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AAMC Responds to HHS Proposed Update of Rules Governing Human Subjects Research

October 28, 2011—The AAMC Oct. 25 submitted  a response to the Department of Health and Human Services (HHS) proposal to revise the regulations that govern federally-supported research involving human subjects, known as the Common Rule.

The AAMC letter supports the proposals to streamline the initial and continuing review of research and to improve the informed consent requirements to make the process more meaningful to research subjects. The AAMC also provides HHS with feedback on how the proposals to standardize data security protections and to ensure meaningful review of large multi-site trials could be revised to reduce unintended consequences for institutions and research subjects.

The advance notice of proposed rulemaking (ANPRM), which was announced on July 22 and published in the July 26 Federal Register, set forth the department’s intent to strengthen the protections for human subjects while recognizing that the categories of research being conducted, the prevalence of multisite trials, and the types of data being collected have changed dramatically in the 20 years since the Common Rule was adopted [see Washington Highlights, July 29].

The notice requested comment on a number of broad issues, including revising the existing risk-based framework to more accurately calibrate the level of review to the level of risk; updating the forms and processes used for informed consent; and providing uniform guidance on federal regulations.  In the Sept. 1 Federal Register, HHS extended the comment period to Oct. 26 “to allow sufficient time for a full review of the ANPRM.”


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

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