Research Adverse Events Committee

The purpose of Research Adverse Events Committee (RAEC) is to screen serious events, both internal and external, and to make recommendations to the Institutional Review Board regarding changes to informed consent forms or protocols.

All serious adverse events must be reported using the on-line Adverse Event Reporting System. Serious internal events that are both expected and related or that are unexpected must be reported within five working days of becoming aware of the event. External serious events that are unexpected must be reported within ten working days of becoming aware of the event.

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

The following types of adverse events must also be reported in summary format at the time of continuation.  The IRB has developed an adverse event reporting template that may be used for such reporting.

• internal, non-serious, unexpected, only if related to the study

• internal, serious, expected

• internal, serious, unexpected (required at continuation even though previously reported)

• external, serious, expected

• external, serious, unexpected

• all deaths

The current membership of the RAEC is as follows: