Payments and stipends for research participants remain one of the most debated—and misunderstood—elements of clinical trial design. While both the Common Rule and FDA regulations clearly permit participant payment, Institutional Review Boards (IRBs), sponsors, and sites often struggle to balance ethical safeguards with the practical realities of recruitment, retention, and participant burden.

This session brings together IRB decision‑making insights drawn from the analysis of 24,000+ consent‑form reviews with real‑world operational frameworks aimed at standardizing participant benefits beyond stipends alone. Together, the speakers will unpack the most common IRB‑requested payment modifications, highlight where well‑intended institutional policies may inadvertently create inequity or limit access, and share a modernized approach to building participant‑support packages that are ethical, transparent, consistent, and inclusive—especially for underrepresented communities.

Learning Objectives:

1. Differentiate ethical, regulatory, and operational considerations that shape participant payments and broader benefit structures, including how IRBs evaluate and modify payment language.
2. Identify common equity pitfalls—such as undue influence concerns, inconsistent institutional policies, or unclear consent‑form language—and apply evidence‑based strategies to avoid them.
3. Develop or refine a standardized participant‑support framework (covering stipends, reimbursements, convenience support, and non‑monetary benefits) that improves recruitment, retention, and participant trust while maintaining regulatory and ethical integrity.