As preclinical science shifts away from traditional animal models toward New Approach Methodologies (NAMs)—including AI-driven modeling, organoids, organ-on-chip systems, and human-based data—IRBs are increasingly asked to evaluate protocols supported by unfamiliar forms of evidence. This session examines how evolving FDA expectations and emerging scientific approaches are reshaping what counts as sufficient preclinical support and how IRBs should assess risk, uncertainty, and participant protections in this new landscape.
Through practical examples and applied discussion, speakers will equip attendees to evaluate AI-assisted and human-based preclinical data, identify key ethical and regulatory considerations, and make defensible review decisions as NAMs become more integrated into the research enterprise.