79C3C34C52B45572883A05D425EB0F82
Implementing Regulations of the Law of Ethics of Research on Living Creatures
https://prod.kau.edu.sa/Med/ali/files/Publications/Guide/National_Committe_of_BioEthics-Regulations_of_the_Law_of_Ethics_of_Research_on_Living_Creatures.pdf
http://leaux.net/URLS/ConvertAPI Text Files/6B4752478C47B30CFDE45209A85A271C.en.txt
Examining the file media/Synopses/6B4752478C47B30CFDE45209A85A271C.html:
This file was generated: 2020-12-01 07:56:06
| Indicators in focus are typically shown highlighted in yellow; |
Peer Indicators (that share the same Vulnerability association) are shown highlighted in pink; |
"Outside" Indicators (those that do NOT share the same Vulnerability association) are shown highlighted in green; |
Trigger Words/Phrases are shown highlighted in gray. |
Link to Orphaned Trigger Words (Appendix (Indicator List, Indicator Peers, Trigger Words, Type/Vulnerability/Indicator Overlay)
Applicable Type / Vulnerability / Indicator Overlay for this Input
Political / Criminal Convictions
Searching for indicator prisoners:
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p.000074: 1. A written authorization from the National Committee is obtained.
p.000074: 2. The stem cell bank can only be established in a center affiliated with a
p.000074: government agency.
p.000074: 3. It is prohibited to send any stem cells to be stored outside the Kingdom.
p.000074: 4. Stem cells stored in stem cell banks for therapeutic purposes may not be used for research purposes
p.000074: without the permission of the local committee and the stem cells’ owner’s consent;
p.000074: 5. An accurate and strict mechanism shall be set up to safeguard all
p.000074: information and data with the utmost safety and confidentiality.
p.000074: 6. Each sample shall be given a permanent identification label specifying its ownership. Information included in
p.000074: said label shall be updated by the principal investigator under the supervision of the local committee.
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p.000076: Chapter Nine: Research on Inmates
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p.000076: Article 24
p.000076: Prisoners, including those sentenced to death, shall be treated like other persons as regards conducting
p.000076: medical research on them. The Regulations shall specify ethical controls for conducting research on prisoners.
p.000076:
p.000076: Article (24.1)
p.000076: When serving as subjects in medical research, inmates, even if sentenced to death, shall not be treated
p.000076: differently. Their confinement may not be exploited to compel them to consent to be research subjects.
p.000076:
p.000076: Article (24.2)
p.000076: The local committee may not approve research on inmates unless said research aims to achieve any of the
p.000076: following:
p.000076: 1. Study the criminal behavior of inmates, provided the research does not expose them to more than the minimal
p.000076: potential risk;
p.000076: 2. Study conditions of prisons and inmates as well as prevailing diseases and identify the circumstances leading to
p.000076: crime;
p.000076: 3. Study administrative rules and operational procedures applicable in prisons, so as to improve health
p.000076: and living conditions of inmates;
p.000076: 4. Inmates may not be subject to clinical research whether by coercion or
p.000076: inducement or for any purposes other than those set forth in this Article.
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Political / Illegal Activity
Searching for indicator crime:
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p.000012: representative of King Faisal Specialist Hospital and Research Center
p.000012: Member
p.000012: A representative of Human Rights Commission Member The Director of Research Ethics Monitoring
p.000012: Office Member A representative of the private sector selected by the Chairman of the Council of the
p.000012: Chambers of Commerce and Industry Member A legal counselor selected by the President of KACST
p.000012: Member
p.000012: 2. The President of KACST shall issue the committee-formation decision, and said committee shall report
p.000012: to him.
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p.000013:
p.000013: 3. The President of KACST shall appoint a secretary for the committee.
p.000013: 4. Committee members shall elect from among themselves a vice president.
p.000013:
p.000013: Article (4.1)
p.000013: 1. The President of KACST shall send a request for nomination to ministers and heads of relevant agencies
p.000013: as specified in Article 4 of the Law not less than three months before the formation or re-formation of the National
p.000013: Committee.
p.000013: 2. Each Minister or head of a relevant agency shall name a representative at the National Committee in ample
p.000013: time prior to the date set for formation of the committee, taking into consideration the following
p.000013: conditions:
p.000013: a. Be a Saudi national;
p.000013: b. Have academic qualification and experience necessary for
p.000013: contribution to committee work;
p.000013: c. Be known for integrity and competency;
p.000013: d. Not be previously convicted of a crime impinging on religion or honor.
p.000013: 3. If any member of the National Committee is unable to complete his term for any reason, or if he expresses
p.000013: his desire to discontinue his membership in the committee, or if he fails to attend three consecutive or seven
p.000013: non-consecutive meetings within the same year without an excuse acceptable to KACST President, a
p.000013: replacement shall be appointed in the same manner the replaced member was appointed to serve the remainder of his
p.000013: term.
p.000013: 4. Committee membership shall be a renewable term of three years, provided half the members are replaced
p.000013: upon committee re-formation
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p.000014: for the third time. Membership may not be renewed for more than three consecutive terms.
p.000014:
p.000014: Article (4.2)
p.000014: 1. The National Committee shall have a chairman in accordance with the Law. Said chairman shall have a deputy to be
p.000014: elected by members of the National Committee by secret ballot in the second committee meeting. The President of KACST
p.000014: shall be notified of the ballot result.
p.000014: 2. The Chairman of the National Committee shall oversee its activities and all its administrative, financial and
p.000014: technical matters, particularly the following:
p.000014: a. Call for National Committee meetings and approve meeting agendas;
p.000014: b. Preside over and manage National Committee meetings;
p.000014: c. Ensure that National Committee decisions and recommendations are properly reported and pursue implementation
p.000014: thereof;
p.000014: d. Submit National Committee budget to KACST President;
p.000014: e. Represent the National Committee before governmental, judicial
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p.000076: Chapter Nine: Research on Inmates
p.000076:
p.000076: Article 24
p.000076: Prisoners, including those sentenced to death, shall be treated like other persons as regards conducting
p.000076: medical research on them. The Regulations shall specify ethical controls for conducting research on prisoners.
p.000076:
p.000076: Article (24.1)
p.000076: When serving as subjects in medical research, inmates, even if sentenced to death, shall not be treated
p.000076: differently. Their confinement may not be exploited to compel them to consent to be research subjects.
p.000076:
p.000076: Article (24.2)
p.000076: The local committee may not approve research on inmates unless said research aims to achieve any of the
p.000076: following:
p.000076: 1. Study the criminal behavior of inmates, provided the research does not expose them to more than the minimal
p.000076: potential risk;
p.000076: 2. Study conditions of prisons and inmates as well as prevailing diseases and identify the circumstances leading to
p.000076: crime;
p.000076: 3. Study administrative rules and operational procedures applicable in prisons, so as to improve health
p.000076: and living conditions of inmates;
p.000076: 4. Inmates may not be subject to clinical research whether by coercion or
p.000076: inducement or for any purposes other than those set forth in this Article.
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p.000078:
p.000078: Chapter Ten: Research on Special Cases
p.000078:
p.000078: Article 25
p.000078: Research may not be conducted on minors, incompetent or disabled persons unless the interest of these
p.000078: categories so requires. The Regulations shall specify ethical controls for conducting research on said
p.000078: categories.
p.000078:
p.000078: Article (25.1)
p.000078: 1. Research may not be conducted on minors, incompetent or mentally disabled persons without obtaining the
p.000078: “Informed Consent” from parents or the legal guardians in accordance with conditions set forth in the Law and
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p.000110: year after detection without taking any action.
p.000110:
p.000110: Article (42.15)
p.000110: The Violation Review Committee shall consider civil suits and notify the defendant of the date of hearing at least ten
p.000110: days in advance. The notification shall include a copy of the petition and any other documents submitted by the
p.000110: claimant; date, time and place of the hearing, summoning the defendant or his representative to appear before the
p.000110: committee and present his defense.
p.000110:
p.000110: Article (42.16)
p.000110: If the defendant or his legal representative fails to attend the first hearing, the Violation Review Committee
p.000110: shall adjourn the hearing and notify the defendant of the new hearing date. If the defendant fails to attend a
p.000110: second time, though properly notified, the Violation Review Committee
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p.000111: may proceed with the consideration of the case as if he was present. The defendant shall be deemed present if he
p.000111: attends one hearing and fails to attend the rest of the hearings.
p.000111:
p.000111: Article (42.17)
p.000111: The secretary of the Violation Review Committee shall draft the hearing minutes under the supervision of the
p.000111: hearing chairman, provided the minutes include names of attending members, place and time of the hearing, names of
p.000111: attending parties to the suit or their representatives, all hearing proceedings, as well as statements and defenses of
p.000111: parties. The minutes shall be signed by the committee chairman, members, secretary and parties to the suit or their
p.000111: representatives.
p.000111:
p.000111: Article (42.18)
p.000111: If the Violation Review Committee finds that the violation considered includes a crime punishable by other
p.000111: laws, it shall refer the criminal case to the competent agencies to take legal action, in accordance with said laws,
p.000111: and shall decide the violation under consideration unless it finds that either violation cannot be decided separately
p.000111: from the other.
p.000111:
p.000111: Article (42.19)
p.000111: Decisions of the Violation Review Committee shall be reasoned and shall include a rebuttal of all defenses raised by
p.000111: parties to the suit. A committee member (or the chairman) adopting a different opinion shall include said opinion in
p.000111: the minutes with the reasons thereof.
p.000111:
p.000111: Article (42.20)
p.000111: The Violation Review Committee secretariat shall notify the parties
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p.000112: concerned of committee resolutions by official letters delivered to them or their legal representatives,
p.000112: provided that the notification letter includes the following text: “A party against whom a committee decision has been
p.000112: issued may appeal before the Board of Grievances within sixty days from date of notification.”
p.000112:
p.000112: Article (42.21)
p.000112: Procedures of the Board of Grievances shall apply to matters not provided for in the Violation Review Committee
p.000112: Procedures.
p.000112:
p.000112: Article (42.22)
p.000112: An aggrieved party may appeal Violation Review Committee decision before the Board of Grievances within sixty
p.000112: days from date of notification thereof.
p.000112:
p.000112: Article (42.23)
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Political / criminal
Searching for indicator criminal:
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p.000052: has taken place as a direct result of the research but has not been referred to in the research proposal, it may
p.000052: take appropriate measures to stop the harm, including suspension of research project;
p.000052: 2. If the local committee finds that the investigator has not obtained required approvals, it shall suspend
p.000052: the research project and refer the matter to the Monitoring Office to submit it to the Violations Committee to decide
p.000052: appropriate penalties against the investigator.
p.000052: 3. The local committee shall notify head of the establishment of any
p.000052: research that is suspended or referred to the Monitoring Office.
p.000052:
p.000052: Article (10.32)
p.000052: The local committee may exempt the following research projects from the
p.000052: periodic follow-up:
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p.000053: 1. Research involving study of information and data previously collected,
p.000053: provided one of the two following terms is fulfilled:
p.000053: a. If the information is generally and publicly available;
p.000053: b. If the information is recorded in a manner that does not reveal the identity of the source person.
p.000053: 2. Research including educational tests, surveys, interviews or public behavior monitoring, except in the
p.000053: two following cases:
p.000053: a. If the information is recorded in a manner that reveals the identity of the source person.
p.000053: b. If participation in the research should bring a person outside the scope of research to be subject to
p.000053: criminal or civil liability or jeopardize his financial position or career.
p.000053: 3. Research conducted for educational purposes.
p.000053:
p.000053: Article (10.33)
p.000053: 1. Subject to the provisions of the following paragraph 2 hereunder, the local committee, following Standard
p.000053: procedures, shall conduct the periodic monitoring of research based on the periodic reports submitted by the
p.000053: principal investigator in accordance with the procedures it sets up in this regard.
p.000053: 2. As an exception from the provision of the preceding paragraph 1 hereabove, the local committee may
p.000053: exempt certain research projects that it has previously approved from periodic evaluation in either of the following
p.000053: cases:
p.000053: a. If the only objective of research continuation is a long-term monitoring of persons who took part
p.000053: in the research and no additional risk emerged in the research;
p.000053: b. If the research is nearly finished and only analysis of data and
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p.000054: conclusion of results are remaining.
p.000054: 3. After the periodic assessment of the research is carried out, the local committee shall issue a decision including
p.000054: its approval or rejection of continuation of the said research.
p.000054:
p.000054: Article (10.34)
p.000054: If, after the periodic assessment, the local committee disapproves of research continuation, it shall suspend the
p.000054: research project without prejudice to its right of extending the treatment period in case its sudden suspension may
p.000054: cause harm to the human subject.
p.000054:
p.000054: Article (10.35)
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p.000074: said label shall be updated by the principal investigator under the supervision of the local committee.
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p.000076:
p.000076: Chapter Nine: Research on Inmates
p.000076:
p.000076: Article 24
p.000076: Prisoners, including those sentenced to death, shall be treated like other persons as regards conducting
p.000076: medical research on them. The Regulations shall specify ethical controls for conducting research on prisoners.
p.000076:
p.000076: Article (24.1)
p.000076: When serving as subjects in medical research, inmates, even if sentenced to death, shall not be treated
p.000076: differently. Their confinement may not be exploited to compel them to consent to be research subjects.
p.000076:
p.000076: Article (24.2)
p.000076: The local committee may not approve research on inmates unless said research aims to achieve any of the
p.000076: following:
p.000076: 1. Study the criminal behavior of inmates, provided the research does not expose them to more than the minimal
p.000076: potential risk;
p.000076: 2. Study conditions of prisons and inmates as well as prevailing diseases and identify the circumstances leading to
p.000076: crime;
p.000076: 3. Study administrative rules and operational procedures applicable in prisons, so as to improve health
p.000076: and living conditions of inmates;
p.000076: 4. Inmates may not be subject to clinical research whether by coercion or
p.000076: inducement or for any purposes other than those set forth in this Article.
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p.000078: Chapter Ten: Research on Special Cases
p.000078:
p.000078: Article 25
p.000078: Research may not be conducted on minors, incompetent or disabled persons unless the interest of these
p.000078: categories so requires. The Regulations shall specify ethical controls for conducting research on said
p.000078: categories.
p.000078:
p.000078: Article (25.1)
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p.000110:
p.000110: Article (42.15)
p.000110: The Violation Review Committee shall consider civil suits and notify the defendant of the date of hearing at least ten
p.000110: days in advance. The notification shall include a copy of the petition and any other documents submitted by the
p.000110: claimant; date, time and place of the hearing, summoning the defendant or his representative to appear before the
p.000110: committee and present his defense.
p.000110:
p.000110: Article (42.16)
p.000110: If the defendant or his legal representative fails to attend the first hearing, the Violation Review Committee
p.000110: shall adjourn the hearing and notify the defendant of the new hearing date. If the defendant fails to attend a
p.000110: second time, though properly notified, the Violation Review Committee
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p.000111:
p.000111: may proceed with the consideration of the case as if he was present. The defendant shall be deemed present if he
p.000111: attends one hearing and fails to attend the rest of the hearings.
p.000111:
p.000111: Article (42.17)
p.000111: The secretary of the Violation Review Committee shall draft the hearing minutes under the supervision of the
p.000111: hearing chairman, provided the minutes include names of attending members, place and time of the hearing, names of
p.000111: attending parties to the suit or their representatives, all hearing proceedings, as well as statements and defenses of
p.000111: parties. The minutes shall be signed by the committee chairman, members, secretary and parties to the suit or their
p.000111: representatives.
p.000111:
p.000111: Article (42.18)
p.000111: If the Violation Review Committee finds that the violation considered includes a crime punishable by other
p.000111: laws, it shall refer the criminal case to the competent agencies to take legal action, in accordance with said laws,
p.000111: and shall decide the violation under consideration unless it finds that either violation cannot be decided separately
p.000111: from the other.
p.000111:
p.000111: Article (42.19)
p.000111: Decisions of the Violation Review Committee shall be reasoned and shall include a rebuttal of all defenses raised by
p.000111: parties to the suit. A committee member (or the chairman) adopting a different opinion shall include said opinion in
p.000111: the minutes with the reasons thereof.
p.000111:
p.000111: Article (42.20)
p.000111: The Violation Review Committee secretariat shall notify the parties
p.000111:
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p.000112:
p.000112: concerned of committee resolutions by official letters delivered to them or their legal representatives,
p.000112: provided that the notification letter includes the following text: “A party against whom a committee decision has been
p.000112: issued may appeal before the Board of Grievances within sixty days from date of notification.”
p.000112:
p.000112: Article (42.21)
p.000112: Procedures of the Board of Grievances shall apply to matters not provided for in the Violation Review Committee
p.000112: Procedures.
p.000112:
p.000112: Article (42.22)
p.000112: An aggrieved party may appeal Violation Review Committee decision before the Board of Grievances within sixty
p.000112: days from date of notification thereof.
p.000112:
p.000112: Article (42.23)
p.000112: Remuneration of Violation Review Committee’s chairman and members shall be determined according to Regulations of
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Political / person in detention center
Searching for indicator detained:
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p.000006:
p.000006: Article (1.1)
p.000006: Without prejudice to the meanings of the terms and phrases specified in Article 1 of the Law, the following
p.000006: terms and phrases – wherever used in the Law – shall have the meanings assigned to them, unless otherwise required
p.000006: by context.
p.000006: Human Subject (Participant): A person who consents or whose guardian consents to conduct clinical, non-clinical or
p.000006: therapeutic research or experiments on him.
p.000006: Principal Investigator: Lead researcher in charge of planning and conducting the research,
p.000006: collecting and analyzing data, and directing interventions stated in the research plan.
p.000006: Clinical Research: Any research related to collecting and analyzing data for volunteers or patients for the purpose of
p.000006: obtaining general knowledge that can be applied to other individuals with regard to mechanism of disease, its
p.000006: incidence, prevalence, transmission or treatment of a disease.
p.000006: Non-Clinical Research: Any research related to collecting and analyzing data not directly related to people for
p.000006: the purpose of obtaining general knowledge or facts.
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p.000007: Clinical Trial: Experiments conducted on human volunteers to examine safety and effectiveness of a new medication or
p.000007: medical device.
p.000007: Prisoner: A person deprived of liberty, whether serving a prison sentence, detained on trial, or is a correction
p.000007: facility inmate.
p.000007: Vulnerable groups: Groups of individuals in need of additional protection due to their lack of legal capacity, their
p.000007: questionable or diminished capacity or their lack of freedom to choose.
p.000007: Stillborn: A fetus delivered, came out of, or removed from the uterus with no signs of life such as heartbeat, natural
p.000007: breathing, movement, or pulsation of the umbilical cord if still connected.
p.000007: Diagnostic Procedure: A test aiming at finding a certain disorder or disease
p.000007: in a living creature.
p.000007: Medication: A chemical compound administered to a living creature to help diagnose, treat, prevent, cure or
p.000007: alleviate the effects of a disease or organic disorder.
p.000007: Periodic Assessment: Observation of research progress by safety assessment and information monitoring
p.000007: committee to ascertain safety of the human subject on a continuous basis and to ensure nonexistence of any reason for
p.000007: discontinuation or modification of the research.
p.000007: Periodic Follow-up: Review of the periodic report submitted by the principal investigator to the local
p.000007: committee to evaluate research progress and conformity with the approved research plan.
p.000007: Expedited Review: An evaluation carried out by the local committee chairman, or by a committee member
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p.000007: breathing, movement, or pulsation of the umbilical cord if still connected.
p.000007: Diagnostic Procedure: A test aiming at finding a certain disorder or disease
p.000007: in a living creature.
p.000007: Medication: A chemical compound administered to a living creature to help diagnose, treat, prevent, cure or
p.000007: alleviate the effects of a disease or organic disorder.
p.000007: Periodic Assessment: Observation of research progress by safety assessment and information monitoring
p.000007: committee to ascertain safety of the human subject on a continuous basis and to ensure nonexistence of any reason for
p.000007: discontinuation or modification of the research.
p.000007: Periodic Follow-up: Review of the periodic report submitted by the principal investigator to the local
p.000007: committee to evaluate research progress and conformity with the approved research plan.
p.000007: Expedited Review: An evaluation carried out by the local committee chairman, or by a committee member
p.000007: designated by him, of a new research project or modifications of a previously approved research where potential risk to
p.000007: the human subject does not exceed minimal risk.
p.000007: Genetic Therapy Research: Any research which includes insertion or deletion of genetic material within body
p.000007: cells or targeting the same whether
p.000008: 8
p.000008:
p.000008: by modification or deactivation for finding a treatment for hereditary or
p.000008: other diseases.
p.000008: Confidentiality: Non-disclosure or passing of any data, information or results related to the research or the
p.000008: human subject, to any third party not connected with the research.
p.000008: Privacy: Observing common values, including traditions, thoughts and norms.
p.000008: Safety Assessment and Information Monitoring Committee: A group of scientists, physicians, and statisticians
p.000008: independent from researchers, whose task is to review accumulated data during clinical experiments for prompt
p.000008: analysis and to observe any significant likelihood towards a certain trend in the results or unacceptable side effects
p.000008: requiring a recommendation for suspension of research or modification of its plan.
p.000008: Genes: Molecular units of heredity data in all living organisms that encode the information required for building and
p.000008: preserving cells and performing all vital functions, and hence building bodies of Living Creatures and giving
p.000008: them their characteristic features.
p.000008: Major Harm: Any harm leading to a participant’s death, jeopardy to his life, hospitalization beyond expectation,
p.000008: permanent disability, or deformation of fetus. This harm is deemed unexpected if not stated in the “informed consent.”
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p.000009: 9
p.000009:
p.000009: General Provisions
p.000009:
p.000009: Article (1.2)
p.000009: Scope of Application
p.000009: 1. The provisions of the Law and its Regulations shall apply to any research establishment conducting
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p.000035: submitted by researchers in vicinity of the establishment upon agreement with the researcher, if there is no local
p.000035: committee in the establishment where these researchers are affiliated, provided the absence of a local committee is not
p.000035: the result of an administrative negligence to establish such a committee.
p.000035: 6. In the case of researchers from multiple establishments participating in a joint project, it is not
p.000035: necessary to obtain approval of the local committee of every center participating in the research
p.000035: project. One of the local registered committees shall in this case review the project, and the principal investigator
p.000035: must be from the establishment where the local committee which approves the project, and monitors it.
p.000035:
p.000035: Article (10.6)
p.000035: Committee membership shall be terminated for any of the following reasons:
p.000035:
p.000036: 36
p.000036:
p.000036: 1. Resignation;
p.000036: 2. Death;
p.000036: 3. Chronic illness that prevents a member from attending local committee meetings;
p.000036: 4. If any member fails to attend three consecutive or five non-consecutive meetings within the same year without an
p.000036: excuse acceptable to the local committee chairman;
p.000036: 5. Expiration and non-renewal of term of membership;
p.000036: 6. If a member is proved to have violated his commitment to keep information confidential and the
p.000036: committee chairman has issued a decision to this effect based on proven facts.
p.000036:
p.000036: Article (10.7)
p.000036: If the membership of any local committee member is terminated for any reason, committee chairman shall instantly
p.000036: address the concerned party to appoint a replacement to fill in the remainder of said member’s term, and shall notify
p.000036: the Monitoring Office thereof.
p.000036:
p.000036: Article (10.8)
p.000036: If the local committee chairman finds that one committee member does not effectively take part in committee activities
p.000036: or that he has not appropriately accomplished the duties assigned to him, he may notify the concerned party
p.000036: thereof and suggest whatever action he deems fit, including dismissal of said member and appointment of a replacement.
p.000036:
p.000036: Article (10.9)
p.000036: 1. The local committee shall convene upon a call by its chairman whenever required;
p.000036:
p.000037: 37
p.000037:
p.000037: 2. Local committee meeting shall not be valid unless attended by the
p.000037: majority of its members including the chairman or his designee;
p.000037: 3. If the quorum is not reached within half an hour of the designated date of the meeting, the meeting chairman shall
p.000037: adjourn the meeting to be held within fifteen days thereafter;
p.000037: 4. Invitations for the meeting shall be delivered by hand or sent via ordinary mail or e-mail at least ten
p.000037: work days before convention date. The meeting agenda and all papers and documents related to topics proposed
p.000037: for discussion shall be attached to the invitations;
p.000037: 5. Local committee secretary shall record the meeting minutes, and attending members and committee
p.000037: secretary shall sign the minutes directly after the meeting or in the next meeting.
p.000037:
p.000037: Article (10.10)
p.000037: If a local committee member finds that he or any other member has any sort of direct or indirect interest related to
p.000037: any topic proposed for discussion by the committee, said member shall disclose such interest at the beginning of the
p.000037: meeting. In that case, the committee chairman shall ask the member who has declared such interest to withdraw from the
p.000037: meeting during discussion of related topic and shall record this action in the meeting minutes.
p.000037:
p.000037: Article (10.11)
p.000037: 1. The local committee may invite experts and consultants to attend its meetings whenever a proposed item on the
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p.000037: (vulnerable groups), the committee chairman shall invite a specialist with experience in this field to take
p.000038: 38
p.000038:
p.000038: part in discussing said subject. Said specialist shall have the right to take part in discussion and in voting. If said
p.000038: specialist fails to attend the meeting, it shall be required to obtain a specialist’s written opinion of the matter.
p.000038: 3. If it deems it necessary, the local committee may invite the principal investigator to attend one of its meetings,
p.000038: provided he does not attend the meeting during which the final decision on the research project is made.
p.000038:
p.000038: Article (10.12)
p.000038: 1. Local committee resolutions shall pass by simple majority vote of attending members. In case of a tie,
p.000038: the meeting chairman shall have the casting vote.
p.000038: 2. Local committee chairman shall determine the voting method in committee meetings.
p.000038: 3. Issued resolution shall be printed on local committee or establishment official stationary, and shall include
p.000038: a clear statement of resolution text. Committee chairman shall notify the principal investigator of said resolution
p.000038: in writing.
p.000038: 4. In case the research application is rejected, the resolution shall state the reasons for rejection.
p.000038: 5. Local committee may issue non-binding recommendations, if necessary,
p.000038: and attach them to rejection resolution.
p.000038: 6. Local committee may issue a conditional approval, and the resolution shall determine the necessary procedure to
p.000038: reconsider the application and any requirements or suggestions for reassessment.
p.000038: 7. An aggrieved party may appeal local committee resolutions of rejection
p.000038: or provisional approval before local committee. If the local committee
p.000038:
p.000039: 39
p.000039:
p.000039: dismisses the complaint as unconvincing, the aggrieved party may have
p.000039: recourse to the Monitoring Office to review the matter.
p.000039:
p.000039: Article (10.13)
p.000039: The principal investigator, whether he belongs to the establishment or not, shall submit the research approval to the
p.000039: local committee, including the research proposal. Upon setting of research proposal, the researcher shall observe the
p.000039: following:
p.000039: 1. Design of study shall be appropriate to its objectives;
p.000039: 2. Expected benefits and possible harms to which the human subject may be subject shall be in balance;
p.000039: 3. Research location shall be appropriate to the assistant group, including available potentials and emergency
p.000039: measures.
p.000039:
p.000039: Article (10.14)
p.000039: The research proposal shall comprise the following:
p.000039: 1. An abstract of the research within one page (Size: A4);
p.000039: 2. Research objectives;
p.000039: 3. Statistical methodology, including sample size calculations, taking into account possibility of obtaining
p.000039: statistically significant results by using the minimum number of research subjects;
p.000039: 4. Rationale for introducing any procedure, tool or device that has not been used before;
p.000039: 5. Rationale for using any substances that could be dangerous or harmful to the human subject or his surroundings and
p.000039: methods of disposal of said substances after research is completed;
p.000039: 6. Plan for dealing with risky cases;
p.000039: 7. Plan for disposal of extra biological samples;
p.000039:
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p.000040:
p.000040: 8. A clear description of duties and responsibilities of research team;
p.000040: 9. Time schedule of research and criteria of research suspension or termination;
p.000040: 10. Case registration forms, daily cards, and questionnaires set for research
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p.000043:
p.000044: 44
p.000044:
p.000044: 8. Ensuring that sufficient measures are taken to protect privacy of the human subject and maintain
p.000044: confidentiality of data.
p.000044: 9. In the case of clinical research involving testing drugs or equipment on humans, the authorization of the Saudi
p.000044: Food and Drug Authority must be obtained according to observed laws and regulations.
p.000044: 10. Every clinical research project must be registered first with the Saudi Food and Drug Authority before
p.000044: human subjects are invited to participate.
p.000044: 11. The Saudi Food and Drug Authority clinical studies database must be
p.000044: checked first to avoid conducting duplicate research.
p.000044:
p.000044: Article (10.18)
p.000044: The local committee may approve certain research by using the expedited review procedure in the following cases:
p.000044: 1. If the risk that the human subject may be exposed to does not exceed
p.000044: the minimal risk level;
p.000044: 2. If the research does not reveal the identity of the human subject;
p.000044: 3. If the research deals with clinical studies on drugs or medical equipment, provided:
p.000044: a. The drug is used in accordance with its licensing and dosages approved by the concerned party, and does
p.000044: not entail any increase in potential risk for the human subject;
p.000044: b. The medical equipment in use has originally been licensed by the concerned party and has already been utilized
p.000044: accordingly.
p.000044: 4. If taking biological samples for research purposes is carried out via non-invasive methods such as
p.000044: analysis of urine, saliva, nail or hair clippings, etc.
p.000044: 5. If research data is to be collected by using medical equipment approved
p.000044:
p.000045: 45
p.000045:
p.000045: by the concerned party, such as:
p.000045: a. Sensors which are directly applied on body surface or at a close distance thereto and which do not expose the
p.000045: body to a significant amount of energy and do not violate the privacy of the human subject;
p.000045: b. Weight taking or audiometry devices;
p.000045: c. Magnetic resonance imaging (MRI) or ultrasonography imaging devices;
p.000045: d. Electrography (ECG & EEG), Thermal Imaging, normal nuclear radiation rate measuring,
p.000045: infra-red imaging, blood flow measurement with ultrasound imaging (Doppler sonography), and echocardiography
p.000045: devices;
p.000045: e. Moderate exercise, muscle strength, body ratios (such as body fat ratio) and measurement of joint and
p.000045: muscle flexibility devices, provided these tests are deemed appropriate after taking age, weight and health condition
p.000045: into account;
p.000045: f. Search for information, records or samples that were previously collected or will be collected in the
p.000045: future for non-research purposes;
p.000045: g. Collect information via audio or video taping (static or moving) for the purpose of looking for the attributes or
p.000045: behavior of an individual or group without violation of privacy of the human subject.
p.000045: However, excepted from these devices is the use of X-ray or electromagnetic microwavedevices.
p.000045:
p.000045: Article (10.19)
p.000045: 1. Approval by expedited review shall be issued by local committee chairman or by one or more members
p.000045: selected by committee chairman for their experience.
p.000045:
p.000046: 46
p.000046:
p.000046: 2. In case of expedited review, the research evaluator shall have all the powers given to the local committee except
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p.000064:
p.000064: Chapter Eight: Research on Humans
p.000064:
p.000064: Article 15
p.000064: Research conducted on humans shall be for clear scientific objectives, and shall be preceded by sufficient laboratory
p.000064: experiments on animals if the nature of the research so requires.
p.000064:
p.000064: Article (15.1)
p.000064: 1. Each research proposal shall be subject to the approval of the local
p.000064: committee;
p.000064: 2. The local committee shall verify the scientific objectives of the research
p.000064: proposal;
p.000064: 3. The researcher shall obtain the “Informed Consent” from the human
p.000064: subject according to the provisions of the Law and Regulations.
p.000064:
p.000064: Article (15.2)
p.000064: Prior to conducting clinical research on humans, the following shall be observed:
p.000064: 1. The investigator shall clearly and accurately specify his objectives and
p.000064: methodology;
p.000064: 2. The research shall be preceded by sufficient experiments on animals if
p.000064: the nature of the research so requires.
p.000064: 3. Potential risks shall not be greater than expected benefits.
p.000064:
p.000064: Article (15.3)
p.000064: Unprecedented experimental surgeries and medical research shall be consistent with controls and criteria
p.000064: set forth in laws and regulations applicable in the Kingdom as well as the relevant agreements to which the
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p.000065:
p.000065: Kingdom is party.
p.000065:
p.000065: Article (15.4)
p.000065: The investigator or research team conducting the experimental surgeries and medical research shall be specialized and
p.000065: shall have adequate scientific qualification, expertise and competence.
p.000065:
p.000065: Article 16
p.000065: The expected benefit from the experiment or research to the human subject shall be greater than the possible harm.
p.000065:
p.000065: Article (16.1)
p.000065: 1. The investigator shall evaluate the expected benefit to the human subject and the extent to which it is greater
p.000065: than the potential risk according to a scientific evaluation carried out by the researcher and submitted to the local
p.000065: committee.
p.000065: 2. If the local committee finds that the potential risk to the human subject is greater than the expected benefit, it
p.000065: must deny permission to conduct the research.
p.000065: 3. The local committee shall verify, through periodic reports submitted by the investigator, that the expected
p.000065: benefit is still greater than the potential risk.
p.000065:
p.000065: Article (16.2)
p.000065: 1. Prior to approving research on humans, the local committee shall verify that the investigator takes into
p.000065: consideration the right of human subject to normal life and safety from all types of physical and psychological harm,
p.000065: and shall not affect him wholly or partially except with his
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p.000095:
p.000095: Article (38.4)
p.000095: When reviewing research proposals involving animal and plant experiments,
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p.000096:
p.000096: the local committee must verify that the research proposal includes the following mandatory elements:
p.000096: 1. Principal investigator and research team credentials,
p.000096: 2. Animal/plant species used for the experiment, source and quantity.
p.000096: 3. Any agreements with other parties related to the experiment, or to the experiment’s results.
p.000096: 4. A detailed account of the locations where the experiment will be carried
p.000096: out to conduct field visits when necessary.
p.000096: 5. The system of identification used to distinguish the animals and plants used in the experiment, and the system
p.000096: used to save the information and data related to every animal or plant in the experiment’s records.
p.000096: 6. Emergency and hazards management plans.
p.000096: 7. Means and mechanism for the disposal of the experiment’s components.
p.000096: 8. System used to save all data and information resulting from the experiment in dedicated databases.
p.000096: 9. The authorizations of relevant authorities when needed.
p.000096:
p.000096: Article (38.5)
p.000096: When reviewing research proposals resulting in pain and suffering of animals, the local committee must
p.000096: thoroughly assess the proposal, and confirm that:
p.000096: 1. The experiment is not prohibited or restricted by international or regional conventions or rulings where
p.000096: the Kingdom of Saudi Arabia is a party or a signatory.
p.000096: 2. There are no other possible alternatives to achieve the same required results.
p.000096: 3. The research team is fully competent and qualified, and the tools , materials and laboratory
p.000096: environment of the experiment are perfectly adequate.
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p.000097:
p.000097: Article (38.6)
p.000097: The research protocol shall take all measures necessary to prevent animal suffering, using the minimum number of
p.000097: research animals which have a low level of neurological or physiological sensation.
p.000097:
p.000097: Article (38.7)
p.000097: Artificial hybridization may not be conducted except between animals of the same species, even if breeds are different,
p.000097: provided that the expected benefit outweighs the risks and that such risks can be prevented or controlled.
p.000097:
p.000097: Article (38.8)
p.000097: Animals may not be cloned unless medically proven safe as per a medical report approved by at least two specialists.
p.000097:
p.000097: Article (38.9)
p.000097: Transplant of animal fetuses shall be subject to the same conditions governing the process of artificial
p.000097: insemination set forth in Article (38.7).
p.000097:
p.000097: Article (38.10)
p.000097: Banks for preserving animal sperms or eggs for production or research purposes may be established,
p.000097: without prejudice to rules of artificial insemination.
p.000097:
p.000097: Article (38.11)
p.000097: Research and experiments causing pain to animals may not be conducted
p.000097: unless the following two conditions are satisfied:
p.000097: 1. The investigator is well versed in physiology, and the research or
p.000097: experiment is beneficial to science, such as leading to the discovery
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p.000111: hearing chairman, provided the minutes include names of attending members, place and time of the hearing, names of
p.000111: attending parties to the suit or their representatives, all hearing proceedings, as well as statements and defenses of
p.000111: parties. The minutes shall be signed by the committee chairman, members, secretary and parties to the suit or their
p.000111: representatives.
p.000111:
p.000111: Article (42.18)
p.000111: If the Violation Review Committee finds that the violation considered includes a crime punishable by other
p.000111: laws, it shall refer the criminal case to the competent agencies to take legal action, in accordance with said laws,
p.000111: and shall decide the violation under consideration unless it finds that either violation cannot be decided separately
p.000111: from the other.
p.000111:
p.000111: Article (42.19)
p.000111: Decisions of the Violation Review Committee shall be reasoned and shall include a rebuttal of all defenses raised by
p.000111: parties to the suit. A committee member (or the chairman) adopting a different opinion shall include said opinion in
p.000111: the minutes with the reasons thereof.
p.000111:
p.000111: Article (42.20)
p.000111: The Violation Review Committee secretariat shall notify the parties
p.000111:
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p.000112:
p.000112: concerned of committee resolutions by official letters delivered to them or their legal representatives,
p.000112: provided that the notification letter includes the following text: “A party against whom a committee decision has been
p.000112: issued may appeal before the Board of Grievances within sixty days from date of notification.”
p.000112:
p.000112: Article (42.21)
p.000112: Procedures of the Board of Grievances shall apply to matters not provided for in the Violation Review Committee
p.000112: Procedures.
p.000112:
p.000112: Article (42.22)
p.000112: An aggrieved party may appeal Violation Review Committee decision before the Board of Grievances within sixty
p.000112: days from date of notification thereof.
p.000112:
p.000112: Article (42.23)
p.000112: Remuneration of Violation Review Committee’s chairman and members shall be determined according to Regulations of
p.000112: Joint Governmental Committees and their Work Procedures issued pursuant to Civil Service Council Decision No.
p.000112: (1/1270) dated 21/11/1428 H approved by wired High Order under No. (3759/MB) dated 12/6/1432 H.
p.000112:
p.000112: Article 43
p.000112: Public prosecution before the committee shall be carried out by competent personnel designated by
p.000112: KACST President.
p.000112:
p.000112: Article (43.1)
p.000112: One or more public prosecution representatives shall be appointed pursuant
p.000112:
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p.000113:
p.000113: to a decision by KACST President to file suit and litigate before the
p.000113: Violation Review Committee against violators of the Law and Regulations.
p.000113:
p.000113: Article (43.2)
p.000113: Based upon the contents of the violation detection report, the public prosecution representative shall
p.000113: file the public suit before the Violation Review Committee.
p.000113:
p.000113: Article (43.3)
p.000113: The Violation Review Committee shall consider the suit without delay, and if it is necessary to consider
p.000113: the suit in more than one hearing, the committee shall notify the parties concerned of the date, time and
p.000113: location ofeachhearing.
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p.000115:
p.000115: Article (44.4)
p.000115: The National Committee may impose a fine not exceeding two hundred thousand (200,000) riyals on the researcher,
p.000115: the institution, or both if violation is established.
p.000115:
p.000115: Article (44.5)
p.000115: If the National Committee finds that the violation committed requires imprisonment, it shall take Article
p.000115: (45.1) into consideration.
p.000115:
p.000115: Article 45
p.000115: If the committee decides to impose a penalty including imprisonment, a recommendation to this effect shall be submitted
p.000115: to KACST President for referral to the competent court.
p.000115:
p.000115: Article (45.1)
p.000115: The Committee shall recommend an imprisonment term appropriate to the violation committed and state reasons for not
p.000115: imposing a lesser penalty.
p.000115:
p.000115: Article 46
p.000115: The committee may include in the final penalty decision publication of the decision text at the expense of the violator
p.000115: in not more than three local newspapers, one of which at least is published in the region where he resides. If no such
p.000115: newspaper is published in the region, the decision shall be published in the newspaper published in the nearest region.
p.000115:
p.000115: Article (46.1)
p.000115: A copy of the decision shall be delivered in person or through registered mail to the person against whom the penalty
p.000115: decision was issued.
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p.000116:
p.000116: Article (46.2)
p.000116: If it is decided to publish the violation text in newspapers, it shall be noted that the researcher deliberately
p.000116: committed the violation or insisted on committing it.
p.000116:
p.000116: Article 47
p.000116: An aggrieved party may appeal the penalty decision before the Board of Grievances within sixty days from date of
p.000116: notification.
p.000116:
p.000116: Article (47.1)
p.000116: Provisions of Article (42.22) of these Regulations shall be taken into
p.000116: consideration.
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p.000118:
p.000118: Chapter Fifteen: Concluding Provisions
p.000118:
p.000118: Article 48
p.000118: KACST President shall issue the Implementing Regulations of this Law within ninety days from date of
p.000118: publication of this Law.
p.000118:
p.000118: Article (48.1)
p.000118: These Regulations shall be published in the Official Gazette, and shall enter
p.000118: into force as of its publication date.
p.000118:
p.000118: Article (48.2)
p.000118: No amendments to these Regulations may be made except in the same manner they were issued.
p.000118:
p.000118: Article 49 This law shall
...
Political / vulnerable
Searching for indicator vulnerable:
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p.000006:
p.000006: Article (1.1)
p.000006: Without prejudice to the meanings of the terms and phrases specified in Article 1 of the Law, the following
p.000006: terms and phrases – wherever used in the Law – shall have the meanings assigned to them, unless otherwise required
p.000006: by context.
p.000006: Human Subject (Participant): A person who consents or whose guardian consents to conduct clinical, non-clinical or
p.000006: therapeutic research or experiments on him.
p.000006: Principal Investigator: Lead researcher in charge of planning and conducting the research,
p.000006: collecting and analyzing data, and directing interventions stated in the research plan.
p.000006: Clinical Research: Any research related to collecting and analyzing data for volunteers or patients for the purpose of
p.000006: obtaining general knowledge that can be applied to other individuals with regard to mechanism of disease, its
p.000006: incidence, prevalence, transmission or treatment of a disease.
p.000006: Non-Clinical Research: Any research related to collecting and analyzing data not directly related to people for
p.000006: the purpose of obtaining general knowledge or facts.
p.000006:
p.000007: 7
p.000007:
p.000007: Clinical Trial: Experiments conducted on human volunteers to examine safety and effectiveness of a new medication or
p.000007: medical device.
p.000007: Prisoner: A person deprived of liberty, whether serving a prison sentence, detained on trial, or is a correction
p.000007: facility inmate.
p.000007: Vulnerable groups: Groups of individuals in need of additional protection due to their lack of legal capacity, their
p.000007: questionable or diminished capacity or their lack of freedom to choose.
p.000007: Stillborn: A fetus delivered, came out of, or removed from the uterus with no signs of life such as heartbeat, natural
p.000007: breathing, movement, or pulsation of the umbilical cord if still connected.
p.000007: Diagnostic Procedure: A test aiming at finding a certain disorder or disease
p.000007: in a living creature.
p.000007: Medication: A chemical compound administered to a living creature to help diagnose, treat, prevent, cure or
p.000007: alleviate the effects of a disease or organic disorder.
p.000007: Periodic Assessment: Observation of research progress by safety assessment and information monitoring
p.000007: committee to ascertain safety of the human subject on a continuous basis and to ensure nonexistence of any reason for
p.000007: discontinuation or modification of the research.
p.000007: Periodic Follow-up: Review of the periodic report submitted by the principal investigator to the local
p.000007: committee to evaluate research progress and conformity with the approved research plan.
p.000007: Expedited Review: An evaluation carried out by the local committee chairman, or by a committee member
p.000007: designated by him, of a new research project or modifications of a previously approved research where potential risk to
...
p.000034: components and documents, and present the same to the committee chairman;
p.000034: 2. Prepare agendas and minutes of committee meetings;
p.000034: 3. Coordinate local committee activities and communications with researchers and with the
p.000034: National Committee;
p.000034: 4. Archive copies of committee meeting minutes, including names of attending members, decisions issued,
p.000034: results of voting on such decisions, and a summary of the discussions taking place during every meeting;
p.000034: 5. Prepare letters of notification of committee decisions and
p.000034: recommendations to be signed by the committee chairman;
p.000034: 6. Any other work-related tasks assigned to him by the committee or its chairman;
p.000034: 7. Maintain confidentiality of information he is privy to and not disclose
p.000034: any information in the research or research ideas and proposals.
p.000034:
p.000034: Article (10.5)
p.000034: The local committee shall seek to achieve the following:
p.000034:
p.000035: 35
p.000035:
p.000035: 1. Protect the human subject of the research, as well as protect and ensure the human subject’s rights and safety;
p.000035: 2. Verify compliance with all requested and documented procedures in the research project regarding the treatment of
p.000035: human subject participants and biological materials.
p.000035: 3. Provide necessary equipment and ensure that such equipment is
p.000035: adequate for the safety of the human subject participants.
p.000035: 4. Ensure especially that minors, legally incompetent or disabled persons, or any other persons from (vulnerable
p.000035: groups) are never abused under any circumstance.
p.000035: 5. The local committee will review the research project requests submitted by researchers associated with the
p.000035: establishment where the committee is affiliated. It also has the right to review the research project requests
p.000035: submitted by researchers in vicinity of the establishment upon agreement with the researcher, if there is no local
p.000035: committee in the establishment where these researchers are affiliated, provided the absence of a local committee is not
p.000035: the result of an administrative negligence to establish such a committee.
p.000035: 6. In the case of researchers from multiple establishments participating in a joint project, it is not
p.000035: necessary to obtain approval of the local committee of every center participating in the research
p.000035: project. One of the local registered committees shall in this case review the project, and the principal investigator
p.000035: must be from the establishment where the local committee which approves the project, and monitors it.
p.000035:
p.000035: Article (10.6)
p.000035: Committee membership shall be terminated for any of the following reasons:
p.000035:
p.000036: 36
p.000036:
p.000036: 1. Resignation;
p.000036: 2. Death;
p.000036: 3. Chronic illness that prevents a member from attending local committee meetings;
p.000036: 4. If any member fails to attend three consecutive or five non-consecutive meetings within the same year without an
p.000036: excuse acceptable to the local committee chairman;
p.000036: 5. Expiration and non-renewal of term of membership;
p.000036: 6. If a member is proved to have violated his commitment to keep information confidential and the
...
p.000037: 37
p.000037:
p.000037: 2. Local committee meeting shall not be valid unless attended by the
p.000037: majority of its members including the chairman or his designee;
p.000037: 3. If the quorum is not reached within half an hour of the designated date of the meeting, the meeting chairman shall
p.000037: adjourn the meeting to be held within fifteen days thereafter;
p.000037: 4. Invitations for the meeting shall be delivered by hand or sent via ordinary mail or e-mail at least ten
p.000037: work days before convention date. The meeting agenda and all papers and documents related to topics proposed
p.000037: for discussion shall be attached to the invitations;
p.000037: 5. Local committee secretary shall record the meeting minutes, and attending members and committee
p.000037: secretary shall sign the minutes directly after the meeting or in the next meeting.
p.000037:
p.000037: Article (10.10)
p.000037: If a local committee member finds that he or any other member has any sort of direct or indirect interest related to
p.000037: any topic proposed for discussion by the committee, said member shall disclose such interest at the beginning of the
p.000037: meeting. In that case, the committee chairman shall ask the member who has declared such interest to withdraw from the
p.000037: meeting during discussion of related topic and shall record this action in the meeting minutes.
p.000037:
p.000037: Article (10.11)
p.000037: 1. The local committee may invite experts and consultants to attend its meetings whenever a proposed item on the
p.000037: committee meeting agenda requires so. These expert guests do not have the right to vote.
p.000037: 2. If the research subject proposed for discussion by the local committee is related to any category of the
p.000037: (vulnerable groups), the committee chairman shall invite a specialist with experience in this field to take
p.000038: 38
p.000038:
p.000038: part in discussing said subject. Said specialist shall have the right to take part in discussion and in voting. If said
p.000038: specialist fails to attend the meeting, it shall be required to obtain a specialist’s written opinion of the matter.
p.000038: 3. If it deems it necessary, the local committee may invite the principal investigator to attend one of its meetings,
p.000038: provided he does not attend the meeting during which the final decision on the research project is made.
p.000038:
p.000038: Article (10.12)
p.000038: 1. Local committee resolutions shall pass by simple majority vote of attending members. In case of a tie,
p.000038: the meeting chairman shall have the casting vote.
p.000038: 2. Local committee chairman shall determine the voting method in committee meetings.
p.000038: 3. Issued resolution shall be printed on local committee or establishment official stationary, and shall include
p.000038: a clear statement of resolution text. Committee chairman shall notify the principal investigator of said resolution
p.000038: in writing.
p.000038: 4. In case the research application is rejected, the resolution shall state the reasons for rejection.
p.000038: 5. Local committee may issue non-binding recommendations, if necessary,
p.000038: and attach them to rejection resolution.
p.000038: 6. Local committee may issue a conditional approval, and the resolution shall determine the necessary procedure to
p.000038: reconsider the application and any requirements or suggestions for reassessment.
p.000038: 7. An aggrieved party may appeal local committee resolutions of rejection
...
p.000042: b. Date and number of research project;
p.000042: c. Name of principal investigator and co- investigators;
p.000042: d. Date of resolution.
p.000042: e. Signature of local committee chairman or authorized person and date of signature.
p.000042:
p.000043: 43
p.000043:
p.000043: 10. The following documents shall be attached to the decision: Research forms with their appended documents including
p.000043: Informed Consent (the resolution number must be put on the Informed Consent form).
p.000043:
p.000043: Article (10.17)
p.000043: Before consenting to conduct a research project, the local committee shall confirm the following:
p.000043: 1. The research does not violate Sharia rules or laws or regulations observed in the Kingdom;
p.000043: 2. Potential risk for the human subject is reduced to the minimum level
p.000043: through the following:
p.000043: a. Adopting standard operating procedures and scientific methods for research design which do not expose research
p.000043: human subjects to risks;
p.000043: b. Adopting standard and established procedures for therapeutic or diagnostic purposes as much as
p.000043: possible.
p.000043: 3. Evaluating benefits and risks that might ensue from the research;
p.000043: 4. Ensuring that research subjects have been selected based on their understanding of research
p.000043: objectives, place, time and method of conducting research, with special additional attention in the cases in which
p.000043: the participation of persons requiring additional protection is requested, such as (vulnerable groups)
p.000043: 5. Ensuring that the “Informed Consent” of the human subject contains all
p.000043: the required elements;
p.000043: 6. Ensuring that the research plan includes a periodic monitoring of results
p.000043: to maintain safety of the human subject;
p.000043: 7. Ensuring that the research plan includes management measures to
p.000043: protect the human subject and the human subject’s rights;
p.000043:
p.000044: 44
p.000044:
p.000044: 8. Ensuring that sufficient measures are taken to protect privacy of the human subject and maintain
p.000044: confidentiality of data.
p.000044: 9. In the case of clinical research involving testing drugs or equipment on humans, the authorization of the Saudi
p.000044: Food and Drug Authority must be obtained according to observed laws and regulations.
p.000044: 10. Every clinical research project must be registered first with the Saudi Food and Drug Authority before
p.000044: human subjects are invited to participate.
p.000044: 11. The Saudi Food and Drug Authority clinical studies database must be
p.000044: checked first to avoid conducting duplicate research.
p.000044:
p.000044: Article (10.18)
p.000044: The local committee may approve certain research by using the expedited review procedure in the following cases:
...
p.000045: into account;
p.000045: f. Search for information, records or samples that were previously collected or will be collected in the
p.000045: future for non-research purposes;
p.000045: g. Collect information via audio or video taping (static or moving) for the purpose of looking for the attributes or
p.000045: behavior of an individual or group without violation of privacy of the human subject.
p.000045: However, excepted from these devices is the use of X-ray or electromagnetic microwavedevices.
p.000045:
p.000045: Article (10.19)
p.000045: 1. Approval by expedited review shall be issued by local committee chairman or by one or more members
p.000045: selected by committee chairman for their experience.
p.000045:
p.000046: 46
p.000046:
p.000046: 2. In case of expedited review, the research evaluator shall have all the powers given to the local committee except
p.000046: for rejection of research, which shall be within the jurisdiction of the local committee alone. If the
p.000046: evaluator decides to reject the research, he shall refer it to the committee for reviewing it according to the
p.000046: provisions of this Law and its Regulations.
p.000046: 3. In case approval of research is issued by using expedited review, the committee chairman shall notify all
p.000046: committee members of the research projects that he has approved via whatever notification means he deems appropriate.
p.000046:
p.000046: Article (10.20)
p.000046: The local committee chairman has the authority to approve any amendment of the research previously approved by using
p.000046: expedited review. Exceptions include interviews and surveys conducted on any of the (vulnerable groups), amendment of
p.000046: research project or approval form, which shall be within the jurisdiction of the local committee.
p.000046:
p.000046: Article (10.21)
p.000046: Applications for approval using the expedited review procedure shall observe the terms and requirements
p.000046: stipulated in the basic elements of the Informed Consent in accordance with the provisions set forth in Chapter 5 of
p.000046: the Regulations.
p.000046:
p.000046: Article (10.22)
p.000046: The expedited review procedure may not be used for approving research if
p.000046: the objectives of such research include the following:
p.000046: 1. Addition of a new medication;
p.000046:
p.000047: 47
p.000047:
p.000047: 2. Addition of new medical equipment;
p.000047: 3. Addition of a new invasive or interventional procedure;
p.000047: 4. Increase or decrease of a medication dose, which may lead to increased harms;
p.000047: 5. The research is conducted to identify new potential risks.
p.000047:
p.000047: Article (10.23)
p.000047: 1. If the principal investigator wishes to amend the research proposal approved by the local committee,
p.000047: he shall submit the matter to the local committee to obtain its approval prior to proceeding with the
p.000047: amendment.
p.000047: 2. The following may be exempted from local committee review:
p.000047: a. Amendment of advertising material used for inviting human subjects, provided said amendment does not
p.000047: disrupt the content of such material;
p.000047: b. Amendments that only include providing administrative support to the study;
p.000047: c. Enrolling samples or cases brought from outside the establishment with the same terms.
p.000047: 3. In all cases, the principal investigator shall furnish the local committee with a detailed report on the amendment
...
Health / Drug Usage
Searching for indicator drug:
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p.000012: 12
p.000012:
p.000012: Chapter Three: National Committee of Bioethics
p.000012:
p.000012: Article 4
p.000012: 1. A national committee of bioethics shall be formed at KACST comprising specialists nominated by the
p.000012: competent minister or head of an agency for a renewable term of 3 years, as follows:
p.000012: A representative of KACST Chairman A representative of the
p.000012: Ministry of National Guard Member A representative of the Ministry of Defense
p.000012: Member
p.000012: A representative of the Ministry of Interior Member A representative of the General
p.000012: Presidency of Religious Research and Ifta
p.000012: Member
p.000012: Two representatives from the Ministry of Higher Education (Universities)
p.000012: Members
p.000012: A representative of the Ministry of Health Member
p.000012: A representative of the Ministry of Education Member
p.000012: A representative of the Ministry of Agriculture Member A representative of the Saudi Wildlife
p.000012: Commission Member A representative of the Food and Drug General Authority Member A
p.000012: representative of King Faisal Specialist Hospital and Research Center
p.000012: Member
p.000012: A representative of Human Rights Commission Member The Director of Research Ethics Monitoring
p.000012: Office Member A representative of the private sector selected by the Chairman of the Council of the
p.000012: Chambers of Commerce and Industry Member A legal counselor selected by the President of KACST
p.000012: Member
p.000012: 2. The President of KACST shall issue the committee-formation decision, and said committee shall report
p.000012: to him.
p.000013: 13
p.000013:
p.000013: 3. The President of KACST shall appoint a secretary for the committee.
p.000013: 4. Committee members shall elect from among themselves a vice president.
p.000013:
p.000013: Article (4.1)
p.000013: 1. The President of KACST shall send a request for nomination to ministers and heads of relevant agencies
p.000013: as specified in Article 4 of the Law not less than three months before the formation or re-formation of the National
p.000013: Committee.
p.000013: 2. Each Minister or head of a relevant agency shall name a representative at the National Committee in ample
p.000013: time prior to the date set for formation of the committee, taking into consideration the following
p.000013: conditions:
p.000013: a. Be a Saudi national;
p.000013: b. Have academic qualification and experience necessary for
p.000013: contribution to committee work;
p.000013: c. Be known for integrity and competency;
...
p.000043: through the following:
p.000043: a. Adopting standard operating procedures and scientific methods for research design which do not expose research
p.000043: human subjects to risks;
p.000043: b. Adopting standard and established procedures for therapeutic or diagnostic purposes as much as
p.000043: possible.
p.000043: 3. Evaluating benefits and risks that might ensue from the research;
p.000043: 4. Ensuring that research subjects have been selected based on their understanding of research
p.000043: objectives, place, time and method of conducting research, with special additional attention in the cases in which
p.000043: the participation of persons requiring additional protection is requested, such as (vulnerable groups)
p.000043: 5. Ensuring that the “Informed Consent” of the human subject contains all
p.000043: the required elements;
p.000043: 6. Ensuring that the research plan includes a periodic monitoring of results
p.000043: to maintain safety of the human subject;
p.000043: 7. Ensuring that the research plan includes management measures to
p.000043: protect the human subject and the human subject’s rights;
p.000043:
p.000044: 44
p.000044:
p.000044: 8. Ensuring that sufficient measures are taken to protect privacy of the human subject and maintain
p.000044: confidentiality of data.
p.000044: 9. In the case of clinical research involving testing drugs or equipment on humans, the authorization of the Saudi
p.000044: Food and Drug Authority must be obtained according to observed laws and regulations.
p.000044: 10. Every clinical research project must be registered first with the Saudi Food and Drug Authority before
p.000044: human subjects are invited to participate.
p.000044: 11. The Saudi Food and Drug Authority clinical studies database must be
p.000044: checked first to avoid conducting duplicate research.
p.000044:
p.000044: Article (10.18)
p.000044: The local committee may approve certain research by using the expedited review procedure in the following cases:
p.000044: 1. If the risk that the human subject may be exposed to does not exceed
p.000044: the minimal risk level;
p.000044: 2. If the research does not reveal the identity of the human subject;
p.000044: 3. If the research deals with clinical studies on drugs or medical equipment, provided:
p.000044: a. The drug is used in accordance with its licensing and dosages approved by the concerned party, and does
p.000044: not entail any increase in potential risk for the human subject;
p.000044: b. The medical equipment in use has originally been licensed by the concerned party and has already been utilized
p.000044: accordingly.
p.000044: 4. If taking biological samples for research purposes is carried out via non-invasive methods such as
p.000044: analysis of urine, saliva, nail or hair clippings, etc.
p.000044: 5. If research data is to be collected by using medical equipment approved
p.000044:
p.000045: 45
p.000045:
p.000045: by the concerned party, such as:
p.000045: a. Sensors which are directly applied on body surface or at a close distance thereto and which do not expose the
p.000045: body to a significant amount of energy and do not violate the privacy of the human subject;
p.000045: b. Weight taking or audiometry devices;
p.000045: c. Magnetic resonance imaging (MRI) or ultrasonography imaging devices;
p.000045: d. Electrography (ECG & EEG), Thermal Imaging, normal nuclear radiation rate measuring,
p.000045: infra-red imaging, blood flow measurement with ultrasound imaging (Doppler sonography), and echocardiography
p.000045: devices;
p.000045: e. Moderate exercise, muscle strength, body ratios (such as body fat ratio) and measurement of joint and
p.000045: muscle flexibility devices, provided these tests are deemed appropriate after taking age, weight and health condition
p.000045: into account;
...
p.000072: c. It is pledged in writing not to use these induced pluripotent stem cells on humans.
p.000072: 8. Embryonic cells and derivatives can be imported only from the sources permitted by these regulations, once
p.000072: the authorization of the local committee is obtained. Commercially available induced pluripotent stem cells
p.000072: can also be imported from scientifically recognized sources.
p.000072:
p.000072: Article (23.2)
p.000072: It is prohibited to import the following stem cells:
p.000072: 1. Stem cells obtained from the insemination using a donor ovum and a donor sperm, performed to extract stem cells.
p.000072: 2. Stem cells obtained from deliberately aborted fetuses.
p.000072:
p.000073: 73
p.000073:
p.000073: Article (23.3)
p.000073: Cells can be used in clinical research (therapeutic research) under the following conditions:
p.000073: 1. A written authorization is obtained from the local research ethics committee.
p.000073: 2. A “Informed Consent” form is obtained from the human subject participant before the research
p.000073: project is initiated.
p.000073: 3. A written authorization is obtained from the Saudi Food and Drug Authority.
p.000073: 4. The expected benefit for the human subject and the extent to which it outweighs the possible harm shall
p.000073: be evaluated through a clear and thorough scientific assessment conducted by the investigator and submitted to
p.000073: the local committee.
p.000073: 5. The investigator or research team conducting the research shall be
p.000073: specialized and shall have sufficient scientific expertise and competence.
p.000073: 6. Research objectives shall be clearly and accurately defined, and the research is preceded by
p.000073: sufficient experiments on animals if the nature of the research so requires; subject to the discretion of the
p.000073: local committee.
p.000073: 7. If the local committee finds that the potential harm for the human subject outweighs the expected
p.000073: benefit, it must refrain from authorizing the research project.
p.000073: 8. The local committee shall review periodic reports submitted by the investigator to ensure that the
p.000073: expected benefit continues to outweigh the possible harm.
p.000073: 9. The “Informed Consent” shall be obtained from the human subject prior to conducting the research and the
p.000073: information provided shall contain a full explanation of expected benefits and potential risks of the research.
p.000074: 74
p.000074:
p.000074: 10. The investigator shall keep detailed records of the source of stem cells and the results of their use in the
...
Searching for indicator usage:
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p.000094:
p.000094: Chapter Twelve: Use of Animals and Plants in Experiments
p.000094:
p.000094: Article 38
p.000094: 1. Animals may be used for research employing all experimental or scientific means not causing unusual pain to the
p.000094: animals.
p.000094: 2. Use of animals shall be restricted to research whose objectives cannot be realized without such use.
p.000094: 3. Endangered animal species may not be subject to negative use. The Regulations shall specify ethical conditions and
p.000094: procedures for use of animals in research.
p.000094:
p.000094: Article (38.1)
p.000094: Animals may be used in scientific experiments where research objectives
p.000094: cannot be otherwise realized.
p.000094:
p.000094: Article (38.2)
p.000094: When conducting research on animals, the investigator shall comply with the following:
p.000094: 1. Sharia provisions related to humane treatment of animals.
p.000094: 2. Scientific principles and conventions governing experimental practices
p.000094: on animals.
p.000094: 3. A license must be obtained from the local committee to conduct research on animals according to the licensing
p.000094: procedures of the National Committee.
p.000094: 4. The approval of the local committee to commence the research must be obtained.
p.000094: 5. It must be verified that previous cell research was conducted before
p.000094: conducting research on animals when needed.
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p.000095:
p.000095: 6. Usage must be limited to the minimum number of animals required to
p.000095: achieve research objectives.
p.000095: 7. Potential harm to and suffering of animals must be minimized as much as possible.
p.000095: 8. Observing that the expected results and desired benefits from the research outweigh any risks and
p.000095: harms to the animal subject of the research or the environment in general;
p.000095: 9. The appropriate animal must be selected to provide credible information and results.
p.000095: 10. Practice shall be subject to appropriate and acceptable scientific and
p.000095: experimental principles.
p.000095:
p.000095: Article (38.3)
p.000095: To obtain approval to conduct research on animals, any of the following
p.000095: shall be satisfied:
p.000095: 1- To Prevent, diagnose or treat a disease or a deformity that must
p.000095: be rectified or whose effects must be removed;
p.000095: 2- To explore animal physiology;
p.000095: 3- Protection of the natural environment as well as general health of humans or animals;
p.000095: 4- Achievement of scientific advancement in biological sciences;
p.000095: 5- Contribution to forensic research;
p.000095: 6- Improvement of animal breeding methods and management;
p.000095: 7- Conduct preliminary research on pharmaceutical substances, toxins and radioactive effects.
p.000095:
p.000095: Article (38.4)
p.000095: When reviewing research proposals involving animal and plant experiments,
p.000095:
p.000096: 96
p.000096:
p.000096: the local committee must verify that the research proposal includes the following mandatory elements:
p.000096: 1. Principal investigator and research team credentials,
...
Health / Healthy People
Searching for indicator volunteers:
(return to top)
p.000006: in his physical, sensory, communicative, educational or psychological abilities to an extent that affects
p.000006: the possibility of meeting his common needs compared to his non-disabled peers.
p.000006: Child: A male or female not reaching the age of eighteen years which entails him to give an informed
p.000006: consent.
p.000006: Embryonic Stem Cells: Cells removed from the fertilized egg in its early phases; before the differentiation phase.
p.000006: Adult Stem Cells: Organically unspecialized cells that are removed from the cells of a fully developed living being.
p.000006:
p.000006: Article (1.1)
p.000006: Without prejudice to the meanings of the terms and phrases specified in Article 1 of the Law, the following
p.000006: terms and phrases – wherever used in the Law – shall have the meanings assigned to them, unless otherwise required
p.000006: by context.
p.000006: Human Subject (Participant): A person who consents or whose guardian consents to conduct clinical, non-clinical or
p.000006: therapeutic research or experiments on him.
p.000006: Principal Investigator: Lead researcher in charge of planning and conducting the research,
p.000006: collecting and analyzing data, and directing interventions stated in the research plan.
p.000006: Clinical Research: Any research related to collecting and analyzing data for volunteers or patients for the purpose of
p.000006: obtaining general knowledge that can be applied to other individuals with regard to mechanism of disease, its
p.000006: incidence, prevalence, transmission or treatment of a disease.
p.000006: Non-Clinical Research: Any research related to collecting and analyzing data not directly related to people for
p.000006: the purpose of obtaining general knowledge or facts.
p.000006:
p.000007: 7
p.000007:
p.000007: Clinical Trial: Experiments conducted on human volunteers to examine safety and effectiveness of a new medication or
p.000007: medical device.
p.000007: Prisoner: A person deprived of liberty, whether serving a prison sentence, detained on trial, or is a correction
p.000007: facility inmate.
p.000007: Vulnerable groups: Groups of individuals in need of additional protection due to their lack of legal capacity, their
p.000007: questionable or diminished capacity or their lack of freedom to choose.
p.000007: Stillborn: A fetus delivered, came out of, or removed from the uterus with no signs of life such as heartbeat, natural
p.000007: breathing, movement, or pulsation of the umbilical cord if still connected.
p.000007: Diagnostic Procedure: A test aiming at finding a certain disorder or disease
p.000007: in a living creature.
p.000007: Medication: A chemical compound administered to a living creature to help diagnose, treat, prevent, cure or
p.000007: alleviate the effects of a disease or organic disorder.
p.000007: Periodic Assessment: Observation of research progress by safety assessment and information monitoring
p.000007: committee to ascertain safety of the human subject on a continuous basis and to ensure nonexistence of any reason for
p.000007: discontinuation or modification of the research.
p.000007: Periodic Follow-up: Review of the periodic report submitted by the principal investigator to the local
...
p.000046: the Regulations.
p.000046:
p.000046: Article (10.22)
p.000046: The expedited review procedure may not be used for approving research if
p.000046: the objectives of such research include the following:
p.000046: 1. Addition of a new medication;
p.000046:
p.000047: 47
p.000047:
p.000047: 2. Addition of new medical equipment;
p.000047: 3. Addition of a new invasive or interventional procedure;
p.000047: 4. Increase or decrease of a medication dose, which may lead to increased harms;
p.000047: 5. The research is conducted to identify new potential risks.
p.000047:
p.000047: Article (10.23)
p.000047: 1. If the principal investigator wishes to amend the research proposal approved by the local committee,
p.000047: he shall submit the matter to the local committee to obtain its approval prior to proceeding with the
p.000047: amendment.
p.000047: 2. The following may be exempted from local committee review:
p.000047: a. Amendment of advertising material used for inviting human subjects, provided said amendment does not
p.000047: disrupt the content of such material;
p.000047: b. Amendments that only include providing administrative support to the study;
p.000047: c. Enrolling samples or cases brought from outside the establishment with the same terms.
p.000047: 3. In all cases, the principal investigator shall furnish the local committee with a detailed report on the amendment
p.000047: he has carried out.
p.000047:
p.000047: Article (10.24)
p.000047: 1. The principal investigator shall obtain the local committee approval of all types of advertisements
p.000047: aiming to invite people to participate as volunteers in the research project such as newspaper ads, posters,
p.000047: folders, etc. prior to distribution or publication thereof;
p.000047: 2. Any advertisement proposed by the principal investigator to invite
p.000047:
p.000048: 48
p.000048:
p.000048: persons to participate as subjects of the research shall include the
p.000048: following data:
p.000048: a. Research title;
p.000048: b. Research objective;
p.000048: c. Attributes qualifying persons targeted to be the research subjects
p.000048: (participants or volunteers);
p.000048: d. Indication of all facilities to be provided to human subject;
p.000048: e. Number of research project in the local committee and expected
p.000048: date of completion;
p.000048: f. Expected risks of the research, if any;
p.000048: g. Name and address of principal investigator or his representative, his contact numbers and his electronic
p.000048: mail address so that individuals aiming to join the research group may call him for further
p.000048: information.
p.000048:
p.000048: Article (10.25)
p.000048: If the principal investigator decides to transfer research supervision responsibility to a different
p.000048: investigator, he shall take the following measures:
p.000048: 1. Submit a written application to this effect to the local committee, including the following:
p.000048: a. A written agreement for the replacement investigator to take responsibility for the research;
p.000048: b. A written statement by the replacement investigator indicating his readiness to fulfill all commitments and
p.000048: obligations made by the principal investigator;
p.000048: c. CV of the replacement investigator;
p.000048: d. A statement indicating that all samples and medical information
p.000048:
p.000049: 49
p.000049:
p.000049: related to the research have been delivered to the replacement investigator;
p.000049: e. A statement indicating that no part of research samples or results shall be used in any future research
p.000049: unless a new approval is obtained from the local committee.
p.000049: 2. The principal investigator shall proceed with his supervision of the research until the local
p.000049: committee has reviewed the application;
p.000049: 3. The local committee shall decide the application within a period not exceeding one month from date of
...
Health / Mentally Disabled
Searching for indicator disabled:
(return to top)
p.000005: Guardian: A person having the right of legal authority over another person.
p.000005: Sperm: The product of fertilization up to forty days.
p.000005: Zygotes: An egg fertilized by a male sperm; from the time of fertilization until the time of division into eight cells.
p.000005: Gamete: The product of fertilization; from the end of the zygote phase until the phase of nidation where the
p.000005: zygote is implanted in the uterus. Cloning: The process of producing a complete individual genetically
p.000005: identical to another without sexual intercourse.
p.000005: Product of Pregnancy: A fetus that comes out of or removed from the uterus. Experimental Animals: Animals raised in
p.000005: cages or at certain places to be used in scientific experiments.
p.000005: Minimal Risk: Minor harm not exceeding potential risk encountered in daily life, which cannot be avoided during
p.000005: ordinary clinical or psychological examination, including potential discomfort and inconvenience.
p.000005: Legally Incompetent: A person lacking full legal capacity due to being a minor, lacking the ability of sound reasoning
p.000005: and judgment or being subject of a court ruling placing him under custody or continuation thereof which bars him from
p.000005: entering into a legal relation on his own.
p.000005: Disabled: A person suffering from a permanent full or partial deficiency
p.000005:
p.000006: 6
p.000006:
p.000006: in his physical, sensory, communicative, educational or psychological abilities to an extent that affects
p.000006: the possibility of meeting his common needs compared to his non-disabled peers.
p.000006: Child: A male or female not reaching the age of eighteen years which entails him to give an informed
p.000006: consent.
p.000006: Embryonic Stem Cells: Cells removed from the fertilized egg in its early phases; before the differentiation phase.
p.000006: Adult Stem Cells: Organically unspecialized cells that are removed from the cells of a fully developed living being.
p.000006:
p.000006: Article (1.1)
p.000006: Without prejudice to the meanings of the terms and phrases specified in Article 1 of the Law, the following
p.000006: terms and phrases – wherever used in the Law – shall have the meanings assigned to them, unless otherwise required
p.000006: by context.
p.000006: Human Subject (Participant): A person who consents or whose guardian consents to conduct clinical, non-clinical or
p.000006: therapeutic research or experiments on him.
p.000006: Principal Investigator: Lead researcher in charge of planning and conducting the research,
p.000006: collecting and analyzing data, and directing interventions stated in the research plan.
p.000006: Clinical Research: Any research related to collecting and analyzing data for volunteers or patients for the purpose of
p.000006: obtaining general knowledge that can be applied to other individuals with regard to mechanism of disease, its
p.000006: incidence, prevalence, transmission or treatment of a disease.
p.000006: Non-Clinical Research: Any research related to collecting and analyzing data not directly related to people for
...
p.000034: components and documents, and present the same to the committee chairman;
p.000034: 2. Prepare agendas and minutes of committee meetings;
p.000034: 3. Coordinate local committee activities and communications with researchers and with the
p.000034: National Committee;
p.000034: 4. Archive copies of committee meeting minutes, including names of attending members, decisions issued,
p.000034: results of voting on such decisions, and a summary of the discussions taking place during every meeting;
p.000034: 5. Prepare letters of notification of committee decisions and
p.000034: recommendations to be signed by the committee chairman;
p.000034: 6. Any other work-related tasks assigned to him by the committee or its chairman;
p.000034: 7. Maintain confidentiality of information he is privy to and not disclose
p.000034: any information in the research or research ideas and proposals.
p.000034:
p.000034: Article (10.5)
p.000034: The local committee shall seek to achieve the following:
p.000034:
p.000035: 35
p.000035:
p.000035: 1. Protect the human subject of the research, as well as protect and ensure the human subject’s rights and safety;
p.000035: 2. Verify compliance with all requested and documented procedures in the research project regarding the treatment of
p.000035: human subject participants and biological materials.
p.000035: 3. Provide necessary equipment and ensure that such equipment is
p.000035: adequate for the safety of the human subject participants.
p.000035: 4. Ensure especially that minors, legally incompetent or disabled persons, or any other persons from (vulnerable
p.000035: groups) are never abused under any circumstance.
p.000035: 5. The local committee will review the research project requests submitted by researchers associated with the
p.000035: establishment where the committee is affiliated. It also has the right to review the research project requests
p.000035: submitted by researchers in vicinity of the establishment upon agreement with the researcher, if there is no local
p.000035: committee in the establishment where these researchers are affiliated, provided the absence of a local committee is not
p.000035: the result of an administrative negligence to establish such a committee.
p.000035: 6. In the case of researchers from multiple establishments participating in a joint project, it is not
p.000035: necessary to obtain approval of the local committee of every center participating in the research
p.000035: project. One of the local registered committees shall in this case review the project, and the principal investigator
p.000035: must be from the establishment where the local committee which approves the project, and monitors it.
p.000035:
p.000035: Article (10.6)
p.000035: Committee membership shall be terminated for any of the following reasons:
p.000035:
p.000036: 36
p.000036:
p.000036: 1. Resignation;
p.000036: 2. Death;
p.000036: 3. Chronic illness that prevents a member from attending local committee meetings;
p.000036: 4. If any member fails to attend three consecutive or five non-consecutive meetings within the same year without an
p.000036: excuse acceptable to the local committee chairman;
p.000036: 5. Expiration and non-renewal of term of membership;
...
p.000076:
p.000076: Article (24.2)
p.000076: The local committee may not approve research on inmates unless said research aims to achieve any of the
p.000076: following:
p.000076: 1. Study the criminal behavior of inmates, provided the research does not expose them to more than the minimal
p.000076: potential risk;
p.000076: 2. Study conditions of prisons and inmates as well as prevailing diseases and identify the circumstances leading to
p.000076: crime;
p.000076: 3. Study administrative rules and operational procedures applicable in prisons, so as to improve health
p.000076: and living conditions of inmates;
p.000076: 4. Inmates may not be subject to clinical research whether by coercion or
p.000076: inducement or for any purposes other than those set forth in this Article.
p.000076:
p.000076:
p.000076:
p.000076:
p.000076:
p.000076:
p.000076:
p.000076:
p.000077: 77
p.000077:
p.000077:
p.000077:
p.000077:
p.000077:
p.000077:
p.000077:
p.000077:
p.000077:
p.000077:
p.000077:
p.000077:
p.000077:
p.000077:
p.000077:
p.000077:
p.000077:
p.000077:
p.000077:
p.000077:
p.000077:
p.000077:
p.000077:
p.000077:
p.000077:
p.000077:
p.000077:
p.000077:
p.000077:
p.000077:
p.000077:
p.000077:
p.000077:
p.000077:
p.000077:
p.000077:
p.000077:
p.000077:
p.000077:
p.000077:
p.000077:
p.000078: 78
p.000078:
p.000078: Chapter Ten: Research on Special Cases
p.000078:
p.000078: Article 25
p.000078: Research may not be conducted on minors, incompetent or disabled persons unless the interest of these
p.000078: categories so requires. The Regulations shall specify ethical controls for conducting research on said
p.000078: categories.
p.000078:
p.000078: Article (25.1)
p.000078: 1. Research may not be conducted on minors, incompetent or mentally disabled persons without obtaining the
p.000078: “Informed Consent” from parents or the legal guardians in accordance with conditions set forth in the Law and
p.000078: Regulations, provided they are informed of the level of risk and its probability as well as the person’s assent.
p.000078: 2. Either parent or the legal guardian may grant the “Informed Consent” on behalf of minors, incompetent or mentally
p.000078: disabled persons provided his decision is based on the fact that the minor, incompetent or mentally disabled person is
p.000078: subject to no harm and may benefit from the research.
p.000078: 3. After granting the “Informed Consent”, either parent or the guardian may withdraw the consent at any phase of the
p.000078: research if he finds that the research conflicts with the interests of the minor, incompetent or mentally disabled
p.000078: person or if the research deviates from the objectives upon which the consent was granted.
p.000078:
p.000078: Article (25.2)
p.000078: The local committee shall grant its approval for research on minors, incompetent or mentally disabled
p.000078: persons subject to the following conditions:
p.000078:
p.000079: 79
p.000079:
p.000079: 1. It is not possible to conduct the research on a competent person;
p.000079: 2. The interest of the minor, incompetent or mentally disabled person requires subjecting him to the
p.000079: research, provided he is not exposed to more than the minimal potential risk;
p.000079: 3. The research protocol includes clear and appropriate measures to minimize potential risk as much as
p.000079: possible;
p.000079: 4. Evaluation of potential risk and expected benefit from the research shall indicate type, nature, degree and
p.000079: possibility of risk as well as the direct benefit for the minor, incompetent or mentally disabled person subject of the
p.000079: research and for similar persons;
p.000079: 5. The research shall be conducted in a school, camp, hospital, or institution where the majority of occupants are
p.000079: incompetent or disabled, provided the research subject belongs to this category.
p.000079:
p.000079: Article (25.3)
p.000079: If the local committee finds that the research in whole or in part achieves a direct benefit for the
p.000079: minor, incompetent or mentally disabled person but that its risk exceeds the minimal expected level, it may grant
p.000079: its approval to conduct the research pursuant to the following conditions:
p.000079: 1. The potential risk shall be within acceptable levels in accordance
p.000079: with medical standards, if compared with expected benefits;
p.000079: 2. The ratio of the expected benefit shall exceed that of other methods
p.000079: available outside the scope of the research;
p.000079: 3. The research shall lead to a better understanding of an important problem that affects the minor, incompetent or
p.000079: mentally disabled person or his interest, help reduce such problem, or prevent some of its negative effects;
p.000079:
p.000080: 80
p.000080:
p.000080: 4. Obtaining the “Informed Consent” from either parent or from the legal guardian.
p.000080:
p.000080: Article (25.4)
p.000080: If the local committee finds that the research does not directly benefit the minor, incompetent or mentally disabled
p.000080: person but does not expose him to more than the minimal potential risk, it may approve the research in the following
p.000080: cases:
p.000080: 1. If he had given the “Informed Consent” when he was competent or before the disability occurred, and
p.000080: his legal guardian later gave the “Informed Consent”;
p.000080: 2. If precautionary measures taken for his protection are adequate and acceptable;
p.000080: 3. If there are sufficient reasons that make it possible to obtain significant
p.000080: information through the research for understanding the case under study.
p.000080:
p.000080: Article (25.5)
p.000080: The local committee may, prior to giving its approval of conducting research on the minor, incompetent or
p.000080: mentally disabled person, require appointing a qualified lawyer experienced to handle such case. Said lawyer shall have
p.000080: no relation with the researcher or the institution supervising and funding the research and shall observe the interest
p.000080: of the minor subject of the research, in coordination with his parents or guardian.
p.000080:
p.000080: Article (25.6)
p.000080: The physically, but not mentally, disabled person shall be treated as a normal person, in terms of his responsibility
p.000080: for giving the “Informed Consent” and his understanding of research potential risks and expected benefits.
p.000081: 81
p.000081:
p.000081: Article 26
p.000081: Pregnant women, fetuses and the product of pregnancy may not be used in research except in accordance with
p.000081: controls specified by the Regulations.
p.000081:
p.000081: Article (26.1)
p.000081: An investigator may not initiate any research on a pregnant woman unless
p.000081: the following conditions are satisfied:
p.000081: 1. Conduct appropriate studies, when possible, on animals and non- pregnant women that confirm the
p.000081: safety of methods and means of research, provided the results of such research are published in
p.000081: internationally recognized scientific journals in accordance with the provisions of the Law and
p.000081: Regulations;
p.000081: 2. The level of risk the research project poses to pregnant woman or her
p.000081: fetus does not exceed the minimum risk level;
p.000081: 3. The investigator shall not have any role in deciding how and when the pregnancy will be terminated or whether
...
p.000083:
p.000083: Article 29
p.000083: Banks for preserving reproductive male or female cells with the intent of conducting research thereon may not be
p.000083: established.
p.000083:
p.000083: Article 30
p.000083: Organs and tissues of fetuses aborted before reaching one hundred twenty days may be used in research and experiments
p.000083: in accordance with controls and conditions set forth in the Regulations.
p.000083:
p.000083: Article (30.1)
p.000083: Research may be conducted on a pre-quickening stillborn fetus, if deemed necessary by the local committee, provided the
p.000083: research project is beneficial and contributes to the progress of applied sciences.
p.000083:
p.000083: Article (30.2)
p.000083: Samples may be taken from a stillborn fetus upon obtaining approval of the local committee, provided said samples are
p.000083: legally stored at approved gene banks.
p.000083:
p.000083: Article (30.3)
p.000083: 1. Research may be conducted on products of conception if the two
p.000083: following conditions are satisfied:
p.000083:
p.000084: 84
p.000084:
p.000084: a. It is established through a medical report signed by two consultant physicians, upon medical examination of
p.000084: products of conception, that it has no chance for survival;
p.000084: b. The conditions set forth in the Law and Regulations regarding research on the minor, incompetent or
p.000084: mentally disabled person shall be applied.
p.000084: 2. Research may be conducted on products of conception if said research aims to improve fetus chances of
p.000084: survival and obtain important information that may not be otherwise obtained, unless there is additional
p.000084: risk to the products of pregnancy.
p.000084:
p.000084: Article (30.4)
p.000084: If the research is conducted on an aborted or miscarried fetus, the following controls shall be observed:
p.000084: 1. Obtain the “Informed Consent” from the woman and her husband in accordance with the provisions of the Law and
p.000084: Regulations as well as controls and procedures set by the National Committee in this regard;
p.000084: 2. The woman and her husband shall be informed of the methodology used in the research on the aborted
p.000084: or miscarried fetus and whether there is an intention to store tissues taken therefrom to be used later for
p.000084: research;
p.000084: 3. Only miscarried and lawfully aborted fetuses according to the Law of Practicing Healthcare Professions may be used
p.000084: in research.
p.000084:
p.000084:
p.000084:
p.000084:
p.000084:
p.000084:
p.000084:
p.000084:
p.000084:
p.000085: 85
p.000085:
p.000085:
p.000085:
p.000085:
p.000085:
p.000085:
p.000085:
p.000085:
p.000085:
p.000085:
p.000085:
p.000085:
p.000085:
p.000085:
p.000085:
p.000085:
p.000085:
p.000085:
p.000085:
p.000085:
p.000085:
p.000085:
p.000085:
p.000085:
p.000085:
p.000085:
p.000085:
p.000085:
p.000085:
p.000085:
...
Searching for indicator mentally:
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p.000076: potential risk;
p.000076: 2. Study conditions of prisons and inmates as well as prevailing diseases and identify the circumstances leading to
p.000076: crime;
p.000076: 3. Study administrative rules and operational procedures applicable in prisons, so as to improve health
p.000076: and living conditions of inmates;
p.000076: 4. Inmates may not be subject to clinical research whether by coercion or
p.000076: inducement or for any purposes other than those set forth in this Article.
p.000076:
p.000076:
p.000076:
p.000076:
p.000076:
p.000076:
p.000076:
p.000076:
p.000077: 77
p.000077:
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p.000077:
p.000077:
p.000077:
p.000077:
p.000077:
p.000077:
p.000077:
p.000077:
p.000078: 78
p.000078:
p.000078: Chapter Ten: Research on Special Cases
p.000078:
p.000078: Article 25
p.000078: Research may not be conducted on minors, incompetent or disabled persons unless the interest of these
p.000078: categories so requires. The Regulations shall specify ethical controls for conducting research on said
p.000078: categories.
p.000078:
p.000078: Article (25.1)
p.000078: 1. Research may not be conducted on minors, incompetent or mentally disabled persons without obtaining the
p.000078: “Informed Consent” from parents or the legal guardians in accordance with conditions set forth in the Law and
p.000078: Regulations, provided they are informed of the level of risk and its probability as well as the person’s assent.
p.000078: 2. Either parent or the legal guardian may grant the “Informed Consent” on behalf of minors, incompetent or mentally
p.000078: disabled persons provided his decision is based on the fact that the minor, incompetent or mentally disabled person is
p.000078: subject to no harm and may benefit from the research.
p.000078: 3. After granting the “Informed Consent”, either parent or the guardian may withdraw the consent at any phase of the
p.000078: research if he finds that the research conflicts with the interests of the minor, incompetent or mentally disabled
p.000078: person or if the research deviates from the objectives upon which the consent was granted.
p.000078:
p.000078: Article (25.2)
p.000078: The local committee shall grant its approval for research on minors, incompetent or mentally disabled
p.000078: persons subject to the following conditions:
p.000078:
p.000079: 79
p.000079:
p.000079: 1. It is not possible to conduct the research on a competent person;
p.000079: 2. The interest of the minor, incompetent or mentally disabled person requires subjecting him to the
p.000079: research, provided he is not exposed to more than the minimal potential risk;
p.000079: 3. The research protocol includes clear and appropriate measures to minimize potential risk as much as
p.000079: possible;
p.000079: 4. Evaluation of potential risk and expected benefit from the research shall indicate type, nature, degree and
p.000079: possibility of risk as well as the direct benefit for the minor, incompetent or mentally disabled person subject of the
p.000079: research and for similar persons;
p.000079: 5. The research shall be conducted in a school, camp, hospital, or institution where the majority of occupants are
p.000079: incompetent or disabled, provided the research subject belongs to this category.
p.000079:
p.000079: Article (25.3)
p.000079: If the local committee finds that the research in whole or in part achieves a direct benefit for the
p.000079: minor, incompetent or mentally disabled person but that its risk exceeds the minimal expected level, it may grant
p.000079: its approval to conduct the research pursuant to the following conditions:
p.000079: 1. The potential risk shall be within acceptable levels in accordance
p.000079: with medical standards, if compared with expected benefits;
p.000079: 2. The ratio of the expected benefit shall exceed that of other methods
p.000079: available outside the scope of the research;
p.000079: 3. The research shall lead to a better understanding of an important problem that affects the minor, incompetent or
p.000079: mentally disabled person or his interest, help reduce such problem, or prevent some of its negative effects;
p.000079:
p.000080: 80
p.000080:
p.000080: 4. Obtaining the “Informed Consent” from either parent or from the legal guardian.
p.000080:
p.000080: Article (25.4)
p.000080: If the local committee finds that the research does not directly benefit the minor, incompetent or mentally disabled
p.000080: person but does not expose him to more than the minimal potential risk, it may approve the research in the following
p.000080: cases:
p.000080: 1. If he had given the “Informed Consent” when he was competent or before the disability occurred, and
p.000080: his legal guardian later gave the “Informed Consent”;
p.000080: 2. If precautionary measures taken for his protection are adequate and acceptable;
p.000080: 3. If there are sufficient reasons that make it possible to obtain significant
p.000080: information through the research for understanding the case under study.
p.000080:
p.000080: Article (25.5)
p.000080: The local committee may, prior to giving its approval of conducting research on the minor, incompetent or
p.000080: mentally disabled person, require appointing a qualified lawyer experienced to handle such case. Said lawyer shall have
p.000080: no relation with the researcher or the institution supervising and funding the research and shall observe the interest
p.000080: of the minor subject of the research, in coordination with his parents or guardian.
p.000080:
p.000080: Article (25.6)
p.000080: The physically, but not mentally, disabled person shall be treated as a normal person, in terms of his responsibility
p.000080: for giving the “Informed Consent” and his understanding of research potential risks and expected benefits.
p.000081: 81
p.000081:
p.000081: Article 26
p.000081: Pregnant women, fetuses and the product of pregnancy may not be used in research except in accordance with
p.000081: controls specified by the Regulations.
p.000081:
p.000081: Article (26.1)
p.000081: An investigator may not initiate any research on a pregnant woman unless
p.000081: the following conditions are satisfied:
p.000081: 1. Conduct appropriate studies, when possible, on animals and non- pregnant women that confirm the
p.000081: safety of methods and means of research, provided the results of such research are published in
p.000081: internationally recognized scientific journals in accordance with the provisions of the Law and
p.000081: Regulations;
p.000081: 2. The level of risk the research project poses to pregnant woman or her
p.000081: fetus does not exceed the minimum risk level;
...
p.000083: the provisions of the Law and Implementing Regulations and instructions issued by the National Committee.
p.000083:
p.000083: Article 29
p.000083: Banks for preserving reproductive male or female cells with the intent of conducting research thereon may not be
p.000083: established.
p.000083:
p.000083: Article 30
p.000083: Organs and tissues of fetuses aborted before reaching one hundred twenty days may be used in research and experiments
p.000083: in accordance with controls and conditions set forth in the Regulations.
p.000083:
p.000083: Article (30.1)
p.000083: Research may be conducted on a pre-quickening stillborn fetus, if deemed necessary by the local committee, provided the
p.000083: research project is beneficial and contributes to the progress of applied sciences.
p.000083:
p.000083: Article (30.2)
p.000083: Samples may be taken from a stillborn fetus upon obtaining approval of the local committee, provided said samples are
p.000083: legally stored at approved gene banks.
p.000083:
p.000083: Article (30.3)
p.000083: 1. Research may be conducted on products of conception if the two
p.000083: following conditions are satisfied:
p.000083:
p.000084: 84
p.000084:
p.000084: a. It is established through a medical report signed by two consultant physicians, upon medical examination of
p.000084: products of conception, that it has no chance for survival;
p.000084: b. The conditions set forth in the Law and Regulations regarding research on the minor, incompetent or
p.000084: mentally disabled person shall be applied.
p.000084: 2. Research may be conducted on products of conception if said research aims to improve fetus chances of
p.000084: survival and obtain important information that may not be otherwise obtained, unless there is additional
p.000084: risk to the products of pregnancy.
p.000084:
p.000084: Article (30.4)
p.000084: If the research is conducted on an aborted or miscarried fetus, the following controls shall be observed:
p.000084: 1. Obtain the “Informed Consent” from the woman and her husband in accordance with the provisions of the Law and
p.000084: Regulations as well as controls and procedures set by the National Committee in this regard;
p.000084: 2. The woman and her husband shall be informed of the methodology used in the research on the aborted
p.000084: or miscarried fetus and whether there is an intention to store tissues taken therefrom to be used later for
p.000084: research;
p.000084: 3. Only miscarried and lawfully aborted fetuses according to the Law of Practicing Healthcare Professions may be used
p.000084: in research.
p.000084:
p.000084:
p.000084:
p.000084:
p.000084:
p.000084:
p.000084:
p.000084:
p.000084:
p.000085: 85
p.000085:
p.000085:
p.000085:
p.000085:
p.000085:
p.000085:
p.000085:
p.000085:
p.000085:
p.000085:
p.000085:
p.000085:
p.000085:
p.000085:
p.000085:
p.000085:
p.000085:
p.000085:
p.000085:
p.000085:
...
Searching for indicator disability:
(return to top)
p.000007: the human subject does not exceed minimal risk.
p.000007: Genetic Therapy Research: Any research which includes insertion or deletion of genetic material within body
p.000007: cells or targeting the same whether
p.000008: 8
p.000008:
p.000008: by modification or deactivation for finding a treatment for hereditary or
p.000008: other diseases.
p.000008: Confidentiality: Non-disclosure or passing of any data, information or results related to the research or the
p.000008: human subject, to any third party not connected with the research.
p.000008: Privacy: Observing common values, including traditions, thoughts and norms.
p.000008: Safety Assessment and Information Monitoring Committee: A group of scientists, physicians, and statisticians
p.000008: independent from researchers, whose task is to review accumulated data during clinical experiments for prompt
p.000008: analysis and to observe any significant likelihood towards a certain trend in the results or unacceptable side effects
p.000008: requiring a recommendation for suspension of research or modification of its plan.
p.000008: Genes: Molecular units of heredity data in all living organisms that encode the information required for building and
p.000008: preserving cells and performing all vital functions, and hence building bodies of Living Creatures and giving
p.000008: them their characteristic features.
p.000008: Major Harm: Any harm leading to a participant’s death, jeopardy to his life, hospitalization beyond expectation,
p.000008: permanent disability, or deformation of fetus. This harm is deemed unexpected if not stated in the “informed consent.”
p.000008:
p.000008:
p.000008:
p.000008:
p.000008:
p.000008:
p.000008:
p.000008:
p.000008:
p.000008:
p.000008:
p.000008:
p.000009: 9
p.000009:
p.000009: General Provisions
p.000009:
p.000009: Article (1.2)
p.000009: Scope of Application
p.000009: 1. The provisions of the Law and its Regulations shall apply to any research establishment conducting
p.000009: research on living creatures in the Kingdom of Saudi Arabia.
p.000009: 1. Research conducted on samples taken from within the Kingdom shall be subject to the provisions of the Law and its
p.000009: Implementing Regulations as regards taking the informed consent and sending genetic samples abroad.
p.000009:
p.000009: Article (1.3)
p.000009: Principles Governing Provisions of the Law and its Regulations
p.000009: In interpretation and application, the provisions of the Law and its Regulations shall be subject to
p.000009: Sharia provisions as adopted by official bodies in the Kingdom, laws and controls set by the National Committee,
p.000009: and principles of human rights, without prejudice to provisions of Sharia.
p.000009:
p.000009: Article (1.4)
p.000009: Banning Biological Research outside Licensed Establishments Conducting biological research outside the premise and
p.000009: scope of supervision of licensed establishments shall be deemed a violation of the provisions of
p.000009: theLawanditsRegulations.
p.000009:
p.000009:
p.000009:
p.000009:
p.000009:
p.000009:
p.000009:
p.000010: 10
p.000010:
p.000010: Chapter Two: Objectives of the Law
...
p.000040: 10. Case registration forms, daily cards, and questionnaires set for research
p.000040: subjects, in case of clinical research;
p.000040: 11. Research sample shall be determined according to the following considerations:
p.000040: a. Characteristics of sample from which the subjects will be selected;
p.000040: b. Criteria for inclusion and exclusion of the human subject;
p.000040: c. Methods through which initial contact and selection are carried out;
p.000040: d. Means of providing complete information to potential participants in the research or their representatives.
p.000040: 12. In clinical research, the principal investigator shall present a description of the individuals who will be given
p.000040: access to personal data of research subjects, including medical records and biological samples;
p.000040: 13. A list of expected results and ways to benefit therefrom;
p.000040: 14. A list of references.
p.000040:
p.000040: Article (10.15)
p.000040: The principal investigator shall, if necessary, enclose the following documents with his research
p.000040: proposal:
p.000040: 1. Any plans to stop or prevent administration of standard treatments because of the research and
p.000040: justifications for preventing ordinary standard treatments for conducting the research;
p.000040: 2. Medical care offered to human subjects during and after the research;
p.000040: 3. A description of the efficacy of social, psychological and medical supervision for all human
p.000040: subjects;
p.000040: 4. A statement of the compensation or treatment that can be provided for
p.000040:
p.000041: 41
p.000041:
p.000041: human subjects in case of injury, disability or death as a result of the
p.000041: research;
p.000041: 5. Arrangements taken to provide compensation, if required;
p.000041: 6. Indication of research funding methods and any research agreements related to the research.
p.000041: The human subject shall not incur any financial expenses for conducting
p.000041: the research on him.
p.000041:
p.000041: Article (10.16)
p.000041: To approve the research proposals submitted to the local committee, the following procedures shall be followed:
p.000041: 1. The local committee shall prepare a special approval application form and publish it on its website, including the
p.000041: following:
p.000041: a. Name of local committee and its postal address, electronic mail address and contact numbers;
p.000041: b. Name of principal investigator and his ordinary and electronic mail address and contact numbers;
p.000041: c. Title, duration and objectives of research project;
p.000041: d. Date of submission of application.
p.000041: 2. The principal investigator shall submit the application for approval according to the form referred to in
p.000041: the preceding paragraph 1 hereabove;
p.000041: 3. The principal investigator shall fill in the approval form, and shall
p.000041: append with it the following documents:
p.000041: a. The research proposal;
p.000041: b. An updated, signed and dated CV of the principal investigator and co- investigators;
p.000041: c. Methods used for inviting human subjects, including advertisements;
p.000041: d. “Informed Consent” form;
p.000041:
p.000042: 42
p.000042:
p.000042: e. Proof of passing a valid research ethics course;
p.000042: 4. The local committee shall receive the application against a receipt given to the applicant indicating reception
...
p.000079: with medical standards, if compared with expected benefits;
p.000079: 2. The ratio of the expected benefit shall exceed that of other methods
p.000079: available outside the scope of the research;
p.000079: 3. The research shall lead to a better understanding of an important problem that affects the minor, incompetent or
p.000079: mentally disabled person or his interest, help reduce such problem, or prevent some of its negative effects;
p.000079:
p.000080: 80
p.000080:
p.000080: 4. Obtaining the “Informed Consent” from either parent or from the legal guardian.
p.000080:
p.000080: Article (25.4)
p.000080: If the local committee finds that the research does not directly benefit the minor, incompetent or mentally disabled
p.000080: person but does not expose him to more than the minimal potential risk, it may approve the research in the following
p.000080: cases:
p.000080: 1. If he had given the “Informed Consent” when he was competent or before the disability occurred, and
p.000080: his legal guardian later gave the “Informed Consent”;
p.000080: 2. If precautionary measures taken for his protection are adequate and acceptable;
p.000080: 3. If there are sufficient reasons that make it possible to obtain significant
p.000080: information through the research for understanding the case under study.
p.000080:
p.000080: Article (25.5)
p.000080: The local committee may, prior to giving its approval of conducting research on the minor, incompetent or
p.000080: mentally disabled person, require appointing a qualified lawyer experienced to handle such case. Said lawyer shall have
p.000080: no relation with the researcher or the institution supervising and funding the research and shall observe the interest
p.000080: of the minor subject of the research, in coordination with his parents or guardian.
p.000080:
p.000080: Article (25.6)
p.000080: The physically, but not mentally, disabled person shall be treated as a normal person, in terms of his responsibility
...
Health / Motherhood/Family
Searching for indicator family:
(return to top)
p.000090: related to donors in accordance with the provisions of the Law and Regulations.
p.000090:
p.000090: Article 35
p.000090: The local committee may restrict the researcher’s use of research results on genetic material if said results
p.000090: harm public interest, provided the National Committee approves the same.
p.000090:
p.000090: Article (35.1)
p.000090: The local committee may restrict the principal investigator’s use of research results on genetic material if
p.000090: publishing said results would harm public interest, subject to the approval of the National Committee.
p.000090:
p.000090:
p.000090:
p.000090:
p.000091: 91
p.000091:
p.000091: Article (35.2)
p.000091: If prevented from using results of his research, the investigator may claim
p.000091: indemnification for research expenses from the institution.
p.000091:
p.000091: Article 36
p.000091: Research with negative impacts on society may not be conducted, especially research reinforcing racial
p.000091: discrimination.
p.000091:
p.000091: Article (36.1)
p.000091: Conducting research on diseases that are particular among a certain group for the purpose of treatment and
p.000091: understanding of mechanisms of transmission of said diseases may not be construed as promoting racial
p.000091: discrimination.
p.000091:
p.000091: Article (36.2)
p.000091: Scientific results shall not be leaked to the media if this could lead to promoting discrimination on the
p.000091: basis of race or family or tribal affiliation.
p.000091:
p.000091: Article 37
p.000091: The Regulations shall specify the ethical controls and criteria of genetic treatment research.
p.000091:
p.000091: Article (37.1)
p.000091: The following ethical controls and criteria shall be complied with when conducting genetic treatment research:
p.000091: 1. A written approval shall be obtained from the National Committee in all matters related to gene therapy research;
p.000091: 2. Gene therapy research shall be subject to controls and provisions set
p.000091:
p.000092: 92
p.000092:
p.000092: forth in the Law and Regulations and provisions set by the National Committee;
p.000092: 3. The research shall be consistent with the provisions of Shari’a, and the research plan shall include
p.000092: proof of taking such provisions into consideration;
p.000092: 4. The research shall comply with the controls and criteria set forth in international agreements
p.000092: related to gene therapy and amendments thereto, without prejudice to Shari’a rules and provisions;
p.000092: 5. Said research shall be limited to incurable diseases affecting human life, which have not yet been
p.000092: successfully treated by conventional medical methods;
p.000092: 6. Prior to approval of research, it shall be ascertained that all available treatment options have been exhausted;
p.000092: 7. The local committee evaluating this type of research shall comprise at least two persons with scientific
p.000092: competence to evaluate gene therapy research. The local committee may invite experienced consultants to attend its
p.000092: meetings to help evaluate the research project;
p.000092: 8. Gene therapy research shall be conducted in qualified hospitals and research centers with required
p.000092: medical specializations, as well as experienced and qualified staff;
...
Health / Physically Disabled
Searching for indicator illness:
(return to top)
p.000035: human subject participants and biological materials.
p.000035: 3. Provide necessary equipment and ensure that such equipment is
p.000035: adequate for the safety of the human subject participants.
p.000035: 4. Ensure especially that minors, legally incompetent or disabled persons, or any other persons from (vulnerable
p.000035: groups) are never abused under any circumstance.
p.000035: 5. The local committee will review the research project requests submitted by researchers associated with the
p.000035: establishment where the committee is affiliated. It also has the right to review the research project requests
p.000035: submitted by researchers in vicinity of the establishment upon agreement with the researcher, if there is no local
p.000035: committee in the establishment where these researchers are affiliated, provided the absence of a local committee is not
p.000035: the result of an administrative negligence to establish such a committee.
p.000035: 6. In the case of researchers from multiple establishments participating in a joint project, it is not
p.000035: necessary to obtain approval of the local committee of every center participating in the research
p.000035: project. One of the local registered committees shall in this case review the project, and the principal investigator
p.000035: must be from the establishment where the local committee which approves the project, and monitors it.
p.000035:
p.000035: Article (10.6)
p.000035: Committee membership shall be terminated for any of the following reasons:
p.000035:
p.000036: 36
p.000036:
p.000036: 1. Resignation;
p.000036: 2. Death;
p.000036: 3. Chronic illness that prevents a member from attending local committee meetings;
p.000036: 4. If any member fails to attend three consecutive or five non-consecutive meetings within the same year without an
p.000036: excuse acceptable to the local committee chairman;
p.000036: 5. Expiration and non-renewal of term of membership;
p.000036: 6. If a member is proved to have violated his commitment to keep information confidential and the
p.000036: committee chairman has issued a decision to this effect based on proven facts.
p.000036:
p.000036: Article (10.7)
p.000036: If the membership of any local committee member is terminated for any reason, committee chairman shall instantly
p.000036: address the concerned party to appoint a replacement to fill in the remainder of said member’s term, and shall notify
p.000036: the Monitoring Office thereof.
p.000036:
p.000036: Article (10.8)
p.000036: If the local committee chairman finds that one committee member does not effectively take part in committee activities
p.000036: or that he has not appropriately accomplished the duties assigned to him, he may notify the concerned party
p.000036: thereof and suggest whatever action he deems fit, including dismissal of said member and appointment of a replacement.
p.000036:
p.000036: Article (10.9)
p.000036: 1. The local committee shall convene upon a call by its chairman whenever required;
p.000036:
p.000037: 37
p.000037:
p.000037: 2. Local committee meeting shall not be valid unless attended by the
p.000037: majority of its members including the chairman or his designee;
p.000037: 3. If the quorum is not reached within half an hour of the designated date of the meeting, the meeting chairman shall
...
Searching for indicator physically:
(return to top)
p.000080: person but does not expose him to more than the minimal potential risk, it may approve the research in the following
p.000080: cases:
p.000080: 1. If he had given the “Informed Consent” when he was competent or before the disability occurred, and
p.000080: his legal guardian later gave the “Informed Consent”;
p.000080: 2. If precautionary measures taken for his protection are adequate and acceptable;
p.000080: 3. If there are sufficient reasons that make it possible to obtain significant
p.000080: information through the research for understanding the case under study.
p.000080:
p.000080: Article (25.5)
p.000080: The local committee may, prior to giving its approval of conducting research on the minor, incompetent or
p.000080: mentally disabled person, require appointing a qualified lawyer experienced to handle such case. Said lawyer shall have
p.000080: no relation with the researcher or the institution supervising and funding the research and shall observe the interest
p.000080: of the minor subject of the research, in coordination with his parents or guardian.
p.000080:
p.000080: Article (25.6)
p.000080: The physically, but not mentally, disabled person shall be treated as a normal person, in terms of his responsibility
p.000080: for giving the “Informed Consent” and his understanding of research potential risks and expected benefits.
p.000081: 81
p.000081:
p.000081: Article 26
p.000081: Pregnant women, fetuses and the product of pregnancy may not be used in research except in accordance with
p.000081: controls specified by the Regulations.
p.000081:
p.000081: Article (26.1)
p.000081: An investigator may not initiate any research on a pregnant woman unless
p.000081: the following conditions are satisfied:
p.000081: 1. Conduct appropriate studies, when possible, on animals and non- pregnant women that confirm the
p.000081: safety of methods and means of research, provided the results of such research are published in
p.000081: internationally recognized scientific journals in accordance with the provisions of the Law and
p.000081: Regulations;
p.000081: 2. The level of risk the research project poses to pregnant woman or her
p.000081: fetus does not exceed the minimum risk level;
...
Health / Pregnant
Searching for indicator pregnant:
(return to top)
p.000080: his legal guardian later gave the “Informed Consent”;
p.000080: 2. If precautionary measures taken for his protection are adequate and acceptable;
p.000080: 3. If there are sufficient reasons that make it possible to obtain significant
p.000080: information through the research for understanding the case under study.
p.000080:
p.000080: Article (25.5)
p.000080: The local committee may, prior to giving its approval of conducting research on the minor, incompetent or
p.000080: mentally disabled person, require appointing a qualified lawyer experienced to handle such case. Said lawyer shall have
p.000080: no relation with the researcher or the institution supervising and funding the research and shall observe the interest
p.000080: of the minor subject of the research, in coordination with his parents or guardian.
p.000080:
p.000080: Article (25.6)
p.000080: The physically, but not mentally, disabled person shall be treated as a normal person, in terms of his responsibility
p.000080: for giving the “Informed Consent” and his understanding of research potential risks and expected benefits.
p.000081: 81
p.000081:
p.000081: Article 26
p.000081: Pregnant women, fetuses and the product of pregnancy may not be used in research except in accordance with
p.000081: controls specified by the Regulations.
p.000081:
p.000081: Article (26.1)
p.000081: An investigator may not initiate any research on a pregnant woman unless
p.000081: the following conditions are satisfied:
p.000081: 1. Conduct appropriate studies, when possible, on animals and non- pregnant women that confirm the
p.000081: safety of methods and means of research, provided the results of such research are published in
p.000081: internationally recognized scientific journals in accordance with the provisions of the Law and
p.000081: Regulations;
p.000081: 2. The level of risk the research project poses to pregnant woman or her
p.000081: fetus does not exceed the minimum risk level;
p.000081: 3. The investigator shall not have any role in deciding how and when the pregnancy will be terminated or whether
p.000081: the fetus can survive after termination of pregnancy;
p.000081: 4. The research shall not lead to a change in pregnancy termination procedure if such change leads to more
p.000081: than the minimum level of risk to the pregnant woman or her fetus;
p.000081: 5. The research project aims to provide health requirements for the pregnant woman and her fetus and
p.000081: acquire information that cannot otherwise be obtained;
p.000081: 6. The principal investigator shall comit not to offer any type of reward in return for termination of pregnancy for
p.000081: research purposes;
p.000081: 7. Obtain the “Informed Consent” from both the pregnant woman and her husband.
p.000081:
p.000082: 82
p.000082:
p.000082: Article (26.2)
p.000082: No research on fetuses may be initiated unless the following conditions are
p.000082: satisfied:
p.000082: 1. The research shall not harm or endanger the life of the fetus;
p.000082: 2. The research project shall aim to provide health requirements for the
p.000082: fetus and to acquire information that cannot otherwise be obtained;
p.000082: 3. No research may be conducted on a living fetus unless it is nearly certain that its life is threatened
p.000082: or that the level of risk the fetus may face in case it remains in the uterus could be lessened, provided there is no
p.000082: safer means to achieve the same.
p.000082:
p.000082: Article 27
p.000082: Cells, tissues and derivatives of human sperms, gametes and zygotes may not be transported or exploited for the
p.000082: purpose of research except in accordance with conditions and restrictions laid down by the National Committee.
p.000082:
p.000082: Article (27.1)
p.000082: The National Committee shall set controls required for transfer and use of cells, tissues and derivatives
p.000082: constituents of human sperms, gametes and zygotes for research purposes. Said controls shall be reported to the
p.000082: Research Ethics Monitoring Office and local committees to abide by.
p.000082:
p.000082: Article 28
...
Health / sensory impairment
Searching for indicator sensory:
(return to top)
p.000005: Sperm: The product of fertilization up to forty days.
p.000005: Zygotes: An egg fertilized by a male sperm; from the time of fertilization until the time of division into eight cells.
p.000005: Gamete: The product of fertilization; from the end of the zygote phase until the phase of nidation where the
p.000005: zygote is implanted in the uterus. Cloning: The process of producing a complete individual genetically
p.000005: identical to another without sexual intercourse.
p.000005: Product of Pregnancy: A fetus that comes out of or removed from the uterus. Experimental Animals: Animals raised in
p.000005: cages or at certain places to be used in scientific experiments.
p.000005: Minimal Risk: Minor harm not exceeding potential risk encountered in daily life, which cannot be avoided during
p.000005: ordinary clinical or psychological examination, including potential discomfort and inconvenience.
p.000005: Legally Incompetent: A person lacking full legal capacity due to being a minor, lacking the ability of sound reasoning
p.000005: and judgment or being subject of a court ruling placing him under custody or continuation thereof which bars him from
p.000005: entering into a legal relation on his own.
p.000005: Disabled: A person suffering from a permanent full or partial deficiency
p.000005:
p.000006: 6
p.000006:
p.000006: in his physical, sensory, communicative, educational or psychological abilities to an extent that affects
p.000006: the possibility of meeting his common needs compared to his non-disabled peers.
p.000006: Child: A male or female not reaching the age of eighteen years which entails him to give an informed
p.000006: consent.
p.000006: Embryonic Stem Cells: Cells removed from the fertilized egg in its early phases; before the differentiation phase.
p.000006: Adult Stem Cells: Organically unspecialized cells that are removed from the cells of a fully developed living being.
p.000006:
p.000006: Article (1.1)
p.000006: Without prejudice to the meanings of the terms and phrases specified in Article 1 of the Law, the following
p.000006: terms and phrases – wherever used in the Law – shall have the meanings assigned to them, unless otherwise required
p.000006: by context.
p.000006: Human Subject (Participant): A person who consents or whose guardian consents to conduct clinical, non-clinical or
p.000006: therapeutic research or experiments on him.
p.000006: Principal Investigator: Lead researcher in charge of planning and conducting the research,
p.000006: collecting and analyzing data, and directing interventions stated in the research plan.
p.000006: Clinical Research: Any research related to collecting and analyzing data for volunteers or patients for the purpose of
...
Health / stem cells
Searching for indicator stem cells:
(return to top)
p.000005: cages or at certain places to be used in scientific experiments.
p.000005: Minimal Risk: Minor harm not exceeding potential risk encountered in daily life, which cannot be avoided during
p.000005: ordinary clinical or psychological examination, including potential discomfort and inconvenience.
p.000005: Legally Incompetent: A person lacking full legal capacity due to being a minor, lacking the ability of sound reasoning
p.000005: and judgment or being subject of a court ruling placing him under custody or continuation thereof which bars him from
p.000005: entering into a legal relation on his own.
p.000005: Disabled: A person suffering from a permanent full or partial deficiency
p.000005:
p.000006: 6
p.000006:
p.000006: in his physical, sensory, communicative, educational or psychological abilities to an extent that affects
p.000006: the possibility of meeting his common needs compared to his non-disabled peers.
p.000006: Child: A male or female not reaching the age of eighteen years which entails him to give an informed
p.000006: consent.
p.000006: Embryonic Stem Cells: Cells removed from the fertilized egg in its early phases; before the differentiation phase.
p.000006: Adult Stem Cells: Organically unspecialized cells that are removed from the cells of a fully developed living being.
p.000006:
p.000006: Article (1.1)
p.000006: Without prejudice to the meanings of the terms and phrases specified in Article 1 of the Law, the following
p.000006: terms and phrases – wherever used in the Law – shall have the meanings assigned to them, unless otherwise required
p.000006: by context.
p.000006: Human Subject (Participant): A person who consents or whose guardian consents to conduct clinical, non-clinical or
p.000006: therapeutic research or experiments on him.
p.000006: Principal Investigator: Lead researcher in charge of planning and conducting the research,
p.000006: collecting and analyzing data, and directing interventions stated in the research plan.
p.000006: Clinical Research: Any research related to collecting and analyzing data for volunteers or patients for the purpose of
p.000006: obtaining general knowledge that can be applied to other individuals with regard to mechanism of disease, its
p.000006: incidence, prevalence, transmission or treatment of a disease.
p.000006: Non-Clinical Research: Any research related to collecting and analyzing data not directly related to people for
p.000006: the purpose of obtaining general knowledge or facts.
p.000006:
p.000007: 7
p.000007:
p.000007: Clinical Trial: Experiments conducted on human volunteers to examine safety and effectiveness of a new medication or
p.000007: medical device.
p.000007: Prisoner: A person deprived of liberty, whether serving a prison sentence, detained on trial, or is a correction
...
p.000070: techniques or knowledge of human diseases.
p.000070:
p.000070: Article (21.5)
p.000070: The investigator shall use the minimum number of fetuses to achieve research purposes.
p.000070:
p.000070: Article (21.6)
p.000070: In cases of research conducted to acquire new knowledge, the researcher shall submit to the local committee proof that
p.000070: potential risk for the fetus is minimal.
p.000070:
p.000070: Article (21.7)
p.000070: The investigator shall prepare and keep records of the source of each fetus and the results of using said fetus in the
p.000070: research, and shall submit periodic reports on the research to the local committee.
p.000070:
p.000070: Article (21.8)
p.000070: The investigator shall abide by the controls and procedures set by the National Committee regarding
p.000070: research on stem cells, zygotes, gametes and fetuses.
p.000070:
p.000070: Article 22
p.000070: No research may be conducted for the purpose of human cloning.
p.000070:
p.000071: 71
p.000071:
p.000071: Article (22.1)
p.000071: No investigator shall be permitted to conduct research on human cloning and any reproductive and research
p.000071: applications resulting therefrom due to constraints determined by sharia, ethical principles and health-related
p.000071: harms, where harms and dangers to humanity outweigh the expected benefits.
p.000071:
p.000071: Article 23
p.000071: Research may be conducted on tissues, living cells and separated parts, including stem cells extracted from the
p.000071: umbilical cord or adult stem cells, upon obtaining the informed consent.
p.000071:
p.000071: Article (23.1) Subject to the
p.000071: provisions and principles set forth in the Law and Implementing Regulations and directives issued by the National
p.000071: Committee, research may be conducted on tissues, living cells and separated parts, including stem cells extracted from
p.000071: the umbilical cord or adult stem cells, upon fulfilling the following conditions:
p.000071: 1. Fetuses may not be cloned for the purpose of obtaining and using stem cells in research.
p.000071: 2. Excess fertilized eggs from in vitro fertilization procedures or from insemination using donor ovum
p.000071: and sperm, shall neither be used for therapeutic purposes nor in stem cell research.
p.000071: 3. Male or female gametes taken from sperms or eggs may not be donated to produce fertilized eggs that can grow into
p.000071: a fetus for the purpose of generating stem cells therefrom.
p.000071: 4. Embryonic stem cells derived from aborted fetuses may be used for therapeutic purposes. Likewise, miscarried
p.000071: fetuses without any signs
p.000072: 72
p.000072:
p.000072: of life yet may be used in research or in scientific and laboratory
p.000072: experiments in accordance with observed Sharia rules in the Kingdom.
p.000072: 5. In case of stillborn fetuses, embryonic stem cells may be transferred and used in research.
p.000072: 6. Stem cells of an adult human may be used, provided said human is not subject to any harm, and such stem cells can
p.000072: be used to treat a patient, and the expected benefit outweighs the possible harm.
p.000072: 7. Induced pluripotent stem cells, in which adult stem cells are induced to obtain pluripotent cells which can be
p.000072: developed into other kinds of cells, such as nerve cells and others, can be used solely at an experimental and animal
p.000072: level, provided the following conditions are fulfilled:
p.000072: a. The research is conducted at a research center affiliated with a government agency, or with the
p.000072: participation of the said government agency.
p.000072: b. A written authorization is obtained from the local research ethics committee.
p.000072: c. It is pledged in writing not to use these induced pluripotent stem cells on humans.
p.000072: 8. Embryonic cells and derivatives can be imported only from the sources permitted by these regulations, once
p.000072: the authorization of the local committee is obtained. Commercially available induced pluripotent stem cells
p.000072: can also be imported from scientifically recognized sources.
p.000072:
p.000072: Article (23.2)
p.000072: It is prohibited to import the following stem cells:
p.000072: 1. Stem cells obtained from the insemination using a donor ovum and a donor sperm, performed to extract stem cells.
p.000072: 2. Stem cells obtained from deliberately aborted fetuses.
p.000072:
p.000073: 73
p.000073:
p.000073: Article (23.3)
p.000073: Cells can be used in clinical research (therapeutic research) under the following conditions:
p.000073: 1. A written authorization is obtained from the local research ethics committee.
p.000073: 2. A “Informed Consent” form is obtained from the human subject participant before the research
p.000073: project is initiated.
p.000073: 3. A written authorization is obtained from the Saudi Food and Drug Authority.
p.000073: 4. The expected benefit for the human subject and the extent to which it outweighs the possible harm shall
p.000073: be evaluated through a clear and thorough scientific assessment conducted by the investigator and submitted to
p.000073: the local committee.
p.000073: 5. The investigator or research team conducting the research shall be
p.000073: specialized and shall have sufficient scientific expertise and competence.
p.000073: 6. Research objectives shall be clearly and accurately defined, and the research is preceded by
p.000073: sufficient experiments on animals if the nature of the research so requires; subject to the discretion of the
p.000073: local committee.
p.000073: 7. If the local committee finds that the potential harm for the human subject outweighs the expected
p.000073: benefit, it must refrain from authorizing the research project.
p.000073: 8. The local committee shall review periodic reports submitted by the investigator to ensure that the
p.000073: expected benefit continues to outweigh the possible harm.
p.000073: 9. The “Informed Consent” shall be obtained from the human subject prior to conducting the research and the
p.000073: information provided shall contain a full explanation of expected benefits and potential risks of the research.
p.000074: 74
p.000074:
p.000074: 10. The investigator shall keep detailed records of the source of stem cells and the results of their use in the
p.000074: research, and shall submit periodic research reports to the local committee.
p.000074:
p.000074: Article (23.4)
p.000074: Stem Cell Banks may be established under the following conditions:
p.000074: 1. A written authorization from the National Committee is obtained.
p.000074: 2. The stem cell bank can only be established in a center affiliated with a
p.000074: government agency.
p.000074: 3. It is prohibited to send any stem cells to be stored outside the Kingdom.
p.000074: 4. Stem cells stored in stem cell banks for therapeutic purposes may not be used for research purposes
p.000074: without the permission of the local committee and the stem cells’ owner’s consent;
p.000074: 5. An accurate and strict mechanism shall be set up to safeguard all
p.000074: information and data with the utmost safety and confidentiality.
p.000074: 6. Each sample shall be given a permanent identification label specifying its ownership. Information included in
p.000074: said label shall be updated by the principal investigator under the supervision of the local committee.
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p.000076:
p.000076: Chapter Nine: Research on Inmates
p.000076:
p.000076: Article 24
p.000076: Prisoners, including those sentenced to death, shall be treated like other persons as regards conducting
p.000076: medical research on them. The Regulations shall specify ethical controls for conducting research on prisoners.
p.000076:
p.000076: Article (24.1)
...
p.000082: satisfied:
p.000082: 1. The research shall not harm or endanger the life of the fetus;
p.000082: 2. The research project shall aim to provide health requirements for the
p.000082: fetus and to acquire information that cannot otherwise be obtained;
p.000082: 3. No research may be conducted on a living fetus unless it is nearly certain that its life is threatened
p.000082: or that the level of risk the fetus may face in case it remains in the uterus could be lessened, provided there is no
p.000082: safer means to achieve the same.
p.000082:
p.000082: Article 27
p.000082: Cells, tissues and derivatives of human sperms, gametes and zygotes may not be transported or exploited for the
p.000082: purpose of research except in accordance with conditions and restrictions laid down by the National Committee.
p.000082:
p.000082: Article (27.1)
p.000082: The National Committee shall set controls required for transfer and use of cells, tissues and derivatives
p.000082: constituents of human sperms, gametes and zygotes for research purposes. Said controls shall be reported to the
p.000082: Research Ethics Monitoring Office and local committees to abide by.
p.000082:
p.000082: Article 28
p.000082: Fetuses may not be cloned for the purpose of obtaining embryonic stem cells, nor may male or female gametes taken from
p.000082: sperms or eggs be donated to produce fertilized eggs that can grow into a fetus for the purpose of generating stem
p.000082: cells therefrom and conducting research thereon.
p.000083: 83
p.000083:
p.000083: Article (28.1)
p.000083: The National Committee shall monitor institutions where fertilized eggs are produced to ensure their compliance with
p.000083: the provisions of the Law and Implementing Regulations and instructions issued by the National Committee.
p.000083:
p.000083: Article 29
p.000083: Banks for preserving reproductive male or female cells with the intent of conducting research thereon may not be
p.000083: established.
p.000083:
p.000083: Article 30
p.000083: Organs and tissues of fetuses aborted before reaching one hundred twenty days may be used in research and experiments
p.000083: in accordance with controls and conditions set forth in the Regulations.
p.000083:
p.000083: Article (30.1)
p.000083: Research may be conducted on a pre-quickening stillborn fetus, if deemed necessary by the local committee, provided the
p.000083: research project is beneficial and contributes to the progress of applied sciences.
p.000083:
p.000083: Article (30.2)
p.000083: Samples may be taken from a stillborn fetus upon obtaining approval of the local committee, provided said samples are
p.000083: legally stored at approved gene banks.
p.000083:
p.000083: Article (30.3)
p.000083: 1. Research may be conducted on products of conception if the two
p.000083: following conditions are satisfied:
p.000083:
p.000084: 84
p.000084:
...
p.000092: 5. Said research shall be limited to incurable diseases affecting human life, which have not yet been
p.000092: successfully treated by conventional medical methods;
p.000092: 6. Prior to approval of research, it shall be ascertained that all available treatment options have been exhausted;
p.000092: 7. The local committee evaluating this type of research shall comprise at least two persons with scientific
p.000092: competence to evaluate gene therapy research. The local committee may invite experienced consultants to attend its
p.000092: meetings to help evaluate the research project;
p.000092: 8. Gene therapy research shall be conducted in qualified hospitals and research centers with required
p.000092: medical specializations, as well as experienced and qualified staff;
p.000092: 9. The research plan shall include a detailed description of research objectives, methodology, expected
p.000092: benefits, difficulties, risks and health complications for the human subject;
p.000092: 10. The research shall be based on scientific principles, and preceded by sufficient laboratory experiments and
p.000092: animal testing;
p.000092: 11. The expected benefit from the research shall outweigh any potential
p.000092: risks;
p.000092: 12. The research shall be conducted by a qualified investigator specialized
p.000092:
p.000093: 93
p.000093:
p.000093: in genetic medicine and assisted by a highly efficient medical team. Said investigator shall be well versed in genetic
p.000093: and scientific material related to the subject of the research;
p.000093: 13. Gene therapy may not be carried out for research purposes on gametes (sperms and ova) or experimental research on
p.000093: stem cells obtained from fertilized zygotes or related to reproductive cloning;
p.000093: 14. Handling of genetic material in research, storage and disposal thereof, as well as collaborative research with
p.000093: centers abroad shall be in accordance with the controls set forth in the Law and Regulations.
p.000093:
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p.000094:
p.000094: Chapter Twelve: Use of Animals and Plants in Experiments
p.000094:
p.000094: Article 38
p.000094: 1. Animals may be used for research employing all experimental or scientific means not causing unusual pain to the
p.000094: animals.
p.000094: 2. Use of animals shall be restricted to research whose objectives cannot be realized without such use.
p.000094: 3. Endangered animal species may not be subject to negative use. The Regulations shall specify ethical conditions and
p.000094: procedures for use of animals in research.
p.000094:
p.000094: Article (38.1)
p.000094: Animals may be used in scientific experiments where research objectives
p.000094: cannot be otherwise realized.
p.000094:
p.000094: Article (38.2)
p.000094: When conducting research on animals, the investigator shall comply with the following:
p.000094: 1. Sharia provisions related to humane treatment of animals.
p.000094: 2. Scientific principles and conventions governing experimental practices
p.000094: on animals.
...
Social / Access to Social Goods
Searching for indicator access:
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p.000015: committee’s work procedures and meetings as well as remuneration of members in accordance with applicable
p.000015: laws, resolutions and directives.
p.000015:
p.000015: Article (5.1)
p.000015: 1. The National Committee shall hold a monthly meeting upon a call by its Chairman or designee;
p.000015: 2. The National Committee may hold extraordinary meetings if its Chairman or designee deems it
p.000015: necessary. Said meetings shall only discuss items on the agenda without adding any other items unless the
p.000016: 16
p.000016:
p.000016: Committee Chairman or designee decides otherwise;
p.000016: 3. If one or more members deem it necessary to hold an extraordinary meeting and this is supported by at least one
p.000016: third of the members of the National Committee, they shall submit a request in writing or by e-mail to the Committee
p.000016: Chairman or his designee, naming the members in support of the meeting and the topic(s) to be discussed. In this case,
p.000016: the Chairman or his designee shall call the committee to convene within a period not exceeding ten days from the
p.000016: request submission date.
p.000016: 4. The National Committee shall convene at its headquarters or at any other place set by the Committee
p.000016: Chairman or his designee if necessary.
p.000016: 5. Invitations for the meeting shall be sent to Committee members at least ten working days prior to the
p.000016: meeting date. Invitations shall be delivered by hand or sent via ordinary mail or e-mail.
p.000016: 6. Invitations shall include venue, date and time of meeting. Papers and documents related to proposed items on the
p.000016: agenda shall be enclosed therein except for classified documents. Members may have access to all documents at
p.000016: the meeting place whether prior to or during the meeting.
p.000016: 7. The agenda of the National Committee meeting shall include the following items:
p.000016: a. Minutes of the previous meeting for approval;
p.000016: b. Topics proposed by the National Committee Chairman or members;
p.000016: c. Monthly reports prepared by National Committee Secretariat, if any, upon approval by Committee
p.000016: Chairman.
p.000016:
p.000016: Article (5.2)
p.000016: 1. National Committee meetings shall not be valid unless attended by two-thirds of its members including
p.000016: the Chairman or his designee.
p.000017: 17
p.000017:
p.000017: 2. If the quorum provided for in Paragraph (1) above is not met within half an hour of the designated time of the
p.000017: meeting, the Chairman shall adjourn the meeting and set a new date within ten days. The call for said meeting shall be
p.000017: made at least five working days prior to the meeting date.
p.000017: 3. If the National Committee Chairman or his deputy fails to attend the meeting within half an hour of the
p.000017: meeting time, the Committee Secretary shall adjourn the meeting.
p.000017: 4. If the National Committee Chairman becomes aware that neither he nor his deputy can attend the meeting,
p.000017: and it is necessary to hold the meeting, he may delegate a Committee member to chair the meeting, and he shall have the
p.000017: powers of the Committee Chairman with regards to managing the meeting.
p.000017: 5. If any of the National Committee members has an interest in a proposed item for discussion that may affect his
p.000017: opinion or neutrality, he shall declare the same prior to the meeting. In such case, the Committee Chairman
...
p.000028: from the application submission date.
p.000028: 4. The Monitoring Office shall decide on the application within 15 working days from the date of receipt of
p.000028: the complete application, render a decision to this effect, and promptly notify the concerned establishment of said
p.000028: decision, provided the notification includes registration number and date.
p.000028: 5. The Monitoring Office may not reject any application for registration except on legal grounds. If the application
p.000028: is rejected, the Monitoring Office shall notify the establishment of the reasons for rejection.
p.000028:
p.000028: Article (9.3)
p.000028: In its supervision of registered local committees, the Monitoring Office
p.000028: may undertake the following:
p.000028: 1. Assign any person it deems fit to conduct field visits to the registered establishment at least once a year for
p.000028: examining committee documents and papers;
p.000028: 2. Assign any person it deems fit to attend local committee meetings, if
p.000028: required;
p.000028: 3. Ensure local committee compliance with relevant laws, regulations, rules and directives and coordinate
p.000028: therewith for this purpose;
p.000028: 4. Review complaints or grievances submitted by the principal investigator
p.000028:
p.000029: 29
p.000029:
p.000029: or by any member of the research team against local committee decisions;
p.000029: 5. Review complaints submitted by the human subject in case he claims to
p.000029: have been harmed as a result of the research.
p.000029:
p.000029: Article (9.4)
p.000029: In its monitoring of local committee compliance with the provisions of the Law and its Regulations, the
p.000029: Monitoring Office may undertake the following:
p.000029: 1. Having access to all records and documents of research registered with the local committee;
p.000029: 2. Contact the participating human subject, if required;
p.000029: 3. Cancel, suspend, terminate or prevent prompt evaluation, if necessary;
p.000029: 4. Record any violation committed by the local committee and take necessary actions in accordance with
p.000029: the Law and Regulations;
p.000029: 5. The Monitoring Office shall conduct periodic ethical evaluation and monitoring of national laboratories,
p.000029: and shall monitor medical research and experiments conducted on Living Creatures to ensure legitimacy thereof.
p.000029: 6. Upon verification of occurrence of a violation or a reasonable possibility of a valid claim of harm, the
p.000029: Monitoring Office may refer the matter to the Violation Committee referred to in Article (42.1) of the Regulations to
p.000029: take appropriate action.
p.000029:
p.000029: Article (9.5)
p.000029: The Committee Chairman shall appoint office staff upon recommendation of the director of the Monitoring Office
p.000029: in accordance with applicable procedures including office secretariat to help carry out administrative and
p.000030: 30
p.000030:
p.000030: technical work.
p.000030:
p.000030: Article (9.6)
p.000030: The Office may, if necessary, seek the assistance of specialists, experts and consultants as it deems fit; remuneration
p.000030: of said persons shall be according to KACST applicable rules.
p.000030:
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p.000039: measures.
p.000039:
p.000039: Article (10.14)
p.000039: The research proposal shall comprise the following:
p.000039: 1. An abstract of the research within one page (Size: A4);
p.000039: 2. Research objectives;
p.000039: 3. Statistical methodology, including sample size calculations, taking into account possibility of obtaining
p.000039: statistically significant results by using the minimum number of research subjects;
p.000039: 4. Rationale for introducing any procedure, tool or device that has not been used before;
p.000039: 5. Rationale for using any substances that could be dangerous or harmful to the human subject or his surroundings and
p.000039: methods of disposal of said substances after research is completed;
p.000039: 6. Plan for dealing with risky cases;
p.000039: 7. Plan for disposal of extra biological samples;
p.000039:
p.000040: 40
p.000040:
p.000040: 8. A clear description of duties and responsibilities of research team;
p.000040: 9. Time schedule of research and criteria of research suspension or termination;
p.000040: 10. Case registration forms, daily cards, and questionnaires set for research
p.000040: subjects, in case of clinical research;
p.000040: 11. Research sample shall be determined according to the following considerations:
p.000040: a. Characteristics of sample from which the subjects will be selected;
p.000040: b. Criteria for inclusion and exclusion of the human subject;
p.000040: c. Methods through which initial contact and selection are carried out;
p.000040: d. Means of providing complete information to potential participants in the research or their representatives.
p.000040: 12. In clinical research, the principal investigator shall present a description of the individuals who will be given
p.000040: access to personal data of research subjects, including medical records and biological samples;
p.000040: 13. A list of expected results and ways to benefit therefrom;
p.000040: 14. A list of references.
p.000040:
p.000040: Article (10.15)
p.000040: The principal investigator shall, if necessary, enclose the following documents with his research
p.000040: proposal:
p.000040: 1. Any plans to stop or prevent administration of standard treatments because of the research and
p.000040: justifications for preventing ordinary standard treatments for conducting the research;
p.000040: 2. Medical care offered to human subjects during and after the research;
p.000040: 3. A description of the efficacy of social, psychological and medical supervision for all human
p.000040: subjects;
p.000040: 4. A statement of the compensation or treatment that can be provided for
p.000040:
p.000041: 41
p.000041:
p.000041: human subjects in case of injury, disability or death as a result of the
p.000041: research;
p.000041: 5. Arrangements taken to provide compensation, if required;
p.000041: 6. Indication of research funding methods and any research agreements related to the research.
p.000041: The human subject shall not incur any financial expenses for conducting
p.000041: the research on him.
p.000041:
p.000041: Article (10.16)
p.000041: To approve the research proposals submitted to the local committee, the following procedures shall be followed:
p.000041: 1. The local committee shall prepare a special approval application form and publish it on its website, including the
p.000041: following:
p.000041: a. Name of local committee and its postal address, electronic mail address and contact numbers;
...
Social / Age
Searching for indicator age:
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p.000005: Law: Law of Ethics of Research on Living Creatures.
p.000005: Regulations: Implementing Regulations of the Law of Ethics of Research on Living Creatures.
p.000005: KACST: King Abdul Aziz City for Science and Technology.
p.000005: President of KACST: President of King Abdul Aziz City for Science and Technology.
p.000005: National Committee: National Committee of Biomedical Ethics.
p.000005: Monitoring Office: Research Ethics Monitoring Office.
p.000005: Local Committee: Committee for licensing research formed at an establishment in accordance with the
p.000005: provisions of this Law.
p.000005: Establishment: A public or private corporate entity engaged in research activities on Living Creatures.
p.000005: Researcher: A person academically qualified in a subject related to research
p.000005: and has completed a course on research ethics.
p.000005: Research: A systematic experimental investigation aiming at improvement of biosciences or enrichment or
p.000005: development of general knowledge by using a living creature or parts thereof.
p.000005: Living Creatures: Human beings, animals and plants.
p.000005: Genetic Material: Chain of nitrogenous bases that exist within the cells or are extracted therefrom and are
p.000005: responsible for carrying traits and characteristics from the mother cell to the sub-cell and from one
p.000005: living creature to its offspring.
p.000005:
p.000005: 5
p.000005:
p.000005: Legal Capacity: Reaching the age of eighteen, with mental ability to enter into legal relation on his own.
p.000005: Informed Consent: A person giving his consent with his free will, without exploitation or coercion and upon full
p.000005: understanding of what is required from him and of the research objectives and potential risks as well as of rights and
p.000005: obligations arising out of his participation therein.
p.000005: Minor: A person under eighteen years of age.
p.000005: Fetus: Outcome of pregnancy from the beginning of nidation in the uterus to the time of its delivery or removal.
p.000005: Guardian: A person having the right of legal authority over another person.
p.000005: Sperm: The product of fertilization up to forty days.
p.000005: Zygotes: An egg fertilized by a male sperm; from the time of fertilization until the time of division into eight cells.
p.000005: Gamete: The product of fertilization; from the end of the zygote phase until the phase of nidation where the
p.000005: zygote is implanted in the uterus. Cloning: The process of producing a complete individual genetically
p.000005: identical to another without sexual intercourse.
p.000005: Product of Pregnancy: A fetus that comes out of or removed from the uterus. Experimental Animals: Animals raised in
p.000005: cages or at certain places to be used in scientific experiments.
p.000005: Minimal Risk: Minor harm not exceeding potential risk encountered in daily life, which cannot be avoided during
p.000005: ordinary clinical or psychological examination, including potential discomfort and inconvenience.
p.000005: Legally Incompetent: A person lacking full legal capacity due to being a minor, lacking the ability of sound reasoning
p.000005: and judgment or being subject of a court ruling placing him under custody or continuation thereof which bars him from
p.000005: entering into a legal relation on his own.
p.000005: Disabled: A person suffering from a permanent full or partial deficiency
p.000005:
p.000006: 6
p.000006:
p.000006: in his physical, sensory, communicative, educational or psychological abilities to an extent that affects
p.000006: the possibility of meeting his common needs compared to his non-disabled peers.
p.000006: Child: A male or female not reaching the age of eighteen years which entails him to give an informed
p.000006: consent.
p.000006: Embryonic Stem Cells: Cells removed from the fertilized egg in its early phases; before the differentiation phase.
p.000006: Adult Stem Cells: Organically unspecialized cells that are removed from the cells of a fully developed living being.
p.000006:
p.000006: Article (1.1)
p.000006: Without prejudice to the meanings of the terms and phrases specified in Article 1 of the Law, the following
p.000006: terms and phrases – wherever used in the Law – shall have the meanings assigned to them, unless otherwise required
p.000006: by context.
p.000006: Human Subject (Participant): A person who consents or whose guardian consents to conduct clinical, non-clinical or
p.000006: therapeutic research or experiments on him.
p.000006: Principal Investigator: Lead researcher in charge of planning and conducting the research,
p.000006: collecting and analyzing data, and directing interventions stated in the research plan.
p.000006: Clinical Research: Any research related to collecting and analyzing data for volunteers or patients for the purpose of
p.000006: obtaining general knowledge that can be applied to other individuals with regard to mechanism of disease, its
p.000006: incidence, prevalence, transmission or treatment of a disease.
p.000006: Non-Clinical Research: Any research related to collecting and analyzing data not directly related to people for
p.000006: the purpose of obtaining general knowledge or facts.
p.000006:
p.000007: 7
p.000007:
...
p.000044: a. The drug is used in accordance with its licensing and dosages approved by the concerned party, and does
p.000044: not entail any increase in potential risk for the human subject;
p.000044: b. The medical equipment in use has originally been licensed by the concerned party and has already been utilized
p.000044: accordingly.
p.000044: 4. If taking biological samples for research purposes is carried out via non-invasive methods such as
p.000044: analysis of urine, saliva, nail or hair clippings, etc.
p.000044: 5. If research data is to be collected by using medical equipment approved
p.000044:
p.000045: 45
p.000045:
p.000045: by the concerned party, such as:
p.000045: a. Sensors which are directly applied on body surface or at a close distance thereto and which do not expose the
p.000045: body to a significant amount of energy and do not violate the privacy of the human subject;
p.000045: b. Weight taking or audiometry devices;
p.000045: c. Magnetic resonance imaging (MRI) or ultrasonography imaging devices;
p.000045: d. Electrography (ECG & EEG), Thermal Imaging, normal nuclear radiation rate measuring,
p.000045: infra-red imaging, blood flow measurement with ultrasound imaging (Doppler sonography), and echocardiography
p.000045: devices;
p.000045: e. Moderate exercise, muscle strength, body ratios (such as body fat ratio) and measurement of joint and
p.000045: muscle flexibility devices, provided these tests are deemed appropriate after taking age, weight and health condition
p.000045: into account;
p.000045: f. Search for information, records or samples that were previously collected or will be collected in the
p.000045: future for non-research purposes;
p.000045: g. Collect information via audio or video taping (static or moving) for the purpose of looking for the attributes or
p.000045: behavior of an individual or group without violation of privacy of the human subject.
p.000045: However, excepted from these devices is the use of X-ray or electromagnetic microwavedevices.
p.000045:
p.000045: Article (10.19)
p.000045: 1. Approval by expedited review shall be issued by local committee chairman or by one or more members
p.000045: selected by committee chairman for their experience.
p.000045:
p.000046: 46
p.000046:
p.000046: 2. In case of expedited review, the research evaluator shall have all the powers given to the local committee except
p.000046: for rejection of research, which shall be within the jurisdiction of the local committee alone. If the
p.000046: evaluator decides to reject the research, he shall refer it to the committee for reviewing it according to the
p.000046: provisions of this Law and its Regulations.
p.000046: 3. In case approval of research is issued by using expedited review, the committee chairman shall notify all
p.000046: committee members of the research projects that he has approved via whatever notification means he deems appropriate.
p.000046:
p.000046: Article (10.20)
p.000046: The local committee chairman has the authority to approve any amendment of the research previously approved by using
p.000046: expedited review. Exceptions include interviews and surveys conducted on any of the (vulnerable groups), amendment of
...
Social / Child
Searching for indicator child:
(return to top)
p.000005: identical to another without sexual intercourse.
p.000005: Product of Pregnancy: A fetus that comes out of or removed from the uterus. Experimental Animals: Animals raised in
p.000005: cages or at certain places to be used in scientific experiments.
p.000005: Minimal Risk: Minor harm not exceeding potential risk encountered in daily life, which cannot be avoided during
p.000005: ordinary clinical or psychological examination, including potential discomfort and inconvenience.
p.000005: Legally Incompetent: A person lacking full legal capacity due to being a minor, lacking the ability of sound reasoning
p.000005: and judgment or being subject of a court ruling placing him under custody or continuation thereof which bars him from
p.000005: entering into a legal relation on his own.
p.000005: Disabled: A person suffering from a permanent full or partial deficiency
p.000005:
p.000006: 6
p.000006:
p.000006: in his physical, sensory, communicative, educational or psychological abilities to an extent that affects
p.000006: the possibility of meeting his common needs compared to his non-disabled peers.
p.000006: Child: A male or female not reaching the age of eighteen years which entails him to give an informed
p.000006: consent.
p.000006: Embryonic Stem Cells: Cells removed from the fertilized egg in its early phases; before the differentiation phase.
p.000006: Adult Stem Cells: Organically unspecialized cells that are removed from the cells of a fully developed living being.
p.000006:
p.000006: Article (1.1)
p.000006: Without prejudice to the meanings of the terms and phrases specified in Article 1 of the Law, the following
p.000006: terms and phrases – wherever used in the Law – shall have the meanings assigned to them, unless otherwise required
p.000006: by context.
p.000006: Human Subject (Participant): A person who consents or whose guardian consents to conduct clinical, non-clinical or
p.000006: therapeutic research or experiments on him.
p.000006: Principal Investigator: Lead researcher in charge of planning and conducting the research,
p.000006: collecting and analyzing data, and directing interventions stated in the research plan.
p.000006: Clinical Research: Any research related to collecting and analyzing data for volunteers or patients for the purpose of
p.000006: obtaining general knowledge that can be applied to other individuals with regard to mechanism of disease, its
p.000006: incidence, prevalence, transmission or treatment of a disease.
p.000006: Non-Clinical Research: Any research related to collecting and analyzing data not directly related to people for
p.000006: the purpose of obtaining general knowledge or facts.
p.000006:
p.000007: 7
p.000007:
...
Social / Fetus/Neonate
Searching for indicator fetus:
(return to top)
p.000005: provisions of this Law.
p.000005: Establishment: A public or private corporate entity engaged in research activities on Living Creatures.
p.000005: Researcher: A person academically qualified in a subject related to research
p.000005: and has completed a course on research ethics.
p.000005: Research: A systematic experimental investigation aiming at improvement of biosciences or enrichment or
p.000005: development of general knowledge by using a living creature or parts thereof.
p.000005: Living Creatures: Human beings, animals and plants.
p.000005: Genetic Material: Chain of nitrogenous bases that exist within the cells or are extracted therefrom and are
p.000005: responsible for carrying traits and characteristics from the mother cell to the sub-cell and from one
p.000005: living creature to its offspring.
p.000005:
p.000005: 5
p.000005:
p.000005: Legal Capacity: Reaching the age of eighteen, with mental ability to enter into legal relation on his own.
p.000005: Informed Consent: A person giving his consent with his free will, without exploitation or coercion and upon full
p.000005: understanding of what is required from him and of the research objectives and potential risks as well as of rights and
p.000005: obligations arising out of his participation therein.
p.000005: Minor: A person under eighteen years of age.
p.000005: Fetus: Outcome of pregnancy from the beginning of nidation in the uterus to the time of its delivery or removal.
p.000005: Guardian: A person having the right of legal authority over another person.
p.000005: Sperm: The product of fertilization up to forty days.
p.000005: Zygotes: An egg fertilized by a male sperm; from the time of fertilization until the time of division into eight cells.
p.000005: Gamete: The product of fertilization; from the end of the zygote phase until the phase of nidation where the
p.000005: zygote is implanted in the uterus. Cloning: The process of producing a complete individual genetically
p.000005: identical to another without sexual intercourse.
p.000005: Product of Pregnancy: A fetus that comes out of or removed from the uterus. Experimental Animals: Animals raised in
p.000005: cages or at certain places to be used in scientific experiments.
p.000005: Minimal Risk: Minor harm not exceeding potential risk encountered in daily life, which cannot be avoided during
p.000005: ordinary clinical or psychological examination, including potential discomfort and inconvenience.
p.000005: Legally Incompetent: A person lacking full legal capacity due to being a minor, lacking the ability of sound reasoning
p.000005: and judgment or being subject of a court ruling placing him under custody or continuation thereof which bars him from
p.000005: entering into a legal relation on his own.
p.000005: Disabled: A person suffering from a permanent full or partial deficiency
p.000005:
p.000006: 6
p.000006:
p.000006: in his physical, sensory, communicative, educational or psychological abilities to an extent that affects
p.000006: the possibility of meeting his common needs compared to his non-disabled peers.
p.000006: Child: A male or female not reaching the age of eighteen years which entails him to give an informed
p.000006: consent.
...
p.000006: Principal Investigator: Lead researcher in charge of planning and conducting the research,
p.000006: collecting and analyzing data, and directing interventions stated in the research plan.
p.000006: Clinical Research: Any research related to collecting and analyzing data for volunteers or patients for the purpose of
p.000006: obtaining general knowledge that can be applied to other individuals with regard to mechanism of disease, its
p.000006: incidence, prevalence, transmission or treatment of a disease.
p.000006: Non-Clinical Research: Any research related to collecting and analyzing data not directly related to people for
p.000006: the purpose of obtaining general knowledge or facts.
p.000006:
p.000007: 7
p.000007:
p.000007: Clinical Trial: Experiments conducted on human volunteers to examine safety and effectiveness of a new medication or
p.000007: medical device.
p.000007: Prisoner: A person deprived of liberty, whether serving a prison sentence, detained on trial, or is a correction
p.000007: facility inmate.
p.000007: Vulnerable groups: Groups of individuals in need of additional protection due to their lack of legal capacity, their
p.000007: questionable or diminished capacity or their lack of freedom to choose.
p.000007: Stillborn: A fetus delivered, came out of, or removed from the uterus with no signs of life such as heartbeat, natural
p.000007: breathing, movement, or pulsation of the umbilical cord if still connected.
p.000007: Diagnostic Procedure: A test aiming at finding a certain disorder or disease
p.000007: in a living creature.
p.000007: Medication: A chemical compound administered to a living creature to help diagnose, treat, prevent, cure or
p.000007: alleviate the effects of a disease or organic disorder.
p.000007: Periodic Assessment: Observation of research progress by safety assessment and information monitoring
p.000007: committee to ascertain safety of the human subject on a continuous basis and to ensure nonexistence of any reason for
p.000007: discontinuation or modification of the research.
p.000007: Periodic Follow-up: Review of the periodic report submitted by the principal investigator to the local
p.000007: committee to evaluate research progress and conformity with the approved research plan.
p.000007: Expedited Review: An evaluation carried out by the local committee chairman, or by a committee member
p.000007: designated by him, of a new research project or modifications of a previously approved research where potential risk to
p.000007: the human subject does not exceed minimal risk.
p.000007: Genetic Therapy Research: Any research which includes insertion or deletion of genetic material within body
p.000007: cells or targeting the same whether
p.000008: 8
p.000008:
p.000008: by modification or deactivation for finding a treatment for hereditary or
p.000008: other diseases.
p.000008: Confidentiality: Non-disclosure or passing of any data, information or results related to the research or the
p.000008: human subject, to any third party not connected with the research.
p.000008: Privacy: Observing common values, including traditions, thoughts and norms.
p.000008: Safety Assessment and Information Monitoring Committee: A group of scientists, physicians, and statisticians
p.000008: independent from researchers, whose task is to review accumulated data during clinical experiments for prompt
p.000008: analysis and to observe any significant likelihood towards a certain trend in the results or unacceptable side effects
p.000008: requiring a recommendation for suspension of research or modification of its plan.
p.000008: Genes: Molecular units of heredity data in all living organisms that encode the information required for building and
p.000008: preserving cells and performing all vital functions, and hence building bodies of Living Creatures and giving
p.000008: them their characteristic features.
p.000008: Major Harm: Any harm leading to a participant’s death, jeopardy to his life, hospitalization beyond expectation,
p.000008: permanent disability, or deformation of fetus. This harm is deemed unexpected if not stated in the “informed consent.”
p.000008:
p.000008:
p.000008:
p.000008:
p.000008:
p.000008:
p.000008:
p.000008:
p.000008:
p.000008:
p.000008:
p.000008:
p.000009: 9
p.000009:
p.000009: General Provisions
p.000009:
p.000009: Article (1.2)
p.000009: Scope of Application
p.000009: 1. The provisions of the Law and its Regulations shall apply to any research establishment conducting
p.000009: research on living creatures in the Kingdom of Saudi Arabia.
p.000009: 1. Research conducted on samples taken from within the Kingdom shall be subject to the provisions of the Law and its
p.000009: Implementing Regulations as regards taking the informed consent and sending genetic samples abroad.
p.000009:
p.000009: Article (1.3)
p.000009: Principles Governing Provisions of the Law and its Regulations
p.000009: In interpretation and application, the provisions of the Law and its Regulations shall be subject to
p.000009: Sharia provisions as adopted by official bodies in the Kingdom, laws and controls set by the National Committee,
p.000009: and principles of human rights, without prejudice to provisions of Sharia.
p.000009:
p.000009: Article (1.4)
p.000009: Banning Biological Research outside Licensed Establishments Conducting biological research outside the premise and
p.000009: scope of supervision of licensed establishments shall be deemed a violation of the provisions of
p.000009: theLawanditsRegulations.
p.000009:
p.000009:
p.000009:
p.000009:
p.000009:
p.000009:
p.000009:
p.000010: 10
p.000010:
p.000010: Chapter Two: Objectives of the Law
p.000010:
p.000010: Article 2
...
p.000069: 1. Find a treatment for reproductive problems, in which case the research shall be conducted in an institution
p.000069: approved for treatment of such problems;
p.000069: 2. Conduct a new experiment expected to benefit human fetuses;
p.000069: 3. Acquire new knowledge about the condition of fetuses if it is not
p.000069: expected to achieve a direct benefit.
p.000069:
p.000069:
p.000069:
p.000069:
p.000070: 70
p.000070:
p.000070: Article (21.4)
p.000070: The research proposal on human fetuses shall include the indication that the expected benefit from the research would
p.000070: not be realized without using such fetuses, and that a similar benefit has been previously obtained through conducting
p.000070: research on animals, and that the research is justified in terms of its contribution to improvement of treatment
p.000070: techniques or knowledge of human diseases.
p.000070:
p.000070: Article (21.5)
p.000070: The investigator shall use the minimum number of fetuses to achieve research purposes.
p.000070:
p.000070: Article (21.6)
p.000070: In cases of research conducted to acquire new knowledge, the researcher shall submit to the local committee proof that
p.000070: potential risk for the fetus is minimal.
p.000070:
p.000070: Article (21.7)
p.000070: The investigator shall prepare and keep records of the source of each fetus and the results of using said fetus in the
p.000070: research, and shall submit periodic reports on the research to the local committee.
p.000070:
p.000070: Article (21.8)
p.000070: The investigator shall abide by the controls and procedures set by the National Committee regarding
p.000070: research on stem cells, zygotes, gametes and fetuses.
p.000070:
p.000070: Article 22
p.000070: No research may be conducted for the purpose of human cloning.
p.000070:
p.000071: 71
p.000071:
p.000071: Article (22.1)
p.000071: No investigator shall be permitted to conduct research on human cloning and any reproductive and research
p.000071: applications resulting therefrom due to constraints determined by sharia, ethical principles and health-related
p.000071: harms, where harms and dangers to humanity outweigh the expected benefits.
p.000071:
p.000071: Article 23
p.000071: Research may be conducted on tissues, living cells and separated parts, including stem cells extracted from the
p.000071: umbilical cord or adult stem cells, upon obtaining the informed consent.
p.000071:
p.000071: Article (23.1) Subject to the
p.000071: provisions and principles set forth in the Law and Implementing Regulations and directives issued by the National
p.000071: Committee, research may be conducted on tissues, living cells and separated parts, including stem cells extracted from
p.000071: the umbilical cord or adult stem cells, upon fulfilling the following conditions:
p.000071: 1. Fetuses may not be cloned for the purpose of obtaining and using stem cells in research.
p.000071: 2. Excess fertilized eggs from in vitro fertilization procedures or from insemination using donor ovum
p.000071: and sperm, shall neither be used for therapeutic purposes nor in stem cell research.
p.000071: 3. Male or female gametes taken from sperms or eggs may not be donated to produce fertilized eggs that can grow into
p.000071: a fetus for the purpose of generating stem cells therefrom.
p.000071: 4. Embryonic stem cells derived from aborted fetuses may be used for therapeutic purposes. Likewise, miscarried
p.000071: fetuses without any signs
p.000072: 72
p.000072:
p.000072: of life yet may be used in research or in scientific and laboratory
p.000072: experiments in accordance with observed Sharia rules in the Kingdom.
p.000072: 5. In case of stillborn fetuses, embryonic stem cells may be transferred and used in research.
p.000072: 6. Stem cells of an adult human may be used, provided said human is not subject to any harm, and such stem cells can
p.000072: be used to treat a patient, and the expected benefit outweighs the possible harm.
p.000072: 7. Induced pluripotent stem cells, in which adult stem cells are induced to obtain pluripotent cells which can be
p.000072: developed into other kinds of cells, such as nerve cells and others, can be used solely at an experimental and animal
p.000072: level, provided the following conditions are fulfilled:
...
p.000080:
p.000080: Article (25.6)
p.000080: The physically, but not mentally, disabled person shall be treated as a normal person, in terms of his responsibility
p.000080: for giving the “Informed Consent” and his understanding of research potential risks and expected benefits.
p.000081: 81
p.000081:
p.000081: Article 26
p.000081: Pregnant women, fetuses and the product of pregnancy may not be used in research except in accordance with
p.000081: controls specified by the Regulations.
p.000081:
p.000081: Article (26.1)
p.000081: An investigator may not initiate any research on a pregnant woman unless
p.000081: the following conditions are satisfied:
p.000081: 1. Conduct appropriate studies, when possible, on animals and non- pregnant women that confirm the
p.000081: safety of methods and means of research, provided the results of such research are published in
p.000081: internationally recognized scientific journals in accordance with the provisions of the Law and
p.000081: Regulations;
p.000081: 2. The level of risk the research project poses to pregnant woman or her
p.000081: fetus does not exceed the minimum risk level;
p.000081: 3. The investigator shall not have any role in deciding how and when the pregnancy will be terminated or whether
p.000081: the fetus can survive after termination of pregnancy;
p.000081: 4. The research shall not lead to a change in pregnancy termination procedure if such change leads to more
p.000081: than the minimum level of risk to the pregnant woman or her fetus;
p.000081: 5. The research project aims to provide health requirements for the pregnant woman and her fetus and
p.000081: acquire information that cannot otherwise be obtained;
p.000081: 6. The principal investigator shall comit not to offer any type of reward in return for termination of pregnancy for
p.000081: research purposes;
p.000081: 7. Obtain the “Informed Consent” from both the pregnant woman and her husband.
p.000081:
p.000082: 82
p.000082:
p.000082: Article (26.2)
p.000082: No research on fetuses may be initiated unless the following conditions are
p.000082: satisfied:
p.000082: 1. The research shall not harm or endanger the life of the fetus;
p.000082: 2. The research project shall aim to provide health requirements for the
p.000082: fetus and to acquire information that cannot otherwise be obtained;
p.000082: 3. No research may be conducted on a living fetus unless it is nearly certain that its life is threatened
p.000082: or that the level of risk the fetus may face in case it remains in the uterus could be lessened, provided there is no
p.000082: safer means to achieve the same.
p.000082:
p.000082: Article 27
p.000082: Cells, tissues and derivatives of human sperms, gametes and zygotes may not be transported or exploited for the
p.000082: purpose of research except in accordance with conditions and restrictions laid down by the National Committee.
p.000082:
p.000082: Article (27.1)
p.000082: The National Committee shall set controls required for transfer and use of cells, tissues and derivatives
p.000082: constituents of human sperms, gametes and zygotes for research purposes. Said controls shall be reported to the
p.000082: Research Ethics Monitoring Office and local committees to abide by.
p.000082:
p.000082: Article 28
p.000082: Fetuses may not be cloned for the purpose of obtaining embryonic stem cells, nor may male or female gametes taken from
p.000082: sperms or eggs be donated to produce fertilized eggs that can grow into a fetus for the purpose of generating stem
p.000082: cells therefrom and conducting research thereon.
p.000083: 83
p.000083:
p.000083: Article (28.1)
p.000083: The National Committee shall monitor institutions where fertilized eggs are produced to ensure their compliance with
p.000083: the provisions of the Law and Implementing Regulations and instructions issued by the National Committee.
p.000083:
p.000083: Article 29
p.000083: Banks for preserving reproductive male or female cells with the intent of conducting research thereon may not be
p.000083: established.
p.000083:
p.000083: Article 30
p.000083: Organs and tissues of fetuses aborted before reaching one hundred twenty days may be used in research and experiments
p.000083: in accordance with controls and conditions set forth in the Regulations.
p.000083:
p.000083: Article (30.1)
p.000083: Research may be conducted on a pre-quickening stillborn fetus, if deemed necessary by the local committee, provided the
p.000083: research project is beneficial and contributes to the progress of applied sciences.
p.000083:
p.000083: Article (30.2)
p.000083: Samples may be taken from a stillborn fetus upon obtaining approval of the local committee, provided said samples are
p.000083: legally stored at approved gene banks.
p.000083:
p.000083: Article (30.3)
p.000083: 1. Research may be conducted on products of conception if the two
p.000083: following conditions are satisfied:
p.000083:
p.000084: 84
p.000084:
p.000084: a. It is established through a medical report signed by two consultant physicians, upon medical examination of
p.000084: products of conception, that it has no chance for survival;
p.000084: b. The conditions set forth in the Law and Regulations regarding research on the minor, incompetent or
p.000084: mentally disabled person shall be applied.
p.000084: 2. Research may be conducted on products of conception if said research aims to improve fetus chances of
p.000084: survival and obtain important information that may not be otherwise obtained, unless there is additional
p.000084: risk to the products of pregnancy.
p.000084:
p.000084: Article (30.4)
p.000084: If the research is conducted on an aborted or miscarried fetus, the following controls shall be observed:
p.000084: 1. Obtain the “Informed Consent” from the woman and her husband in accordance with the provisions of the Law and
p.000084: Regulations as well as controls and procedures set by the National Committee in this regard;
p.000084: 2. The woman and her husband shall be informed of the methodology used in the research on the aborted
p.000084: or miscarried fetus and whether there is an intention to store tissues taken therefrom to be used later for
p.000084: research;
p.000084: 3. Only miscarried and lawfully aborted fetuses according to the Law of Practicing Healthcare Professions may be used
p.000084: in research.
p.000084:
p.000084:
p.000084:
p.000084:
p.000084:
p.000084:
p.000084:
p.000084:
p.000084:
p.000085: 85
p.000085:
p.000085:
p.000085:
p.000085:
p.000085:
p.000085:
p.000085:
p.000085:
p.000085:
p.000085:
p.000085:
p.000085:
p.000085:
p.000085:
p.000085:
p.000085:
p.000085:
p.000085:
p.000085:
p.000085:
p.000085:
p.000085:
p.000085:
p.000085:
p.000085:
p.000085:
p.000085:
p.000085:
p.000085:
p.000085:
p.000085:
p.000085:
p.000085:
p.000085:
p.000085:
p.000085:
p.000085:
p.000085:
p.000085:
p.000085:
p.000085:
p.000086: 86
p.000086:
p.000086: Chapter Eleven: Dealing with Genetic Material and its Banks
p.000086:
p.000086: Article 31
p.000086: A central data bank shall be established within KACST for the purpose of maintaining information related
p.000086: to genetic material and regulating use thereof in accordance with procedures specified by the Regulations. Said bank
p.000086: shall provide information for research using genetic material in the Kingdom.
p.000086:
p.000086: Article (31.1)
p.000086: The Central Data Bank and the local gene banks shall provide parties concerned with information available
p.000086: on different diseases affecting individuals, families or the community, subject to maintaining the privacy of the
p.000086: genetic material source and barring the possibility to identify the source of the sample.
p.000086:
p.000086: Article (31.2)
...
Searching for indicator fetuses:
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p.000067: purpose of trading therein.
p.000067:
p.000067: Article (19.2)
p.000067: In case the investigator is found guilty of violating Article (19.1) of the Regulations, he shall be subject to the
p.000067: appropriate penalties set forth in the Law and Regulations as well as laws prohibiting trade in human organs and not in
p.000067: conflict with Sharia.
p.000067:
p.000067: Article 20
p.000067: An organ removed for a purely medical purpose may be used in scientific research upon obtaining the
p.000067: informed consent.
p.000068: 68
p.000068:
p.000068: Article (20.1)
p.000068: Subject to the provisions of the Law and Regulations regarding obtaining the “Informed Consent”, human organs removed
p.000068: for medical purposes may be used in scientific research in a way not conflicting with the provisions of the Law and
p.000068: Regulations.
p.000068:
p.000068: Article (20.2)
p.000068: When conducting research on samples previously collected for another research purpose or for a purely medical
p.000068: care purpose and it is still possible to relate the said samples to their source, consent of the person from whom the
p.000068: samples have been collected is required prior to conducting research thereon.
p.000068:
p.000068: Article (20.3)
p.000068: When conducting research on samples previously collected for another research or for a purely medical care
p.000068: purpose and it is no longer possible to relate said samples to their source, permission of the local committee to
p.000068: conduct the research may deem sufficient.
p.000068:
p.000068: Article 21
p.000068: No research may be conducted on human zygotes, gametes or fetuses except under controls specified by the Regulations.
p.000068:
p.000068: Article (21.1)
p.000068: No research may be conducted on human zygotes or gametes except under the following controls:
p.000068: 1. The practices indicated in the research proposal shall be consistent with the provisions of Sharia
p.000068: and standard medical principles, and
p.000069: 69
p.000069:
p.000069: the research shall be justified in terms of its contribution to medical
p.000069: knowledge or technical applications;
p.000069: 2. The investigator shall obtain the “Informed Consent” from the person donating zygotes or gametes in accordance
p.000069: with Article 11 of the Law.
p.000069: 3. The investigator shall provide all research-related information to the persons donating zygotes or gametes, and
p.000069: their spouses, if any. Said information shall include a full explanation of the research potential risk and expected
p.000069: benefit.
p.000069:
p.000069: Article (21.2)
p.000069: When conducting research on human zygotes or gametes, the researcher shall accurately record all required data and
p.000069: information about the human subject and each person related to the zygotes or gametes under research, and all research
p.000069: findings. He shall keep records of the same for at least five years from date of research completion, and shall submit
p.000069: periodic reports on the research to the local committee.
p.000069:
p.000069: Article (21.3)
p.000069: No research may be conducted on human fetuses except for one of the following purposes:
p.000069: 1. Find a treatment for reproductive problems, in which case the research shall be conducted in an institution
p.000069: approved for treatment of such problems;
p.000069: 2. Conduct a new experiment expected to benefit human fetuses;
p.000069: 3. Acquire new knowledge about the condition of fetuses if it is not
p.000069: expected to achieve a direct benefit.
p.000069:
p.000069:
p.000069:
p.000069:
p.000070: 70
p.000070:
p.000070: Article (21.4)
p.000070: The research proposal on human fetuses shall include the indication that the expected benefit from the research would
p.000070: not be realized without using such fetuses, and that a similar benefit has been previously obtained through conducting
p.000070: research on animals, and that the research is justified in terms of its contribution to improvement of treatment
p.000070: techniques or knowledge of human diseases.
p.000070:
p.000070: Article (21.5)
p.000070: The investigator shall use the minimum number of fetuses to achieve research purposes.
p.000070:
p.000070: Article (21.6)
p.000070: In cases of research conducted to acquire new knowledge, the researcher shall submit to the local committee proof that
p.000070: potential risk for the fetus is minimal.
p.000070:
p.000070: Article (21.7)
p.000070: The investigator shall prepare and keep records of the source of each fetus and the results of using said fetus in the
p.000070: research, and shall submit periodic reports on the research to the local committee.
p.000070:
p.000070: Article (21.8)
p.000070: The investigator shall abide by the controls and procedures set by the National Committee regarding
p.000070: research on stem cells, zygotes, gametes and fetuses.
p.000070:
p.000070: Article 22
p.000070: No research may be conducted for the purpose of human cloning.
p.000070:
p.000071: 71
p.000071:
p.000071: Article (22.1)
p.000071: No investigator shall be permitted to conduct research on human cloning and any reproductive and research
p.000071: applications resulting therefrom due to constraints determined by sharia, ethical principles and health-related
p.000071: harms, where harms and dangers to humanity outweigh the expected benefits.
p.000071:
p.000071: Article 23
p.000071: Research may be conducted on tissues, living cells and separated parts, including stem cells extracted from the
p.000071: umbilical cord or adult stem cells, upon obtaining the informed consent.
p.000071:
p.000071: Article (23.1) Subject to the
p.000071: provisions and principles set forth in the Law and Implementing Regulations and directives issued by the National
p.000071: Committee, research may be conducted on tissues, living cells and separated parts, including stem cells extracted from
p.000071: the umbilical cord or adult stem cells, upon fulfilling the following conditions:
p.000071: 1. Fetuses may not be cloned for the purpose of obtaining and using stem cells in research.
p.000071: 2. Excess fertilized eggs from in vitro fertilization procedures or from insemination using donor ovum
p.000071: and sperm, shall neither be used for therapeutic purposes nor in stem cell research.
p.000071: 3. Male or female gametes taken from sperms or eggs may not be donated to produce fertilized eggs that can grow into
p.000071: a fetus for the purpose of generating stem cells therefrom.
p.000071: 4. Embryonic stem cells derived from aborted fetuses may be used for therapeutic purposes. Likewise, miscarried
p.000071: fetuses without any signs
p.000072: 72
p.000072:
p.000072: of life yet may be used in research or in scientific and laboratory
p.000072: experiments in accordance with observed Sharia rules in the Kingdom.
p.000072: 5. In case of stillborn fetuses, embryonic stem cells may be transferred and used in research.
p.000072: 6. Stem cells of an adult human may be used, provided said human is not subject to any harm, and such stem cells can
p.000072: be used to treat a patient, and the expected benefit outweighs the possible harm.
p.000072: 7. Induced pluripotent stem cells, in which adult stem cells are induced to obtain pluripotent cells which can be
p.000072: developed into other kinds of cells, such as nerve cells and others, can be used solely at an experimental and animal
p.000072: level, provided the following conditions are fulfilled:
p.000072: a. The research is conducted at a research center affiliated with a government agency, or with the
p.000072: participation of the said government agency.
p.000072: b. A written authorization is obtained from the local research ethics committee.
p.000072: c. It is pledged in writing not to use these induced pluripotent stem cells on humans.
p.000072: 8. Embryonic cells and derivatives can be imported only from the sources permitted by these regulations, once
p.000072: the authorization of the local committee is obtained. Commercially available induced pluripotent stem cells
p.000072: can also be imported from scientifically recognized sources.
p.000072:
p.000072: Article (23.2)
p.000072: It is prohibited to import the following stem cells:
p.000072: 1. Stem cells obtained from the insemination using a donor ovum and a donor sperm, performed to extract stem cells.
p.000072: 2. Stem cells obtained from deliberately aborted fetuses.
p.000072:
p.000073: 73
p.000073:
p.000073: Article (23.3)
p.000073: Cells can be used in clinical research (therapeutic research) under the following conditions:
p.000073: 1. A written authorization is obtained from the local research ethics committee.
p.000073: 2. A “Informed Consent” form is obtained from the human subject participant before the research
p.000073: project is initiated.
p.000073: 3. A written authorization is obtained from the Saudi Food and Drug Authority.
p.000073: 4. The expected benefit for the human subject and the extent to which it outweighs the possible harm shall
p.000073: be evaluated through a clear and thorough scientific assessment conducted by the investigator and submitted to
p.000073: the local committee.
p.000073: 5. The investigator or research team conducting the research shall be
p.000073: specialized and shall have sufficient scientific expertise and competence.
p.000073: 6. Research objectives shall be clearly and accurately defined, and the research is preceded by
p.000073: sufficient experiments on animals if the nature of the research so requires; subject to the discretion of the
p.000073: local committee.
p.000073: 7. If the local committee finds that the potential harm for the human subject outweighs the expected
p.000073: benefit, it must refrain from authorizing the research project.
p.000073: 8. The local committee shall review periodic reports submitted by the investigator to ensure that the
...
p.000080: 2. If precautionary measures taken for his protection are adequate and acceptable;
p.000080: 3. If there are sufficient reasons that make it possible to obtain significant
p.000080: information through the research for understanding the case under study.
p.000080:
p.000080: Article (25.5)
p.000080: The local committee may, prior to giving its approval of conducting research on the minor, incompetent or
p.000080: mentally disabled person, require appointing a qualified lawyer experienced to handle such case. Said lawyer shall have
p.000080: no relation with the researcher or the institution supervising and funding the research and shall observe the interest
p.000080: of the minor subject of the research, in coordination with his parents or guardian.
p.000080:
p.000080: Article (25.6)
p.000080: The physically, but not mentally, disabled person shall be treated as a normal person, in terms of his responsibility
p.000080: for giving the “Informed Consent” and his understanding of research potential risks and expected benefits.
p.000081: 81
p.000081:
p.000081: Article 26
p.000081: Pregnant women, fetuses and the product of pregnancy may not be used in research except in accordance with
p.000081: controls specified by the Regulations.
p.000081:
p.000081: Article (26.1)
p.000081: An investigator may not initiate any research on a pregnant woman unless
p.000081: the following conditions are satisfied:
p.000081: 1. Conduct appropriate studies, when possible, on animals and non- pregnant women that confirm the
p.000081: safety of methods and means of research, provided the results of such research are published in
p.000081: internationally recognized scientific journals in accordance with the provisions of the Law and
p.000081: Regulations;
p.000081: 2. The level of risk the research project poses to pregnant woman or her
p.000081: fetus does not exceed the minimum risk level;
p.000081: 3. The investigator shall not have any role in deciding how and when the pregnancy will be terminated or whether
p.000081: the fetus can survive after termination of pregnancy;
p.000081: 4. The research shall not lead to a change in pregnancy termination procedure if such change leads to more
p.000081: than the minimum level of risk to the pregnant woman or her fetus;
p.000081: 5. The research project aims to provide health requirements for the pregnant woman and her fetus and
p.000081: acquire information that cannot otherwise be obtained;
p.000081: 6. The principal investigator shall comit not to offer any type of reward in return for termination of pregnancy for
p.000081: research purposes;
p.000081: 7. Obtain the “Informed Consent” from both the pregnant woman and her husband.
p.000081:
p.000082: 82
p.000082:
p.000082: Article (26.2)
p.000082: No research on fetuses may be initiated unless the following conditions are
p.000082: satisfied:
p.000082: 1. The research shall not harm or endanger the life of the fetus;
p.000082: 2. The research project shall aim to provide health requirements for the
p.000082: fetus and to acquire information that cannot otherwise be obtained;
p.000082: 3. No research may be conducted on a living fetus unless it is nearly certain that its life is threatened
p.000082: or that the level of risk the fetus may face in case it remains in the uterus could be lessened, provided there is no
p.000082: safer means to achieve the same.
p.000082:
p.000082: Article 27
p.000082: Cells, tissues and derivatives of human sperms, gametes and zygotes may not be transported or exploited for the
p.000082: purpose of research except in accordance with conditions and restrictions laid down by the National Committee.
p.000082:
p.000082: Article (27.1)
p.000082: The National Committee shall set controls required for transfer and use of cells, tissues and derivatives
p.000082: constituents of human sperms, gametes and zygotes for research purposes. Said controls shall be reported to the
p.000082: Research Ethics Monitoring Office and local committees to abide by.
p.000082:
p.000082: Article 28
p.000082: Fetuses may not be cloned for the purpose of obtaining embryonic stem cells, nor may male or female gametes taken from
p.000082: sperms or eggs be donated to produce fertilized eggs that can grow into a fetus for the purpose of generating stem
p.000082: cells therefrom and conducting research thereon.
p.000083: 83
p.000083:
p.000083: Article (28.1)
p.000083: The National Committee shall monitor institutions where fertilized eggs are produced to ensure their compliance with
p.000083: the provisions of the Law and Implementing Regulations and instructions issued by the National Committee.
p.000083:
p.000083: Article 29
p.000083: Banks for preserving reproductive male or female cells with the intent of conducting research thereon may not be
p.000083: established.
p.000083:
p.000083: Article 30
p.000083: Organs and tissues of fetuses aborted before reaching one hundred twenty days may be used in research and experiments
p.000083: in accordance with controls and conditions set forth in the Regulations.
p.000083:
p.000083: Article (30.1)
p.000083: Research may be conducted on a pre-quickening stillborn fetus, if deemed necessary by the local committee, provided the
p.000083: research project is beneficial and contributes to the progress of applied sciences.
p.000083:
p.000083: Article (30.2)
p.000083: Samples may be taken from a stillborn fetus upon obtaining approval of the local committee, provided said samples are
p.000083: legally stored at approved gene banks.
p.000083:
p.000083: Article (30.3)
p.000083: 1. Research may be conducted on products of conception if the two
p.000083: following conditions are satisfied:
p.000083:
p.000084: 84
p.000084:
p.000084: a. It is established through a medical report signed by two consultant physicians, upon medical examination of
p.000084: products of conception, that it has no chance for survival;
p.000084: b. The conditions set forth in the Law and Regulations regarding research on the minor, incompetent or
p.000084: mentally disabled person shall be applied.
p.000084: 2. Research may be conducted on products of conception if said research aims to improve fetus chances of
p.000084: survival and obtain important information that may not be otherwise obtained, unless there is additional
p.000084: risk to the products of pregnancy.
p.000084:
p.000084: Article (30.4)
p.000084: If the research is conducted on an aborted or miscarried fetus, the following controls shall be observed:
p.000084: 1. Obtain the “Informed Consent” from the woman and her husband in accordance with the provisions of the Law and
p.000084: Regulations as well as controls and procedures set by the National Committee in this regard;
p.000084: 2. The woman and her husband shall be informed of the methodology used in the research on the aborted
p.000084: or miscarried fetus and whether there is an intention to store tissues taken therefrom to be used later for
p.000084: research;
p.000084: 3. Only miscarried and lawfully aborted fetuses according to the Law of Practicing Healthcare Professions may be used
p.000084: in research.
p.000084:
p.000084:
p.000084:
p.000084:
p.000084:
p.000084:
p.000084:
p.000084:
p.000084:
p.000085: 85
p.000085:
p.000085:
p.000085:
p.000085:
p.000085:
p.000085:
p.000085:
p.000085:
p.000085:
p.000085:
p.000085:
p.000085:
p.000085:
p.000085:
p.000085:
p.000085:
p.000085:
p.000085:
p.000085:
p.000085:
p.000085:
p.000085:
p.000085:
p.000085:
p.000085:
p.000085:
p.000085:
p.000085:
p.000085:
p.000085:
p.000085:
p.000085:
p.000085:
p.000085:
p.000085:
p.000085:
p.000085:
p.000085:
p.000085:
p.000085:
p.000085:
p.000086: 86
p.000086:
p.000086: Chapter Eleven: Dealing with Genetic Material and its Banks
p.000086:
p.000086: Article 31
p.000086: A central data bank shall be established within KACST for the purpose of maintaining information related
p.000086: to genetic material and regulating use thereof in accordance with procedures specified by the Regulations. Said bank
p.000086: shall provide information for research using genetic material in the Kingdom.
p.000086:
p.000086: Article (31.1)
p.000086: The Central Data Bank and the local gene banks shall provide parties concerned with information available
p.000086: on different diseases affecting individuals, families or the community, subject to maintaining the privacy of the
p.000086: genetic material source and barring the possibility to identify the source of the sample.
p.000086:
p.000086: Article (31.2)
p.000086: The investigator shall maintain the confidentiality of research conclusions,
p.000086: and not identify their source.
p.000086:
p.000086: Article (31.3)
p.000086: When conducting research on genetic material, the following shall be observed:
...
p.000096: 8. System used to save all data and information resulting from the experiment in dedicated databases.
p.000096: 9. The authorizations of relevant authorities when needed.
p.000096:
p.000096: Article (38.5)
p.000096: When reviewing research proposals resulting in pain and suffering of animals, the local committee must
p.000096: thoroughly assess the proposal, and confirm that:
p.000096: 1. The experiment is not prohibited or restricted by international or regional conventions or rulings where
p.000096: the Kingdom of Saudi Arabia is a party or a signatory.
p.000096: 2. There are no other possible alternatives to achieve the same required results.
p.000096: 3. The research team is fully competent and qualified, and the tools , materials and laboratory
p.000096: environment of the experiment are perfectly adequate.
p.000096:
p.000097: 97
p.000097:
p.000097: Article (38.6)
p.000097: The research protocol shall take all measures necessary to prevent animal suffering, using the minimum number of
p.000097: research animals which have a low level of neurological or physiological sensation.
p.000097:
p.000097: Article (38.7)
p.000097: Artificial hybridization may not be conducted except between animals of the same species, even if breeds are different,
p.000097: provided that the expected benefit outweighs the risks and that such risks can be prevented or controlled.
p.000097:
p.000097: Article (38.8)
p.000097: Animals may not be cloned unless medically proven safe as per a medical report approved by at least two specialists.
p.000097:
p.000097: Article (38.9)
p.000097: Transplant of animal fetuses shall be subject to the same conditions governing the process of artificial
p.000097: insemination set forth in Article (38.7).
p.000097:
p.000097: Article (38.10)
p.000097: Banks for preserving animal sperms or eggs for production or research purposes may be established,
p.000097: without prejudice to rules of artificial insemination.
p.000097:
p.000097: Article (38.11)
p.000097: Research and experiments causing pain to animals may not be conducted
p.000097: unless the following two conditions are satisfied:
p.000097: 1. The investigator is well versed in physiology, and the research or
p.000097: experiment is beneficial to science, such as leading to the discovery
p.000097:
p.000098: 98
p.000098:
p.000098: of disease or treatment that can help combat diseases and ailments, protecting health and the
p.000098: environment.
p.000098: 2. The investigator shall obtain local committee approval.
p.000098:
p.000098: Article (38.12)
p.000098: Pain-causing research and experiments on animals must be conducted under anesthesia unless this undermines research
p.000098: objectives, at the discretion of the investigator.
p.000098:
p.000098: Article (38.13)
p.000098: In all cases, upon completion, the animal subject of research shall be disposed of while under anesthesia,
p.000098: in accordance with the provisions of Shari’a.
p.000098:
p.000098: Article (38.14)
p.000098: Animals earmarked for experimentation shall be disposed of if they contract an infectious disease other than the one
p.000098: under study. However, if it is possible to treat such animals, this shall be carried out in isolated places, and all
p.000098: procedures of epidemic quarantine shall be enforced under the supervision of the veterinarian in charge. The disease
p.000098: and the measures taken for its control or treatment shall be reported to the competent authorities.
...
Social / Incarcerated
Searching for indicator liberty:
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p.000006: Adult Stem Cells: Organically unspecialized cells that are removed from the cells of a fully developed living being.
p.000006:
p.000006: Article (1.1)
p.000006: Without prejudice to the meanings of the terms and phrases specified in Article 1 of the Law, the following
p.000006: terms and phrases – wherever used in the Law – shall have the meanings assigned to them, unless otherwise required
p.000006: by context.
p.000006: Human Subject (Participant): A person who consents or whose guardian consents to conduct clinical, non-clinical or
p.000006: therapeutic research or experiments on him.
p.000006: Principal Investigator: Lead researcher in charge of planning and conducting the research,
p.000006: collecting and analyzing data, and directing interventions stated in the research plan.
p.000006: Clinical Research: Any research related to collecting and analyzing data for volunteers or patients for the purpose of
p.000006: obtaining general knowledge that can be applied to other individuals with regard to mechanism of disease, its
p.000006: incidence, prevalence, transmission or treatment of a disease.
p.000006: Non-Clinical Research: Any research related to collecting and analyzing data not directly related to people for
p.000006: the purpose of obtaining general knowledge or facts.
p.000006:
p.000007: 7
p.000007:
p.000007: Clinical Trial: Experiments conducted on human volunteers to examine safety and effectiveness of a new medication or
p.000007: medical device.
p.000007: Prisoner: A person deprived of liberty, whether serving a prison sentence, detained on trial, or is a correction
p.000007: facility inmate.
p.000007: Vulnerable groups: Groups of individuals in need of additional protection due to their lack of legal capacity, their
p.000007: questionable or diminished capacity or their lack of freedom to choose.
p.000007: Stillborn: A fetus delivered, came out of, or removed from the uterus with no signs of life such as heartbeat, natural
p.000007: breathing, movement, or pulsation of the umbilical cord if still connected.
p.000007: Diagnostic Procedure: A test aiming at finding a certain disorder or disease
p.000007: in a living creature.
p.000007: Medication: A chemical compound administered to a living creature to help diagnose, treat, prevent, cure or
p.000007: alleviate the effects of a disease or organic disorder.
p.000007: Periodic Assessment: Observation of research progress by safety assessment and information monitoring
p.000007: committee to ascertain safety of the human subject on a continuous basis and to ensure nonexistence of any reason for
p.000007: discontinuation or modification of the research.
p.000007: Periodic Follow-up: Review of the periodic report submitted by the principal investigator to the local
p.000007: committee to evaluate research progress and conformity with the approved research plan.
...
Searching for indicator prison:
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p.000006:
p.000006: Article (1.1)
p.000006: Without prejudice to the meanings of the terms and phrases specified in Article 1 of the Law, the following
p.000006: terms and phrases – wherever used in the Law – shall have the meanings assigned to them, unless otherwise required
p.000006: by context.
p.000006: Human Subject (Participant): A person who consents or whose guardian consents to conduct clinical, non-clinical or
p.000006: therapeutic research or experiments on him.
p.000006: Principal Investigator: Lead researcher in charge of planning and conducting the research,
p.000006: collecting and analyzing data, and directing interventions stated in the research plan.
p.000006: Clinical Research: Any research related to collecting and analyzing data for volunteers or patients for the purpose of
p.000006: obtaining general knowledge that can be applied to other individuals with regard to mechanism of disease, its
p.000006: incidence, prevalence, transmission or treatment of a disease.
p.000006: Non-Clinical Research: Any research related to collecting and analyzing data not directly related to people for
p.000006: the purpose of obtaining general knowledge or facts.
p.000006:
p.000007: 7
p.000007:
p.000007: Clinical Trial: Experiments conducted on human volunteers to examine safety and effectiveness of a new medication or
p.000007: medical device.
p.000007: Prisoner: A person deprived of liberty, whether serving a prison sentence, detained on trial, or is a correction
p.000007: facility inmate.
p.000007: Vulnerable groups: Groups of individuals in need of additional protection due to their lack of legal capacity, their
p.000007: questionable or diminished capacity or their lack of freedom to choose.
p.000007: Stillborn: A fetus delivered, came out of, or removed from the uterus with no signs of life such as heartbeat, natural
p.000007: breathing, movement, or pulsation of the umbilical cord if still connected.
p.000007: Diagnostic Procedure: A test aiming at finding a certain disorder or disease
p.000007: in a living creature.
p.000007: Medication: A chemical compound administered to a living creature to help diagnose, treat, prevent, cure or
p.000007: alleviate the effects of a disease or organic disorder.
p.000007: Periodic Assessment: Observation of research progress by safety assessment and information monitoring
p.000007: committee to ascertain safety of the human subject on a continuous basis and to ensure nonexistence of any reason for
p.000007: discontinuation or modification of the research.
p.000007: Periodic Follow-up: Review of the periodic report submitted by the principal investigator to the local
p.000007: committee to evaluate research progress and conformity with the approved research plan.
p.000007: Expedited Review: An evaluation carried out by the local committee chairman, or by a committee member
...
Searching for indicator restricted:
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p.000092: 10. The research shall be based on scientific principles, and preceded by sufficient laboratory experiments and
p.000092: animal testing;
p.000092: 11. The expected benefit from the research shall outweigh any potential
p.000092: risks;
p.000092: 12. The research shall be conducted by a qualified investigator specialized
p.000092:
p.000093: 93
p.000093:
p.000093: in genetic medicine and assisted by a highly efficient medical team. Said investigator shall be well versed in genetic
p.000093: and scientific material related to the subject of the research;
p.000093: 13. Gene therapy may not be carried out for research purposes on gametes (sperms and ova) or experimental research on
p.000093: stem cells obtained from fertilized zygotes or related to reproductive cloning;
p.000093: 14. Handling of genetic material in research, storage and disposal thereof, as well as collaborative research with
p.000093: centers abroad shall be in accordance with the controls set forth in the Law and Regulations.
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p.000094: 94
p.000094:
p.000094: Chapter Twelve: Use of Animals and Plants in Experiments
p.000094:
p.000094: Article 38
p.000094: 1. Animals may be used for research employing all experimental or scientific means not causing unusual pain to the
p.000094: animals.
p.000094: 2. Use of animals shall be restricted to research whose objectives cannot be realized without such use.
p.000094: 3. Endangered animal species may not be subject to negative use. The Regulations shall specify ethical conditions and
p.000094: procedures for use of animals in research.
p.000094:
p.000094: Article (38.1)
p.000094: Animals may be used in scientific experiments where research objectives
p.000094: cannot be otherwise realized.
p.000094:
p.000094: Article (38.2)
p.000094: When conducting research on animals, the investigator shall comply with the following:
p.000094: 1. Sharia provisions related to humane treatment of animals.
p.000094: 2. Scientific principles and conventions governing experimental practices
p.000094: on animals.
p.000094: 3. A license must be obtained from the local committee to conduct research on animals according to the licensing
p.000094: procedures of the National Committee.
p.000094: 4. The approval of the local committee to commence the research must be obtained.
p.000094: 5. It must be verified that previous cell research was conducted before
p.000094: conducting research on animals when needed.
p.000094:
p.000095: 95
p.000095:
p.000095: 6. Usage must be limited to the minimum number of animals required to
p.000095: achieve research objectives.
p.000095: 7. Potential harm to and suffering of animals must be minimized as much as possible.
p.000095: 8. Observing that the expected results and desired benefits from the research outweigh any risks and
p.000095: harms to the animal subject of the research or the environment in general;
p.000095: 9. The appropriate animal must be selected to provide credible information and results.
p.000095: 10. Practice shall be subject to appropriate and acceptable scientific and
...
p.000095: 5- Contribution to forensic research;
p.000095: 6- Improvement of animal breeding methods and management;
p.000095: 7- Conduct preliminary research on pharmaceutical substances, toxins and radioactive effects.
p.000095:
p.000095: Article (38.4)
p.000095: When reviewing research proposals involving animal and plant experiments,
p.000095:
p.000096: 96
p.000096:
p.000096: the local committee must verify that the research proposal includes the following mandatory elements:
p.000096: 1. Principal investigator and research team credentials,
p.000096: 2. Animal/plant species used for the experiment, source and quantity.
p.000096: 3. Any agreements with other parties related to the experiment, or to the experiment’s results.
p.000096: 4. A detailed account of the locations where the experiment will be carried
p.000096: out to conduct field visits when necessary.
p.000096: 5. The system of identification used to distinguish the animals and plants used in the experiment, and the system
p.000096: used to save the information and data related to every animal or plant in the experiment’s records.
p.000096: 6. Emergency and hazards management plans.
p.000096: 7. Means and mechanism for the disposal of the experiment’s components.
p.000096: 8. System used to save all data and information resulting from the experiment in dedicated databases.
p.000096: 9. The authorizations of relevant authorities when needed.
p.000096:
p.000096: Article (38.5)
p.000096: When reviewing research proposals resulting in pain and suffering of animals, the local committee must
p.000096: thoroughly assess the proposal, and confirm that:
p.000096: 1. The experiment is not prohibited or restricted by international or regional conventions or rulings where
p.000096: the Kingdom of Saudi Arabia is a party or a signatory.
p.000096: 2. There are no other possible alternatives to achieve the same required results.
p.000096: 3. The research team is fully competent and qualified, and the tools , materials and laboratory
p.000096: environment of the experiment are perfectly adequate.
p.000096:
p.000097: 97
p.000097:
p.000097: Article (38.6)
p.000097: The research protocol shall take all measures necessary to prevent animal suffering, using the minimum number of
p.000097: research animals which have a low level of neurological or physiological sensation.
p.000097:
p.000097: Article (38.7)
p.000097: Artificial hybridization may not be conducted except between animals of the same species, even if breeds are different,
p.000097: provided that the expected benefit outweighs the risks and that such risks can be prevented or controlled.
p.000097:
p.000097: Article (38.8)
p.000097: Animals may not be cloned unless medically proven safe as per a medical report approved by at least two specialists.
p.000097:
p.000097: Article (38.9)
p.000097: Transplant of animal fetuses shall be subject to the same conditions governing the process of artificial
p.000097: insemination set forth in Article (38.7).
p.000097:
p.000097: Article (38.10)
p.000097: Banks for preserving animal sperms or eggs for production or research purposes may be established,
p.000097: without prejudice to rules of artificial insemination.
p.000097:
p.000097: Article (38.11)
p.000097: Research and experiments causing pain to animals may not be conducted
p.000097: unless the following two conditions are satisfied:
...
Social / Laboratory Staff
Searching for indicator research staff:
(return to top)
p.000010: thereof or their genetic material in research in light of applicable professional ethics not conflicting
p.000010: with Sharia.
p.000010:
p.000010: Article (2.1)
p.000010: The Law aims to protect the rights of the human subject or part thereto, guarantee his safety and dignity, and
p.000010: not harm animals or plants when conducting research.
p.000010:
p.000010: Article (2.2)
p.000010: Sharia dictates and professional ethics enforced in official bodies in the Kingdom as well as rules and
p.000010: procedures set by the National Committee shall be observed in implementing the provisions of the Law and its
p.000010: Regulations.
p.000010:
p.000010: Article 3
p.000010: No establishment may conduct research on a living creature except upon fulfilling procedures required under
p.000010: this Law. Research shall be subject to periodic inspection by the National Committee in accordance with the
p.000010: Regulations.
p.000010:
p.000010: Article (3.1)
p.000010: No establishment may conduct research on Living Creatures except after registration of a local committee that
p.000010: grants licensing for conducting
p.000011: 11
p.000011:
p.000011: research and monitors research ethics in accordance with provisions of the Law and its Regulations.
p.000011:
p.000011: Article (3.2)
p.000011: The establishment shall be responsible for any research conducted therein and shall, through local committees, ensure
p.000011: that the researcher and research staff comply with controls, procedures and provisions set forth in the Law and its
p.000011: Regulations as well as decisions of the National Committee.
p.000011:
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p.000011:
p.000012: 12
p.000012:
p.000012: Chapter Three: National Committee of Bioethics
p.000012:
p.000012: Article 4
p.000012: 1. A national committee of bioethics shall be formed at KACST comprising specialists nominated by the
p.000012: competent minister or head of an agency for a renewable term of 3 years, as follows:
p.000012: A representative of KACST Chairman A representative of the
p.000012: Ministry of National Guard Member A representative of the Ministry of Defense
p.000012: Member
p.000012: A representative of the Ministry of Interior Member A representative of the General
p.000012: Presidency of Religious Research and Ifta
p.000012: Member
p.000012: Two representatives from the Ministry of Higher Education (Universities)
p.000012: Members
p.000012: A representative of the Ministry of Health Member
p.000012: A representative of the Ministry of Education Member
p.000012: A representative of the Ministry of Agriculture Member A representative of the Saudi Wildlife
...
Social / Property Ownership
Searching for indicator property:
(return to top)
p.000024: 24
p.000024:
p.000024: Chapter Four: Committee Revenues
p.000024:
p.000024: Article 7
p.000024: An annual financial allocation shall be set for the National Committee within the budget of KACST along with endowments
p.000024: allocated therefor.
p.000024:
p.000024: Article (7.1)
p.000024: 1. Committee revenues shall comprise the following:
p.000024: a. Financial allocations set for it within KACST’s budget;
p.000024: b. Endowments allocated for the Committee.
p.000024: 2. Upon setting allocations referred to in Paragraph (a) above, the following procedures shall be
p.000024: observed:
p.000024: a. The National Committee Chairman shall submit the allocations set for the following fiscal year to be approved by
p.000024: the Committee 30 days before its submission to KACST President;
p.000024: b. Upon approval of allocations by the National Committee, the Committee Chairman shall submit said
p.000024: allocations to KACST President.
p.000024: c. The Committee Chairman shall coordinate with relevant departments at KACST to incorporate said allocations in
p.000024: KACST budget. Upon discussing such allocations, the Chairman may, if necessary, seek the assistance of any person
p.000024: either from relevant departments at KACST or from the Ministry of Finance, as he deems fit.
p.000024: d. Upon approval of the budget and setting the financial allocations for the National Committee, the Committee
p.000024: Chairman shall present to the Committee the allocations and the proposed spending plan.
p.000024: 3. Upon allocating endowments for the National Committee, the following procedures shall be observed:
p.000024:
p.000025: 25
p.000025:
p.000025: a. If the National Committee receives a request to endow any property for its activities, said request shall be
p.000025: presented to its members for discussion and decision thereon.
p.000025: b. Upon reviewing the endowment request, the National Committee shall observe all relevant laws, decisions and
p.000025: directives.
p.000025: c. If the endowment is accepted, the National Committee shall set necessary controls and procedures for
p.000025: dealing therewith.
p.000025: d. The National Committee Chairman shall submit annual reports to the Committee regarding the endowments allocated
p.000025: for its activities. The Committee may take any decision it deems necessary in this regard.
p.000025: e. The National Committee may, if required, form from among its members or others a subcommittee to
p.000025: manage endowments.
p.000025:
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p.000026: 26
p.000026:
p.000026: Chapter Five: Research Ethics Monitoring Office
p.000026:
p.000026: Article 8
p.000026: Pursuant to this Law, an office for monitoring research ethics shall be established, and it shall report to the
p.000026: National Committee. Said office shall be located at KACST in Riyadh, and it may establish branches in the Kingdom’s
p.000026: provinces pursuant to a decision by KACST President upon recommendation by the National Committee. The office
p.000026: shall be headed by a specialist with experience in medical and scientific research and research ethics.
p.000026:
p.000026: Article (8.1)
...
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p.000086: 86
p.000086:
p.000086: Chapter Eleven: Dealing with Genetic Material and its Banks
p.000086:
p.000086: Article 31
p.000086: A central data bank shall be established within KACST for the purpose of maintaining information related
p.000086: to genetic material and regulating use thereof in accordance with procedures specified by the Regulations. Said bank
p.000086: shall provide information for research using genetic material in the Kingdom.
p.000086:
p.000086: Article (31.1)
p.000086: The Central Data Bank and the local gene banks shall provide parties concerned with information available
p.000086: on different diseases affecting individuals, families or the community, subject to maintaining the privacy of the
p.000086: genetic material source and barring the possibility to identify the source of the sample.
p.000086:
p.000086: Article (31.2)
p.000086: The investigator shall maintain the confidentiality of research conclusions,
p.000086: and not identify their source.
p.000086:
p.000086: Article (31.3)
p.000086: When conducting research on genetic material, the following shall be observed:
p.000086: 1. Islamic values, local culture and environmental safety;
p.000086: 2. Applicable and internationally recognized practices relating to conducting research on genetic
p.000086: material.
p.000086:
p.000086:
p.000086:
p.000086:
p.000087: 87
p.000087:
p.000087: Article (31.4)
p.000087: Results of the research on genetic material shall be the property of the State. Neither the researcher nor the
p.000087: institution may provide said results to any internal or foreign body without permission from the National Committee,
p.000087: provided the material and scientific rights of the researcher or research team and the research subject are
p.000087: preserved.
p.000087:
p.000087: Article (31.5)
p.000087: The local genetic material biobank shall provide the Central Data Bank with an annual report including
p.000087: the following data:
p.000087: 1. A classified list of genetic material available at the local bank, indicating
p.000087: date of acquisition and use;
p.000087: 2. A list of genetic materials withdrawn from the local bank, indicating date of withdrawal and investigator or
p.000087: institution using it;
p.000087: 3. A summary of research conducted on samples withdrawn from the local bank and used.
p.000087:
p.000087: Article 32
p.000087: When setting up local data banks for the preservation of genetic material, establishments conducting
p.000087: research on such genetic material shall comply with conditions and procedures specified by the Regulations.
p.000087:
p.000087: Article (32.1)
p.000087: Prior to initiating research on genetic samples, the investigator or research team shall observe the following
p.000087: procedures:
p.000087: 1. Set a detailed plan including, but not limited to, research objectives,
p.000087: study approach, expected results and risks, and submit the same to the
p.000087:
p.000088: 88
p.000088:
p.000088: local committee;
p.000088: 2. Explain to the donor, if known, the subject and nature of the research, expected results, and potential risks,
p.000088: particularly if the research has an unclear genetic therapeutic nature provided that the research plan is
p.000088: accompanied with proof thereof;
...
Social / Racial Minority
Searching for indicator race:
(return to top)
p.000090: related to donors in accordance with the provisions of the Law and Regulations.
p.000090:
p.000090: Article 35
p.000090: The local committee may restrict the researcher’s use of research results on genetic material if said results
p.000090: harm public interest, provided the National Committee approves the same.
p.000090:
p.000090: Article (35.1)
p.000090: The local committee may restrict the principal investigator’s use of research results on genetic material if
p.000090: publishing said results would harm public interest, subject to the approval of the National Committee.
p.000090:
p.000090:
p.000090:
p.000090:
p.000091: 91
p.000091:
p.000091: Article (35.2)
p.000091: If prevented from using results of his research, the investigator may claim
p.000091: indemnification for research expenses from the institution.
p.000091:
p.000091: Article 36
p.000091: Research with negative impacts on society may not be conducted, especially research reinforcing racial
p.000091: discrimination.
p.000091:
p.000091: Article (36.1)
p.000091: Conducting research on diseases that are particular among a certain group for the purpose of treatment and
p.000091: understanding of mechanisms of transmission of said diseases may not be construed as promoting racial
p.000091: discrimination.
p.000091:
p.000091: Article (36.2)
p.000091: Scientific results shall not be leaked to the media if this could lead to promoting discrimination on the
p.000091: basis of race or family or tribal affiliation.
p.000091:
p.000091: Article 37
p.000091: The Regulations shall specify the ethical controls and criteria of genetic treatment research.
p.000091:
p.000091: Article (37.1)
p.000091: The following ethical controls and criteria shall be complied with when conducting genetic treatment research:
p.000091: 1. A written approval shall be obtained from the National Committee in all matters related to gene therapy research;
p.000091: 2. Gene therapy research shall be subject to controls and provisions set
p.000091:
p.000092: 92
p.000092:
p.000092: forth in the Law and Regulations and provisions set by the National Committee;
p.000092: 3. The research shall be consistent with the provisions of Shari’a, and the research plan shall include
p.000092: proof of taking such provisions into consideration;
p.000092: 4. The research shall comply with the controls and criteria set forth in international agreements
p.000092: related to gene therapy and amendments thereto, without prejudice to Shari’a rules and provisions;
p.000092: 5. Said research shall be limited to incurable diseases affecting human life, which have not yet been
p.000092: successfully treated by conventional medical methods;
p.000092: 6. Prior to approval of research, it shall be ascertained that all available treatment options have been exhausted;
p.000092: 7. The local committee evaluating this type of research shall comprise at least two persons with scientific
p.000092: competence to evaluate gene therapy research. The local committee may invite experienced consultants to attend its
p.000092: meetings to help evaluate the research project;
p.000092: 8. Gene therapy research shall be conducted in qualified hospitals and research centers with required
...
Searching for indicator racial:
(return to top)
p.000090: The researcher shall observe the privacy and confidentiality of information related to those from
p.000090: whom the research samples have been collected.
p.000090:
p.000090: Article (34.1)
p.000090: The principal investigator shall be responsible for maintaining the privacy and confidentiality of information related
p.000090: to donors and shall be liable for any damage sustained by the donors or the community.
p.000090:
p.000090: Article (34.2)
p.000090: If local or international researchers are invited to conduct joint research on genetic material, the institution and
p.000090: principal investigator shall emphasize the necessity of observing the privacy and confidentiality of information
p.000090: related to donors in accordance with the provisions of the Law and Regulations.
p.000090:
p.000090: Article 35
p.000090: The local committee may restrict the researcher’s use of research results on genetic material if said results
p.000090: harm public interest, provided the National Committee approves the same.
p.000090:
p.000090: Article (35.1)
p.000090: The local committee may restrict the principal investigator’s use of research results on genetic material if
p.000090: publishing said results would harm public interest, subject to the approval of the National Committee.
p.000090:
p.000090:
p.000090:
p.000090:
p.000091: 91
p.000091:
p.000091: Article (35.2)
p.000091: If prevented from using results of his research, the investigator may claim
p.000091: indemnification for research expenses from the institution.
p.000091:
p.000091: Article 36
p.000091: Research with negative impacts on society may not be conducted, especially research reinforcing racial
p.000091: discrimination.
p.000091:
p.000091: Article (36.1)
p.000091: Conducting research on diseases that are particular among a certain group for the purpose of treatment and
p.000091: understanding of mechanisms of transmission of said diseases may not be construed as promoting racial
p.000091: discrimination.
p.000091:
p.000091: Article (36.2)
p.000091: Scientific results shall not be leaked to the media if this could lead to promoting discrimination on the
p.000091: basis of race or family or tribal affiliation.
p.000091:
p.000091: Article 37
p.000091: The Regulations shall specify the ethical controls and criteria of genetic treatment research.
p.000091:
p.000091: Article (37.1)
p.000091: The following ethical controls and criteria shall be complied with when conducting genetic treatment research:
p.000091: 1. A written approval shall be obtained from the National Committee in all matters related to gene therapy research;
p.000091: 2. Gene therapy research shall be subject to controls and provisions set
p.000091:
p.000092: 92
p.000092:
p.000092: forth in the Law and Regulations and provisions set by the National Committee;
p.000092: 3. The research shall be consistent with the provisions of Shari’a, and the research plan shall include
p.000092: proof of taking such provisions into consideration;
p.000092: 4. The research shall comply with the controls and criteria set forth in international agreements
p.000092: related to gene therapy and amendments thereto, without prejudice to Shari’a rules and provisions;
p.000092: 5. Said research shall be limited to incurable diseases affecting human life, which have not yet been
p.000092: successfully treated by conventional medical methods;
p.000092: 6. Prior to approval of research, it shall be ascertained that all available treatment options have been exhausted;
p.000092: 7. The local committee evaluating this type of research shall comprise at least two persons with scientific
...
Social / Religion
Searching for indicator religion:
(return to top)
p.000012: representative of King Faisal Specialist Hospital and Research Center
p.000012: Member
p.000012: A representative of Human Rights Commission Member The Director of Research Ethics Monitoring
p.000012: Office Member A representative of the private sector selected by the Chairman of the Council of the
p.000012: Chambers of Commerce and Industry Member A legal counselor selected by the President of KACST
p.000012: Member
p.000012: 2. The President of KACST shall issue the committee-formation decision, and said committee shall report
p.000012: to him.
p.000013: 13
p.000013:
p.000013: 3. The President of KACST shall appoint a secretary for the committee.
p.000013: 4. Committee members shall elect from among themselves a vice president.
p.000013:
p.000013: Article (4.1)
p.000013: 1. The President of KACST shall send a request for nomination to ministers and heads of relevant agencies
p.000013: as specified in Article 4 of the Law not less than three months before the formation or re-formation of the National
p.000013: Committee.
p.000013: 2. Each Minister or head of a relevant agency shall name a representative at the National Committee in ample
p.000013: time prior to the date set for formation of the committee, taking into consideration the following
p.000013: conditions:
p.000013: a. Be a Saudi national;
p.000013: b. Have academic qualification and experience necessary for
p.000013: contribution to committee work;
p.000013: c. Be known for integrity and competency;
p.000013: d. Not be previously convicted of a crime impinging on religion or honor.
p.000013: 3. If any member of the National Committee is unable to complete his term for any reason, or if he expresses
p.000013: his desire to discontinue his membership in the committee, or if he fails to attend three consecutive or seven
p.000013: non-consecutive meetings within the same year without an excuse acceptable to KACST President, a
p.000013: replacement shall be appointed in the same manner the replaced member was appointed to serve the remainder of his
p.000013: term.
p.000013: 4. Committee membership shall be a renewable term of three years, provided half the members are replaced
p.000013: upon committee re-formation
p.000014: 14
p.000014:
p.000014: for the third time. Membership may not be renewed for more than three consecutive terms.
p.000014:
p.000014: Article (4.2)
p.000014: 1. The National Committee shall have a chairman in accordance with the Law. Said chairman shall have a deputy to be
p.000014: elected by members of the National Committee by secret ballot in the second committee meeting. The President of KACST
p.000014: shall be notified of the ballot result.
p.000014: 2. The Chairman of the National Committee shall oversee its activities and all its administrative, financial and
p.000014: technical matters, particularly the following:
p.000014: a. Call for National Committee meetings and approve meeting agendas;
p.000014: b. Preside over and manage National Committee meetings;
p.000014: c. Ensure that National Committee decisions and recommendations are properly reported and pursue implementation
p.000014: thereof;
p.000014: d. Submit National Committee budget to KACST President;
p.000014: e. Represent the National Committee before governmental, judicial
p.000014: and other bodies within the Kingdom and abroad;
...
Searching for indicator religious:
(return to top)
p.000010: grants licensing for conducting
p.000011: 11
p.000011:
p.000011: research and monitors research ethics in accordance with provisions of the Law and its Regulations.
p.000011:
p.000011: Article (3.2)
p.000011: The establishment shall be responsible for any research conducted therein and shall, through local committees, ensure
p.000011: that the researcher and research staff comply with controls, procedures and provisions set forth in the Law and its
p.000011: Regulations as well as decisions of the National Committee.
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
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p.000011:
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p.000011:
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p.000011:
p.000012: 12
p.000012:
p.000012: Chapter Three: National Committee of Bioethics
p.000012:
p.000012: Article 4
p.000012: 1. A national committee of bioethics shall be formed at KACST comprising specialists nominated by the
p.000012: competent minister or head of an agency for a renewable term of 3 years, as follows:
p.000012: A representative of KACST Chairman A representative of the
p.000012: Ministry of National Guard Member A representative of the Ministry of Defense
p.000012: Member
p.000012: A representative of the Ministry of Interior Member A representative of the General
p.000012: Presidency of Religious Research and Ifta
p.000012: Member
p.000012: Two representatives from the Ministry of Higher Education (Universities)
p.000012: Members
p.000012: A representative of the Ministry of Health Member
p.000012: A representative of the Ministry of Education Member
p.000012: A representative of the Ministry of Agriculture Member A representative of the Saudi Wildlife
p.000012: Commission Member A representative of the Food and Drug General Authority Member A
p.000012: representative of King Faisal Specialist Hospital and Research Center
p.000012: Member
p.000012: A representative of Human Rights Commission Member The Director of Research Ethics Monitoring
p.000012: Office Member A representative of the private sector selected by the Chairman of the Council of the
p.000012: Chambers of Commerce and Industry Member A legal counselor selected by the President of KACST
p.000012: Member
p.000012: 2. The President of KACST shall issue the committee-formation decision, and said committee shall report
p.000012: to him.
p.000013: 13
p.000013:
p.000013: 3. The President of KACST shall appoint a secretary for the committee.
p.000013: 4. Committee members shall elect from among themselves a vice president.
p.000013:
p.000013: Article (4.1)
p.000013: 1. The President of KACST shall send a request for nomination to ministers and heads of relevant agencies
...
Social / Women
Searching for indicator women:
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p.000080: his legal guardian later gave the “Informed Consent”;
p.000080: 2. If precautionary measures taken for his protection are adequate and acceptable;
p.000080: 3. If there are sufficient reasons that make it possible to obtain significant
p.000080: information through the research for understanding the case under study.
p.000080:
p.000080: Article (25.5)
p.000080: The local committee may, prior to giving its approval of conducting research on the minor, incompetent or
p.000080: mentally disabled person, require appointing a qualified lawyer experienced to handle such case. Said lawyer shall have
p.000080: no relation with the researcher or the institution supervising and funding the research and shall observe the interest
p.000080: of the minor subject of the research, in coordination with his parents or guardian.
p.000080:
p.000080: Article (25.6)
p.000080: The physically, but not mentally, disabled person shall be treated as a normal person, in terms of his responsibility
p.000080: for giving the “Informed Consent” and his understanding of research potential risks and expected benefits.
p.000081: 81
p.000081:
p.000081: Article 26
p.000081: Pregnant women, fetuses and the product of pregnancy may not be used in research except in accordance with
p.000081: controls specified by the Regulations.
p.000081:
p.000081: Article (26.1)
p.000081: An investigator may not initiate any research on a pregnant woman unless
p.000081: the following conditions are satisfied:
p.000081: 1. Conduct appropriate studies, when possible, on animals and non- pregnant women that confirm the
p.000081: safety of methods and means of research, provided the results of such research are published in
p.000081: internationally recognized scientific journals in accordance with the provisions of the Law and
p.000081: Regulations;
p.000081: 2. The level of risk the research project poses to pregnant woman or her
p.000081: fetus does not exceed the minimum risk level;
p.000081: 3. The investigator shall not have any role in deciding how and when the pregnancy will be terminated or whether
p.000081: the fetus can survive after termination of pregnancy;
p.000081: 4. The research shall not lead to a change in pregnancy termination procedure if such change leads to more
p.000081: than the minimum level of risk to the pregnant woman or her fetus;
p.000081: 5. The research project aims to provide health requirements for the pregnant woman and her fetus and
p.000081: acquire information that cannot otherwise be obtained;
p.000081: 6. The principal investigator shall comit not to offer any type of reward in return for termination of pregnancy for
p.000081: research purposes;
p.000081: 7. Obtain the “Informed Consent” from both the pregnant woman and her husband.
...
Social / Youth/Minors
Searching for indicator minor:
(return to top)
p.000005: Local Committee: Committee for licensing research formed at an establishment in accordance with the
p.000005: provisions of this Law.
p.000005: Establishment: A public or private corporate entity engaged in research activities on Living Creatures.
p.000005: Researcher: A person academically qualified in a subject related to research
p.000005: and has completed a course on research ethics.
p.000005: Research: A systematic experimental investigation aiming at improvement of biosciences or enrichment or
p.000005: development of general knowledge by using a living creature or parts thereof.
p.000005: Living Creatures: Human beings, animals and plants.
p.000005: Genetic Material: Chain of nitrogenous bases that exist within the cells or are extracted therefrom and are
p.000005: responsible for carrying traits and characteristics from the mother cell to the sub-cell and from one
p.000005: living creature to its offspring.
p.000005:
p.000005: 5
p.000005:
p.000005: Legal Capacity: Reaching the age of eighteen, with mental ability to enter into legal relation on his own.
p.000005: Informed Consent: A person giving his consent with his free will, without exploitation or coercion and upon full
p.000005: understanding of what is required from him and of the research objectives and potential risks as well as of rights and
p.000005: obligations arising out of his participation therein.
p.000005: Minor: A person under eighteen years of age.
p.000005: Fetus: Outcome of pregnancy from the beginning of nidation in the uterus to the time of its delivery or removal.
p.000005: Guardian: A person having the right of legal authority over another person.
p.000005: Sperm: The product of fertilization up to forty days.
p.000005: Zygotes: An egg fertilized by a male sperm; from the time of fertilization until the time of division into eight cells.
p.000005: Gamete: The product of fertilization; from the end of the zygote phase until the phase of nidation where the
p.000005: zygote is implanted in the uterus. Cloning: The process of producing a complete individual genetically
p.000005: identical to another without sexual intercourse.
p.000005: Product of Pregnancy: A fetus that comes out of or removed from the uterus. Experimental Animals: Animals raised in
p.000005: cages or at certain places to be used in scientific experiments.
p.000005: Minimal Risk: Minor harm not exceeding potential risk encountered in daily life, which cannot be avoided during
p.000005: ordinary clinical or psychological examination, including potential discomfort and inconvenience.
p.000005: Legally Incompetent: A person lacking full legal capacity due to being a minor, lacking the ability of sound reasoning
p.000005: and judgment or being subject of a court ruling placing him under custody or continuation thereof which bars him from
p.000005: entering into a legal relation on his own.
p.000005: Disabled: A person suffering from a permanent full or partial deficiency
p.000005:
p.000006: 6
p.000006:
p.000006: in his physical, sensory, communicative, educational or psychological abilities to an extent that affects
p.000006: the possibility of meeting his common needs compared to his non-disabled peers.
p.000006: Child: A male or female not reaching the age of eighteen years which entails him to give an informed
p.000006: consent.
p.000006: Embryonic Stem Cells: Cells removed from the fertilized egg in its early phases; before the differentiation phase.
p.000006: Adult Stem Cells: Organically unspecialized cells that are removed from the cells of a fully developed living being.
p.000006:
p.000006: Article (1.1)
p.000006: Without prejudice to the meanings of the terms and phrases specified in Article 1 of the Law, the following
p.000006: terms and phrases – wherever used in the Law – shall have the meanings assigned to them, unless otherwise required
p.000006: by context.
p.000006: Human Subject (Participant): A person who consents or whose guardian consents to conduct clinical, non-clinical or
...
p.000051: the local committee may end the suspension the research project, and notify the investigator not to be remiss in
p.000051: submitting reports in the future;
p.000051: 5. If the principal investigator persists in ignoring to submit the periodic report, the local committee shall refer
p.000051: the whole matter to the Monitoring Office to submit it to the Violations Committee to suspend the research project and
p.000051: decide appropriate penalties.
p.000051:
p.000051: Article (10.30)
p.000051: 1. The principal investigator and the local committee must immediately notify of any major harm occurring
p.000051: during or after conducting the research, according to the following procedures:
p.000051: a. The principal investigator shall immediately notify the local committee as well as the research
p.000051: sponsor of any unexpected major harm occurring during or after conducting the research, providing the committee with
p.000051: all information pertaining to the harm related incident, indicating whether this incident is definitely, probably or by
p.000051: no means related to the research.
p.000051: b. The local committee shall notify the Monitoring Office of the major harm incident and all related details as soon
p.000051: as possible either in writing or by telephone within a period of twenty-four hours at the latest from the time of the
p.000051: harm related incident.
p.000051: 2. The principal investigator and the local committee must notify of any minor harm occurring during or after
p.000051: conducting the research, according to the following procedures:
p.000051: a. The principal investigator shall notify the local committee of any
p.000051:
p.000052: 52
p.000052:
p.000052: minor harm occurring during or after conducting the research within seven days at the latest from the date of
p.000052: the incident, providing the committee with all information pertaining to the harm related incident, indicating
p.000052: whether this incident is definitely, probably or by no means related to the research.
p.000052: b. The local committee shall notify the Monitoring Office of the incident of minor harm and all related
p.000052: details either in writing or by telephone within two weeks at the latest from the date of the incident, depending on
p.000052: the relevance of the incident.
p.000052: 3. The principal investigator shall include all expected or unexpected harms in his periodic report
p.000052: submitted to the local committee.
p.000052:
p.000052: Article (10.31)
p.000052: 1. If the local committee finds, through periodic monitoring of the research, that an unexpected harm
p.000052: has taken place as a direct result of the research but has not been referred to in the research proposal, it may
p.000052: take appropriate measures to stop the harm, including suspension of research project;
p.000052: 2. If the local committee finds that the investigator has not obtained required approvals, it shall suspend
p.000052: the research project and refer the matter to the Monitoring Office to submit it to the Violations Committee to decide
p.000052: appropriate penalties against the investigator.
p.000052: 3. The local committee shall notify head of the establishment of any
p.000052: research that is suspended or referred to the Monitoring Office.
p.000052:
p.000052: Article (10.32)
p.000052: The local committee may exempt the following research projects from the
p.000052: periodic follow-up:
p.000052:
p.000053: 53
p.000053:
p.000053: 1. Research involving study of information and data previously collected,
p.000053: provided one of the two following terms is fulfilled:
p.000053: a. If the information is generally and publicly available;
p.000053: b. If the information is recorded in a manner that does not reveal the identity of the source person.
...
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p.000078: 78
p.000078:
p.000078: Chapter Ten: Research on Special Cases
p.000078:
p.000078: Article 25
p.000078: Research may not be conducted on minors, incompetent or disabled persons unless the interest of these
p.000078: categories so requires. The Regulations shall specify ethical controls for conducting research on said
p.000078: categories.
p.000078:
p.000078: Article (25.1)
p.000078: 1. Research may not be conducted on minors, incompetent or mentally disabled persons without obtaining the
p.000078: “Informed Consent” from parents or the legal guardians in accordance with conditions set forth in the Law and
p.000078: Regulations, provided they are informed of the level of risk and its probability as well as the person’s assent.
p.000078: 2. Either parent or the legal guardian may grant the “Informed Consent” on behalf of minors, incompetent or mentally
p.000078: disabled persons provided his decision is based on the fact that the minor, incompetent or mentally disabled person is
p.000078: subject to no harm and may benefit from the research.
p.000078: 3. After granting the “Informed Consent”, either parent or the guardian may withdraw the consent at any phase of the
p.000078: research if he finds that the research conflicts with the interests of the minor, incompetent or mentally disabled
p.000078: person or if the research deviates from the objectives upon which the consent was granted.
p.000078:
p.000078: Article (25.2)
p.000078: The local committee shall grant its approval for research on minors, incompetent or mentally disabled
p.000078: persons subject to the following conditions:
p.000078:
p.000079: 79
p.000079:
p.000079: 1. It is not possible to conduct the research on a competent person;
p.000079: 2. The interest of the minor, incompetent or mentally disabled person requires subjecting him to the
p.000079: research, provided he is not exposed to more than the minimal potential risk;
p.000079: 3. The research protocol includes clear and appropriate measures to minimize potential risk as much as
p.000079: possible;
p.000079: 4. Evaluation of potential risk and expected benefit from the research shall indicate type, nature, degree and
p.000079: possibility of risk as well as the direct benefit for the minor, incompetent or mentally disabled person subject of the
p.000079: research and for similar persons;
p.000079: 5. The research shall be conducted in a school, camp, hospital, or institution where the majority of occupants are
p.000079: incompetent or disabled, provided the research subject belongs to this category.
p.000079:
p.000079: Article (25.3)
p.000079: If the local committee finds that the research in whole or in part achieves a direct benefit for the
p.000079: minor, incompetent or mentally disabled person but that its risk exceeds the minimal expected level, it may grant
p.000079: its approval to conduct the research pursuant to the following conditions:
p.000079: 1. The potential risk shall be within acceptable levels in accordance
p.000079: with medical standards, if compared with expected benefits;
p.000079: 2. The ratio of the expected benefit shall exceed that of other methods
p.000079: available outside the scope of the research;
p.000079: 3. The research shall lead to a better understanding of an important problem that affects the minor, incompetent or
p.000079: mentally disabled person or his interest, help reduce such problem, or prevent some of its negative effects;
p.000079:
p.000080: 80
p.000080:
p.000080: 4. Obtaining the “Informed Consent” from either parent or from the legal guardian.
p.000080:
p.000080: Article (25.4)
p.000080: If the local committee finds that the research does not directly benefit the minor, incompetent or mentally disabled
p.000080: person but does not expose him to more than the minimal potential risk, it may approve the research in the following
p.000080: cases:
p.000080: 1. If he had given the “Informed Consent” when he was competent or before the disability occurred, and
p.000080: his legal guardian later gave the “Informed Consent”;
p.000080: 2. If precautionary measures taken for his protection are adequate and acceptable;
p.000080: 3. If there are sufficient reasons that make it possible to obtain significant
p.000080: information through the research for understanding the case under study.
p.000080:
p.000080: Article (25.5)
p.000080: The local committee may, prior to giving its approval of conducting research on the minor, incompetent or
p.000080: mentally disabled person, require appointing a qualified lawyer experienced to handle such case. Said lawyer shall have
p.000080: no relation with the researcher or the institution supervising and funding the research and shall observe the interest
p.000080: of the minor subject of the research, in coordination with his parents or guardian.
p.000080:
p.000080: Article (25.6)
p.000080: The physically, but not mentally, disabled person shall be treated as a normal person, in terms of his responsibility
p.000080: for giving the “Informed Consent” and his understanding of research potential risks and expected benefits.
p.000081: 81
p.000081:
p.000081: Article 26
p.000081: Pregnant women, fetuses and the product of pregnancy may not be used in research except in accordance with
p.000081: controls specified by the Regulations.
p.000081:
p.000081: Article (26.1)
p.000081: An investigator may not initiate any research on a pregnant woman unless
p.000081: the following conditions are satisfied:
p.000081: 1. Conduct appropriate studies, when possible, on animals and non- pregnant women that confirm the
p.000081: safety of methods and means of research, provided the results of such research are published in
p.000081: internationally recognized scientific journals in accordance with the provisions of the Law and
p.000081: Regulations;
p.000081: 2. The level of risk the research project poses to pregnant woman or her
...
p.000083: 83
p.000083:
p.000083: Article (28.1)
p.000083: The National Committee shall monitor institutions where fertilized eggs are produced to ensure their compliance with
p.000083: the provisions of the Law and Implementing Regulations and instructions issued by the National Committee.
p.000083:
p.000083: Article 29
p.000083: Banks for preserving reproductive male or female cells with the intent of conducting research thereon may not be
p.000083: established.
p.000083:
p.000083: Article 30
p.000083: Organs and tissues of fetuses aborted before reaching one hundred twenty days may be used in research and experiments
p.000083: in accordance with controls and conditions set forth in the Regulations.
p.000083:
p.000083: Article (30.1)
p.000083: Research may be conducted on a pre-quickening stillborn fetus, if deemed necessary by the local committee, provided the
p.000083: research project is beneficial and contributes to the progress of applied sciences.
p.000083:
p.000083: Article (30.2)
p.000083: Samples may be taken from a stillborn fetus upon obtaining approval of the local committee, provided said samples are
p.000083: legally stored at approved gene banks.
p.000083:
p.000083: Article (30.3)
p.000083: 1. Research may be conducted on products of conception if the two
p.000083: following conditions are satisfied:
p.000083:
p.000084: 84
p.000084:
p.000084: a. It is established through a medical report signed by two consultant physicians, upon medical examination of
p.000084: products of conception, that it has no chance for survival;
p.000084: b. The conditions set forth in the Law and Regulations regarding research on the minor, incompetent or
p.000084: mentally disabled person shall be applied.
p.000084: 2. Research may be conducted on products of conception if said research aims to improve fetus chances of
p.000084: survival and obtain important information that may not be otherwise obtained, unless there is additional
p.000084: risk to the products of pregnancy.
p.000084:
p.000084: Article (30.4)
p.000084: If the research is conducted on an aborted or miscarried fetus, the following controls shall be observed:
p.000084: 1. Obtain the “Informed Consent” from the woman and her husband in accordance with the provisions of the Law and
p.000084: Regulations as well as controls and procedures set by the National Committee in this regard;
p.000084: 2. The woman and her husband shall be informed of the methodology used in the research on the aborted
p.000084: or miscarried fetus and whether there is an intention to store tissues taken therefrom to be used later for
p.000084: research;
p.000084: 3. Only miscarried and lawfully aborted fetuses according to the Law of Practicing Healthcare Professions may be used
p.000084: in research.
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Social / education
Searching for indicator education:
(return to top)
p.000011:
p.000011: Article (3.2)
p.000011: The establishment shall be responsible for any research conducted therein and shall, through local committees, ensure
p.000011: that the researcher and research staff comply with controls, procedures and provisions set forth in the Law and its
p.000011: Regulations as well as decisions of the National Committee.
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p.000012: 12
p.000012:
p.000012: Chapter Three: National Committee of Bioethics
p.000012:
p.000012: Article 4
p.000012: 1. A national committee of bioethics shall be formed at KACST comprising specialists nominated by the
p.000012: competent minister or head of an agency for a renewable term of 3 years, as follows:
p.000012: A representative of KACST Chairman A representative of the
p.000012: Ministry of National Guard Member A representative of the Ministry of Defense
p.000012: Member
p.000012: A representative of the Ministry of Interior Member A representative of the General
p.000012: Presidency of Religious Research and Ifta
p.000012: Member
p.000012: Two representatives from the Ministry of Higher Education (Universities)
p.000012: Members
p.000012: A representative of the Ministry of Health Member
p.000012: A representative of the Ministry of Education Member
p.000012: A representative of the Ministry of Agriculture Member A representative of the Saudi Wildlife
p.000012: Commission Member A representative of the Food and Drug General Authority Member A
p.000012: representative of King Faisal Specialist Hospital and Research Center
p.000012: Member
p.000012: A representative of Human Rights Commission Member The Director of Research Ethics Monitoring
p.000012: Office Member A representative of the private sector selected by the Chairman of the Council of the
p.000012: Chambers of Commerce and Industry Member A legal counselor selected by the President of KACST
p.000012: Member
p.000012: 2. The President of KACST shall issue the committee-formation decision, and said committee shall report
p.000012: to him.
p.000013: 13
p.000013:
p.000013: 3. The President of KACST shall appoint a secretary for the committee.
p.000013: 4. Committee members shall elect from among themselves a vice president.
p.000013:
p.000013: Article (4.1)
p.000013: 1. The President of KACST shall send a request for nomination to ministers and heads of relevant agencies
p.000013: as specified in Article 4 of the Law not less than three months before the formation or re-formation of the National
p.000013: Committee.
p.000013: 2. Each Minister or head of a relevant agency shall name a representative at the National Committee in ample
p.000013: time prior to the date set for formation of the committee, taking into consideration the following
p.000013: conditions:
p.000013: a. Be a Saudi national;
...
p.000032: The committee shall especially, but not exclusively, undertake the following:
p.000032: 1. Verify that the research conforms to applicable laws in the Kingdom;
p.000032: 2. Verify the validity of the informed consent procedures;
p.000032: 3. Issue approval to conduct research from an ethical aspect;
p.000032: 4. Monitor research implementation on a periodic basis;
p.000032: 5. Monitor the health condition of the human subject during the experiment;
p.000032: 6. Coordinate with the monitoring office as regards its relevant activities.
p.000032:
p.000032: Article (10.1)
p.000032: The local committee shall be formed of at least five members in accordance with the procedures set forth in
p.000032: Article (9.2) of the Regulations. Upon formation of said committee, the following shall be observed:
p.000032: First: The Committee chairman or his deputy shall be of Saudi nationality
p.000032: with experience in the field of biological research.
p.000032: Second: The number of members shall be determined according to volume and type of research expected to be reviewed.
p.000032: Third: Members shall be of different specializations, and when named the following shall be observed:
p.000032: 1. One member at least shall have an interest in the main research field of
p.000032:
p.000033: 33
p.000033:
p.000033: the establishment;
p.000033: 2. One member at least shall be from outside the establishment, and shall
p.000033: fulfill the following conditions:
p.000033: a. He shall have no business relation nor direct or indirect interest with the establishment;
p.000033: b. He shall be of an acceptable level of education;
p.000033: 3. One member at least shall have an interest in biomedical ethics;
p.000033: 4. One member at least shall have adequate knowledge in research design and statistical analysis;
p.000033: 5. One member at least shall be adequately familiar with the customs, traditions and values of the
p.000033: Saudi Society.
p.000033:
p.000033: Article (10.2)
p.000033: 1. The local committee shall be formed by decision of the president of the establishment or competent agency stating
p.000033: the names of committee members, chairman and his deputy. The chairman and his deputy shall have interest in biomedical
p.000033: ethics.
p.000033: 2. The relevant establishment or competent agency commits to providing the financial support needed for the
p.000033: local committee as well as committee members remunerations such as to ensure and preserve the independence
p.000033: of committee decisions and to ensure its continued operation.
p.000033: 3. Committee members, employees and all persons invited to attend committee meetings shall keep as
p.000033: confidential all information they come by and shall not disclose any information included in research or research
p.000033: ideas and proposals.
p.000033:
p.000033:
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p.000034: 34
p.000034:
p.000034: Article (10.3)
p.000034: Local committee members shall be appointed for a renewable term of 3 years, provided half the members be replaced upon
p.000034: re-formation for the third time. Membership may not be renewed for more than three consecutive terms.
p.000034:
p.000034: Article (10.4)
p.000034: The head of the establishment shall appoint a secretary for the local committee upon the recommendation
...
p.000104: enter and inspect institutions licensed under the Law, examine records and documents, request necessary data, and
p.000104: question employees therein. Institution owners and officials shall facilitate the work of the inspection employees.
p.000104:
p.000104: Article (41.3)
p.000104: Inspection employees shall record every violation in an official report including name of violator or
p.000104: violating institution as the case may be, a description of the violation, time of detection, recording of any relevant
p.000104: sample, paper, or document seized therein. The report shall be signed by the relevant inspection employee and the
p.000104: violator. If the violator refuses to sign, such incident shall be recorded in the report.
p.000104:
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p.000105:
p.000105: Article (41.4)
p.000105: The violator shall be notified of the detected violation in writing.
p.000105:
p.000105: Article 42
p.000105: a- A committee shall be formed pursuant to a decision by KACST president to review violations of the
p.000105: provisions of this Law and decide appropriate penalties, except for imprisonment, according to this Law. Said committee
p.000105: shall determine amount of damages for private claims. The committee shall comprise the following:
p.000105: 1. A Sharia counselor named by Minister of Justice Chairman
p.000105: 2. A faculty member of a Saudi medical college, of a rank not lower than associate professor, named by the
p.000105: Minister of Higher Education Member
p.000105: 3. A researcher specialized in genetic material, of a rank not lower than associate professor or
p.000105: equivalent, selected by KACST President Member
p.000105: 4. A qualified and experienced researcher specialized in bioethics, selected by KACST President
p.000105: Member
p.000105: 5. A legal counselor selected by KACST President Member
p.000105: 6. A faculty member of a Saudi university specialized in zoology, of a rank not lower than associate professor,
p.000105: named by the Minister of Higher Education Member
p.000105: 7. A faculty member of a Saudi university specialized in botany, of a rank not lower than associate professor, named
p.000105: by the Minister of Higher Education Member
p.000105: Said committee may seek the assistance of one or more experts as regards the issue in question.
p.000105: b- The committee seat shall be at KACST in the city of Riyadh. Similar
p.000105:
p.000106: 106
p.000106:
p.000106: committees may be established the Kingdom’s provinces pursuant to a decision by KACST President.
p.000106: c- Remuneration of committee chairman and members shall be determined in the Regulations according to
p.000106: applicable laws, decisions and directives.
p.000106: d- The Regulations shall determine committee rules, procedures and meetings.
p.000106: e- Committee term of membership shall be three renewable years. If a member is unable to complete his term for any
p.000106: reason, a replacement shall be appointed in the same manner the replaced member was appointed.
p.000106: f- The committee shall convene if attended by two-thirds of its members upon a call by the Chairman as needed.
p.000106: Committee resolutions shall pass by majority vote of attending members. In case of a tie, the Chairman
p.000106: shall have the casting vote.
p.000106:
p.000106: Article (42.1)
p.000106: One or more committees shall be formed pursuant to a decision by KACST President to review violations of the provisions
p.000106: of the Law and Regulations, upon nomination of members of said committee(s) by competent bodies in accordance with
p.000106: Article 42 of the Law.
p.000106:
p.000106: Article (42.2)
p.000106: Violation Review Committee term of membership shall be three renewable years. If any member is unable to complete his
p.000106: term for any reason, or if he declares his wish to discontinue his committee membership, or if he fails to attend three
...
Searching for indicator educational:
(return to top)
p.000005: Zygotes: An egg fertilized by a male sperm; from the time of fertilization until the time of division into eight cells.
p.000005: Gamete: The product of fertilization; from the end of the zygote phase until the phase of nidation where the
p.000005: zygote is implanted in the uterus. Cloning: The process of producing a complete individual genetically
p.000005: identical to another without sexual intercourse.
p.000005: Product of Pregnancy: A fetus that comes out of or removed from the uterus. Experimental Animals: Animals raised in
p.000005: cages or at certain places to be used in scientific experiments.
p.000005: Minimal Risk: Minor harm not exceeding potential risk encountered in daily life, which cannot be avoided during
p.000005: ordinary clinical or psychological examination, including potential discomfort and inconvenience.
p.000005: Legally Incompetent: A person lacking full legal capacity due to being a minor, lacking the ability of sound reasoning
p.000005: and judgment or being subject of a court ruling placing him under custody or continuation thereof which bars him from
p.000005: entering into a legal relation on his own.
p.000005: Disabled: A person suffering from a permanent full or partial deficiency
p.000005:
p.000006: 6
p.000006:
p.000006: in his physical, sensory, communicative, educational or psychological abilities to an extent that affects
p.000006: the possibility of meeting his common needs compared to his non-disabled peers.
p.000006: Child: A male or female not reaching the age of eighteen years which entails him to give an informed
p.000006: consent.
p.000006: Embryonic Stem Cells: Cells removed from the fertilized egg in its early phases; before the differentiation phase.
p.000006: Adult Stem Cells: Organically unspecialized cells that are removed from the cells of a fully developed living being.
p.000006:
p.000006: Article (1.1)
p.000006: Without prejudice to the meanings of the terms and phrases specified in Article 1 of the Law, the following
p.000006: terms and phrases – wherever used in the Law – shall have the meanings assigned to them, unless otherwise required
p.000006: by context.
p.000006: Human Subject (Participant): A person who consents or whose guardian consents to conduct clinical, non-clinical or
p.000006: therapeutic research or experiments on him.
p.000006: Principal Investigator: Lead researcher in charge of planning and conducting the research,
p.000006: collecting and analyzing data, and directing interventions stated in the research plan.
p.000006: Clinical Research: Any research related to collecting and analyzing data for volunteers or patients for the purpose of
p.000006: obtaining general knowledge that can be applied to other individuals with regard to mechanism of disease, its
...
p.000052: the relevance of the incident.
p.000052: 3. The principal investigator shall include all expected or unexpected harms in his periodic report
p.000052: submitted to the local committee.
p.000052:
p.000052: Article (10.31)
p.000052: 1. If the local committee finds, through periodic monitoring of the research, that an unexpected harm
p.000052: has taken place as a direct result of the research but has not been referred to in the research proposal, it may
p.000052: take appropriate measures to stop the harm, including suspension of research project;
p.000052: 2. If the local committee finds that the investigator has not obtained required approvals, it shall suspend
p.000052: the research project and refer the matter to the Monitoring Office to submit it to the Violations Committee to decide
p.000052: appropriate penalties against the investigator.
p.000052: 3. The local committee shall notify head of the establishment of any
p.000052: research that is suspended or referred to the Monitoring Office.
p.000052:
p.000052: Article (10.32)
p.000052: The local committee may exempt the following research projects from the
p.000052: periodic follow-up:
p.000052:
p.000053: 53
p.000053:
p.000053: 1. Research involving study of information and data previously collected,
p.000053: provided one of the two following terms is fulfilled:
p.000053: a. If the information is generally and publicly available;
p.000053: b. If the information is recorded in a manner that does not reveal the identity of the source person.
p.000053: 2. Research including educational tests, surveys, interviews or public behavior monitoring, except in the
p.000053: two following cases:
p.000053: a. If the information is recorded in a manner that reveals the identity of the source person.
p.000053: b. If participation in the research should bring a person outside the scope of research to be subject to
p.000053: criminal or civil liability or jeopardize his financial position or career.
p.000053: 3. Research conducted for educational purposes.
p.000053:
p.000053: Article (10.33)
p.000053: 1. Subject to the provisions of the following paragraph 2 hereunder, the local committee, following Standard
p.000053: procedures, shall conduct the periodic monitoring of research based on the periodic reports submitted by the
p.000053: principal investigator in accordance with the procedures it sets up in this regard.
p.000053: 2. As an exception from the provision of the preceding paragraph 1 hereabove, the local committee may
p.000053: exempt certain research projects that it has previously approved from periodic evaluation in either of the following
p.000053: cases:
p.000053: a. If the only objective of research continuation is a long-term monitoring of persons who took part
p.000053: in the research and no additional risk emerged in the research;
p.000053: b. If the research is nearly finished and only analysis of data and
p.000053:
p.000054: 54
p.000054:
p.000054: conclusion of results are remaining.
p.000054: 3. After the periodic assessment of the research is carried out, the local committee shall issue a decision including
p.000054: its approval or rejection of continuation of the said research.
p.000054:
p.000054: Article (10.34)
p.000054: If, after the periodic assessment, the local committee disapproves of research continuation, it shall suspend the
p.000054: research project without prejudice to its right of extending the treatment period in case its sudden suspension may
p.000054: cause harm to the human subject.
p.000054:
p.000054: Article (10.35)
p.000054: 1. If the research project is suspended, the investigator may request the local committee to reconsider the
p.000054: suspension decision, by appending reasons for his request;
...
p.000059: his rights, or to report any harm sustained. Said numbers and addresses shall include the contact numbers and
p.000059: e-mail addresses of the local committee and researcher;
p.000059: 17. Signature of the human subject (male or female) or guardian, the
p.000059:
p.000060: 60
p.000060:
p.000060: researcher, and any other person whose signature on the form is required in accordance with the provisions of the Law
p.000060: and Regulations;
p.000060: 18. Date and place of the “Informed Consent”;
p.000060: 19. Method of compensating of the human subject in case he sustains any
p.000060: harm resulting from the research.
p.000060:
p.000060: Article 12
p.000060: Upon obtaining the informed consent, the investigator shall clearly explain to the human subject or his
p.000060: guardian all potential outcomes of the research including harmful ones, if any, which result from withdrawal
p.000060: of the informed consent.
p.000060:
p.000060: Article (12.1)
p.000060: 1. When obtaining the “Informed Consent”, the investigator shall in all cases observe the following:
p.000060: a. He shall, in a clear and simple manner, explain in person the information stated in the “Informed
p.000060: Consent” form to the human subject (or his guardian if the subject is incompetent);
p.000060: b. The explanation shall be appropriate to the educational level, culture and understanding of the human
p.000060: subject (or guardian if the subject is incompetent);
p.000060: c. He shall, if required, explain any additional information not stated in the “Informed Consent” form;
p.000060: d. He shall answer any question raised by the human subject (or guardian if the subject is
p.000060: incompetent);
p.000060: e. He shall not obtain the consent in haste or use coercion or undue inducement to obtain it.
p.000060: f. He shall ensure via suitable methods that the human subject (or
p.000060:
p.000061: 61
p.000061:
p.000061: guardian if the subject is incompetent) has understood all the information provided to him prior to
p.000061: signing the “Informed Consent” form;
p.000061: 2. If the human subject is a patient, a person other than his attending physician shall obtain his
p.000061: “Informed Consent,” provided said person is well-informed about the research and able to answer all the patient’s
p.000061: questions.
p.000061:
p.000061: Article (12.2)
p.000061: The “Informed Consent” form or the explanation presented by the investigator to obtain the consent may not
p.000061: include any statement absolving the investigator (or the institution) from liability against any unexpected error or
p.000061: harm that may occur during the research.
p.000061:
p.000061: Article 13
...
Social / employees
Searching for indicator employees:
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p.000032: Second: The number of members shall be determined according to volume and type of research expected to be reviewed.
p.000032: Third: Members shall be of different specializations, and when named the following shall be observed:
p.000032: 1. One member at least shall have an interest in the main research field of
p.000032:
p.000033: 33
p.000033:
p.000033: the establishment;
p.000033: 2. One member at least shall be from outside the establishment, and shall
p.000033: fulfill the following conditions:
p.000033: a. He shall have no business relation nor direct or indirect interest with the establishment;
p.000033: b. He shall be of an acceptable level of education;
p.000033: 3. One member at least shall have an interest in biomedical ethics;
p.000033: 4. One member at least shall have adequate knowledge in research design and statistical analysis;
p.000033: 5. One member at least shall be adequately familiar with the customs, traditions and values of the
p.000033: Saudi Society.
p.000033:
p.000033: Article (10.2)
p.000033: 1. The local committee shall be formed by decision of the president of the establishment or competent agency stating
p.000033: the names of committee members, chairman and his deputy. The chairman and his deputy shall have interest in biomedical
p.000033: ethics.
p.000033: 2. The relevant establishment or competent agency commits to providing the financial support needed for the
p.000033: local committee as well as committee members remunerations such as to ensure and preserve the independence
p.000033: of committee decisions and to ensure its continued operation.
p.000033: 3. Committee members, employees and all persons invited to attend committee meetings shall keep as
p.000033: confidential all information they come by and shall not disclose any information included in research or research
p.000033: ideas and proposals.
p.000033:
p.000033:
p.000033:
p.000033:
p.000034: 34
p.000034:
p.000034: Article (10.3)
p.000034: Local committee members shall be appointed for a renewable term of 3 years, provided half the members be replaced upon
p.000034: re-formation for the third time. Membership may not be renewed for more than three consecutive terms.
p.000034:
p.000034: Article (10.4)
p.000034: The head of the establishment shall appoint a secretary for the local committee upon the recommendation
p.000034: of its chairman, to undertake the following:
p.000034: 1. Receive applications submitted to the committee and verify that they meet all conditions, and include all
p.000034: components and documents, and present the same to the committee chairman;
p.000034: 2. Prepare agendas and minutes of committee meetings;
p.000034: 3. Coordinate local committee activities and communications with researchers and with the
p.000034: National Committee;
p.000034: 4. Archive copies of committee meeting minutes, including names of attending members, decisions issued,
p.000034: results of voting on such decisions, and a summary of the discussions taking place during every meeting;
p.000034: 5. Prepare letters of notification of committee decisions and
p.000034: recommendations to be signed by the committee chairman;
p.000034: 6. Any other work-related tasks assigned to him by the committee or its chairman;
p.000034: 7. Maintain confidentiality of information he is privy to and not disclose
p.000034: any information in the research or research ideas and proposals.
p.000034:
p.000034: Article (10.5)
...
p.000102: as Wildlife Reserves Law and the Law of Fishing, Investment and Protection of Marine Life in Territorial Waters and
p.000102: all relevant laws and regulations in the Kingdom
p.000102:
p.000102: Article (39.3)
p.000102: Penalties set forth in the Law and Regulations shall be imposed on any person violating controls and provisions therein
p.000102: according to the jurisdiction of the National Committee.
p.000102:
p.000102: Article 40
p.000102: If research includes conducting genetic modification experiments on Living Creatures, the investigator shall take all
p.000102: necessary measures to prevent their escape from research laboratories.
p.000102:
p.000102: Article (40.1)
p.000102: Genetic modification research on animals and plants shall be conducted in laboratories designated for this purpose,
p.000102: provided all measures are taken to prevent escape of genetically modified creatures.
p.000102:
p.000102:
p.000103: 103
p.000103:
p.000103: Article (40.2)
p.000103: Microorganisms subject to the research and their outcome shall be disposed of through standard scientific procedures.
p.000103:
p.000103:
p.000103:
p.000103:
p.000103:
p.000103:
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p.000103:
p.000103:
p.000103:
p.000103:
p.000103:
p.000103:
p.000103:
p.000103:
p.000103:
p.000103:
p.000103:
p.000103:
p.000103:
p.000103:
p.000103:
p.000104: 104
p.000104:
p.000104: Chapter Thirteen: Violation Review Committee
p.000104:
p.000104: Article 41
p.000104: KACST President shall designate inspection employees in charge of detecting violations of the provisions of this
p.000104: Law and its Regulations in accordance with procedures specified by the Regulations.
p.000104:
p.000104: Article (41.1)
p.000104: Inspection employees, named pursuant to a decision by KACST President, shall be in charge of detecting violations of
p.000104: the provisions of the Law and Regulations, without prejudice to the authority of the Monitoring Office and the local
p.000104: committee with regard to detection of such violations.
p.000104:
p.000104: Article (41.2)
p.000104: For the purpose of detecting violations of the provisions of the Law and Regulations, the inspection employees may
p.000104: enter and inspect institutions licensed under the Law, examine records and documents, request necessary data, and
p.000104: question employees therein. Institution owners and officials shall facilitate the work of the inspection employees.
p.000104:
p.000104: Article (41.3)
p.000104: Inspection employees shall record every violation in an official report including name of violator or
p.000104: violating institution as the case may be, a description of the violation, time of detection, recording of any relevant
p.000104: sample, paper, or document seized therein. The report shall be signed by the relevant inspection employee and the
p.000104: violator. If the violator refuses to sign, such incident shall be recorded in the report.
p.000104:
p.000104:
p.000105: 105
p.000105:
p.000105: Article (41.4)
p.000105: The violator shall be notified of the detected violation in writing.
p.000105:
p.000105: Article 42
p.000105: a- A committee shall be formed pursuant to a decision by KACST president to review violations of the
p.000105: provisions of this Law and decide appropriate penalties, except for imprisonment, according to this Law. Said committee
p.000105: shall determine amount of damages for private claims. The committee shall comprise the following:
p.000105: 1. A Sharia counselor named by Minister of Justice Chairman
p.000105: 2. A faculty member of a Saudi medical college, of a rank not lower than associate professor, named by the
p.000105: Minister of Higher Education Member
p.000105: 3. A researcher specialized in genetic material, of a rank not lower than associate professor or
p.000105: equivalent, selected by KACST President Member
p.000105: 4. A qualified and experienced researcher specialized in bioethics, selected by KACST President
p.000105: Member
p.000105: 5. A legal counselor selected by KACST President Member
...
Social / parents
Searching for indicator parent:
(return to top)
p.000076: inducement or for any purposes other than those set forth in this Article.
p.000076:
p.000076:
p.000076:
p.000076:
p.000076:
p.000076:
p.000076:
p.000076:
p.000077: 77
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p.000077:
p.000078: 78
p.000078:
p.000078: Chapter Ten: Research on Special Cases
p.000078:
p.000078: Article 25
p.000078: Research may not be conducted on minors, incompetent or disabled persons unless the interest of these
p.000078: categories so requires. The Regulations shall specify ethical controls for conducting research on said
p.000078: categories.
p.000078:
p.000078: Article (25.1)
p.000078: 1. Research may not be conducted on minors, incompetent or mentally disabled persons without obtaining the
p.000078: “Informed Consent” from parents or the legal guardians in accordance with conditions set forth in the Law and
p.000078: Regulations, provided they are informed of the level of risk and its probability as well as the person’s assent.
p.000078: 2. Either parent or the legal guardian may grant the “Informed Consent” on behalf of minors, incompetent or mentally
p.000078: disabled persons provided his decision is based on the fact that the minor, incompetent or mentally disabled person is
p.000078: subject to no harm and may benefit from the research.
p.000078: 3. After granting the “Informed Consent”, either parent or the guardian may withdraw the consent at any phase of the
p.000078: research if he finds that the research conflicts with the interests of the minor, incompetent or mentally disabled
p.000078: person or if the research deviates from the objectives upon which the consent was granted.
p.000078:
p.000078: Article (25.2)
p.000078: The local committee shall grant its approval for research on minors, incompetent or mentally disabled
p.000078: persons subject to the following conditions:
p.000078:
p.000079: 79
p.000079:
p.000079: 1. It is not possible to conduct the research on a competent person;
p.000079: 2. The interest of the minor, incompetent or mentally disabled person requires subjecting him to the
p.000079: research, provided he is not exposed to more than the minimal potential risk;
p.000079: 3. The research protocol includes clear and appropriate measures to minimize potential risk as much as
p.000079: possible;
p.000079: 4. Evaluation of potential risk and expected benefit from the research shall indicate type, nature, degree and
...
p.000079: research and for similar persons;
p.000079: 5. The research shall be conducted in a school, camp, hospital, or institution where the majority of occupants are
p.000079: incompetent or disabled, provided the research subject belongs to this category.
p.000079:
p.000079: Article (25.3)
p.000079: If the local committee finds that the research in whole or in part achieves a direct benefit for the
p.000079: minor, incompetent or mentally disabled person but that its risk exceeds the minimal expected level, it may grant
p.000079: its approval to conduct the research pursuant to the following conditions:
p.000079: 1. The potential risk shall be within acceptable levels in accordance
p.000079: with medical standards, if compared with expected benefits;
p.000079: 2. The ratio of the expected benefit shall exceed that of other methods
p.000079: available outside the scope of the research;
p.000079: 3. The research shall lead to a better understanding of an important problem that affects the minor, incompetent or
p.000079: mentally disabled person or his interest, help reduce such problem, or prevent some of its negative effects;
p.000079:
p.000080: 80
p.000080:
p.000080: 4. Obtaining the “Informed Consent” from either parent or from the legal guardian.
p.000080:
p.000080: Article (25.4)
p.000080: If the local committee finds that the research does not directly benefit the minor, incompetent or mentally disabled
p.000080: person but does not expose him to more than the minimal potential risk, it may approve the research in the following
p.000080: cases:
p.000080: 1. If he had given the “Informed Consent” when he was competent or before the disability occurred, and
p.000080: his legal guardian later gave the “Informed Consent”;
p.000080: 2. If precautionary measures taken for his protection are adequate and acceptable;
p.000080: 3. If there are sufficient reasons that make it possible to obtain significant
p.000080: information through the research for understanding the case under study.
p.000080:
p.000080: Article (25.5)
p.000080: The local committee may, prior to giving its approval of conducting research on the minor, incompetent or
p.000080: mentally disabled person, require appointing a qualified lawyer experienced to handle such case. Said lawyer shall have
p.000080: no relation with the researcher or the institution supervising and funding the research and shall observe the interest
...
Searching for indicator parents:
(return to top)
p.000076: crime;
p.000076: 3. Study administrative rules and operational procedures applicable in prisons, so as to improve health
p.000076: and living conditions of inmates;
p.000076: 4. Inmates may not be subject to clinical research whether by coercion or
p.000076: inducement or for any purposes other than those set forth in this Article.
p.000076:
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p.000076:
p.000076:
p.000076:
p.000076:
p.000076:
p.000076:
p.000077: 77
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p.000077:
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p.000077:
p.000078: 78
p.000078:
p.000078: Chapter Ten: Research on Special Cases
p.000078:
p.000078: Article 25
p.000078: Research may not be conducted on minors, incompetent or disabled persons unless the interest of these
p.000078: categories so requires. The Regulations shall specify ethical controls for conducting research on said
p.000078: categories.
p.000078:
p.000078: Article (25.1)
p.000078: 1. Research may not be conducted on minors, incompetent or mentally disabled persons without obtaining the
p.000078: “Informed Consent” from parents or the legal guardians in accordance with conditions set forth in the Law and
p.000078: Regulations, provided they are informed of the level of risk and its probability as well as the person’s assent.
p.000078: 2. Either parent or the legal guardian may grant the “Informed Consent” on behalf of minors, incompetent or mentally
p.000078: disabled persons provided his decision is based on the fact that the minor, incompetent or mentally disabled person is
p.000078: subject to no harm and may benefit from the research.
p.000078: 3. After granting the “Informed Consent”, either parent or the guardian may withdraw the consent at any phase of the
p.000078: research if he finds that the research conflicts with the interests of the minor, incompetent or mentally disabled
p.000078: person or if the research deviates from the objectives upon which the consent was granted.
p.000078:
p.000078: Article (25.2)
...
p.000080: person but does not expose him to more than the minimal potential risk, it may approve the research in the following
p.000080: cases:
p.000080: 1. If he had given the “Informed Consent” when he was competent or before the disability occurred, and
p.000080: his legal guardian later gave the “Informed Consent”;
p.000080: 2. If precautionary measures taken for his protection are adequate and acceptable;
p.000080: 3. If there are sufficient reasons that make it possible to obtain significant
p.000080: information through the research for understanding the case under study.
p.000080:
p.000080: Article (25.5)
p.000080: The local committee may, prior to giving its approval of conducting research on the minor, incompetent or
p.000080: mentally disabled person, require appointing a qualified lawyer experienced to handle such case. Said lawyer shall have
p.000080: no relation with the researcher or the institution supervising and funding the research and shall observe the interest
p.000080: of the minor subject of the research, in coordination with his parents or guardian.
p.000080:
p.000080: Article (25.6)
p.000080: The physically, but not mentally, disabled person shall be treated as a normal person, in terms of his responsibility
p.000080: for giving the “Informed Consent” and his understanding of research potential risks and expected benefits.
p.000081: 81
p.000081:
p.000081: Article 26
p.000081: Pregnant women, fetuses and the product of pregnancy may not be used in research except in accordance with
p.000081: controls specified by the Regulations.
p.000081:
p.000081: Article (26.1)
p.000081: An investigator may not initiate any research on a pregnant woman unless
p.000081: the following conditions are satisfied:
p.000081: 1. Conduct appropriate studies, when possible, on animals and non- pregnant women that confirm the
p.000081: safety of methods and means of research, provided the results of such research are published in
p.000081: internationally recognized scientific journals in accordance with the provisions of the Law and
p.000081: Regulations;
p.000081: 2. The level of risk the research project poses to pregnant woman or her
...
Social / philosophical differences/differences of opinion
Searching for indicator different opinion:
(return to top)
p.000110: shall adjourn the hearing and notify the defendant of the new hearing date. If the defendant fails to attend a
p.000110: second time, though properly notified, the Violation Review Committee
p.000111: 111
p.000111:
p.000111: may proceed with the consideration of the case as if he was present. The defendant shall be deemed present if he
p.000111: attends one hearing and fails to attend the rest of the hearings.
p.000111:
p.000111: Article (42.17)
p.000111: The secretary of the Violation Review Committee shall draft the hearing minutes under the supervision of the
p.000111: hearing chairman, provided the minutes include names of attending members, place and time of the hearing, names of
p.000111: attending parties to the suit or their representatives, all hearing proceedings, as well as statements and defenses of
p.000111: parties. The minutes shall be signed by the committee chairman, members, secretary and parties to the suit or their
p.000111: representatives.
p.000111:
p.000111: Article (42.18)
p.000111: If the Violation Review Committee finds that the violation considered includes a crime punishable by other
p.000111: laws, it shall refer the criminal case to the competent agencies to take legal action, in accordance with said laws,
p.000111: and shall decide the violation under consideration unless it finds that either violation cannot be decided separately
p.000111: from the other.
p.000111:
p.000111: Article (42.19)
p.000111: Decisions of the Violation Review Committee shall be reasoned and shall include a rebuttal of all defenses raised by
p.000111: parties to the suit. A committee member (or the chairman) adopting a different opinion shall include said opinion in
p.000111: the minutes with the reasons thereof.
p.000111:
p.000111: Article (42.20)
p.000111: The Violation Review Committee secretariat shall notify the parties
p.000111:
p.000112: 112
p.000112:
p.000112: concerned of committee resolutions by official letters delivered to them or their legal representatives,
p.000112: provided that the notification letter includes the following text: “A party against whom a committee decision has been
p.000112: issued may appeal before the Board of Grievances within sixty days from date of notification.”
p.000112:
p.000112: Article (42.21)
p.000112: Procedures of the Board of Grievances shall apply to matters not provided for in the Violation Review Committee
p.000112: Procedures.
p.000112:
p.000112: Article (42.22)
p.000112: An aggrieved party may appeal Violation Review Committee decision before the Board of Grievances within sixty
p.000112: days from date of notification thereof.
p.000112:
p.000112: Article (42.23)
p.000112: Remuneration of Violation Review Committee’s chairman and members shall be determined according to Regulations of
p.000112: Joint Governmental Committees and their Work Procedures issued pursuant to Civil Service Council Decision No.
p.000112: (1/1270) dated 21/11/1428 H approved by wired High Order under No. (3759/MB) dated 12/6/1432 H.
p.000112:
p.000112: Article 43
p.000112: Public prosecution before the committee shall be carried out by competent personnel designated by
p.000112: KACST President.
p.000112:
p.000112: Article (43.1)
p.000112: One or more public prosecution representatives shall be appointed pursuant
p.000112:
...
Searching for indicator opinion:
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p.000016: agenda shall be enclosed therein except for classified documents. Members may have access to all documents at
p.000016: the meeting place whether prior to or during the meeting.
p.000016: 7. The agenda of the National Committee meeting shall include the following items:
p.000016: a. Minutes of the previous meeting for approval;
p.000016: b. Topics proposed by the National Committee Chairman or members;
p.000016: c. Monthly reports prepared by National Committee Secretariat, if any, upon approval by Committee
p.000016: Chairman.
p.000016:
p.000016: Article (5.2)
p.000016: 1. National Committee meetings shall not be valid unless attended by two-thirds of its members including
p.000016: the Chairman or his designee.
p.000017: 17
p.000017:
p.000017: 2. If the quorum provided for in Paragraph (1) above is not met within half an hour of the designated time of the
p.000017: meeting, the Chairman shall adjourn the meeting and set a new date within ten days. The call for said meeting shall be
p.000017: made at least five working days prior to the meeting date.
p.000017: 3. If the National Committee Chairman or his deputy fails to attend the meeting within half an hour of the
p.000017: meeting time, the Committee Secretary shall adjourn the meeting.
p.000017: 4. If the National Committee Chairman becomes aware that neither he nor his deputy can attend the meeting,
p.000017: and it is necessary to hold the meeting, he may delegate a Committee member to chair the meeting, and he shall have the
p.000017: powers of the Committee Chairman with regards to managing the meeting.
p.000017: 5. If any of the National Committee members has an interest in a proposed item for discussion that may affect his
p.000017: opinion or neutrality, he shall declare the same prior to the meeting. In such case, the Committee Chairman
p.000017: may ask him to leave the meeting or to remain without the right to participate in the discussion or voting. If the
p.000017: Chairman leaves for such reason, his designee shall chair the meeting.
p.000017:
p.000017: Article (5.3)
p.000017: 1. Committee resolutions shall pass by simple majority vote of attending
p.000017: members. In case of a tie, the meeting Chairman shall have the casting vote.
p.000017: 2. Votes may be taken by a show of hands, secret ballot, electronically, or by any other means decided by the
p.000017: Chairman.
p.000017: 3. The National Committee may, if necessary, pass a resolution by circulation if approved by two-thirds
p.000017: of its members. Committee approval of said resolution shall be included in the subsequent meeting minutes.
p.000017:
p.000018: 18
p.000018:
p.000018: Article (5.4)
p.000018: The National Committee may, upon a call of its Chairman or his designee, invite persons with expertise in the item
p.000018: under discussion, whether from within or outside KACST, without such persons having the right to vote.
p.000018:
p.000018: Article (5.5)
p.000018: Remuneration of the National Committee Chairman and members shall be determined in accordance with laws and procedures
p.000018: applicable at KACST.
p.000018:
p.000018: Article 6
p.000018: The National Committee shall set standards for biological research ethics and oversee enforcement thereof.
p.000018: It shall be the authority regarding overseeing research ethics and monitoring implementation thereof. It shall
p.000018: particularly undertake the following:
...
p.000037: work days before convention date. The meeting agenda and all papers and documents related to topics proposed
p.000037: for discussion shall be attached to the invitations;
p.000037: 5. Local committee secretary shall record the meeting minutes, and attending members and committee
p.000037: secretary shall sign the minutes directly after the meeting or in the next meeting.
p.000037:
p.000037: Article (10.10)
p.000037: If a local committee member finds that he or any other member has any sort of direct or indirect interest related to
p.000037: any topic proposed for discussion by the committee, said member shall disclose such interest at the beginning of the
p.000037: meeting. In that case, the committee chairman shall ask the member who has declared such interest to withdraw from the
p.000037: meeting during discussion of related topic and shall record this action in the meeting minutes.
p.000037:
p.000037: Article (10.11)
p.000037: 1. The local committee may invite experts and consultants to attend its meetings whenever a proposed item on the
p.000037: committee meeting agenda requires so. These expert guests do not have the right to vote.
p.000037: 2. If the research subject proposed for discussion by the local committee is related to any category of the
p.000037: (vulnerable groups), the committee chairman shall invite a specialist with experience in this field to take
p.000038: 38
p.000038:
p.000038: part in discussing said subject. Said specialist shall have the right to take part in discussion and in voting. If said
p.000038: specialist fails to attend the meeting, it shall be required to obtain a specialist’s written opinion of the matter.
p.000038: 3. If it deems it necessary, the local committee may invite the principal investigator to attend one of its meetings,
p.000038: provided he does not attend the meeting during which the final decision on the research project is made.
p.000038:
p.000038: Article (10.12)
p.000038: 1. Local committee resolutions shall pass by simple majority vote of attending members. In case of a tie,
p.000038: the meeting chairman shall have the casting vote.
p.000038: 2. Local committee chairman shall determine the voting method in committee meetings.
p.000038: 3. Issued resolution shall be printed on local committee or establishment official stationary, and shall include
p.000038: a clear statement of resolution text. Committee chairman shall notify the principal investigator of said resolution
p.000038: in writing.
p.000038: 4. In case the research application is rejected, the resolution shall state the reasons for rejection.
p.000038: 5. Local committee may issue non-binding recommendations, if necessary,
p.000038: and attach them to rejection resolution.
p.000038: 6. Local committee may issue a conditional approval, and the resolution shall determine the necessary procedure to
p.000038: reconsider the application and any requirements or suggestions for reassessment.
p.000038: 7. An aggrieved party may appeal local committee resolutions of rejection
p.000038: or provisional approval before local committee. If the local committee
p.000038:
p.000039: 39
p.000039:
p.000039: dismisses the complaint as unconvincing, the aggrieved party may have
p.000039: recourse to the Monitoring Office to review the matter.
p.000039:
p.000039: Article (10.13)
...
p.000110: second time, though properly notified, the Violation Review Committee
p.000111: 111
p.000111:
p.000111: may proceed with the consideration of the case as if he was present. The defendant shall be deemed present if he
p.000111: attends one hearing and fails to attend the rest of the hearings.
p.000111:
p.000111: Article (42.17)
p.000111: The secretary of the Violation Review Committee shall draft the hearing minutes under the supervision of the
p.000111: hearing chairman, provided the minutes include names of attending members, place and time of the hearing, names of
p.000111: attending parties to the suit or their representatives, all hearing proceedings, as well as statements and defenses of
p.000111: parties. The minutes shall be signed by the committee chairman, members, secretary and parties to the suit or their
p.000111: representatives.
p.000111:
p.000111: Article (42.18)
p.000111: If the Violation Review Committee finds that the violation considered includes a crime punishable by other
p.000111: laws, it shall refer the criminal case to the competent agencies to take legal action, in accordance with said laws,
p.000111: and shall decide the violation under consideration unless it finds that either violation cannot be decided separately
p.000111: from the other.
p.000111:
p.000111: Article (42.19)
p.000111: Decisions of the Violation Review Committee shall be reasoned and shall include a rebuttal of all defenses raised by
p.000111: parties to the suit. A committee member (or the chairman) adopting a different opinion shall include said opinion in
p.000111: the minutes with the reasons thereof.
p.000111:
p.000111: Article (42.20)
p.000111: The Violation Review Committee secretariat shall notify the parties
p.000111:
p.000112: 112
p.000112:
p.000112: concerned of committee resolutions by official letters delivered to them or their legal representatives,
p.000112: provided that the notification letter includes the following text: “A party against whom a committee decision has been
p.000112: issued may appeal before the Board of Grievances within sixty days from date of notification.”
p.000112:
p.000112: Article (42.21)
p.000112: Procedures of the Board of Grievances shall apply to matters not provided for in the Violation Review Committee
p.000112: Procedures.
p.000112:
p.000112: Article (42.22)
p.000112: An aggrieved party may appeal Violation Review Committee decision before the Board of Grievances within sixty
p.000112: days from date of notification thereof.
p.000112:
p.000112: Article (42.23)
p.000112: Remuneration of Violation Review Committee’s chairman and members shall be determined according to Regulations of
p.000112: Joint Governmental Committees and their Work Procedures issued pursuant to Civil Service Council Decision No.
p.000112: (1/1270) dated 21/11/1428 H approved by wired High Order under No. (3759/MB) dated 12/6/1432 H.
p.000112:
p.000112: Article 43
p.000112: Public prosecution before the committee shall be carried out by competent personnel designated by
p.000112: KACST President.
p.000112:
p.000112: Article (43.1)
p.000112: One or more public prosecution representatives shall be appointed pursuant
p.000112:
p.000113: 113
p.000113:
p.000113: to a decision by KACST President to file suit and litigate before the
...
General/Other / Diminished Autonomy
Searching for indicator diminished:
(return to top)
p.000006: Human Subject (Participant): A person who consents or whose guardian consents to conduct clinical, non-clinical or
p.000006: therapeutic research or experiments on him.
p.000006: Principal Investigator: Lead researcher in charge of planning and conducting the research,
p.000006: collecting and analyzing data, and directing interventions stated in the research plan.
p.000006: Clinical Research: Any research related to collecting and analyzing data for volunteers or patients for the purpose of
p.000006: obtaining general knowledge that can be applied to other individuals with regard to mechanism of disease, its
p.000006: incidence, prevalence, transmission or treatment of a disease.
p.000006: Non-Clinical Research: Any research related to collecting and analyzing data not directly related to people for
p.000006: the purpose of obtaining general knowledge or facts.
p.000006:
p.000007: 7
p.000007:
p.000007: Clinical Trial: Experiments conducted on human volunteers to examine safety and effectiveness of a new medication or
p.000007: medical device.
p.000007: Prisoner: A person deprived of liberty, whether serving a prison sentence, detained on trial, or is a correction
p.000007: facility inmate.
p.000007: Vulnerable groups: Groups of individuals in need of additional protection due to their lack of legal capacity, their
p.000007: questionable or diminished capacity or their lack of freedom to choose.
p.000007: Stillborn: A fetus delivered, came out of, or removed from the uterus with no signs of life such as heartbeat, natural
p.000007: breathing, movement, or pulsation of the umbilical cord if still connected.
p.000007: Diagnostic Procedure: A test aiming at finding a certain disorder or disease
p.000007: in a living creature.
p.000007: Medication: A chemical compound administered to a living creature to help diagnose, treat, prevent, cure or
p.000007: alleviate the effects of a disease or organic disorder.
p.000007: Periodic Assessment: Observation of research progress by safety assessment and information monitoring
p.000007: committee to ascertain safety of the human subject on a continuous basis and to ensure nonexistence of any reason for
p.000007: discontinuation or modification of the research.
p.000007: Periodic Follow-up: Review of the periodic report submitted by the principal investigator to the local
p.000007: committee to evaluate research progress and conformity with the approved research plan.
p.000007: Expedited Review: An evaluation carried out by the local committee chairman, or by a committee member
p.000007: designated by him, of a new research project or modifications of a previously approved research where potential risk to
p.000007: the human subject does not exceed minimal risk.
p.000007: Genetic Therapy Research: Any research which includes insertion or deletion of genetic material within body
p.000007: cells or targeting the same whether
p.000008: 8
p.000008:
p.000008: by modification or deactivation for finding a treatment for hereditary or
...
General/Other / Public Emergency
Searching for indicator emergency:
(return to top)
p.000038: 3. Issued resolution shall be printed on local committee or establishment official stationary, and shall include
p.000038: a clear statement of resolution text. Committee chairman shall notify the principal investigator of said resolution
p.000038: in writing.
p.000038: 4. In case the research application is rejected, the resolution shall state the reasons for rejection.
p.000038: 5. Local committee may issue non-binding recommendations, if necessary,
p.000038: and attach them to rejection resolution.
p.000038: 6. Local committee may issue a conditional approval, and the resolution shall determine the necessary procedure to
p.000038: reconsider the application and any requirements or suggestions for reassessment.
p.000038: 7. An aggrieved party may appeal local committee resolutions of rejection
p.000038: or provisional approval before local committee. If the local committee
p.000038:
p.000039: 39
p.000039:
p.000039: dismisses the complaint as unconvincing, the aggrieved party may have
p.000039: recourse to the Monitoring Office to review the matter.
p.000039:
p.000039: Article (10.13)
p.000039: The principal investigator, whether he belongs to the establishment or not, shall submit the research approval to the
p.000039: local committee, including the research proposal. Upon setting of research proposal, the researcher shall observe the
p.000039: following:
p.000039: 1. Design of study shall be appropriate to its objectives;
p.000039: 2. Expected benefits and possible harms to which the human subject may be subject shall be in balance;
p.000039: 3. Research location shall be appropriate to the assistant group, including available potentials and emergency
p.000039: measures.
p.000039:
p.000039: Article (10.14)
p.000039: The research proposal shall comprise the following:
p.000039: 1. An abstract of the research within one page (Size: A4);
p.000039: 2. Research objectives;
p.000039: 3. Statistical methodology, including sample size calculations, taking into account possibility of obtaining
p.000039: statistically significant results by using the minimum number of research subjects;
p.000039: 4. Rationale for introducing any procedure, tool or device that has not been used before;
p.000039: 5. Rationale for using any substances that could be dangerous or harmful to the human subject or his surroundings and
p.000039: methods of disposal of said substances after research is completed;
p.000039: 6. Plan for dealing with risky cases;
p.000039: 7. Plan for disposal of extra biological samples;
p.000039:
p.000040: 40
p.000040:
p.000040: 8. A clear description of duties and responsibilities of research team;
p.000040: 9. Time schedule of research and criteria of research suspension or termination;
p.000040: 10. Case registration forms, daily cards, and questionnaires set for research
p.000040: subjects, in case of clinical research;
p.000040: 11. Research sample shall be determined according to the following considerations:
p.000040: a. Characteristics of sample from which the subjects will be selected;
p.000040: b. Criteria for inclusion and exclusion of the human subject;
p.000040: c. Methods through which initial contact and selection are carried out;
p.000040: d. Means of providing complete information to potential participants in the research or their representatives.
p.000040: 12. In clinical research, the principal investigator shall present a description of the individuals who will be given
...
p.000095: experimental principles.
p.000095:
p.000095: Article (38.3)
p.000095: To obtain approval to conduct research on animals, any of the following
p.000095: shall be satisfied:
p.000095: 1- To Prevent, diagnose or treat a disease or a deformity that must
p.000095: be rectified or whose effects must be removed;
p.000095: 2- To explore animal physiology;
p.000095: 3- Protection of the natural environment as well as general health of humans or animals;
p.000095: 4- Achievement of scientific advancement in biological sciences;
p.000095: 5- Contribution to forensic research;
p.000095: 6- Improvement of animal breeding methods and management;
p.000095: 7- Conduct preliminary research on pharmaceutical substances, toxins and radioactive effects.
p.000095:
p.000095: Article (38.4)
p.000095: When reviewing research proposals involving animal and plant experiments,
p.000095:
p.000096: 96
p.000096:
p.000096: the local committee must verify that the research proposal includes the following mandatory elements:
p.000096: 1. Principal investigator and research team credentials,
p.000096: 2. Animal/plant species used for the experiment, source and quantity.
p.000096: 3. Any agreements with other parties related to the experiment, or to the experiment’s results.
p.000096: 4. A detailed account of the locations where the experiment will be carried
p.000096: out to conduct field visits when necessary.
p.000096: 5. The system of identification used to distinguish the animals and plants used in the experiment, and the system
p.000096: used to save the information and data related to every animal or plant in the experiment’s records.
p.000096: 6. Emergency and hazards management plans.
p.000096: 7. Means and mechanism for the disposal of the experiment’s components.
p.000096: 8. System used to save all data and information resulting from the experiment in dedicated databases.
p.000096: 9. The authorizations of relevant authorities when needed.
p.000096:
p.000096: Article (38.5)
p.000096: When reviewing research proposals resulting in pain and suffering of animals, the local committee must
p.000096: thoroughly assess the proposal, and confirm that:
p.000096: 1. The experiment is not prohibited or restricted by international or regional conventions or rulings where
p.000096: the Kingdom of Saudi Arabia is a party or a signatory.
p.000096: 2. There are no other possible alternatives to achieve the same required results.
p.000096: 3. The research team is fully competent and qualified, and the tools , materials and laboratory
p.000096: environment of the experiment are perfectly adequate.
p.000096:
p.000097: 97
p.000097:
p.000097: Article (38.6)
p.000097: The research protocol shall take all measures necessary to prevent animal suffering, using the minimum number of
p.000097: research animals which have a low level of neurological or physiological sensation.
p.000097:
p.000097: Article (38.7)
p.000097: Artificial hybridization may not be conducted except between animals of the same species, even if breeds are different,
p.000097: provided that the expected benefit outweighs the risks and that such risks can be prevented or controlled.
p.000097:
p.000097: Article (38.8)
p.000097: Animals may not be cloned unless medically proven safe as per a medical report approved by at least two specialists.
p.000097:
p.000097: Article (38.9)
...
General/Other / Relationship to Authority
Searching for indicator authority:
(return to top)
p.000005: and has completed a course on research ethics.
p.000005: Research: A systematic experimental investigation aiming at improvement of biosciences or enrichment or
p.000005: development of general knowledge by using a living creature or parts thereof.
p.000005: Living Creatures: Human beings, animals and plants.
p.000005: Genetic Material: Chain of nitrogenous bases that exist within the cells or are extracted therefrom and are
p.000005: responsible for carrying traits and characteristics from the mother cell to the sub-cell and from one
p.000005: living creature to its offspring.
p.000005:
p.000005: 5
p.000005:
p.000005: Legal Capacity: Reaching the age of eighteen, with mental ability to enter into legal relation on his own.
p.000005: Informed Consent: A person giving his consent with his free will, without exploitation or coercion and upon full
p.000005: understanding of what is required from him and of the research objectives and potential risks as well as of rights and
p.000005: obligations arising out of his participation therein.
p.000005: Minor: A person under eighteen years of age.
p.000005: Fetus: Outcome of pregnancy from the beginning of nidation in the uterus to the time of its delivery or removal.
p.000005: Guardian: A person having the right of legal authority over another person.
p.000005: Sperm: The product of fertilization up to forty days.
p.000005: Zygotes: An egg fertilized by a male sperm; from the time of fertilization until the time of division into eight cells.
p.000005: Gamete: The product of fertilization; from the end of the zygote phase until the phase of nidation where the
p.000005: zygote is implanted in the uterus. Cloning: The process of producing a complete individual genetically
p.000005: identical to another without sexual intercourse.
p.000005: Product of Pregnancy: A fetus that comes out of or removed from the uterus. Experimental Animals: Animals raised in
p.000005: cages or at certain places to be used in scientific experiments.
p.000005: Minimal Risk: Minor harm not exceeding potential risk encountered in daily life, which cannot be avoided during
p.000005: ordinary clinical or psychological examination, including potential discomfort and inconvenience.
p.000005: Legally Incompetent: A person lacking full legal capacity due to being a minor, lacking the ability of sound reasoning
p.000005: and judgment or being subject of a court ruling placing him under custody or continuation thereof which bars him from
p.000005: entering into a legal relation on his own.
p.000005: Disabled: A person suffering from a permanent full or partial deficiency
p.000005:
p.000006: 6
p.000006:
...
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:
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.000012: 12
p.000012:
p.000012: Chapter Three: National Committee of Bioethics
p.000012:
p.000012: Article 4
p.000012: 1. A national committee of bioethics shall be formed at KACST comprising specialists nominated by the
p.000012: competent minister or head of an agency for a renewable term of 3 years, as follows:
p.000012: A representative of KACST Chairman A representative of the
p.000012: Ministry of National Guard Member A representative of the Ministry of Defense
p.000012: Member
p.000012: A representative of the Ministry of Interior Member A representative of the General
p.000012: Presidency of Religious Research and Ifta
p.000012: Member
p.000012: Two representatives from the Ministry of Higher Education (Universities)
p.000012: Members
p.000012: A representative of the Ministry of Health Member
p.000012: A representative of the Ministry of Education Member
p.000012: A representative of the Ministry of Agriculture Member A representative of the Saudi Wildlife
p.000012: Commission Member A representative of the Food and Drug General Authority Member A
p.000012: representative of King Faisal Specialist Hospital and Research Center
p.000012: Member
p.000012: A representative of Human Rights Commission Member The Director of Research Ethics Monitoring
p.000012: Office Member A representative of the private sector selected by the Chairman of the Council of the
p.000012: Chambers of Commerce and Industry Member A legal counselor selected by the President of KACST
p.000012: Member
p.000012: 2. The President of KACST shall issue the committee-formation decision, and said committee shall report
p.000012: to him.
p.000013: 13
p.000013:
p.000013: 3. The President of KACST shall appoint a secretary for the committee.
p.000013: 4. Committee members shall elect from among themselves a vice president.
p.000013:
p.000013: Article (4.1)
p.000013: 1. The President of KACST shall send a request for nomination to ministers and heads of relevant agencies
p.000013: as specified in Article 4 of the Law not less than three months before the formation or re-formation of the National
p.000013: Committee.
p.000013: 2. Each Minister or head of a relevant agency shall name a representative at the National Committee in ample
p.000013: time prior to the date set for formation of the committee, taking into consideration the following
p.000013: conditions:
p.000013: a. Be a Saudi national;
p.000013: b. Have academic qualification and experience necessary for
p.000013: contribution to committee work;
p.000013: c. Be known for integrity and competency;
p.000013: d. Not be previously convicted of a crime impinging on religion or honor.
...
p.000017: 5. If any of the National Committee members has an interest in a proposed item for discussion that may affect his
p.000017: opinion or neutrality, he shall declare the same prior to the meeting. In such case, the Committee Chairman
p.000017: may ask him to leave the meeting or to remain without the right to participate in the discussion or voting. If the
p.000017: Chairman leaves for such reason, his designee shall chair the meeting.
p.000017:
p.000017: Article (5.3)
p.000017: 1. Committee resolutions shall pass by simple majority vote of attending
p.000017: members. In case of a tie, the meeting Chairman shall have the casting vote.
p.000017: 2. Votes may be taken by a show of hands, secret ballot, electronically, or by any other means decided by the
p.000017: Chairman.
p.000017: 3. The National Committee may, if necessary, pass a resolution by circulation if approved by two-thirds
p.000017: of its members. Committee approval of said resolution shall be included in the subsequent meeting minutes.
p.000017:
p.000018: 18
p.000018:
p.000018: Article (5.4)
p.000018: The National Committee may, upon a call of its Chairman or his designee, invite persons with expertise in the item
p.000018: under discussion, whether from within or outside KACST, without such persons having the right to vote.
p.000018:
p.000018: Article (5.5)
p.000018: Remuneration of the National Committee Chairman and members shall be determined in accordance with laws and procedures
p.000018: applicable at KACST.
p.000018:
p.000018: Article 6
p.000018: The National Committee shall set standards for biological research ethics and oversee enforcement thereof.
p.000018: It shall be the authority regarding overseeing research ethics and monitoring implementation thereof. It shall
p.000018: particularly undertake the following:
p.000018: 1. Prepare bioethics research regulations and review them in accordance with recent
p.000018: developments.
p.000018: 2. Propose amendment to the Law and its Regulations.
p.000018: 3. Form specialized subcommittees for conducting detailed studies on research fields within the jurisdiction of the
p.000018: National Committee.
p.000018: 4. Set controls for sending biological samples to laboratories outside the Kingdom.
p.000018: 5. Oversee local committees and monitor compliance with Sharia and statutory rules when dealing with biological
p.000018: material.
p.000018: 6. Set ethical controls and monitor implementation thereof to safeguard rights of human subjects
p.000018: during research and ensure confidentiality and security of research information.
p.000018: 7. Establish a database for saving and retrieving national information on genetic material of Saudi society.
p.000019: 19
p.000019:
p.000019: 8. Coordinate between the Kingdom and other countries as well as Arab and international organizations with regard to
p.000019: its jurisdiction, in accordance with applicable legal procedures.
p.000019: 9. Set bylaws for the National Committee.
p.000019: 10. Propose annual budget of both the National Committee and the Research Ethics Monitoring Office.
p.000019: 11. Oversee and monitor the central information system for national genetic material banks and set controls for
p.000019: documentation and retrieval thereof.
p.000019: 12. Set rules and principles for ethical recognition of research laboratories working in
p.000019: biomedical fields.
...
p.000043: through the following:
p.000043: a. Adopting standard operating procedures and scientific methods for research design which do not expose research
p.000043: human subjects to risks;
p.000043: b. Adopting standard and established procedures for therapeutic or diagnostic purposes as much as
p.000043: possible.
p.000043: 3. Evaluating benefits and risks that might ensue from the research;
p.000043: 4. Ensuring that research subjects have been selected based on their understanding of research
p.000043: objectives, place, time and method of conducting research, with special additional attention in the cases in which
p.000043: the participation of persons requiring additional protection is requested, such as (vulnerable groups)
p.000043: 5. Ensuring that the “Informed Consent” of the human subject contains all
p.000043: the required elements;
p.000043: 6. Ensuring that the research plan includes a periodic monitoring of results
p.000043: to maintain safety of the human subject;
p.000043: 7. Ensuring that the research plan includes management measures to
p.000043: protect the human subject and the human subject’s rights;
p.000043:
p.000044: 44
p.000044:
p.000044: 8. Ensuring that sufficient measures are taken to protect privacy of the human subject and maintain
p.000044: confidentiality of data.
p.000044: 9. In the case of clinical research involving testing drugs or equipment on humans, the authorization of the Saudi
p.000044: Food and Drug Authority must be obtained according to observed laws and regulations.
p.000044: 10. Every clinical research project must be registered first with the Saudi Food and Drug Authority before
p.000044: human subjects are invited to participate.
p.000044: 11. The Saudi Food and Drug Authority clinical studies database must be
p.000044: checked first to avoid conducting duplicate research.
p.000044:
p.000044: Article (10.18)
p.000044: The local committee may approve certain research by using the expedited review procedure in the following cases:
p.000044: 1. If the risk that the human subject may be exposed to does not exceed
p.000044: the minimal risk level;
p.000044: 2. If the research does not reveal the identity of the human subject;
p.000044: 3. If the research deals with clinical studies on drugs or medical equipment, provided:
p.000044: a. The drug is used in accordance with its licensing and dosages approved by the concerned party, and does
p.000044: not entail any increase in potential risk for the human subject;
p.000044: b. The medical equipment in use has originally been licensed by the concerned party and has already been utilized
p.000044: accordingly.
p.000044: 4. If taking biological samples for research purposes is carried out via non-invasive methods such as
p.000044: analysis of urine, saliva, nail or hair clippings, etc.
p.000044: 5. If research data is to be collected by using medical equipment approved
p.000044:
p.000045: 45
p.000045:
p.000045: by the concerned party, such as:
p.000045: a. Sensors which are directly applied on body surface or at a close distance thereto and which do not expose the
p.000045: body to a significant amount of energy and do not violate the privacy of the human subject;
...
p.000045: devices;
p.000045: e. Moderate exercise, muscle strength, body ratios (such as body fat ratio) and measurement of joint and
p.000045: muscle flexibility devices, provided these tests are deemed appropriate after taking age, weight and health condition
p.000045: into account;
p.000045: f. Search for information, records or samples that were previously collected or will be collected in the
p.000045: future for non-research purposes;
p.000045: g. Collect information via audio or video taping (static or moving) for the purpose of looking for the attributes or
p.000045: behavior of an individual or group without violation of privacy of the human subject.
p.000045: However, excepted from these devices is the use of X-ray or electromagnetic microwavedevices.
p.000045:
p.000045: Article (10.19)
p.000045: 1. Approval by expedited review shall be issued by local committee chairman or by one or more members
p.000045: selected by committee chairman for their experience.
p.000045:
p.000046: 46
p.000046:
p.000046: 2. In case of expedited review, the research evaluator shall have all the powers given to the local committee except
p.000046: for rejection of research, which shall be within the jurisdiction of the local committee alone. If the
p.000046: evaluator decides to reject the research, he shall refer it to the committee for reviewing it according to the
p.000046: provisions of this Law and its Regulations.
p.000046: 3. In case approval of research is issued by using expedited review, the committee chairman shall notify all
p.000046: committee members of the research projects that he has approved via whatever notification means he deems appropriate.
p.000046:
p.000046: Article (10.20)
p.000046: The local committee chairman has the authority to approve any amendment of the research previously approved by using
p.000046: expedited review. Exceptions include interviews and surveys conducted on any of the (vulnerable groups), amendment of
p.000046: research project or approval form, which shall be within the jurisdiction of the local committee.
p.000046:
p.000046: Article (10.21)
p.000046: Applications for approval using the expedited review procedure shall observe the terms and requirements
p.000046: stipulated in the basic elements of the Informed Consent in accordance with the provisions set forth in Chapter 5 of
p.000046: the Regulations.
p.000046:
p.000046: Article (10.22)
p.000046: The expedited review procedure may not be used for approving research if
p.000046: the objectives of such research include the following:
p.000046: 1. Addition of a new medication;
p.000046:
p.000047: 47
p.000047:
p.000047: 2. Addition of new medical equipment;
p.000047: 3. Addition of a new invasive or interventional procedure;
p.000047: 4. Increase or decrease of a medication dose, which may lead to increased harms;
p.000047: 5. The research is conducted to identify new potential risks.
p.000047:
p.000047: Article (10.23)
p.000047: 1. If the principal investigator wishes to amend the research proposal approved by the local committee,
p.000047: he shall submit the matter to the local committee to obtain its approval prior to proceeding with the
p.000047: amendment.
p.000047: 2. The following may be exempted from local committee review:
p.000047: a. Amendment of advertising material used for inviting human subjects, provided said amendment does not
p.000047: disrupt the content of such material;
p.000047: b. Amendments that only include providing administrative support to the study;
...
p.000072: c. It is pledged in writing not to use these induced pluripotent stem cells on humans.
p.000072: 8. Embryonic cells and derivatives can be imported only from the sources permitted by these regulations, once
p.000072: the authorization of the local committee is obtained. Commercially available induced pluripotent stem cells
p.000072: can also be imported from scientifically recognized sources.
p.000072:
p.000072: Article (23.2)
p.000072: It is prohibited to import the following stem cells:
p.000072: 1. Stem cells obtained from the insemination using a donor ovum and a donor sperm, performed to extract stem cells.
p.000072: 2. Stem cells obtained from deliberately aborted fetuses.
p.000072:
p.000073: 73
p.000073:
p.000073: Article (23.3)
p.000073: Cells can be used in clinical research (therapeutic research) under the following conditions:
p.000073: 1. A written authorization is obtained from the local research ethics committee.
p.000073: 2. A “Informed Consent” form is obtained from the human subject participant before the research
p.000073: project is initiated.
p.000073: 3. A written authorization is obtained from the Saudi Food and Drug Authority.
p.000073: 4. The expected benefit for the human subject and the extent to which it outweighs the possible harm shall
p.000073: be evaluated through a clear and thorough scientific assessment conducted by the investigator and submitted to
p.000073: the local committee.
p.000073: 5. The investigator or research team conducting the research shall be
p.000073: specialized and shall have sufficient scientific expertise and competence.
p.000073: 6. Research objectives shall be clearly and accurately defined, and the research is preceded by
p.000073: sufficient experiments on animals if the nature of the research so requires; subject to the discretion of the
p.000073: local committee.
p.000073: 7. If the local committee finds that the potential harm for the human subject outweighs the expected
p.000073: benefit, it must refrain from authorizing the research project.
p.000073: 8. The local committee shall review periodic reports submitted by the investigator to ensure that the
p.000073: expected benefit continues to outweigh the possible harm.
p.000073: 9. The “Informed Consent” shall be obtained from the human subject prior to conducting the research and the
p.000073: information provided shall contain a full explanation of expected benefits and potential risks of the research.
p.000074: 74
p.000074:
p.000074: 10. The investigator shall keep detailed records of the source of stem cells and the results of their use in the
p.000074: research, and shall submit periodic research reports to the local committee.
p.000074:
p.000074: Article (23.4)
...
p.000099:
p.000099: Article (38.18)
p.000099: Captured animals shall be subject to quarantine in their natural habitat before being moved to the research
p.000099: unit wherein they are to be quarantined once again before conducting the research. The National Committee shall set
p.000099: conditions for the quarantine and its duration.
p.000099:
p.000099: Article (38.19)
p.000099: Wild animals may not be used in scientific research except in the following
p.000099: cases:
p.000099: 1. If it is impossible to achieve study objectives by using other alternatives;
p.000099: 2. Increase the number of animals subject of the research and protect them
p.000099: from extinction without affecting their genetic nature;
p.000099: 3. Detect whether the animal subject carries any zoonotic or epidemic
p.000099: diseases or immunize said animal to prevent spread of such diseases.
p.000099:
p.000100: 100
p.000100:
p.000100: Article (38.20)
p.000100: Upon completion of the research and ascertaining the well-being of the research animal, it shall be
p.000100: released and returned to its original habitat, whenever possible.
p.000100:
p.000100: Article (38.21)
p.000100: 1. Wild animals foreign to the Kingdom’s wildlife may not be introduced thereto for the purposes of research;
p.000100: 2. Wild animals may not be returned to their habitat after being genetically
p.000100: modified;
p.000100: 3. No research may be conducted to increase the population of certain species of wild animals at the
p.000100: expense of other species unless said species is in danger of extinction.
p.000100:
p.000100: Article (38.22)
p.000100: For capturing terrestrial and marine animals for the purposes of research, a permit from the relevant authority
p.000100: indicating the term of the license, and type of animal shall be obtained, without prejudice to the hunting laws in the
p.000100: Kingdom.
p.000100:
p.000100: Article (38.23)
p.000100: Animals or products thereof exposed to chemical, biological or genetic substances for the purposes of research
p.000100: may not be consumed, sold or given away. Said animals as well as wastes and products thereof shall be disposed of
p.000100: through established scientific practices under veterinary supervision.
p.000100:
p.000100: Article (38.24)
p.000100: The institution licensed to conduct research on animals shall have facilities
p.000100:
p.000101: 101
p.000101:
p.000101: for the care of experimental animals, comprising the following:
p.000101: 1. Enclosures for the care of experimental animals appropriately equipped for animal living conditions;
p.000101: 2. A person qualified to monitor animal safety and health and care for
p.000101: animals prior to commencement of research;
p.000101: 3. Fully equipped laboratories appropriate for conducting experiments
p.000101: and reaching sound scientific results.
p.000101:
p.000101: Article (38.25)
p.000101: The institution licensed to conduct research on animals shall submit an annual report to the Monitoring Office,
p.000101: including: activities, experiments conducted, numbers, types and sources of animals used, results of each experiment,
p.000101: and destruction procedures, pursuant to forms prepared for this purpose.
p.000101:
p.000101: Article (38.26)
p.000101: Persons licensed to conduct experiments on animals as well as institutions,
p.000101: places and experiments shall be monitored by the Monitoring Office.
p.000101:
p.000101: Article (38.27)
p.000101: The National Committee shall set up rules and controls governing use of animals in research experiments
...
p.000102: If research includes conducting genetic modification experiments on Living Creatures, the investigator shall take all
p.000102: necessary measures to prevent their escape from research laboratories.
p.000102:
p.000102: Article (40.1)
p.000102: Genetic modification research on animals and plants shall be conducted in laboratories designated for this purpose,
p.000102: provided all measures are taken to prevent escape of genetically modified creatures.
p.000102:
p.000102:
p.000103: 103
p.000103:
p.000103: Article (40.2)
p.000103: Microorganisms subject to the research and their outcome shall be disposed of through standard scientific procedures.
p.000103:
p.000103:
p.000103:
p.000103:
p.000103:
p.000103:
p.000103:
p.000103:
p.000103:
p.000103:
p.000103:
p.000103:
p.000103:
p.000103:
p.000103:
p.000103:
p.000103:
p.000103:
p.000103:
p.000103:
p.000103:
p.000103:
p.000103:
p.000103:
p.000103:
p.000103:
p.000103:
p.000103:
p.000103:
p.000103:
p.000103:
p.000103:
p.000103:
p.000103:
p.000103:
p.000103:
p.000103:
p.000103:
p.000103:
p.000103:
p.000103:
p.000103:
p.000103:
p.000103:
p.000104: 104
p.000104:
p.000104: Chapter Thirteen: Violation Review Committee
p.000104:
p.000104: Article 41
p.000104: KACST President shall designate inspection employees in charge of detecting violations of the provisions of this
p.000104: Law and its Regulations in accordance with procedures specified by the Regulations.
p.000104:
p.000104: Article (41.1)
p.000104: Inspection employees, named pursuant to a decision by KACST President, shall be in charge of detecting violations of
p.000104: the provisions of the Law and Regulations, without prejudice to the authority of the Monitoring Office and the local
p.000104: committee with regard to detection of such violations.
p.000104:
p.000104: Article (41.2)
p.000104: For the purpose of detecting violations of the provisions of the Law and Regulations, the inspection employees may
p.000104: enter and inspect institutions licensed under the Law, examine records and documents, request necessary data, and
p.000104: question employees therein. Institution owners and officials shall facilitate the work of the inspection employees.
p.000104:
p.000104: Article (41.3)
p.000104: Inspection employees shall record every violation in an official report including name of violator or
p.000104: violating institution as the case may be, a description of the violation, time of detection, recording of any relevant
p.000104: sample, paper, or document seized therein. The report shall be signed by the relevant inspection employee and the
p.000104: violator. If the violator refuses to sign, such incident shall be recorded in the report.
p.000104:
p.000104:
p.000105: 105
p.000105:
p.000105: Article (41.4)
p.000105: The violator shall be notified of the detected violation in writing.
p.000105:
p.000105: Article 42
p.000105: a- A committee shall be formed pursuant to a decision by KACST president to review violations of the
p.000105: provisions of this Law and decide appropriate penalties, except for imprisonment, according to this Law. Said committee
p.000105: shall determine amount of damages for private claims. The committee shall comprise the following:
p.000105: 1. A Sharia counselor named by Minister of Justice Chairman
...
Orphaned Trigger Words
p.000005: Living Creatures: Human beings, animals and plants.
p.000005: Genetic Material: Chain of nitrogenous bases that exist within the cells or are extracted therefrom and are
p.000005: responsible for carrying traits and characteristics from the mother cell to the sub-cell and from one
p.000005: living creature to its offspring.
p.000005:
p.000005: 5
p.000005:
p.000005: Legal Capacity: Reaching the age of eighteen, with mental ability to enter into legal relation on his own.
p.000005: Informed Consent: A person giving his consent with his free will, without exploitation or coercion and upon full
p.000005: understanding of what is required from him and of the research objectives and potential risks as well as of rights and
p.000005: obligations arising out of his participation therein.
p.000005: Minor: A person under eighteen years of age.
p.000005: Fetus: Outcome of pregnancy from the beginning of nidation in the uterus to the time of its delivery or removal.
p.000005: Guardian: A person having the right of legal authority over another person.
p.000005: Sperm: The product of fertilization up to forty days.
p.000005: Zygotes: An egg fertilized by a male sperm; from the time of fertilization until the time of division into eight cells.
p.000005: Gamete: The product of fertilization; from the end of the zygote phase until the phase of nidation where the
p.000005: zygote is implanted in the uterus. Cloning: The process of producing a complete individual genetically
p.000005: identical to another without sexual intercourse.
p.000005: Product of Pregnancy: A fetus that comes out of or removed from the uterus. Experimental Animals: Animals raised in
p.000005: cages or at certain places to be used in scientific experiments.
p.000005: Minimal Risk: Minor harm not exceeding potential risk encountered in daily life, which cannot be avoided during
p.000005: ordinary clinical or psychological examination, including potential discomfort and inconvenience.
p.000005: Legally Incompetent: A person lacking full legal capacity due to being a minor, lacking the ability of sound reasoning
p.000005: and judgment or being subject of a court ruling placing him under custody or continuation thereof which bars him from
p.000005: entering into a legal relation on his own.
p.000005: Disabled: A person suffering from a permanent full or partial deficiency
p.000005:
p.000006: 6
p.000006:
p.000006: in his physical, sensory, communicative, educational or psychological abilities to an extent that affects
p.000006: the possibility of meeting his common needs compared to his non-disabled peers.
p.000006: Child: A male or female not reaching the age of eighteen years which entails him to give an informed
p.000006: consent.
p.000006: Embryonic StemXCells: Cells removed from the fertilized egg in its early phases; before the differentiation phase.
p.000006: Adult StemXCells: Organically unspecialized cells that are removed from the cells of a fully developed living being.
p.000006:
p.000006: Article (1.1)
p.000006: Without prejudice to the meanings of the terms and phrases specified in Article 1 of the Law, the following
p.000006: terms and phrases – wherever used in the Law – shall have the meanings assigned to them, unless otherwise required
p.000006: by context.
p.000006: Human Subject (Participant): A person who consents or whose guardian consents to conduct clinical, non-clinical or
p.000006: therapeutic research or experiments on him.
p.000006: Principal Investigator: Lead researcher in charge of planning and conducting the research,
p.000006: collecting and analyzing data, and directing interventions stated in the research plan.
p.000006: Clinical Research: Any research related to collecting and analyzing data for volunteers or patients for the purpose of
p.000006: obtaining general knowledge that can be applied to other individuals with regard to mechanism of disease, its
p.000006: incidence, prevalence, transmission or treatment of a disease.
p.000006: Non-Clinical Research: Any research related to collecting and analyzing data not directly related to people for
p.000006: the purpose of obtaining general knowledge or facts.
p.000006:
p.000007: 7
p.000007:
p.000007: Clinical Trial: Experiments conducted on human volunteers to examine safety and effectiveness of a new medication or
p.000007: medical device.
p.000007: Prisoner: A person deprived of liberty, whether serving a prison sentence, detained on trial, or is a correction
p.000007: facility inmate.
p.000007: Vulnerable groups: Groups of individuals in need of additional protection due to their lack of legal capacity, their
p.000007: questionable or diminished capacity or their lack of freedom to choose.
p.000007: Stillborn: A fetus delivered, came out of, or removed from the uterus with no signs of life such as heartbeat, natural
p.000007: breathing, movement, or pulsation of the umbilical cord if still connected.
p.000007: Diagnostic Procedure: A test aiming at finding a certain disorder or disease
p.000007: in a living creature.
p.000007: Medication: A chemical compound administered to a living creature to help diagnose, treat, prevent, cure or
p.000007: alleviate the effects of a disease or organic disorder.
p.000007: Periodic Assessment: Observation of research progress by safety assessment and information monitoring
p.000007: committee to ascertain safety of the human subject on a continuous basis and to ensure nonexistence of any reason for
p.000007: discontinuation or modification of the research.
p.000007: Periodic Follow-up: Review of the periodic report submitted by the principal investigator to the local
p.000007: committee to evaluate research progress and conformity with the approved research plan.
p.000007: Expedited Review: An evaluation carried out by the local committee chairman, or by a committee member
p.000007: designated by him, of a new research project or modifications of a previously approved research where potential risk to
p.000007: the human subject does not exceed minimal risk.
p.000007: Genetic Therapy Research: Any research which includes insertion or deletion of genetic material within body
p.000007: cells or targeting the same whether
p.000008: 8
p.000008:
p.000008: by modification or deactivation for finding a treatment for hereditary or
p.000008: other diseases.
p.000008: Confidentiality: Non-disclosure or passing of any data, information or results related to the research or the
p.000008: human subject, to any third party not connected with the research.
p.000008: Privacy: Observing common values, including traditions, thoughts and norms.
p.000008: Safety Assessment and Information Monitoring Committee: A group of scientists, physicians, and statisticians
p.000008: independent from researchers, whose task is to review accumulated data during clinical experiments for prompt
p.000008: analysis and to observe any significant likelihood towards a certain trend in the results or unacceptable side effects
p.000008: requiring a recommendation for suspension of research or modification of its plan.
p.000008: Genes: Molecular units of heredity data in all living organisms that encode the information required for building and
p.000008: preserving cells and performing all vital functions, and hence building bodies of Living Creatures and giving
p.000008: them their characteristic features.
p.000008: Major Harm: Any harm leading to a participant’s death, jeopardy to his life, hospitalization beyond expectation,
p.000008: permanent disability, or deformation of fetus. This harm is deemed unexpected if not stated in the “informed consent.”
p.000008:
p.000008:
p.000008:
p.000008:
p.000008:
p.000008:
p.000008:
p.000008:
p.000008:
p.000008:
p.000008:
p.000008:
p.000009: 9
p.000009:
p.000009: General Provisions
p.000009:
p.000009: Article (1.2)
p.000009: Scope of Application
p.000009: 1. The provisions of the Law and its Regulations shall apply to any research establishment conducting
p.000009: research on living creatures in the Kingdom of Saudi Arabia.
p.000009: 1. Research conducted on samples taken from within the Kingdom shall be subject to the provisions of the Law and its
p.000009: Implementing Regulations as regards taking the informed consent and sending genetic samples abroad.
p.000009:
p.000009: Article (1.3)
p.000009: Principles Governing Provisions of the Law and its Regulations
p.000009: In interpretation and application, the provisions of the Law and its Regulations shall be subject to
p.000009: Sharia provisions as adopted by official bodies in the Kingdom, laws and controls set by the National Committee,
p.000009: and principles of human rights, without prejudice to provisions of Sharia.
p.000009:
p.000009: Article (1.4)
p.000009: Banning Biological Research outside Licensed Establishments Conducting biological research outside the premise and
p.000009: scope of supervision of licensed establishments shall be deemed a violation of the provisions of
p.000009: theLawanditsRegulations.
p.000009:
p.000009:
p.000009:
p.000009:
p.000009:
p.000009:
p.000009:
p.000010: 10
p.000010:
p.000010: Chapter Two: Objectives of the Law
p.000010:
p.000010: Article 2
p.000010: This Law aims at setting the general principles and controls necessary for dealing with Living Creatures, parts
p.000010: thereof or their genetic material in research in light of applicable professional ethics not conflicting
p.000010: with Sharia.
p.000010:
p.000010: Article (2.1)
p.000010: The Law aims to protect the rights of the human subject or part thereto, guarantee his safety and dignity, and
p.000010: not harm animals or plants when conducting research.
p.000010:
p.000010: Article (2.2)
p.000010: Sharia dictates and professional ethics enforced in official bodies in the Kingdom as well as rules and
p.000010: procedures set by the National Committee shall be observed in implementing the provisions of the Law and its
p.000010: Regulations.
p.000010:
p.000010: Article 3
p.000010: No establishment may conduct research on a living creature except upon fulfilling procedures required under
p.000010: this Law. Research shall be subject to periodic inspection by the National Committee in accordance with the
p.000010: Regulations.
p.000010:
p.000010: Article (3.1)
p.000010: No establishment may conduct research on Living Creatures except after registration of a local committee that
p.000010: grants licensing for conducting
p.000011: 11
p.000011:
p.000011: research and monitors research ethics in accordance with provisions of the Law and its Regulations.
p.000011:
p.000011: Article (3.2)
p.000011: The establishment shall be responsible for any research conducted therein and shall, through local committees, ensure
p.000011: that the researcher and researchXstaff comply with controls, procedures and provisions set forth in the Law and its
p.000011: Regulations as well as decisions of the National Committee.
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p.000012: 12
p.000012:
p.000012: Chapter Three: National Committee of Bioethics
p.000012:
p.000012: Article 4
p.000012: 1. A national committee of bioethics shall be formed at KACST comprising specialists nominated by the
p.000012: competent minister or head of an agency for a renewable term of 3 years, as follows:
p.000012: A representative of KACST Chairman A representative of the
p.000012: Ministry of National Guard Member A representative of the Ministry of Defense
p.000012: Member
p.000012: A representative of the Ministry of Interior Member A representative of the General
p.000012: Presidency of Religious Research and Ifta
p.000012: Member
p.000012: Two representatives from the Ministry of Higher Education (Universities)
p.000012: Members
p.000012: A representative of the Ministry of Health Member
p.000012: A representative of the Ministry of Education Member
p.000012: A representative of the Ministry of Agriculture Member A representative of the Saudi Wildlife
p.000012: Commission Member A representative of the Food and Drug General Authority Member A
p.000012: representative of King Faisal Specialist Hospital and Research Center
p.000012: Member
p.000012: A representative of Human Rights Commission Member The Director of Research Ethics Monitoring
p.000012: Office Member A representative of the private sector selected by the Chairman of the Council of the
p.000012: Chambers of Commerce and Industry Member A legal counselor selected by the President of KACST
p.000012: Member
p.000012: 2. The President of KACST shall issue the committee-formation decision, and said committee shall report
p.000012: to him.
p.000013: 13
p.000013:
p.000013: 3. The President of KACST shall appoint a secretary for the committee.
p.000013: 4. Committee members shall elect from among themselves a vice president.
p.000013:
p.000013: Article (4.1)
p.000013: 1. The President of KACST shall send a request for nomination to ministers and heads of relevant agencies
p.000013: as specified in Article 4 of the Law not less than three months before the formation or re-formation of the National
p.000013: Committee.
p.000013: 2. Each Minister or head of a relevant agency shall name a representative at the National Committee in ample
p.000013: time prior to the date set for formation of the committee, taking into consideration the following
p.000013: conditions:
p.000013: a. Be a Saudi national;
p.000013: b. Have academic qualification and experience necessary for
p.000013: contribution to committee work;
p.000013: c. Be known for integrity and competency;
p.000013: d. Not be previously convicted of a crime impinging on religion or honor.
p.000013: 3. If any member of the National Committee is unable to complete his term for any reason, or if he expresses
p.000013: his desire to discontinue his membership in the committee, or if he fails to attend three consecutive or seven
p.000013: non-consecutive meetings within the same year without an excuse acceptable to KACST President, a
p.000013: replacement shall be appointed in the same manner the replaced member was appointed to serve the remainder of his
p.000013: term.
p.000013: 4. Committee membership shall be a renewable term of three years, provided half the members are replaced
p.000013: upon committee re-formation
p.000014: 14
p.000014:
p.000014: for the third time. Membership may not be renewed for more than three consecutive terms.
p.000014:
p.000014: Article (4.2)
...
p.000016: request submission date.
p.000016: 4. The National Committee shall convene at its headquarters or at any other place set by the Committee
p.000016: Chairman or his designee if necessary.
p.000016: 5. Invitations for the meeting shall be sent to Committee members at least ten working days prior to the
p.000016: meeting date. Invitations shall be delivered by hand or sent via ordinary mail or e-mail.
p.000016: 6. Invitations shall include venue, date and time of meeting. Papers and documents related to proposed items on the
p.000016: agenda shall be enclosed therein except for classified documents. Members may have access to all documents at
p.000016: the meeting place whether prior to or during the meeting.
p.000016: 7. The agenda of the National Committee meeting shall include the following items:
p.000016: a. Minutes of the previous meeting for approval;
p.000016: b. Topics proposed by the National Committee Chairman or members;
p.000016: c. Monthly reports prepared by National Committee Secretariat, if any, upon approval by Committee
p.000016: Chairman.
p.000016:
p.000016: Article (5.2)
p.000016: 1. National Committee meetings shall not be valid unless attended by two-thirds of its members including
p.000016: the Chairman or his designee.
p.000017: 17
p.000017:
p.000017: 2. If the quorum provided for in Paragraph (1) above is not met within half an hour of the designated time of the
p.000017: meeting, the Chairman shall adjourn the meeting and set a new date within ten days. The call for said meeting shall be
p.000017: made at least five working days prior to the meeting date.
p.000017: 3. If the National Committee Chairman or his deputy fails to attend the meeting within half an hour of the
p.000017: meeting time, the Committee Secretary shall adjourn the meeting.
p.000017: 4. If the National Committee Chairman becomes aware that neither he nor his deputy can attend the meeting,
p.000017: and it is necessary to hold the meeting, he may delegate a Committee member to chair the meeting, and he shall have the
p.000017: powers of the Committee Chairman with regards to managing the meeting.
p.000017: 5. If any of the National Committee members has an interest in a proposed item for discussion that may affect his
p.000017: opinion or neutrality, he shall declare the same prior to the meeting. In such case, the Committee Chairman
p.000017: may ask him to leave the meeting or to remain without the right to participate in the discussion or voting. If the
p.000017: Chairman leaves for such reason, his designee shall chair the meeting.
p.000017:
p.000017: Article (5.3)
p.000017: 1. Committee resolutions shall pass by simple majority vote of attending
p.000017: members. In case of a tie, the meeting Chairman shall have the casting vote.
p.000017: 2. Votes may be taken by a show of hands, secret ballot, electronically, or by any other means decided by the
p.000017: Chairman.
p.000017: 3. The National Committee may, if necessary, pass a resolution by circulation if approved by two-thirds
p.000017: of its members. Committee approval of said resolution shall be included in the subsequent meeting minutes.
p.000017:
p.000018: 18
p.000018:
p.000018: Article (5.4)
p.000018: The National Committee may, upon a call of its Chairman or his designee, invite persons with expertise in the item
p.000018: under discussion, whether from within or outside KACST, without such persons having the right to vote.
p.000018:
p.000018: Article (5.5)
p.000018: Remuneration of the National Committee Chairman and members shall be determined in accordance with laws and procedures
p.000018: applicable at KACST.
p.000018:
p.000018: Article 6
p.000018: The National Committee shall set standards for biological research ethics and oversee enforcement thereof.
p.000018: It shall be the authority regarding overseeing research ethics and monitoring implementation thereof. It shall
p.000018: particularly undertake the following:
p.000018: 1. Prepare bioethics research regulations and review them in accordance with recent
p.000018: developments.
p.000018: 2. Propose amendment to the Law and its Regulations.
p.000018: 3. Form specialized subcommittees for conducting detailed studies on research fields within the jurisdiction of the
p.000018: National Committee.
p.000018: 4. Set controls for sending biological samples to laboratories outside the Kingdom.
p.000018: 5. Oversee local committees and monitor compliance with Sharia and statutory rules when dealing with biological
p.000018: material.
p.000018: 6. Set ethical controls and monitor implementation thereof to safeguard rights of human subjects
p.000018: during research and ensure confidentiality and security of research information.
p.000018: 7. Establish a database for saving and retrieving national information on genetic material of Saudi society.
p.000019: 19
p.000019:
p.000019: 8. Coordinate between the Kingdom and other countries as well as Arab and international organizations with regard to
p.000019: its jurisdiction, in accordance with applicable legal procedures.
p.000019: 9. Set bylaws for the National Committee.
p.000019: 10. Propose annual budget of both the National Committee and the Research Ethics Monitoring Office.
p.000019: 11. Oversee and monitor the central information system for national genetic material banks and set controls for
p.000019: documentation and retrieval thereof.
p.000019: 12. Set rules and principles for ethical recognition of research laboratories working in
p.000019: biomedical fields.
p.000019: 13. Conduct periodic ethical evaluation and monitoring of national laboratories, and monitor medical
p.000019: research and experiments conducted on Living Creatures to ensure legitimacy.
p.000019: The Committee may seek consultation from experts, associations, scientific centers or specialized agencies
p.000019: within the Kingdom and abroad.
p.000019:
p.000019: Article (6.1)
p.000019: The National Committee Chairman or any of its members may propose amendment to the Law or Regulations. Said
p.000019: proposal shall be submitted for review by the Committee in accordance with its work procedures, and shall then be
p.000019: referred to the President of KACST to address concerned authorities in this regard.
p.000019:
p.000019: Article (6.2)
p.000019: Approval of amendments to the Law or Regulations shall be by majority
p.000019: vote of National Committee members.
p.000019:
p.000020: 20
p.000020:
p.000020: Article (6.3)
...
p.000022: 3. Importing cells or other materials from commercial suppliers licensed in the country of origin for research
p.000022: purposes does not require obtaining an ethical approval.
p.000022:
p.000022: Article (6.6)
p.000022: A database shall be established at KACST for saving and retrieving national information on genetic material
p.000022: of the Saudi society. KACST shall supervise and monitor said database as follows:
p.000022: 1. Provide facilities, human resources and equipment required for setting up databases;
p.000022: 2. Receive data of genetic material from local genetic material banks available in research institutions;
p.000022: 3. Establish a central bank for safekeeping and retrieving information on genetic material and provide said
p.000022: information for local genetic material
p.000023: 23
p.000023:
p.000023: banks;
p.000023: 4. Set controls and procedures for saving, retrieving and ensuring
p.000023: confidentiality of information on genetic material.
p.000023: 5. Set controls and procedures for requesting information on genetic material from the central genetic
p.000023: information bank.
p.000023: The procedures for saving and retrieving data and information on genetic
p.000023: material shall be subject to provisions of the Law and Regulations.
p.000023:
p.000023: Article (6.7)
p.000023: Research laboratories operating in biomedical fields shall be ethically
p.000023: recognized upon satisfying the following conditions:
p.000023: 1. Laboratories are supervised by a governmental institution or a private agency licensed by competent authorities;
p.000023: 2. Laboratories are run by specialists qualified to perform their technical
p.000023: and administrative duties and responsibilities;
p.000023: 3. Laboratories, if not affiliated with a governmental institution, satisfy
p.000023: conditions set forth in the “Law of Private Laboratories”;
p.000023: 4. The institution is able to meet legal liability arising from damage caused
p.000023: by practices conducted within its affiliated laboratories;
p.000023: 5. Laboratories meet safety conditions and preventive measures observed in establishing biomedical research
p.000023: laboratories;
p.000023: 6. Laboratories observe confidentiality and privacy with regard to Living
p.000023: Creatures or genetic material information available therein.
p.000023:
p.000023: Article (6.8)
p.000023: When coordinating between the Kingdom and other countries, or Arab or international organizations, the National
p.000023: Committee, in the context of exercising its jurisdiction, shall observe applicable legal procedures.
p.000024: 24
p.000024:
p.000024: Chapter Four: Committee Revenues
p.000024:
p.000024: Article 7
p.000024: An annual financial allocation shall be set for the National Committee within the budget of KACST along with endowments
p.000024: allocated therefor.
p.000024:
p.000024: Article (7.1)
p.000024: 1. Committee revenues shall comprise the following:
p.000024: a. Financial allocations set for it within KACST’s budget;
p.000024: b. Endowments allocated for the Committee.
p.000024: 2. Upon setting allocations referred to in Paragraph (a) above, the following procedures shall be
p.000024: observed:
p.000024: a. The National Committee Chairman shall submit the allocations set for the following fiscal year to be approved by
p.000024: the Committee 30 days before its submission to KACST President;
p.000024: b. Upon approval of allocations by the National Committee, the Committee Chairman shall submit said
p.000024: allocations to KACST President.
p.000024: c. The Committee Chairman shall coordinate with relevant departments at KACST to incorporate said allocations in
p.000024: KACST budget. Upon discussing such allocations, the Chairman may, if necessary, seek the assistance of any person
p.000024: either from relevant departments at KACST or from the Ministry of Finance, as he deems fit.
p.000024: d. Upon approval of the budget and setting the financial allocations for the National Committee, the Committee
p.000024: Chairman shall present to the Committee the allocations and the proposed spending plan.
p.000024: 3. Upon allocating endowments for the National Committee, the following procedures shall be observed:
p.000024:
p.000025: 25
p.000025:
p.000025: a. If the National Committee receives a request to endow any property for its activities, said request shall be
p.000025: presented to its members for discussion and decision thereon.
p.000025: b. Upon reviewing the endowment request, the National Committee shall observe all relevant laws, decisions and
p.000025: directives.
...
p.000029: Monitoring Office may undertake the following:
p.000029: 1. Having access to all records and documents of research registered with the local committee;
p.000029: 2. Contact the participating human subject, if required;
p.000029: 3. Cancel, suspend, terminate or prevent prompt evaluation, if necessary;
p.000029: 4. Record any violation committed by the local committee and take necessary actions in accordance with
p.000029: the Law and Regulations;
p.000029: 5. The Monitoring Office shall conduct periodic ethical evaluation and monitoring of national laboratories,
...
p.000033: b. He shall be of an acceptable level of education;
p.000033: 3. One member at least shall have an interest in biomedical ethics;
p.000033: 4. One member at least shall have adequate knowledge in research design and statistical analysis;
p.000033: 5. One member at least shall be adequately familiar with the customs, traditions and values of the
p.000033: Saudi Society.
p.000033:
p.000033: Article (10.2)
p.000033: 1. The local committee shall be formed by decision of the president of the establishment or competent agency stating
p.000033: the names of committee members, chairman and his deputy. The chairman and his deputy shall have interest in biomedical
p.000033: ethics.
p.000033: 2. The relevant establishment or competent agency commits to providing the financial support needed for the
p.000033: local committee as well as committee members remunerations such as to ensure and preserve the independence
p.000033: of committee decisions and to ensure its continued operation.
p.000033: 3. Committee members, employees and all persons invited to attend committee meetings shall keep as
p.000033: confidential all information they come by and shall not disclose any information included in research or research
p.000033: ideas and proposals.
p.000033:
p.000033:
p.000033:
p.000033:
p.000034: 34
p.000034:
p.000034: Article (10.3)
p.000034: Local committee members shall be appointed for a renewable term of 3 years, provided half the members be replaced upon
p.000034: re-formation for the third time. Membership may not be renewed for more than three consecutive terms.
p.000034:
p.000034: Article (10.4)
p.000034: The head of the establishment shall appoint a secretary for the local committee upon the recommendation
p.000034: of its chairman, to undertake the following:
p.000034: 1. Receive applications submitted to the committee and verify that they meet all conditions, and include all
p.000034: components and documents, and present the same to the committee chairman;
p.000034: 2. Prepare agendas and minutes of committee meetings;
p.000034: 3. Coordinate local committee activities and communications with researchers and with the
p.000034: National Committee;
p.000034: 4. Archive copies of committee meeting minutes, including names of attending members, decisions issued,
p.000034: results of voting on such decisions, and a summary of the discussions taking place during every meeting;
p.000034: 5. Prepare letters of notification of committee decisions and
p.000034: recommendations to be signed by the committee chairman;
p.000034: 6. Any other work-related tasks assigned to him by the committee or its chairman;
p.000034: 7. Maintain confidentiality of information he is privy to and not disclose
p.000034: any information in the research or research ideas and proposals.
p.000034:
p.000034: Article (10.5)
p.000034: The local committee shall seek to achieve the following:
p.000034:
p.000035: 35
p.000035:
p.000035: 1. Protect the human subject of the research, as well as protect and ensure the human subject’s rights and safety;
p.000035: 2. Verify compliance with all requested and documented procedures in the research project regarding the treatment of
p.000035: human subject participants and biological materials.
p.000035: 3. Provide necessary equipment and ensure that such equipment is
p.000035: adequate for the safety of the human subject participants.
p.000035: 4. Ensure especially that minors, legally incompetent or disabled persons, or any other persons from (vulnerable
p.000035: groups) are never abused under any circumstance.
p.000035: 5. The local committee will review the research project requests submitted by researchers associated with the
p.000035: establishment where the committee is affiliated. It also has the right to review the research project requests
p.000035: submitted by researchers in vicinity of the establishment upon agreement with the researcher, if there is no local
p.000035: committee in the establishment where these researchers are affiliated, provided the absence of a local committee is not
p.000035: the result of an administrative negligence to establish such a committee.
p.000035: 6. In the case of researchers from multiple establishments participating in a joint project, it is not
p.000035: necessary to obtain approval of the local committee of every center participating in the research
p.000035: project. One of the local registered committees shall in this case review the project, and the principal investigator
p.000035: must be from the establishment where the local committee which approves the project, and monitors it.
p.000035:
p.000035: Article (10.6)
p.000035: Committee membership shall be terminated for any of the following reasons:
p.000035:
p.000036: 36
p.000036:
p.000036: 1. Resignation;
p.000036: 2. Death;
p.000036: 3. Chronic illness that prevents a member from attending local committee meetings;
p.000036: 4. If any member fails to attend three consecutive or five non-consecutive meetings within the same year without an
p.000036: excuse acceptable to the local committee chairman;
p.000036: 5. Expiration and non-renewal of term of membership;
p.000036: 6. If a member is proved to have violated his commitment to keep information confidential and the
p.000036: committee chairman has issued a decision to this effect based on proven facts.
p.000036:
p.000036: Article (10.7)
p.000036: If the membership of any local committee member is terminated for any reason, committee chairman shall instantly
p.000036: address the concerned party to appoint a replacement to fill in the remainder of said member’s term, and shall notify
p.000036: the Monitoring Office thereof.
p.000036:
p.000036: Article (10.8)
p.000036: If the local committee chairman finds that one committee member does not effectively take part in committee activities
p.000036: or that he has not appropriately accomplished the duties assigned to him, he may notify the concerned party
p.000036: thereof and suggest whatever action he deems fit, including dismissal of said member and appointment of a replacement.
p.000036:
p.000036: Article (10.9)
p.000036: 1. The local committee shall convene upon a call by its chairman whenever required;
p.000036:
p.000037: 37
p.000037:
p.000037: 2. Local committee meeting shall not be valid unless attended by the
p.000037: majority of its members including the chairman or his designee;
p.000037: 3. If the quorum is not reached within half an hour of the designated date of the meeting, the meeting chairman shall
p.000037: adjourn the meeting to be held within fifteen days thereafter;
p.000037: 4. Invitations for the meeting shall be delivered by hand or sent via ordinary mail or e-mail at least ten
p.000037: work days before convention date. The meeting agenda and all papers and documents related to topics proposed
p.000037: for discussion shall be attached to the invitations;
p.000037: 5. Local committee secretary shall record the meeting minutes, and attending members and committee
p.000037: secretary shall sign the minutes directly after the meeting or in the next meeting.
p.000037:
p.000037: Article (10.10)
p.000037: If a local committee member finds that he or any other member has any sort of direct or indirect interest related to
p.000037: any topic proposed for discussion by the committee, said member shall disclose such interest at the beginning of the
p.000037: meeting. In that case, the committee chairman shall ask the member who has declared such interest to withdraw from the
p.000037: meeting during discussion of related topic and shall record this action in the meeting minutes.
p.000037:
p.000037: Article (10.11)
p.000037: 1. The local committee may invite experts and consultants to attend its meetings whenever a proposed item on the
p.000037: committee meeting agenda requires so. These expert guests do not have the right to vote.
p.000037: 2. If the research subject proposed for discussion by the local committee is related to any category of the
p.000037: (vulnerable groups), the committee chairman shall invite a specialist with experience in this field to take
p.000038: 38
p.000038:
p.000038: part in discussing said subject. Said specialist shall have the right to take part in discussion and in voting. If said
p.000038: specialist fails to attend the meeting, it shall be required to obtain a specialist’s written opinion of the matter.
p.000038: 3. If it deems it necessary, the local committee may invite the principal investigator to attend one of its meetings,
p.000038: provided he does not attend the meeting during which the final decision on the research project is made.
p.000038:
p.000038: Article (10.12)
p.000038: 1. Local committee resolutions shall pass by simple majority vote of attending members. In case of a tie,
p.000038: the meeting chairman shall have the casting vote.
p.000038: 2. Local committee chairman shall determine the voting method in committee meetings.
p.000038: 3. Issued resolution shall be printed on local committee or establishment official stationary, and shall include
p.000038: a clear statement of resolution text. Committee chairman shall notify the principal investigator of said resolution
p.000038: in writing.
p.000038: 4. In case the research application is rejected, the resolution shall state the reasons for rejection.
p.000038: 5. Local committee may issue non-binding recommendations, if necessary,
p.000038: and attach them to rejection resolution.
p.000038: 6. Local committee may issue a conditional approval, and the resolution shall determine the necessary procedure to
p.000038: reconsider the application and any requirements or suggestions for reassessment.
p.000038: 7. An aggrieved party may appeal local committee resolutions of rejection
p.000038: or provisional approval before local committee. If the local committee
p.000038:
p.000039: 39
p.000039:
p.000039: dismisses the complaint as unconvincing, the aggrieved party may have
p.000039: recourse to the Monitoring Office to review the matter.
p.000039:
p.000039: Article (10.13)
p.000039: The principal investigator, whether he belongs to the establishment or not, shall submit the research approval to the
p.000039: local committee, including the research proposal. Upon setting of research proposal, the researcher shall observe the
p.000039: following:
p.000039: 1. Design of study shall be appropriate to its objectives;
p.000039: 2. Expected benefits and possible harms to which the human subject may be subject shall be in balance;
p.000039: 3. Research location shall be appropriate to the assistant group, including available potentials and emergency
p.000039: measures.
p.000039:
p.000039: Article (10.14)
p.000039: The research proposal shall comprise the following:
p.000039: 1. An abstract of the research within one page (Size: A4);
p.000039: 2. Research objectives;
p.000039: 3. Statistical methodology, including sample size calculations, taking into account possibility of obtaining
p.000039: statistically significant results by using the minimum number of research subjects;
p.000039: 4. Rationale for introducing any procedure, tool or device that has not been used before;
p.000039: 5. Rationale for using any substances that could be dangerous or harmful to the human subject or his surroundings and
p.000039: methods of disposal of said substances after research is completed;
p.000039: 6. Plan for dealing with risky cases;
p.000039: 7. Plan for disposal of extra biological samples;
p.000039:
p.000040: 40
p.000040:
p.000040: 8. A clear description of duties and responsibilities of research team;
p.000040: 9. Time schedule of research and criteria of research suspension or termination;
p.000040: 10. Case registration forms, daily cards, and questionnaires set for research
p.000040: subjects, in case of clinical research;
p.000040: 11. Research sample shall be determined according to the following considerations:
p.000040: a. Characteristics of sample from which the subjects will be selected;
p.000040: b. Criteria for inclusion and exclusion of the human subject;
p.000040: c. Methods through which initial contact and selection are carried out;
p.000040: d. Means of providing complete information to potential participants in the research or their representatives.
p.000040: 12. In clinical research, the principal investigator shall present a description of the individuals who will be given
p.000040: access to personal data of research subjects, including medical records and biological samples;
p.000040: 13. A list of expected results and ways to benefit therefrom;
p.000040: 14. A list of references.
p.000040:
p.000040: Article (10.15)
p.000040: The principal investigator shall, if necessary, enclose the following documents with his research
p.000040: proposal:
p.000040: 1. Any plans to stop or prevent administration of standard treatments because of the research and
p.000040: justifications for preventing ordinary standard treatments for conducting the research;
p.000040: 2. Medical care offered to human subjects during and after the research;
p.000040: 3. A description of the efficacy of social, psychological and medical supervision for all human
p.000040: subjects;
p.000040: 4. A statement of the compensation or treatment that can be provided for
p.000040:
p.000041: 41
p.000041:
p.000041: human subjects in case of injury, disability or death as a result of the
p.000041: research;
p.000041: 5. Arrangements taken to provide compensation, if required;
p.000041: 6. Indication of research funding methods and any research agreements related to the research.
p.000041: The human subject shall not incur any financial expenses for conducting
p.000041: the research on him.
p.000041:
p.000041: Article (10.16)
p.000041: To approve the research proposals submitted to the local committee, the following procedures shall be followed:
p.000041: 1. The local committee shall prepare a special approval application form and publish it on its website, including the
p.000041: following:
p.000041: a. Name of local committee and its postal address, electronic mail address and contact numbers;
p.000041: b. Name of principal investigator and his ordinary and electronic mail address and contact numbers;
p.000041: c. Title, duration and objectives of research project;
p.000041: d. Date of submission of application.
...
p.000043: the participation of persons requiring additional protection is requested, such as (vulnerable groups)
p.000043: 5. Ensuring that the “Informed Consent” of the human subject contains all
p.000043: the required elements;
p.000043: 6. Ensuring that the research plan includes a periodic monitoring of results
p.000043: to maintain safety of the human subject;
p.000043: 7. Ensuring that the research plan includes management measures to
p.000043: protect the human subject and the human subject’s rights;
p.000043:
p.000044: 44
p.000044:
p.000044: 8. Ensuring that sufficient measures are taken to protect privacy of the human subject and maintain
p.000044: confidentiality of data.
p.000044: 9. In the case of clinical research involving testing drugs or equipment on humans, the authorization of the Saudi
p.000044: Food and Drug Authority must be obtained according to observed laws and regulations.
p.000044: 10. Every clinical research project must be registered first with the Saudi Food and Drug Authority before
p.000044: human subjects are invited to participate.
p.000044: 11. The Saudi Food and Drug Authority clinical studies database must be
p.000044: checked first to avoid conducting duplicate research.
p.000044:
p.000044: Article (10.18)
p.000044: The local committee may approve certain research by using the expedited review procedure in the following cases:
p.000044: 1. If the risk that the human subject may be exposed to does not exceed
p.000044: the minimal risk level;
p.000044: 2. If the research does not reveal the identity of the human subject;
p.000044: 3. If the research deals with clinical studies on drugs or medical equipment, provided:
p.000044: a. The drug is used in accordance with its licensing and dosages approved by the concerned party, and does
p.000044: not entail any increase in potential risk for the human subject;
p.000044: b. The medical equipment in use has originally been licensed by the concerned party and has already been utilized
p.000044: accordingly.
p.000044: 4. If taking biological samples for research purposes is carried out via non-invasive methods such as
p.000044: analysis of urine, saliva, nail or hair clippings, etc.
p.000044: 5. If research data is to be collected by using medical equipment approved
p.000044:
p.000045: 45
p.000045:
p.000045: by the concerned party, such as:
p.000045: a. Sensors which are directly applied on body surface or at a close distance thereto and which do not expose the
p.000045: body to a significant amount of energy and do not violate the privacy of the human subject;
p.000045: b. Weight taking or audiometry devices;
p.000045: c. Magnetic resonance imaging (MRI) or ultrasonography imaging devices;
p.000045: d. Electrography (ECG & EEG), Thermal Imaging, normal nuclear radiation rate measuring,
p.000045: infra-red imaging, blood flow measurement with ultrasound imaging (Doppler sonography), and echocardiography
p.000045: devices;
p.000045: e. Moderate exercise, muscle strength, body ratios (such as body fat ratio) and measurement of joint and
p.000045: muscle flexibility devices, provided these tests are deemed appropriate after taking age, weight and health condition
p.000045: into account;
p.000045: f. Search for information, records or samples that were previously collected or will be collected in the
p.000045: future for non-research purposes;
p.000045: g. Collect information via audio or video taping (static or moving) for the purpose of looking for the attributes or
p.000045: behavior of an individual or group without violation of privacy of the human subject.
p.000045: However, excepted from these devices is the use of X-ray or electromagnetic microwavedevices.
p.000045:
p.000045: Article (10.19)
p.000045: 1. Approval by expedited review shall be issued by local committee chairman or by one or more members
p.000045: selected by committee chairman for their experience.
p.000045:
p.000046: 46
p.000046:
p.000046: 2. In case of expedited review, the research evaluator shall have all the powers given to the local committee except
p.000046: for rejection of research, which shall be within the jurisdiction of the local committee alone. If the
p.000046: evaluator decides to reject the research, he shall refer it to the committee for reviewing it according to the
p.000046: provisions of this Law and its Regulations.
p.000046: 3. In case approval of research is issued by using expedited review, the committee chairman shall notify all
p.000046: committee members of the research projects that he has approved via whatever notification means he deems appropriate.
p.000046:
p.000046: Article (10.20)
p.000046: The local committee chairman has the authority to approve any amendment of the research previously approved by using
p.000046: expedited review. Exceptions include interviews and surveys conducted on any of the (vulnerable groups), amendment of
p.000046: research project or approval form, which shall be within the jurisdiction of the local committee.
p.000046:
p.000046: Article (10.21)
p.000046: Applications for approval using the expedited review procedure shall observe the terms and requirements
p.000046: stipulated in the basic elements of the Informed Consent in accordance with the provisions set forth in Chapter 5 of
p.000046: the Regulations.
p.000046:
p.000046: Article (10.22)
p.000046: The expedited review procedure may not be used for approving research if
p.000046: the objectives of such research include the following:
p.000046: 1. Addition of a new medication;
p.000046:
p.000047: 47
p.000047:
p.000047: 2. Addition of new medical equipment;
p.000047: 3. Addition of a new invasive or interventional procedure;
p.000047: 4. Increase or decrease of a medication dose, which may lead to increased harms;
p.000047: 5. The research is conducted to identify new potential risks.
p.000047:
p.000047: Article (10.23)
p.000047: 1. If the principal investigator wishes to amend the research proposal approved by the local committee,
p.000047: he shall submit the matter to the local committee to obtain its approval prior to proceeding with the
p.000047: amendment.
p.000047: 2. The following may be exempted from local committee review:
p.000047: a. Amendment of advertising material used for inviting human subjects, provided said amendment does not
p.000047: disrupt the content of such material;
p.000047: b. Amendments that only include providing administrative support to the study;
p.000047: c. Enrolling samples or cases brought from outside the establishment with the same terms.
p.000047: 3. In all cases, the principal investigator shall furnish the local committee with a detailed report on the amendment
p.000047: he has carried out.
p.000047:
p.000047: Article (10.24)
p.000047: 1. The principal investigator shall obtain the local committee approval of all types of advertisements
p.000047: aiming to invite people to participate as volunteers in the research project such as newspaper ads, posters,
p.000047: folders, etc. prior to distribution or publication thereof;
p.000047: 2. Any advertisement proposed by the principal investigator to invite
p.000047:
p.000048: 48
p.000048:
p.000048: persons to participate as subjects of the research shall include the
p.000048: following data:
p.000048: a. Research title;
p.000048: b. Research objective;
p.000048: c. Attributes qualifying persons targeted to be the research subjects
p.000048: (participants or volunteers);
p.000048: d. Indication of all facilities to be provided to human subject;
p.000048: e. Number of research project in the local committee and expected
p.000048: date of completion;
p.000048: f. Expected risks of the research, if any;
p.000048: g. Name and address of principal investigator or his representative, his contact numbers and his electronic
p.000048: mail address so that individuals aiming to join the research group may call him for further
p.000048: information.
p.000048:
p.000048: Article (10.25)
p.000048: If the principal investigator decides to transfer research supervision responsibility to a different
p.000048: investigator, he shall take the following measures:
p.000048: 1. Submit a written application to this effect to the local committee, including the following:
p.000048: a. A written agreement for the replacement investigator to take responsibility for the research;
p.000048: b. A written statement by the replacement investigator indicating his readiness to fulfill all commitments and
p.000048: obligations made by the principal investigator;
p.000048: c. CV of the replacement investigator;
...
p.000051: submitting reports in the future;
p.000051: 5. If the principal investigator persists in ignoring to submit the periodic report, the local committee shall refer
p.000051: the whole matter to the Monitoring Office to submit it to the Violations Committee to suspend the research project and
p.000051: decide appropriate penalties.
p.000051:
p.000051: Article (10.30)
p.000051: 1. The principal investigator and the local committee must immediately notify of any major harm occurring
p.000051: during or after conducting the research, according to the following procedures:
p.000051: a. The principal investigator shall immediately notify the local committee as well as the research
p.000051: sponsor of any unexpected major harm occurring during or after conducting the research, providing the committee with
p.000051: all information pertaining to the harm related incident, indicating whether this incident is definitely, probably or by
p.000051: no means related to the research.
p.000051: b. The local committee shall notify the Monitoring Office of the major harm incident and all related details as soon
p.000051: as possible either in writing or by telephone within a period of twenty-four hours at the latest from the time of the
p.000051: harm related incident.
p.000051: 2. The principal investigator and the local committee must notify of any minor harm occurring during or after
p.000051: conducting the research, according to the following procedures:
p.000051: a. The principal investigator shall notify the local committee of any
p.000051:
p.000052: 52
p.000052:
p.000052: minor harm occurring during or after conducting the research within seven days at the latest from the date of
p.000052: the incident, providing the committee with all information pertaining to the harm related incident, indicating
p.000052: whether this incident is definitely, probably or by no means related to the research.
p.000052: b. The local committee shall notify the Monitoring Office of the incident of minor harm and all related
p.000052: details either in writing or by telephone within two weeks at the latest from the date of the incident, depending on
p.000052: the relevance of the incident.
p.000052: 3. The principal investigator shall include all expected or unexpected harms in his periodic report
p.000052: submitted to the local committee.
p.000052:
p.000052: Article (10.31)
p.000052: 1. If the local committee finds, through periodic monitoring of the research, that an unexpected harm
p.000052: has taken place as a direct result of the research but has not been referred to in the research proposal, it may
p.000052: take appropriate measures to stop the harm, including suspension of research project;
p.000052: 2. If the local committee finds that the investigator has not obtained required approvals, it shall suspend
p.000052: the research project and refer the matter to the Monitoring Office to submit it to the Violations Committee to decide
p.000052: appropriate penalties against the investigator.
p.000052: 3. The local committee shall notify head of the establishment of any
p.000052: research that is suspended or referred to the Monitoring Office.
p.000052:
p.000052: Article (10.32)
p.000052: The local committee may exempt the following research projects from the
p.000052: periodic follow-up:
p.000052:
p.000053: 53
p.000053:
p.000053: 1. Research involving study of information and data previously collected,
p.000053: provided one of the two following terms is fulfilled:
p.000053: a. If the information is generally and publicly available;
p.000053: b. If the information is recorded in a manner that does not reveal the identity of the source person.
p.000053: 2. Research including educational tests, surveys, interviews or public behavior monitoring, except in the
p.000053: two following cases:
p.000053: a. If the information is recorded in a manner that reveals the identity of the source person.
p.000053: b. If participation in the research should bring a person outside the scope of research to be subject to
p.000053: criminal or civil liability or jeopardize his financial position or career.
p.000053: 3. Research conducted for educational purposes.
p.000053:
p.000053: Article (10.33)
p.000053: 1. Subject to the provisions of the following paragraph 2 hereunder, the local committee, following Standard
p.000053: procedures, shall conduct the periodic monitoring of research based on the periodic reports submitted by the
p.000053: principal investigator in accordance with the procedures it sets up in this regard.
p.000053: 2. As an exception from the provision of the preceding paragraph 1 hereabove, the local committee may
p.000053: exempt certain research projects that it has previously approved from periodic evaluation in either of the following
p.000053: cases:
p.000053: a. If the only objective of research continuation is a long-term monitoring of persons who took part
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p.000065: 65
p.000065:
p.000065: Kingdom is party.
p.000065:
p.000065: Article (15.4)
p.000065: The investigator or research team conducting the experimental surgeries and medical research shall be specialized and
p.000065: shall have adequate scientific qualification, expertise and competence.
p.000065:
p.000065: Article 16
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p.000068:
p.000068: Article 21
p.000068: No research may be conducted on human zygotes, gametes or fetuses except under controls specified by the Regulations.
p.000068:
p.000068: Article (21.1)
p.000068: No research may be conducted on human zygotes or gametes except under the following controls:
p.000068: 1. The practices indicated in the research proposal shall be consistent with the provisions of Sharia
p.000068: and standard medical principles, and
p.000069: 69
p.000069:
p.000069: the research shall be justified in terms of its contribution to medical
p.000069: knowledge or technical applications;
p.000069: 2. The investigator shall obtain the “Informed Consent” from the person donating zygotes or gametes in accordance
p.000069: with Article 11 of the Law.
p.000069: 3. The investigator shall provide all research-related information to the persons donating zygotes or gametes, and
p.000069: their spouses, if any. Said information shall include a full explanation of the research potential risk and expected
p.000069: benefit.
p.000069:
p.000069: Article (21.2)
p.000069: When conducting research on human zygotes or gametes, the researcher shall accurately record all required data and
p.000069: information about the human subject and each person related to the zygotes or gametes under research, and all research
p.000069: findings. He shall keep records of the same for at least five years from date of research completion, and shall submit
p.000069: periodic reports on the research to the local committee.
p.000069:
p.000069: Article (21.3)
p.000069: No research may be conducted on human fetuses except for one of the following purposes:
p.000069: 1. Find a treatment for reproductive problems, in which case the research shall be conducted in an institution
p.000069: approved for treatment of such problems;
p.000069: 2. Conduct a new experiment expected to benefit human fetuses;
p.000069: 3. Acquire new knowledge about the condition of fetuses if it is not
p.000069: expected to achieve a direct benefit.
p.000069:
p.000069:
p.000069:
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p.000070:
p.000070: Article (21.4)
p.000070: The research proposal on human fetuses shall include the indication that the expected benefit from the research would
p.000070: not be realized without using such fetuses, and that a similar benefit has been previously obtained through conducting
p.000070: research on animals, and that the research is justified in terms of its contribution to improvement of treatment
p.000070: techniques or knowledge of human diseases.
p.000070:
p.000070: Article (21.5)
p.000070: The investigator shall use the minimum number of fetuses to achieve research purposes.
p.000070:
p.000070: Article (21.6)
p.000070: In cases of research conducted to acquire new knowledge, the researcher shall submit to the local committee proof that
p.000070: potential risk for the fetus is minimal.
p.000070:
p.000070: Article (21.7)
p.000070: The investigator shall prepare and keep records of the source of each fetus and the results of using said fetus in the
p.000070: research, and shall submit periodic reports on the research to the local committee.
p.000070:
p.000070: Article (21.8)
p.000070: The investigator shall abide by the controls and procedures set by the National Committee regarding
p.000070: research on stem cells, zygotes, gametes and fetuses.
p.000070:
p.000070: Article 22
p.000070: No research may be conducted for the purpose of human cloning.
p.000070:
p.000071: 71
p.000071:
p.000071: Article (22.1)
p.000071: No investigator shall be permitted to conduct research on human cloning and any reproductive and research
p.000071: applications resulting therefrom due to constraints determined by sharia, ethical principles and health-related
p.000071: harms, where harms and dangers to humanity outweigh the expected benefits.
p.000071:
p.000071: Article 23
p.000071: Research may be conducted on tissues, living cells and separated parts, including stemXcells extracted from the
p.000071: umbilical cord or adult stemXcells, upon obtaining the informed consent.
p.000071:
p.000071: Article (23.1) Subject to the
p.000071: provisions and principles set forth in the Law and Implementing Regulations and directives issued by the National
p.000071: Committee, research may be conducted on tissues, living cells and separated parts, including stemXcells extracted from
p.000071: the umbilical cord or adult stemXcells, upon fulfilling the following conditions:
p.000071: 1. Fetuses may not be cloned for the purpose of obtaining and using stemXcells in research.
p.000071: 2. Excess fertilized eggs from in vitro fertilization procedures or from insemination using donor ovum
p.000071: and sperm, shall neither be used for therapeutic purposes nor in stem cell research.
p.000071: 3. Male or female gametes taken from sperms or eggs may not be donated to produce fertilized eggs that can grow into
p.000071: a fetus for the purpose of generating stemXcells therefrom.
p.000071: 4. Embryonic stemXcells derived from aborted fetuses may be used for therapeutic purposes. Likewise, miscarried
p.000071: fetuses without any signs
p.000072: 72
p.000072:
p.000072: of life yet may be used in research or in scientific and laboratory
p.000072: experiments in accordance with observed Sharia rules in the Kingdom.
p.000072: 5. In case of stillborn fetuses, embryonic stemXcells may be transferred and used in research.
p.000072: 6. StemXcells of an adult human may be used, provided said human is not subject to any harm, and such stemXcells can
p.000072: be used to treat a patient, and the expected benefit outweighs the possible harm.
p.000072: 7. Induced pluripotent stemXcells, in which adult stemXcells are induced to obtain pluripotent cells which can be
p.000072: developed into other kinds of cells, such as nerve cells and others, can be used solely at an experimental and animal
p.000072: level, provided the following conditions are fulfilled:
p.000072: a. The research is conducted at a research center affiliated with a government agency, or with the
p.000072: participation of the said government agency.
p.000072: b. A written authorization is obtained from the local research ethics committee.
p.000072: c. It is pledged in writing not to use these induced pluripotent stemXcells on humans.
p.000072: 8. Embryonic cells and derivatives can be imported only from the sources permitted by these regulations, once
p.000072: the authorization of the local committee is obtained. Commercially available induced pluripotent stemXcells
p.000072: can also be imported from scientifically recognized sources.
p.000072:
p.000072: Article (23.2)
p.000072: It is prohibited to import the following stemXcells:
p.000072: 1. StemXcells obtained from the insemination using a donor ovum and a donor sperm, performed to extract stemXcells.
p.000072: 2. StemXcells obtained from deliberately aborted fetuses.
p.000072:
p.000073: 73
p.000073:
p.000073: Article (23.3)
p.000073: Cells can be used in clinical research (therapeutic research) under the following conditions:
p.000073: 1. A written authorization is obtained from the local research ethics committee.
p.000073: 2. A “Informed Consent” form is obtained from the human subject participant before the research
p.000073: project is initiated.
p.000073: 3. A written authorization is obtained from the Saudi Food and Drug Authority.
p.000073: 4. The expected benefit for the human subject and the extent to which it outweighs the possible harm shall
p.000073: be evaluated through a clear and thorough scientific assessment conducted by the investigator and submitted to
p.000073: the local committee.
p.000073: 5. The investigator or research team conducting the research shall be
p.000073: specialized and shall have sufficient scientific expertise and competence.
p.000073: 6. Research objectives shall be clearly and accurately defined, and the research is preceded by
p.000073: sufficient experiments on animals if the nature of the research so requires; subject to the discretion of the
p.000073: local committee.
p.000073: 7. If the local committee finds that the potential harm for the human subject outweighs the expected
p.000073: benefit, it must refrain from authorizing the research project.
p.000073: 8. The local committee shall review periodic reports submitted by the investigator to ensure that the
p.000073: expected benefit continues to outweigh the possible harm.
p.000073: 9. The “Informed Consent” shall be obtained from the human subject prior to conducting the research and the
p.000073: information provided shall contain a full explanation of expected benefits and potential risks of the research.
p.000074: 74
p.000074:
p.000074: 10. The investigator shall keep detailed records of the source of stemXcells and the results of their use in the
p.000074: research, and shall submit periodic research reports to the local committee.
p.000074:
p.000074: Article (23.4)
p.000074: Stem Cell Banks may be established under the following conditions:
p.000074: 1. A written authorization from the National Committee is obtained.
p.000074: 2. The stem cell bank can only be established in a center affiliated with a
p.000074: government agency.
p.000074: 3. It is prohibited to send any stemXcells to be stored outside the Kingdom.
p.000074: 4. Stem cells stored in stem cell banks for therapeutic purposes may not be used for research purposes
p.000074: without the permission of the local committee and the stem cells’ owner’s consent;
p.000074: 5. An accurate and strict mechanism shall be set up to safeguard all
p.000074: information and data with the utmost safety and confidentiality.
p.000074: 6. Each sample shall be given a permanent identification label specifying its ownership. Information included in
p.000074: said label shall be updated by the principal investigator under the supervision of the local committee.
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p.000076: Chapter Nine: Research on Inmates
p.000076:
p.000076: Article 24
p.000076: Prisoners, including those sentenced to death, shall be treated like other persons as regards conducting
p.000076: medical research on them. The Regulations shall specify ethical controls for conducting research on prisoners.
p.000076:
p.000076: Article (24.1)
p.000076: When serving as subjects in medical research, inmates, even if sentenced to death, shall not be treated
p.000076: differently. Their confinement may not be exploited to compel them to consent to be research subjects.
p.000076:
p.000076: Article (24.2)
p.000076: The local committee may not approve research on inmates unless said research aims to achieve any of the
p.000076: following:
p.000076: 1. Study the criminal behavior of inmates, provided the research does not expose them to more than the minimal
p.000076: potential risk;
p.000076: 2. Study conditions of prisons and inmates as well as prevailing diseases and identify the circumstances leading to
p.000076: crime;
p.000076: 3. Study administrative rules and operational procedures applicable in prisons, so as to improve health
p.000076: and living conditions of inmates;
p.000076: 4. Inmates may not be subject to clinical research whether by coercion or
p.000076: inducement or for any purposes other than those set forth in this Article.
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p.000078: Chapter Ten: Research on Special Cases
p.000078:
p.000078: Article 25
p.000078: Research may not be conducted on minors, incompetent or disabled persons unless the interest of these
p.000078: categories so requires. The Regulations shall specify ethical controls for conducting research on said
p.000078: categories.
p.000078:
p.000078: Article (25.1)
p.000078: 1. Research may not be conducted on minors, incompetent or mentally disabled persons without obtaining the
p.000078: “Informed Consent” from parents or the legal guardians in accordance with conditions set forth in the Law and
p.000078: Regulations, provided they are informed of the level of risk and its probability as well as the person’s assent.
p.000078: 2. Either parent or the legal guardian may grant the “Informed Consent” on behalf of minors, incompetent or mentally
p.000078: disabled persons provided his decision is based on the fact that the minor, incompetent or mentally disabled person is
p.000078: subject to no harm and may benefit from the research.
p.000078: 3. After granting the “Informed Consent”, either parent or the guardian may withdraw the consent at any phase of the
p.000078: research if he finds that the research conflicts with the interests of the minor, incompetent or mentally disabled
p.000078: person or if the research deviates from the objectives upon which the consent was granted.
p.000078:
p.000078: Article (25.2)
p.000078: The local committee shall grant its approval for research on minors, incompetent or mentally disabled
p.000078: persons subject to the following conditions:
p.000078:
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p.000079:
p.000079: 1. It is not possible to conduct the research on a competent person;
p.000079: 2. The interest of the minor, incompetent or mentally disabled person requires subjecting him to the
p.000079: research, provided he is not exposed to more than the minimal potential risk;
p.000079: 3. The research protocol includes clear and appropriate measures to minimize potential risk as much as
p.000079: possible;
p.000079: 4. Evaluation of potential risk and expected benefit from the research shall indicate type, nature, degree and
p.000079: possibility of risk as well as the direct benefit for the minor, incompetent or mentally disabled person subject of the
p.000079: research and for similar persons;
p.000079: 5. The research shall be conducted in a school, camp, hospital, or institution where the majority of occupants are
p.000079: incompetent or disabled, provided the research subject belongs to this category.
p.000079:
p.000079: Article (25.3)
p.000079: If the local committee finds that the research in whole or in part achieves a direct benefit for the
p.000079: minor, incompetent or mentally disabled person but that its risk exceeds the minimal expected level, it may grant
p.000079: its approval to conduct the research pursuant to the following conditions:
p.000079: 1. The potential risk shall be within acceptable levels in accordance
p.000079: with medical standards, if compared with expected benefits;
p.000079: 2. The ratio of the expected benefit shall exceed that of other methods
p.000079: available outside the scope of the research;
p.000079: 3. The research shall lead to a better understanding of an important problem that affects the minor, incompetent or
p.000079: mentally disabled person or his interest, help reduce such problem, or prevent some of its negative effects;
p.000079:
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p.000080:
p.000080: 4. Obtaining the “Informed Consent” from either parent or from the legal guardian.
p.000080:
p.000080: Article (25.4)
p.000080: If the local committee finds that the research does not directly benefit the minor, incompetent or mentally disabled
p.000080: person but does not expose him to more than the minimal potential risk, it may approve the research in the following
p.000080: cases:
p.000080: 1. If he had given the “Informed Consent” when he was competent or before the disability occurred, and
p.000080: his legal guardian later gave the “Informed Consent”;
p.000080: 2. If precautionary measures taken for his protection are adequate and acceptable;
p.000080: 3. If there are sufficient reasons that make it possible to obtain significant
p.000080: information through the research for understanding the case under study.
p.000080:
p.000080: Article (25.5)
p.000080: The local committee may, prior to giving its approval of conducting research on the minor, incompetent or
p.000080: mentally disabled person, require appointing a qualified lawyer experienced to handle such case. Said lawyer shall have
p.000080: no relation with the researcher or the institution supervising and funding the research and shall observe the interest
p.000080: of the minor subject of the research, in coordination with his parents or guardian.
p.000080:
p.000080: Article (25.6)
p.000080: The physically, but not mentally, disabled person shall be treated as a normal person, in terms of his responsibility
p.000080: for giving the “Informed Consent” and his understanding of research potential risks and expected benefits.
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p.000081:
p.000081: Article 26
p.000081: Pregnant women, fetuses and the product of pregnancy may not be used in research except in accordance with
p.000081: controls specified by the Regulations.
p.000081:
p.000081: Article (26.1)
p.000081: An investigator may not initiate any research on a pregnant woman unless
p.000081: the following conditions are satisfied:
p.000081: 1. Conduct appropriate studies, when possible, on animals and non- pregnant women that confirm the
p.000081: safety of methods and means of research, provided the results of such research are published in
p.000081: internationally recognized scientific journals in accordance with the provisions of the Law and
p.000081: Regulations;
p.000081: 2. The level of risk the research project poses to pregnant woman or her
p.000081: fetus does not exceed the minimum risk level;
p.000081: 3. The investigator shall not have any role in deciding how and when the pregnancy will be terminated or whether
p.000081: the fetus can survive after termination of pregnancy;
p.000081: 4. The research shall not lead to a change in pregnancy termination procedure if such change leads to more
p.000081: than the minimum level of risk to the pregnant woman or her fetus;
p.000081: 5. The research project aims to provide health requirements for the pregnant woman and her fetus and
p.000081: acquire information that cannot otherwise be obtained;
p.000081: 6. The principal investigator shall comit not to offer any type of reward in return for termination of pregnancy for
p.000081: research purposes;
p.000081: 7. Obtain the “Informed Consent” from both the pregnant woman and her husband.
p.000081:
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p.000082:
p.000082: Article (26.2)
p.000082: No research on fetuses may be initiated unless the following conditions are
p.000082: satisfied:
p.000082: 1. The research shall not harm or endanger the life of the fetus;
p.000082: 2. The research project shall aim to provide health requirements for the
p.000082: fetus and to acquire information that cannot otherwise be obtained;
p.000082: 3. No research may be conducted on a living fetus unless it is nearly certain that its life is threatened
p.000082: or that the level of risk the fetus may face in case it remains in the uterus could be lessened, provided there is no
p.000082: safer means to achieve the same.
p.000082:
p.000082: Article 27
p.000082: Cells, tissues and derivatives of human sperms, gametes and zygotes may not be transported or exploited for the
p.000082: purpose of research except in accordance with conditions and restrictions laid down by the National Committee.
p.000082:
p.000082: Article (27.1)
p.000082: The National Committee shall set controls required for transfer and use of cells, tissues and derivatives
p.000082: constituents of human sperms, gametes and zygotes for research purposes. Said controls shall be reported to the
p.000082: Research Ethics Monitoring Office and local committees to abide by.
p.000082:
p.000082: Article 28
p.000082: Fetuses may not be cloned for the purpose of obtaining embryonic stemXcells, nor may male or female gametes taken from
p.000082: sperms or eggs be donated to produce fertilized eggs that can grow into a fetus for the purpose of generating stem
p.000082: cells therefrom and conducting research thereon.
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p.000083:
p.000083: Article (28.1)
p.000083: The National Committee shall monitor institutions where fertilized eggs are produced to ensure their compliance with
p.000083: the provisions of the Law and Implementing Regulations and instructions issued by the National Committee.
p.000083:
p.000083: Article 29
p.000083: Banks for preserving reproductive male or female cells with the intent of conducting research thereon may not be
p.000083: established.
p.000083:
p.000083: Article 30
p.000083: Organs and tissues of fetuses aborted before reaching one hundred twenty days may be used in research and experiments
p.000083: in accordance with controls and conditions set forth in the Regulations.
p.000083:
p.000083: Article (30.1)
p.000083: Research may be conducted on a pre-quickening stillborn fetus, if deemed necessary by the local committee, provided the
p.000083: research project is beneficial and contributes to the progress of applied sciences.
p.000083:
p.000083: Article (30.2)
p.000083: Samples may be taken from a stillborn fetus upon obtaining approval of the local committee, provided said samples are
p.000083: legally stored at approved gene banks.
p.000083:
p.000083: Article (30.3)
p.000083: 1. Research may be conducted on products of conception if the two
p.000083: following conditions are satisfied:
p.000083:
p.000084: 84
p.000084:
p.000084: a. It is established through a medical report signed by two consultant physicians, upon medical examination of
p.000084: products of conception, that it has no chance for survival;
p.000084: b. The conditions set forth in the Law and Regulations regarding research on the minor, incompetent or
p.000084: mentally disabled person shall be applied.
p.000084: 2. Research may be conducted on products of conception if said research aims to improve fetus chances of
p.000084: survival and obtain important information that may not be otherwise obtained, unless there is additional
p.000084: risk to the products of pregnancy.
p.000084:
p.000084: Article (30.4)
p.000084: If the research is conducted on an aborted or miscarried fetus, the following controls shall be observed:
p.000084: 1. Obtain the “Informed Consent” from the woman and her husband in accordance with the provisions of the Law and
p.000084: Regulations as well as controls and procedures set by the National Committee in this regard;
p.000084: 2. The woman and her husband shall be informed of the methodology used in the research on the aborted
p.000084: or miscarried fetus and whether there is an intention to store tissues taken therefrom to be used later for
p.000084: research;
p.000084: 3. Only miscarried and lawfully aborted fetuses according to the Law of Practicing Healthcare Professions may be used
p.000084: in research.
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p.000086: 86
p.000086:
p.000086: Chapter Eleven: Dealing with Genetic Material and its Banks
p.000086:
p.000086: Article 31
p.000086: A central data bank shall be established within KACST for the purpose of maintaining information related
p.000086: to genetic material and regulating use thereof in accordance with procedures specified by the Regulations. Said bank
p.000086: shall provide information for research using genetic material in the Kingdom.
p.000086:
p.000086: Article (31.1)
p.000086: The Central Data Bank and the local gene banks shall provide parties concerned with information available
p.000086: on different diseases affecting individuals, families or the community, subject to maintaining the privacy of the
p.000086: genetic material source and barring the possibility to identify the source of the sample.
p.000086:
p.000086: Article (31.2)
p.000086: The investigator shall maintain the confidentiality of research conclusions,
p.000086: and not identify their source.
p.000086:
p.000086: Article (31.3)
p.000086: When conducting research on genetic material, the following shall be observed:
p.000086: 1. Islamic values, local culture and environmental safety;
p.000086: 2. Applicable and internationally recognized practices relating to conducting research on genetic
p.000086: material.
p.000086:
p.000086:
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p.000087:
p.000087: Article (31.4)
...
p.000091: If prevented from using results of his research, the investigator may claim
p.000091: indemnification for research expenses from the institution.
p.000091:
p.000091: Article 36
p.000091: Research with negative impacts on society may not be conducted, especially research reinforcing racial
p.000091: discrimination.
p.000091:
p.000091: Article (36.1)
p.000091: Conducting research on diseases that are particular among a certain group for the purpose of treatment and
p.000091: understanding of mechanisms of transmission of said diseases may not be construed as promoting racial
p.000091: discrimination.
p.000091:
p.000091: Article (36.2)
p.000091: Scientific results shall not be leaked to the media if this could lead to promoting discrimination on the
p.000091: basis of race or family or tribal affiliation.
p.000091:
p.000091: Article 37
p.000091: The Regulations shall specify the ethical controls and criteria of genetic treatment research.
p.000091:
p.000091: Article (37.1)
p.000091: The following ethical controls and criteria shall be complied with when conducting genetic treatment research:
p.000091: 1. A written approval shall be obtained from the National Committee in all matters related to gene therapy research;
p.000091: 2. Gene therapy research shall be subject to controls and provisions set
p.000091:
p.000092: 92
p.000092:
p.000092: forth in the Law and Regulations and provisions set by the National Committee;
p.000092: 3. The research shall be consistent with the provisions of Shari’a, and the research plan shall include
p.000092: proof of taking such provisions into consideration;
p.000092: 4. The research shall comply with the controls and criteria set forth in international agreements
p.000092: related to gene therapy and amendments thereto, without prejudice to Shari’a rules and provisions;
p.000092: 5. Said research shall be limited to incurable diseases affecting human life, which have not yet been
p.000092: successfully treated by conventional medical methods;
p.000092: 6. Prior to approval of research, it shall be ascertained that all available treatment options have been exhausted;
p.000092: 7. The local committee evaluating this type of research shall comprise at least two persons with scientific
p.000092: competence to evaluate gene therapy research. The local committee may invite experienced consultants to attend its
p.000092: meetings to help evaluate the research project;
p.000092: 8. Gene therapy research shall be conducted in qualified hospitals and research centers with required
p.000092: medical specializations, as well as experienced and qualified staff;
p.000092: 9. The research plan shall include a detailed description of research objectives, methodology, expected
p.000092: benefits, difficulties, risks and health complications for the human subject;
p.000092: 10. The research shall be based on scientific principles, and preceded by sufficient laboratory experiments and
p.000092: animal testing;
p.000092: 11. The expected benefit from the research shall outweigh any potential
p.000092: risks;
p.000092: 12. The research shall be conducted by a qualified investigator specialized
p.000092:
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p.000093:
p.000093: in genetic medicine and assisted by a highly efficient medical team. Said investigator shall be well versed in genetic
p.000093: and scientific material related to the subject of the research;
p.000093: 13. Gene therapy may not be carried out for research purposes on gametes (sperms and ova) or experimental research on
p.000093: stemXcells obtained from fertilized zygotes or related to reproductive cloning;
p.000093: 14. Handling of genetic material in research, storage and disposal thereof, as well as collaborative research with
p.000093: centers abroad shall be in accordance with the controls set forth in the Law and Regulations.
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p.000094:
p.000094: Chapter Twelve: Use of Animals and Plants in Experiments
p.000094:
p.000094: Article 38
p.000094: 1. Animals may be used for research employing all experimental or scientific means not causing unusual pain to the
p.000094: animals.
p.000094: 2. Use of animals shall be restricted to research whose objectives cannot be realized without such use.
p.000094: 3. Endangered animal species may not be subject to negative use. The Regulations shall specify ethical conditions and
p.000094: procedures for use of animals in research.
p.000094:
p.000094: Article (38.1)
p.000094: Animals may be used in scientific experiments where research objectives
p.000094: cannot be otherwise realized.
p.000094:
p.000094: Article (38.2)
p.000094: When conducting research on animals, the investigator shall comply with the following:
p.000094: 1. Sharia provisions related to humane treatment of animals.
p.000094: 2. Scientific principles and conventions governing experimental practices
p.000094: on animals.
p.000094: 3. A license must be obtained from the local committee to conduct research on animals according to the licensing
p.000094: procedures of the National Committee.
p.000094: 4. The approval of the local committee to commence the research must be obtained.
p.000094: 5. It must be verified that previous cell research was conducted before
p.000094: conducting research on animals when needed.
p.000094:
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p.000095:
p.000095: 6. Usage must be limited to the minimum number of animals required to
p.000095: achieve research objectives.
p.000095: 7. Potential harm to and suffering of animals must be minimized as much as possible.
p.000095: 8. Observing that the expected results and desired benefits from the research outweigh any risks and
p.000095: harms to the animal subject of the research or the environment in general;
p.000095: 9. The appropriate animal must be selected to provide credible information and results.
p.000095: 10. Practice shall be subject to appropriate and acceptable scientific and
p.000095: experimental principles.
p.000095:
p.000095: Article (38.3)
p.000095: To obtain approval to conduct research on animals, any of the following
p.000095: shall be satisfied:
p.000095: 1- To Prevent, diagnose or treat a disease or a deformity that must
p.000095: be rectified or whose effects must be removed;
p.000095: 2- To explore animal physiology;
p.000095: 3- Protection of the natural environment as well as general health of humans or animals;
p.000095: 4- Achievement of scientific advancement in biological sciences;
p.000095: 5- Contribution to forensic research;
p.000095: 6- Improvement of animal breeding methods and management;
p.000095: 7- Conduct preliminary research on pharmaceutical substances, toxins and radioactive effects.
p.000095:
p.000095: Article (38.4)
p.000095: When reviewing research proposals involving animal and plant experiments,
p.000095:
p.000096: 96
p.000096:
p.000096: the local committee must verify that the research proposal includes the following mandatory elements:
p.000096: 1. Principal investigator and research team credentials,
p.000096: 2. Animal/plant species used for the experiment, source and quantity.
p.000096: 3. Any agreements with other parties related to the experiment, or to the experiment’s results.
p.000096: 4. A detailed account of the locations where the experiment will be carried
p.000096: out to conduct field visits when necessary.
p.000096: 5. The system of identification used to distinguish the animals and plants used in the experiment, and the system
p.000096: used to save the information and data related to every animal or plant in the experiment’s records.
p.000096: 6. Emergency and hazards management plans.
p.000096: 7. Means and mechanism for the disposal of the experiment’s components.
p.000096: 8. System used to save all data and information resulting from the experiment in dedicated databases.
p.000096: 9. The authorizations of relevant authorities when needed.
p.000096:
p.000096: Article (38.5)
p.000096: When reviewing research proposals resulting in pain and suffering of animals, the local committee must
p.000096: thoroughly assess the proposal, and confirm that:
p.000096: 1. The experiment is not prohibited or restricted by international or regional conventions or rulings where
p.000096: the Kingdom of Saudi Arabia is a party or a signatory.
p.000096: 2. There are no other possible alternatives to achieve the same required results.
p.000096: 3. The research team is fully competent and qualified, and the tools , materials and laboratory
p.000096: environment of the experiment are perfectly adequate.
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p.000097:
p.000097: Article (38.6)
p.000097: The research protocol shall take all measures necessary to prevent animal suffering, using the minimum number of
p.000097: research animals which have a low level of neurological or physiological sensation.
p.000097:
p.000097: Article (38.7)
p.000097: Artificial hybridization may not be conducted except between animals of the same species, even if breeds are different,
p.000097: provided that the expected benefit outweighs the risks and that such risks can be prevented or controlled.
p.000097:
p.000097: Article (38.8)
p.000097: Animals may not be cloned unless medically proven safe as per a medical report approved by at least two specialists.
p.000097:
p.000097: Article (38.9)
p.000097: Transplant of animal fetuses shall be subject to the same conditions governing the process of artificial
p.000097: insemination set forth in Article (38.7).
p.000097:
p.000097: Article (38.10)
p.000097: Banks for preserving animal sperms or eggs for production or research purposes may be established,
p.000097: without prejudice to rules of artificial insemination.
p.000097:
p.000097: Article (38.11)
p.000097: Research and experiments causing pain to animals may not be conducted
p.000097: unless the following two conditions are satisfied:
p.000097: 1. The investigator is well versed in physiology, and the research or
p.000097: experiment is beneficial to science, such as leading to the discovery
p.000097:
p.000098: 98
p.000098:
p.000098: of disease or treatment that can help combat diseases and ailments, protecting health and the
p.000098: environment.
p.000098: 2. The investigator shall obtain local committee approval.
p.000098:
p.000098: Article (38.12)
p.000098: Pain-causing research and experiments on animals must be conducted under anesthesia unless this undermines research
p.000098: objectives, at the discretion of the investigator.
p.000098:
p.000098: Article (38.13)
p.000098: In all cases, upon completion, the animal subject of research shall be disposed of while under anesthesia,
p.000098: in accordance with the provisions of Shari’a.
p.000098:
p.000098: Article (38.14)
p.000098: Animals earmarked for experimentation shall be disposed of if they contract an infectious disease other than the one
p.000098: under study. However, if it is possible to treat such animals, this shall be carried out in isolated places, and all
p.000098: procedures of epidemic quarantine shall be enforced under the supervision of the veterinarian in charge. The disease
p.000098: and the measures taken for its control or treatment shall be reported to the competent authorities.
p.000098:
p.000098: Article (38.15)
p.000098: 1. No research or experiment may be conducted on animals for the purpose of acquiring skills or practical training
p.000098: without using anesthetics except in cases where the animal is not subject to severe pain or torture;
p.000098: 2. Research and experiments may be conducted on animals for the purpose of demonstration and explanation to students,
p.000098: provided it is undertaken
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p.000099:
p.000099: by a qualified person and the said research or experiment is necessary to explain theoretical information and
p.000099: furnish students with useful scientific knowledge.
p.000099:
p.000099: Article (38.16)
p.000099: Endangered animal species may not be used in research or experiments unless said research or experiments are
p.000099: required for breeding or preservation of species. The approval of the Monitoring Office shall be obtained before
p.000099: conducting the research.
p.000099:
p.000099: Article (38.17)
p.000099: Painful or harmful methods may not be used in hunting wild animals for the purpose of research.
p.000099:
p.000099: Article (38.18)
p.000099: Captured animals shall be subject to quarantine in their natural habitat before being moved to the research
p.000099: unit wherein they are to be quarantined once again before conducting the research. The National Committee shall set
p.000099: conditions for the quarantine and its duration.
p.000099:
p.000099: Article (38.19)
p.000099: Wild animals may not be used in scientific research except in the following
p.000099: cases:
p.000099: 1. If it is impossible to achieve study objectives by using other alternatives;
p.000099: 2. Increase the number of animals subject of the research and protect them
p.000099: from extinction without affecting their genetic nature;
p.000099: 3. Detect whether the animal subject carries any zoonotic or epidemic
p.000099: diseases or immunize said animal to prevent spread of such diseases.
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p.000100:
p.000100: Article (38.20)
p.000100: Upon completion of the research and ascertaining the well-being of the research animal, it shall be
p.000100: released and returned to its original habitat, whenever possible.
p.000100:
p.000100: Article (38.21)
p.000100: 1. Wild animals foreign to the Kingdom’s wildlife may not be introduced thereto for the purposes of research;
p.000100: 2. Wild animals may not be returned to their habitat after being genetically
p.000100: modified;
p.000100: 3. No research may be conducted to increase the population of certain species of wild animals at the
p.000100: expense of other species unless said species is in danger of extinction.
p.000100:
p.000100: Article (38.22)
p.000100: For capturing terrestrial and marine animals for the purposes of research, a permit from the relevant authority
p.000100: indicating the term of the license, and type of animal shall be obtained, without prejudice to the hunting laws in the
p.000100: Kingdom.
p.000100:
p.000100: Article (38.23)
p.000100: Animals or products thereof exposed to chemical, biological or genetic substances for the purposes of research
p.000100: may not be consumed, sold or given away. Said animals as well as wastes and products thereof shall be disposed of
p.000100: through established scientific practices under veterinary supervision.
p.000100:
p.000100: Article (38.24)
p.000100: The institution licensed to conduct research on animals shall have facilities
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p.000101:
p.000101: for the care of experimental animals, comprising the following:
p.000101: 1. Enclosures for the care of experimental animals appropriately equipped for animal living conditions;
p.000101: 2. A person qualified to monitor animal safety and health and care for
p.000101: animals prior to commencement of research;
p.000101: 3. Fully equipped laboratories appropriate for conducting experiments
p.000101: and reaching sound scientific results.
p.000101:
p.000101: Article (38.25)
p.000101: The institution licensed to conduct research on animals shall submit an annual report to the Monitoring Office,
p.000101: including: activities, experiments conducted, numbers, types and sources of animals used, results of each experiment,
p.000101: and destruction procedures, pursuant to forms prepared for this purpose.
p.000101:
p.000101: Article (38.26)
p.000101: Persons licensed to conduct experiments on animals as well as institutions,
p.000101: places and experiments shall be monitored by the Monitoring Office.
p.000101:
p.000101: Article (38.27)
p.000101: The National Committee shall set up rules and controls governing use of animals in research experiments
p.000101: in matters not provided for in these Regulations.
p.000101:
p.000101: Article 39
p.000101: Plants may not be used in research that upsets environmental balance and distribution of vegetation. Endangered plant
p.000101: species may not be subject to negative use. The Regulations shall specify ethical terms and procedures of research on
p.000101: plants.
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p.000102:
p.000102: Article (39.1)
p.000102: No research may be conducted on endangered plants unless it is necessary for reproduction or preservation of plants.
p.000102: The approval of the Monitoring Office shall be obtained prior to conducting the research.
p.000102:
p.000102: Article (39.2)
p.000102: Persons licensed to conduct experiments on plants as well as institutions, places and experiments shall be subject
p.000102: to auditing by the Monitoring Office, without prejudice to laws pertaining to food, drugs, and agriculture as well
p.000102: as Wildlife Reserves Law and the Law of Fishing, Investment and Protection of Marine Life in Territorial Waters and
p.000102: all relevant laws and regulations in the Kingdom
p.000102:
p.000102: Article (39.3)
p.000102: Penalties set forth in the Law and Regulations shall be imposed on any person violating controls and provisions therein
p.000102: according to the jurisdiction of the National Committee.
p.000102:
p.000102: Article 40
p.000102: If research includes conducting genetic modification experiments on Living Creatures, the investigator shall take all
p.000102: necessary measures to prevent their escape from research laboratories.
p.000102:
p.000102: Article (40.1)
p.000102: Genetic modification research on animals and plants shall be conducted in laboratories designated for this purpose,
p.000102: provided all measures are taken to prevent escape of genetically modified creatures.
p.000102:
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p.000103:
p.000103: Article (40.2)
p.000103: Microorganisms subject to the research and their outcome shall be disposed of through standard scientific procedures.
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p.000103:
p.000103:
p.000103:
p.000103:
p.000103:
p.000103:
p.000103:
p.000103:
p.000103:
p.000103:
p.000103:
p.000103:
p.000104: 104
p.000104:
p.000104: Chapter Thirteen: Violation Review Committee
p.000104:
p.000104: Article 41
p.000104: KACST President shall designate inspection employees in charge of detecting violations of the provisions of this
p.000104: Law and its Regulations in accordance with procedures specified by the Regulations.
p.000104:
p.000104: Article (41.1)
p.000104: Inspection employees, named pursuant to a decision by KACST President, shall be in charge of detecting violations of
p.000104: the provisions of the Law and Regulations, without prejudice to the authority of the Monitoring Office and the local
p.000104: committee with regard to detection of such violations.
p.000104:
p.000104: Article (41.2)
p.000104: For the purpose of detecting violations of the provisions of the Law and Regulations, the inspection employees may
p.000104: enter and inspect institutions licensed under the Law, examine records and documents, request necessary data, and
p.000104: question employees therein. Institution owners and officials shall facilitate the work of the inspection employees.
p.000104:
p.000104: Article (41.3)
p.000104: Inspection employees shall record every violation in an official report including name of violator or
p.000104: violating institution as the case may be, a description of the violation, time of detection, recording of any relevant
p.000104: sample, paper, or document seized therein. The report shall be signed by the relevant inspection employee and the
p.000104: violator. If the violator refuses to sign, such incident shall be recorded in the report.
p.000104:
p.000104:
p.000105: 105
p.000105:
p.000105: Article (41.4)
p.000105: The violator shall be notified of the detected violation in writing.
p.000105:
p.000105: Article 42
p.000105: a- A committee shall be formed pursuant to a decision by KACST president to review violations of the
p.000105: provisions of this Law and decide appropriate penalties, except for imprisonment, according to this Law. Said committee
p.000105: shall determine amount of damages for private claims. The committee shall comprise the following:
p.000105: 1. A Sharia counselor named by Minister of Justice Chairman
p.000105: 2. A faculty member of a Saudi medical college, of a rank not lower than associate professor, named by the
p.000105: Minister of Higher Education Member
p.000105: 3. A researcher specialized in genetic material, of a rank not lower than associate professor or
p.000105: equivalent, selected by KACST President Member
p.000105: 4. A qualified and experienced researcher specialized in bioethics, selected by KACST President
p.000105: Member
p.000105: 5. A legal counselor selected by KACST President Member
p.000105: 6. A faculty member of a Saudi university specialized in zoology, of a rank not lower than associate professor,
p.000105: named by the Minister of Higher Education Member
p.000105: 7. A faculty member of a Saudi university specialized in botany, of a rank not lower than associate professor, named
p.000105: by the Minister of Higher Education Member
p.000105: Said committee may seek the assistance of one or more experts as regards the issue in question.
p.000105: b- The committee seat shall be at KACST in the city of Riyadh. Similar
p.000105:
p.000106: 106
p.000106:
p.000106: committees may be established the Kingdom’s provinces pursuant to a decision by KACST President.
p.000106: c- Remuneration of committee chairman and members shall be determined in the Regulations according to
p.000106: applicable laws, decisions and directives.
p.000106: d- The Regulations shall determine committee rules, procedures and meetings.
p.000106: e- Committee term of membership shall be three renewable years. If a member is unable to complete his term for any
p.000106: reason, a replacement shall be appointed in the same manner the replaced member was appointed.
p.000106: f- The committee shall convene if attended by two-thirds of its members upon a call by the Chairman as needed.
p.000106: Committee resolutions shall pass by majority vote of attending members. In case of a tie, the Chairman
p.000106: shall have the casting vote.
p.000106:
p.000106: Article (42.1)
p.000106: One or more committees shall be formed pursuant to a decision by KACST President to review violations of the provisions
p.000106: of the Law and Regulations, upon nomination of members of said committee(s) by competent bodies in accordance with
p.000106: Article 42 of the Law.
p.000106:
p.000106: Article (42.2)
p.000106: Violation Review Committee term of membership shall be three renewable years. If any member is unable to complete his
p.000106: term for any reason, or if he declares his wish to discontinue his committee membership, or if he fails to attend three
p.000106: consecutive or seven non-consecutive meetings within the same year without an excuse acceptable to KACST President, a
p.000106: replacement
p.000107: 107
p.000107:
p.000107: shall be appointed in the same manner the replaced member was appointed
p.000107: to fill out the remainder of his term.
p.000107:
p.000107: Article (42.3)
p.000107: The Violation Review Committee chairman shall manage its affairs and head its meetings, and committee members shall
p.000107: deliberate in camera.
p.000107:
p.000107: Article (42.4)
p.000107: The Violation Review Committee shall particularly perform the following tasks:
p.000107: 1. Review claims submitted thereto by KACST representative of public prosecution against violators of the
p.000107: provisions of the Law and Regulations;
p.000107: 2. Decide appropriate penalty from among the penalties set forth in Article 44 of the Law, except for
p.000107: imprisonment, against the violator after hearing his statements and reviewing his defense;
p.000107: 3. Submit a recommendation to KACST President for referral of violators to the competent court if the committee finds
p.000107: that the violation detected requires a penalty including imprisonment. KACST President shall refer the case to
p.000107: the Bureau of Investigation and Prosecution to submit it to the competent court;
p.000107: 4. Review compensation claims filed therewith by civil suit claimants and estimate the appropriate
p.000107: compensation if deemed justifiable, after hearing the defendant;
p.000107: 5. Compel the violator to publish the decision text at his expense in at least three local newspapers, one of which
p.000107: at least is published in the region where he resides. If no such newspaper is published in the region, the decision
p.000107: shall be published in the newspaper published in the nearest region.
p.000107:
p.000108: 108
p.000108:
p.000108: Article (42.5)
p.000108: The Violation Review Committee shall hold its meetings at KACST upon a call by its Chairman as needed, and may, if
p.000108: necessary, hold its meetings at any other place with the approval of KACST President. Committee meetings
p.000108: shall not be valid unless attended by two thirds of its members, including the chairman. Committee resolutions shall
p.000108: pass by majority vote of attending members. In case of a tie, the Chairman shall have the casting vote.
p.000108:
p.000108: Article (42.6)
p.000108: Violation Review Committee members shall be notified of each meeting date at least ten days prior to the meeting, and
p.000108: meeting proceedings shall be recorded in special minutes set for such purpose.
p.000108:
p.000108: Article (42.7)
p.000108: The Violation Review Committee may seek technical assistance from specialists or experts with regard to an
p.000108: issue before it, provided the letter sent to said specialists or experts specifies the remuneration.
p.000108:
p.000108: Article (42.8)
p.000108: In a compensation claim, if the claimant requests technical assistance from any agency with experience, the Violation
p.000108: Review Committee may, at its discretion, approve his request and refer the claim papers to said agency.
p.000108:
p.000108: Article (42.9)
p.000108: The Violation Review Committee may summon any of KACST personnel
p.000108: whose presence it deems necessary to seek advice on matters filed therewith.
p.000108:
p.000108:
p.000108:
p.000109: 109
p.000109:
p.000109: Article (42.10)
p.000109: The Violation Review Committee may, if necessary, approach public and private agencies as regards any of its affairs.
p.000109:
p.000109: Article (42.11)
p.000109: The Violation Review Committee may take any measures necessary to proceed with claims filed with it. It may
p.000109: itself conduct the inspection or delegate a member for this purpose, provided said member submits an
p.000109: inspection report.
p.000109:
p.000109: Article (42.12)
p.000109: The Violation Review Committee shall have a secretary appointed pursuant to a decision by KACST President.
p.000109:
p.000109: Article (42.13)
p.000109: The secretary shall manage the technical and administrative affairs of the Violation Review Committee, and
p.000109: shall particularly undertake the following duties:
p.000109: 1. Prepare committee minutes and arrange its meetings;
p.000109: 2. Coordinate between the committee and parties concerned from within and outside KACST, including meeting dates and
p.000109: notification of notices and decisions;
p.000109: 3. Perform typing, copying, and archiving tasks and save and retrieve
p.000109: files;
p.000109: 4. Keep a file for violations which includes the following:
p.000109: a. Violations with serial numbers;
p.000109: b. Name of violator;
p.000109: c. Date of receipt of violation report;
p.000109:
p.000110: 110
p.000110:
p.000110: d. Description of violation;
p.000110: e. Penalty imposed by the committee, and penalty decision and date thereof;
p.000110: f. Decision of the Board of Grievances with regard to the violation in case of an appeal.
p.000110:
p.000110: Article (42.14)
p.000110: 1. The Violation Review Committee shall consider public suits and notify the violator of the date of hearing
p.000110: at least ten days in advance. The notification shall include a description of the violation; date, time and place
p.000110: of scheduled hearing, summoning the violator or his representative to appear before the committee and present his
p.000110: defense.
p.000110: 2. The Violation Review Committee may not consider public suits for a violation after the elapse of more than one
p.000110: year after detection without taking any action.
p.000110:
p.000110: Article (42.15)
p.000110: The Violation Review Committee shall consider civil suits and notify the defendant of the date of hearing at least ten
p.000110: days in advance. The notification shall include a copy of the petition and any other documents submitted by the
p.000110: claimant; date, time and place of the hearing, summoning the defendant or his representative to appear before the
p.000110: committee and present his defense.
p.000110:
p.000110: Article (42.16)
p.000110: If the defendant or his legal representative fails to attend the first hearing, the Violation Review Committee
p.000110: shall adjourn the hearing and notify the defendant of the new hearing date. If the defendant fails to attend a
p.000110: second time, though properly notified, the Violation Review Committee
p.000111: 111
p.000111:
p.000111: may proceed with the consideration of the case as if he was present. The defendant shall be deemed present if he
p.000111: attends one hearing and fails to attend the rest of the hearings.
p.000111:
p.000111: Article (42.17)
p.000111: The secretary of the Violation Review Committee shall draft the hearing minutes under the supervision of the
p.000111: hearing chairman, provided the minutes include names of attending members, place and time of the hearing, names of
p.000111: attending parties to the suit or their representatives, all hearing proceedings, as well as statements and defenses of
p.000111: parties. The minutes shall be signed by the committee chairman, members, secretary and parties to the suit or their
p.000111: representatives.
p.000111:
p.000111: Article (42.18)
p.000111: If the Violation Review Committee finds that the violation considered includes a crime punishable by other
p.000111: laws, it shall refer the criminal case to the competent agencies to take legal action, in accordance with said laws,
p.000111: and shall decide the violation under consideration unless it finds that either violation cannot be decided separately
p.000111: from the other.
p.000111:
p.000111: Article (42.19)
p.000111: Decisions of the Violation Review Committee shall be reasoned and shall include a rebuttal of all defenses raised by
p.000111: parties to the suit. A committee member (or the chairman) adopting a differentXopinion shall include said opinion in
p.000111: the minutes with the reasons thereof.
p.000111:
p.000111: Article (42.20)
p.000111: The Violation Review Committee secretariat shall notify the parties
p.000111:
p.000112: 112
p.000112:
p.000112: concerned of committee resolutions by official letters delivered to them or their legal representatives,
p.000112: provided that the notification letter includes the following text: “A party against whom a committee decision has been
p.000112: issued may appeal before the Board of Grievances within sixty days from date of notification.”
p.000112:
p.000112: Article (42.21)
p.000112: Procedures of the Board of Grievances shall apply to matters not provided for in the Violation Review Committee
p.000112: Procedures.
p.000112:
p.000112: Article (42.22)
p.000112: An aggrieved party may appeal Violation Review Committee decision before the Board of Grievances within sixty
p.000112: days from date of notification thereof.
p.000112:
p.000112: Article (42.23)
p.000112: Remuneration of Violation Review Committee’s chairman and members shall be determined according to Regulations of
p.000112: Joint Governmental Committees and their Work Procedures issued pursuant to Civil Service Council Decision No.
p.000112: (1/1270) dated 21/11/1428 H approved by wired High Order under No. (3759/MB) dated 12/6/1432 H.
p.000112:
p.000112: Article 43
p.000112: Public prosecution before the committee shall be carried out by competent personnel designated by
p.000112: KACST President.
p.000112:
p.000112: Article (43.1)
p.000112: One or more public prosecution representatives shall be appointed pursuant
p.000112:
p.000113: 113
p.000113:
p.000113: to a decision by KACST President to file suit and litigate before the
p.000113: Violation Review Committee against violators of the Law and Regulations.
p.000113:
p.000113: Article (43.2)
p.000113: Based upon the contents of the violation detection report, the public prosecution representative shall
p.000113: file the public suit before the Violation Review Committee.
p.000113:
p.000113: Article (43.3)
p.000113: The Violation Review Committee shall consider the suit without delay, and if it is necessary to consider
p.000113: the suit in more than one hearing, the committee shall notify the parties concerned of the date, time and
p.000113: location ofeachhearing.
p.000113:
p.000113:
p.000113:
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p.000113:
p.000113:
p.000113:
p.000114: 114
p.000114:
p.000114: Chapter Fourteen: Penalties
p.000114:
p.000114: Article 44
p.000114: Without prejudice to any severer penalty prescribed by other laws, a person violating any provision of this Law shall
p.000114: be subject to one or more of the following penalties:
p.000114: 1. Warning,
p.000114: 2. Suspension of research until the effects of the violation are rectified;
p.000114: 3. Barring the researcher from conducting the research subject of the violation;
p.000114: 4. A fine not exceeding two hundred thousand (200,000) riyals;
p.000114: 5. Imprisonment for a period not exceeding six months.
p.000114:
p.000114: Article (44.1)
p.000114: The National Committee may warn the researcher, the institution, or both if it finds that the violation committed does
p.000114: not require a severer penalty, taking into consideration that repeating the violation may require additional penalties
p.000114: at the discretion of the committee.
p.000114:
p.000114: Article (44.2)
p.000114: If the penalty is a suspension of research, the suspension period shall not exceed two years. If the violation is
p.000114: not rectified, the research shall be cancelled.
p.000114:
p.000114: Article (44.3)
p.000114: The National Committee may bar the principal investigator from conducting the research subject of the violation, or
p.000114: from practicing any other activity that may affect the research.
p.000114:
p.000115: 115
p.000115:
p.000115: Article (44.4)
p.000115: The National Committee may impose a fine not exceeding two hundred thousand (200,000) riyals on the researcher,
p.000115: the institution, or both if violation is established.
p.000115:
p.000115: Article (44.5)
p.000115: If the National Committee finds that the violation committed requires imprisonment, it shall take Article
p.000115: (45.1) into consideration.
p.000115:
p.000115: Article 45
p.000115: If the committee decides to impose a penalty including imprisonment, a recommendation to this effect shall be submitted
p.000115: to KACST President for referral to the competent court.
p.000115:
p.000115: Article (45.1)
p.000115: The Committee shall recommend an imprisonment term appropriate to the violation committed and state reasons for not
p.000115: imposing a lesser penalty.
p.000115:
p.000115: Article 46
p.000115: The committee may include in the final penalty decision publication of the decision text at the expense of the violator
p.000115: in not more than three local newspapers, one of which at least is published in the region where he resides. If no such
p.000115: newspaper is published in the region, the decision shall be published in the newspaper published in the nearest region.
p.000115:
p.000115: Article (46.1)
p.000115: A copy of the decision shall be delivered in person or through registered mail to the person against whom the penalty
p.000115: decision was issued.
p.000116: 116
p.000116:
p.000116: Article (46.2)
p.000116: If it is decided to publish the violation text in newspapers, it shall be noted that the researcher deliberately
p.000116: committed the violation or insisted on committing it.
p.000116:
p.000116: Article 47
p.000116: An aggrieved party may appeal the penalty decision before the Board of Grievances within sixty days from date of
p.000116: notification.
p.000116:
p.000116: Article (47.1)
p.000116: Provisions of Article (42.22) of these Regulations shall be taken into
p.000116: consideration.
p.000116:
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p.000117: 117
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p.000117:
p.000118: 118
p.000118:
p.000118: Chapter Fifteen: Concluding Provisions
p.000118:
p.000118: Article 48
p.000118: KACST President shall issue the Implementing Regulations of this Law within ninety days from date of
p.000118: publication of this Law.
p.000118:
p.000118: Article (48.1)
p.000118: These Regulations shall be published in the Official Gazette, and shall enter
p.000118: into force as of its publication date.
p.000118:
p.000118: Article (48.2)
p.000118: No amendments to these Regulations may be made except in the same manner they were issued.
p.000118:
p.000118: Article 49 This law shall
p.000118: enter into force ninety days from the date of its publication in the Official Gazette.
p.000118:
p.000118: Article 50
p.000118: Existing establishments shall fulfill necessary conditions and requirements and adjust their
p.000118: status within ninety days from the effective date of this Law.
p.000118:
p.000118: Article (50.1)
...
Appendix
Indicator List
| Indicator | Vulnerability |
|---|
| access | Access to Social Goods |
| age | Age |
| authority | Relationship to Authority |
| child | Child |
| crime | Illegal Activity |
| criminal | criminal |
| detained | person in detention center |
| different opinion | philosophical differences/differences of opinion |
| diminished | Diminished Autonomy |
| disability | Mentally Disabled |
| disabled | Mentally Disabled |
| drug | Drug Usage |
| education | education |
| educational | education |
| emergency | Public Emergency |
| employees | employees |
| family | Motherhood/Family |
| fetus | Fetus/Neonate |
| fetuses | Fetus/Neonate |
| illness | Physically Disabled |
| liberty | Incarcerated |
| mentally | Mentally Disabled |
| minor | Youth/Minors |
| opinion | philosophical differences/differences of opinion |
| parent | parents |
| parents | parents |
| party | political affiliation |
| physically | Physically Disabled |
| pregnant | Pregnant |
| prison | Incarcerated |
| prisoners | Criminal Convictions |
| property | Property Ownership |
| race | Racial Minority |
| racial | Racial Minority |
| religion | Religion |
| religious | Religion |
| research staff | Laboratory Staff |
| restricted | Incarcerated |
| sensory | sensory impairment |
| stem cells | stem cells |
| usage | Drug Usage |
| volunteers | Healthy People |
| vulnerable | vulnerable |
| women | Women |
Indicator Peers (Indicators in Same Vulnerability)
| Indicator | Peers |
|---|
| different opinion | ['opinion'] |
| disability | ['disabled', 'mentally'] |
| disabled | ['mentally', 'disability'] |
| drug | ['usage'] |
| education | ['educational'] |
| educational | ['education'] |
| fetus | ['fetuses'] |
| fetuses | ['fetus'] |
| illness | ['physically'] |
| liberty | ['prison', 'restricted'] |
| mentally | ['disabled', 'disability'] |
| opinion | ['differentXopinion'] |
| parent | ['parents'] |
| parents | ['parent'] |
| physically | ['illness'] |
| prison | ['liberty', 'restricted'] |
| race | ['racial'] |
| racial | ['race'] |
| religion | ['religious'] |
| religious | ['religion'] |
| restricted | ['liberty', 'prison'] |
| usage | ['drug'] |
Trigger Words
capacity
coercion
consent
ethics
exploit
harm
justice
protect
protection
risk
volunteer
Applicable Type / Vulnerability / Indicator Overlay for this Input