There is a new clarification to the IRB reporting criteria for Gene Transfer protocols. The guidance clarifies that SAE’s that meet the criteria for an Unanticipated Problem (unexpected, related to the research and harmful) need to be promptly reported to the IRB. Please refer to the IRB Prompt Reporting Guidance for further information. All adverse events (expected events and other unrelated events) still need to be reported to the IRB at the time of continuing review.
Please note that this clarification is ONLY for IRB reporting. Other reporting as required by the Biosafety Panel or other departments should continue as directed.
Feel free to contact Shana Stolarczyk, Senior IRB Manager, Panel 1, if you have any questions.