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    Reducing Regulatory Burden

    May 6, 2019

    Latest Updates

    May 6, 2019 - The White House National Science and Technology Council announced the formation of a joint committee that will examine issues related to "administrative burdens on federally-funded research, protecting American research assets, rigor and integrity in research and the existence of safe, inclusive and equitable research settings." The committee is co- chaired by the White House Office of Science and Technology Policy, leaders at the National Institutes of Health, the National Science Foundation, the National Institute of Standards and Technology, and the Department of Energy.

    Evidenced-Based Policymaking

    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 here.

    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 September 7, 2017, and drawing on recommendations in the final report, Speaker Paul Ryan (R-Wis.) and Patty Murry (D-WA) on October 31, 2017, introduced the Foundations of Evidence-Based Policymaking Act. The legislation was passed by the House on November 15, 2017 and is awaiting vote in the Senate. AAMC's Comments to the Commission on Evidence Based Policymaking can be found here.

    Reforming Animal Research Regulations - On December 7, 2018 the National Institutes of Health (NIH) Office of Laboratory Animal Welfare (OLAW) issued a request for input on the draft report, Reducing Administrative Burden for Researchers: Animal Care and Use in Research (PDF). Mike Lauer, MD, NIH Deputy Director for Extramural Research, explains the background and purpose of the RFI in an Open Mike blog post.

    • February 20, 2019 - The AAMC submitted comments 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 21st Century Cures Act (P.L. 114-255). The AAMC's comments can be found here.

    • 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.

    • October 24, 2017 - The Federation of American Societies for Experimental Biology (FASEB), AAMC, the Council on Governmental Relations (COGR), and the National Association of Biomedical Research (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, AAMC, and COGR (with support from NABR) to "provide actionable recommendations for promoting regulatory efficiency, animal welfare, and sound science."
       

    National Academies of Sciences, Engineering and Medicine Report - The Academies June 2016 report, Optimizing the Nation's Investment in Academic Research - A New Regulatory Framework for the 21st Century (PDF), 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 AAMC's 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 December 13, 2016, providing significant funding for research initiatives at the National Institutes of Health (NIH) and 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 USDA and FDA, to review and revise regulations and policies governing the care and use of laboratory animals to reduce administrative burden.

    See below for additional information on 21st Century Cures and resources on presidential orders and memoranda on regulatory reform and reducing regulatory burden.

    Resources:

    21st Century Cures Act and Regulatory Burden

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    Executive Orders and Memoranda

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    For questions, contact Heather Pierce, JD, MPH, Senior Director, Science Policy and Regulatory Counsel at hpierce@aamc.org or (202) 478-9926 or Daria Grayer, JD, MA, Senior Lead Specialist, Science Policy and Regulations at dgrayer@aamc.org or (202) 741-5474.

    Last Updated: November 13, 2018

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