Compensation for Research Participation

There are different types of payments in research:

• Reimbursement covers expenses (e.g., travel, parking)
• Compensation reflects time and effort
• Completion Bonuses are additional payments intended to encourage participation or completion

While payment is allowed, it must not pressure individuals to participate or remain in a study against their better judgment.

If your study includes compensation, you must address the following:

1. Clearly Describe the Compensation Plan. Include the amount, method, timing, and purpose of payment in both the protocol and consent form. If no compensation is provided, this must also be clearly stated.
2. Avoid Coercion or Undue Influence. Compensation must not be so high that it encourages participants to take risks they would otherwise avoid or to stay in a study when they would prefer to withdraw.
3. Provide Payment in a Prorated Manner. Whenever possible, compensation should be provided over time as participants complete study activities, rather than only at the end of the study. This helps ensure participants can withdraw at any time without losing compensation they have already earned.
4. Ensure Payments Are Reasonable. Any completion bonus or final payment must be reasonable and not large enough to unduly influence participation.
5. Compensate Participants Who Withdraw. Participants who leave the study early should still be compensated for the activities they have already completed.
6. Base Compensation on Time and Burden. Compensation should reflect the time, effort, and inconvenience associated with participation.
7. Apply Compensation Fairly. All participants in the same study should be compensated using the same approach. For example, if there is no prospect of direct benefit, both healthy volunteers and affected participants should be compensated using the same criteria.
8. Do Not Present Compensation as a Benefit. Compensation should not be described as a “benefit” of the research in protocol documents, consent forms, or recruitment materials.
9. Do Not Overemphasize Payment in Recruitment Materials. Payment information should not be highlighted in a way that could unduly influence someone to enroll.
10. Allow Participation Without Compensation. Participants may choose not to accept payment and still take part in the study.

FDA-Regulated Research

For FDA-regulated studies:

• Compensation cannot be offered as a coupon or discount for a product once it is approved
• Recruitment materials must not suggest that the investigational product is safe or effective

Research Involving Children

Special considerations apply when enrolling minors:

• Children and adolescents may be more influenced by financial incentives
• Reimbursement for expenses may be directed to parents or guardians
• Compensation for participation may be provided to the child, but should be age-appropriate
  • For younger children, non-cash options (e.g., gift cards, toys, books) may be more appropriate
• The protocol and consent must clearly state who will receive payment (parent/guardian and/or child)

International Research

When conducting research outside the U.S., consider local cultural and societal norms when determining compensation amounts and methods.

Compensation should still be fair and not so large that it influences participation against a person’s better judgment.

Compensation can support recruitment and retention, but it must be handled carefully.

Your responsibility is to ensure that compensation is:

• Transparent
• Fair
• Proportionate to participation
• Free from coercion or undue influence