Deputizing Institutional Review Boards to Police (Audit?) Biomedical Research

Posted: 7 Mar 2004 Last revised: 6 Feb 2014

Lars Noah

University of Florida - Levin College of Law

Abstract

This paper responds to a new article by Carl Coleman that critiques the risk assessment process applied to biomedical research by institutional review boards (IRBs). Coleman's central argument that IRBs exercise delegated governmental authority and should strive to emulate appellate decision making suffers from several flaws: it exaggerates the centrality of these boards in existing systems of human subject protection, it incorrectly adopts a court-centered view of the processes used by other regulatory institutions, and it fails to appreciate some of the countervailing advantages of an underproceduralized decision making model. Human research subject protection efforts suffer from many shortcomings, but it would be a mistake to pursue solutions that recast boards as miniature appellate courts in an effort to promote consistency and transparency when an inquisitorial model akin to mechanisms of peer review better describes the activities of IRBs.

JEL Classification: I18, K23

Suggested Citation

Noah, Lars, Deputizing Institutional Review Boards to Police (Audit?) Biomedical Research. Journal of Legal Medicine, Vol. 25, 2004. Available at SSRN: https://ssrn.com/abstract=506883

Lars Noah (Contact Author)

University of Florida - Levin College of Law ( email )

P.O. Box 117625
Gainesville, FL 32611-7625
United States
352-273-0923 (Phone)
352-392-3005 (Fax)

HOME PAGE: http://www.law.ufl.edu/faculty/lars-noah

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