Reporting Adverse Events

Unexpected research-related injuries, adverse events, or breaches of participant confidentiality must be reported immediately in Cayuse. The MTSU IRB requires researchers to report the adverse event through Cayuse within 24-48 hours of detection. Subsequently, the PI or faculty advisor must complete the adverse event report form in the Cayuse system.

The Office of Compliance will take remedial action once the report is made. Depending on the event, the protocol may be suspended, amended with restrictions, or revoked, with additional recommendations if negligence or purposeful misconduct is identified.