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OHRP Issues Draft Guidance on Disclosing Risks of Standard of Care Research

October 24, 2014— The Office for Human Research Protections (OHRP) Oct. 24 released draft guidance on appropriately assessing risks to human subjects involved in research that compares current “standard of care” medical practices.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 will be available on the OHRP website.

The widely anticipated draft guidance follows a compliance oversight determination letter issued by OHRP following its investigation into a study looking at optimal oxygenation levels for severely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.

An Aug. 28, 2013, public meeting was held on this topic.  Prior to that meeting, AAMC submitted a letter to OHRP  emphasizing that the risks inherent in the standards of care being researched should not be conflated with the risks inherent in research itself and expressing concerns with the potential “chilling effect” on critical research that provides an evidence base for clinical decision-making [See Washington Highlights, Aug. 9, 2013].

Comments on the new draft guidance must be submitted to OHRP or at by Dec. 23, 2014.


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