Graduate School

A reportable event is any event that the SIUE IRB determines is an unanticipated problem involving risks to subjects or other serious or continuing noncompliance with the federal regulations or IRB requirements. The IRB must be notified of any reportable event no later than 72 hours from the time of the identification of the unanticipated problem.

If SIUE is not the IRB of record, the reporting obligations detailed in the reliance agreement must be followed. Any unanticipated problem, deviation, suspension and termination, participant complaints, etc. shall be reported to the PI at the external institution acting as the IRB of record. The PI is responsible for reporting any issues to the external IRB. The external IRB of record will notify the SIUE IRB of any reports received.

The Office of Human Research Protections (OHRP) considers unanticipated problems, to include any incident, experience, or outcome that meets all of the following:

1. Unexpected (in terms of nature, severity, or frequency) given (a) the research procedures that are described in the protocol-related documents, such as the IRB-approved research protocol and informed consent document; and (b) the characteristics of the subject population being studied;
2. Related or possibly related to participation in the research(possibly related means there is a reasonable possibility that the incident, experience, or outcome may have been caused by the procedures involved in the research); and
3. Suggests that the research places subjects or others at a greater risk of harm (including physical, psychological, economic, or social harm) than was previously known or recognized.

For more information, please read the guidance here.

If you are a principal investigator (PI) on a project, you can submit a reportable event to the IRB in Kuali Research by going into your protocol and clicking “Reportable Events” at the top of the page.

A reportable event can also be submitted to the IRB by calling 618-650-3010 or by emailing [email protected].

If you are unsure if an event is reportable, please do not hesitate to contact SIUE Research Compliance at 618-650-3010 or [email protected].