Accelerating clinical research studies benefits researchers, research participants, and all who stand to gain from research results. Today, the time it takes to go from a sound research idea to the launch of a new, multi-site clinical research study is too long. A major contributor to the delay is that too many institutional review boards (IRBs) are reviewing the protocol and consent documents for the same study, often with no added benefit in terms of the protections for research participants. To address this bottleneck, NIH has issued a new policy to streamline the review process for NIH-funded, multi-site clinical research studies in the United States. The NIH Policy on the Use of a Single Institutional Review Board (IRB) for Multi-Site Research sets the expectation that multi-site studies conducting the same protocol use a single IRB to carry out the ethical review of the proposed research.
This policy applies to all competing grant applications (new, renewal, revision, or resubmission) with receipt dates on or after May 25, 2017. Ongoing, non-competing awards will not be expected to comply with this policy until the grantee submits a competing renewal application. For contracts, the policy applies to all solicitations issued on or after May 25, 2017. For the intramural program, the policy applies to intramural multi-site studies submitted for initial review after May 25, 2017.
IRBs play a critical role in reviewing and approving studies involving human research participants. IRBs evaluate the potential benefits of research and risks to participants. In the past, most clinical research studies were carried out at single institutions. Now 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. However, for the majority of multi-site studies, the IRB at each participating site continues to conduct an independent review. This review adds time, but generally does not meaningfully enhance protections for the participants. This new NIH policy seeks to end duplicative reviews that slow down the start of the research.
NIH will support applicant and awardee institutions as they implement the new policy with guidance and resources, such as a model authorization agreement that lays out the roles and responsibilities of each signatory, and a model communication plan that identifies which documents are to be completed, and when.
Francis S. Collins, M.D., Ph.D.
Director, National Institutes of Health
Email questions to: SingleIRBPolicy@mail.nih.gov