Researchers and the IRB must:

• ensure participants are recruited fairly, informed adequately, and paid equitably (i.e., payment amount is commensurate with the time and effort required for participation)
• ensure the rewards offered for participation in research do not cause undue enticement
• ensure the amount paid as a bonus for completion is reasonable and not so large to coerce participants to stay in the study when they would have otherwise withdrawn

Payment that is excessive or inappropriate in relation to the research procedures is problematic. Individuals may participate against their better judgment. Individuals may be encouraged to lie or to withhold information to participate in the study when they do not meet the eligibility criteria. This impacts not only the integrity of the research and the validity of the data but can also compromise the safety of subjects. Inappropriate payment can also create coercive situations when given to third parties. Offers that are excessive or overly attractive may:

• distort the perception of risks for participation in a study
• impair a prospective participant's ability to exercise proper judgment
• prompt prospective participants to lie or conceal information that, if known, would make them ineligible to enroll in the research

Assessing the appropriateness of an incentive or payment may require consideration of the prevailing payment practices within an institution or general locale, or among a particular research population. For example: A $100 incentive to physicians for a one-hour focus group during the work day may be considered an appropriate incentive. A $100 incentive to high school students to participate in the same focus group may not be appropriate.

Payment for participation in research that involves the assumption of risk or significant discomfort requires a thorough assessment. The following questions may be useful for researchers and the IRB to assess the appropriateness of payment for greater than minimal risk research:

1. Are the conditions for research participation consistent with standards for voluntary and informed consent?
2. Are the incentives/payments offered reasonable given the participant population and the complexities, inconveniences, and risks of the study?
3. How likely is it the incentives/payments may induce an individual to participate when she/he/they might otherwise not volunteer?
4. Are there special standards the IRB ought to apply to the review of research in which volunteers are asked to assume significant risk?
5. Should the IRB monitor participant recruitment or consent to evaluate whether the incentives/payments may be a disproportionate inducement to prospective participants?

For studies involving multiple contacts or a lengthy time commitment, payment should accrue as the study progresses (as appropriate to the research). Participants who withdraw before completing the study would receive the amount earned according to time spent in the research. Completion of a research activity may not be a criterion for payment, except for small, non-coercive bonuses added as an incentive to accrued payments.

Researchers must describe the amount, distribution schedule and processes for incentives/payments in the appropriate researcher form at the time of initial review, or in a protocol amendment if an inventive/payment is being added to an approved study. This requirement applies to all review levels: exempt, expedited, and full committee.

Policy:

Participants must be accurately informed through the consent process about any payment/incentive for participation. If or when questions or complaints arise regarding payment, the consent form becomes the source document for the information that was provided to participants. The information about incentives/payment should be clear, detailed, and consistent with the protocol. The following information must be disclosed to prospective participants prior to enrollment:

• amount of incentives or payments, including the approximate value of non-cash gifts
• payment schedule
• the odds of winning (if incentives/payments will be in the form of a drawing)
• participant requirements to receive incentives/payments (including if receipts are required for reimbursable expenses)
• conditions under which payment will be reduced (e.g., participant withdraws part way through the research)
• institutional requirements for the researchers to report participant information to disburse payment.