In addition to the information below, please see RPG03 Payments to Human Participants in Research for Penn State guidance on payment methods.
The Institutional Review Board (IRB) should determine that the risks to subjects are reasonable in relation to anticipated benefits and that the consent document contains an adequate description of the study procedures as well as the risks and benefits. It is not uncommon for subjects to be paid for their participation in research. Payment to research subjects for participation in studies is not considered a benefit, it is a recruitment incentive.
Financial remuneration is often used when health benefits to subjects are remote or non-existent. The amount and schedule of all payments should be presented to the IRB at the time of initial review. The IRB should review both the amount of payment and the proposed method and timing of disbursement to assure that either are coercive or present undue influence [21 CFR 50.20]. Any credit for payment should accrue as the study progresses and not be contingent upon the subject completing the entire study. Unless it creates undue inconvenience or a coercive practice, payment to subjects who withdraw from the study may be made at the time they would have completed the study (or completed a phase of the study) had they not withdrawn. For example, in a study lasting only a few days, an IRB may find it permissible to allow a single payment date at the end of the study, even to subjects who had withdrawn before that date. While the entire payment should not be contingent upon completion of the entire study, payment of a small proportion as an incentive for completion of the study is acceptable to FDA, providing that such incentive is not coercive. The IRB should determine that the amount paid as a bonus for completion is reasonable and not so large as to unduly induce subjects to stay in the study when they would otherwise have withdrawn. All information concerning payment, including the amount and schedule of payment(s), should be set forth in the informed consent document.