AAMC (Association of American Medical Colleges) President and CEO Darrell G. Kirch, MD, issued the following statement on the release of regulations governing federally supported research involving human subjects, known as the Common Rule, by the Department of Health and Human Services (HHS) and 15 other federal agencies:
“The long-awaited revisions to the Common Rule were issued as a final rule, but they cannot be the final step in achieving the agencies’ commendable goals. The AAMC hopes that HHS and other agencies implement these changes in a way that truly engages patients and populations, protects human subjects, and facilitates important, ethical research.
With member institutions that conduct more than 50 percent of the extramural research funded by the National Institutes of Health (NIH), the AAMC has long promoted the need to substantially revise the Common Rule to appropriately protect and engage human subjects, to better reflect changes in the research landscape, and to harmonize regulations across agencies. A strong and effective regulatory framework promotes public trust in the research community, provides clarity to researchers and institutions, and increases an individual’s ability to make an informed decision about participating in research.
The final regulation is much improved from the proposed rule, and provides some welcome and overdue changes that decrease unnecessary burdens and delays for researchers and institutions. We appreciate that HHS took into account our comments—and those of many others—regarding the regulation of biospecimens, and did not include these burdensome and ineffective provisions in the final rule. We are also pleased that the agency responded to criticism that the proposed rule lacked flexibility and the ability to adapt over time.
The AAMC remains concerned about the provision requiring that institutions conducting cooperative research rely on a single institutional review board, or IRB. We hope that the implementation of this provision by the relevant agencies over the next three years is marked by the flexibility suggested by the final rule text and informed by the experiences of research institutions as they work to put in place a similar policy from the NIH.
We had hoped that the first changes to this regulation in more than a quarter of a century would better capitalize on the opportunity to clarify and improve the rule to truly modernize regulations that must adapt for a changing world of big data, learning health systems, and public engagement.
While this new rule is a good first step, the AAMC looks forward to working with HHS to achieve these goals while also protecting human subjects and furthering research that advances discovery 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 152 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.