Recent federal policy changes from the Department of Health and Human Services (HHS) clarify the situations in which researchers should use a single Institutional Review Board (IRB) review for federally funded multisite trials. An NIH-funded study being conducted at more than one U.S. site involving nonexempt human subjects research may be subject to the NIH Single IRB policy and/or the revised Common Rule cooperative research provision.
Latest Updates
August 2022 - The AAMC submitted a letter to the HHS Office for Human Research Protections (OHRP) in response to the OHRP’s request for comments on the draft guidance Use of a Single Institutional Review Board for Cooperative Research. The draft guidance is intended to assist institutions, IRBs, and human research protection staff to implement the 2018 requirement on the use of a single IRB for cooperative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.
January 2020 - Beginning Jan. 20, 2020, all cooperative research studies subject to the revised Common Rule are required to use a single IRB.
November 2019 - The OHRP announced that research conducted or supported by the 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 Jan. 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 the 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 - he AAMC, with the AAU, the APLU, and COGR, sent a letter to the 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 Jan. 19, 2017, the HHS 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 Jan. 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 single IRB review should approve all multisite research.
NIH Single IRB of Record
Separate from the revised Common Rule, the NIH on June 21, 2016, issued a final policy requiring the use of a single IRB of record for all domestic research sites participating in agency-funded multisite 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 multisite 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 multisite studies involving nonexempt human subjects research must use a single IRB of record. All NIH grants applications (new, renewal, revision, or resubmission) are required to submit a plan indicating the use of a single IRB in the application/proposal.
AAMC Resources
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"OHRP Issues Single IRB Draft Guidance" (Sept. 9, 2022, Washington Highlights).
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AAC, AAU, APLU, COGR joint letter to HHS Office for Human Research Protections (May 2019).
External Resources
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Additional guidance on the NIH single IRB policy (January 2020).
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Evaluation Framework for the NIH Single IRB Policy (September 2019).
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Guidance on implementation of the NIH Policy for single IRB for multisite research (October 2017).
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NIH Single IRB Policy FAQs for the Extramural Community (December 2016).
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Final policy on single IRB for multisite research (June 2016).
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Draft policy on use of an single IRB for multisite research (December 2014).