University of Vermont

Human Subjects Research - Institutional Review Boards - IRBs

forms_safety

Safety and Protocol Deviation Review Materials

The IRB must review all unanticipated problems that potentially affect risk to subjects or others.  Section 9.B of Research Manual has further information.  We will also acknowledge any new information not affecting risk. Submit one copy of the appropriate form for review.

Safety and Protocol Deviation Review Materials


Last Updated

Unanticipated Problem Potentially Involving Risk to Subjects or Others


05/15/14

New Safety Information Not Affecting Risk to Subjects or Others

05/15/14



Also include the following if applicable:

-Interim findings from sponsor potentially affecting risk
-Copy of DSMB meetings/minutes
-Corrective action plans when there are protocol deviations
-For adverse events attach pertinent medical information with subject name obscured
-FAHC Safe Report
-FDA Medwatch Form
-If HIPAA deviation, copy of correspondence to FAHC HIPAA Privacy Officer
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Last modified May 15 2014 02:29 PM

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