The IRB requires PI to promptly report (within 5 days) a summary of reportable events (including unanticipated problems and deviations) using the Reportable Events Report in Cayuse IRB.  Examples of events that require reporting to the IRB include but are not limited to the following:

• Information that indicates a new or increased risk, or a new safety issue.
• Harm experienced by a subject or other individual, which in the opinion of the investigator are unexpected and probably related to the research procedures.
• Non-compliance with the federal regulations governing human research or with the requirements or determinations of the IRB or the institution, or an allegation of such non-compliance.
• Audit, inspection, or inquiry by a federal agency or any other outside entity and any resulting reports.
• Failure to follow the protocol whether planned or unplanned (deviations).
• Breach of confidentiality.
• Change to the protocol taken without prior IRB review to eliminate an apparent immediate hazard to a subject.
• Incarceration of a subject in a study not approved by the IRB to involve prisoners.
• Complaint of a subject that cannot be resolved by the research team.
• Premature suspension or termination of the protocol by the sponsor, investigator, or institution.
• Unanticipated adverse device effect.