Unanticipated problems in research include events that are both serious and unanticipated and require IRB review to determine if the event is serious or represents continuing non-compliance with research requirements.
Unanticipated Problems can include protocol deviations, adverse events or any other occurrence that may identify unanticipated risks to subjects or others or indicate other problems in the research.

The IIRB, Inc. has a comprehensive listing of criteria to assist the Principal Investigator in identifying unanticipated problems in research and has completed a form for reporting potential unanticipated problems. To view this listing please review the Unanticipated Problems section of the Investigator’s Guidebook.

To submit an unanticipated problem complete the
Unanticipated Problem Form.