Bioethics Blogs

NIH Releases Draft Policy on Use of Single IRB for Multi-Site Research

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

On December 3, the National Institutes of Health (NIH) issued a request for comments on a  its “Draft NIH Policy on the Use of a Single Institutional Review Board for Multi-Site Research,” which “proposes that all NIH-funded multi-site studies carried out in the [United States], whether supported through grants, contracts, or the NIH intramural program, should use a single IRB.”

Citing a changed research landscape, the background section of the policy suggests that the use of a single IRB for the review of multi-site research will reduce administrative burdens and inefficiencies, and enhance and streamline IRB review.

Federal regulations, as well as prior guidance documents from the Food and Drug Administration and the Office for Human Research Protections, have established the acceptability of utilizing a single IRB for multi-site research. In its request for comments on the draft policy, NIH indicates that this option has nevertheless been largely underutilized.

In explaining the rationale for the draft guidance, NIH further states “…there is no evidence that multiple IRB reviews enhance protections for human subjects. In fact, the use of single IRBs may lead to enhanced protections for research participants by eliminating the problem of distributed accountability, minimizing institutional conflicts of interest, and refocusing IRB time and resources toward review of other studies.” It goes on to suggest that risk/benefit assessments and adequacy of informed consent documents do not generally require input of local IRBs, as such issues can be addressed through the inclusion of ad hoc members and consultants with site-specific knowledge.

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.