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Human Subjects Division (HSD)

Regulatory Updates

OHRP: Two Guidance Documents on Multicenter Clinical Trials Archived

Jan 5, 2010 at 6:34am

OHRP has moved two guidance documents to its archive of guidance documents no longer in effect. The two documents are "Local IRB Review of Multicenter Clinical Trials" and "Local Institutional Review Board (IRB) Review of Multicenter Clinical Trials Sponsored by the Division of Aids (DAIDS) National Institute of Allergy and Infectious Diseases (NIAID)."

These documents have been archived because OHRP's policy regarding local IRB review has changed and they no longer represent OHRP's policy. OHRP policy continues to be that a reviewing IRB should have knowledge of the local context for studies it reviews, but that review by a local IRB is not favored over review by a non-local IRB.

All archived OHRP documents may be accessed on the OHRP Web site at: http://www.hhs.gov/ohrp/archive/policy/archive.html.