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NIH Policy on Single IRB for Multisite Trials

On June 21, 2016, the National Institutes of Health (NIH) released a final policy requiring the use of a single Institutional Review Board (IRB) of record for all domestic sites participating in agency-funded multi-site clinical trials. This policy is “intended 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 policy takes effect on September 25, 2017 (see below).

In response to the NIH’s December 3, 2014 request for comments on the draft policy, the AAMC submitted a letter which recognized the potential benefits of single IRB review for multi-site trials and strongly recommended that the NIH use the results from research on central IRBs to inform the implementation of a broader requirement to use single IRBs.

Delay of Implementation Date for Single IRB Policy

On October 24, 2016, the AAMC joined the Association of American Universities (AAU), the Association of Public and Land Grant Universities (APLU), and the Council on Government Relations (COGR) in a letter to NIH requesting a one year extension to the May 25, 2017 implementation deadline. In response to this request, NIH Director Francis Collins announced at the December 8 NIH Advisory Committee to the Director meeting, the new September 25, 2017 implementation date.

On June 16, 2017, the NIH released a notice extending the effective date to January 25, 2018 of the NIH Single IRB Policy, previously set to go into effect in September. The policy will apply to all competing grant applications for due dates on or after January 25, 2018. For R&D contracts, the policy will apply to all solicitations issued on or after this effective date.

AAMC Webinar on the NIH Final Policy on Single IRBs in Multisite Clinical Trials

A webinar for AAMC member institutions was held on Monday, July 11, 2016 to discuss the NIH Final Policy as well as the resources that the NIH has developed to assist with implementation. Log into your AAMC account to access the presentation-- The Use of a Single Institutional Review Board for Multi-Site Research: Implementation and Implications of the NIH Final Policy — (Slides) (Audio)

Internal Resources

AAMC Comments on the Draft Policy

AAMC, AAU, APLU, COGR Joint Letter to NIH

External Resources

NIH Policy and Additional Resources

Single IRB Policy FAQs for the Extramural Community (December 16, 2016) 

Final Policy on the Use of a Single IRB for Multi-Site Research (June 21, 2016)

Draft Policy on the Use of a Single IRB for Multi-Site Research (December 3, 2014)