The HHS Office for Human Research Protections (OHRP) issued an updated guidance, titled Reporting Incidents to OHRP (2022) to replace 2011’s Guidance on Reporting Incidents to OHRP. It describes the submission and review processes, while providing recommendations and detailing specific requirements under HHS regulations at 45 CFR part 46.
Who is this guidance intended for?
This guidance is intended for IRBs, institutional officials, and organizations that review, oversee, or conduct human subjects research covered by an OHRP-approved assurance.
What issues does the guidance address?
The guidance examines the following topics:
- How to apply incident reporting requirements
- What to include in incident reports
- The time frame for reporting incidents
- How OHRP processes incident reports
- How to submit incident reports
- Additional relevant OHRP guidance
View the official page for the complete guidance and for more information including mini-tutorial videos on reporting to OHRP.