Reporting Adverse Events


Unexpected research-related injuries or adverse events experienced by research participants or breach of participant confidentiality must be reported immediately to the Office of Compliance.  The MTSU IRB requires researchers to initially report the adverse event through one or more of the following means within 48-72 hours after the event has been first detected.  Subsequently, the PI or the faculty advisor (if the student is the PI) must complete an adverse event report found in the "FORMS" section of the IRB home page.  

The Office of Compliance will initiate remedial action once the initial report is made.  If needed, the protocol will be temporarily suspended until further IRB directive is received.  Depending on the type of event and how the participants are affected, the IRB will add restrictions to the protocol or it may permanently revoke the study.  The IRB will also make appropriate recommendation to the concerned University office to take additional action if the researchers acted negligently or acted to cause the adverse event purposefully.