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.

Speakers:

Raffaella Hart, MS, CIP | Sr. Vice President, IRB and IBC Services, BRANY

Raffaella Hart, MS, CIP, serves as Senior Vice President at BRANY, where she leads the organization’s IRB, IBC, and Quality Assurance services. A Certified IRB Professional (CIP) with over 25 years of experience in IBC and IRB administration, she was instrumental in achieving and maintaining BRANY IRB’s full AAHRPP accreditation. Hart holds a Master of Science in Healthcare Science with a focus in Clinical Research Administration from The George Washington University and a B.S. in Psychobiology from Binghamton University.

Catina O'Leary, PhD, MSW | President & CEO, Health Literacy Media

Catina O'Leary, PhD, MSW, is President & CEO of Health Literacy Media. Dr. O’Leary has led the organization's growth into a globally recognized leader in health literacy and science communication. A licensed master social worker, she brings extensive experience in community-based research, multi-site clinical trials, and IRB protocol development, including service on the Human Research Protection Office's continuing review committee at Washington University School of Medicine. Dr. O'Leary is a Founding Member and Treasurer of the United States Health Literacy Association and Secretariat of the International Health Literacy Association.

Lindsay McNair, MD, MPH, MSB - Moderator | Principal Consultant, Equipoise Consulting

Lindsay McNair, MD, MPH, MSB, is Principal Consultant at Equipoise Consulting. Previously, Dr. McNair was the Chief Medical Officer for WCG, including the WCG IRB. With more than 25 years of experience in drug development, she provides consultation to biopharma and healthcare institutions on issues related to protocol design, regulatory compliance, human participant protections, and ethical policy development. Dr. McNair has an MD from the University of CT, an MPH (epidemiology/biostatistics) from Boston University, and an MSBioethics (research ethics) from Union Graduate College.