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

Today, in the Federal Register and the NIH Guide to Grants and Contracts, the NIH published its final NIH Policy on the Use of a Single Institutional Review Board for Multi-Site Research.  This policy establishes the expectation that all sites participating in multi-site studies involving non­exempt human subjects research funded by the NIH will use a single Institutional Review Board (sIRB) to conduct the ethical review required by the Department of Health and Human Services regulations for the Protection of Human Subjects.  The intent of this policy is to enhance and streamline the process of IRB review and reduce inefficiencies so that research can proceed as expeditiously as possible without compromising ethical principles and protections for human research participants.

The NIH recognizes that the sIRB policy will be a paradigm shift in IRB review.  As such, the final policy will not take effect until May 25, 2017.  NIH has prepared a number of resources to assist the research community in preparing for the implementation of the policy.  A set of FAQs, as well as guidance on scenarios illustrating the use of direct and indirect costs for single IRB review under the policy are now available on the NIH Office of Science Policy website.  Another tool available for the research community is the NIH National Center for Advancing Translational Sciences (NCATS) single IRB reliance platform for multi-site clinical studies: the NCATS SMART IRB Reliance Platform.

For additional perspectives on this issue, we encourage you to read a statement on the importance of the sIRB policy from NIH Director, Dr. Francis Collins, as well as the latest “Under the Poliscope” blog co-authored by Dr. Carrie D. Wolinetz, and Dr. Mike Lauer.

The resources and guidance above are available now on the NIH Office of Science Policy website. Additional resources will be added to the website as they become available.  

If you have any questions or require further information about the single IRB policy, please contact us at SingleIRBpolicy@mail.nih.gov