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

Barbara A. Noah

Western New England University School of Law

Date Written: 2004

Abstract

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

Suggested Citation

Noah, Barbara A., Bioethical Malpractice: Risk and Responsibility in Human Research (2004). Journal of Health Care Law and Policy, Vol. 7, No. 2, p. 175, 2004. Available at SSRN: https://ssrn.com/abstract=1983444

Barbara A. Noah (Contact Author)

Western New England University School of Law ( email )

1215 Wilbraham Road
Springfield, MA 01119
United States
413-782-1432 (Phone)

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