A Framework for Ethical Payment to Research Participants. In this article, the writers set our approach to this problem in a practical framework. The potential for undue influence specifically arises when participant compensation is excessive. Nonetheless, there are ethically permissible rationales for providing compensation: namely, reimbursing participants for their out-of-pocket expenses, compensating participants for time and associated burdens, and incentivizing participation. Informative inducement: study payment as a signal of risk. This "efficiency"-driven (Phillips 2011a) rationale is widely acknowledged. Berman Institute of Bioethics, Johns Hopkins University, Baltimore, Maryland USA. . This page was processed by aws-apollo-l200 in 0.246 seconds, Using these links will ensure access to this page indefinitely. . Subjects will also undergo a clinical examination and provide blood and urine samples. Europe PMC is part of the ELIXIR infrastructure. As a library, NLM provides access to scientific literature. The main "pragmatic" reason (Largent and Lynch 2017a, p. 77 fn. The central ethical question is whether a payment is excessive whether it conflicts with the obligation, recognized in the US regulations governing human-subjects research and bioethical guidelines, to minimize the possibility of coercion and undue influence during the informed consent process. IRB 39: 1-9, 2017 Medline, Google Scholar: 4. N Engl J Med. As a result, they are likely to take unreasonable risks to gain financial rewards. Office of the Commissioner. If an investigator expects differences in time or burden between the interventions being studied, and attempts to equalize them through payments, then the findings may not reflect the overall treatment effect expected in normal care without payment. Patients views concerning research on medical practices: Implications for consent, Comparison of Approaches for Notification and Authorization in Pragmatic Clinical Research Evaluating Commonly Used Medical Practices. eCollection 2023 Apr-Jun. Some types of research, such as studies involving only the collection of blood or urine or survey data, pose only minimal risks to participants, while others, such as oncology clinical trials, pose more than minimal risks, while offering research subjects potential benefits, such as treatment for their disease. Incentives and Payments in Pragmatic Clinical Trials: Scientific A Framework for Ethical Payment to Research Participants. However, it is unclear whether this prohibition extends to the use of personal data for research. In this paper we examine a set of issues related to incentives and other payments to patients in PCTs. Most IRBs require investigators to provide them with enrollment data during continuing review of research, so they can ascertain whether studies are meeting their goals. While the potential for exploitation is high in clinical trials sponsored by pharmaceutical companies in developing nations (Hawkins and Emanuel 2008), it is very low in survey research sponsored by government agencies. One might argue that justice requires researchers to help people of low SES gain access to studies that offer potential benefits. Lynch HF. All Rights Reserved. In this article, I will argue that our ethical qualms about the negative impact of money on decisions concerning research participation are largely unfounded and reflect more general concerns about the need to avoid repeating abuses of human subjects that occurred in the past. Gelinas L, Largent EA, Cohen IG, Kornetsky S, Bierer BE, Lynch HF. A National Survey of Investigators and IRB Chairpersons. i. glenn cohen Join Advarras Talented team to take on engaging work in a dynamic environment. However, as with reimbursements, payments for extra time may affect how well the results can inform stakeholders choices in usual care. Most of these cases involved blatant violations of informed consent, egregious harms to human subjects, exploitation, or all three. 2023 Apr;28:60-70. doi: 10.1016/j.jcbs.2023.03.009. 4. Promoting Ethical Payment in Human Infection Challenge Studies Department of Homeland Security, Department of Agriculture, Department of Energy, National Aeronautics and Space Administration, Department of Commerce, Social Security Administration, Agency for International Development Data collection is often a burdensome and time-consuming activity for research participants, particularly when it involves hours-long surveys. As mentioned earlier, regulations governing research prohibit payment for accepting risks associated with research. The Supplementary Appendix, available with the full text of this article at NEJM.org, contains more information about the composition of the working group and the scope of its involvement. One exception could be experimental interventions related to behavioral economics, where the incentive itself is part of what is being studied. In these circumstances, it would be impractical or impossible to pay those included, yet having a different means of respecting their contributions seems important. The ethical anatomy of payment for research participants Citiz Sci. We address these in turn. The New England Journal of Medicine, 378(8), 766 . Epub 2023 Mar 10. It reflects input from a working group that comprised ethicists, members of IRBs, investigators, regulators, research participants, and industry representatives, who together considered payments in publicly and privately funded research, at academic institutions and elsewhere, and in various phases of research. Nursing students as research participants: a framework for ethical practice Nurse Educ Today. Nevertheless, worries about undue influence continue to have a disproportionate impact on debates about payments to research subjects. The Continued Complexities of Paying Research Participants Sometimes participating in a trial may seem valuable to someone. A second way that offering too much money for research participation could constitute an undue influence would be if it encourages some people to deceive investigators about their health history or other important information to qualify for enrollment. Chambers 2001) argue that any form of payment for research participation is ethically suspect because people should enroll in studies for altruistic motives, most ethicists agree that some form of remuneration is acceptable (Largent and Fernandez Lynch 2017a). The framework provides a transparent, fair and consistent method of calculating compensation for research participants by itemizing factors that contribute to the total amount. N Engl J Med 2018; 378: 766-771. Cryder et al. However, the arguments and evidence explored in this paper imply that bioethicists and IRB members should be skeptical of the idea that competent, adult human subjects need special protections from the influence of money. Inducements for research participants are considered controversial. Evidence from a web-based experiment. In contrast, some people might have such a firm commitment to honesty that they will not lie to earn money, regardless of the level of payment. Although those included in PCTs can include patients, clinicians, and/or institutions, and thereby be the potential recipients of incentives and payments, in this paper we focus on included patients, leaving important issues related to clinicians and institutions for another analysis. If we rule out trial designs that are very large because they cost too much, then we will not study interventions that could have large aggregate effects, but small individual effects. Am J Bioeth. February 22, 2018 2018;378(8):766-771. Sponsors, investigators and institutions might therefore be prone to use their power, knowledge or expertise to take advantage of subjects in various ways, and they might also use money to entice subjects to participate in studies that are exploitative. official website and that any information you provide is encrypted sharing sensitive information, make sure youre on a federal Macklin 1981) have adopted a similar view of the potential impact of money on informed consent for research participation. First, they identify and address foundational concerns that have been expressed about offers of payment to research participants. Epub 2023 May 8. and transmitted securely. Ethical Payment to Participants in Human Infection Challenge - SSRN Inspired by their work, we have developed the Framework for Ethical Research Practice for use in a nursing context. 3. The proposal was against their best interests or values because it would undermine marital fidelity. The practice of paying research participants has received significant attention in the bioethics literature, but the focus has been almost exclusively on consideration of factors relevant to determining acceptable payment amounts. An analysis of U.S. practices of paying research participants, Exploitation and Developing Countries: The Ethics of Clinical Research, The importance of social, cultural, and economic contexts, and empirical research in examining undue inducement, How IRBs view and make decisions about coercion and undue influence, Paying research participants: regulatory uncertainty, conceptual confusion, and a path forward, Yale Journal of Health Policy, Law, and Ethics, Paying research participants: the outsized influence of undue influence, Addressing financial barriers to enrollment in clinical trials. It might be the case that SES affects willingness to participate or risk assessment, but further research is needed to ascertain whether this occurs (Klitzman 2005; Largent and Fernandez Lynch 2017a, 2017b). They then propose and defend a framework that distinguishes three rationales for payment: reimbursement for out-of-pocket expenses, compensation for time and burdens associated with research participation, and incentive to motivate participation. Google Scholar. The https:// ensures that you are connecting to the 2017;39(4):1-9. When a study is not likely to meet its enrollment goals, the risks to human subjects will not be justified because the value of the knowledge gained is minimal or nonexistent (Largent and Fernandez Lynch 2017a, 2017b). FOIA Various options include disclosing results, reporting on study and implementation progress, facilitating entry to patient support communities, or even giving some way for participants to know that they were part of the trial so that they could mention it to their friends and family. We live in a society in which competent adults routinely exchange money for goods and services. The site is secure. Even so, it may be appropriate to compensate patients for access to private information about them. A Framework for Ethical Payment to Research Participants https://www.wired.com/story/opinion-give-data-pricing-power-to-the-people/, Paid at timepoints; $15 at baseline, scaling up to $30 at 12 months, plus $5 for each of the 9 monthly assessments, Patients receive free TENS unit and $200; clinics receive $200 per subject enrolled and bonuses for completing training, For completing a study survey (increased to $20 from $10), For responding to PRO assessments; loaning smartphones/tablets, Gift cards and CME credit for clinicians who complete study training, Piloted an incentive program for adherence targets, For participation in baseline and follow-up interviews, ranging from $20 to $50. The study found that the amount of payment affected willingness to participate but did not have a negative impact on risk assessment (Cryder et al. 2019). Could there be alternative benefits, such as lower copays for broad consent to research. What is fair participant selection? Genetic data, for example, has narrow and well-defined privacy risks at the individual level, but when combined with many other peoples genetic information the nature of the risk can change. Research involving children: regulations, review boards and reform. What kinds of use should be paid for? Incentives for treatment completion or ongoing adherence to the treatment plan will usually not occur in standard practice. It is difficult to describe accurately the range of practices regarding payments in PCTs because there is a paucity of systematic information about PCT practices. 2002;23(6):519-36. doi: 10.1023/a:1021337801802. This paper proposes a practical framework for itemizing and evaluating these justifications for monetary compensation so as to limit the risk of unduly influencing potential research participants. Are Payments to Human Research Subjects Ethically Suspect? We conclude by offering some policy implications. There are two problems with Emanuels critique of the unreasonable risk view. IRB 34 (1):1-8. An official website of the United States government. Paying research participants: the outsized . Although many of the ethical concerns related to incentives and payments in explanatory trials pertain to PCTs, the pragmatic features may introduce additional challenges. Largent EA, Lynch HF. 2018. - Abstract - Europe PMC. Providing participants with enough compensation helps investigators do this (Largent and Fernandez Lynch 2018). Nevertheless, such payments continue to engender controversy, and the payment-related policies and practices of institutional review boards (IRBs) often reflect some discomfort with payment. (2013) found that 43% of subjects failed to disclose concurrent enrollment in another study, 28% did not disclose prescription drug use, 25% admitted to exaggerating symptoms, and 14% said they had pretended to have a health problem they did not have. After carefully considering both sides of the debate, they argue that concerns about undue influence have had a disproportionate impact on bioethical thinking about paying research subjects and that we should pay greater attention to the problems related to underpayment (Largent and Fernandez Lynch 2017b). Thus far, we have seen that, while empirical evidence suggests that money is often a motivating factor for enrolling in research, it does not support the widely held belief that money frequently unduly influences judgment and decision-making related to participation. The New England Journal of Medicine, DOI: 10.1056/NEJMsb1710591, Forthcoming, Harvard University - Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics, Harvard University - Department of Health Policy & Management, Harvard University - Boston Childrens Hospital, Harvard University - Harvard Medical School, Department of Medical Ethics and Health Policy, Perelman School of Medicine, University of Pennsylvania. Gelinas L, Largent EA, Cohen IG, et al. Furthermore, researchers may pursue non-monetary ways to accommodate subjects interests and to express appreciation for their contributions. Second, the studies did not test for the effect of socioeconomic status (SES) on decision-making, although they did include participants from diverse educational and income levels. They found that payment influenced willingness to participate but not assessment of risk. Experimental evidence, Journal of Empirical Research on Human Research Ethics. Other studies have found rates of deception by research subjects ranging from 3% to 25% (Lee at al. Concealment and fabrication by experienced research subjects, Whats the price of a research subject? None of the foregoing discussion suggests that bioethicists and IRB members should not be concerned about the potential for effects of financial compensation on research subjects decision-making and behavior. (2013) found that a significant percentage of respondents admitted that they had lied to investigators or withheld information to qualify for enrollment in a study. The ethics of payments to research participants | 3ie First, oversight committees are not perfect, and they sometimes make mistakes concerning risk/benefit assessments due to lack of information about risks, insufficient time to review proposals, or a failure to appreciate the seriousness of risks (Klitzman 2015, Resnik 2018). 2023 Apr-Jun 01;37(2):107-112. doi: 10.1097/WAD.0000000000000556. FOIA Chen et al. This is the third in a series of blogs on ethics in social science research. 8600 Rockville Pike Money for Research Participation: Does It Jeopardize Informed Consent? Having examined ethical issues related to paying human subjects too much money, we shall now consider issues related to underpayment. A Framework for Ethical Payment to Research Participants by Luke Gelinas, Emily Largent, I. Glenn Cohen, Susan Kornetsky, Barbara Bierer, Holly Fernandez Lynch :: SSRN Not Available For Download A Framework for Ethical Payment to Research Participants The New England Journal of Medicine, DOI: 10.1056/NEJMsb1710591, Forthcoming Posted: 24 Sep 2018 Incentives are used in explanatory trials with the intent to change participant behaviors, such as adherence to a study intervention or attending study visits. McNeill (1999), for example, argues that offers to pay individuals money to participate in research might interfere with their ability to assess risks and benefits. This framework divides payment into reimbursement, compensation, and incentives, focusing on fairness and promoting adequate . A Framework for Ethical Payment to Research Participants Bioethicist and IRB Chair at the National Institute of Environmental Health Science, National Institutes of Health. If a payment or incentive is ethically appropriate in a PCT, it will be for reasons that would make it appropriate in an explanatory trial. Since members of the control group had no reason to lie about their vaccination status, their responses to this question were used as a baseline estimate of the vaccination rate for this population (Fernandez Lynch et al. To learn more, visit A response to Wilkinson and Moore, Does incentivising pill-taking crowd out risk-information processing? In: The TiME Trial: A Fully Embedded, Cluster-Randomized, Pragmatic Trial of Hemodialysis Session Duration, An analysis of U.S. Practices of paying research participants, Why Do We Pay?