Bioethics Blogs

PRIM&R’s Response to NIH’s Draft Policy on the Use of a Single Institutional Review Board for Multi-Site Research

by Elisa A. Hurley, PhD, Executive Director, and Avery Avrakotos, Education and Policy Manager

The biomedical research landscape has evolved dramatically since the publication of the federal regulations for the protection of human subjects in 1974. In particular, research with human subjects has become an increasingly complex endeavor in which multi-center rather than institution-based research is increasingly the norm. In light of this shift, it is sensible to consider whether an alternative structure for research review better safeguards the rights and welfare of research participants and lessens unnecessary administrative burdens.

In December, the National Institutes of Health (NIH) took a step in this direction with the release of a draft policy aimed at reducing inefficiencies associated with multiple IRB reviews. The policy, titled “Draft Policy on the Use of a Single Institutional Review Board for Multi-Site Research,” calls for all domestic sites participating in NIH-conducted or -supported multi-site studies “to rely on a single IRB to carry out the functions that are required for institutional compliance with IRB review set forth in the [Department of Health and Human Services (DHHS)] regulations for the Protection of Human Subjects.”

Earlier this month, we summarized the changes proposed in the draft policy. Today, we are pleased to share PRIM&R’s response to the draft policy. In our response, we acknowledge that the use of a single IRB can be a beneficial approach for some multi-site studies, but emphasize that it is premature and perhaps inappropriate to mandate single IRB review for all NIH-funded and conducted studies.

PRIM&R believes that, before such a policy is implemented, further reliable empirical evidence is needed on the various ways in which a single IRB can be used to provide ethical review of multi‐site research, and on whether such review is better, from the perspectives of subject protections, administrative costs, efficiency, and quality of review, than relying on local IRBs.

The views, opinions and positions expressed by these authors and blogs are theirs and do not necessarily represent that of the Bioethics Research Library and Kennedy Institute of Ethics or Georgetown University.