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Human Subjects Division (HSD)

Regulatory Updates

OHRP: Guidance on IRB Approval of Research with Conditions

Dec 2, 2010 at 6:28pm

OHRP has posted on its website a finalized guidance document entitled, "Guidance on IRB Approval of Research with Conditions." The guidance document provides OHRP's first formal guidance on this topic.  The guidance document finalizes the draft guidance that was made available for public comment through a notice in the Federal Register on November 6, 2009 (74 FR 57486). The public comments submitted on our draft document were very helpful to us as we finalized this guidance document, and we thank those of you who took the time to provide us with your feedback.

The finalized guidance document is available on the OHRP website at: http://www.hhs.gov/ohrp/policy/conditionalapproval2010.html or  http://www.hhs.gov/ohrp/policy/conditionalapproval2010.pdf.

The Federal Register notice announcing the availability of this new guidance document can be found at: http://edocket.access.gpo.gov/2010/2010-30201.htm or http://edocket.access.gpo.gov/2010/pdf/2010-30201.pdf.