SUBJECT:  Subject Compensation

Payment to research subjects for participation in studies is not considered a benefit.  Rather, it should be considered compensation for time and inconvenience or a recruitment incentive. The amount and schedule of all payments should be presented to the HRAC at the time of initial review. The HRAC should review both the amount of payment and the proposed method and timing of disbursement to assure that neither are coercive nor present undue influence.

1. Timing of Payments.  Credit for payment should accrue as the study progresses and not be contingent upon the subject completing the entire study. The subject should be paid in proportion to their time and inconvenience as a result of participation in the research study. Unless it creates undue inconvenience or a coercive practice, payment to subjects who withdraw from the study may be paid at the time they would have completed the study (or completed a phase of the study) had they not withdrawn.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days, an HRAC may find it permissible to allow a single payment date at the end of the study, even to subjects who had withdrawn before that date.

2. Completion Bonus.  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, providing that such incentive is not coercive. The HRAC 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is reasonable and not so large as to unduly induce subjects to stay in the study when they would otherwise have withdrawn.

3. Disclosure of Payments.  All information concerning payment, including the amount and schedule of payment(s) should be set forth in the informed consent document.

4. Advertisement of Payments.  Advertisements may state that subjects will be paid or compensated, but should not emphasize the payment or the amount to be paid, by such means as larger or bold type.

Alterations in Payments.  Any alterations in human research subject payment or liberalization of the payment schedule must be reported to the HRAC prior to implementation as an amendment.