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Institutional Review Boards: A Crisis in Confidence

Robert J. Levine, MD
[+] Article, Author, and Disclosure Information

Dr. Levine: Yale University School of Medicine; New Haven, CT 06520

Grant Support: In part by the National Institute of Mental Health and the National Institute on Drug Abuse (PO1 MH/DA 56 826-01A1).

Requests for Single Reprints: Robert J. Levine, MD, Room 204 CLP, Yale University School of Medicine, 47 College Street, New Haven, CT 06520.

Ann Intern Med. 2001;134(2):161-163. doi:10.7326/0003-4819-134-2-200101160-00018
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There is a sense of crisis in the country about the effectiveness of the nationwide system that protects the rights and welfare of human research subjects. Reports of problems appear on television or in newspapers almost weekly and focus attention on the system's centerpiece, the institutional review board (IRB). University hospitals' entire research programs have been suspended on grounds of inadequate IRB performance, and governmental agencies have found that the IRB system is incapable of coping with its workload.

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