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New NIH Policy on Single IRB (sIRB) Review

August 31, 2016

On June 21, 2016, the National Institutes of Health (NIH) released the Final NIH Policy on the Use of a Single Institutional Review Board for Multi-Site Research. The policy, effective May 25, 2017, requires that all sites participating in human subjects research funded by NIH utilize a single IRB (sIRB). The sIRB will provide IRB review for all participating sites and all sites will be expected to accept the review and approval of the sIRB. The policy is intended to facilitate research by streamlining IRB review and reducing inefficiencies, while also ensuring human subjects are protected appropriately.

Use of single IRB systems is becoming increasingly common among human research protection programs. The IU Human Subjects Office (HSO) acknowledges the advantages of single IRB review to investigators and sponsors, and is committed to facilitating IU’s participation. HSO staff members already participate in several single IRB initiatives with collaborating institutions around the country, and HSO regularly considers and approves reliance on external IRBs. The NIH policy is formalization of a process in which many institutions, including IU, already engage.

That being said, the NIH policy will have a significant impact on both investigators and HSO staff. Most importantly, investigators who apply for NIH grants after the effective date will be required to include a mechanism for sIRB review in the proposal, including identification of the sIRB, confirmation that all sites will agree to use the sIRB, a plan for communication across sites, and allocation of sIRB costs. HSO staff members are looking forward helping IU investigators address these issues in their proposals. In addition, HSO is considering the possibility that the IU IRBs may be asked to serve as the sIRB and is actively working to address the relevant issues.

HSO is considering the impacts of the policy carefully and will offer IU-specific guidance and training well before the effective date. NIH has promised additional guidance regarding implementation of the policy. IU’s specific guidance will be published after that guidance becomes available in order to incorporate the additional information. In the meantime, investigators are encouraged to contact HSO with questions and/or concerns.

For questions about the NIH policy, collaborating with external institutions or investigators, or deferring IRB review, please contact Amy Waltz, HSO Associate Director, at acthurst@iu.edu or 317-278-5431.

The full NIH policy and additional resources are available on the NIH website HERE.