Federal regulations and OHRP and FDA guidance require the PI, sponsor or CRO to report any unanticipated problem involving risk to human subjects or others (UPs) to the IRB.
Each report will be reviewed and follow-up information may be required.
Unanticipated problems are events that are (FDA regulated):
- Serious; and
- Have implications for the conduct of the study (e.g., protocol amendment, revised informed consent, new or modified safety monitoring, change of inclusion/exclusion criteria).
Unanticipated problems are events that are (non-FDA regulated):
- Related or possibly related to research; and
- Suggests that the research places the subject or others at increased risk for harm.
- Breaches of subject confidentiality
- Unanticipated additional cost to study subjects
- Unanticipated legal risk to a subject
- Adverse events of greater frequency or severity than originally anticipated.
The sponsor/CRO must use their judgment to determine whether a specific event meets the above criteria for a UP. Please refer to the Subject Safety Reporting Decision Chart for further assistance.
UPs must be reported to the Board within 10 business days of the site becoming aware of the problem. However, if the UP involves a death it must be reported within 24 hours of discovery. Use the Subject Safety Report to submit a UP to the Board. Acknowledgment of receipt will be provided to the submitting party via e-mail.