Regulatory Concern

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).