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    Reducing Regulatory Burden

    Many reports have identified a need for federal agencies to reduce administrative workload and costs for federally funded researchers and academic institutions to optimize the time and effort that researchers can spend conducting research. The AAMC’s efforts to streamline research regulations from federal agencies and promote the use of evidence-based policymaking are summarized below.

    AAMC Conflict of Interest (COI) Metrics Project

    The AAMC worked with member medical schools and teaching hospitals to measure the effect and effectiveness of the Department of Health and Human Services' (HHS’) final rule on financial conflicts of interest in federally funded research using aggregate data about participating institutions' conflict of interest review systems, disclosures made by investigators to the institution, and financial conflicts of interest identified and reported to federal funding agencies. Results from the COI Metrics Project were cited in the Government Accountability Office's June 2016 report, Opportunities Remain for Agencies to Streamline Administrative Requirements. Key results from the COI Metrics Project can be accessed in this 2015 Analysis in Brief.

    Commission on Evidence-Based Policymaking

    Through the bipartisan Evidence-Based Policymaking Commission Act of 2016 (P.L. 114-140), the Commission on Evidence Based-Policymaking was established and charged with examining ways to increase the use and availability of evidence to inform policy and regulatory decisions. The commission's final report was released on Sept. 7, 2017, and drawing on recommendations in the final report, Speaker Paul Ryan (R-Wis.) and Patty Murry (D-Wash.) on Oct. 31, 2017, introduced the Foundations of Evidence-Based Policymaking Act, which was signed into law on Jan. 14, 2019. The AAMC's comments to the commission can be found here (PDF).

    National Academies of Sciences, Engineering and Medicine Report

    The National Academies June 2016 report, Optimizing the Nation's Investment in Academic Research: A New Regulatory Framework for the 21st Century, examined the impact of federal research regulations on research universities, finding “little rigorous analysis or supporting data precisely quantifying the total burden and cost to investigators and research institutions of complying with federal regulations specific to the conduct of federally funded research.” The report cites the AAMC COI Metrics Project as an example of how data can be used to quantify the impact and burden of research regulations on academic institutions.

    21st Century Cures Act

    The 21st Century Cures Act (H.R. 34, "Cures") was signed into law on Dec. 13, 2016, providing significant funding for research initiatives at the National Institutes of Health (NIH) and the Food and Drug Administration (FDA) to aid the acceleration of safe and effective new drugs and devices and enhance states' opioid response. Cures implements recommendations in Part 1 of the Academies' report such as the creation of a research policy board [Section 2034(f)] to modify and harmonize policies and regulations across federal agencies. Cures also requires the director of the NIH, in coordination with the U.S. Department of Agriculture and the FDA, to review and revise regulations and policies governing the care and use of laboratory animals to reduce administrative burden.

    Reforming Animal Research Regulations

    The AAMC works closely with partner scientific and higher education organizations in efforts to clarify and streamline reporting requirements for the care and use of animals in medical research.

    Oct. 22, 2023
    The AAMC submitted comments (PDF) to the NIH Office of Laboratory Animal Welfare (OLAW) on proposed changes to clarify OLAW’s Guidance Disclaimer

    Oct. 28, 2021
    The AAMC submitted joint comments (PDF) to NIH OLAW with the Council on Governmental Relations (COGR) and the National Association for Biomedical Research (NABR) on clarifying 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.

    Feb. 20, 2019
    The AAMC submitted comments (PDF) to OLAW in response to the draft report, Reducing Administrative Burden for Researchers: Animal Care and Use in Research. In its comments, the AAMC encouraged the agency to "take steps to reduce overlapping regulations and policies in animal care and use and improve coordination between agencies" as required by the Cures Act.

    March 14, 2018
    OLAW announced a request for information "to improve the coordination of regulations and policies with respect to research with laboratory animals" (comments due June 2018). The AAMC's comments to OLAW can be found here (PDF).

    Oct. 24, 2017
    The Federation of American Societies for Experimental Biology (FASEB), the AAMC, COGR, and NABR released the report, Reforming Animal Research Regulations: Workshop Recommendations to Reduce Regulatory Burden (PDF), addressing ineffective and outdated regulations that do not improve animal welfare. The report is the result of an April 2017 workshop organized by FASEB, the AAMC, and COGR (with support from NABR) to "provide actionable recommendations for promoting regulatory efficiency, animal welfare, and sound science."

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