Research on human

Chapter Eight: Research on Humans

 
Article 15
Research conducted on humans shall be for clear scientific objectives, and shall be preceded by sufficient laboratory experiments on animals if the nature of the research so requires.
 
Article (15.1)
1-  Each research proposal shall be subject to the approval of the local committee;
2-  The local committee shall verify the scientific objectives of the research proposal;
3-  The researcher shall obtain the "Informed Consent" from the human subject according to the provisions of the Law and Regulations.
 
Article (15.2)
Prior to conducting clinical research on humans, the following shall be observed:
1-  The investigator shall clearly and accurately specify his objectives and methodology;
2-  The research shall be preceded by sufficient experiments on animals if the nature of the research so requires.
3-  Potential risks shall not be greater than expected benefits.
 
Article (15.3)
Unprecedented experimental surgeries and medical research shall be consistent with controls and criteria set forth in laws and regulations applicable in the Kingdom as well as the relevant agreements to which the Kingdom is party.
 
 
 
Article (15.4)
The investigator or research team conducting the experimental surgeries and medical research shall be specialized and shall have adequate scientific qualification, expertise and competence.
 
Article 16
The expected benefit from the experiment or research to the human subject shall be greater than the possible harm.
 
Article (16.1)
1-  The investigator shall evaluate the expected benefit to the human subject and the extent to which it is greater than the potential risk according to a scientific evaluation carried out by the researcher and submitted to the local committee.
2-  If the local committee finds that the potential risk to the human subject is greater than the expected benefit, it must deny permission to conduct the research.
3-  The local committee shall verify, through periodic reports submitted by the investigator, that the expected benefit is still greater than the potential risk.
 
Article (16.2)
1- Prior to approving research on humans, the local committee shall verify that the investigator takes into consideration the right of human subject to normal life and safety from all types of physical and psychological harm, and shall not affect him wholly or partially except with his consent and in accordance with the provisions of Sharia and applicable laws. This shall include all body organs and their components, such as living tissues and cells whether connected or otherwise.
2-  The investigator or research team may not conduct any medical intervention on the human subject for research purposes that do not entail any expected benefit. 
3-  Approval of all competent government bodies shall be obtained in cases related thereto.
4-  The local committee or the Research Ethics Monitoring Office may impose additional restrictions on any research on humans if conducting said research would endanger the human subject.
 
Article (16.3)
The human subject may seek indemnification for any harm resulting from conducting the research on him by filing a complaint with the local committee. If the local committee fails to respond, the human subject may submit the complaint directly to the Monitoring Office.
 
Article 17
The researcher may not in any way exploit the conditions of the human subject and shall not expose him to any type of coercion or exploitation.
 
Article (17.1)
The provisions of Articles (24.1), (24.2), (25.1) and (25.2) of the Regulations shall be observed.
 
Article 18
Approval to conduct research on humans shall take into consideration their right to normal life and their safety from all types of harm in accordance with the provisions of Sharia.
 
Article (18.1)
The provisions and controls of the "Informed Consent" referred to in Article 11 of the Law and Articles (10.17), (11.1), and (11.2) of the Regulations shall be observed.
Article 19
The investigator may not exploit the human subject for the purpose of trading in gametes, zygotes, organs, tissues, cells or any parts thereof or genetic data related to human derivatives or products.
 
Article (19.1)
The investigator may not exploit the human subject or any part thereof, including gametes, zygotes, organs, tissues, cells or parts thereof or genetic data related to human derivatives or products or human images for the purpose of trading therein.
 
Article (19.2)
In case the investigator is found guilty of violating Article (19.1) of the Regulations, he shall be subject to the appropriate penalties set forth in the Law and Regulations as well as laws prohibiting trade in human organs and not in conflict with Sharia.
 
Article 20
An organ removed for a purely medical purpose may be used in scientific research upon obtaining the informed consent.
 
Article (20.1)
Subject to the provisions of the Law and Regulations regarding obtaining the "Informed Consent", human organs removed for medical purposes may be used in scientific research in a way not conflicting with the provisions of the Law and Regulations.
 
 
 
Article (20.2)
When conducting research on samples previously extracted for another research purpose or a purely medical purpose and it is still possible to relate said samples to their source, consent of the person from whom the samples have been collected is required prior to conducting research thereon.
 
Article (20.3)
When conducting research on samples previously extracted for another research or a purely medical purpose and it is no longer possible to relate said samples to their source, the local committee permission to conduct the research may be deemed sufficient.
 
Article 21
No research may be conducted on human zygotes, gametes or fetuses except under controls specified by the Regulations.
 
Article (21.1)
No research may be conducted on human zygotes or gametes except under the following controls:
1-  The practices indicated in the research proposal shall be consistent with the provisions of Sharia and standard medical principles, and the research shall be justified in terms of its contribution to medical knowledge or technical applications;
2-  The investigator shall obtain the "Informed Consent" from the person donating zygotes or gametes in accordance with Article 11 of the Law.
3-  The investigator shall provide all research-related information to the persons donating zygotes or gametes, and their spouses, if any. Said information shall include a full explanation of the research potential risk and expected benefit.
 
Article (21.2)
When conducting research on human zygotes or gametes, the researcher shall accurately record all required data and information about the human subject and each person related to the zygotes or gametes under research, and all research findings. He shall keep records of the same for at least five years from date of research completion, and shall submit periodic reports on the research to the local committee.
 
Article (21.3)
No research may be conducted on human fetuses except for one of the following purposes:
1-  Find a treatment for reproductive problems, in which case the research shall be conducted in an institution approved for treatment of such problems;
2-  Conduct a new experiment expected to benefit human fetuses;
3-  Acquire new knowledge about the condition of fetuses if it is not expected to achieve a direct benefit.
 
Article (21.4)
The research proposal on human fetuses shall include the indication that the expected benefit from the research would not be realized without using such fetuses, and that a similar benefit has been previously obtained through conducting research on animals, and that the research is justified in terms of its contribution to improvement of treatment techniques or knowledge of human diseases.
 
Article (21.5)
The investigator shall use the minimum number of fetuses to achieve research purposes.
 
Article (21.6)
In cases of research conducted to acquire new knowledge, the researcher shall submit to the local committee proof that potential risk for the fetus is minimal.
 
Article (21.7)
The investigator shall prepare and keep records of the source of each fetus and the results of using said fetus in the research, and shall submit periodic reports on the research to the local committee.
 
Article (21.8)
The investigator shall abide by the controls and procedures set by the National Committee regarding research on stem cells, zygotes, gametes and fetuses.
 
Article 22
No research may be conducted for the purpose of human cloning.
 
Article (22.1)
No investigator shall be permitted to conduct research on human cloning and any reproductive and research applications resulting therefrom due to constraints determined by sharia, ethical principles and health-related harms, where harms and dangers to humanity outweigh the expected benefits.  
 
Article 23
Research may be conducted on tissues, living cells and separated parts, including stem cells extracted from the umbilical cord or adult stem cells, upon obtaining the informed consent.
 
 
 
Article (23.1)
Subject to provisions and controls set forth in the Law and Implementing Regulations and directives issued by the local committee, research may be conducted on tissues, living cells and separated parts, including stem cells extracted from the umbilical cord or adult stem cells, upon fulfilling the following conditions:
1-    Fetuses may not be cloned for the purpose of obtaining and using stem cells in research;
2-    Excess fertilized eggs from in vitro fertilization procedures performed for medical indications shall not be used for therapeutic purposes or in stem cell research;
3-    Male or female gametes taken from sperms or eggs may not be donated to produce fertilized eggs that can grow into a fetus for the purpose of generating stem cells therefrom;
4-    Embryonic stem cells derived from aborted fetuses may be used for therapeutic purposes. Likewise, miscarried fetuses without any signs of life yet may not be used whether in research or in scientific and laboratory experiments in accordance with applicable Sharia rules in the Kingdom.
5-    In case of stillborn fetuses, embryonic stem cells may be transferred and used in research;
6-    Stem cells of an adult human may be used, provided said human is not subject to any harm, and such stem cells can be used to treat a patient, and the expected benefit outweighs the possible harm;
7-    Research objectives shall be clearly and accurately defined, and the research is preceded by sufficient experiments on animals if the nature of the research so requires; subject to the discretion of the local committee;
8-    Assessing the expected benefit for the human subject and the extent to which it outweighs the possible harm shall be through a clear and thorough scientific assessment conducted by the investigator and submitted to the local committee;
9-    If the local committee finds that the potential harm for the human subject outweighs the expected benefit, it shall not approve the research project;
10-  The local committee shall review periodic reports submitted by the investigator to ensure that the expected benefit continues to outweigh the possible harm;
11-  The investigator or research team conducting the research shall be specialized and shall have sufficient scientific expertise and scientific competence;
12-  The "Informed Consent" shall be obtained from the human subject prior to conducting the research and the information provided shall contain a full explanation of expected benefits and potential risks of the research;
13-  The investigator shall keep detailed records of the source of stem cells and results of their use in the research, and shall submit periodic research reports to the local committee.
14-  The institution may set up its own bank to store stem cells for research purposes subject to the approval of the National Committee;
15-  Stem cells stored in stem cell banks may not be used for research purposes without the prior permission of the local committee and the owner's consent, and upon obtaining the "Informed Consent" from the donor;
16-  Each sample shall be given a permanent label indicating to whom it belongs. Information included in said label shall be updated by the principal investigator under the supervision of the local committee;
17-  The institution shall set up a special record for research conducted on the sample under the supervision and monitoring of the local committee;
18-  The institution shall safeguard the sample and shall destroy it under the supervision of the local committee when it is no longer needed or if the donor so requests;
19-  The institution shall prepare a periodic report on research conducted on the sample for submission to the local committee;
20-  The investigator shall submit, along with the research proposal, a description of the mechanism of safeguarding samples and records thereof;
21-  All personal data resulting from the research conducted on the sample shall be part of the rights of the donor, and they may not be used or published without his consent, taking confidentiality and privacy into consideration;
22-    The national committee may, when necessary, add or amend conditions for use of stem cells.

Send to Friend

Click here to enter an extra message...