The Rise of Litigation in Human Subjects Research

Published In: Annals of Internal Medicine, v. 139, no. 1, July 1, 2003, p. 40-E46

Posted on RAND.org on December 31, 2002

by Michelle M Mello, David M. Studdert, Troyen A Brennan

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Owing to widespread public concern about the adequacy of protections for human research subjects and recent instances of serious injury to subjects at several major research institutions, lawsuits against investigators, institutional review boards, and academic institutions are becoming increasingly common. Several claim-promoting conditions are ripe to promote the further growth of this litigation and raise the stakes for research institutions. While this litigation may serve a valuable compensation function for injured subjects, it will also have profound effects on institutional review boards, leading to a more legalistic, mechanistic approach to ethical review that does not further the interests of human subjects or scientific progress.

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