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Human Subjects Division (HSD)

Regulatory Updates

OHRP: Guidance on Reporting Incidents to OHRP

Jul 5, 2011 at 11:40am
OHRP has posted on its website a finalized guidance document entitled, "Guidance on Reporting Incidents to OHRP." This guidance replaces OHRP's May 27, 2005 guidance entitled "Guidance On Reporting Incidents To OHRP" (http://www.hhs.gov/ohrp/compliance/reports/index.html). This guidance has been updated to clarify what information regarding serious or continuing noncompliance by the institutional review board needs to be reported, and to update OHRP's contact information.  We are also pleased to announce a new email box for sending incident reports.  The address is IRPT.OS@hhs.gov. We encourage institutions to submit incident reports to this email address, PDF or Word format preferred.