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HHS Proposes to Update Rules Governing Human Subjects Research

July 29, 2011—The Department of Health and Human Services (HHS) July 22 announced that the department is proposing sweeping changes to the regulations that govern federally supported research involving human subjects.  Revisions to the regulations, known as the Common Rule, are intended to strengthen the protections for human subjects while recognizing that the categories of research being conducted, the prevalence of multi-site trials, and the types of data being collected have changed dramatically in the 20 years since the Common Rule was adopted. 

HHS issued the advanced notice of proposed rulemaking in the July 26 Federal Register, and the deadline for submission of comments is Sept. 26.  The notice requests comment on a number of broad issues, namely:

  • Revising the existing risk-based framework to calibrate more accurately the level of review to the level of risk;

  • Using a single Institutional Review Board review for all domestic sites of multi-site studies;

  • Updating the forms and processes used for informed consent;

  • Establishing mandatory data security and information protection standards for all studies involving identifiable or potentially identifiable data;

  • Implementing a systematic approach to the collection and analysis of data on unanticipated problems and adverse events across all trials to harmonize the complicated array of definitions and reporting requirements, and to make the collection of data more efficient;

  • Extending federal regulatory protections to apply to all research conducted at U.S. institutions receiving funding from the Common Rule agencies; and,

  • Providing uniform guidance on federal regulations.

In a July 22 statement, AAMC Chief Scientific Officer Ann Bonham, Ph.D., noted the HHS announcement “marks a significant step toward bringing the Common Rule into the 21st century, ensuring the safety and welfare of research participants while better enabling research that leads to innovations in health.”


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


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Washington Highlights, a weekly electronic newsletter, features brief updates on the latest legislative and regulatory activities affecting medical schools and teaching hospitals.

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Jason Kleinman
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Telephone: 202-903-0806