An unanticipated problem
is any event or information that was unforeseen and indicates that the research procedures caused harm
(including physical, psychological, economic, or social harm) to participants or others or indicates that participants or others are at increased risk of harm than was previously known or recognized.
Events that meet the definition of an unanticipated problem must be reported
to COMIRB within 5 days
of their occurrence. Click here
for a list of reportable problems.
Events that do not meet the definition of an unanticipated problem may be reported in summary form at continuing review, but need not be reported using the Unanticipated Problem Form. External safety reports and adverse events should be reviewed by the local PI prior to submission to determine whether the event meets the definition of unanticipated problem. For further guidance in reporting external events (events at an non-affiliated institution), refer to the Safety Report Decision Tree
Unanticipated problems are first reviewed by a COMIRB chair. The chair may note the report, require minor modifications, or defer the report to the Full Board for review. The investigator will receive notification of the chair's decision. If the report is deferred to Full Board, the investigator must respond to any questions raised by the chair, then resubmit for further review.
It is important to include as part of your submission:
- Communication from the sponsor (if applicable)
- IND Safety reports (if applicable)
- Revised Investigator Drug Brochure or Package Insert (if applicable)
- DSMB / DMC / Safety Officer reports (if applicable)