Institutional review boards: what's old? What's new? What needs to change?
Institutional review boards have come under fire for being burdened with work, causing delays in the progress of human subject research without improvements in the protection of human subjects. Over the years, there have been increases in the numbers of clinical trials, the use of multisite studies, and the amount of bureaucracy, but there have been no changes to the system to accommodate these advancements. Proposed changes include the use of a centralized institutional review board for multisite studies and harmonization of reporting requirements among agencies. The purposes of this article are to review the history, structure, and purpose of the institutional review board, to assess the criticisms of the current system, and to discuss solutions for improvement.
Ann Arbor, Mich. From the Section of Plastic Surgery, Department of Surgery, The University of Michigan Health System; and the University of Michigan Medical School.
Sandra V
SV
Kotsis
Kevin C
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Chung
D028744:Ethics Committees, Research / Q000266:history / Q000458:organization & administration / Q000592:standards; D049673:History, 20th Century; D049674:History, 21st Century; D006805:Human Experimentation; D006801:Humans; D014481:United States