Who’s the Real Participant? Broadening the Scope of IRB Considerations

Institutional Review Boards (IRBs) are designed to protect the rights and welfare of research participants, but they can sometimes overlook important groups—such as clinicians, consumers, or students—especially in studies that don’t follow the typical participant-researcher model.

In this session, Kate Saylor will explore how gaps in research ethics literature and regulations have led to these blind spots. Ken Richman will share evidence from chart review studies that often misidentify participants, and Kathy Zaiken will discuss the practicality of alternative strategies—like community deliberation and posted notices—for ensuring protections in real-world research settings.

The session will conclude with an audience discussion on how to shift thinking and implement new approaches without creating unnecessary administrative burden or weakening safeguards for patients.

Kate Saylor earned an MS in Neuroscience from Oregon Health & Sciences University, and a PhD in Public Policy from the University of North Carolina, Chapel Hill. Her work integrates ethics, simulation modeling and quantitative analysis to examine and advance health equity. She has written about the ethical values embedded in quantitative methods and developed arguments to support fair inclusion in medical research and equitable access to genomic medicine.