Clinical Trial Payments FAQ
Should the cost of living within particular regions be considered when determining participant compensation?
Yes — this can be considered when building the budget for participant payments. The cost of living varies widely based on zip code, and it would be ethical to tailor payments based on this information. This could be more burdensome for sponsors and sites to manage, but it would be a reasonable way to allocate compensation budgets.
For sites or sponsors of placebo-controlled trials, is there any concern of undue influence for incentive offerings that aren't tied directly to trial procedures, such as reimbursement for gym memberships?
There is no ethical concern or concern of undue influence for providing participants with reimbursements for things that contribute to their overall wellness or support of healthy living, such as a gym membership. These are seen as less of a direct reimbursement, and more of a benefit and can be applied to any clinical trial, not just placebo-controlled trials.
Is it true that some sites follow guidelines stating that research participants must be treated the same as patients not enrolled in a study?
Some sites may have those types of policies. It can be difficult to distinguish between standard medical procedures and procedures only done for research in some types of studies. While this is difficult for sites, not providing compensation passes that burden to participants. We suggest working with your institution to improve the policy to allow for fair compensation.
Sometimes sites will delay participant remuneration until later in the study, as a way to reduce early withdrawal. If this approach is clearly outlined in the consent form, it's considered acceptable since the participant agrees knowingly — but how do you view this in relation to concerns about undue influence?
Generally, we would expect participants to be paid on a per visit basis. Unless the study is very short, we would not want to see a single payment at the completion of the study unless that payment is pro-rated for the activities they did complete. Completion bonuses can be approved, but they should not be so large as to exert undue influence on a participant staying in a study against their better judgement, so this can be a sticking point for IRBs and sponsors and sites should provide a rationale when using this type of structure.
If a patient would have gone to the clinic anyway for regular care, should the clinical trial still reimburse their expenses? Should we cover all costs, or only the extra costs caused by participating in the trial?
For a research study, the expectation is that research activities would be considered for reimbursements and compensation. This would exclude medical care participants would receive regardless of the research.
Can participant compensation be changed (lowered or increased) in the middle of a study as a way of improving recruitment or handling budgetary contraints?
Changing compensation during a trial is common and permissable once it is approved by the IRB. The informed consent form will need to be updated and any participants who are already enrolled will need to be informed of the change.
Is it mandatory for patients and sites to collect all receipts to demonstrate site visit expenses?
This is not an IRB requirement, but for payments to be considered reimbursements for tax purposes, receipts need to be provided by the participant in some way.
What if consent guarantees full reimbursement, but reimbursement was unfortunately not mentioned in the CTA. How can a site and/or IRB pressure a sponsor/CRO do right by their consent promises?
A site should not be submitting a consent form to the IRB unless it can provide the compensation described. This should be reviewed carefully during the clinical trial budgeting process. Sites should request budget for participant compensation. If a discrepancy is realized later, a revised consent form should be submitted to the IRB right away, and participants who have already been consented and started participation would still need to be compensated, even if by the site directly.
In terms of ICF language, what is the best approach to documenting when a patient will be provided reimbursement for travel?
The language should be as complete as possible, but we understand reimbursements vary. If you are paying based on mileage, the ICF should say this. If you have any caps on reimbursements, those should also be included.
How specific does the reimbursement/stipend language need to be in the ICF?
Participants should understand what costs they will incur (if any) and also know any payments they will receive. This should be clearly disclosed in the consent form. For reimbursements, it may not be possible to provide an exact dollar amount, but the language should be clear about which expenses will be reimbursed and if there are any limits/restrictions.
Under what conditions may participation payments to federal employees (including when the payments are based upon federal funds) be considered dual compensation? The question often arises among researchers trying to recruit federal employees.
Needs input
Some consent forms mention the option of home visits, which participants may choose for convenience — such as avoiding time off work or arranging childcare. In these cases, is the participant still entitled to the honorarium? And can the honorarium instead be used to cover the site staff's time and travel for the home visit?
This will be the type of balance a site will need to consider when negotiating a clinical trial budget. We think it is reasonable to reimburse participants for travel to a site, but not when the visit is in their home. Stipends for time and effort may also be lowered if time time spent by the participant is shorter for the home visit.
Would a reimbursement of a co-pay that a participant would not have had but for the study count as a reimbursable expense?
Needs input
Sponsors often set an overall budget cap for site costs on a study. In longer or high-volume studies, sites worry that increasing patient compensation might limit their ability to negotiate fair funding for their operational expenses. Do you have suggestions for how to balance these needs or prevent this trade-off?
This is really difficult, and we think this is often how participant payments are negotiated down. We recognize that there are budgetary constraints for all studies. We recommend trying to balance participant burden with site burden to achieve the best outcome possible for each study. In the context of a clinical trial agreement, the cost associated with the patient's participation should be viewed by both the sponsor and the site as any other vendor. The cost of patient participation is not a function of any other line item in the budget. If an insufficient budget is made available, then the sponsor is effectively asking the patient and/or the caregiver to help finance the cost of the study.
Standard of Care (SOC) is not the same at each site and/or each institution. However a protocol may state SOC is expected to be covered/paid for by the clinical study participant. Do you see a concern with HCP services not considered as SOC to be paid for by a clinical study Sponsor?
We do not think it is unethical for a sponsor to pay for standard of care treatment for participants in a research study when that treatment is part of the protocol. It is not uncommon for an insurance provider to deny payment for SOC when SOC is provided in the context of a clinical trial or if care has been provided across state lines. In these situations the financial liability will be carried by the patient (or his/her family) but should be the responsibility of the sponsor.
What’s the ethical consideration if the Sponsor’s requesting that the site provide a stipend to a participant that is much higher than a typical amount? Also, if the site provides that higher stipend on one study, would this set a precedent for the site to increase that stipend on future studies?
We think it's ethical to provide the higher stipend (assuming it is still a reasonable amount). We have seen no benefit to reducing stipends on one trial because other trials do not compensate as well. We also understand that budgets may not allow sites to provide the maximum stipend for all trials. Some variation is to be expected. In order to make progress in this area, stipends will need to increase, and they may vary from study to study even at the same site. We understand that institutions are juggling many administrative and regulatory tasks to support research, so we understand where this type of policy originates, but we respectfully suggest revisiting policies like this. Flexibility is not inherently unfair, and rigidity may perpetuate less ethical payments.
What can sites say to sponsors when they lower the stipend between an RCT and open label extension that requires just as much participant time?
It is in the best interest of the study sponsor to provide sufficient financial support to the participant to prevent that individual from dropping out of the study on account of the financial burden being imposed on them as a result of a lack of payment. It may be useful to put this scenario in terms that your counterpart(s) at the sponsor would understand. Would they accept reducing their salary during the open label extension if it required just as much time/effort on their part?
Have you seen studies where lost wages have been successfully paid?
It is common for payment to be made, generally, for time/effort. The amounts provided are typically standardized (and should be made in addition to expense reimbursement). We have not experienced replacing lost wages based on the actual salary/compensation of the individual.
Are there guidelines for stipends for studies that require care partners? We have trials where our participants have capacity, but a study partner is required to be there after lumbar punctures or during MRIs. How do you figure out a reasonable stipend?
We support payments to caregivers when a participant needs assistance, regardless of their capacity to consent. We suggest using a similar method as for participant payments. Start with fully reimbursing expenses and then use a reasonable hourly rate (minimum wage as a floor) to calculate a reasonable time and effort payment.
If the Sponsor does not offer a stipend for screen failure visits, what amount would be fair to offer these subjects for time and transportation? Oftentimes screen failure is not known until almost full screening is completed-for example waiting for a lab result and other times it is known almost immediately.
Best practice would be to reimburse participants for expenses as fully as possible and then compensate them for their time at a reasonable rate (e.g. based on median household income or another reasonable/logical framework).
Can a site pay a specific participant with other funding than the sponsor budget? Does this need to get IRB approval?
We do not review sponsor budgets, so from an IRB perspective, this would be permissible. Sponsors and institutions may have additional policies about this. In the case of a study where no financial support is provided by the study sponsor, the site may also consider referring a participant with a need to a non-profit organization that provides grants to assist low-income patients afford to participate.
How does the IRB feel about stipends for subject referrals?
WCG IRB does not approve physician referral fees. Participant to participant referral stipends may be considered on a case-by-case basis.
How should IRBs assess participant-to-participant recruitment, and the parameters for when such a payment may or may not be appropriate?
These can be difficult for IRBs to review because of the issues around not only compensation but also privacy. We have seen these types of payments approved, and we suggest reaching out early to your IRB to discuss this type of design to make sure you provide sufficient information for the IRB to consider.
Can you provide clarification around stipend payments for minors and different considerations for small children vs. teens. Who is filling out W9, using patient vs. parent/LAR information, and who receives the stipends and thus has the tax implication via 1099s at end of year?
This is dependent on region. For example, in the EU, trials involving incapacitated adults, minors, or breastfeeding women, no incentive or financial inducement may be given to the subjects or their legally designated representatives except for compensation of expenses or loss of earnings that are directly related to participation in the trial. In Canada, guardians and authorized third parties should not receive incentive for arranging the involvement in research for the individual that they're representing, but they can receive reasonable incentives or compensation on behalf of that individual as long as its suitable to the circumstances. In the US, there's no explicit prohibition against compensating parents or cargivers. We do see payments for studies involving both children and adults who can't consent for themselves. For young children, we commonly see small gifts (e.g. coloring books or toys) in lieu of financial compensation. For older teens, who could legally work, a payment for their participation might be appropriate. It's important to prioritize the reimbursement of expenses related to the trial. While a six-year-old may not have lost wages as a result of participating, they may have the expense of a plane ticket (if long-distance travel is required), along with meal expenses, etc. Be thoughtful about neutralizing participant expenses and eliminating the hurdles the caregivers may experience.
If the patient received a device or a specific research treatment in the study for free, is it ethical to consider this the "payment" or should the subject be provided an additional stipend?
WCG IRB does not review research where the participant is expected to pay for the study treatment, and the study treatment (which is experimental) is not considered compensation. We recommend considering reimbursement and compensation for study activities.
How does the amount participants are paid in a current clinical trial influence participation or expectations in future trials within the same community?
The impact of one trial on another is dependent on the type of research and the nature of the participant pool you're engageing. You might consider treating particpants like customers. The better you treat them, the more likely they are to participate or refer someone else to participate on your next trial. If you consistently deliver high-quality experiences, including fair compensation, you will develop a favorable reputation over time that will attract more potential participants.
How do I convince potential participants to take part in my study vs another similar study that provides greater compensation?
If you can't match the compensation of a competing trial, you can consider leveraging other benefits or value propositions of your study to attract participants. Lean into the value of the interactions your participants have with your clinical operators and the quality of experience they can expect. You can also use the knowledge of compensation comparisonss in future budget negotiations to try and secure more funding for participant payments in the next clinical trials.
Is there a difference in ethical considerations for payment for a research participant versus an oncology research participant?
In the U.S., not typically, but in other countries there may be regulations about this. This is actually one of the myths we hope to disprove. Oncology research participants often undergo arduous days of testing and procedures and it's ethical and reasonable to compensate them for their burden.
Do you see a difference in compensation for Phase I vs. Phase III trials? Does that vary in different geographic regions like the EU, UK, or Canada?
Yes, there are usually differences in participant compensation between Phase I and Phase III clinical trials, and these differences do vary by geographic region. Phase I trials typically offer higher compensation, because of the time burden involved (e.g. overnight stays, frequent blood draws, etc.) which is typically consistent across countries. However, the regulations and ethics of each region significantly shapes how much compensation is allowed and how it’s framed. When planning a multinational study, work closely with local ethics committees to ensure compliance with regional norms, or partner with a clinical trial management platform like Mural Health that supports global research and who can manage regional nuances for you.
If a sponsor wants to include participant payments in a study, but we as a site want to decline them because not all sponsors are offering study payments, is that okay or does that pose an ethical concern?
Any refusal to pay participants for their engagement in your clinical research poses an ethical concern. The burden on patients to participate in trials can be financial, physical, and emotional, and participants deserve to at least receive fair compensation for their time, effort, and inconvenience. At a minimum, participants should be fully reimbursed for the costs incurred to them during their engagement with the trial.
Do you have advice for navigating SSN collection to remain compliant and ready for audits (i.e. suggestions on good template language or ways to explain to participants and put them at ease)?
It's important to first note that a payor only needs to collect a SSN or other tax identification number (TIN) if they anticipate tax reporting requirements and the issuance of 1099 forms. If only reimbursement will be provided, collection of SSN is not required. If it will be collected, include language in the informed-consent-forms-icf that states your intention and reason for collecting SSN or other TIN. For example: "To issue payment for your participation in this study, we may be required to collect your SSN to comply with federal tax reporting laws. Your SSN will be used only for this purpose. It will be kept secure and confidential, and will be accessed only by authorized personnel. Providing your SSN is voluntary, but if you choose not to provide it, we may not be able to issue compensation beyond a certain amount."
How should you handle budgets that come from sponsors without stipends included?
We need to differentiate between not providing stipends, and not providing any form of compensation. If a sponsor has not included any participant compensation within their budget, it's worth considering the ethical implications, especially if the research requires a significnat number of site visits, travel, and tests or procedures. If participants are uncompensated or undercompensated, the site operators may need to propose an amendment to the study design or budget and advocate for additional funds. It's also unlikely an IRB would approve study protocols without fair compensation of participants — this point can help build the case for incorporating those funds into the budget.
What is the minimal appropriate documentation required for participants who refuse to be paid, and where should this documentation be filed?
If a participant refuses payment, site operators must collect a signed and dated note or form from the participant indicating that they were offered compensation and voluntarily declined it. This can be an addendum to a consent form or a separate form — but it should then be placed in the participant's research file and submitted to the IRB if/when necessary.
How can clinical researchers differentiate between reasonable and coercive participant compensation?
In clinical trial paymets, coercion is largely irrelevant. It indicates threats of harm, which are not applicable for trial participants payments. Instead, focus should be directed to undue influence. Undue influence is the use of money, incentives, or persuasion to influence participants to overlook the risks of the research in making their decision to participate. While certain payment structures or amounts could be unduly influential, covering the trial-related and reasonable expenses of participants is not considered undue influence. Undue influence would only come into play after participants are made whole for their reasonable expenses and compensated for their time. What's key is to fairly compensate participants for their time, travel, inconvenience, and any risks, all without creating undue influence or pressure that may compromise their voluntary consent.
For more information and advice, check out these additional resources we developed with WCG:
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