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Per 45 CFR 46, the U.S. Department of Health and Human Services (HHS) requires organizations to report incidents such as unanticipated problems involving risk to subject or others, serious or continuing noncompliance, or suspension or termination of IRB approval. On 27 July 2021, OHRP issued a new Incident Reporting Form and Instructions for completing the form. Further, in September 2022, OHRP issued guidance entitled Reporting Incidents to OHRP (2022) that describes how to submit incident reports to OHRP and how OHRP reviews and processes the reports.