Research Adverse Events Committee

The Research Adverse Events Committee (RAEC) screens internal and external serious adverse events and makes recommendations to the Institutional Review Board (IRB) regarding changes to informed consent forms and/or protocols. the RAEC is advisory to the IRB and the IRB makes the final determination as to whether changes to the consent and/or protocol are required.

All investigators and study personnel must be familiar with the Adverse Event Reporting Policy (Word). Algorithms and samples for categorizing adverse events (Word) are also available to investigators and study personnel as guidance tools for reporting adverse events.

Serious adverse events that require expedited reporting must be filed using the on-line Adverse Event Reporting System. Serious internal events that are both expected and related or that are unexpected must be reported on-line within five working days (7 calendar days) of becoming aware of the event. External serious events that are unexpected must be reported on-line within ten working days (14 calendar days) of becoming aware of the event.

Once reported in the system, and with the opinion of the principal investigator noted, three individuals are automatically notified to review the event. The individuals are the Director of the Human Subjects Protection Office, the Research Compliance Monitor and the Research Subject Advocate. Each individual reviewer may either agree with the opinion of the principal investigator or refer the event to the RAEC for further review and discussion. The RAEC may then either agree with the opinion of the PI or refer the matter to the IRB with recommendations for changes.

The following table summarizes the reporting requirements or adverse events: