of Health (NIH) awarded a grant to the Law-Medicine Institute of Boston University to study the legal and ethical aspects of conducting research with human subjects. The resulting report, published in 1963, suggested (among other things) "group consideration" or prior review of such research.2 In 1966, the surgeon general adopted that recommendation by requiring NIH grantees to provide prior review of research with human subjects by an institutional committee.3 A year later, Pappworth published a compendium, drawn from reputable journals, of experiments in which people were subjected to a variety of highly risky procedures and suffered a disquieting number of serious adverse effects (including meningitis, shock, liver damage, cardiac arrest, and punctures of main arteries or major organs).4 Pappworth concluded that because self-regulation was clearly ineffective, legislative remedies—including prior review by "Medical Research Committees"—were required.5

Concurrently, legal scholars turned their attention to issues of liability, and some suggested prior review of research as a method of limiting the risk to which subjects would be exposed (thereby limiting potential liability).6 Possibly in response to multidisciplinary pressures, the Public Health Service modified its policies in 1971 to require the broader composition of institutional review committees:

The committee must be composed of sufficient members with varying backgrounds to assure complete and adequate review of projects. … The committee should be able to determine acceptability of the proposal in terms of institutional commitments and regulations, applicable law, standards of professional conduct and practice, and community attitudes.7

The revised Department of Health, Education, and Welfare (DHEW) policy, familiarly known as the "Yellow Book," thus imposed additional requirements designed to avoid conflicts of interest in the review process. Scientists initially protested that nonscientists on the review committees would unreasonably impede the conduct of research; however, the public pressures and scholarly recommendations were such that the new requirements withstood the negative pressure from academic administrators and clinical investigators.8

In sum, the IRB system was developed by the Public Health Service incrementally over a period of years and was supported by articles in respected scientific and medical journals, as well as by scholarly writings of experts in law and ethics. At the same time, public pressure for reform appeared in the lay press, and NIH administrators recognized both the need for change and the importance of an interdisciplinary approach to the development of new policies.



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