OHRP Finalizes Guidance on Elimination of IRB Review of Research Applications and Proposals

Bass, Berry & Sims PLC

Bass, Berry & Sims PLC

Today, the Office for Human Research Protections (OHRP) will publish a notice in the Federal Register that its “Guidance on Elimination of Institutional Review Board (IRB) Review of Research Applications and Proposals: 2018 Requirements” (Guidance) – made available for public comment through a notice in the Federal Register on July 25, 2018 – has been finalized.

Before the publication of the revised Common Rule (subpart A of 45 CFR Part 46) on January 19, 2017 (later amended to delay implementation until January 21, 2019), an institution with an approved assurance was required to certify to the Department of Health and Human Services (HHS) that each application or proposal covered by an OHRP-approved assurance and by 45 CFR 46.103 has been reviewed and approved by the IRB. These “grant congruency reviews” were intended to ensure that the research described in the proposal was entirely consistent with the study protocol submitted to the IRB, which the IRB is also required to review under the Common Rule. These certifications had to be submitted with the application or proposal or in accordance with the National Institutes of Health’s (NIH) Just-in-Time procedures, adding a significant burden to already-overworked IRBs.

The Guidance formalizes OHRP’s interpretation that the revised Common Rule eliminates the requirement that grant applications or proposals themselves undergo IRB review and approval for certification. Institutions must still certify that each proposed research study covered by an OHRP-approved assurance and by 45 CFR 46.103 has been reviewed and approved by an IRB. While the NIH had already announced that it no longer required IRB review of grant applications effective January 21, 2019, not all HHS funding agencies have made similar announcements, and some institutions have not eliminated this review requirement.

The Guidance should provide institutions the comfort they need to remove congruence review for a  new research grant or contract proposals to an HHS funding agency, or task an institutional office other than the IRB with this review if they choose. Note that some non-HHS agencies that have adopted the Common Rule have not issued similar notices, and while funding agency requirements should continue to be followed, the Guidance may spur similar confirmations from non-HHS agencies. Note also, of course, that the OHRP guidance does not apply to congruence review of animal research proposals by an Institutional Animal Care and Use Committee.

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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