As it relates to the need to report to the IRB, this would be an issue or incident of non-compliance with laws and regulation or to an incident or information that regulations require an IRB consider. In the ORIO guidance the term is used as a criterion for determining what kinds of submission should be sent to the IRB within 7 days. Examples include but are not limited to:
- Unanticipated problems.
- Deviations from the research in order to eliminate hazards to subjects or others.
- New information about safety concerns.
- Failure to obtain consent.
- Documenting informed consent of a non-English speaking/reading subject or the legally authorized representative of the subject on an English-only informed consent document.
- Improper training of study team (e.g., the PI did not require new staff, fellows, or students to complete the appropriate PEERRS human subject modules).