What should the IRB/IEC review regarding participant compensation in trials?

• A. The sponsor's responsibilities include determining compensation.
• B. The IRB/IEC should review the amount and method of payment to ensure there is no coercion or undue influence on participants.
• C. Payments should be withheld until the trial is completed.
• D. Compensation must be the same for all participants regardless of participation.

Answer: (B)

Compensation for trial participants must be evaluated to prevent coercion or undue influence. The IRB/IEC reviews how much is paid and how it is given, making sure the amount is fair for the time, procedures, and inconveniences involved, and that the payment method doesn’t push people to take part for financial reasons they wouldn’t otherwise consider.

This means payments should reimburse reasonable expenses and fairly compensate for time and burden, but they shouldn’t be so large or so immediate that they unduly sway someone to enroll or stay in a study despite risks or downsides. The IRB also considers how payments are dispensed—whether upfront, per visit, or after completion—and aims for a process that respects voluntary, informed decision-making without pressuring participants.

Other options aren’t correct because the sponsor may propose a compensation plan, but the IRB/IEC must review and approve it to ensure ethical safeguards are in place. Withholding payments until the end is not a universal rule and could be coercive in some contexts, and paying everyone the same amount regardless of differing burdens or risks isn’t required or always appropriate, since compensation should reflect time and potential inconveniences, which can vary across participants.