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June 20 — The NIH finalized a policy to streamline the clinical research process by requiring one ethics panel to review human subject protections at all locations of the same multi-site study.
The “Final NIH Policy on the Use of a Single Institutional Review Board for Multi-Site Research” implements a draft version of the policy issued in December 2014. The National Institutes of Health is moving to eliminate what the agency sees as a duplicative process.
“The problem that this policy was trying to solve was that we were seeing delays and complications in moving research forward in a way that wasn't providing commensurate protections for human research participants,” Carrie D. Wolinetz, NIH associate director for science policy, told Bloomberg BNA on June 20. “If we thought that having multiple IRBs review the research resulted in a stronger fabric of protection for participants, we would be all for it. But there's no evidence that that is the case.”
The issue of a single IRB requirement has come up through multiple legal and policy channels as one way to combat the increasing time and costs required to develop new therapies; it's now estimated that developing a treatment spans more than a decade and costs $2.6 billion. The House-passed 21st Century Cures bill (H.R. 6) includes a single IRB requirement, as does the first-ever effort to overhaul the “Common Rule” regulations governing human research subjects (45 C.F.R. 46) (9 LSLR 1031, 9/18/15). But because the NIH is the world's largest funder of biomedical research, the policy is expected to spur greater adoption of the single IRB model.
“The pharma companies and the device companies all favor, in general, the central IRB model. And now that NIH is going to favor the central IRB model, I think we could well see certain IRBs at strong universities and academic medical centers emerge as big players,” Mark Barnes, a research attorney at Ropes & Gray 's Boston office, told Bloomberg BNA on June 20. “Ultimately some of the local IRBs will be diminished in their stature, and probably in the resources they'll get. Long term, I think that's what's going to happen.”
The final policy has a lot of similarities to the draft version, but Wolinetz said the agency added some clarifications based on the comments received.
The single IRB requirement applies to domestic sites of NIH-funded studies, where each site will conduct the same study protocol. Wolinetz said this was a clarification from the draft version in response to questions about if this policy applies to sites that have different roles for carrying out the research.
Under the policy, NIH grant applications must include a plan describing the use of a single IRB that will be selected to serve as the IRB of record for all study sites, and awardees can include the costs of establishing the IRB in the grant. NIH awardees must ensure there is an authorization agreement between the single IRB and all the study sites; and the funding NIH institute or center is responsible for review and oversight of the grantee's proposed plan for complying with the single IRB policy.
“All sites participating in a multi-site study are expected to rely on an sIRB to carry out the functions that are required for institutional compliance with IRB review set forth in the HHS regulations at 45 CFR 46,” the final policy said. “Participating sites are responsible for meeting other regulatory obligations, such as obtaining informed consent, overseeing the implementation of the approved protocol, and reporting unanticipated problems and study progress to the sIRB.”
The final policy doesn't apply to career development, research training or fellowship awards; nor does it apply to foreign study sites. The NIH also said it will grant exceptions if state, federal or tribal laws or regulations prohibit the use of a single IRB, or if the grantee can provide a “compelling justification” for why a study warrants an exception.
The NIH doesn't prohibit local IRBs from conducting their own reviews, but that site can't use NIH grant funds to pay for the additional local review.
About 70 percent of responses to the NIH draft policy supported the change. But groups like the Health and Human Services Secretary's Advisory Committee on Human Research Protections and Public Responsibility in Medicine & Research have said a single IRB mandate is premature. Scientists generally have hailed the policy as a welcome change, and Francis S. Collins has advocated for the single IRB model from his early days as NIH director. But IRB administrators have raised concerns that the new requirement won't actually reduce the amount of work but could increase an institution's liability risks.
“The final policy is not unexpected,” Barnes said. “I think some of the objections that were voiced during this process were discussed in the comments. But they are not really addressed in the actual text of the guidance.”
Specifically, he said, it would have been preferable if the NIH policy had provided more direction as to what the on-site ethics review should encompass, and how the single IRB will account for issues such as cultural context and different capacities of individual investigators. Barnes also noted that the IRB will be a contractor of the NIH awardees, and it's unclear in the final policy whether this would be a sole-source, or no-bid, contract, and what the standards will be for selecting an individual IRB.
Wolinetz said she is hopeful that some of the refinements in the final version—along with future guidance—will address some of these concerns. “I don’t know that we’ll be seeing anyone in the institutional world necessarily embracing it as much as we would like given our very positive intent,” she said. “But certainly I am hopeful we worked through some of the issues we heard about in the comments.”
The policy will take effect May 25, 2017, and the NIH said it plans to issue guidance and resources in the meantime to help institutions adjust to the changes.Wolinetz said the guidance will address direct costs versus indirect costs for single IRB charges and how they apply to the grants.
As institutions prepare to implement this new policy, Barnes said, they are going to have to decide whether they want their IRB to be in the running as one of the major central IRBs.
“If so, they’re going to need to beef up their staffing, their capacity, their ability to analyze local regulatory conditions. They’re going to need to be fully compliant with the subparts,” he said, noting that—for example—an IRB would need to have a prisoner representative for any study that falls under Subpart C, which includes additional protections for prisoners. He also said “those that want to be players in the central IRB model” will want to become accredited. “That will be a way to distinguish themselves from other IRBs.”
The policy is set to be published in the June 21 Federal Register.
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The NIH final policy on single IRBs is available at http://src.bna.com/f3E.
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