Medical Research Oversight from the Corporate Governance Perspective: Comparing Institutional Review Boards and Corporate Boards
Richard S. Saver
University of North Carolina (UNC) at Chapel Hill - School of Law
William and Mary Law Review, Vol. 46, November 2004
Federal research regulations require that institutional review boards (IRBs) review, approve, and monitor clinical trials involving human subjects. Recent governmental reports conclude that IRBs lack sufficient resources, and critics charge that the IRB review system is in danger of imploding. While IRBs receive much criticism, however, few studies have examined how IRBs functionally perform in relation to comparable oversight bodies. This Article explores how IRBs and corporate boards exhibit remarkably similar institutional strengths and limitations. Both share significant degrees of insularity and both face similar information and time constraints in performing their monitoring duties. Additionally, IRBs and corporate boards are comprised of a mix of inside and outside interests, a feature that complicates monitoring effectiveness. Also, individuals serving on IRBs and corporate boards face enormous conformity pressures and possible social sanction for aggressive oversight. While IRB members and corporate directors are expected to exert monitoring effort, they face limited liability for subpar performance and there exist few other incentives to persevere in monitoring. Nonetheless, the corporate board perspective identifies multiple non-monitoring functions, such as mediating, that IRBs remain uniquely positioned to perform. Attempts to strengthen the monitoring role of IRBs may undercut these important non-monitoring functions. Finally, this Article asks what IRB reformers could learn from corporate boards. A note of caution is sounded regarding proposals to increase the number of outside, community members serving on IRBs, as this reform, without more, will likely have limited impact on board function. Also, the corporate board perspective suggests that calls for IRBs to take on a more direct role in reviewing financial conflicts of interest are misguided, as IRBs remain institutionally ill-suited to do this type of review.
Number of Pages in PDF File: 112
Keywords: Institutional review board, IRB, medical research, human subject, clinical trial, experimentation, corporate board, directorsAccepted Paper Series
Date posted: July 27, 2004
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