AI Meets Informed Consent: Opportunity, Risk, and What IRBs Need to See

Protecting research participants while advancing science requires more than regulatory checklists—it demands thoughtful oversight, clear communication, and ethical decision-making at every stage of study design and review. This webinar brings together three seasoned leaders in human research protections to explore how IRBs, investigators, and sponsors can better align compliance, ethics, and participant understanding.

Raffaella Hart, MS, CIP, draws on more than 25 years of IRB and IBC leadership to share practical insights into maintaining high-quality review processes and sustaining accreditation in a complex regulatory environment. Catina O’Leary, PhD, MSW, adds a critical lens on health literacy, highlighting how informed consent and participant-facing materials can be strengthened to improve comprehension, trust, and equitable participation. Moderated by Lindsay McNair, MD, MPH, MSB, the discussion connects regulatory rigor with real-world research operations, ethical policy development, and participant protections.

Attendees will gain actionable perspectives on improving protocol quality, enhancing consent practices, and navigating evolving expectations in human subjects research. Join this conversation to deepen your understanding of how ethics, literacy, and oversight intersect in today’s clinical research landscape.