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 Early Developments - Isolated organizations first began establishing ethical review bodies for the independent review of human research in the mid 1950s. These bodies (called Institutional Review Boards or IRBs) have evolved to review both the science and the ethics of proposals, set conditions, and ensure consent, unless properly waived. By the 1960s, evidence surfaced that liberties were being taken in the treatment of humans as subjects of research. By the mid 1970s, a crescendo of urgency prompted Congressional action (provoked by the now infamous Tuskegee Syphilis Study). The first versions of current regulations were created to spell out the required procedures for protections, but only for research conducted or supported by what is now the Department of Health and Human Services (DHHS).
Ethical Principles - A national commission produced the Belmont Report (ethical principles of Autonomy, Beneficence, and Justice). The Belmont principles can be thought of as (1) respect for persons, (2) minimal risks in pursuit of maximum benefits, and (3) fairness in selecting who participates, mindful of who is likely to ultimately benefit. The principles are to the Bill of Rights what the regulations are to the Constitution. The former values provide the focus for applying the latter rules of process.
Procedural Protections - By the early 1980s, the now DHHS completed the process of perfecting and extending protections to specified vulnerable populations. By the early 1990s, the vast majority of the basic rules survived and were adopted by most Federal departments and agencies. The Food and Drug Administration has overlapping and additional rules for its own unique jurisdiction (research subject to the Food, Drug and Cosmetic Act). However, it must be appreciated that all these rules only apply to federally conducted, supported, or regulated research or as may be otherwise voluntarily elected. The remainder of the 1990s were punctuated with numerous cases of noncompliance with existing requirements. This resulted in heightened attention by all concerned.
Protection of Subjects by Subjects - At no time during this fifty year period has there been equivalent development of the means by which subjects can more actively participate in their own protection. As it stands, subjects should expect that procedural protections for them by others have been undertaken in the interests of their safety and well-being. That's good. Such procedures are necessary to competent protections.
However, if left only to consent or decline, unprepared subjects may conclude that either (1) they are not capable to judge and decline to play it safe or (2) uncritically consent to participate in the trusting belief that others have essentially decided for them that there is no reason to decline. The former possibility can result in unnecessary loss of subjects to worthy research and the latter can lead to shortsighted participation that is later questioned, withdrawn, or proven to be ill-advised.
 Protections cannot be truly sufficient in the absence of an informed, skilled, and able subject. Meaningful consent of the knowing and willing subject, in the absence of avoidable pressure, depends on being prepared. It's in the best interests of all concerned. The reason the GRSSM website exists is to help educate prospective subjects about protections and provide a resource that encourages truly informed and meaningful consent.
(01-29-07)
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