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  • Washington Highlights

    National Academies Releases Recommendations for a New Regulatory Framework for Research

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

    The National Academies Sept. 22 released a report titled, “Optimizing the Nation's Investment in Academic Research: A New Regulatory Framework for the 21st Century, Part 1.” The report details the expansion of the federal regulatory system and associated requirements, and concludes that the current regulatory framework is diminishing the effectiveness of the nation’s research investment by directing investigators’ time away from research and toward administrative duties.

    The findings presented are the result of a congressionally mandated study carried out under the Academies’ Committee on Science, Technology, and Law (CSTL) and the Board of Higher Education and Workforce (BHEW) to identify actions that would reduce regulatory burden on the research enterprise.

    The report notes that the cumulative effect of regulations is difficult to determine due to a lack of empirical data. Existing efforts to quantify the burden of research regulations are cited, including the AAMC Conflict of Interest Metrics Project, which collects annual aggregate data from institutions to understand the impact of the U.S. Department of Health and Human Services’ final rule on financial conflicts of interest.

    To address issues resulting from the current regulatory framework, the report lists specific actions to be taken by Congress, the White House Office of Management and Budget, federal research agencies, and research institutions, in four overarching recommendations:

    • The research regulatory regime (comprising laws, regulations, rules, policies, guidances, and requirements) should be critically reexamined and recalibrated;
    • Universities must foster a culture of integrity and accountability and demand the highest standards in individual and institutional behavior;
    • Inspectors General responsibilities should give consideration to both uncovering waste, fraud, and abuse, and to advising on economy, efficiency, and effectiveness; and
    • The creation of a new entity, a government-linked Research Policy Board, and a new Associate Director for Academic Research Enterprise in the White House Office of Science and Technology Policy, to foster a more effective conception, development, and harmonization of research policies.

    The release of the report was expedited due to a request from Senate Health, Education, Labor, and Pensions (HELP) Committee Chair Sen. Lamar Alexander (R-Tenn.), to identify actions to reduce regulatory burden. In response to the report, Chairman Alexander stated, “This report has specific steps Congress and the administration can take to fix this problem, and we intend to include many of the recommendations in legislation we will introduce this year to speed innovation in health care.”