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  • Washington Highlights

    OHRP Issues Single IRB Draft Guidance

    Daria Grayer, Director, Regulation and Policy
    Heather Pierce, Senior Director, Science Policy & Regulatory Counsel
    For Media Inquiries

    The AAMC submitted an Aug. 26 letter to the Department of Health and Human Services (HHS) Office for Human Research Protections (OHRP) in response to the OHRP’s request for comments on the draft guidance Use of a Single Institutional Review Board for Cooperative Research. The draft guidance is intended to assist institutions, institutional review boards (IRBs), and human research protection staff to implement the 2018 requirement on the use of a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 Federal Policy for the Protection of Human Subjects (also known as the Common Rule) which went into effect Jan. 21, 2020 (refer to Washington Highlights, Jan. 7, 2016).

    The draft guidance clarifies several key topics including when an institution should rely on a single IRB, exceptions to the single IRB requirement, the process for determining which IRB will serve as the single IRB of record, responsibilities of the reviewing IRB, and local and state considerations. The AAMC commended the OHRP for issuing guidance to assist the regulated community with implementation and compliance with the revised Common Rule and recommended issuance of additional guidance addressing other key areas of the regulations that are of importance to the research community. Among other recommendations, the AAMC proposed the following as the OHRP takes steps to finalize the draft guidance:

    • Provide clarification on issues related to the Federalwide Assurance process, a nonregulatory change requiring institutions engaged in research under the Common Rule to provide written assurance to ensure compliance with the Common Rule requirements.
    • Elaborate on specific aspects of the draft guidance such as the assessment of “local context” information across clinical trial sites, the impact of differing community standards on participant recruitment and retention, and implications of state and local law requirements on the IRB review process.
    • Develop additional tools and resources to assist the regulated community with implementation of the single IRB requirements, including opportunities for continued engagement to expand on areas in the draft guidance that would benefit from additional clarification and precision.

    The AAMC recommended routine evaluation of the effectiveness of the single IRB approach and will continue to follow these efforts as the OHRP takes next steps to finalize the draft guidance.