General Assembly Resolution # 111
A resolution to improve worldwide human and civil rights.
THIS WORLD ASSEMBLY,
RECOGNIZING the importance of medical research in supporting the body of knowledge in the field of medicine and improving the quality of life for all peoples.
REALIZING that medical research can be performed unethically, and cause permanent harm to the subject, sometimes without consent.
UNDERSTANDING that ethical dilemmas exist in medical research, including:
i. Excessive coercion or deception of prospective testing subjects.
ii. Exploiting weak, undereducated, or emotionally unstable subjects.
DEFINES an Institutional Review Board (IRB) as a board of individuals qualified to impartially analyze medical research proposals.
DECLARES that the use of prisoners of war for medical research is strictly forbidden.
REQUIRES WA member nations to create and regulate an IRB system, or by treaty to create an IRB system in conjunction with other WA member nations for collaborative scientific research efforts, to provide for nations that do not have a high amount of medical research or where establishing an IRB would be prohibitively expensive to the nation.
FURTHER REQUIRES that any entity within a WA nation that performs medical research on any individuals must have this research verified as ethical by the IRB to which their nation subscribes.
ESTABLISHES that all prospective researchers must provide the following documentation to the IRB:
i. A protocol that defines the purpose of the study, the methods to be used, the expected results and procedures in the event the trial has a negative impact on one or more trial subjects.
ii. The subject consent form, which accurately details the study and provides info about contacts for complaints.
iii. Information concerning qualification and contact info of all research personnel.
iv. Information concerning the subjects and how they are chosen.
v. Additional documentation as determined by national law.
FURTHER ESTABLISHES that research must be reviewed every year by an IRB. If the research is not approved, termination of the research must occur when all patients can be considered stable for release, and the IRB may take measures to ensure this happens in a timely manner for quick termination.
MANDATES that the IRBs be free from political pressure in their review of research.
REQUIRES that the IRBs reject any research that they reasonably believe may:
i. Cause participation that is not a result of an informed, impartial, and rational decision to provide consent except where the subjects legal rights were removed by due process of law
ii. Cause preventable death, serious injury, or significant physical or psychological damage to a subject.
ENSURES that WA nations regulate issues regarding consent of individuals and how that consent can be responsibly terminated.