Commentary: FDA Guidance On Payment And Reimbursement To Research Subjects

This article examines FDA guidance on payment and reimbursement for clinical trial participants, with commentary highlighting key considerations for ethical and effective compensation. It clarifies that payments to participants — often used as recruitment incentives — are generally acceptable, but the Institutional Review Board (IRB) determines appropriate amounts and purposes, ensuring fairness without undue influence. Distinctions are made between stipends, which compensate for time, inconvenience, or discomfort and are taxable, and reimbursements for travel or related expenses, which are non-taxable and not considered coercive. Properly structured payments should be just, distributed fairly, and not contingent on study completion, though small completion bonuses may be permissible.

The article also emphasizes the importance of timely, flexible payment methods, and how reducing out-of-pocket burdens can support participant retention and trial diversity. Throughout, ethical principles such as justice are highlighted, noting that insufficient payments disproportionately impact participants with limited resources, potentially limiting trial accessibility.

By exploring these regulations, distinctions, and practical considerations, the piece provides insight into the complex landscape of participant compensation, the role of IRBs, and how thoughtfully designed payment structures can support clinical trial participation while maintaining ethical standards.