A Penny for Your Thoughts? Moving Research Payment Transparency from Idiom to Policy

Payment for participation in research—especially clinical research—is a common practice, but researchers often find themselves working in a “black hole” regarding payment. There are no well-described standards for decision-making on payment amounts and forms of payment, apart from the Belmont Report’s abstract warnings against exerting “coercion and undue influence” (HHS, 1979). Without tools to support decision-making in this area, payment decision practices tend to be subjective and based on personal experience; researchers with no experience in this area may make payment decisions for research participation based on available funds, personal notions, and guesswork of “what’s best.”

Nonetheless, the authors know from personal experience that payment decisions can significantly impact studies at each step of the CONSORT process, from screening and enrollment to condition allocation and retention and, ultimately, data analysis and reporting (Altman et al., 2001). Emerging data on payment decision-making—although still limited—reveals a complex web of factors that drive payment amounts, including participant type, proximity to the study site, risks involved, procedure invasiveness, and the expectations of research participants themselves, which may be based on their experiences in other studies. Given the potential influence of these myriad factors on study participation, it is therefore surprising that to date there has been a relative absence of attention and transparency on what, how, when, and by whom participant payments are determined (Anderson and Brown, 2021).

The prevailing worry about participant payments is that they could be coercive or cause undue influence on participants’ decisions to participate in research or undertake certain study procedures. More recently, however, ethicists have moved away from this paradigm to focus on the opposite issue: underpayment of people who participate in research, and the ethical principle of beneficence (Largent and Lynch, 2017). Although ethics committees do not typically consider payment in the risk/benefit ratio when reviewing research, participants may view payment as another benefit of research participation.

 

Progress in the Science of Participant Payment

Over a decade ago, the authors proposed the creation of an incentives database to help with research decision-making (Brown and Merritt, 2013). This was easier said than done; a better understanding is still needed of what data points to collect, as well as the range of incentives to study, so as to more accurately guide decision-making according to specific research project types. In 2018, a New England Journal of Medicine article defined three types of payments—incentives, compensation, and reimbursement— which laid the groundwork for the future establishment of a practical and implementable framework (Dominguez et al., 2012). The National Institutes of Health have internal payment guidelines as part of their clinical research enterprise, indicating that scientists have indeed faced the debate of standardizing payment, at least in the primary federal agency that conducts and supports medical research (Gelinas et al., 2018).

The recently revised Common Rule offers one potential solution to the current lack of available payment data by requiring that researchers post informed consent forms on clinicaltrials.gov and regulations.gov (HHS, 2022). Since consent forms should contain payment types and amounts, the publication of these forms finally makes it possible to mine the data. But unexplained payment amounts in research suggest that a systematic collection of study features is required in order to make any useful inferences on payment data (Grady et al., 2005).

 

Data, Commitment, and Policy

Payment data exist but are not uniformly made public. Researchers should be required to transparently and publicly report these data (i.e., in databases and publications), just as they are required to do so for other key research elements such as study duration, specific study procedures, assurance of compliance to research ethics, potential conflicts of interest, and dissemination plans. Some studies have collected data on the perspectives of individual stakeholders regarding payment, with the majority of data coming from research participants themselves (Largent et al., 2022; Ripley et al., 2010). Progress in this area, however, will require the perspectives of all major research stakeholders—not only participants, but also ethics committees, lead researchers, sponsoring institutions, and funders. Without this information, it is not possible to balance all stakeholder interests. For example, participants may want higher payments, but ethics committees may be concerned that high payments have the potential of undue influence. Meanwhile, funders may want lower participant payments so as to permit the funding of more projects, while researchers may just be making their best guess at an appropriate payment amount that fits their budget. Guesswork is clearly suboptimal, and a clear payment reporting policy could make a significant difference. The policy should be data-driven, and the increasing transparency of participant payment is a promising first step. But this commitment to transparency will only work if all stakeholders are involved in collecting and framing the data.

Data which tell a more complete story are emerging—through surveys, interviews, focus groups, vignettes, and retrospective data reviews—but they remain very limited (Polonijo et al., 2022; Brown et al., 2021; Galea et al., 2021). Table 1 outlines various activities that different stakeholders may undertake to increase the transparency of payment data, and how these stakeholders may benefit from their efforts (see Table 1).

 

Increased availability and transparency of payment data, as outlined in Table 1, will allow researchers to more robustly analyze factors linked to payments and will provide the inputs to a payment database to drive real-world decision-making. Such a payment database may collect study- and participant-related factors, then provide decision-makers with a range of payment types and amounts offered in previous and current studies. The database may find that payment decision-making should be fluid and dynamic, similar to decision-making on what funding to pursue for specific types of research or even decision-making outside of research, such as choosing an airline flight, selecting an item from online markets, or choosing an internet service provider. But without data, decision-makers cannot and do not know. The process of deciding on the factors to include in a payment database is complex, but it is achievable.

Participant payment determination is an area with clear and achievable opportunities for research advancement. A payment database can be used to develop minimum and maximum acceptable payment amounts in research based on data distribution, measures of central tendency, and variability, or it can be used simply as a growing reference for data-driven decision-making in future research. Either way, it is time to move from idiom to policy in payment for participation in research.

 

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Tweet this! “Participant payment determination is an area with clear and achievable opportunities for research advancement.” A new #NAMPerspectives calls for increased data availability on research participant payment: https://doi.org/10.31478/202305a

Tweet this! Payment for participation in research is common, but researchers often do not have access to data about payment amounts, leading to guesswork. Authors of a new #NAMPerspectives call for greater transparency in research participant payment: https://doi.org/10.31478/202305a

Tweet this! “Payment reporting policy should be data-driven, and the increasing transparency of participant payment is a promising first step. But this commitment to transparency will only work if all stakeholders are involved.” Read more: https://doi.org/10.31478/202305a #NAMPerspectives

 

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References

 

1. Altman, D. G., K. F. Schulz, D. Moher, M. Egger, F. Davidoff, D. Elbourne, P. C. Gøtzsche, and T. Lang for the CONSORT Group. 2001. The revised CONSORT statement for reporting randomized trials: Explanation and elaboration. Annals of Internal Medicine 134(8): 663–694. https://doi.org/10.7326/0003-4819-134-8-200104170-00012.
2. Anderson, E. E., and B. Brown. 2021. A call for radical transparency regarding research payments. The American Journal of Bioethics 21(3): 45–47. https://doi.org/10.1080/15265161.2020.1870763.
3. Brown, B., and M. W. Merritt. 2013. A global public incentive database for human subjects research. IRB 35(2):14–17.
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10. HHS. 1979. The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research. Available at: https://www.hhs.gov/ohrp/regulations-and-policy/belmont-report/read-the-belmont-report/index.html (accessed May 4, 2023).
11. Largent, E. A., and H. F. Lynch. 2017. Paying research participants: The outsized influence of “undue influence.” IRB 39(4): 1–9. Available at: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5640154/ (accessed May 4, 2023).
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