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IOM report on the system for protecting human research participants.

In response to society’s concerns about the use of human subjects in research, the Department of Health and Human Services commissioned the Institute of Medicine to perform a comprehensive assessment of current systems of research participant protection in the U.S., including recommendations for reform (Committee 2002). Although the committee declared its frustration over the lack of data, it found ample evidence to indicate that there are pivotal weaknesses in the current system. First, it discovered dissatisfaction with the current system from virtually every quarter and at virtually every level. Second, it found evidence that IRBs are under severe strain and performing inadequately. Third, it found that the existing regulatory framework—the IRB system and the Common Rule—has not and probably now cannot react adequately to the constantly evolving research environment. Some of these problems might be handled through federal agencies, but the committee holds that the problems are more extensive and will require additional institutional support and professional attention. The committee found that federal protection requirements should be extended to every research project—private, public, or otherwise. Subjects should be, in this respect, equally protected in privately sponsored research. The committee found that the IRB system is in important respects a failure, especially when it alone is relied upon for ethics reviews in institutions. One set of problems concerns the proper education of IRB members. The committee recommends that all members henceforth be given a specialized knowledge of human research ethics. It finds that IRB deliberations commonly have been dominated by scientists, who often marginalize the perspectives of nonscientist members. It therefore recommends that unaffiliated members, nonscientists, local community representatives, and those representing the participant-perspective comprise at least 25 percent of the membership. It also recommends that no protocol be approved without three-quarters of the voting members concurring.