FAQ: How do I report an unanticipated problem?

Researchers must promptly report all unanticipated problems that may involve risk to subjects or others to the Michigan State University (MSU) Institutional Review Board.

In urgent situations, contact the IRB office to report the problem to the MSU IRB within 24 hours of knowledge of the event or sooner as appropriate.

For all other unanticipated problems that may involve risk to subjects or others, the unanticipated problem reporting form (clinical or non-clinical) with any pertinent supporting documents (e.g., study sponsor report, communications) should be completed and submitted by the investigator within 72 hours to the IRB.

More information can be found in the HRPP Manual Section 9-1, Unanticipated Problems Involving Risks to Subjects or Others.