On August 5, 2021, PRIM&R hosted a webinar entitled IRB Review of Expanded Access Protocols that Collect Real World Data: Considerations and Guidance. During this webinar, Alison Bateman-House, PhD, MPH, MA (a bioethicist) and Hayley Belli, PhD, MS (a biostatistician), from the NYU Grossman School of Medicine Working Group on Compassionate Use and Preapproval Access, discussed ethical and analytical considerations when collecting real world data from Expanded Access. In this document, speakers provide further discussion on questions and topics raised in the webinar.