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Washington Highlights

HHS Extends Comment Period on OHRP Draft Standard of Care Research Guidance

December 19, 2014—The Department of Health and Human Services (HHS) Dec. 19 announced a 30 day extension of the comment period for draft guidance on appropriately assessing risks to human subjects involved in research that compares current “standard of care” medical practices. The AAMC Nov. 18 submitted a letter to the Office for Human Research Protections (OHRP), requesting a 60 day extension for comments on this draft guidance [see Washington Highlights, Nov. 21].

The document titled “Guidance on Disclosing Reasonably Foreseeable Risks in Research Evaluating Standards of Care,” is described in the Oct. 24 Federal Register and is available on the OHRP website [see Washington Highlights, Oct. 24].

The announcement of the extension will be published in the Dec. 22 Federal Register. The new deadline for comment submission on the draft guidance is January 22, 2015.

Comments must be submitted to OHRP or at


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