13
Jan2015

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 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In explaining the rationale for the draft guidance, NIH further states "…there is no evidence that multiple IRB reviews enhance protections for human subjects.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.

If enacted, the policy will require 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." The designated IRB would serve as the IRB of record for all participating sites and "…IRB Authorization Agreements [would] document the delegation of responsibilities of IRB review to the designated IRB of record and that IRB site’s acceptance of [those] responsibilities."

While the draft policy does not expressly prohibit individual participating sites from conducting their own IRB reviews, it does indicate that such a practice is discouraged and that those sites would be required to bear the costs of any such additional review. The policy also allows for limited exemptions "if the designated single IRB is unable to meet the needs of specific populations or where local IRB review is required by federal, tribal, or state laws or regulations."

In a blog post on the draft policy, Sally Rockey, PhD, NIH’s deputy director for extramural research, noted: "I believe this proposed policy is a step forward to reducing burdens associated with NIH-funded clinical research and enhancing the efficiency of the process while still ensuring protections of all the volunteers who generously participate in human subjects research for the betterment of us all."

With the release of this draft policy, NIH seems to be moving ahead with some of the most prominent and discussed changes proposed in DHHS’ 2011 Advance Notice of Proposed Rulemaking (ANPRM), Human Subjects Research Protections: Enhancing Protections for Research Subjects and Reducing Burden, Delay, and Ambiguity for Investigators. But with the status of a subsequent NPRM still unclear, some are expressing concern that this move by NIH may perpetuate a piecemeal approach to regulatory change and a lack of harmonization amongst regulatory requirements from different funding agencies.

NIH is accepting comments on the draft policy through January 29, 2015. In the coming weeks, PRIM&R’s Public Policy Committee will prepare comments in response to the draft for submission to NIH and we look forward to sharing them here once finalized.

In the meantime, we encourage and welcome you to share your thoughts on the draft policy in the comments. Is there adequate evidence to support NIH’s move toward mandating the use of single IRBs for all multi-site research funded by the agency? What are the implications of the policy for subject protections? What implementation challenges does the draft policy present?


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