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ACP supports National Academies’ call for withdrawal of NPRM for ‘Common Rule’ and for appointing new commission

Philadelphia, July 12, 2016 -- Nitin Damle, MD, MS, FACP, president of the American College of Physicians (ACP), issued the following statement about Optimizing the Nation's Investment in Academic Research: A New Regulatory Framework for the 21st Century, a report issued by the National Academies of Sciences, Engineering, and Medicine (the Academies). The report includes a recommendation to withdraw the Notice of Proposed Rulemaking (NPRM) for the “Common Rule” (formally known as the Federal Policy for Protection of Human Subjects) and calls for a commission to examine the protection of human subjects in research.

“The American College of Physicians supports the Academies’ recommendations to withdraw the Notice of Proposed Rulemaking for the ‘Common Rule’ and to form a commission to examine the protection of human subjects in research.

In ACP’s comments submitted to the U.S. Department of Health and Human Services in December 2015, we found that the NPRM did not consistently prioritize enhancing protections for human subjects over reducing burdens for researchers. The patchwork approach and unclear language and concepts of the NPRM made it difficult to understand. Furthermore, the proposed changes did not seem likely to help build public trust and confidence in biomedical research.

To ensure that research meets ethical standards, new guidance is needed. While ACP shares the goals of the NPRM to modernize the regulations and make them more effective and efficient, this must be done in a manner that protects the welfare and interests of human subjects, putting patients-subjects first. ACP, for example, did not find the consent proposals in the NPRM for biospecimen research to be ethically sufficient and the proposals failed to give necessary weight to the importance of informational risks for, and harms to, subjects. This was in part because the NPRM also misinterpreted research ethics principles and the Belmont Report on which the original regulations were based.

If foundational principles of research ethics are to be applied in new ways, this must be done only after thoughtful debate that includes subjects, patients and their advocates, ethicists, researchers, professional societies, and other stakeholders. Therefore, ACP also agrees with the Academies’ recommendation for the appointment of a new commission to examine the regulatory framework for human subjects research.

ACP’s Ethics Manual provides guidance on protections of human subjects in research, and we would welcome the opportunity to work with the administration to assure that research is valid, has potentially important value, and is ethically conducted.”

The American College of Physicians is the largest medical specialty organization and the second-largest physician group in the United States. ACP members include 148,000 internal medicine physicians (internists), related subspecialists, and medical students. Internal medicine physicians are specialists who apply scientific knowledge and clinical expertise to the diagnosis, treatment, and compassionate care of adults across the spectrum from health to complex illness. Follow ACP on Twitter and Facebook.