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What is a reportable event?

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 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);
  2. Related or possibly related to participation in the research; and
  3. Suggests that the research places subjects or others at a greater risk of 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 at researchcompliance@siue.edu or by calling 618-650-3010. Please do not hesitate to call or email with any questions or concerns.