Rethinking Participant Payments In Clinical Trials: A Standardized Framework For Fair And Ethical Compensation

The conversation surrounding participant payments in clinical trials has long been fraught with inconsistency, raising questions about the role of Institutional Review Boards (IRBs), tax implications, and fair reimbursement structures. Mural Health is addressing these concerns through a standardized participant payment model that ensures ethical and equitable compensation while aligning with regulatory guidelines.

IRBs, following Health and Human Services (HHS) guidance, accept participant payments as ethical but caution against excessive incentives that could be coercive. Improper classification of payments can create financial burdens and even disqualify low-income participants from government benefits, ultimately affecting trial diversity. To counteract this, Mural Health’s model clearly delineates payment types: direct payments (non-taxable), reimbursements (non-taxable with documentation), prepayments (conditionally non-taxable), and stipends (taxable).

By prioritizing direct payments and reimbursements over stipends, the model minimizes out-of-pocket costs for participants, safeguards welfare eligibility, and enhances trial accessibility. Engaging IRBs early in the budgeting process ensures compliance and ethical transparency. This structured approach benefits sponsors and Contract Research Organizations (CROs) by reducing financial confusion, improving participant retention, and fostering more diverse trial populations.