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Second Opinion

Learn about policy issues important to medical schools and teaching hospitals, with Executive Vice President Atul Grover, M.D., Ph.D.

Washington Highlights

House Subcommittee Hearing on the Impact of Regulatory Burden on Research

September 30, 2016—The House Science, Space, and Technology Subcommittee on Research and Technology held a Sept. 29 hearing titled, “Academic Research Regulatory Relief: A Review of New Recommendations.”

The subcommittee discussed recommendations in a report issued by the National Academies of Sciences, Engineering and Medicine, “Optimizing the Nation’s Investment in Academic Research: A New Regulatory Framework for the 21st Century” and a report from the Government Accountability Office (GAO), “Opportunities Remain for Agencies to Streamline Administrative Requirements.”

The Academies report examines the expansion of the federal regulatory system and the related requirements, concluding that the unintended cumulative effect of the current regulatory system is diminishing the effectiveness of the nation’s research investment by directing investigators’ time away from research. The report notes that there’s little analysis and supporting data to determine the cumulative effect of regulations and cites the AAMC Conflict of Interest (COI) Metrics Project as an existing effort to quantify the burden of research regulations [see Washington Highlights, Sep. 25, 2015]. 

Witnesses at the hearing also referenced the Academies’ recommendation to suspend the proposed revisions to the Department of Health and Human Services’ (HHS) Common Rule, which governs federally-funded research with human subjects. The report states the Common Rule does not “adequately or effectively address the breadth, depth, and import of unanswered questions and contemporary challenges related to human subjects research.” This supports the AAMC’s concern that certain aspects of the proposed revisions, specifically the provision that requires consent for all research involving biospecimens, would increase administrative burden and cost without providing meaningful protections for research participants [see Washington Highlights, Jan. 8]. The Academies recommended that a new commission be established to reconsider the process for protecting and engaging human subjects in research.

During the hearing, GAO Natural Resources and Environment Team Director John Neumann discussed the GAO’s recommendations for streamlining administrative requirements related to federal research grants and their administrative workload and costs. The GAO report also cites the COI Metrics Project in reference to HHS’s efforts to measure the effectiveness of financial conflicts of interest requirements and identify areas of administrative burden.

In response to the hearing, AAMC President and CEO Darrell G. Kirch, MD, issued a press release stating, “The AAMC is supportive of the work that has gone into these recommendations and sees the potential to regulate research more efficiently to allow researchers to spend more time doing research. We look forward to working with policymakers to develop a regulatory framework that provides both clarity and flexibility to institutions, investigators, and research subjects, and advances ethical research to improve the health of all.”

Contact:

Heather Pierce, JD, MPH
Sr. Director, Science Policy & Regulatory Counsel
Telephone: 202-478-9926
Email: hpierce@aamc.org

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Washington Highlights, a weekly electronic newsletter, features brief updates on the latest legislative and regulatory activities affecting medical schools and teaching hospitals.


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Jason Kleinman
Sr. Legislative Analyst, Govt. Relations
Telephone: 202-903-0806
Email: jkleinman@aamc.org