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HHS Issues Notice of Proposed Revised Regulations to Protect Participants in Research Studies

Posted by on September 3rd, 2015 Posted in: Announcements, Consumer Health, General


The U.S. Department of Health and Human Services (HHS) has issued a Notice of Proposed Rule Making (NPRM) to revise the Common Rule for the protection of human participants in research. It is now posted on the Federal Register’s public inspection website and will appear on Tuesday, September 8, in the printed version of the Federal Register for a 90-day public comment period. The major reforms propose to: 1) calibrate oversight to level of risk; 2) enhance respect for research participants; 3) facilitate broad participation in research; 4) increase privacy and security safeguards for research with biospecimens and data; 5) simplify consent documents; and 6) streamline IRB review. All interested stakeholders are encouraged to review the proposed revisions and make comments.

Image of the author ABOUT Alan Carr
Alan Carr is the Associate Director, National Network of Libraries of Medicine, Pacific Southwest Region, based at UCLA.

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