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  • Washington Highlights

    AAMC Comments on the Harmonization of FDA Human Subject Protection Regulations


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

    On Dec. 28, 2022, the AAMC submitted two letters to the Food and Drug Administration (FDA) in response to notices of proposed rulemaking to harmonize the agency’s human subject protection regulations with the Department of Health and Human Services' (HHS’) analogous regulations, Federal Policy for the Protection of Human Subjects, also known as the Common Rule. The FDA stated that these efforts are intended “to streamline the [institutional review board] review process and decrease administrative burdens and inefficiencies for investigators and IRBs without compromising human subject protections.”   

    The Common Rule is a governmentwide policy that ensures the protection of human subjects in HHS-conducted and -supported research, and was simultaneously adopted by 15 federal departments and agencies in 1991 and 19 agencies (including the HHS) following the January 2017 revisions to the regulations [refer to Washington Highlights, Jan. 7, 2016]. Notably, the FDA is not a Common Rule agency, resulting in differing requirements between the revised Common Rule and the FDA’s regulations. The FDA’s current efforts to modernize its regulations are in response to a mandate in the 21st Century Cures Act (P.L. 114-255, Section 3023) that the HHS and the FDA harmonize the two sets of regulations designed to protect human subjects. 

    The first proposed rule, Protection of Human Subjects and Institutional Review Boards (87 Fed. Reg. 58733), focused on those provisions of the Common Rule related to informed consent requirements for potential research participants. The FDA indicated that the proposed changes “will invite broader participation in clinical research, advancing [its] efforts to ensure that clinical trials reflect the diversity of patient populations and that these patient populations feel engaged by the clinical research community.” In its letter, the AAMC agreed with the areas the FDA proposed for harmonization and supported the agency’s interest in working with federal partners and the research community to develop guidance on additional areas in the proposed rule that could benefit from clarification or harmonization. The AAMC also proposed the FDA take the following steps in furtherance of this goal:  

    • Evaluate additional definitions and terminology that would benefit from further alignment or clarification such as terms in the revised Common Rule that are broader in scope than those in the FDA’s regulations.  
    • In collaboration with the HHS and the research community, identify and develop tools that reinforce the flexibility of the regulations and provide examples of acceptable language.  

    • Conduct regular assessments on the effect and effectiveness of this proposed rule, as well as the companion proposed rule on cooperative research.  

    • Coordinate with the HHS on its current activities to develop and implement an Equity Action Plan in accordance with Executive Order 13985, Advancing Racial Equity and Support for Underserved Communities through the Federal Government [refer to Washington Highlights, July 2021]. 

      The second proposed rule, Institutional Review Boards; Cooperative Research (87 Fed. Reg. 58752), generally proposes to adopt the Common Rule requirement that a single institutional review board (IRB) be used for the review of multisite, or cooperative, clinical research. In response, the AAMC acknowledged the benefits to harmonization across agency regulations but also expressed its longstanding concerns regarding requiring single IRB review for most or all multisite research [refer to Washington Highlights, Jan 29. 2015]. The association also recommended the FDA adopt a two-year implementation period prior to the effective date of the single IRB requirement to ensure the agency has time to evaluate whether additional guidance, exceptions, or flexibilities are warranted. Among other recommendations, the AAMC suggested the FDA: 

    • Coordinate with the HHS’ Office of Human Research Protections (OHRP) when developing exceptions to the single IRB requirement to ensure consistent implementation of the proposed regulations.  

    • Develop additional guidance and/or resources to address complicated areas in the proposed rule such as those related to specific populations, local context, and IRB expertise.  

    • Create opportunities for the regulated community to provide the FDA with data and information to better understand the benefits and burdens of single IRB review.  

    In both letters to the FDA, the AAMC encouraged the close review of the comments from individual medical schools and teaching hospitals that provided the agency with recommendations from the unique perspective of having implemented the revisions to the Common Rule through policy and practice.