Site operations

Patient stipends and travel reimbursement: what sites can offer

By TrialNotice · Updated
Smiling coordinator handing an envelope to a young woman at a clinic reception desk
Short answerFDA does not consider reimbursement for travel and associated costs, such as airfare, parking, and lodging, to raise undue influence concerns. Payment for time and inconvenience is allowed but reviewed by the IRB, should accrue as the study progresses rather than depend on completion, and may include a small completion bonus the IRB finds reasonable. Payment is not considered a benefit of the research.
General information. Your IRB approves the amount, method, and timing of all participant payments.

What does FDA say about reimbursement?

FDA does not consider reimbursement for travel to and from the trial site and associated costs, such as airfare, parking, and lodging, to raise issues of undue influence (FDA).

What about payment for participation?

  • The IRB reviews both the amount and the method and timing of payment, to ensure neither is coercive or an undue influence (FDA).
  • Payment should not be contingent on completing the whole study; payment should accrue as the study progresses (FDA).
  • A small completion bonus is acceptable if the IRB finds it reasonable and not so large it keeps people enrolled who would otherwise withdraw (FDA).
  • Payment details, including any prorating, should appear in the consent document (University of Utah IRB).
  • Payment is not considered a benefit of participation (University of Utah IRB).

How do payments affect enrollment and retention?

Practical costs are real barriers: travel, parking, time off work. Removing them helps people say yes and keeps them through the last visit, which matters when Phase II and III dropout averages 19.1% (Tufts CSDD).

How should sites set it up?

  1. Negotiate reimbursement and stipend budgets with the sponsor.
  2. Offer reimbursement for actual travel costs, including parking.
  3. Pay per visit, promptly, using a method participants can access easily.
  4. Explain payments plainly at consent.

Does payment replace a good recruitment source?

No. Payment helps people say yes; it does not tell them the study exists. Only 10% of people who never participated were ever asked (CISCRP). The doctor who already treats them is still the most trusted way for patients to hear about a study.

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Sources

  1. FDA, "Payment and Reimbursement to Research Subjects" Information Sheet (January 2018)
  2. University of Utah IRB, Compensation of Research Subjects guidance
  3. Applied Clinical Trials, "Can Recruitment and Retention Get Any Worse?" (Tufts CSDD screen failure study)
  4. CISCRP, 2017 Perceptions and Insights Study: Decision Making Process

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