Single IRB for Multisite Trials

Latest Updates

August 2022 - AAMC submitted a letter to the Department of Health and Human Services Office for Human Research Protections (OHRP) in response to the OHRP’s request for comments on the draft guidance Use of a Single Institutional Review Board for Cooperative Research. The draft guidance is intended to assist institutions, institutional review boards (IRBs), and human research protection staff to implement the 2018 requirement on the use of a single IRB for cooperative research projects (Subpart A of 45 CFR part 46.114). This requirement is included in the revised Common Rule. Also see AAMC resources and updates: Common Rule.

January 2020 - Beginning January 20, 2020, all cooperative research studies subject to the revised Common Rule are required to use a single IRB.

November 2019 - The HHS Office for Human Research Protections (OHRP) announced that research conducted or supported by HHS under the revised Common Rule may continue to use multiple IRBs in lieu of a single IRB for cooperative research if 1) the IRB approved the research before the January 20, 2020 delayed compliance date for the single IRB requirement, or 2) the NIH single IRB policy does not apply, and the research was approved by an IRB or the NIH excepted the research from the single IRB policy before January 20, 2020. This decision was in direct response to an AAMC May 2019 joint letter, expressing concerns about HHS’ assertion that multisite research studies approved by multiple IRBs after the effective date of the revised regulations must have a single IRB of record by January 20, 2020.

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.

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

• AAMC Letter to OHRP on Draft Single IRB Guidance (September 9, 2022, Washington Highlights)

• AAMC Common Rule Resources and Updates

• AAC, AAU, APLU, COGR Joint Letter to HHS Office for Human Research Protections (May 2019)

• AAMC, AAU, APLU, COGR Joint Letter to NIH Requesting an Extension to the NIH Single IRB Policy (October 2016)

• AAMC Comments on the NIH Draft Policy (January 2015)
   

External Resources

• Additional Guidance on the NIH Single IRB Policy (January 2020)

• Evaluation Framework for the NIH Single IRB Policy (September 2019)

• NIH Policy and Additional Resources

• Single IRB and Exception Process Webinar (October 2017)

• Guidance on Implementation of the NIH Policy on the Use of a Single Institutional Review Board for Multi-Site Research (October 2017)

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

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

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

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: January 17, 2020