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Additional Guidance and Resources:

• OHRP Reporting to OHRP: Unanticipated Problems (2020)
• OHRP Unanticipated Problems Involving Risks & Adverse Events Guidance (2007)
• FDA Guidance for Clinical Investigators, Sponsors, and IRBs Adverse Event Reporting to IRBs — Improving Human Subject Protection
• “Reporting research related events or new information to the IRB.” (Chapter 9). In NIH Investigator Manual for Human Subjects Research

Presentations:

• OHSRP Education Series presentation: Reporting Research Events and Non-compliance in Human Subjects Research (2019) (Slides and Videocast)