Paying individuals to participate in a clinical trial is still a controversial practice in the clinical research industry. This controversy is in some part due to the historically minimal guidance provided by regulatory bodies on the practice. The FDA recently released a guidance that specifies their position on reimbursements versus compensation for participation in clinical trials. However, this guidance still does not stipulate whether or not researchers should pay subjects, how to pay subjects, nor do they describe how to calculate an appropriate wage. In search of greater clarity, we look deeper into the research surrounding payment to research participants.
Is there a general consensus on offering compensation to participants?
Quite a bit of research has been conducted in the area of remuneration for research participation. Regardless of opinion on participant payment, it is agreed there is a lack of consistency on how much to pay subjects within studies, sites, and IRBs. For example, in a review of participating institutions, it was found that, while IRBs generally approved compensation for research participation, compensation differed between sites up to eight-fold and extended beyond simple reimbursement of expenses (Kimberly, 2006). Largent et al. surveyed IRB professionals (persons who self-identified as having an interest in IRBs and human subjects protection) regarding their perceptions of payment to research subjects. In this survey, they found the majority of IRB professionals felt it appropriate to reimburse subjects for expenses, time, and inconvenience. Half of those surveyed felt it was appropriate to offer compensation as an incentive to participate. However, only approximately one-third felt it appropriate to compensate subjects based on the level of risk they were asked to undergo.
With so much variability in policies across institutions, is there such thing as a neutral compensation practice?
Institutional policy varies as much as the survey responses described in the above paragraph. Wright and Robertson received varying levels of acceptance regarding the inclusion of compensation in research advertising (Wright, 2014). In their research of NIH funded institutions, they describe a wide range of policies: those that prohibit discussion of compensation in recruitment materials, those that encouraged inclusion of information, those that required disclosure of any compensation, etc. Based on the variability found in compensation practices, Phillips proposes a living, hourly wage for research subjects, regulated by the federal government (Phillips, 2011).
Do participants feel obligated to participate when offered compensation?
Variability in payment perceptions does not only lie with the IRB. Radecki Breitfopf et al. described a post-trial survey of normal female volunteers for a gynecologic imaging study. While many of these women worked at a medical school, they felt that payment was a benefit. Additionally, the consensus was that payment would not be an undue inducement; if they did not want to participate in the procedure, they would not, regardless of compensation.
Does the perception of potential risk increase as the compensation amount increases?
Cryder et al. conducted three web-based survey studies focused on the perception of risk associated with study payment. Their work concluded that, as study payment increased, so did the perception of risk the potential subject was asked to take on. They also found that the amount of information an individual sought before making a decision regarding participation also increased with the amount of payment. Another study on subject expectations regarding compensation by Devine et al., found that subjects expected greater compensation for riskier procedures, with minimum median payment of $20 for undertaking any study procedure.
These are only a few examples of the published research looking at the practices surrounding the compensation of research participants. All in all, my takeaway is that more research is needed to better (and more uniformly) inform the practice of compensating subjects to participate in research. What are your thoughts? What, if anything, is needed in the area of payments to research subjects?
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- Cryder CE, London AJ, Volpp KG, Lowewnstein G. Informative inducement: Study payment as a signal of risk. Social Science & Medicine. 2010; 70: 455-464.
- Devine EG, Knapp CM, Sarid-Segal O, O’Keefe SM, Wardell C, Baskett M, Pecchia A, Ferrell K, Ciraulo DA. Payment expectations for research participation among subjects who tell the truth, subjects who conceal information, and subjects who fabricate information. Contemporary Clinical Trials. 2015; 41: 55-61.
- Largent E, Grady C, Miller FG, Wertheimer A. Misconceptions about coercion and undue influence: Reflections on the views of IRB members. Bioethics. 2013; 27(9): 500-507.
- Kimberly MB, Hoehn KS, Feudtner C, Nelson RM, Schreiner M. Variation in standards of research compensation and child assent practices: A comparison of 69 institutional review board-approved informed permission and assent forms for 3 multicenter clinical trials. Pediatrics. 2006; 117(5): 1706-1711.
- Phillips TB. A living wage for research subjects. Journal of Law, Medicine & Ethics. 2011; 243-253.
- Radecki Breitkopf C, Loza M, Vincent K, Moench T, Stanberry LR, Rosenthal SL. Perceptions of reimbursement for clinical trial participation. Journal of Empirical Research on Human Research Ethics. 2011; 6(3): 31-38.
- Wright MS, Robertson CT. Heterogeneity in IRB policies with regard to disclosures about payment for participation in recruitment materials. Journal of Law, Medicine & Ethics. 2014; 42: 375-382.