Post by Ananke II on Apr 21, 2010 2:33:38 GMT -5
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Medical Research Ethics Act
A resolution to improve worldwide human and civil rights.
A resolution to improve worldwide human and civil rights.
Category: Human Rights
Strength: Significant
Proposed by: Quadrimmina
Description: THIS WORLD ASSEMBLY,
RECOGNIZING the importance of ethicality in medical research that involves living citizens, prisoners, and those denied citizenship.
REALIZING that there is no doctrine to ensure that this ethicality is maintained consistently among nations.
FURTHER REALIZING that this lack of a common rule can lead to human rights violations in the name of scientific progress.
UNDERSTANDING that ethical dilemmas exist in medical research, including but not limited to:
i. Excessive coercion of prospective testing subjects.
ii. Misleading subjects about the nature of the research.
iii. Endangering the lives of subjects without proper consent.
iv. Use of criminals or war prisoners as subjects without proper consent.
v. Exploiting weak, undereducated, or emotionally unstable subjects.
DEFINES an Institutional Review Board (IRB) as a board of people qualified to make a decision about the ethicality of medical research.
MANDATES that any entity within a WA nation that performs medical research on living citizens, prisoners, and those denied citizenship have this research verified as ethical by an IRB within the nation.
FORBIDS any research from taking place that is not approved by an IRB.
ALLOWS WA nations to regulate their own IRB system, with all research accountable to some IRB, that nation must have an IRB responsible for the research, be it public or private.
REQUIRES all prospective researchers to provide the following documentation to an IRB, in addition to any other documentation as determined by national law:
i. A protocol must be present.
ii. The subject consent form must be present, which accurately details the study and provides info about contacts for complaints.
iii. Information concerning qualification and contact info of all research personnel must be present.
iv. Information concerning the subjects needed and how they are chosen must be included.
v. The research must be reapproved every year by an IRB. Failure to do this must result in immediate termination of the research until approval is granted.
FURTHER REQUIRES that the IRBs, whether they be government-operated or operated by an institution such as a university, be free from political pressure in their review of research.
ALLOWS the creation of Regional IRBs in regions for collaborative scientific research efforts or to provide for nations that do not have a high amount of medical research. In this case, a researcher can choose to submit research to any IRB in his/her jurisdiction.
MANDATES that the IRBs reject any research that they reasonably believe may:
i. Involve deception or coercion of test subjects to the extent that a reasonable test subject would otherwise refuse to participate in the research, such that the participation cannot be a result of an informed, impartial, and rational decision.
ii. Cause death, serious injury, or significant physical or psychological damage to a subject.
ALLOWS subjects in medical research to terminate their consent at any time.
CREATES a Medical Research Ethics Board, whose purpose is to review research approved by IRBs in WA nations and ensure that the approval is valid, based on conceptions of human rights, medical ethics, and international and national law. If a country's IRBs or IRB laws are found to be inadequate, the MREB will have the ability to shut down national IRBs and take over their role until a suitable replacement is implemented.