What Do I Report?

What Issues & Events Do I Need to Report to the IRB?

Unanticipated Problems & Noncompliance

 

Certain problems that occur during the conduct of the research must be promptly reported to the IRB. In general, any event that is unexpected, related or possibly related to participation in the research, and suggests that the research places subjects or others at greater risk, including physical, psychological, economic, or social harm, must be promptly reported to the IRB.

Any unanticipated problem associated with a study must be reported to the IRB Office within 5 working days of notification.

To report an unanticipated problem to the IRB use the Prompt Reporting Form located on the Forms page.

Noncompliance

All noncompliance must be promptly reported to the IRB. Noncompliance is any action or activity associated with the conduct or oversight of research involving human subjects that fails to comply with federal or state regulations, or institutional policies governing human subjects research or the requirements or determinations of the IRB.

Any noncompliance associated with a study must be reported to the IRB Office within 5 working days of notification of the event.

To report Noncompliance to the IRB use the Noncompliance Reporting Form located on the Forms page.