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  • Washington Highlights

    HHS Releases Proposed Rule Revising Regulations for Human Subjects Research

    Heather Pierce, Senior Director, Science Policy & Regulatory Counsel

    The Department of Health and Human Services (HHS) Sept. 2 released a 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 HHS Office of Human Research Protections (OHRP) states that the proposed revisions will modernize, strengthen, and make more effective the Federal Policy for the Protection of Human Subjects. HHS lists the major issues addressed in the rule as:

    • Strengthened informed consent provisions;
    • Increased efficiency of institutional review board (IRB) review;
    • New standards for privacy and security;
    • Requirements for written consent for biospecimen use;
    • A mandate for a single IRB for multisite research studies; and
    • The application of the proposed rule to all clinical trials conducted at a U.S. institution that involves federal funding for research involving human subjects.

    HHS issued an Advanced Notice of Proposed Rulemaking (ANPRM) in July 2011, and the AAMC submitted a response in October 2011, supporting an overhaul of existing regulations.

    The proposed rule is scheduled to be published in the Federal Register on Sept. 8, when the docket will open for a 90-day public comment period.