7 Best Practices to Structure Your Participant Payments

In a recent webinar Mural Health co hosted with WCG, titled “Demystifying Participant Payment Myths”, we invited attendees to ask us questions regarding clinical trial participant payments. Many of the questions asked revolved around the structure, type, and amounts of participant payments: How much should participants get paid? What should they be paid for? How can payments be equitable across different communities? And which programs and structures of payments are best-in-class?

This is a topic that we at Mural Health have spent significant time thinking about (and solving for). Using 15+ years of our team’s expertise in participant payments, we designed a standard framework for participant payments that has been reviewed and supported by WCG and Advarra, and have created a proprietary tool that helps estimate appropriate participant management budgets. In our work, we have seen firsthand how critical getting payments right is for the participants’ ability to join a trial and remain in it, knowing that the financial toll the trial takes is mitigated by their trial sponsor. ‍

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Key principles for participant payments

#1 - Paying for trial related expenses is not only allowed, but encouraged.‍

Many industry stakeholders express a concern that there is potential to “overpay” participants, even when payments are only made to reimburse trial-related expenses and enable net neutrality for the participant. They believe an IRB might reject a submission that has relatively high reimbursement, arguing that it amounts to undue influence. In actuality, this should not be a concern. As expressed by Kelly FitzGerald, IRB Executive Chair and VP IBC Affairs at WCG, during our recent webinar, the test that IRBs apply to payments is: Can the payment be reasonably tied to the burden the participant is undertaking as part of their trial participation? If not, does the payment intend to blind the participants to the trial risks and influence them to do something they wouldn’t otherwise do?

When payments cover the expenses and burden that come with trial participation, they will not be considered undue influence, even if they offer high reimbursement amounts. What is more, IRBs agree that participants’ expenses should be reimbursed. As stated by Kelly FitzGerald in a previous piece on Clinical Researcher, “the time has come for sponsors and clinical research organizations to accurately assess the costs to individuals tied to their research participation and provide them with just compensation for their service”.

‍#2 - You can pay participants for more than you may think.‍

Many sponsors and sites have a narrow view of what qualifies for reimbursement, often recognizing only travel, lodging, and meals as trial-related expenses. However, a participant’s trial-related expenses can be much broader: think childcare, lost wages, WiFi (for remote reporting), and more. These expense types have been recognized by IRBs as part of the payment scope, and can be covered as part of trial reimbursements. Further, in trials that require international travel, we have seen additional expenses covered by sponsors, such as visa services and long-term housing.  

‍#3 - Amounts of Participant Payments can vary if expenses vary.‍

It is common practice for many sponsors to provide all participants with a flat amount for all of their expenses. This is referred to as a stipend. Stipends present many challenges (see #4 below), and one is that they do not take into consideration the unique circumstances of every participant. Say a sponsor chooses to give each of its participants a $100 stipend per visit. For a participant who lives within walking distance from the research site, a $100 stipend may exceed their expenses for that visit. But for a participant in the same study who is required to drive 5 hours each leg to get to the site, a $100 stipend will likely come up short. 

As sponsors work to ensure their trial budget is best utilized, it is important to use a payments approach that allows consideration of the individual participant. This approach can be critical to expanding the recruitable population and retaining participants in the trial.

‍#4 - Not all payment types are the same.

‍When classifying U.S. clinical trial payments, the terms “stipend” and “reimbursement” are sometimes used interchangeably. This is problematic, because in reality, there’s a distinction between them that holds important meaning for participants: Reimbursements are payments made for the specific expenses incurred, and are not considered taxable income (and therefore do not need to be reported to the IRS). Stipends, however, are payments made as a flat fee to cover trial expenses, are considered income, and need to be reported to the IRS. If they are equal to or greater than $600 in a calendar year, the clinical trial payer is required to issue the participant a 1099 form. This means that payments categorized as stipends might be taxed. This creates a barrier to participation for millions of Americans, as it threatens their welfare program eligibility. We at Mural Health advocate for clear, equitable participant payment practices–including our Harley Jacobsen Tax Act, which is designed to help eliminate this barrier and make clinical research more accessible to all. For this reason, sponsors should always prefer paying for trial-related expenses in the form of reimbursements, and only provide stipends if the stipends reflect additional compensation beyond covering expenses. 

‍#5 - Paying a “fair market value” should be based on current prices, not historical payments.‍

Fair Market Value (FMV) is a well-known concept used in site and sponsor negotiations, where sponsors rely on historical line item amounts to determine price benchmarks. There have been recent attempts to bring the same concept into participant payments, offering databases of historical payments as a benchmark for how much sponsors should pay participants. But this approach overcomplicates things and works directly against participants: why would sponsors pay participants for their rideshare to the site based on amounts other sites have used, when they can easily check what the average rideshare cost per mile is today, for their relevant regions? This data is readily available online, and can be aggregated and incorporated into a budget estimate by your applicable vendor. This is especially true knowing the data around participant payments: as was shared in a recent DIA Global Forum article, average payment amounts can be nominal, and far below the relevant cost. If we are to make participants financially neutral, we should reimburse them based on their actual expenses. 

‍#6 - The participant payment method matters.‍

When thinking about participant payments, it is important to also consider the way in which you are paying participants. Not all payment methods make sense for all participants. For example: paper check payments sent to participants in the mail can create a delay in receiving payment and not all participants can afford to wait. Reloadable prepaid debit cards might be beneficial for the unbanked, but have significant operational challenges for sites and participants, and almost all versions of these cards charge usage fees, such as withdrawal fees and inactivity fees (for more on this, see Mural Health’s eBook on Costly Reimbursements). Sponsors should offer optionality, allowing participants to receive payment in the way that makes most sense for them, instead of a one-size-fits-all approach. 

‍#7 - A global perspective is needed for global trials.‍

To design a participant payment budget for a global trial, sponsors and CROs must be knowledgeable about the relevant regulation, common practices, and site preferences in the countries the trial will take place in. Certain countries allow reimbursements but do not allow payments for time and effort, while others do not state clearly what their approach is, so different sponsors develop different approaches to payments. Understanding the local approach to participant payments, the methods of work, the unique challenges, the tax structure, the relevant payment methods, and more, is important to serving all participants in a way that makes sense for them.‍

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What does this mean for you?

Our tactical recommendations

✅ Have a standard approach for trial payments that can be implemented across all trials. This will offer clarity internally, a faster payment review and approval process, and a better experience for sites and participants.

✅ Prioritize paying as early as possible and with as little tax implications as possible, minimizing the risk of barriers to participation.

✅ Avoid deciding on participant payment amounts based on historical tools.You will find more accurate information by simply researching the current cost for the relevant expense.

‍✅ Offer various payment options to your participants, to truly meet them where they are.

‍✅ Whatever payment method you choose, read the fine print. Make sure there are no associated fees for usage, and that the payment method is secure so that you can detect and address cases of fraud.

At Mural Health, we care deeply about making trials accessible to all. If you are unsure about your budget structure or amounts, feel free to reach out to our team, and we’d be happy to help you think through your budget structure, or share our payments policy at no cost.