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  • Washington Highlights

    NIH Releases Final Report Streamlining Requirements in Animal Research

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

    The National Institutes of Health’s (NIH) Office of Laboratory Animal Welfare issued the final report of a multiagency working group, including the U.S. Department of Agriculture and the Food and Drug Administration, for reforming requirements in the care and use of animals in medical research.

    The working group review was conducted in response to the 21st Century Cures Act (P.L. 114-255), which included provisions to address the various types of “regulatory burden” on medical researchers and institutions, including for the protection of animal welfare. Critically, the working group review, the Cures Act itself, and the communities providing input committed to sustaining current, high levels of protection for the welfare of animals used in research. Specifically, these stakeholders sought to remove duplicative or contradictory requirements, and streamline or “harmonize” regulations remaining in effect to remove any efforts that were not productive to the protections for research animals.

    The final report advances several changes to inspections, protocol review, and reporting requirements. The report also commits to improved coordination among agencies funding animal research. In comments on a draft version of the working group report, the AAMC commended the agencies’ diligence in the review, but expressed concern that the recommendations were not commensurate with the scope of reform called for by the 21st Century Cures Act [see Washington Highlights, Feb. 21, 2019]. The final report reflects the incremental changes proposed in the earlier draft, but nevertheless commits to important reforms that will be implemented, some through rulemaking, over the next year.