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This Article provides an overview of Institutional Review Board (IRB) operations, reviews the sources of regulatory guidance, and examines the weaknesses of the existing system for the protection of human research subjects. It then discusses the scant case law relating to IRB negligence in the protection of human research subjects and explores some hypothetical circumstances under which it may be appropriate to hold a board accountable for injuries to clinical trial participants. Finally, this Article considers the potential consequences of expanded IRB liability, concluding that tort lawsometimes may serve an important function as a catalyst to regulatory reform when professional self-regulation and governmental supervision fail.

Recommended Citation

7 J. Health Care L. & Pol'y 175 (2004)