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AAMC Submits Letter to OHRP to Extend Comment Period on Standard of Care Research

November 21, 2014—The AAMC submitted a Nov. 18 letter  to the Department of Health and Human Services (HHS) Office for Human Research Protections (OHRP), requesting a 60-day extension for comments on the draft guidance on appropriately assessing risks to human subjects involved in research that compares current “standard of care” medical practices. 

The draft 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The draft guidance follows a compliance oversight determination letter issued by OHRP following its investigation into a study looking at optimal oxygenation levels for severely premature infants and the subsequent debates in the research community about what constitutes risks that need to be disclosed to research participants when standard of care interventions are being compared.

The current deadline for comment submission on the draft guidance is Dec. 23, 2014. 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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