U.S. Department of Health and Human Services
NATIONAL INSTITUTES OF HEALTH NIH News
NIH Office of the Director (OD) <https://www.nih.gov/institutes-nih/nih-office-director>
For Immediate Release: Tuesday, June 21, 2016
CONTACT: NIH Office of Communications, 301-496-5787, <e-mail:nihnmb@xxxxxxxxxxxx>
SINGLE IRB POLICY TO STREAMLINE REVIEWS OF MULTI-SITE RESEARCH
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 <http://osp.od.nih.gov/sites/default/files/NIH_sIRB_Policy_Multi_site_Research_UPDATED2016.pdf>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.
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 <https://ncats.nih.gov/expertise/clinical/smartirb>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. You can learn more about the process that NIH followed to come to this final policy, including gathering public feedback, at the related links.
Francis S. Collins, M.D., Ph.D.
Director, National Institutes of Health
About the National Institutes of Health (NIH): NIH, the nation's medical research agency, includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. NIH is the primary federal agency conducting and supporting basic, clinical, and translational medical research, and is investigating the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit <https://www.nih.gov>.
NIH...Turning Discovery into Health -- Registered, U.S. Patent and Trademark Office.
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RELATED LINKS:
--NIH Policy on the Use of a Single Institution Review Board for Multi-Site Research<http://osp.od.nih.gov/sites/default/files/NIH_sIRB_Policy_Multi_site_Research_UPDATED2016.pdf>
--OSP-OER Co-Authored Blog: Accelerating Clinical Research by Streamlining Multi-Site Review of Human Subjects Research<http://osp.od.nih.gov/under-the-poliscope/2016/06/accelerating-clinical-research-streamlining-multi-site-review-human-subjects-research>
--NIH Guide Notice on Single IRB Policy <http://grants.nih.gov/grants/guide/notice-files/NOT-OD-16-094.html>
--NIH Guide Notice on Scenarios for Direct and Indirect Cost Determinations for sIRBs <http://grants.nih.gov/grants/guide/notice-files/NOT-OD-16-109.html>
--Smart IRB Platform <https://ncats.nih.gov/expertise/clinical/smartirb>
--NIH takes steps to speed initiation of clinical research by ensuring use of single IRB <https://www.nih.gov/news-events/news-releases/nih-takes-step-speed-initiation-clinical-research-ensuring-use-single-irb>
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This Statement is available online at:
<https://www.nih.gov/about-nih/who-we-are/nih-director/statements/single-irb-policy-streamline-reviews-multi-site-research>
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