the ethical anatomy of payment for research participants

The principle of respect for autonomy has a high relevance for the practice of payment for research subjects as one of the most commonly expressed concerns is that payment can be coercive or constitute an undue inducement (undue influence), thus compromising the validity of informed consent (e.g., Macklin 1981; Faden and Beauchamp 1986; McNeill 1997; Dickert and Grady 1999, 2008; Largent et al. And the prospect of receiving monetary compensation is one of three top reasons (34% mentioning) impacting a decision to enroll into a study (Center for Information and Study on Clinical Research Participation 2019). - Abstract - Europe PMC Europe PMC is an archive of life sciences journal literature. 2019. How IRBs view and make decisions about coercion and undue influence. Journal of Evaluation in Clinical Practice 16 (2): 318322. Recruitment criteria should reflect the scientific purpose of the study, not target populations which are considered easy to recruit simply because of their easy availability, their compromised position, or their manipulability (National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. Aim: Our aim was to examine REC policies . BMJ. 2008. 2019). 2018; Manton et al. New York: Oxford University Press. Socially valuable human biomedical research is critically dependent on successful enrolment and retention of a sufficient number of appropriate participants, and on their willingness to comply with study procedures and conditions. 2019. The reason being the fact that the consequentialistic principle of social beneficence does not exhaust the reining normative framework for human biomedical research. Resnik, David B. American Journal of Bioethics 1 (2): 5354. For the sake of the analysis to come, it is assumed that paid participation in biomedical research is a form of paid bodily services, and it should be no more worrisome to commodify a persons labor [bodily serviceJR] as a research subject than to commodify a persons labor in other contexts, which happens all the time (Lynch 2014, p. 159). Carlisle, Benjamin, Jonathan Kimmelman, Tim Ramsay, and Nathalie MacKinnon. PLoS ONE 10 (5): e0127242. Although space does not permit discussing in details how a proper amount of such defined payment should be calculated, a proposal widely advocated in the literature should be mentioned here, namely a minimum hourly wage benchmark. Definitions Reimbursement: Money given to the research participant that reflects out of pocket expenses associated with participating in a research study (e.g. Probstfield, Jeffrey L., and Robert L. Frye. The ethics of payments to research participants | 3ie Regulations (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC. Central to the ethical challenges in financially compensating participants in research is that money may unduly induce people to take part. Insufficient or slow recruitment and poor retention rates are, however, a common problem within biomedical research, especially in randomized controlled trials (Salman et al. To report or not to report: Exploring healthy volunteers rationales for disclosing adverse events in Phase I drug trials. Barriers to patient enrollment in therapeutic clinical trials for cancer: a landscape report. 2018, 2020). Exploiting a research underclass in phase 1 clinical trials. Recompense may include three sub-categories of payments: (i) reimbursement of direct financial expenses incurred as a result of participation in research (e.g. 2001. 2018; Manton et al. U.S. Food and Drug Administration: Office of the Commissioner, Office of Clinical Policy and Programs, Office of Clinical Policy, Office of Good Clinical Practice. The mild-torture economy: exploring the world of professional research subjects and its ethical implications. If remuneration is considered as a price for participation, the amount of payment is determined by market forcessupply and demand, and it does not have to be proportionate to the value of the subjects contribution. The paper deals with the widespread practice of paying research participants in exchange for their valuable service without determining whether the service should be treated as an unskilled labor, regular work, body renting, or a unique sui generis endeavor (cf. Joanna Ryska. Offering disproportionally high and/or differential remuneration does not violate requirements of justice insofar as the payment is designed to help the study to meet its social and scientific goals by enhancing recruitment and retention of the necessary category of subjects, and it does not reproduce or reinforce wider social inequities and injustices, e.g., racial biases or class differences (Persad et al. BMC Medical Research Methodology 6 (1): 19. Journal of Medical Ethics 30 (3): 293298. Payment for Research Participation: A Coercive Offer? Radder, Hans. For an individual prospective participant, the payment is a part of an equation for the overall attractiveness of a research project. Journal of Medical Ethics 31 (9): 542547. Google Scholar. However, when it is to be offered, the offer should satisfy the requirement of distributive and commutative justice. Such a deceptive behavior by participants may take various forms (e.g., nondisclosure of concurrent enrollment in other studies, concealment of tobacco use, alcohol consumption, or illicit substance abuse, concealment of pre-existing medical conditions, falsification of current health status, over-reporting of a study protocol adherence, etc. Firstly, biomedical research is a social practice embedded in specific social reality shaped by its historical and cultural roots, reigning power- and economic relations, and normative fabrics. 2015; Carlisle et al. These categories are distinguished by a different impact each of them has on the participants economic position as evaluated ex post. The ethical anatomy of payment for research participants The Belmont report: Ethical principles and guidelines for the protection of human subjects of research. Whats in a wage? Nine Rules for Billing Ethically and Getting Paid on Time 2001. JAMA 283 (20): 27012711. primary guidance on ethical principles for researchers and Research Ethics Boards (REBs) that are important to consider when making decisions about compensation for research participants (TCPS, 2014). Paying Research Participants: Regulatory Uncertainty, Conceptual 2005. McNeill, Paul. Thus, societies have a prima facie moral obligation to promote the conduct of biomedical research, including research involving human subjects. 2002. Abstract. This paper aims at clarifying these issues. To date, neither the rate of payment-induced deception nor the influence of payment amount has been systematically studied in a nationally representative randomized survey experiment. 2007. Why do we pay? These latter obligations may be viewed as constituting a general imperative of non-exploitation that sets boundaries for the practice of human biomedical research, in general, and for the practice of paying participant, in specific. 2013, 2019). King Reame, Nancy. Association between financial incentives and participant deception about study eligibility. Is payment a benefit. Cryder, Cynthia E., Alex J. London, Kevin G. Volpp, and George Loewenstein. JAMA 293 (5): 609612. 2015. Medicine, Health Care and Philosophy The recruitment of normal healthy volunteers: A review of the literature on the use of financial incentives. I would like to thank Greene and Brown (2022) for their comments on my paper "The ethical anatomy of payment for research participants" (Ryska 2022), and for giving me an opportunity to . Journal of Law, Medicine & Ethics 32 (1): 100105. Bioethical issues in providing financial incentives to research articipants. Abstract. 2010). Geneva: Council for International Organizations of Medical Sciences. Grady, Christine, Neal Dickert, Tom Jawetz, Gary Gensler, and Ezekiel J. Emanuel. To sum-up, the payment for research subjects is an incentive or inducement for participation grounded in the principle of social beneficence. Finally, what is rarely observed, the principle of respect for autonomy provides a general support for public policies which allow remuneration of research subjects for their contributionsboth in the form of reward and priceas it calls for respecting peoples right to decide freely in what practices and activates they what to engage in for the sake of earning their living. 2000, p. 2706). A theory of justice. 2019). The authors propose a framework for evaluating the appropriateness of payments to research participants. Exploitation in clinical research. 2001. 2019b; Chino and Zafar 2019), reimbursement of direct expenses may improve access to potentially beneficial studies for patients, who otherwise would not be able to participate due to their low SES or disease-caused greater sensitivity to economic burdens associated with research. Bioethics 27: 105116. Largent, Emily A., Ezekiel J. Emanuel, and Holly Fernandez Lynch. Most probably, it is because research is about advancing the interests of science and society, not the interests of individual participants (Emanuel et al. Accessed 28 Aug 2021. Compensating for research risk: Permissible but not obligatory. Background: Payment of research participants helps to increase recruitment for research studies, but can pose ethical dilemmas. Money, Coercion, and Undue Inducement: Attitudes about Payments to Barriers to clinical trial enrollment in racial and ethnic minority patients with cancer. Yes. They may, however, be higher than rewards and they may vary within the same study on the basis of salient characteristics of particular groups of participants (i.e., their age, sex, race, ethnicity, rare clinical status etc.). Center for Bioethics and Biolaw, Faculty of Philosophy, University of Warsaw, Krakowskie Przedmiescie 3, 00-047, Warsaw, Poland, You can also search for this author in Additionally, only very small portion of eligible adult oncological patients choose to enroll into trialsdepending on a source the portion range from 3 to 5% or 8% (Bell and Balneaves 2015; American Cancer Society Cancer Action Network 2018)leading to a conclusion that if the proportion of patients with cancer who agree to participate in clinical trials were to increase from its current 5% to 10%, the usual study completion rate would decrease from around 4years to 1year. The ethical anatomy of payment for research participants by Dr. Joanna Ryska This is a foundational paper that offers a systematic, principle-based ethical analysis of payment practices and . 2010. 2010; Probstfield and Frye 2011; Treweek et al. Ezekiel J. Emanuel - 2004 - Journal of Law, Medicine and Ethics 32 (1):100-105. 2018. 2018; Persad et al. Remuneration is equitable when it does not violate the norm equal pay for equal work (Dickert and Grady 1999; Resnik 2015; Gelinas et al. Rawls, John. Cancer patient decision making related to clinical trial participation: An integrative review with implications for patients relational autonomy. 2022 May 24. doi: 10.1007/s11019-022-10092-1. Additionally, some studies suggest that payment can enhance autonomous decision-making by drawing prospective subjects attention to research risks and inconveniences (Cryder et al. Fortaleza, Brazil. 2014. International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. Statistics and ethics in medical research: III How large a sample? Kennedy Institute of Ethics Journal 29 (4): 305331. Communicate the fee arrangement before you start the case. Admittedly, biomedical research enterprise does not aim at broadening the scope of subjects freedom or autonomy. U.S. Code of Federal Regulations, Title 45: Public Welfare, Part 46: Protection of human subjects. Most research participants declare they spend the money on everyday living, and only a small part on drugs (Festinger & Dugosh, 2012; Slomka et al., 2007). Numerous authors and guidelines suggest that the amount should be based on the minimum hourly wage in the region or country as a point of reference (Council for International Organizations of Medical Sciences 2016, Commentary to Guideline 15, 53; National Health and Medical Research Council 2019, Appendix 1, 7) with augmentations for particularly burdensome procedures (Ackerman 1989; Dickert and Grady 1999; Grady 2005; Gelinas et al. In contrast to most publications on the ethics of paying research subjects, which start by identifying and analyzing major ethical concerns raised by the practice (in particular, risks of undue inducement and exploitation) and end with a set ofmore or less well-justifiedethical recommendations for using payment schemes immune to these problems. Also the UK Health Research Authority sympathises with the view that not to allow payments on the basis of risk would be unduly paternalistic in the absence of evidence that the participants ability to provide valid consent would be compromised (2014, par. Glannon, William. 2019. 2005a. Largent, Emily A., Christine Grady, Franklin G. Miller, and Allan Wertheimer. 2007. Campbell, Marion K., Claire Snowdon, David Francis, Diana R. Elbourne, Alison M. McDonald, Resemary C. Knight, Vikki Entwistle, Jo Garcia, Ian Roberts, and STEPS Group. Wertheimer, Alan. 90. https://rm.coe.int/16800d3810. We also included a multiple-choice question on research ethics guidelines: If an ethics . Dickert, Neal W. 2009. 2011. Clinical Trials 17 (3): 264272. Although a detailed analysis of this issue goes beyond the scope of this analysis, three following arguments provide strong reasons for arguing that adequate remuneration for research subjects should be proportionate also to the level of risk involved in participation: (i) an argument from consistency, which notices that risk-based remuneration is accepted in many non-research contexts, e.g., in high-risk professions (Menikoff 2001; Jones and Liddell 2009); (ii) an argument from the nature of human guinea pigging which claims that the assumption of risk is often an essential contribution of research participants (Menikoff 2001; Ryska 2018; Malmqvist 2019); (iii) an argument for public trust, which argues that paying proportionally to the incurred risk meets expectations regarding the fair treatment of a significant portion of prospective subjects as well as researchers, REC/IRB members, and other members of the research community (Czarny et al. Remuneration is adequate when it is proportionate in value to the value of participants contribution to the study. Payment is a recruitment incentive justified and prima facie required by social beneficence, not by justice or fairness. 2019. Yale Journal of Health Policy, Law, and Ethics 17 (1): 61141. Therefore, there are no ethical grounds (either paternalistic or non-paternalistic) for depriving competent individuals an opportunity to serve as research subjects in exchange for money, provided that their decision to participate in a given study is autonomous (i.e., based on comprehensive and adequately understood information, and free from unduly controlling influences). https://www.wma.net/policies-post/wma-declaration-of-helsinki-ethical-principles-for-medical-research-involving-human-subjects/. Moriarty, Jeffrey. But it does not require paying participants of low SES in order to alleviate or remove hardships of their position. 2013; Heller et al. 2010. The strength of the obligation to offer payment for participation grows in relation to studies which are urgently needed, e.g., to address acute public-health emergencies (such as a dire pandemic), or when there is strong evidence that without payment recruitment, retention and completion of socially valuable studies would be doomed or severely compromised. 2017a. Cancer Control 23 (4): 327337. While they do not provide an ethical rationale for offering payment for research participations by themselves, they set contours for an ethically sound payment practice. 22) for offering payment to research participants is to boost recruitment and retention rates. A Framework for Ethical Payment to Research Participants 2021. 2002; Grady et al. A Framework for Ethical Payment to Research Participants. Clinical Trials 14 (5): 526536. Largent, Emanuel and Lynch claim that when goods and services are not indented as gifts, failure to pay for them is a problem: we call it theft (2019, p. 1), thus suggesting that this is exactly what happens when participants are not fairly paid for their contribution to the common good. Accessed 28 Aug 2021. Systematic review and meta-analysis of the magnitude of structural, clinical, and physician and patient barriers to cancer clinical trial participation. Since progress in biomedical science and healthcare is not ethically discretionary, this section argues that neither efficient enrolment nor payment for research subjects, being conductive to the latter, are value-neutral practices. What makes clinical research ethical? PubMedGoogle Scholar. Thus, the principle of respect for autonomy supports paying subjects recompenses, which make the participation in research a cost-free and revenue-neutral activity. In other words, an adequate diversity of gender, race, ethnicity, age and SES in research should be sought (Geller et al. Fry, Craig L., Alison Ritter, Simon Baldwin, Kathryn J. Bowen, T. Paul Gardiner, Rebecca Jenkinson Holt, and Jennifer Johnston. The latter value necessary depends on various factors, including (i) time allotted to research; (ii) efforts or types of services rendered (e.g., performing psychological or physical tests, taking drugs or using device as instructed, conducting self-monitoring or gathering other research-relevant information); (iii) discomfort, burdens or inconveniences associated with participation (e.g., stress, pain, suffering, but also burdens related to sticking to a dietary regime or inconveniences caused by the expected lifestyle changes); (iv) the level of risk involved in research, and (v) special/unique value of the input of the specific subject (e.g. Social Epistemology 31 (5): 431450. 2013; Gelinas et al. Compensating clinical trial participants from limited resource settings in internationally sponsored clinical trials: A proposal. 2009. However, the same principle justifies the claim that payment for participation should not be overly attractive. 2009, p. 70). An ethical framework for the practice of paying research subjects. loss of wage in result of taking unpaid leave from work); and (iii) compensation for financial and non-financial losses resulting from injuries suffered as a direct consequence of participation in research. Lynch, Holly F., Thomas C. Darton, Jae Levy, Frank McCormick, Ubaka Ogbogu, Puth O. Payne, Alvin E. Roth, Akilah Jefferson Shah, Thomas Smiley, and Emily A. Largent. Contemporary Clinical Trials 72: 146157. Improving informed consent and enhancing recruitment for research by understanding economic behavior. Health Technology Assessment. European Union. Guinea-pigging. good which has two characteristics: it is non-exhaustible (one persons use does not diminish anothers use)and is beneficial for all or almost all members of a society.Footnote 2. 1971. 2013. https://doi.org/10.1136/bmj.b4145. 2011. The principle of justice provides a strong ethical reason for not offering recompenses for lost wages (or loss of other reasonably expected profits). Explanatory report to Additional Protocol to Convention on human rights and biomedicine concerning biomedical research. Paying research participants: Regulatory uncertainty, conceptual confusion, and a path forward. 3.1.2., 3.1.8., 3.1.9.) https://www.acscan.org/policy-resources/clinical-trial-barriers. The New England Journal of Medicine 378 (8): 766771. The term recompense stands for any payment that entails no net benefit to recipients. 2003. Dunn, Laura B., and Nora E. Gordon. Contemporary Clinical Trials 39 (2): 169182. Controlled Human Infection Print (CHIM) research involves the infection by otherwise healthy participants with disease often by the sake away vaccine d. The COVID-19 pandemic has emphasised the urgency of enhancing CHIM research capability and the importance of having clearance ethic guidance for their execution. Jamrozik, Euzebiusz, and Michael J. Selgelid. 2004. Although prominent international guidelines and national regulations call attention to the crucial moral issues that payment raises (in particular, the risk of undue influence), they offer little substantive guidance on how to pay research subjects in an ethical way, and if they do so, they often provide contradictory advice. Macklin, Ruth. 2019). Paying people to participate in research: Why not? Bioethics 11 (5): 373389. Moreover, all canonical guidelines on human research ethics exclude non-direct and non-medical benefits to research subjects, such as payment, from the riskbenefit analysis, thereby forbidding IRBs/RECs to take payment into account as a benefit to counterbalance research risks (Emanuel et al. Journal of Clinical Research Best Practices 15 (6): 2374. Australian Research Council and Universities Australia. Kim. Center for Information and Study on Clinical Research Participation. Millum, Joseph, and Michael Garnett. Journal of Medical Ethics 36 (1): 3436. A Framework for Ethical Payment to Research Participants. 2015. 2018. The removal of these barriers by covering the relevant expenses is important for promoting potential subjects autonomy, because it enables individuals to exercise their free will to contribute to the development of science by serving as research subjects. 1997. Nuffield Council on Bioethics. The ambiguity undermines the conceptual and normative value of highly popular payment scheme advocated by Gelinas, Largent, Lynch, and collaborators (Gelinas et al. https://doi.org/10.1007/s11019-022-10092-1, DOI: https://doi.org/10.1007/s11019-022-10092-1. Williams, Rebecca J., Tony Tse, Katelyn DiPiazza, and Deborah A. Zarin. In the United Kingdom, the NHS Health Research Authority guidance (2014) follows terminology developed by the Nuffield Council on Bioethics. This principle grounds a general prima facie moral obligation of offering payment to research subjects. Hamel, Lauren M., Louis A. Penner, Terrance L. Albrecht, Elisabeth Heath, Klement C. Gwede, and Susan Eggly. Miller, Franklin G., and Howard Brody. The Lancet 383 (9912): 176185. Accessed 28 Aug 2021. 2019. transportation, or parking). There is some evidence that too attractive remuneration may increase the risk of jeopardizing subjects health by encouraging them to conceal or misrepresent information important for their safety in order to ensure recruitment or continued participation in paid research (Bentley and Thacker 2004; Devine et al.
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