University of Vermont

Human Subjects Research - Institutional Review Boards - IRBs


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 through InfoEd.

Safety and Protocol Deviation Review Materials

Last Updated

Unanticipated Problem or Noncompliance Potentially Involving Risk to Subjects or Others


New Safety Information Not Affecting Risk to Subjects or Others


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
-UVM Medical Center Safe Report
-FDA Medwatch Form
-If HIPAA deviation, copy of correspondence to UVM Medical Center HIPAA Privacy Officer

Last modified August 02 2017 01:15 PM

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