Congressional Subcommittee Examines Impact of Regulatory Burden on Research

AAMC (Association of American Medical Colleges) President and CEO Darrell G. Kirch, MD, issued the following statement in response to the U.S. House Committee on Science, Space, and Technology Subcommittee on Research and Technology hearing, "Academic Research Regulatory Relief: A Review of New Recommendations:"

“The AAMC commends the subcommittee for convening a hearing to examine potential solutions to the expanding regulatory and administrative requirements that burden researchers and institutions. These requirements have the potential to slow advancements in basic and medical research that provide hope to millions of Americans and their families who are facing life-changing illnesses like cancer, Alzheimer’s, diabetes, and many more.

The hearing raised a number of issues important to medical research, such as the proposed revisions to the Department of Health and Human Services’ Common Rule—which governs federally funded research with human subjects—and the cost and burden of financial conflict of interest reporting regulations.

The bold recommendations of a recent National Academies of Sciences, Engineering, and Medicine report included creating a Research Policy Board to anticipate the impact of future regulations, and withdrawing proposed revisions to the Common Rule. The report’s critique of the new approach to the Common Rule echoes the AAMC’s concerns about a rule that virtually prohibits all research with unidentified biospecimens without written consent. This change would increase administrative burden and cost without enhancing protections or engaging research participants in a meaningful way.

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 conducting 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.

The Association of American Medical Colleges is a not-for-profit association dedicated to transforming health care through innovative medical education, cutting-edge patient care, and groundbreaking medical research. Its members are all 154 accredited U.S. and 17 accredited Canadian medical schools; nearly 400 major teaching hospitals and health systems, including 51 Department of Veterans Affairs medical centers; and more than 80 academic societies. Through these institutions and organizations, the AAMC serves the leaders of America’s medical schools and teaching hospitals and their more than 173,000 full-time faculty members, 89,000 medical students, 129,000 resident physicians, and more than 60,000 graduate students and postdoctoral researchers in the biomedical sciences.