably over the past years.These changes provide welcome clarification of the legal framework within which such
p.000004: research can be carried out. Specific legislation has been introduced in Scotland1 and England and Wales2 relating to
...
p.000005: to participate in ethically designed research projects as those who do not lack capacity but must not be put at
p.000005: unwarranted risk.Their participation needs to be agreed by someone who is independent of the study and who can assess
p.000005: the potential participant’s interests in accordance with current legislation and guidance.This person may be a
p.000005: relative, a carer or an independent representative.
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005: 6Declaration of Helsinki, 2000: www.wma.net/e/policy/b3.htm.
p.000005: 7Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology
p.000005: and Medicine: Convention on Human Rights and Biomedicine Oviedo, 4.IV.1997 Chapter 1 article 2.
p.000005: 8Excluding, at present, Northern Ireland.
p.000005: 9National Research Ethics Service: www.nres.npsa.nhs.uk/applicants/help/guidance.htm#awi.
p.000005:
p.000005: MRC ETHICS GUIDE
p.000005: Medical research involving adults who cannot consent 2007
p.000006: 6
p.000006:
p.000006:
p.000006: If possible, the proposed study should also be discussed or communicated with the person themselves in a way
p.000006: appropriate to their understanding. In an emergency setting, consultation with the representative or participant may
p.000006: not be immediately possible but should occur as soon as practical. (There is more information about emergency
p.000006: situations in section 4.3).
p.000006:
p.000006: Someone who lacks the mental capacity to consent to take part in research should not take part in a study if he or she
p.000006: does not seem in agreement with any intervention or part of the study, even if agreement has been given by another
p.000006: person. If this happens, researchers are expected to inform the individual’s independant representative that the
p.000006: individual will not be taking part despite the representative’s agreement, and tell them the reasons for this decision.
p.000006:
p.000006: The risks and benefits of participation in any research must always be weighed up so that potential direct benefits
p.000006: outweigh any risks. Any potential risks must be minimised through the study design. If no direct benefit is anticipated
p.000006: the risks must be negligible (see Table 1).
p.000006:
p.000006:
p.000006: Table 1: Key principles when considering the participation of adults who lack capacity in research
p.000006: • The interests of the individual must always outweigh those of science and society.
p.000006: • The research must relate to a condition or impairment that affects the individual or the treatment of this
p.000006: condition10.
p.000006: • It must not be possible to conduct equally effective research with adults who have the capacity to consent.
p.000006: • The potential benefits of the project should outweigh the risks: the level of acceptable risk depends partly on the
p.000006: possible benefit to the individual.
...
p.000014: 2. Nearest relative or
p.000014: 3. Doctor primarily responsible for adult’s treatment, or another independent person nominated by healthcare provider
p.000014:
p.000014: Carer or consultee
p.000014: 1. Unpaid person with an interest in the welfare of the potential participant or
p.000014: 2. Person who is independent of project
p.000014:
p.000014: 1. Guardian or welfare attorney authorised to take decisions about the research or
p.000014: 2. Nearest relative
p.000014: What should they be asked
p.000014:
p.000014: Presumed will of participant
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014: Presumed will of participant
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014: Opinion on views and feelings of participant
p.000014:
p.000014:
p.000014:
p.000014: Their consent
p.000014: What is given?
p.000014:
p.000014:
p.000014: Informed consent
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014: Informed consent
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014: Advice as to whether participant
p.000014: would decline to take part if he or she had capacity
p.000014:
p.000014: Consent
p.000014:
p.000014: Note: Emergency recruitment to research projects has separate requirements which are summarised in section 4.3.
p.000014:
p.000014: MRC ETHICS GUIDE
p.000014: Medical research involving adults who cannot consent 2007
p.000015: 15
p.000015:
p.000015:
p.000015: 3.2.2 Loss of capacity during the course of the research
p.000015: (See separate guidance for transitional arrangements for studies already underway in England and Wales on 1 October
p.000015: 2007.)
p.000015:
p.000015: 1. Clinical Trials Regulations:
p.000015: In a clinical trial (as defined by the CT Regulations – see more details in section 4.1), consent from an adult to
p.000015: participate in a trial remains valid after loss of capacity, providing the trial is not significantly altered. It is
p.000015: good practice in such a case to consult with carers and take note of any signs of objection or distress from the
p.000015: participant.The investigator should consider withdrawing a participant if any objections are raised.
p.000015:
p.000015: 2. Mental Capacity Act:
p.000015: 1.Where it is known that a participant has lost capacity following agreement to take part in a study and further
p.000015: consent is required from all participants, for
p.000015: example for further blood sample collection, researchers should comply with the requirements of the MCA.
p.000015:
...
p.000020: order to refer to the correct section, the key questions are:
p.000020:
p.000020:
p.000020: Is this a clinical trial?
p.000020: no
p.000020: Is the research in Scotland?
p.000020: no
p.000020: Section 4.2.2
p.000020:
p.000020: yes
p.000020:
p.000020:
p.000020: yes
p.000020:
p.000020: 4.2.1
p.000020:
p.000020: 4.2.3
p.000020:
p.000020:
p.000020:
p.000020: 32 Of relevance, section (45) of the Human Tissue Act relating to DNA analysis also applies in Scotland. For further
p.000020: guidance on the use of human tissue in research, please refer to separate MRC publications.
p.000020: 33At the time of publication in October 2007, a draft Bill amending this Act was being prepared.
p.000020:
p.000020: MRC ETHICS GUIDE
p.000020: Medical research involving adults who cannot consent 2007
p.000021: 21
p.000021:
p.000021:
p.000021: 4.2.1 Clinical trials (all of the UK)
p.000021: Clinical trials that fall under the CT Regulations are defined above (section 4.1): In order to comply with the CT
p.000021: Regulations, a trial must be approved by a recognised research ethics committee (REC) and licensed by the MHRA. All
p.000021: clinical trials must comply with the Good Clinical Practice (GCP) guidelines issued by the International Conference on
p.000021: Harmonisation. In relation to adults who lack mental capacity to consent, the GCP guidelines have specific requirements
p.000021: that must be met.These are summarised here. Please note that there are separate requirements for research in emergency
p.000021: situations, which is discussed in section 4.3.
p.000021:
p.000021: Trial design
p.000021: • A clinical trial must relate directly to a life-threatening or debilitating clinical condition from which a
p.000021: potential participant suffers. (Note that this differs from the requirements for other types of research, which must be
p.000021: relevant to the condition or impairment causing the loss of capacity.) See Example F.
p.000021:
p.000021:
p.000021: Example F: clinical trials that relate directly to a participant’s condition
p.000021: 1. Researchers have designed a trial studying adults with head injury and impaired consciousness.They wish to assess
p.000021: the effects of a 48-hour infusion of corticosteroids on survival and neurological disability.
p.000021: This trial relates directly to the cause of the impaired consciousness in this group of patients.
p.000021:
p.000021: 2.A trial is underway comparing the efficacy of two different dietary plans on blood glucose control in late-onset
p.000021: diabetes. Mrs F has advanced dementia and diabetes. Her family have read about the trial and request that she be
p.000021: included.The researchers consult the REC as to whether they could approve an amendment to the protocol to allow
p.000021: incapacitated adults to be included. In this case the study (which is not a clinical trial of a medicinal product) does
...
p.000025: • The project must not significantly interfere with freedom of action or privacy.
p.000025: • The project must not be unduly invasive or restrictive.
p.000025:
p.000025:
p.000025:
p.000025: 37MCA Code of Practice 2005 at 11.14.
p.000025:
p.000025: MRC ETHICS GUIDE
p.000025: Medical research involving adults who cannot consent 2007
p.000026: 26
p.000026:
p.000026:
p.000026: The MCA Code of Practice states that “actions will not usually be classed as unduly invasive if they do not go beyond
p.000026: the experience of daily life, a routine medical examination or a psychological examination”38.
p.000026:
p.000026: 2. Consulting carers or others
p.000026: The MCA stipulates that before any decision is taken to involve a particular person in research with REC approval,
p.000026: researchers must identify a ‘consultee’ who is willing to be consulted about the person’s participation.There are two
p.000026: possible types of consultee:
p.000026: 1. If available, the researchers must consult a ‘personal consultee’.This is someone who cares for the potential
p.000026: participant or is interested in his or her welfare other than in a professional capacity or because they are paid to do
p.000026: so.The researcher must take reasonable steps to identify such a person.
p.000026: 2. If a personal consultee is not available, the researcher must consult a ‘nominated consultee’.This person must have
p.000026: no connection with the project. Researchers must include in the protocol submitted to the REC the arrangements for
p.000026: identifying and consulting with this person. In emergency circumstances, a consultee does not need to be consulted
p.000026: prior to enrolment in the study.The conditions under which this can happen are clearly defined – see section 4.3.
p.000026:
p.000026: Difficulty in finding a personal consultee may arise if the person most appropriate to be consulted is a paid
p.000026: carer.This could occur, for example, if the potential participant had no relatives or only distant relatives.The MCA
p.000026: specifically requires that the person consulted is not paid for the care he or she provides to the potential
p.000026: participant.The consultee may hold power of attorney39 for the patient
p.000026: or be a court-appointed deputy, so long as this is in a personal (not professional or paid) capacity – for instance, a
p.000026: participant’s solicitor would be excluded from being a personal consultee.
p.000026:
p.000026: The MRC recommends that it is good practice to involve any paid carers who are close to the participant in the
p.000026: decision-making process – even if the decision has to be taken by an independent nominee.
p.000026:
p.000026: It is important that personal nominees appreciate that this is a voluntary role and that they are not under any
p.000026: pressure to agree to fill this position if they do not wish to do so.This should be made clear by the researchers.
p.000026:
p.000026:
p.000026:
p.000026: 38MCA Code of Practice at 11.19.
p.000026: 39The MCA 2005 allows an adult to assign power of attorney to another person prior to loss of capacity; the power
p.000026: assigned may extend to financial affairs and/or personal welfare.
p.000026:
p.000026: MRC ETHICS GUIDE
...
p.000029: • Objectives, design, methodology, statistical considerations and organisation of the research.
p.000029: • Relevance of the research and study design.
p.000029: • Justification of predictable risks and inconveniences weighed against the anticipated benefits for research
p.000029: participants and future participants.
p.000029: • Suitability of the lead researcher.
p.000029: • Adequacy of the written information and procedures for obtaining consent.
p.000029: • Arrangements for recruitment of participants.
p.000029:
p.000029:
p.000029:
p.000029:
p.000029:
p.000029:
p.000029:
p.000029:
p.000029:
p.000029:
p.000029: 43The Adults With Incapacity (Ethics Committee) (Scotland) Regulations 2002 No. 190.
p.000029:
p.000029: MRC ETHICS GUIDE
p.000029: Medical research involving adults who cannot consent 2007
p.000030: 30
p.000030:
p.000030:
p.000030: 4.2.4 Other research (Northern Ireland)
p.000030: As at October 2007, the recommendations from a review of mental health legislation in Northern Ireland were being
p.000030: considered. Further guidance relating to this region will be issued once available. At present, there is no specific
p.000030: legislation applicable to research involving adults who lack capacity.All research must be approved by an ethics
p.000030: committee and must comply with common law principles.
p.000030:
p.000030: 4.3 Requirements for research in emergency situations
p.000030: Specific allowance is made for research in emergency situations when it may not be possible to consult as required by
p.000030: the various laws.These allowances apply to research which fulfils the other requirements of the relevant legislation
p.000030: but
p.000030: where it is not possible to obtain the consent or agreement of a consultee before participation in a clinical trial or
p.000030: other study begins.This exception can only be relied upon until it is possible to consult or seek consent in the normal
p.000030: manner.
p.000030:
p.000030: 4.3.1 Clinical trials in emergency situations (all of UK)
p.000030: The CT Regulations were amended in 200644 to allow patients to be recruited into trials in emergency situations.This is
p.000030: now possible if:
p.000030: • Treatment is being given or is about to be given to a person who lacks capacity and
p.000030: • Due to the nature of the clinical trial and the particular circumstances, it is necessary to take action for the
p.000030: purposes of the trial but
p.000030: • It is not practical to meet the conditions required for consultation and
p.000030: • The ethics review committee has approved the procedure for such recruitment.
p.000030:
p.000030: When designing such a study researchers should consider the arrangements that will be made. In the information provided
p.000030: to the REC it should be explained why it is necessary to include participants in the trial before consent can be sought
p.000030: from a legal representative.The researchers should also document what steps will be taken to obtain appropriate consent
p.000030: once a participant has been recruited and how they will address refusal of such consent.Two examples (H and I) are
p.000030: provided below.
p.000030:
p.000030:
p.000030:
p.000030:
p.000030:
p.000030:
p.000030:
p.000030:
p.000030:
p.000030: 44The Medicines for Human Use (Clinical Trials) Amendment (no.2) Regulations 2006. SI 2006 No. 2984.
p.000030:
p.000030: MRC ETHICS GUIDE
p.000030: Medical research involving adults who cannot consent 2007
p.000031: 31
p.000031:
p.000031:
p.000031: Examples of clinical trials requiring immediate recruitment
...
p.000031: I. A multicentre clinical trial is being set up to compare the effectiveness of two antiepileptic drugs in pregnant
p.000031: women with eclampsia. Many
p.000031: of these patients will be temporarily unable to consent due to their medical condition.They may be unaccompanied when
p.000031: they arrive at hospital and/or have an eclamptic fit.When designing the protocol, the researchers addressed the various
p.000031: possibilities for obtaining consent. This included discussing the trial with women at particular risk of eclampsia and
p.000031: obtaining consent prior to the condition occurring. Careful communication was important, as it can be difficult to
p.000031: identify which women may actually develop eclampsia – the researchers did not wish to unnecessarily alarm women who
p.000031: would not then require therapy.They also considered how consent would be obtained if a woman was enrolled in the study
p.000031: before she had consented, and decided that this could be through a relative before the woman regained capacity, or from
p.000031: the participant herself when she regained capacity.
p.000031:
p.000031: 4.3.2 Other research in emergency situations (England and Wales) The MCA allows patients to be recruited into research
p.000031: studies in an emergency without consultation with a relative or carer. However, recruitment in an emergency can only
p.000031: occur if treatment needs to be given to the patient as a matter of urgency and enrolment into the research also has to
p.000031: be done as a matter of urgency. If
p.000031: there is not time to consult, as described in section 4.2, the researcher should have agreement from a registered
p.000031: doctor who is independent of the project. If this is also impractical, recruitment into the study may occur if it is
p.000031: done in accordance with a protocol already agreed by an ethics committee. See Example J.
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031: 45European Journal of Clinical Investigation. 2005 May;35(5):315-23.
p.000031:
p.000031: MRC ETHICS GUIDE
p.000031: Medical research involving adults who cannot consent 2007
p.000032: 32
p.000032:
p.000032:
p.000032: Example J: Research in an emergencyXsituation
p.000032: A research study is proposed to examine the changes in certain inflammatory markers in acute trauma patients who are
p.000032: unconscious on admission to hospital.The study involves taking initial blood and urine samples on admission to
p.000032: intensive care and regular samples thereafter. When such patients are admitted there will often not be a relative
p.000032: immediately available with whom to discuss the study.The samples would be taken from intravenous lines inserted to
p.000032: manage the patients’ clinical condition. In the protocol the researchers propose that, where available, a consultant
p.000032: anaesthetist unconnected with the study will be consulted about inclusion of each patient.Where this is not possible,
p.000032: for instance at
p.000032: nights or weekends, the patients will be enrolled into the study and baseline and further blood tests and data
p.000032: collected. However, as soon as a relative or unpaid carer is available they will be consulted about the continued
p.000032: participation of the patient in the study. If and when the patient regains consciousness the research project will be
p.000032: fully explained and they will be able to choose whether their data should remain in the study cohort.The approved this
p.000032: protocol.
p.000032:
p.000032:
p.000032: 4.3.4 Other research in emergency situations (Scotland)
p.000032: At this time there is no provision for recruitment into non-clinical research in an emergency without the consultative
p.000032: steps described in section 4.3.This means that such research cannot be lawfully carried out in Scotland at present. If
p.000032: researchers believe that this may affect a study they are considering, they should seek further advice from the MRC or
p.000032: the Scotland A REC.
p.000032:
p.000032: 4.3.5 Data Protection Act 1998 and research in emergency situations (all of UK)
p.000032: It has been established46 that data may be processed for research in emergency situations involving incapacitated
p.000032: adults providing information about this work is given to them on recovery of capacity. At this point they may refuse to
p.000032: participate in the research, including refusal to allow further processing of data already collected. This makes the
p.000032: use of data for research purposes in this situation acceptable in relation to the Data Protection Act. Any research
p.000032: must always also comply with any other legal requirements such as the MCA,AWIS or CT Regulations.
p.000032:
p.000032:
p.000032:
p.000032: 46Time to get our Acts together. Reid CL and Menon DK. BMJ: 355; 415.
p.000032:
p.000032: MRC ETHICS GUIDE
p.000032: Medical research involving adults who cannot consent 2007
p.000033: 33
p.000033:
p.000033: Glossary
p.000033:
p.000033: AWIS Adults with Incapacity (Scotland) Act 2000
p.000033: CT Regulations Medicines for Human Use (Clinical Trials) Regulations 2004
p.000033: HTA Human Tissue Authority
p.000033: HTAct Human Tissue Act 2004
p.000033: ICH GCP International Conference on Harmonisation: Good
p.000033: Clinical Practice
p.000033: MCA Mental Capacity Act 2005
p.000033: MHRA Medicines and Healthcare products Regulatory Agency
p.000033: NRES National Research Ethics Service (formerly COREC)
...
General/Other / declaration of helsinki
Searching for indicator helsinki:
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p.000004: is conducted in a legally and ethically acceptable manner. It
p.000004: is also intended to give confidence to researchers that adults with incapacity can be included in their studies so
p.000004: that, when appropriate, they will make the opportunity available, in accordance with the required and recommended
p.000004: safeguards described here.
p.000004:
p.000004:
p.000004: 1Adults with Incapacity Act 2000.
p.000004: 2Mental Capacity Act 2005.
p.000004: 3Medicines for Human Use (Clinical Trials) Regulations 2004. SI 2004 1031 (as amended).
p.000004: 4MRC Ethics Guide: Research involving children, 2004.
p.000004: 5The Ethical Conduct of Research in the Mentally Incapacitated. MRC 1991.
p.000004:
p.000004: MRC ETHICS GUIDE
p.000004: Medical research involving adults who cannot consent 2007
p.000005: 5
p.000005:
p.000005: 2. Ethical principles
p.000005:
p.000005: 2.1 General principles
p.000005: As with any research, the need to respect the interests of an individual participant is more important than any
p.000005: potential benefits of the research to others6,7.
p.000005:
p.000005: All medical research studies, including those involving adults who lack mental capacity, should comply with accepted
p.000005: principles of good practice, including the Declaration of Helsinki and relevant European and UK legislation. In
p.000005: accordance with section 13 of the Declaration, the research protocol should be submitted to and approved by an
p.000005: independent research ethics committee (REC). Under UK
p.000005: legislation relating to research involving adults who lack the capacity to consent, this REC approval is a legal
p.000005: requirement8. Detailed guidance on applying for approval is available from the National Research Ethics Service9.
p.000005:
p.000005: 2.2 Specific principles
p.000005: Individuals unable to consent to participation in a research project due to a lack of mental capacity are a
p.000005: particularly vulnerable group.Their interests must therefore be protected.They should be given the same opportunities
p.000005: to participate in ethically designed research projects as those who do not lack capacity but must not be put at
p.000005: unwarranted risk.Their participation needs to be agreed by someone who is independent of the study and who can assess
p.000005: the potential participant’s interests in accordance with current legislation and guidance.This person may be a
p.000005: relative, a carer or an independent representative.
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005: 6Declaration of Helsinki, 2000: www.wma.net/e/policy/b3.htm.
p.000005: 7Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology
p.000005: and Medicine: Convention on Human Rights and Biomedicine Oviedo, 4.IV.1997 Chapter 1 article 2.
p.000005: 8Excluding, at present, Northern Ireland.
p.000005: 9National Research Ethics Service: www.nres.npsa.nhs.uk/applicants/help/guidance.htm#awi.
p.000005:
p.000005: MRC ETHICS GUIDE
p.000005: Medical research involving adults who cannot consent 2007
p.000006: 6
p.000006:
p.000006:
p.000006: If possible, the proposed study should also be discussed or communicated with the person themselves in a way
p.000006: appropriate to their understanding. In an emergency setting, consultation with the representative or participant may
p.000006: not be immediately possible but should occur as soon as practical. (There is more information about emergency
p.000006: situations in section 4.3).
p.000006:
p.000006: Someone who lacks the mental capacity to consent to take part in research should not take part in a study if he or she
p.000006: does not seem in agreement with any intervention or part of the study, even if agreement has been given by another
p.000006: person. If this happens, researchers are expected to inform the individual’s independant representative that the
...
p.000033: Clinical Practice
p.000033: MCA Mental Capacity Act 2005
p.000033: MHRA Medicines and Healthcare products Regulatory Agency
p.000033: NRES National Research Ethics Service (formerly COREC)
p.000033: REC Research Ethics Committee
p.000033:
p.000033:
p.000033: MRC ETHICS GUIDE
p.000033: Medical research involving adults who cannot consent 2007
p.000034: 34
p.000034:
p.000034: Further Reading
p.000034:
p.000034: Mental Capacity Act Code of Practice:
p.000034: www.opsi.gov.uk/acts/acts2005/related/ukpgacop_20050009_en.pdf
p.000034:
p.000034: Department of Health (England) guidance: www.dh.gov.uk/en/Policyandguidance/Healthandsocialcaretopics/
p.000034: Socialcare/IMCA/MentalCapacityAct2005/index.htm
p.000034:
p.000034: National Research Ethics Service guidance:
p.000034: www.nres.npsa.nhs.uk/applicants/help/guidance.htm#awi
p.000034:
p.000034: Full text of Mental Capacity Act 2005:
p.000034: www.opsi.gov.uk/acts/acts2005/50009--b.htm#30
p.000034:
p.000034: Full text of Adults with Incapacity (Scotland) Act 2000:
p.000034: www.opsi.gov.uk/legislation/scotland/acts2000/20000004.htm
p.000034:
p.000034: Full text of Medicines for Human Use (Clinical Trial) Regulations 2004:
p.000034: www.opsi.gov.uk/si/si2004/20041031.htm
p.000034:
p.000034: Declaration of Helsinki:
p.000034: www.wma.net/e/policy/b3.htm
p.000034: (at the time of publication the World Medical Association was consulting on a revision of the Declaration)
p.000034:
p.000034: This MRC guidance is based upon the previous 1992 guidance and updated in October 2007 in light of subsequent
p.000034: legislation.
p.000034:
p.000034: Comments or questions should be addressed to Dr Catherine Elliott at: MRC Head Office
p.000034: 20 Park Crescent London
p.000034: W1B 1AL
p.000034: Email: catherine.elliott@headoffice.mrc.ac.uk
p.000034:
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General/Other / oviedo
Searching for indicator oviedo:
(return to top)
p.000005: requirement8. Detailed guidance on applying for approval is available from the National Research Ethics Service9.
p.000005:
p.000005: 2.2 Specific principles
p.000005: Individuals unable to consent to participation in a research project due to a lack of mental capacity are a
p.000005: particularly vulnerable group.Their interests must therefore be protected.They should be given the same opportunities
p.000005: to participate in ethically designed research projects as those who do not lack capacity but must not be put at
p.000005: unwarranted risk.Their participation needs to be agreed by someone who is independent of the study and who can assess
p.000005: the potential participant’s interests in accordance with current legislation and guidance.This person may be a
p.000005: relative, a carer or an independent representative.
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005: 6Declaration of Helsinki, 2000: www.wma.net/e/policy/b3.htm.
p.000005: 7Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology
p.000005: and Medicine: Convention on Human Rights and Biomedicine Oviedo, 4.IV.1997 Chapter 1 article 2.
p.000005: 8Excluding, at present, Northern Ireland.
p.000005: 9National Research Ethics Service: www.nres.npsa.nhs.uk/applicants/help/guidance.htm#awi.
p.000005:
p.000005: MRC ETHICS GUIDE
p.000005: Medical research involving adults who cannot consent 2007
p.000006: 6
p.000006:
p.000006:
p.000006: If possible, the proposed study should also be discussed or communicated with the person themselves in a way
p.000006: appropriate to their understanding. In an emergency setting, consultation with the representative or participant may
p.000006: not be immediately possible but should occur as soon as practical. (There is more information about emergency
p.000006: situations in section 4.3).
p.000006:
p.000006: Someone who lacks the mental capacity to consent to take part in research should not take part in a study if he or she
p.000006: does not seem in agreement with any intervention or part of the study, even if agreement has been given by another
p.000006: person. If this happens, researchers are expected to inform the individual’s independant representative that the
p.000006: individual will not be taking part despite the representative’s agreement, and tell them the reasons for this decision.
p.000006:
p.000006: The risks and benefits of participation in any research must always be weighed up so that potential direct benefits
p.000006: outweigh any risks. Any potential risks must be minimised through the study design. If no direct benefit is anticipated
...
Orphaned Trigger Words
p.000013: facial expression. She seemed able to understand that the physiotherapy would benefit her and to indicate that she
p.000013: would like it.To check that she could retain the information they gave her, the researchers returned to discuss the
p.000013: project on a separate occasion and she responded in the same way.The researchers determined that she had capacity and
p.000013: discussed this with her GP who agreed.The reasons for believing she had capacity were documented in the study records.
p.000013:
p.000013: Mrs C’s daughter was her main carer. Using the same methods the researcher obtained Mrs C’s agreement to discuss the
p.000013: study with her daughter.
p.000013:
p.000013:
p.000013: 3.2.1 Giving consent on behalf of an adult who lacks capacity
p.000013: There are varying interpretations of the meaning of consent by others for an adult who cannot give their own consent to
p.000013: participate in a research study.The laws and regulations relating to medical research involving adults who lack
p.000013: capacity to consent do not use the ‘best interests’ test. Instead they set out the necessary criteria for the research
p.000013: to be legal and allow for varying degrees of consent by others. In relation to all clinical trials throughout the UK
p.000013: (and all types of medical research in Scotland), consent to the participation of an adult lacking capacity is
p.000013: given by the legal representative or relative of the participant (the hierarchy for this is described further
p.000013: below).The Clinical Trials (CT) Regulations described below specify that this consent by a legal representative
p.000013: represents the presumed will of the participant25. For research outside Scotland not covered by the CT Regulations, the
p.000013: person consulted gives agreement rather than consent (see Table 4).
p.000013:
p.000013: 25Medicines for Human Use (Clinical Trial) Regulations SI 2004 no.103sch 3 part 5 (12).
p.000013:
p.000013: MRC ETHICS GUIDE
p.000013: Medical research involving adults who cannot consent 2007
p.000014: 14
p.000014:
p.000014:
p.000014: Table 4
p.000014:
p.000014:
p.000014: Type of study
p.000014:
p.000014:
p.000014: Clinical trial in England,Wales and Northern Ireland
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014: Clinical trial in Scotland
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014: Research which is not a clinical trial (England and Wales)
p.000014:
p.000014:
p.000014:
p.000014:
p.000014: Research which is not a clinical trial (Scotland)
p.000014: Who should be asked
p.000014:
p.000014:
p.000014: Legal representative:
p.000014: 1. Relative or person independent of trial and providing care or
p.000014: 2. Doctor primarily responsible for adult’s treatment, or another independent person nominated by healthcare provider
p.000014:
p.000014: Legal representative:
p.000014: 1. Guardian or welfare attorney authorised to take decisions re research or
p.000014: 2. Nearest relative or
p.000014: 3. Doctor primarily responsible for adult’s treatment, or another independent person nominated by healthcare provider
p.000014:
p.000014: Carer or consultee
p.000014: 1. Unpaid person with an interest in the welfare of the potential participant or
p.000014: 2. Person who is independent of project
p.000014:
p.000014: 1. Guardian or welfare attorney authorised to take decisions about the research or
p.000014: 2. Nearest relative
p.000014: What should they be asked
p.000014:
p.000014: Presumed will of participant
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014: Presumed will of participant
p.000014:
...
p.000015: (See separate guidance for transitional arrangements for studies already underway in England and Wales on 1 October
p.000015: 2007.)
p.000015:
p.000015: 1. Clinical Trials Regulations:
p.000015: In a clinical trial (as defined by the CT Regulations – see more details in section 4.1), consent from an adult to
p.000015: participate in a trial remains valid after loss of capacity, providing the trial is not significantly altered. It is
p.000015: good practice in such a case to consult with carers and take note of any signs of objection or distress from the
p.000015: participant.The investigator should consider withdrawing a participant if any objections are raised.
p.000015:
p.000015: 2. Mental Capacity Act:
p.000015: 1.Where it is known that a participant has lost capacity following agreement to take part in a study and further
p.000015: consent is required from all participants, for
p.000015: example for further blood sample collection, researchers should comply with the requirements of the MCA.
p.000015:
p.000015: 2. For participants who gave consent before 31 March 2008 to take part in a study that began before October 2007, there
p.000015: are specific regulations under the MCA detailing the steps to be taken if a participant is subsequently known to have
p.000015: lost capacity26.
p.000015:
p.000015: 3. For participants and studies that do not fall under guidance for the above dates, the MCA does not specify what
p.000015: steps should be taken if capacity is lost following consent to participate in a study. If no further interventions are
p.000015: required in the study and researchers wish to keep using data or tissues, it is open to interpretation as
p.000015: to whether further consent is required. Current guidance from the Department of Health, England (DH) and the Welsh
p.000015: Assembly Government is that in this situation ‘properly informed and expressed consent’27 given prior to loss of
p.000015: capacity can be relied upon. In the absence of such consent, DH and Welsh Assembly Government guidance says that the
p.000015: requirements of the MCA must be fulfilled.This includes obtaining agreement from a personal or professional consultee
p.000015: for continued use of data or tissues in the study, as well as obtaining REC approval for this.
p.000015:
p.000015:
p.000015:
p.000015:
p.000015: 26Please see separate guidance from the MRC on these transitional arrangements.
p.000015: 27Mental Capacity Act and consent for research, Department of Health (England) and Welsh Assembly Government 2007.
p.000015:
p.000015: MRC ETHICS GUIDE
p.000015: Medical research involving adults who cannot consent 2007
p.000016: 16
p.000016:
p.000016:
p.000016: If an individual has made a decision to participate in research and subsequently loses capacity, it is expected that
p.000016: this consent would be respected in most circumstances and so use of samples or data could continue. Procedures should
p.000016: be in place in any study to ensure that, where necessary, participants can withdraw or be withdrawn from the study at
p.000016: any time. If the participant loses capacity, a request by a representative for withdrawal from a study should be
p.000016: considered carefully to ensure that it reflects the wishes of a participant before loss of capacity, their current
p.000016: situation and any potential benefits or harm that could arise from continued participation in the research study.
p.000016:
p.000016: When designing studies, researchers should consider the risk of participants losing capacity during the course of a
p.000016: study and, where appropriate, should discuss this possibility with them.The consent form should include an option to
...
p.000021: It would therefore not be possible for the REC to approve this amendment. However, if it were a clinical trial
p.000021: comparing oral and subcutaneous insulin Mrs F’s participation could be approved.This is because the study would then be
p.000021: a clinical trial of a medicinal product and would relate directly to a condition – diabetes
p.000021: – from which Mrs F suffers.
p.000021:
p.000021: MRC ETHICS GUIDE
p.000021: Medical research involving adults who cannot consent 2007
p.000022: 22
p.000022:
p.000022:
p.000022: • There must be grounds to expect that administering the medicinal product to be tested in the trial will produce a
p.000022: benefit to the participant that outweighs the risks (or will result in no risk at all).
p.000022:
p.000022: • The clinical trial is essential to validate data obtained:
p.000022: • in other clinical trials involving participants who are able to give informed consent, or
p.000022: • by other research methods.
p.000022:
p.000022: • No incentives or financial inducements may be given to a participant or their legal representative, except provision
p.000022: for compensation in the event of injury or loss34.
p.000022:
p.000022: Consent by legal representative
p.000022: • Consent by a legal representative is required if consent to participate was not
p.000022: given prior to the loss of capacity.
p.000022:
p.000022: • If the proposed study participant refused consent to participate before the loss of capacity, he or she cannot be
p.000022: included in the trial.
p.000022:
p.000022: • In England,Wales and Northern Ireland the legal representative is:
p.000022: • A person independent of the trial, who by virtue of their relationship with the potential study participant is
p.000022: suitable to act as their legal representative for the purposes of that trial, and who is available and willing to so
p.000022: act for those purposes. Or if there is no such person:
p.000022: • A person independent of the trial, who is the doctor primarily responsible for the medical treatment provided to that
p.000022: adult.
p.000022: • Or a person nominated by the relevant healthcare provider.
p.000022:
p.000022: • In Scotland the legal representative is:
p.000022: • The guardian or welfare attorney (this is a person appointed to deal with matters of personal welfare by an
p.000022: individual prior to his or her loss of capacity). Or, if one has not been appointed:
p.000022: • The nearest relative.
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022: 34MRC policy is that, as in other research, payment of legitimate expenses of participants or representatives directly
p.000022: related to participation in the trial is generally considered acceptable.
p.000022:
p.000022: MRC ETHICS GUIDE
p.000022: Medical research involving adults who cannot consent 2007
p.000023: 23
p.000023:
p.000023:
p.000023: Or, if that person is not available:
p.000023: • The doctor responsible for the medical treatment of the patient if they are independent of the study, or a person
p.000023: nominated by the healthcare provider.
p.000023:
p.000023: • The legal representative should have an interview with a member of the investigating team, during which the
p.000023: following should be discussed or made available to them:
p.000023: • Objectives, risks and inconveniences of the trial and the conditions under which it is to be carried out.
p.000023: • Contact details for further information.
p.000023: • Their right to withdraw the participant from the trial at any time without detriment.
p.000023:
p.000023: • After such discussions, the legal representative may give their ‘informed consent’ for the person to participate in
p.000023: the clinical trial. In relation to clinical trials, this consent is taken by the CT Regulations to represent the
p.000023: ‘presumed will’ of the participant.
p.000023:
p.000023: Views of the participant
p.000023: • The potential participant should receive information about the trial and its risks and benefits according to his or
...
Appendix
Indicator List
| Indicator | Vulnerability |
|---|
| access | Access to Social Goods |
| arrest | person under arrest |
| autonomy | Impaired Autonomy |
| child | Child |
| children | Child |
| disability | Mentally Disabled |
| drug | Drug Usage |
| emergency | Public Emergency |
| family | Motherhood/Family |
| hazard | Natural Hazards |
| helsinki | declaration of helsinki |
| home | Property Ownership |
| hospitalised | hospitalized patients |
| impaired | Cognitive Impairment |
| impairment | Cognitive Impairment |
| incapable | Mentally Incapacitated |
| incapacitated | Incapacitated |
| incapacity | Incapacitated |
| language | Linguistic Proficiency |
| mentally | Mentally Disabled |
| opinion | philosophical differences/differences of opinion |
| oviedo | oviedo |
| pregnant | Pregnant |
| religious | Religion |
| restricted | Incarcerated |
| trauma | Victim of Abuse |
| unconscious | Unconscious People |
| usage | Drug Usage |
| vulnerable | vulnerable |
| women | Women |
Indicator Peers (Indicators in Same Vulnerability)
| Indicator | Peers |
|---|
| child | ['children'] |
| children | ['child'] |
| disability | ['mentally'] |
| drug | ['usage'] |
| impaired | ['impairment'] |
| impairment | ['impaired'] |
| incapacitated | ['incapacity'] |
| incapacity | ['incapacitated'] |
| mentally | ['disability'] |
| usage | ['drug'] |
Trigger Words
capacity
consent
ethics
harm
protect
protection
risk
sensitive
welfare
Applicable Type / Vulnerability / Indicator Overlay for this Input