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  • Washington Highlights

    AAMC Joins Comments Clarifying Reporting Requirements in Animal Research


    Stephen Heinig, Director, Science Policy
    Heather Pierce, Senior Director, Science Policy & Regulatory Counsel

    The AAMC joined with the Council on Governmental Relations (COGR) and the National Association for Biomedical Research (NABR) in comments submitted on Oct. 28 to the National Institutes of Health (NIH) on ways to clarify reporting requirements in the care and use of animals in medical research.

    The three associations were responding specifically to a July 20 request for information (RFI) from the NIH’s Office of Laboratory Animal Welfare (OLAW) on reporting requirements when an institution’s treatment of research animals deviates from the advice provided in the Guide for the Care and Use of Laboratory Animals, a standard resource by the National Research Council.

    The OLAW RFI is the latest in a series of steps by that office to respond to directives of the 21st Century Cures Act (P.L. 114–255) that called for agencies to identify and eliminate unnecessary or duplicative regulation in animal research without diminishing humane protections for animals [refer to Washington Highlights, Feb. 20, 2019]. In their comments, the AAMC, COGR, and NABR reiterated the importance of animal models for medical research and their support for streamlining duplicate or unnecessary regulations.

    “Our member institutions are leaders in biomedical research and appreciate the need for clear standards that both protect the health, safety, and welfare of animals used in research and minimize associated administrative burden on researchers, institutional animal care and use committees (IACUCS), and other participants in research animal care and use programs,” the associations stated in the letter. “These goals are not mutually exclusive, as the elimination or tailoring of requirements to remove unnecessary or duplicative items frees time, personnel, and other resources for use in more responsive animal care activities.”

    The associations added that a central concern with OLAW’s proposal to clarify reporting requirements is that the guide itself is not a regulatory document and does not exclude other approaches in humane care. The guide’s use of so-called “should” statements are not intended as prescriptive, and the associations call on OLAW to acknowledge alternatives more comprehensively.

    Overall, the associations perceive OLAW’s response to the 21st Century Cures Act as marginal and incremental, and they call for more transformative regulatory reform. The associations also commented on specific points for reporting requirements in the RFI. Public comments to the OLAW RFI are due Nov. 1.