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by Dominic Chiarelli

Final NIH Policy on Use of a Single Institutional Review Board for Multi-Site Research

Introduction

On June 21, 2016, the National Institute of Health (NIH) published its Final Policy on the Use of a Single Institutional Review Board for Multi-Site Research. This policy, which goes into effect May 25, 2017, establishes that for human subjects research a single Institutional Review Board (sIRB) will conduct the ethical reviews for all domestic sites in an NIH-funded, multi-site study.

Intent of the Policy

The NIH’s stated goal with this new policy is to streamline and enhance the ethical review process. This goal will be realized through expected dramatic improvements in efficiency and consistency that are simply not possible in the current system of concurrent, parallel, and often divergent reviews by multiple ethics review committees (i.e., IRBs).

Public comments on a draft of this policy, however, suggest there is less than universal acceptance that this change will enhance the standards of ethical review. The NIH nevertheless is convinced that multiple reviews of the same protocol do not improve protections for human subjects.  In fact, the NIH has argued that the use of a sIRB is not only equivalent but possibly better than multiple review, in that they are subject to current challenges like distributed accountability, institutional conflicts of interest, or misallocation of IRB time and resources. The NIH predicts that, “Once the transition to the new way of operating is made, the benefits of widespread use of sIRBs will outweigh any costs and, ultimately, reduce burdens to the research process.”

Guidance during the Transition

Importantly, the NIH recognizes that this is a paradigm shift for researchers and research institutions. The agency has provided nearly a year for preparation and has committed to releasing numerous guidance documents. According to the final policy announcement, future materials will include recommendations on

  • Appropriate considerations for selecting an IRB;
  • Roles and responsibilities of the sIRB and participating sites; and
  • Models for gathering and evaluating information regarding community attitudes and the acceptability of the proposed research at each site.

Funding for sIRB

All applications for NIH funding under this policy must include a detailed plan for sIRB review that

  • Identifies the sIRB that will provide ethical review;
  • Confirms all participating sites are willing and able to rely on that sIRB; and
  • Describes how all IRB-related communications with sites will be handled.

The sIRB does not need to be the prime awardee’s internal IRB. If choosing to rely on an external IRB, applicants may request funding specific to the additional direct costs anticipated for the IRB review.

Exceptions

The policy does allow for limited exceptions due to federal, tribal, or state law, regulation, or policy. The NIH, if petitioned, may also determine that there is some other compelling justification. While the policy stops short of prohibiting a site from conducting its own duplicate IRB review, it does not allow the use of any NIH funds to pay for the additional review.

Conclusion

Quorum embraces the NIH’s proposition that a single IRB review can introduce efficiencies and ensure participant protection. We are excited to explore the merits and potential of the NIH’s new approach to multi-site research studies.

For 25 years Quorum has acted as an independent IRB with the mission to safeguard the rights and well-being of research participants while streamlining the clinical research process. Quorum is uniquely qualified to provide a high quality review of research that includes thorough consideration of and respect for institutional standards, community attributes, and state laws. Quorum has also developed a novel infrastructure with a dedicated regulatory attorney team, robust client support, and an easy to use portal for collaboration between sites, sponsors, and Quorum.

Read the complete text of the NIH’s Use of a Single Institutional Review Board for Multi-Site Research.

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