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Content Background

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Single IRB for Multisite Trials

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Latest Updates

May 2019 - The AAMC, with the AAU, the APLU, and COGR, sent a letter to the Office for Human Research Protections (OHRP) expressing concerns about the office’s assertion that multisite research studies approved by multiple IRBs after the effective date of the revised Common Rule must have a single IRB of record by the delayed compliance date of January 20, 2020. The letter asserts that requiring such studies to be re-reviewed by a single IRB after research has already started is contrary to the clear intent of the delayed provision and would mean that “research will be interrupted, and administrative burden and costs will significantly increase, without benefit to the protection of research participants.”

Single IRB and the Revised Common Rule

On January 19, 2017, the U.S Department of Health and Human Services and 15 other Federal Departments and Agencies issued final revisions to the Federal Policy for the Protection for Human Subjects (also known as the "Common Rule"), which went into effect on January 21, 2019. The Common Rule subjects all federally funded research to a standard set of rules, including requirements for informed consent and formal processes for the ethical review of research. Among the changes to the regulations, one of the most significant includes the mandate that a sIRB review and approve all multi-site research. The sIRB requirement requirement is scheduled to go into effect on January 21, 2020.

Additional resources on the Common Rule can be found on the AAMC's webpage Common Rule Resources and Updates.

NIH Single IRB of Record

Separate from the revised Common Rule, the National Institutes of Health (NIH), June 21, 2016, issued a final policy requiring the use of a sIRB of record for all domestic research sites participating in agency-funded multi-site clinical trials, intending 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.” In response to the draft policy, the AAMC submitted a letter recognizing 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 single IRB requirement. Beginning January 25, 2018, all NIH funded multi-site studies involving non-exempt human subjects research must use an sIRB of record. All NIH grants applications (new, renewal, revision, or resubmission) are required to submit a plan indicating the use of an sIRB in the application/proposal.

For more information on the NIH's sIRB policy visit Single IRB Policy for Multi-Site Research.

AAMC Resources

External Resources

For questions, contact Heather Pierce, JD, MPH, Senior Director, Science Policy and Regulatory Counsel at hpierce@aamc.org or (202) 478-9926. Follow Heather on Twitter: twitter.com/HeatherHPierce.

Last updated: July 22, 2019

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