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AAMC Submits Comments to HHS on Common Rule NPRM

January 8, 2016—The AAMC Jan. 6 submitted comments  to the Department of Health and Human Services (HHS) in response to the Notice of Proposed Rulemaking (NPRM) to revise the 1991 regulations [45 CFR 46] that govern federally-supported research involving human subjects, known as the Common Rule.

The AAMC previously submitted a response [see Washington Highlights, Oct. 28, 2011] to the Advanced Notice of Proposed Rulemaking (ANPRM), supporting an overhaul of existing regulations. In the 25 years since the regulations were promulgated, the conduct of research has changed significantly in breadth, approach, technology, and complexity. The current process to update the rule presents a unique opportunity to effect meaningful change in the governance of research and protection of human subjects.

The HHS Office for Human Research Protections (OHRP) intends for the proposed revisions to “modernize, strengthen, and make more effective” the Federal Policy for the Protection of Human Subjects. The AAMC recognizes the effort that it took to come to consensus across 16 departments and agencies, but has strong concerns about the most significant changes to the Common Rule, namely the requirement to obtain consent for all research with unidentified biospecimens and the mandate that a single institutional review board (IRB) review and approve all multi-site research. Among other provisions, the AAMC does not support the NPRM approach of revising the definition of human subject as a means to ensure that all research with biospecimens, whether or not otherwise identifiable, is covered by the Common Rule.

The AAMC notes it is essential that a regulatory framework provide both clarity and flexibility to institutions, investigators, and research subjects. Given the limitations of the NPRM as currently written, the AAMC recommends “revisiting or withdrawal of these proposals and the overall simplification of the proposed rule,” stating that “the increase in administrative burden and cost, the complexity of the proposed rule which is already raising disagreements about its intent and requirements, and the lack of flexibility in the proposed rule’s mandates lead the AAMC to conclude that the proposed changes will not achieve the objectives of the NPRM.”


Heather Pierce, JD, MPH
Sr. Director, Science Policy & Regulatory Counsel
Telephone: 202-478-9926


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