In a recent webinar, Dr. Luke Gelinas, IRB Chair at Advarra, provided a framework for evaluating offers of payment to research participants. In addition to outlining the challenging ethical and regulatory issues and offering key regulatory guidance, he also provided hypothetical “case studies” to highlight challenging ethical and regulatory aspects of paying research participants. More than 1,000 clinical research professionals joined us for the webinar, which was followed by an engaging Q&A session. Below, Dr. Gelinas answers audience questions we weren’t able to address during the webinar. In the weeks ahead, we will publish part two of his responses, addressing additional questions from webinar attendees.

Note: IRB policies may vary; please contact your IRB regarding any specific questions.

Q: Sponsors frequently want to leave terms of compensation vague, while our site encourages them to be specific about the terms (e.g., stipend, meals, parking, mileage). Is it fair/reasonable to expect sponsors to be specific?

LG: Yes, I think sponsor, sites, or whoever is proposing compensation schedules should at the very least disclose the total amount of payment that participants can expect to receive if they comply with all protocol requirements and complete the study. I also think it is fair and best practice to expect sponsors to break down the total amount into the categories you suggest and to disclose the conditions under which participants will be given a pro-rated amount (e.g., if they do not complete the entire study) and how the pro-rated amount will be determined.

Q: Have the ethical considerations of wage stagnation in certain locales been considered in compensation offered within multisite studies? Minimum wage can be drastically different depending on study site location. Does fair compensation have to be based off local minimum wage? Could a fairer compensation model be based off the national salary average?

LG: This is an interesting proposal. One concern is that while the dollar amount paid on this proposal may be the same between sites, the actual buying value of that amount may vary between sites depending on geographical differences in cost of living. In this light, it may be fairer to ensure that each site is sensitive to factors such as cost of living which impact the actual buying power of the payment amounts proposed. A second concern is that the risk of undue influence may be heightened in cases where more than the local minimum wage is offered. That said, I think the underlying intuition here may be that the local minimum wage is in some places unjustly low, and because of this perhaps fairness supports higher compensation rates. This is an understandable and even admirable thought. My own view is that the best way to deal with systemic injustices, such as unfairly low wage rates, is by capacity-building and other benefits aimed at the community rather than payment to individual participants. This approach acknowledges the systemic nature of the problem and avoids concerns about undue influence. Some aspects of this issue are discussed at greater length in a recent journal article I helped write (subscription required).

Q: Does using a minimum wage baseline for time compensation potentially raise the social justice issue of having persons of lower socioeconomic status be overrepresented in studies?

LG: This is a great question and a real worry, and I do not have an easy answer. The question of whether offering payment generally results in disproportionate representation of economically vulnerable people in clinical research is an empirical one. I know of one empirical study on this, and it did not uncover evidence that payment disproportionately motivates lower income individuals to enroll in research. However, more empirical work is surely needed, in particular, to estimate at what point increasing payment would (if at all) attract people with higher income levels. Part of the challenge is also that that the greater the payment sums offered to attract people of higher income, the greater the risk of undue influence is likely to be—which is a tension. It may be thought that eliminating compensation altogether avoids these problems. But I would resist this, as it appears to make things even worse for economically vulnerable populations, removing an opportunity from them when they are already likely to have limited options. As with the previous question, some aspects of this issue are discussed at greater length in a recent journal article I helped write.

Q: What is your opinion on separating reimbursement from compensation? Many of our studies lump these two things together. However, in my mind, if we are stating that someone will be compensated for participation this should be true compensation, not used to offset expenses due to participation (parking costs, mileage, etc.).

LG: I fully agree, and I hope the framework I advanced in the second part of the webinar makes this clear. Reimbursement should be tied to out-of-pocket expenses incurred as part of participation (travel, meals, etc.). Compensation should be based on time, burdens, and/or risks. These are conceptually different and raise different issues. And yes, I think they should ideally always be distinguished in compensation schedules.

Q: How do you determine appropriate compensation when enrollment can result in direct benefit to the participant?

LG: This is a great question over which people are likely to disagree. First, I don’t think prospect of direct benefit should impact reimbursement; even if there is a prospect of direct benefit, I feel that participants should not ideally have to pay out of pocket for expenses directly related to study participation.

However, I take this question to be asking about compensation specifically, which is more difficult. It is important to keep in mind that the prospect of direct benefit is just that—a prospect; benefit is not guaranteed. By contrast, the time commitment and burdens of participation are typically certain and knowable beforehand. Moreover, study participation also typically has burdens and risks, and it is usually not the prospect of direct benefit on its own that outweighs these risks and burdens and makes the study ethically acceptable; it is also the social benefit the study stands to deliver. So, even when the benefit for participants materializes, I don’t think we should assume that the study will be on-balance beneficial for participants; the study may still be overall burdensome and risky for them. Because of these things, I do not think we should assume that prospect of direct benefit by itself is always, or even typically, enough for fair compensation. It seems reasonable to grant the prospect of direct benefit some value as a compensatory mechanism, but perhaps quite small, and further measures may in many cases be appropriate and supported by fairness, depending on how time-consuming, burdensome, and risky the study is.

To learn more about navigating the ethical and regulatory hurdles of participant payment, watch Dr. Gelinas’ presentation Evaluating Payment to Participate in Research: Ethical and Regulatory Issues.

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