HHS "Draft Guidance on Disclosing Reasonably Foreseeable Risks in Research Evaluating Standards of Care" in Federal Register and IOM Ethics meeting on same issues Dec. 2-3

The long awaited guidance from OHRP (Office of Human Research Protections at HHS) was just published in the Federal Register last Friday(following the public hearing re SUPPORT trial August 28, 2013). The guidance is open for input until Dec. 23rd 2014. The Perinatal Section leadership wanted to make sure you are aware of this so you know about the issues and have the invitation to discuss and respond. (See attachment)

Secondly, the Institute of Medicine will also review and debate this issue in public meeting: This workshop is open to the public. To register to attend the workshop in-person, please go to:


 
http://www.surveygizmo.com/s3/1861442/Workshop-on-Ethical-Review-and-Oversight-Issues-in-Research-Involving-Standard-of-Care-Interventions-Attendee-December-2-3-2014.

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