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When IRBs Say No to Participating in Research about Single IRBs

Robert Klitzman

Professor of psychiatry and the director of the Masters of Science in Bioethics Program at Columbia University

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Paul S. Appelbaum

Elizabeth K. Dollard professor of psychiatry, medicine and law and the director of the Center for Law, Ethics and Psychiatry at Columbia University

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Alexandra Murray

Research coordinator at the University of Massachusetts Medical School

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Ekaterina Pivovarova

Assistant professor of psychiatry at the University of Massachusetts Medical School

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Deborah F. Stiles

Chief operating officer and vice president for research operations and policy in the Office of Executive Vice President for Research at Columbia University

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Charles W. Lidz

Research professor emeritus of psychiatry at the University of Massachusetts Medical School

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First published: 22 January 2020

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ABSTRACT

In response to a policy of the National Institutes of Health and requirements in the revised Common Rule, a protocol for a multisite study must be reviewed by a single institutional review board (IRB), rather than by the IRB at each study site. The goal of the single IRB approach is to increase the efficiency of IRB review of multisite research without jeopardizing protections for research subjects. Yet the extent to which these joint goals are being achieved is unclear. To better understand how single IRBs function, we recruited academic, government, and commercial single IRBs (N = 49) to participate in a study involving observation of protocol review meetings and/or interviews with their members, chairs, and administrators. Twenty (40.8%) agreed to participate, of which 50% agreed to both interviews and observation. While 81.8% (9/11) of academic and 50% (4/8) of government single IRBs participated in some way, only 23.3% (7/30) of commercial single IRBs did so. The four largest commercial single IRBs declined to participate. Because evaluation of single IRBs is important to inform development, implementation, monitoring, and refinement of federal policies, single IRBs should be encouraged to participate in research that examines how they function.

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