G12 - [IN-PERSON ONLY] Recent Updates from FDA Guidances on Informed Consent and IRB Review for Expanded Access Use of Investigational Drugs

This session is being held in-person only at PRIMR23. It will not be recorded for on-demand access or for the PRIMR23/SBER23 Virtual Meeting.

In this session, IRB and FDA representatives will discuss recent updates from FDA guidances on the regulatory requirements and timing for FDA and IRB review and obtaining informed consent from patients receiving experimental treatment under different categories of expanded access. The key elements of an FDA informed consent template, which physicians and institutions may use to model their forms for obtaining informed consent, will be shared. The discussion on IRB review for expanded access use of investigational drugs will focus on regulatory requirements, the process for requesting an FDA waiver from full board IRB review, and FDA’s recommendations for IRB review procedures, including factors to be considered by the IRB during review of individual patient expanded access requests.