Bioethical Malpractice: Risk and Responsibility in Human Research
Journal of Health Care Law and Policy, Vol. 7, No. 2, p. 175, 2004
67 Pages Posted: 12 Jan 2012 Last revised: 19 Jan 2012
Date Written: 2004
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 law sometimes may serve an important function as a catalyst to regulatory reform when professional self-regulation and governmental supervision fail.
Keywords: bioethics, human research, malpractice
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