On Tuesday, June 21, the National Institutes of Health (NIH) published the “Final NIH Policy on the Use of a Single Institutional Review Board for Multi-Site Research.” The policy “establishes the expectation that a single IRB of record will be used to conduct ethical reviews for domestic sites of multi-site, non-exempt human subjects research protocols that are funded by NIH.” The single IRB (sIRB) will be responsible for carrying out the review requirements at 45 CFR part 46 for participating sites involved in the study. (The sIRB may also serve as a Privacy Board for HIPAA purposes.) The participating sites will be responsible for other regulatory activities including “obtaining informed consent, overseeing the implementation of the approved protocol, and reporting unanticipated problems and study progress to the sIRB.”
The policy goes into effect May 25, 2017. Although the policy does not expressly prohibit IRBs at participating sites from conducting their own review in a multi-site study where there is a sIRB, it makes clear that NIH funds may not be used to cover the associated costs.
In a statement posted on the NIH’s website, the Director of NIH, Dr. Francis S. Collins, stated that the change in policy is a response to a changed research landscape where “studies are increasingly conducted at multiple sites to help increase the number and diversity of the participants, improve operational efficiencies, and accelerate the generation of research results.”
The final policy document includes a preamble that summarizes the 167 public comments the NIH received in response to its 2014 draft policy. According to the NIH, researchers and patient advocate organizations were for the most part supportive of the policy on the grounds that it will reduce administrative inefficiencies, speed up research subject recruitment, and accelerate research progress.
On the other hand, many IRBs and academic institutions expressed concern about the broad scope of the proposed policy and the ability of any given sIRB to understand, respond to, and support local context, including practices for recruitment and retention, protections for specific vulnerable populations within a research participant base, and PI competencies and capacities.
While the substance of the final policy is very similar to the 2014 draft, there are a few notable differences, including around exceptions. The 2014 draft stated that exceptions would be granted with “appropriate justification,” but only in circumstances in which local IRB review was required by federal, state, or tribal laws or regulations, or the designated sIRB was not able to meet the needs of specific study populations. The final policy says “exceptions to this policy will be made where review by the proposed sIRB would be prohibited by a federal, tribal, or state law, regulation, or policy” (emphasis added), and that NIH will also consider exceptions not based on such legal, regulatory, or policy requirements if there is “compelling justification” for the exception. The policy does not specify what might constitute a compelling justification (though the preamble makes clear that the intent of this change is to allow that such justifications could be for reasons other than an sIRB being unable to meet specific population needs).
Another change involves who has the authority to choose and approve the sIRB. The draft policy stated that the NIH funding Institute or Center would have final authority to approve the selected sIRB. The final policy does not include this language. Instead, it states that applicants need to include in their proposal for research funding “a plan describing the use of an sIRB that will be selected…[including] a statement confirming that participating sites will adhere to the sIRB Policy and [describing] how communications between sites and sIRB will be handled.” The final policy also makes clear that, “It will be the responsibility of the applicant/offeror to assure that the sIRB is qualified to serve; the applicant’s plan will not be evaluated in peer review.”
Many of the comments submitted addressed the issue of the costs associated with sIRB review, who would bear those costs, and how those costs could be accounted for in a study budget. The final policy addresses this by stating that, “The applicant…may request direct cost funding for the additional costs associated with the establishment and review of the multi-site study by the sIRB, with appropriate justification.”
The NIH also clarifies that the final policy will “apply only to studies where the same research protocol (pdf) is being conducted at more than one site,” and not to studies that have multiple sites playing different research roles.
To help the research community with the implementation of the new policy, the NIH will issue guidance over the next 11 months on a range of issues, including:
- “Considerations in the selection of the sIRB
- Process for applicants/offerors to submit a request for an exception and process for NIH review of the request for exception
- Models for gathering and evaluating information from all the reliant sites about community attitudes and the acceptability of proposed research
- Roles and responsibilities of the sIRB and participating sites”
The first such guidance, illustrating the use of direct and indirect costs for sIRB review, was released the same day as the final policy. The NIH is also suggesting that stakeholders use the National Center for Advancing Translational Sciences (NCATS)’s SMART IRB Reliance Platform as a “single IRB reliance model” for multi-site research. The model has a toolkit for investigators and clinical research reviewers.
In response to the NIH’s draft and the similar language in the 2015 Notice of Proposed Rulemaking to revise the Common Rule, PRIM&R expressed concern that a broad mandate for sIRB review is premature, given the current lack of evidence regarding whether sIRB review would in all cases be more efficient and cost effective, and, more importantly, that sIRB review would not have a negative impact on subject protections. We urged the NIH and other policy makers to encourage and incentivize adoption of sIRB review to allow appropriate study of its costs, efficiencies, and impact on human subject protections. We also expressed concern about the criteria by which a sIRB would be selected. Those concerns have not changed, and we look forward to further guidance from the NIH on the sIRB selection criteria and other issues.
Now that the mandate is a reality for NIH funded studies, we will turn our attention to helping the IRB and larger HRPP community implement this policy, both in terms of readiness and capacity to serve as the sIRB for multi-site studies, and in terms of making the procedural, administrative, and other structural changes needed to coordinate local research oversight expertise and efforts with sIRB review.
For more information on the implications of this new policy, join us on July 12 for our webinar, Navigating the New Reliance Agreement Landscape. During this 90-minute program, an IRB director and a research attorney will address common challenges related to implementing and maintaining compliant reliance relationships, in addition to exploring the shift to a regulatory and funding landscape requiring single IRB review of multi-site research. Presenters will answer questions from the audience during a live question and answer session at the conclusion of the program. Please visit our website to learn more and to register.