Which statement about payments to trial subjects is correct?

• A. The sponsor determines the payment amount
• B. Payments to a subject should be prorated and not wholly contingent on completion of the trial by the subject; the IRB should review amount/method to avoid coercion or undue influence
• C. Payments must be fixed upfront
• D. Payments contingent on completion only

Answer: (B)

Compensation for trial participation should fairly reflect the time and burden involved and must be reviewed by the IRB/IEC to prevent coercion or undue influence. The best approach is to prorate payments so participants receive compensation as they contribute time and effort, rather than waiting to the very end for a large sum. This also allows participants to withdraw without losing all compensation and reduces the pressure to stay in the study solely for payment.

The sponsor may propose a plan, but the IRB/IEC must approve the amount and method to ensure it’s fair and not coercive. Fixed upfront payment or making payment depend entirely on completion can create undue influence or keep people in a study against their best interests, which is why those options are not appropriate.