Category: Health, Area of Effect: Bioethics
RECOGNIZING GAR #111, "Medical Research Ethics Act," as an important step in the protection of sapient subjects of medical research, but that it does not protect communities (such as ethnic or racial communities) or animals in medical research, or extend protections in non-medical research.
BELIEVING that individuals, communities, and animals may have the right to protection while participating in any kind of research.
AFFIRMING that scientific research is an essential endeavor in the struggle to reduce the impacts of disease, to ensure consumer product safety, and to further the cause of knowledge, so any limits placed on research should be justified.
SEEKING to strike the proper balance between the necessity of conducting important research and the necessity of protecting sentient species involved in that research.
THEREFORE, the World Assembly,
DEFINES for the purposes of this resolution:"Sentience" as the capability of feeling but not of giving informed consent, and
"Sapience" as the capability of feeling and giving informed consent.
REQUIRES that states protect members of sapient and sentient species that are subjects of research within their jurisdictions.1. Any research with sapient subjects carrying a reasonable level of risk to either the individual subject or to a community of which he is a member shall be required to undergo external review by an entity with sufficient organizational capacity and whose purpose is to protect the interests of the subjects of the research. Such entities will be referred to herein as "Institutional Review Boards" (IRBs).
a. Member states may decide what constitutes a reasonable level of risk, or delegate that decision to organizations performing research.
b. An IRB with "sufficient organizational capacity" to fulfill the requirement of external review must have the following characteristics:i. The IRB must not have a financial or other stake in the completion of the research.
ii. The IRB must be composed of or receive active consultation from an expert or experts in the field at a similar or more advanced level than those conducting the research.
iii. The IRB's approval must be a prerequisite for the legal operation of research, and it must have the discretion to reject proposals that do not adequately protect subjects.
iv. The IRB must review the purpose of the research and its proposed methods for the protection of its sapient subjects and procedures in the case of a negative impact to a subject. It must reject any research that does not:- provide a consent form that accurately, adequately, and understandably informs subjects of risks to themselves, safety procedures, contacts in case the subject wishes to seek external recourse, contact information and the qualifications of those conducting the research, and information about the selection of subjects for the research.
- provide reasonable minimization of risk to subjects through research design and reasonable sharing of risks among communities through subject selection procedures.
c. Should a research subject come to believe that the protections guaranteed by this resolution were not adequately provided, they must be afforded the ability to be removed from the research and pursue whatever civil remedies are available in the jurisdiction in which the alleged violation occurred.
2. Member states shall not use prisoners of war as research subjects.
3. Member states must protect members of sentient species who are the subjects of research by:a. Reducing the use of sentient species as subjects in research that poses risks to them through research design that eliminates the risk or through research design that eliminates the use of a sentient subjects altogether when the same research objectives may be reasonably be obtained without posing those risks to sentient species or posing unreasonable risks to sapient species.
b. Requiring that organizations keeping members of sentient species for the purposes of research provide a minimum level of care to those individuals with respect to their biological needs including at least that which the individual would plausibly be able to obtain if it was not a subject of research. In cases where specific research objectives must be achieved through the withholding of care, only the minimum amount of care required to achieve the research objective may be withheld.
c. Encouraging research that can reasonably be conducted with willing volunteers of a sapient species as subjects be conducted in this manner instead of using sentient subjects, especially in cases where risks are low and willing volunteers could easily be found.
Please share your comments/criticisms/concerns.
Note: Passage of this proposal would render GAR#111 completely superfluous. (The requirements of that resolution are a proper subset of the requirements under this proposal.) Do I have to repeal GAR#111 before this can be considered? [I would otherwise seek the repeal of 111 if and only if this were passed.]
Related resolutions:
GAR #111
GAR #425
Original Draft: (Failed; lack of interest)
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