Animal research

AAMC joins comments clarifying animal research reporting requirements

The AAMC joined the Council on Governmental Relations (COGR) and the National Association for Biomedical Research (NABR) in comments submitted 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 responded specifically to a notice of July 20 request for information (RFI) NIH’s Office of Laboratory Animal Welfare (OLAW) on reporting requirements when an establishment’s treatment of research animals deviates from the guidance provided in the Guide to the care and use of laboratory animals, a standard resource of the National Research Council.

The OLAW RFI is the latest in a series of measures taken by this office to meet the guidelines of the 21st Century Cures Act (PL 114-255) which called on agencies to identify and eliminate unnecessary or duplicative regulations in animal research without diminishing human protections for animals [refer to Washington Highlights, Feb. 20, 2019]. In their comments, AAMC, COGR and NABR reiterated the importance of animal models for medical research and their support in streamlining duplicate or unnecessary regulations.

“Our member institutions are leaders in biomedical research and appreciate the need for clear standards that protect both the health, safety and welfare of animals used in research and minimize the associated administrative burden for researchers. , Institutional Animal Care and Use Committees (IACUCS) and other participants in research animal care and use programs, ”the associations said in the letter. “These goals are not mutually exclusive, as eliminating or adapting the requirements to remove unnecessary or duplicate items frees up time, personnel and other resources to be used 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 to human care. . The guide’s use of so-called “should” statements is not intended to be prescriptive, and the associations are asking OLAW to recognize the alternatives more fully.

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