Participant Payment — Make It Make Cents

By T.J. Sharpe

As a stage IV melanoma patient who participated in two clinical trials, I learned quickly that a clinic visit was often more than just a “routine” visit. The protocol — blood draws, scans, infusions, etc., organized in a nice, orderly table — was rarely as tidy in person as it was in the consent form. This mismatch of expectation versus reality trickled down to all parts of the patient experience, including payments and reimbursements.

My experience also showed me how easily a trial can quantify procedures while leaving the human costs of those procedures off the spreadsheet. Those costs do not disappear simply because they are difficult to calculate; they are transferred to participants and their families as lost time, additional expenses, disrupted responsibilities, and accumulated stress. A fair payment strategy begins by making those costs visible.

WCG reported that 95% of the informed consent forms it analyzed offered no compensation beyond basic reimbursement. In a separate review of nearly 25,000 IRB records, WCG found only 77 payment-related issues. None concerned an amount that was too high. The most frequent issues involved unclear amounts, timing, methods, or responsibility for research-required equipment and procedures.¹ That finding should challenge the assumption that paying for time and effort is inherently too risky.

Start With The Protocol

Too often, sponsors think, "What is an acceptable payment amount?" instead of, "What does this protocol require a person, and the people supporting that person, to absorb?" Only after answering the second question can a sponsor build a payment plan that is fair, compliant, and operationally workable.

To the protocol development team: A payment plan should begin with the schedule of activities, not a standard stipend copied from another study. Review every visit and remote task from the participant's perspective.

Then, consider the need for travel in both directions, time spent (on-site, waiting, fasting, and in recovery), parking, meals, lodging, childcare and/or eldercare, missed work, caregiver time, technology needs, and the trial activities required between visits. Factor in burdens that are harder to price but still affect participation: pain, fatigue, uncertainty, scan-related anxiety, and the cumulative effort of managing treatment alongside ordinary life.

If you look only at procedure time, you miss much of the cost. A 1-hour laboratory visit may consume half a day after travel and waiting. A full infusion day may also consume a caregiver's workday. A separate imaging appointment adds another trip, another parking charge, and another period of anxiety.

To get full breadth of impact, turn that review into a visit-by-visit burden inventory before assigning dollars. If you cannot explain what each payment covers, then you are not ready to defend the budget to an ethics committee, a site, or a participant.

Separate Reimbursement From Compensation

Teams often use reimbursement and compensation as if they mean the same thing. They do not. Reimbursement restores money a participant spent because of the study’s participation requirements. Compensation recognizes the value of time, effort, inconvenience, and other research-related burdens.

Two other terms that fall under the participant payment umbrella are incentives and tangible gifts. An incentive is intended to positively influence enrollment or retention. Gifts are of nominal value and are intended to be a thank-you for participation. The Multi-Regional Clinical Trials Center distinguishes these categories because each carries different ethical, operational, and tax considerations.²

What also separates reimbursement from compensation is how each impact the participant experience. Reimbursing parking does not recognize 4 hours away from work. Covering mileage does not account for the caregiver who drove and waited. A meal voucher does not address the physical effort of a biopsy or the time required to complete an electronic diary every day. “Making whole” isn’t just the coverage of an expense; it is the recognition and appreciation for all that goes into the participation in research by all who are asked to make sacrifices and accommodations for the success of the trial.

The FDA states that payment for participation is generally acceptable and should be just and fair. It also distinguishes reasonable travel reimbursement from other payments that require review for possible undue influence.³ Sponsors should therefore define the purpose of every payment category, keep reimbursement separate from compensation in the budget and consent language, and avoid making most of the payment contingent on study completion. By doing so, sponsors show they appreciate the individual’s time and effort alongside their monetary outlay.

Localize The Plan

Fairness does not require identical payment plans in every country. It requires a consistent method applied within local law, ethics expectations, tax rules, site practices, and payment infrastructure.

At the DIA 2026 Global Annual Meeting, a team of patient advocates led a workshop exercise walking small groups through building payment plans for the same oncology protocol in the U.S., Brazil, and France. The underlying burden did not change, but the permitted categories, terminology, review expectations, payment methods, and timing did. A budget that appeared reasonable in one country could be rejected or impractical in another. Even within one country, local costs and site processes can produce meaningful differences. The groups all came away with markedly different outputs, even from the same countries, as they applied their expertise and experience alongside the boundaries set. If a small group can have such variance, how do we localize plans that often evolve from locale-influenced planners and decision-makers?

Sponsors should establish global principles, then use current country intelligence to translate them. The global standard might require that no participants front their own travel costs, that completed activities receive prorated payment, and that caregiver burden be considered. The local plan determines how those principles can be implemented. Teams should also engage with location-specific subject matter experts and participant communities at the locations they plan to offer the trial to ensure the plan works in each location. It’s like uncovering a great restaurant or tourist experience while traveling — the locals are the experts, so do what they suggest you do, whether it’s dinner or drug development.

Design The Payment Experience

A fair amount can still fail if the payment process is slow, confusing, or inaccessible. Before finalizing the plan, ask whether participants must pay for costs up front, whether they must submit repetitive paperwork or use an unfamiliar application, or wait weeks for repayment. Ask sites whether the proposed process fits their staffing and reconciliation workflows. Ask potential participants or engagement professionals whether the method works for people with limited digital access, limited banking access, disabilities, or concerns about public-benefit eligibility.

Payment timing should follow the participant's contribution. Whenever local rules and operations permit, reimburse expenses promptly and compensate completed visits or tasks as the study progresses. Clearly state the amount, method, timing, and documentation requirements in the consent form. If taxes or means-tested benefits may be affected, provide accurate general information and access to appropriate resources without giving individualized tax advice.

Sponsors should also consider that there are individual circumstances that affect their ability to receive payment. Sometimes these are logistical — people may not have the means to front money or have a certain type of bank account or payment platform. Others are preferential; some people may prefer payment type A, while others prefer B or C or D. Providing flexibility and choices to handle all trial-related payments makes the payment experience more inclusive and patient-friendly and sets a positive direction for the nonmedical aspects that sites control. A prompt, personalized experience for payments helps ensure that happens.

Consider treating site payments, participant reimbursements, and supplier payments as connected processes. Using tools or vendors that integrate the entire payment approach gives sites a simpler operational path to participate in patient support programs. Having an integrated payments approach drives participant satisfaction and retention while helping to reduce technology fatigue and improve financial transparency.

Pressure Test Before Launch

Before approving the budget, bring clinical operations, patient engagement, sites, legal and compliance, finance, the payment vendor, and local experts into the same review. Include patients or experienced patient partners early enough to change the plan. Review the budget and implementation plan with each group and test these five questions:

1. Have we identified the full burden created by each protocol activity?
2. Will participants need to pay for costs they may not be able to afford?
3. Does the plan address tangential expenses, time, effort, and caregiver burden?
4. Does the plan comply with current country and site requirements?
5. Can sites and vendors deliver reliably from the first participant's first visit?

Once these answers are affirmed, the trial is ready to launch with a payment plan that has been comprehensively reviewed and thoughtfully integrated into the wider trial experience.

The Dollars And Sense

A sponsor can have a compliant payment policy and still create an unfair participant experience. The remedy is to cost the protocol through the participants’ lives, separate reimbursement from compensation, localize the plan, and test the delivery process before launch. When a protocol asks more of participants and families, the budget should acknowledge more. Fair payment begins by counting the burden accurately and designing an experience that does not ask participants to quietly subsidize research with their money, time, or family capacity. That requires sponsors to treat payment strategy as part of protocol design, not an administrative detail added after the protocol is set. When the plan reflects what participation truly demands, it removes avoidable barriers and shows participants that their contribution has been understood. That is where the dollars — and the sense — finally align.

References:

1. WCG. WCG 2026 Trends & Insights. 2025. See pp. 28-29, "Improving Participant Experience: What Is Preventing Time and Effort Payments to Participants?" www.wcgclinical.com/wp-content/uploads/2025/12/WCG-2026-Clinical-Research-Trends-Insights-Report.pdf
2. Multi-Regional Clinical Trials Center of Brigham and Women's Hospital and Harvard. An IRB Resource for Investigators: Payment to Research Participants. Version 1, June 2022. mrctcenter.org/diversity-in-clinical-research/wp-content/uploads/sites/8/2022/06/MRCT-Center-An-IRB-Resource-for-Investigators-Payments-to-Participants.pdf
3. U.S. Food and Drug Administration. Payment and Reimbursement to Research Subjects: Guidance for Institutional Review Boards and Clinical Investigators. January 2018. www.fda.gov/regulatory-information/search-fda-guidance-documents/payment-and-reimbursement-research-subjects

About The Author:

T.J. Sharpe is a patient engagement strategist, keynote speaker, writer, and stage IV melanoma survivor. He partners with life sciences companies and healthcare organizations to incorporate practical patient insight into clinical research, from protocol design and participant materials to engagement strategy. He is the founder of Sharpe Patient Insights.