The regulations at 45 CFR 46 for nonexempt research conducted or supported by the U.S. Department of Health and Human Services (HHS) require prompt reporting of incidents to OHRP. These incidents include the following:
- Unanticipated problems involving risk to subject or others
- Serious or continuing noncompliance
- Suspension or termination of IRB approval
On 27 July 2021, OHRP issued a new Incident Reporting Form and Instructions for completing the form.
Visit OHRP’s Reporting Incidents webpage.
