The ethical anatomy of payment for research participants

Joanna Różyńska

doi:10.1007/s11019-022-10092-1

The ethical anatomy of payment for research participants

Różyńska, Joanna 2022-09-01 00:00:00 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 of—more or less well-justified—ethical recommendations for using payment schemes immune to these problems, this paper offers a systematic, principle-based ethical analysis of the practice. It argues that researchers have a prima facie moral obligation to offer payment to research subjects, which stems from the principle of social beneficence. This principle constitutes an ethical “spine” of the practice. Other ethical principles of research ethics (respect for autonomy, individual beneficence, and justice/ fairness) make up an ethical “skeleton” of morally sound payment schemes by providing additional moral reasons for offering participants (1) recompense for reasonable expenses; and (2a) remuneration conceptualized as a reward for their valuable contribution, provided (i) it meets standards of equality, adequacy and non-exploitation, and (ii) it is not overly attractive (i.e., it does not constitute undue inducement for participation or retention, and does not encourage deceptive behaviors); or (2b) remuneration conceptualized as a market-driven price, provided (i) it is necessary and designed to help the study achieve its social and scientific goals, (ii) it does not reinforce wider social injustices and inequalities; (iii) it meets the requirement of non-exploitation; and (iv) it is not overly attractive. The principle of justice provides a strong ethical reason for not offering recompenses for lost wages (or loss of other reasonably expected profits). Keywords Research ethics · Payment for research participants · Social beneficence · Autonomy · Justice/fairness · Undue inducement · Exploitation What are the ethical principles or values which constitute Grady 1999; Grady 2001, 2005; Gelinas et al. 2018; Resnik an ethical rationale for paying research subjects? Do those 2015, 2019; Largent and Lynch 2017a, 2017b). As a con- create a moral obligation to pay individuals for participa- sequence—while there is a growing consensus that an ethi- tion in biomedical research, or rather a mere justification cally sound payment scheme should avoid both excessive for its acceptability? What other ethical principles and val- payment and underpayment, and it should include, at least, ues shape the payment practice, and how? Surprisingly, reimbursement of reasonable expenses and compensation for these questions have been rarely the subject of in-depth some contributions made by research subjects—there is no discussions in the literature. Instead of exploring the ethi- generally accepted view on whether a payment to research cal foundations of payments systematically, scholars and subjects (as such or of a certain kind) is a moral obliga- public-policy makers rather focus on payment-related ethical tion (Council for International Organizations of Medical concerns, in particular of undue inducement and exploita- Sciences 2016), merely an “acceptable practice” (Food and tion, and—from this perspective—recommend or discourage Drug Administration 2018), “ethically discretionary” activ- certain forms, schedules and timings of payment commonly ity (Persad et al. 2019, p. 319), or just a “necessary evil”. used in research practice (e.g., Macklin 1981; Dickert and Equally, there is no common view on what constitutes an ethical source of this purported obligation or acceptability of payment (as such or of a certain kind), and which ethical * Joanna Różyńska reasons lie behind different payment categories and schemes. j.rozynska@uw.edu.pl This paper aims at clarifying these issues. It presumes that any discussion on ethically sound payment practice Center for Bioethics and Biolaw, Faculty of Philosophy, should be preceded by a clear statement of ethical reasons University of Warsaw, Krakowskie Przedmiescie 3, 00-047 Warsaw, Poland Vol.:(0123456789) 1 3 450 J. Różyńska for paying research participants, their deontic nature and “reimbursement” for direct costs and other “payment” for mutual relations. Without full understanding of the ethical participation, which it considered to be more ethically chal- anatomy of payment, it is impossible to determine what we lenging as in some cases it may constitute an undue influence owe, if anything, to research subjects—what for, and how to prospective subjects. The Council of Europe’s Additional much research participants should be paid. Protocol to the Convention on human rights and biomedi- cine, concerning biomedical research mentions „payments and rewards” without any additional differentiations, in the Preliminary terminological remarks Appendix containing a template of an information sheet for the ethics committee (2005a). The term is “unpacked” in the Paying research subjects for their participation in biomedical Explanatory Report to Article 12 of the Additional Protocol studies is an increasingly common practice across different dealing with undue inducement which refers to “compensa- types of research involving healthy volunteers and patients tion” for burdens and inconveniences and “reimbursement” (Grady et al. 2005; Largent and Lynch 2017a). Nevertheless, for expenses and financial losses (Council of Europe 2005b, the payment continues to raise numerous conceptual, ethi- sec. 64). Australian guidelines on Payment of participa- cal and practical controversies among bioethicists, investiga- tion in research: information for researchers, HRECs and tors, research ethics committees/institutional review boards other ethics review bodies issued by the National Health (RECs/IRBs), and other members of the research com- and Medical Research Council (2019) divide “payment” for munity. Although prominent international guidelines and participants in four analytical categories: “reimbursement” national regulations call attention to the crucial moral issues for any research-related expenses; “compensation” for any that payment raises (in particular, the risk of undue influ- documented financial losses resulting from participation in ence), they offer little substantive guidance on how to pay research, including loss of wages, or from an injury suffered research subjects in an ethical way, and if they do so, they as a direct consequence of participation; “remuneration” often provide contradictory advice. For instance, the World paid to participants in recognition of their service for the Medical Association Declaration of Helsinki (2013) does not time spent and other inconveniences resulting from partici- address payment for research participation directly. It only pation; and “incentive or inducement” provided to individu- mentions that information on “incentives for subjects” must als simply to encourage their enrolment or continuation in be contained in the study protocol (par. 22). Also, the U.S. research. In the United Kingdom, the NHS Health Research “Common rule” (Department of Health and Human Services Authority guidance (2014) follows terminology developed 2018) and the European Union “Clinical Trial Regulation” by the Nuffield Council on Bioethics. The Council, in its (2014) offer very limited guidance on payment for partici- report Human bodies: donation for medicine and research pants. All these regulatory lacunas and contradictions are (2011) distinguishes three forms of payment: (i) “recom- reflected in considerable variation in local payment policies pense” offered in recognition of losses incurred which may and practices around the world (Dickert et al. 2002; Grady take a form of “reimbursement” of direct financial expenses, et al. 2005; Fry et al. 2005; Ndebele et al. 2008; Pasqualetti lost earnings, or “compensation” for non-financial losses, et al. 2010; Roche et al. 2013; Largent and Lynch 2017a). such as time, inconvenience and discomfort; (ii) “reward” One of the factors which adds to this confusion is the defined as a “material advantaged gained by a person …that diversity and ambiguity of terminology used in the litera- goes beyond ‘decompensating’ the person for losses they ture and guidelines on research payment. For example, the incurred”; “reward” becomes “remuneration” when calcu- International ethical guidelines for health-related research lated as a wage or equivalent”; and (iii) “purchase”—money involving humans of the Council for International Organi- given in exchange of a “thing” (e.g., biological material for zations of Medical Sciences (CIOMS) make a distinc- research) (Nuffield Council on Bioethics 2011, p. 2). tion between “reimbursement” for reasonable direct costs In order to bring an end to this terminological (and incurred by research subjects and “compensation” for the conceptual) chaos, in this analysis, “payment” is used as time spent and other inconveniences resulting from study an overarching term that encompasses all forms of finan- participation (2016, Guideline 13 and Commentary). The cial and in-kind support provided to research participants. Guideline for good clinical practice issued by the Interna- It covers two sub-categories, which will be referred to as tional Conference on Harmonisation of Technical Require- “recompense” and “remuneration”. These categories are ments for Registration of Pharmaceuticals for Human Use distinguished by a different impact each of them has on the speaks of “payments and compensation” (2016, par. 3.1.2., participant’s economic position as evaluated ex post. 3.1.8., 3.1.9.) with no further explanation. The U.S. Food and Drug Administration Guidance for institutional review board and clinical investigators: payment and reimburse- 1 This is an improved version of the payment typology presented in ment to research subjects (2018) makes a distinction between Różyńska (2021). 1 3 The ethical anatomy of payment for research participants 451 The term “recompense” stands for any payment that entirely different criteria in one scheme. Such a mistake entails no net benefit to recipients. Recompense amends to affects all typologies of research payments which, alongside research participants for financial and non-financial losses or recompenses and remunerations, distinguish “incentives” or injuries resulting from their participation in research. Thus, “inducements” payments. This mistake originates from the this type of payment does not constitute a gain or profit, fact that the former two categories of payments are defined but merely covers—understood in broad terms—costs of the by the payment impact on the subject baseline economic participation. Recompense may include three sub-categories position, the latter is based on the researcher’s intention. of payments: (i) reimbursement of direct financial expenses Secondly, by rejecting the term”compensation”, the pro- incurred as a result of participation in research (e.g. costs of posed typology avoids conceptual and normative confusion travel, accommodation, meals, childcare); (ii) compensation stemming from ambiguity of this notion in legal terminol- for indirect financial expenses, i.e., losses, that arise from ogy, where it stands for both money received in return for participation in research (e.g. loss of wage in result of taking services rendered, especially salaries or wages, and for pay- unpaid leave from work); and (iii) compensation for financial ment of damages for loss or injury (Różyńska 2021). The and non-financial losses resulting from injuries suffered as a ambiguity undermines the conceptual and normative value direct consequence of participation in research. of highly popular payment scheme advocated by Gelinas, “Remuneration” refers to any payment provided to indi- Largent, Lynch, and collaborators (Gelinas et al. 2018; Per- viduals for their service as research participants, which sad et al. 2019; Lynch et al. 2021; Bierer et al. 2021). Fol- exceeds expenses, losses or injuries experienced by par- lowing Christine Grady’s terminology (2005), the authors ticipants as a result of their participation, and brings net separate “reimbursement”, “compensation”, and “incen- benefit (gain, profit) for recipients. The remuneration for tive”. Trapped by the ambiguous language of “compensa- research participation (same as for “regular work”) may be tion”, they frame remuneration as recompense for losses, understood either as a reward given in recognition of and as arguing that “participants' time, as well as their assumption an appreciation for participants’ valuable contribution; or of research-related burden and inconvenience … are criti- as a price—money given in direct, market-driven exchange cal contributions experienced as losses by participants; they for a service provided by participants (cf. Moriarty 2020; are giving up or accepting unfavorable as a result of par- Różyńska 2021). If the remuneration is understood as a ticipation. Thus, the same justifications applicable to reim- reward, the payment should be adequate to the desert, i.e., to bursement applied here” (Lynch et al. 2021, p. 16). At the the value of participants’ contribution. The latter value nec- same time, applying the logic of remuneration, they reject essary depends on various factors, including (i) time allotted compensating participants based on their opportunity costs, to research; (ii) efforts or types of services rendered (e.g., noting that “rather, research compensation is an acknowl- performing psychological or physical tests, taking drugs or edgement of participants’ contributions to research, which using device as instructed, conducting self-monitoring or leads to the conclusion that there generally should be equal gathering other research-relevant information); (iii) discom- pay for equal work” (Lynch et al. 2021, p. 16). fort, burdens or inconveniences associated with participa- Finally, the advocated typology allows for separating pay- tion (e.g., stress, pain, suffering, but also burdens related to ments form small gifts given at the conclusion of a study sticking to a dietary regime or inconveniences caused by the (such as chocolates, T-shirts, cups, pens, cinema-tickets) that expected lifestyle changes); (iv) the level of risk involved have minimal market value, serve only as token of appre- in research, and (v) special/unique value of the input of the ciation, and have likely zero impact on recruitment (Grady specific subject (e.g. due to rarity of a disease suffered by 2005). the person or her genetic make-up). If remuneration is con- Having clarified basic terminological and conceptual sidered as a price for participation, the amount of payment issues, we can move on and explore the ethical anatomy of is determined by market forces—supply and demand, and payment for research participants. It would be useful, how- it does not have to be proportionate to the value of the sub- ever, to indicate briefly—from the outset—the scope of the jects’ contribution. In literature and guidelines, the latter forthcoming analyses. way of thinking about payment if often concealed under the The paper deals with the widespread practice of paying concept of “incentive” or “inducement”, although—as it will research participants in exchange for their valuable service be explained later—these labels are far from being adequate without determining whether the service should be treated and should be abandoned. as an unskilled labor, “regular” work, body renting, or a The above typology of payments for research participation unique sui generis endeavor (cf. Lemmens and Elliott 1999, is preferable over other schemes proposed in the literature 2001; King Reame 2001; Anderson and Weijer 2002; Elliott and regulatory documents at least for three reasons. First, 2008; Abadie 2015; Phillips 2011b; Lynch 2014; Różyńska it is built upon one clearly defined, objective and disjoint 2018). For the sake of the analysis to come, it is assumed divisional criterion, thereby avoiding a mistake of mixing that paid participation in biomedical research is a form of 1 3 452 J. Różyńska paid bodily services, and it should be “no more worrisome Biomedical research is social practice aimed at generat- to commodify a person’s labor [bodily service—JR] as a ing such a common good—generalizable scientific knowl- research subject than to commodify a person’s labor in other edge that may contribute to the improvement of healthcare contexts, which happens all the time” (Lynch 2014, p. 159). interventions and public health measures, thus leading to the Therefore, commodification concerns against research pay - advancement of human health (cf. Schaefer et al. 2009; Rho- ment, raised by some commentators (Macklin 1989; Cham- des 2010; London et al. 2010). Health is highly valued by all bers 2001; Abadie 2010, 2015; Cooper and Waldby 2014; individuals and societies primarily “because of what it ena- Walker and Fisher 2019) will not be explored here. bles us to do” (Duncan 2010, p. 321). A minimum threshold Since the paper focuses on the most fundamental ethi- of physical and mental capacities is necessary (though not cal basis of payment practice, it is limited to monetary sufficient) for an individual to be able to pursue her particu- offers (paid in cash, cheques or pre-paid credit cards) as lar life goals, plans, and projects that express her vision of a a paradigmatic case of payment, leaving aside all forms good life. Since all liberal and democratic societies share a of in-kind support. This paper also leaves aside payments fundamental moral (and political) commitment to protecting to participants unable to give consent, because those raise and respecting each person’s right to lead her life in accord- additional, substantive issues, as well as recompenses for ance with her personal views of what is valuable in human research-related injuries as they would require in-depth legal life, they also share a moral obligation to encourage forms of analysis. The presented analysis applies to research which social collaboration useful in fulfilling basic health needs of RECs/IRBs would consider scientifically and ethically sound their members (London 2003, 2006; Rawls 1971; Nussbaum thus presenting arguments that payment is offered to over - 2013). This includes the practice of healthcare as well as shadow or mask some ethical dec fi iencies of a study project, biomedical research, because the capacity of a society to sat- especially those regarding its risk–benefit profile or criteria isfy its members’ basic health interests is conditional upon of subjects selection. In other words, it considers “research progress in biomedical sciences, which in turn is crucially which ethics committee would allow to proceed, were the dependent on various types of research, including human subject not paid” (Wilkinson and Moore 1997, p. 375). research. Thus, societies have a prima facie moral obligation to promote the conduct of biomedical research, including research involving human subjects. Ethical rationale for paying research Human biomedical research is a complex, collaborative participants social “enterprise”, involving various institutional and indi- vidual stakeholders with various, often conflicting, interests The main “pragmatic” reason (Largent and Lynch 2017a, (London et al. 2010; Różyńska 2015). Therefore, in order to p. 77 fn. 22) for offering payment to research participants is fulfill their obligation to promote biomedical research, socie- to boost recruitment and retention rates. This “efficiency”- ties should develop, implement and support normative and driven (Phillips 2011a) rationale is widely acknowledged. institutional mechanisms aimed ensuring the existence, sta- It is, however, rarely recognized as having not only practi- bility and effectiveness of research practice in attaining the cal, but also an ethical facet. Since progress in biomedical common good (London et al. 2010; Resnik 2011; Różyńska science and healthcare is not ethically discretionary, this 2015). These mechanisms should enhance all stakeholders’ section argues that neither efficient enrolment nor payment trust and willingness to support and invest in the research for research subjects, being conductive to the latter, are enterprise, including prospective research participants with- value-neutral practices. On the contrary, they are ethically out whom biomedical research would not be able to achieve grounded in and governed by the principle of social benefi- its goals. cence that calls for maximization of a common good, i.e. Socially valuable human biomedical research is criti- good which has two characteristics: it is non-exhaustible cally dependent on successful enrolment and retention of a (one person’s use does not diminish another’s use) and is sufficient number of appropriate participants, and on their beneficial for all or almost all members of a society. willingness to comply with study procedures and condi- tions. Failure to recruit or retain participants may lead Developing an appropriate understanding of a common good, also to invalid or inconclusive research data, it may result in referred to as a public, social or collective good, is a challenge that cannot be addressed here. For the sake of this analysis, I use all these terms interchangeably, as is frequently done in the literature. My understanding of a common good is based on the conceptual analy- Footnote 2 (continued) sis provided by Hans Radder (2017). It is also inspired by Alex Lon- don’s idea of “the generic interests conception of the common good” members of the community… interests in being able to develop their by assuming that a social practice or policy is socially valuable when intellectual and affective capacities in order to pursue activities that it overall promotes “a subset of interests that are sufficiently basic they find meaningful, and to engage in meaningful relationships with or fundamental to individuals that they are common to each of the others” (2003, p. 21). 1 3 The ethical anatomy of payment for research participants 453 premature termination of a study, increase research costs, Thus, although it is rightly stressed in the literature that and—what is the most important—delay or even hinder the exact impact of paying for participation on the rates of scientific progress and the anticipated development of research enrollment and retention remains still under-inves- safer and more effective diagnostic, prophylactic and ther - tigated, it is reasonable to assume that payment can make a apeutic interventions (Altman 1980; Halpern et al. 2002; positive difference in this respect (Dunn and Gordon 2005; Gul and Ali 2010; Williams et al. 2015; Carlisle et al. Watson and Torgerson 2006; Caldwell et al. 2010; Probst- 2015). Insufficient or slow recruitment and poor retention field and Frye 2011; Treweek et al. 2013; Nipp et al. 2019b; rates are, however, a common problem within biomedical Parkinson et al. 2019). Money may remove participation bar- research, especially in randomized controlled trials (Sal- riers for those individuals who are unable or unwilling to man et al. 2014). A systematic review shows that less than cover direct costs associated with research, such as costs of half of trials achieve their original recruitment target goal traveling, lodging or hiring a babysitter. The payment may in time (Campbell et al. 2007; cf. Sully Ben et al. 2013; attract people who would be otherwise discouraged from Parkinson et al. 2019). Additionally, only very small por- the participation by the necessity of taking unpaid leave tion of eligible adult oncological patients choose to enroll from work and resulting loss of wages. It may help to make into trials—depending on a source the portion range from a positive enrollment decision for those, who feel forced 3 to 5% or 8% (Bell and Balneaves 2015; American Can- by their low social-economic status (SES) to dedicate time cer Society Cancer Action Network 2018)—leading to a and efforts for searching for a job or earning their living, conclusion that “if the proportion of patients with cancer instead of altruistically contributing to the development of who agree to participate in clinical trials were to increase science. Additionally, an offer of payment could convince from its current 5% to 10%, the usual study completion to participation persons who believe that their private or rate would decrease from around 4 years to 1 year. Another professional time is particularly valuable (for example due estimate suggests that at least 16 million more individu- to their unique responsibilities, competences, or skills), and, als are needed to participate in research trials each year” therefore, they should not allot it to alternative causes with- (Schaefer et al. 2009, p. 70). out an adequate remuneration. In all these cases, payment Many different factors contribute to the low participa- may enhance recruitment, provided it is designed in a way tion and retention rates. Although barriers of structural that targets the underlying barriers, needs, or expectations. and clinical character, such as access to trials and eligibil- Insofar as these factual assumptions about inducing ity requirements, seems to be the most important, concerns potential of money are true—and we concede them for the regarding financial costs and benefits linked to research par - sake of the argument—the principle of social beneficence ticipation also play a significant role in prospective subjects’ provides fundamental ethical rationale for paying research decision-making (Friedman et al. 2015; Hamel et al. 2016; subjects. Offering payment to participants is an ethically American Cancer Society Cancer Action Network 2018; right and prima facie obligatory practice because it increases Nipp et al. 2019a, Unger et al. 2013, 2019). Recent statis- research recruitment and retention, thereby contributing to tics published by the Center for Information and Study on the common good produced by the research enterprise. From Clinical Research Participation show that information about a broader perspective, “it is useful in fulfilling society’s potential costs and their reimbursement as well as informa- obligation to meet the essential [health-related] needs of its tion about compensation for time off from work are among members” (Ackerman 1989, p. 1). The strength of the obli- the most important factors influencing a decision to partici - gation to offer payment for participation grows in relation pate in research for—respectively—58% and 40% potential to studies which are urgently needed, e.g., to address acute subjects (2019). And the prospect of receiving monetary public-health emergencies (such as a dire pandemic), or compensation is one of three top reasons (34% mentioning) when there is strong evidence that without payment recruit- impacting a decision to enroll into a study (Center for Infor- ment, retention and completion of socially valuable studies mation and Study on Clinical Research Participation 2019). would be doomed or severely compromised. The strength These data are consistent with results of numerous empirical of the obligation weakens when—due to study-specific studies on subjects’ motivations for volunteering, conducted features—payment offers are not needed to secure an ade- among patients and healthy volunteers. They all indicate that quate number of participants, i.e., where it is reasonable to although the payment is not the only reason why people assume that people will be willing to join the study for non- agree to participate in biomedical research, it is definitely economic and social reasons, e.g., the prospect of direct or one of the top motivates for enrollment, especially among ancillary medical benefits, the wish to make a contribution healthy volunteers (Tishler and Bartholomae 2002; Almeida to medical progress or the health of others, scientific curios- et al. 2007; Abadie 2010; McCann et al. 2010; Stunkel and ity, interest in the goals of the study, the prospect of making Grady 2011; Grady et al. 2017; Fisher et al. 2018; Manton friends or having new experiences (Stunkel and Grady 2011; et al. 2019). Grady et al. 2017; Fisher et al. 2018; Manton et al. 2019). 1 3 454 J. Różyńska Additionally, the obligation to pay research participants Autonomy and payment may be overridden by justified research budget constraints. If investigators have no money to pay for participation in a One of the core values behind the imperative of non- socially valuable research project, it is better to allow them exploitation in research is the value of human autonomy. to proceed without payment, than obliging them to pay, The principle of respect for autonomy is a cornerstone of thereby forcing them to resign from conducting the study modern research ethics (National Commission for the Pro- (Gelinas et al. 2018). tection of Human Subjects of Biomedical and Behavioral To sum-up, the payment for research subjects is an incen- Research 1979; Faden and Beauchamp 1986; Emanuel et al. tive or inducement for participation grounded in the princi- 2000; Beauchamp and Childress 2001). It is also a bedrock ple of social beneficence. This is expressive verbis acknowl- of a fundamental ethical requirement for research, namely edged by the U.S. Food and Drug Administration (2018) informed consent that serves to “ensure not only that indi- guidance which argues that payment to research subjects viduals control whether or not they enroll in clinical stud- is “a recruitment incentive” and by the European Union’s ies”, but also that “they participate only when doing so is Clinical Trial Regulation (2014) which refers to any pay- consistent with their values and interests” (Emanuel et al. ment offered to trial participants as “incentives or finan- 2000, p. 2706). cial inducements” (art. 31.1(d); art. 32.1(d), 33(d)). Thus, The principle of respect for autonomy has a high rel- payment is not, as some scholars and guidelines suggest, evance for the practice of payment for research subjects a demand of justice or fairness (Gelinas et al. 2018, 2020; as one of the most commonly expressed concerns is that Persad et al. 2019; Lynch et al. 2021) or requirement of payment can be coercive or constitute an undue induce- non-maleficence and beneficence for an individual subject ment (undue influence), thus compromising the validity (Bierer et al. 2021). These principles, supplemented by the of informed consent (e.g., Macklin 1981; Faden and Beau- principle of respect for autonomy and other considerations champ 1986; McNeill 1997; Dickert and Grady 1999, 2008; regarding non-exploitation, are nevertheless very important. Largent et al. 2013; Gelinas et al. 2018, 2020). It is claimed While they do not provide an ethical rationale for offering that very high or (for other reasons) overly attractive pay- payment for research participations by themselves, they set ment may undermine the capacity of individuals to make contours for an ethically sound payment practice. autonomous decisions regarding study participation, by compromising their voluntariness, ability to adequate under- stand and assess research risks and benefits, or by “forc- ing” them to make choices against their “better judgment or Ethical contours of an ethically sound deeply held beliefs” (Council for International Organizations payment practice of Medical Sciences 2016, p. 54). Although there is still a substantial disagreement in the Offering payment for research participants is an incentive literature about whether an offer of payment may be per - prima facie required by the principle of the social benefi- ceived as coercion, what exactly constitutes undue induce- cence. This does not imply, however, that it is ethical to set ment, and whether money can distort or compromise autono- payment at whatever level necessary and sufficient to attract mous decision-making (Macklin 1981, 1989; Wilkinson and an adequate number of proper subjects in a timely fashion. Moore 1997; Grady 1999, 2001, 2005; Grant and Sugarman On the contrary, no matter how payment is important and 2004; Emanuel 2004, 2005; Wertheimer and Miller 2008; effective as an incentive for participation, not every amount, Klitzman 2013; Largent et al. 2013; Resnik 2015, 2019; method and timing of payment is acceptable. The reason Belfrage 2016; Largent and Lynch 2017a, 2017b; Millum being the fact that the consequentialistic principle of social and Garnett 2019), existing guidelines and regulatory docu- beneficence does not exhaust the reining normative frame- ments disallow payment, which may unduly seduce people work for human biomedical research. The ethics of biomedi- to consent for participation (Largent and Lynch 2017a). cal research is built upon a matrix of principles and values Thus, even though overly attractive payment offers could which strives to find an adequate balance between the imper - enhance timely recruitment by “alluring” a sufficient num- ative to advance interests of science and society (“research ber of adequate individuals to join and stay in a study even imperative”) and obligations of all societies to protect other against their better judgment, there is a regulatory consensus important interests of their members, especially interests of that such payment should not be offered. research participants and/or involved communities. These The ethical unacceptability of such an overly attractive latter obligations may be viewed as constituting a general payment stems from the respect for autonomy. However, “imperative of non-exploitation” that sets boundaries for the it also finds support in the principle of social beneficence. practice of human biomedical research, in general, and for Common sense and empirical evidence, although still lim- the practice of paying participant, in specific. ited, suggest that attractive payments may have a negative 1 3 The ethical anatomy of payment for research participants 455 impact on scientific value of research, as it may encourage valuable and risky service or work. Therefore, there are no potential and/or actual participants to withhold or misrep- ethical grounds (either paternalistic or non-paternalistic) for resent information, which are critical for their recruitment depriving competent individuals an opportunity to serve as eligibility or continuation in research (Bentley and Thacker research subjects in exchange for money, provided that their 2004; Dresser 2013; Dickert 2013; Devine et al. 2013, 2015; decision to participate in a given study is autonomous (i.e., Largent and Lynch 2017a; McManus and Fisher 2018; based on comprehensive and adequately understood infor- Lynch et al. 2019). Such a concealment, fabrication or falsi- mation, and free from unduly controlling influences). fication by participants create risks for participants, but also Moreover, some studies suggest that remuneration can for research resources and the integrity of research data as in fact play a positive role in prospective subjects’ consent it can bias the results and undermine the validity of a study process by reducing the therapeutic misconception and high- (Lee et al. 2018). And—if it occurs frequently enough—it lighting research risks. Money might send a message to par- may jeopardize the whole research enterprise. Therefore, ticipants that they take risks and burdens for the sake of the assuming—what stills needs to be explored empirically— benefit of science and society and “should be compensated a positive correlation between the prevalence of deceptive for it, which would not occur if they were … expected to behaviors and the attractiveness of payment (which depends benefit from it.” (Glannon 2006, p. 252; also Dickert and not only on the amount, but also on payment method and Grady 1999; Grady 2001, 2005; Menikoff 2001; Largent and timing), the principle of social beneficence provides ethi- Lynch 2017a). Additionally, some studies suggest that pay- cal reasons for employing payment strategies which do not ment can enhance autonomous decision-making by drawing involve overly attractive payment schemes. prospective subjects’ attention to research risks and incon- The principle of respect for autonomy has fueled much veniences (Cryder et al. 2010; Largent and Lynch 2017a; of scholarly discussion on unethical nature of overly attrac- Fisher et al. 2019). tive payment. However, little attention has been paid to that principle in the context of no-payment and underpayment. Justice, fairness and payment Undoubtedly, the lack of resources to cover direct or indi- rect costs associated with the participation may constitute Another ethical principle that has a direct relevance for the a barrier for individuals, who otherwise would be willing practice of paying research subjects is the principle of jus- to take part in research (American Cancer Society Cancer tice, both in its distributive and commutative dimensions. Action Network 2018; Nipp et al. 2019a; Largent and Lynch Many scholars worry that payment may be more attractive 2018; Bierer et al. 2021). The removal of these barriers by to individuals of lower SES, and thus offering payment for covering the relevant expenses is important for promoting participation may result in unfair distribution of research potential subjects’ autonomy, because it enables individuals benefits and burdens across the general population (e.g., to exercise their free will to contribute to the development of Maclin 1981, 1989; Faden and Beauchamp 1986; Acker- science by serving as research subjects. Thus, the principle man 1989; McNeill 1997; Grady 2005; Dickert and Grady of respect for autonomy supports paying subjects recom- 2008; Gelinas et al. 2018). The worse-off will shoulder a penses, which make the participation in research a cost-free disproportionate share of burdens of research, while the and revenue-neutral activity. benefits will accrue primarily to the better-off. A different, Finally, what is rarely observed, the principle of respect yet linked, concern relates to the risk of exploitation of for autonomy provides a general support for public poli- research participants, especially those of low SES (Lem- cies which allow remuneration of research subjects for their mens and Elliott 1999; Shamoo and Resnik 2006; Elliott contributions—both in the form of reward and price—as it 2008; Elliott and Abadie 2008; Abadie 2010, 2015; Stones calls for respecting people’s right to decide freely in what and McMillan 2010; Phillips 2011a; Resnik 2015, 2019; practices and activates they what to engage in for the sake of Largent and Lynch 2017b; Gelinas et al. 2020; Bierer earning their living. As Wilkinson and Moore note, “denying et al. 2021; MacKay and Walker 2021). Exploitation in people the option of taking inducements reduces their free- research is about the unfair distribution of goods that dom, since it removes an option that they prefer to the alter- arise from interaction between researchers and partici- natives” (Wilkinson and Moore 1997, p. 377). Admittedly, pants (Wertheimer 2008). “One party gets too little, while biomedical research enterprise does not aim at broadening the other gets too much. Often, but not always, the unfair the scope of subjects’ freedom or autonomy. Nevertheless, distribution arises because one party to the interaction is it should not restrict people’s choices without a good rea- in a weak position, due to poverty, ignorance, or extreme son. Participation in socially valuable biomedical research, urgency, which the other party can take advantage of, whether or not one is paid for it, is neither morally wrong offering few benefits” (Emanuel 2004, p. 101). Economi- nor bad for the person concerned. On the contrary, it is con- cally disadvantaged individuals are in need of money and sidered at least as good as engaging in any other socially they tend to value a specific amount of payment more. For 1 3 456 J. Różyńska many of them accepting an offer of unfairly low but still participants to engage in scientifically and socially valuable en bloc beneficial payment for participation might be a biomedical research. reasonable choice. After all, even small payment is better Payment is a recruitment incentive justified and prima than no payment at all, although it constitutes a (mutually facie required by social beneficence, not by justice or fair - beneficial and consensual) exploitation. ness. However, when it is to be offered , the offer should sat - These concerns are highly important, but—as it is shown isfy the requirement of distributive and commutative justice. below—they do not exhaust the role of justice/fairness in It is commonly accepted that the principle of justice shaping an ethically sound payment practice. Moreover, in requires distributing burdens and benefits of study partici - order to fully understand their consequences for ethics of pation in such a way that no segment of the population is paying research subjects, it is essential to note two things. unduly burdened by research or denied its potential or actual Firstly, biomedical research is a social practice embedded benefits. Recruitment criteria should reflect the scientific in specific social reality shaped by its historical and cultural purpose of the study, not target populations which are con- roots, reigning power- and economic relations, and norma- sidered “easy to recruit” “simply because of their easy avail- tive fabrics. This social reality is marked by profound social ability, their compromised position, or their manipulability” and economic inequities (within concrete societies as well (National Commission for the Protection of Human Sub- as at the level of international community), which should be jects of Biomedical and Behavioral Research. 1979). Thus, mitigated, and ideally eliminated by broad social reforms. researchers must neither exploit the vulnerable, in particu- Research enterprise should not entrench or exacerbate these lar economically disadvantaged, nor exclude without good background social injustices. However, it is neither designed reason those who stand to benefit from study participation. for nor capable of actively fighting them, especially against They should strive to recruit an adequate cross-section of participants’ poverty, unemployment or lack of access to the population in order to spread research burdens and ben- high-quality healthcare (Fisher 2019). Justice in research efits fairly across the population. In other words, an ade- requires treating all research participants fairly and equita- quate diversity of gender, race, ethnicity, age and SES in bly, also when it comes to payment for their participation. research should be sought (Geller et al. 2011; Kwiatkowski But it does not require paying participants of low SES in et al. 2013; Heller et al. 2014; Winter et al. 2018; cf. Dickert order to alleviate or remove hardships of their position. Such 2009; Bierer et al. 2021). It is worth noting that the last pos- a positive impact of research payment on subjects’ social or tulate finds an additional support in the principle of social economic condition is laudable, and even desirable, but it is beneficence as it enables the generalization of knowledge not a demand of justice. to be gained in research, thereby enhancing research scien- Moreover, contrary to views of some commentators, the tific and social value (Wilkinson and Moore 1997 ; Grady commutative justice per se does not require offering pay - 2005; Resnik 2015; Largent and Lynch 2017b). Thus, jus- ments to research subjects. Largent, Emanuel and Lynch tice encourages payment schemes which have a potential of claim that “when goods and services are not indented as making distribution of research burdens fairer. And justice gifts, failure to pay for them is a problem: we call it theft” is against schemes that can deepen social inequalities, lead (2019, p. 1), thus suggesting that this is exactly what happens to unfair social distribution of research burdens and benefits when participants are not fairly paid for their contribution to or exploitation. the common good. Despite its rhetorical attractiveness, this What should research subjects be paid for and in which claim cannot be accepted as it rests on two mistakes. Firstly, amount to make payment consistent with demands of jus- it ignores the power of consent. Valid consent of a prospec- tice? Firstly, justice-related considerations provide an ethi- tive subject for using her body for research purposes trans- cal justification for paying research subjects a recompense forms theft into gift, lease, rent, work or other consensual for direct costs related to research participation. By making relation with a researcher. Second, it forgets that it takes two participation in research a cost-free activity, recompense willing parties to change provision of goods or services into removes—at least some—economic barriers for participa- transaction, i.e., exchange of goods and services in return for tion, thus equalizing opportunities for all willing individu- money. Thus, when a researcher is unable (e.g., due to budg- als to contribute to the development of science, no matter etary constraints) or uninterested in offering payment for their SES. Moreover, as studies already referred to suggest prospective participants (e.g., due to availability of sufficient (Unger et al. 2013, 2016, 2019; American Cancer Society number of unpaid subjects), or when a prospective partici- Cancer Action Network 2018; Nipp et al. 2019b; Chino and pant is genuinely willing to contribute to the development of Zafar 2019), reimbursement of direct expenses may improve science without any remuneration and reimbursement, there access to potentially beneficial studies for patients, who is no ground for transaction. And there is nothing essentially otherwise would not be able to participate due to their low unfair in allowing researchers and altruistically motivated SES or disease-caused greater sensitivity to economic bur- dens associated with research. Thus, the reimbursement of 1 3 The ethical anatomy of payment for research participants 457 direct costs has a potential to enhance justice in research not Health Research Authority 2014, par. 3.4; Council for only by reducing inequities in access to research for those International Organizations of Medical Sciences 2016, p. who otherwise could not afford it, but also by contributing 53; Food and Drug Administration 2018; National Health to the fair distribution of clinical benefits associated with and Medical Research Council 2019, par. 1.1). Only a few, participation. however, mention the level of research risks among factors Secondly, the principle of justice provides a strong which should be taken into consideration when determining ethical reason for disallowing recompenses for the loss of an adequate amount of payment. Moreover, those that do so reasonably expected profits, especially lost wages. Such provide conflicting instructions on this matter. For example, recompenses lead to differential payments between par - the CIOMS Guidelines expressis verbis state that “the level ticipants—individuals who receive higher wages get higher of compensation should not be related to the level of risk recompense; those who are lower paid by employees—lower that participants agree to undertake” (2016, Commentary on recompense, and those who are unemployed—no recom- Guideline 13). In contract, the Australian National Health pense at all. This is consistent with a norm of equity, as and Medical Research Council’s guideline reads: “In cases it makes participation a revenue-neutral activity for all, no where risk may be considered as a factor in determining matter how much they earn. Nevertheless, it is very likely payment, payment of participants based on the degree of to reinforce unfair distribution of research risks and ben- risk associated with the research is not prohibited, so long efits between different social strata by prompting research- as there is evidence that a participant’s ability to provide ers to make savings by drawing research participants from valid consent is not likely to be compromised” (2019, par. “cheaper” populations, especially from the unemployed and 1.3.). Also the UK Health Research Authority “sympathises the low-paid (Dickert and Grady 1999; Resnik 2015). with the view that not to allow payments on the basis of risk Thirdly, justice supports remuneration for participants’ would be unduly paternalistic in the absence of evidence that contributions to the development of science and society, pro- the participants’ ability to provide valid consent would be vided it is fair, i.e., equitable, adequate, and non-exploitive. compromised” (2014, par. 3.1.). Remuneration is equitable when it does not violate the norm These regulatory variations mirror the lack of consen- “equal pay for equal work” (Dickert and Grady 1999; Resnik sus regarding risk-based payments among research ethicists 2015; Gelinas et al. 2018, 2020; Persad et al. 2019). Equal (Grady 2001; Menikoff 2001; Jones and Liddell 2009; Saun- time, efforts, burdens and risks associated with participa- ders 2009; Grimwade et al. 2020; Lynch and Largent 2020; tion deserve equal remuneration (measured in market value, Jamrozik and Selgelid 2020). Although a detailed analysis rather than in nominal value in case of multi-site studies of this issue goes beyond the scope of this analysis, three conducted in different settings). However, when different following arguments provide strong reasons for arguing groups of participants in a study are expected to make die ff r - that adequate remuneration for research subjects should be ent contributions, equitable remuneration should reflect dif- proportionate also to the level of risk involved in participa- ferences in their input (Persad et al. 2019). This is consistent tion: (i) an argument from consistency, which notices that with equal respect and concern for each and every individual risk-based remuneration is accepted in many non-research and it prevents discrimination. contexts, e.g., in high-risk professions (Menikoff 2001; Remuneration is adequate when it is proportionate in Jones and Liddell 2009); (ii) an argument from the nature value to the value of participants’ contribution to the study. of human “guinea pigging” which claims that the assump- The latter necessarily depends on various factors which tion of risk is often an essential contribution of research determine how time- and effort-consuming, burdensome and participants (Menikoff 2001; Różyńska 2018; Malmqvist risky give research project is. For example, when a study 2019); (iii) an argument for public trust, which argues that involves 2 visits, each lasting 60-min and requires filling a paying proportionally to the incurred risk meets expectations questionnaire and giving a blood sample for further analysis, regarding the fair treatment of a significant portion of pro- and another project involves 4 visits of the same length and spective subjects as well as researchers, REC/IRB members, level of associated risks and burdens, participants of the lat- and other members of the research community (Czarny et al. ter study—ceteris paribus—should be offered remuneration 2010; Ripley et al. 2010; Largent et al. 2012; Grimwade of double the remuneration offered to the participant of the et al. 2020), thereby enhances public trust in research at first project. large. All guidelines and regulatory documents referred to Finally, remuneration is non-exploitive when it is not above follow this normative logic by recommending or lower than a socially accepted payment which is (or would permitting paying research participants an “appropriate” be) offered for a similarly time- and effort-consuming, bur - or “proportionate” or “just and fair” remuneration for the densome and risky activity, outside research context in time spent and other inconveniences resulting from the the same setting (Gelinas et al. 2018; Largent and Lynch study participation (Council of Europe 2005b, sec. 64; 2017b). Although space does not permit discussing in 1 3 458 J. Różyńska details how a proper amount of such defined payment injustices, e.g., racial biases or class differences (Persad should be calculated, a proposal widely advocated in the et al. 2019). literature should be mentioned here, namely a minimum hourly wage benchmark. Numerous authors and guidelines Individual beneficence and payment suggest that the amount should be based on the minimum hourly wage in the region or country as a point of refer- The principle of individual beneficence is rarely invoked in ence (Council for International Organizations of Medical the discussion on ethical payment practices. Most probably, Sciences 2016, Commentary to Guideline 15, 53; National it is because research is about advancing the interests of sci- Health and Medical Research Council 2019, Appendix 1, ence and society, not the interests of individual participants 7) with augmentations for particularly burdensome proce- (Emanuel et al. 2000; Miller and Brody 2003).While there are dures (Ackerman 1989; Dickert and Grady 1999; Grady studies which have a potential of direct therapeutic benefits for 2005; Gelinas et al. 2020), risks involved (Menikoff 2001), the participants, it is neither the goal of research practice, nor a and even other additional benefits (cf. Anderson and Wei- requirement that research should be beneficial for participants. jer 2002). This proposal has three advantages. It is rela- Moreover, all canonical guidelines on human research eth- tively easy to implement as it provides a clear method of ics exclude non-direct and non-medical benefits to research setting the baseline amount of reimbursement for research subjects, such as payment, from the risk–benefit analysis, participants. It allows for keeping payments sensitive to thereby forbidding IRBs/RECs to take payment into account specific features of the project and subjects’ contributions as a benefit to counterbalance research risks (Emanuel et al. by accepting relevant payment augmentations. And—since 2010; contra Wertheimer 2013). it sets the reference value of an non-exploitive remunera- Nevertheless, despite the above normative premises, in tion relatively low—“more researchers could afford to pay fact, individuals treat money as a benefit when considering an a fair wage and fewer would be inconvenienced by a pro- offer to participate, and deciding on entering the study (Abadie hibition on unfairly low wages” (Phillips 2011a, p. 219). 2010; Czarny et al., 2010; Stunkel and Grady 2011; Grady However, it also faces challenges. Offers of payment calcu- et al. 2017; Fisher et al. 2018; Manton et al. 2019). For an lated in such a way would be attractive for prospective sub- individual prospective participant, the payment is a part of jects with low SES, who have no reasonable alternatives to an equation for the overall attractiveness of a research pro- get engaged in better paid activities. But these offers would ject. Recompenses, when full and adequate, make the research likely have no impact on recruitment of individuals who participation cost-free for subjects, and—as shown above— are better-off, i.e., who have better paid jobs or capacity they can remove at least some entrance barriers for patients to make more money outside research context, thus poten- to potentially clinically beneficial studies. Remunerations— tially biasing the subjects’ recruitment. In contrast, the whether calculated as a reward or as a price—may constitute average-wage benchmark for non-exploitive remuneration, a gain for subjects, thereby making participation in research mentioned by some authors (Phillips 2011a) would seem overall beneficial from their personal perspective. fairer as it would make payment offers reasonably attrac- Thus, the principle of individual beneficence provides addi- tive to both individuals of SES and to those better-off, thus tional support for oe ff ring money to research subjects. How - promoting a fair distribution of research risks and benefits ever, the same principle justifies the claim that payment for between different social strata. participation should not be overly attractive. There is some Fourthly, the principle of justice does not prohibit remu- evidence that too attractive remuneration may increase the risk nerations going beyond what constitutes equitable, adequate, of jeopardizing subjects’ health by encouraging them to con- and minimally non-exploitive payment—i.e., remunerations ceal or misrepresent information important for their safety in driven by a market-driven forces. Although such payments order to ensure recruitment or continued participation in paid are conceptualized as “price” for desired services, in order research (Bentley and Thacker 2004; Devine et al. 2013, 2015; to avoid exploitation, they should not be lower than remu- Lee et al. 2018; Lynch et al. 2019). Such a deceptive behavior neration viewed as “reward”. They may, however, be higher by participants may take various forms (e.g., nondisclosure of than “rewards” and they may vary within the same study on concurrent enrollment in other studies, concealment of tobacco the basis of salient characteristics of particular groups of use, alcohol consumption, or illicit substance abuse, conceal- participants (i.e., their age, sex, race, ethnicity, rare clinical ment of pre-existing medical conditions, falsification of cur - status etc.). Offering disproportionally high and/or differ - rent health status, over-reporting of a study protocol adher- ential remuneration does not violate requirements of jus- ence, etc.), and it may result in severe adverse events or even tice insofar as the payment is designed to help the study to subjects’ death (Lee et al. 2018). 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 1 3 The ethical anatomy of payment for research participants 459 Table 1 The ethical anatomy of payment for research participants Recompense for reasonable Recompense for loss of reasonably Remuneration conceptualized as a reward for Remuneration conceptualized as a price driven expenses expected profits (e.g., wages) contribution (time, affords, burdens, risks) by supply-demand market forces Subject to the reservations listed below, payment for research participants is prima facie obligatory as it promotes the realization of a common good (socially valuable knowledge). Principle of social Enhances recruitment and retention Enhances recruitment and retention Enhances recruitment and retention rates by meeting participants’ financial needs, expectations, and beneficence rates by removing economic entry rates by making participation a aspirations. barriers. revenue-neutral activity. Reservation: When inadequate to contribution Reservation: When overly attractive, may increase and excessive may increase risk of biasing risk of biasing research data by encouraging research data by encouraging subjects to deceive subjects to deceive in order to be recruited and/or in order to be recruited and/or kept in research. kept in research. When inadequate to contribution and scant When unattractive or scant decreases the inducing decreases the inducing potential of payment. potential of payment. Subject to the reservations listed below, ethical payment promotes participants’ autonomy. Principle of Enables realization of an Enables realization of an individual’s Respects individuals’ ability and right to make autonomous choices regarding what profitable activities respect for individual’s free will to participate free will to participate in research by to engage in and what risks to undertake for money. autonomy in research by removing economic making participation a revenue-neutral Reduces risk of therapeutic misconception, thereby making decision to participate in research better entry barriers. activity. informed and more autonomous. Reservation: When excessive and/or overly attractive for other reasons may increase risk of impairing individuals’ judgment or their voluntariness (undue inducement). Subject to the reservations listed below, ethical payment makes participation en bloc more beneficial to participants. Principle of Reduces risk of participation having Reduces risk of participation having a Constitutes an economic gain which makes participation in research – from the subject’s perspective – individual a negative impact on the subject’s negative impact on the subject’s (more) beneficial. beneficence economic position (welfare) by economic position (welfare) by making Reservation: When excessive and/or overly attractive for other reasons may increase risk of making participation a cost-free participation a revenue-neutral activity. jeopardizing subjects’ health by encouraging them to conceal or misrepresent important information on activity. their health or health-related behaviors in order to be recruited and/or kept in research. Improves access to potentially beneficial research for patients with low SES. Subject to the exclusion and reservations listed below, ethical payment promotes fair distribution of research risks and benefits. Principle of Reduces inequality of opportunities UNACCEPTABLE: Promotes fair distribution of research risks and Does not violate the principle of justice, provided it justice to for individuals with low SES by benefits, provided it is equitable, adequate and is non-exploitive and does not reinforce wider Reinforces unfair distribution of removing economic entry barriers. non-exploitive. social injustices and inequalities research risks and benefits between social strata by prompting sponsors to Reservation: When unequitable, inadequate Reservation: When exploitive and/or based on draw participants from populations of and/or exploitive reinforces unfair distribution of background social injustices and inequalities low SES (the unemployed and the low- research risks and benefits between social strata reinforces unfair distribution of research risks and paid). as well as between researchers and participants. benefits between social strata as well as between researchers and participants. remuneration conceptualized as a market-driven price, Conclusions provided (i) the remuneration is necessary and designed to help the study achieve its social and scientific goals, The paper argues that the ethical anatomy of paying (ii) it does not reinforce wider social injustices and ine- research participants is built upon four basic principles qualities; (iii) it meets the requirement of non-exploita- of research ethics (and bioethics in general). The ethical tion; (iv) it is not overly attractive (as defined above). “spine” of the practice is the principle of social benefi- cence, which requires the maximization of the common good—in the case of research practice—socially valu- Obviously, a proper application of this ethical “skel- able scientific knowledge. This principle grounds a gen- eton” into research practice requires investigators and eral prima facie moral obligation of offering payment to RECs/IRBs to take into account “the nature of the study, research subjects. The remaining ethical principles con- the nature of participants contributions and vulnerabilities, stitute a “skeleton” of morally sound payment practices institutional and organizational guidelines, and local and by providing additional moral reasons for offering or not cultural norms” (Grady 2005, p. 1686). Moreover, to make offering certain types of payments to research participants. the proposed scheme fully helpful in determining whether As discussed above and presented in Table 1, the princi- any particular offer of payment is not overtly attractive ples argue for offering research participants: and whether it meets standards of not equality, adequacy and non-exploitation, further detailed analyses of these • recompense for reasonable expenses, but not for lost standards are needed. The proposed scheme should also wages (or loss of other reasonably expected profits); be tested against and enriched by further empirical stud- • remuneration conceptualized as a reward for their valu- ies about payment, especially about how money impacts able contribution, provided (i) the remuneration meets subjects’ decision-making processes and behaviors. standards of equality, adequacy and non-exploitation, and (ii) it is not overly attractive, i.e., it does not con- stitute undue inducement for participation or retention, Funding This analysis was supported by a grant of the National Sci- and does not encourage deceptive behaviors; ence Centre, Poland, No. 2015/17/B/HS1/02390. 1 3 460 J. Różyńska Data availability Not applicable. in clinical research. Journal of Clinical and Translational Sci- ence 5 (1): e159. https:// doi. org/ 10. 1017/ cts. 2021. 816. Caldwell, Patrina H., Sana Hamilton, Alvin Tan, and Jonathan C. Code availability Not applicable. Craig. 2010. 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Publisher: Springer Journals
Copyright: Copyright © The Author(s) 2022
ISSN: 1386-7423
eISSN: 1572-8633
DOI: 10.1007/s11019-022-10092-1
Publisher site: See Article on Publisher Site

Abstract

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 of—more or less well-justified—ethical recommendations for using payment schemes immune to these problems, this paper offers a systematic, principle-based ethical analysis of the practice. It argues that researchers have a prima facie moral obligation to offer payment to research subjects, which stems from the principle of social beneficence. This principle constitutes an ethical “spine” of the practice. Other ethical principles of research ethics (respect for autonomy, individual beneficence, and justice/ fairness) make up an ethical “skeleton” of morally sound payment schemes by providing additional moral reasons for offering participants (1) recompense for reasonable expenses; and (2a) remuneration conceptualized as a reward for their valuable contribution, provided (i) it meets standards of equality, adequacy and non-exploitation, and (ii) it is not overly attractive (i.e., it does not constitute undue inducement for participation or retention, and does not encourage deceptive behaviors); or (2b) remuneration conceptualized as a market-driven price, provided (i) it is necessary and designed to help the study achieve its social and scientific goals, (ii) it does not reinforce wider social injustices and inequalities; (iii) it meets the requirement of non-exploitation; and (iv) it is not overly attractive. The principle of justice provides a strong ethical reason for not offering recompenses for lost wages (or loss of other reasonably expected profits). Keywords Research ethics · Payment for research participants · Social beneficence · Autonomy · Justice/fairness · Undue inducement · Exploitation What are the ethical principles or values which constitute Grady 1999; Grady 2001, 2005; Gelinas et al. 2018; Resnik an ethical rationale for paying research subjects? Do those 2015, 2019; Largent and Lynch 2017a, 2017b). As a con- create a moral obligation to pay individuals for participa- sequence—while there is a growing consensus that an ethi- tion in biomedical research, or rather a mere justification cally sound payment scheme should avoid both excessive for its acceptability? What other ethical principles and val- payment and underpayment, and it should include, at least, ues shape the payment practice, and how? Surprisingly, reimbursement of reasonable expenses and compensation for these questions have been rarely the subject of in-depth some contributions made by research subjects—there is no discussions in the literature. Instead of exploring the ethi- generally accepted view on whether a payment to research cal foundations of payments systematically, scholars and subjects (as such or of a certain kind) is a moral obliga- public-policy makers rather focus on payment-related ethical tion (Council for International Organizations of Medical concerns, in particular of undue inducement and exploita- Sciences 2016), merely an “acceptable practice” (Food and tion, and—from this perspective—recommend or discourage Drug Administration 2018), “ethically discretionary” activ- certain forms, schedules and timings of payment commonly ity (Persad et al. 2019, p. 319), or just a “necessary evil”. used in research practice (e.g., Macklin 1981; Dickert and Equally, there is no common view on what constitutes an ethical source of this purported obligation or acceptability of payment (as such or of a certain kind), and which ethical * Joanna Różyńska reasons lie behind different payment categories and schemes. j.rozynska@uw.edu.pl This paper aims at clarifying these issues. It presumes that any discussion on ethically sound payment practice Center for Bioethics and Biolaw, Faculty of Philosophy, should be preceded by a clear statement of ethical reasons University of Warsaw, Krakowskie Przedmiescie 3, 00-047 Warsaw, Poland Vol.:(0123456789) 1 3 450 J. Różyńska for paying research participants, their deontic nature and “reimbursement” for direct costs and other “payment” for mutual relations. Without full understanding of the ethical participation, which it considered to be more ethically chal- anatomy of payment, it is impossible to determine what we lenging as in some cases it may constitute an undue influence owe, if anything, to research subjects—what for, and how to prospective subjects. The Council of Europe’s Additional much research participants should be paid. Protocol to the Convention on human rights and biomedi- cine, concerning biomedical research mentions „payments and rewards” without any additional differentiations, in the Preliminary terminological remarks Appendix containing a template of an information sheet for the ethics committee (2005a). The term is “unpacked” in the Paying research subjects for their participation in biomedical Explanatory Report to Article 12 of the Additional Protocol studies is an increasingly common practice across different dealing with undue inducement which refers to “compensa- types of research involving healthy volunteers and patients tion” for burdens and inconveniences and “reimbursement” (Grady et al. 2005; Largent and Lynch 2017a). Nevertheless, for expenses and financial losses (Council of Europe 2005b, the payment continues to raise numerous conceptual, ethi- sec. 64). Australian guidelines on Payment of participa- cal and practical controversies among bioethicists, investiga- tion in research: information for researchers, HRECs and tors, research ethics committees/institutional review boards other ethics review bodies issued by the National Health (RECs/IRBs), and other members of the research com- and Medical Research Council (2019) divide “payment” for munity. Although prominent international guidelines and participants in four analytical categories: “reimbursement” national regulations call attention to the crucial moral issues for any research-related expenses; “compensation” for any that payment raises (in particular, the risk of undue influ- documented financial losses resulting from participation in ence), they offer little substantive guidance on how to pay research, including loss of wages, or from an injury suffered research subjects in an ethical way, and if they do so, they as a direct consequence of participation; “remuneration” often provide contradictory advice. For instance, the World paid to participants in recognition of their service for the Medical Association Declaration of Helsinki (2013) does not time spent and other inconveniences resulting from partici- address payment for research participation directly. It only pation; and “incentive or inducement” provided to individu- mentions that information on “incentives for subjects” must als simply to encourage their enrolment or continuation in be contained in the study protocol (par. 22). Also, the U.S. research. In the United Kingdom, the NHS Health Research “Common rule” (Department of Health and Human Services Authority guidance (2014) follows terminology developed 2018) and the European Union “Clinical Trial Regulation” by the Nuffield Council on Bioethics. The Council, in its (2014) offer very limited guidance on payment for partici- report Human bodies: donation for medicine and research pants. All these regulatory lacunas and contradictions are (2011) distinguishes three forms of payment: (i) “recom- reflected in considerable variation in local payment policies pense” offered in recognition of losses incurred which may and practices around the world (Dickert et al. 2002; Grady take a form of “reimbursement” of direct financial expenses, et al. 2005; Fry et al. 2005; Ndebele et al. 2008; Pasqualetti lost earnings, or “compensation” for non-financial losses, et al. 2010; Roche et al. 2013; Largent and Lynch 2017a). such as time, inconvenience and discomfort; (ii) “reward” One of the factors which adds to this confusion is the defined as a “material advantaged gained by a person …that diversity and ambiguity of terminology used in the litera- goes beyond ‘decompensating’ the person for losses they ture and guidelines on research payment. For example, the incurred”; “reward” becomes “remuneration” when calcu- International ethical guidelines for health-related research lated as a wage or equivalent”; and (iii) “purchase”—money involving humans of the Council for International Organi- given in exchange of a “thing” (e.g., biological material for zations of Medical Sciences (CIOMS) make a distinc- research) (Nuffield Council on Bioethics 2011, p. 2). tion between “reimbursement” for reasonable direct costs In order to bring an end to this terminological (and incurred by research subjects and “compensation” for the conceptual) chaos, in this analysis, “payment” is used as time spent and other inconveniences resulting from study an overarching term that encompasses all forms of finan- participation (2016, Guideline 13 and Commentary). The cial and in-kind support provided to research participants. Guideline for good clinical practice issued by the Interna- It covers two sub-categories, which will be referred to as tional Conference on Harmonisation of Technical Require- “recompense” and “remuneration”. These categories are ments for Registration of Pharmaceuticals for Human Use distinguished by a different impact each of them has on the speaks of “payments and compensation” (2016, par. 3.1.2., participant’s economic position as evaluated ex post. 3.1.8., 3.1.9.) with no further explanation. The U.S. Food and Drug Administration Guidance for institutional review board and clinical investigators: payment and reimburse- 1 This is an improved version of the payment typology presented in ment to research subjects (2018) makes a distinction between Różyńska (2021). 1 3 The ethical anatomy of payment for research participants 451 The term “recompense” stands for any payment that entirely different criteria in one scheme. Such a mistake entails no net benefit to recipients. Recompense amends to affects all typologies of research payments which, alongside research participants for financial and non-financial losses or recompenses and remunerations, distinguish “incentives” or injuries resulting from their participation in research. Thus, “inducements” payments. This mistake originates from the this type of payment does not constitute a gain or profit, fact that the former two categories of payments are defined but merely covers—understood in broad terms—costs of the by the payment impact on the subject baseline economic participation. Recompense may include three sub-categories position, the latter is based on the researcher’s intention. of payments: (i) reimbursement of direct financial expenses Secondly, by rejecting the term”compensation”, the pro- incurred as a result of participation in research (e.g. costs of posed typology avoids conceptual and normative confusion travel, accommodation, meals, childcare); (ii) compensation stemming from ambiguity of this notion in legal terminol- for indirect financial expenses, i.e., losses, that arise from ogy, where it stands for both money received in return for participation in research (e.g. loss of wage in result of taking services rendered, especially salaries or wages, and for pay- unpaid leave from work); and (iii) compensation for financial ment of damages for loss or injury (Różyńska 2021). The and non-financial losses resulting from injuries suffered as a ambiguity undermines the conceptual and normative value direct consequence of participation in research. of highly popular payment scheme advocated by Gelinas, “Remuneration” refers to any payment provided to indi- Largent, Lynch, and collaborators (Gelinas et al. 2018; Per- viduals for their service as research participants, which sad et al. 2019; Lynch et al. 2021; Bierer et al. 2021). Fol- exceeds expenses, losses or injuries experienced by par- lowing Christine Grady’s terminology (2005), the authors ticipants as a result of their participation, and brings net separate “reimbursement”, “compensation”, and “incen- benefit (gain, profit) for recipients. The remuneration for tive”. Trapped by the ambiguous language of “compensa- research participation (same as for “regular work”) may be tion”, they frame remuneration as recompense for losses, understood either as a reward given in recognition of and as arguing that “participants' time, as well as their assumption an appreciation for participants’ valuable contribution; or of research-related burden and inconvenience … are criti- as a price—money given in direct, market-driven exchange cal contributions experienced as losses by participants; they for a service provided by participants (cf. Moriarty 2020; are giving up or accepting unfavorable as a result of par- Różyńska 2021). If the remuneration is understood as a ticipation. Thus, the same justifications applicable to reim- reward, the payment should be adequate to the desert, i.e., to bursement applied here” (Lynch et al. 2021, p. 16). At the the value of participants’ contribution. The latter value nec- same time, applying the logic of remuneration, they reject essary depends on various factors, including (i) time allotted compensating participants based on their opportunity costs, to research; (ii) efforts or types of services rendered (e.g., noting that “rather, research compensation is an acknowl- performing psychological or physical tests, taking drugs or edgement of participants’ contributions to research, which using device as instructed, conducting self-monitoring or leads to the conclusion that there generally should be equal gathering other research-relevant information); (iii) discom- pay for equal work” (Lynch et al. 2021, p. 16). fort, burdens or inconveniences associated with participa- Finally, the advocated typology allows for separating pay- tion (e.g., stress, pain, suffering, but also burdens related to ments form small gifts given at the conclusion of a study sticking to a dietary regime or inconveniences caused by the (such as chocolates, T-shirts, cups, pens, cinema-tickets) that expected lifestyle changes); (iv) the level of risk involved have minimal market value, serve only as token of appre- in research, and (v) special/unique value of the input of the ciation, and have likely zero impact on recruitment (Grady specific subject (e.g. due to rarity of a disease suffered by 2005). the person or her genetic make-up). If remuneration is con- Having clarified basic terminological and conceptual sidered as a price for participation, the amount of payment issues, we can move on and explore the ethical anatomy of is determined by market forces—supply and demand, and payment for research participants. It would be useful, how- it does not have to be proportionate to the value of the sub- ever, to indicate briefly—from the outset—the scope of the jects’ contribution. In literature and guidelines, the latter forthcoming analyses. way of thinking about payment if often concealed under the The paper deals with the widespread practice of paying concept of “incentive” or “inducement”, although—as it will research participants in exchange for their valuable service be explained later—these labels are far from being adequate without determining whether the service should be treated and should be abandoned. as an unskilled labor, “regular” work, body renting, or a The above typology of payments for research participation unique sui generis endeavor (cf. Lemmens and Elliott 1999, is preferable over other schemes proposed in the literature 2001; King Reame 2001; Anderson and Weijer 2002; Elliott and regulatory documents at least for three reasons. First, 2008; Abadie 2015; Phillips 2011b; Lynch 2014; Różyńska it is built upon one clearly defined, objective and disjoint 2018). For the sake of the analysis to come, it is assumed divisional criterion, thereby avoiding a mistake of mixing that paid participation in biomedical research is a form of 1 3 452 J. Różyńska paid bodily services, and it should be “no more worrisome Biomedical research is social practice aimed at generat- to commodify a person’s labor [bodily service—JR] as a ing such a common good—generalizable scientific knowl- research subject than to commodify a person’s labor in other edge that may contribute to the improvement of healthcare contexts, which happens all the time” (Lynch 2014, p. 159). interventions and public health measures, thus leading to the Therefore, commodification concerns against research pay - advancement of human health (cf. Schaefer et al. 2009; Rho- ment, raised by some commentators (Macklin 1989; Cham- des 2010; London et al. 2010). Health is highly valued by all bers 2001; Abadie 2010, 2015; Cooper and Waldby 2014; individuals and societies primarily “because of what it ena- Walker and Fisher 2019) will not be explored here. bles us to do” (Duncan 2010, p. 321). A minimum threshold Since the paper focuses on the most fundamental ethi- of physical and mental capacities is necessary (though not cal basis of payment practice, it is limited to monetary sufficient) for an individual to be able to pursue her particu- offers (paid in cash, cheques or pre-paid credit cards) as lar life goals, plans, and projects that express her vision of a a paradigmatic case of payment, leaving aside all forms good life. Since all liberal and democratic societies share a of in-kind support. This paper also leaves aside payments fundamental moral (and political) commitment to protecting to participants unable to give consent, because those raise and respecting each person’s right to lead her life in accord- additional, substantive issues, as well as recompenses for ance with her personal views of what is valuable in human research-related injuries as they would require in-depth legal life, they also share a moral obligation to encourage forms of analysis. The presented analysis applies to research which social collaboration useful in fulfilling basic health needs of RECs/IRBs would consider scientifically and ethically sound their members (London 2003, 2006; Rawls 1971; Nussbaum thus presenting arguments that payment is offered to over - 2013). This includes the practice of healthcare as well as shadow or mask some ethical dec fi iencies of a study project, biomedical research, because the capacity of a society to sat- especially those regarding its risk–benefit profile or criteria isfy its members’ basic health interests is conditional upon of subjects selection. In other words, it considers “research progress in biomedical sciences, which in turn is crucially which ethics committee would allow to proceed, were the dependent on various types of research, including human subject not paid” (Wilkinson and Moore 1997, p. 375). research. Thus, societies have a prima facie moral obligation to promote the conduct of biomedical research, including research involving human subjects. Ethical rationale for paying research Human biomedical research is a complex, collaborative participants social “enterprise”, involving various institutional and indi- vidual stakeholders with various, often conflicting, interests The main “pragmatic” reason (Largent and Lynch 2017a, (London et al. 2010; Różyńska 2015). Therefore, in order to p. 77 fn. 22) for offering payment to research participants is fulfill their obligation to promote biomedical research, socie- to boost recruitment and retention rates. This “efficiency”- ties should develop, implement and support normative and driven (Phillips 2011a) rationale is widely acknowledged. institutional mechanisms aimed ensuring the existence, sta- It is, however, rarely recognized as having not only practi- bility and effectiveness of research practice in attaining the cal, but also an ethical facet. Since progress in biomedical common good (London et al. 2010; Resnik 2011; Różyńska science and healthcare is not ethically discretionary, this 2015). These mechanisms should enhance all stakeholders’ section argues that neither efficient enrolment nor payment trust and willingness to support and invest in the research for research subjects, being conductive to the latter, are enterprise, including prospective research participants with- value-neutral practices. On the contrary, they are ethically out whom biomedical research would not be able to achieve grounded in and governed by the principle of social benefi- its goals. cence that calls for maximization of a common good, i.e. Socially valuable human biomedical research is criti- good which has two characteristics: it is non-exhaustible cally dependent on successful enrolment and retention of a (one person’s use does not diminish another’s use) and is sufficient number of appropriate participants, and on their beneficial for all or almost all members of a society. willingness to comply with study procedures and condi- tions. Failure to recruit or retain participants may lead Developing an appropriate understanding of a common good, also to invalid or inconclusive research data, it may result in referred to as a public, social or collective good, is a challenge that cannot be addressed here. For the sake of this analysis, I use all these terms interchangeably, as is frequently done in the literature. My understanding of a common good is based on the conceptual analy- Footnote 2 (continued) sis provided by Hans Radder (2017). It is also inspired by Alex Lon- don’s idea of “the generic interests conception of the common good” members of the community… interests in being able to develop their by assuming that a social practice or policy is socially valuable when intellectual and affective capacities in order to pursue activities that it overall promotes “a subset of interests that are sufficiently basic they find meaningful, and to engage in meaningful relationships with or fundamental to individuals that they are common to each of the others” (2003, p. 21). 1 3 The ethical anatomy of payment for research participants 453 premature termination of a study, increase research costs, Thus, although it is rightly stressed in the literature that and—what is the most important—delay or even hinder the exact impact of paying for participation on the rates of scientific progress and the anticipated development of research enrollment and retention remains still under-inves- safer and more effective diagnostic, prophylactic and ther - tigated, it is reasonable to assume that payment can make a apeutic interventions (Altman 1980; Halpern et al. 2002; positive difference in this respect (Dunn and Gordon 2005; Gul and Ali 2010; Williams et al. 2015; Carlisle et al. Watson and Torgerson 2006; Caldwell et al. 2010; Probst- 2015). Insufficient or slow recruitment and poor retention field and Frye 2011; Treweek et al. 2013; Nipp et al. 2019b; rates are, however, a common problem within biomedical Parkinson et al. 2019). Money may remove participation bar- research, especially in randomized controlled trials (Sal- riers for those individuals who are unable or unwilling to man et al. 2014). A systematic review shows that less than cover direct costs associated with research, such as costs of half of trials achieve their original recruitment target goal traveling, lodging or hiring a babysitter. The payment may in time (Campbell et al. 2007; cf. Sully Ben et al. 2013; attract people who would be otherwise discouraged from Parkinson et al. 2019). Additionally, only very small por- the participation by the necessity of taking unpaid leave tion of eligible adult oncological patients choose to enroll from work and resulting loss of wages. It may help to make into trials—depending on a source the portion range from a positive enrollment decision for those, who feel forced 3 to 5% or 8% (Bell and Balneaves 2015; American Can- by their low social-economic status (SES) to dedicate time cer Society Cancer Action Network 2018)—leading to a and efforts for searching for a job or earning their living, conclusion that “if the proportion of patients with cancer instead of altruistically contributing to the development of who agree to participate in clinical trials were to increase science. Additionally, an offer of payment could convince from its current 5% to 10%, the usual study completion to participation persons who believe that their private or rate would decrease from around 4 years to 1 year. Another professional time is particularly valuable (for example due estimate suggests that at least 16 million more individu- to their unique responsibilities, competences, or skills), and, als are needed to participate in research trials each year” therefore, they should not allot it to alternative causes with- (Schaefer et al. 2009, p. 70). out an adequate remuneration. In all these cases, payment Many different factors contribute to the low participa- may enhance recruitment, provided it is designed in a way tion and retention rates. Although barriers of structural that targets the underlying barriers, needs, or expectations. and clinical character, such as access to trials and eligibil- Insofar as these factual assumptions about inducing ity requirements, seems to be the most important, concerns potential of money are true—and we concede them for the regarding financial costs and benefits linked to research par - sake of the argument—the principle of social beneficence ticipation also play a significant role in prospective subjects’ provides fundamental ethical rationale for paying research decision-making (Friedman et al. 2015; Hamel et al. 2016; subjects. Offering payment to participants is an ethically American Cancer Society Cancer Action Network 2018; right and prima facie obligatory practice because it increases Nipp et al. 2019a, Unger et al. 2013, 2019). Recent statis- research recruitment and retention, thereby contributing to tics published by the Center for Information and Study on the common good produced by the research enterprise. From Clinical Research Participation show that information about a broader perspective, “it is useful in fulfilling society’s potential costs and their reimbursement as well as informa- obligation to meet the essential [health-related] needs of its tion about compensation for time off from work are among members” (Ackerman 1989, p. 1). The strength of the obli- the most important factors influencing a decision to partici - gation to offer payment for participation grows in relation pate in research for—respectively—58% and 40% potential to studies which are urgently needed, e.g., to address acute subjects (2019). And the prospect of receiving monetary public-health emergencies (such as a dire pandemic), or compensation is one of three top reasons (34% mentioning) when there is strong evidence that without payment recruit- impacting a decision to enroll into a study (Center for Infor- ment, retention and completion of socially valuable studies mation and Study on Clinical Research Participation 2019). would be doomed or severely compromised. The strength These data are consistent with results of numerous empirical of the obligation weakens when—due to study-specific studies on subjects’ motivations for volunteering, conducted features—payment offers are not needed to secure an ade- among patients and healthy volunteers. They all indicate that quate number of participants, i.e., where it is reasonable to although the payment is not the only reason why people assume that people will be willing to join the study for non- agree to participate in biomedical research, it is definitely economic and social reasons, e.g., the prospect of direct or one of the top motivates for enrollment, especially among ancillary medical benefits, the wish to make a contribution healthy volunteers (Tishler and Bartholomae 2002; Almeida to medical progress or the health of others, scientific curios- et al. 2007; Abadie 2010; McCann et al. 2010; Stunkel and ity, interest in the goals of the study, the prospect of making Grady 2011; Grady et al. 2017; Fisher et al. 2018; Manton friends or having new experiences (Stunkel and Grady 2011; et al. 2019). Grady et al. 2017; Fisher et al. 2018; Manton et al. 2019). 1 3 454 J. Różyńska Additionally, the obligation to pay research participants Autonomy and payment may be overridden by justified research budget constraints. If investigators have no money to pay for participation in a One of the core values behind the imperative of non- socially valuable research project, it is better to allow them exploitation in research is the value of human autonomy. to proceed without payment, than obliging them to pay, The principle of respect for autonomy is a cornerstone of thereby forcing them to resign from conducting the study modern research ethics (National Commission for the Pro- (Gelinas et al. 2018). tection of Human Subjects of Biomedical and Behavioral To sum-up, the payment for research subjects is an incen- Research 1979; Faden and Beauchamp 1986; Emanuel et al. tive or inducement for participation grounded in the princi- 2000; Beauchamp and Childress 2001). It is also a bedrock ple of social beneficence. This is expressive verbis acknowl- of a fundamental ethical requirement for research, namely edged by the U.S. Food and Drug Administration (2018) informed consent that serves to “ensure not only that indi- guidance which argues that payment to research subjects viduals control whether or not they enroll in clinical stud- is “a recruitment incentive” and by the European Union’s ies”, but also that “they participate only when doing so is Clinical Trial Regulation (2014) which refers to any pay- consistent with their values and interests” (Emanuel et al. ment offered to trial participants as “incentives or finan- 2000, p. 2706). cial inducements” (art. 31.1(d); art. 32.1(d), 33(d)). Thus, The principle of respect for autonomy has a high rel- payment is not, as some scholars and guidelines suggest, evance for the practice of payment for research subjects a demand of justice or fairness (Gelinas et al. 2018, 2020; as one of the most commonly expressed concerns is that Persad et al. 2019; Lynch et al. 2021) or requirement of payment can be coercive or constitute an undue induce- non-maleficence and beneficence for an individual subject ment (undue influence), thus compromising the validity (Bierer et al. 2021). These principles, supplemented by the of informed consent (e.g., Macklin 1981; Faden and Beau- principle of respect for autonomy and other considerations champ 1986; McNeill 1997; Dickert and Grady 1999, 2008; regarding non-exploitation, are nevertheless very important. Largent et al. 2013; Gelinas et al. 2018, 2020). It is claimed While they do not provide an ethical rationale for offering that very high or (for other reasons) overly attractive pay- payment for research participations by themselves, they set ment may undermine the capacity of individuals to make contours for an ethically sound payment practice. autonomous decisions regarding study participation, by compromising their voluntariness, ability to adequate under- stand and assess research risks and benefits, or by “forc- ing” them to make choices against their “better judgment or Ethical contours of an ethically sound deeply held beliefs” (Council for International Organizations payment practice of Medical Sciences 2016, p. 54). Although there is still a substantial disagreement in the Offering payment for research participants is an incentive literature about whether an offer of payment may be per - prima facie required by the principle of the social benefi- ceived as coercion, what exactly constitutes undue induce- cence. This does not imply, however, that it is ethical to set ment, and whether money can distort or compromise autono- payment at whatever level necessary and sufficient to attract mous decision-making (Macklin 1981, 1989; Wilkinson and an adequate number of proper subjects in a timely fashion. Moore 1997; Grady 1999, 2001, 2005; Grant and Sugarman On the contrary, no matter how payment is important and 2004; Emanuel 2004, 2005; Wertheimer and Miller 2008; effective as an incentive for participation, not every amount, Klitzman 2013; Largent et al. 2013; Resnik 2015, 2019; method and timing of payment is acceptable. The reason Belfrage 2016; Largent and Lynch 2017a, 2017b; Millum being the fact that the consequentialistic principle of social and Garnett 2019), existing guidelines and regulatory docu- beneficence does not exhaust the reining normative frame- ments disallow payment, which may unduly seduce people work for human biomedical research. The ethics of biomedi- to consent for participation (Largent and Lynch 2017a). cal research is built upon a matrix of principles and values Thus, even though overly attractive payment offers could which strives to find an adequate balance between the imper - enhance timely recruitment by “alluring” a sufficient num- ative to advance interests of science and society (“research ber of adequate individuals to join and stay in a study even imperative”) and obligations of all societies to protect other against their better judgment, there is a regulatory consensus important interests of their members, especially interests of that such payment should not be offered. research participants and/or involved communities. These The ethical unacceptability of such an overly attractive latter obligations may be viewed as constituting a general payment stems from the respect for autonomy. However, “imperative of non-exploitation” that sets boundaries for the it also finds support in the principle of social beneficence. practice of human biomedical research, in general, and for Common sense and empirical evidence, although still lim- the practice of paying participant, in specific. ited, suggest that attractive payments may have a negative 1 3 The ethical anatomy of payment for research participants 455 impact on scientific value of research, as it may encourage valuable and risky service or work. Therefore, there are no potential and/or actual participants to withhold or misrep- ethical grounds (either paternalistic or non-paternalistic) for resent information, which are critical for their recruitment depriving competent individuals an opportunity to serve as eligibility or continuation in research (Bentley and Thacker research subjects in exchange for money, provided that their 2004; Dresser 2013; Dickert 2013; Devine et al. 2013, 2015; decision to participate in a given study is autonomous (i.e., Largent and Lynch 2017a; McManus and Fisher 2018; based on comprehensive and adequately understood infor- Lynch et al. 2019). Such a concealment, fabrication or falsi- mation, and free from unduly controlling influences). fication by participants create risks for participants, but also Moreover, some studies suggest that remuneration can for research resources and the integrity of research data as in fact play a positive role in prospective subjects’ consent it can bias the results and undermine the validity of a study process by reducing the therapeutic misconception and high- (Lee et al. 2018). And—if it occurs frequently enough—it lighting research risks. Money might send a message to par- may jeopardize the whole research enterprise. Therefore, ticipants that they take risks and burdens for the sake of the assuming—what stills needs to be explored empirically— benefit of science and society and “should be compensated a positive correlation between the prevalence of deceptive for it, which would not occur if they were … expected to behaviors and the attractiveness of payment (which depends benefit from it.” (Glannon 2006, p. 252; also Dickert and not only on the amount, but also on payment method and Grady 1999; Grady 2001, 2005; Menikoff 2001; Largent and timing), the principle of social beneficence provides ethi- Lynch 2017a). Additionally, some studies suggest that pay- cal reasons for employing payment strategies which do not ment can enhance autonomous decision-making by drawing involve overly attractive payment schemes. prospective subjects’ attention to research risks and incon- The principle of respect for autonomy has fueled much veniences (Cryder et al. 2010; Largent and Lynch 2017a; of scholarly discussion on unethical nature of overly attrac- Fisher et al. 2019). tive payment. However, little attention has been paid to that principle in the context of no-payment and underpayment. Justice, fairness and payment Undoubtedly, the lack of resources to cover direct or indi- rect costs associated with the participation may constitute Another ethical principle that has a direct relevance for the a barrier for individuals, who otherwise would be willing practice of paying research subjects is the principle of jus- to take part in research (American Cancer Society Cancer tice, both in its distributive and commutative dimensions. Action Network 2018; Nipp et al. 2019a; Largent and Lynch Many scholars worry that payment may be more attractive 2018; Bierer et al. 2021). The removal of these barriers by to individuals of lower SES, and thus offering payment for covering the relevant expenses is important for promoting participation may result in unfair distribution of research potential subjects’ autonomy, because it enables individuals benefits and burdens across the general population (e.g., to exercise their free will to contribute to the development of Maclin 1981, 1989; Faden and Beauchamp 1986; Acker- science by serving as research subjects. Thus, the principle man 1989; McNeill 1997; Grady 2005; Dickert and Grady of respect for autonomy supports paying subjects recom- 2008; Gelinas et al. 2018). The worse-off will shoulder a penses, which make the participation in research a cost-free disproportionate share of burdens of research, while the and revenue-neutral activity. benefits will accrue primarily to the better-off. A different, Finally, what is rarely observed, the principle of respect yet linked, concern relates to the risk of exploitation of for autonomy provides a general support for public poli- research participants, especially those of low SES (Lem- cies which allow remuneration of research subjects for their mens and Elliott 1999; Shamoo and Resnik 2006; Elliott contributions—both in the form of reward and price—as it 2008; Elliott and Abadie 2008; Abadie 2010, 2015; Stones calls for respecting people’s right to decide freely in what and McMillan 2010; Phillips 2011a; Resnik 2015, 2019; practices and activates they what to engage in for the sake of Largent and Lynch 2017b; Gelinas et al. 2020; Bierer earning their living. As Wilkinson and Moore note, “denying et al. 2021; MacKay and Walker 2021). Exploitation in people the option of taking inducements reduces their free- research is about the unfair distribution of goods that dom, since it removes an option that they prefer to the alter- arise from interaction between researchers and partici- natives” (Wilkinson and Moore 1997, p. 377). Admittedly, pants (Wertheimer 2008). “One party gets too little, while biomedical research enterprise does not aim at broadening the other gets too much. Often, but not always, the unfair the scope of subjects’ freedom or autonomy. Nevertheless, distribution arises because one party to the interaction is it should not restrict people’s choices without a good rea- in a weak position, due to poverty, ignorance, or extreme son. Participation in socially valuable biomedical research, urgency, which the other party can take advantage of, whether or not one is paid for it, is neither morally wrong offering few benefits” (Emanuel 2004, p. 101). Economi- nor bad for the person concerned. On the contrary, it is con- cally disadvantaged individuals are in need of money and sidered at least as good as engaging in any other socially they tend to value a specific amount of payment more. For 1 3 456 J. Różyńska many of them accepting an offer of unfairly low but still participants to engage in scientifically and socially valuable en bloc beneficial payment for participation might be a biomedical research. reasonable choice. After all, even small payment is better Payment is a recruitment incentive justified and prima than no payment at all, although it constitutes a (mutually facie required by social beneficence, not by justice or fair - beneficial and consensual) exploitation. ness. However, when it is to be offered , the offer should sat - These concerns are highly important, but—as it is shown isfy the requirement of distributive and commutative justice. below—they do not exhaust the role of justice/fairness in It is commonly accepted that the principle of justice shaping an ethically sound payment practice. Moreover, in requires distributing burdens and benefits of study partici - order to fully understand their consequences for ethics of pation in such a way that no segment of the population is paying research subjects, it is essential to note two things. unduly burdened by research or denied its potential or actual Firstly, biomedical research is a social practice embedded benefits. Recruitment criteria should reflect the scientific in specific social reality shaped by its historical and cultural purpose of the study, not target populations which are con- roots, reigning power- and economic relations, and norma- sidered “easy to recruit” “simply because of their easy avail- tive fabrics. This social reality is marked by profound social ability, their compromised position, or their manipulability” and economic inequities (within concrete societies as well (National Commission for the Protection of Human Sub- as at the level of international community), which should be jects of Biomedical and Behavioral Research. 1979). Thus, mitigated, and ideally eliminated by broad social reforms. researchers must neither exploit the vulnerable, in particu- Research enterprise should not entrench or exacerbate these lar economically disadvantaged, nor exclude without good background social injustices. However, it is neither designed reason those who stand to benefit from study participation. for nor capable of actively fighting them, especially against They should strive to recruit an adequate cross-section of participants’ poverty, unemployment or lack of access to the population in order to spread research burdens and ben- high-quality healthcare (Fisher 2019). Justice in research efits fairly across the population. In other words, an ade- requires treating all research participants fairly and equita- quate diversity of gender, race, ethnicity, age and SES in bly, also when it comes to payment for their participation. research should be sought (Geller et al. 2011; Kwiatkowski But it does not require paying participants of low SES in et al. 2013; Heller et al. 2014; Winter et al. 2018; cf. Dickert order to alleviate or remove hardships of their position. Such 2009; Bierer et al. 2021). It is worth noting that the last pos- a positive impact of research payment on subjects’ social or tulate finds an additional support in the principle of social economic condition is laudable, and even desirable, but it is beneficence as it enables the generalization of knowledge not a demand of justice. to be gained in research, thereby enhancing research scien- Moreover, contrary to views of some commentators, the tific and social value (Wilkinson and Moore 1997 ; Grady commutative justice per se does not require offering pay - 2005; Resnik 2015; Largent and Lynch 2017b). Thus, jus- ments to research subjects. Largent, Emanuel and Lynch tice encourages payment schemes which have a potential of claim that “when goods and services are not indented as making distribution of research burdens fairer. And justice gifts, failure to pay for them is a problem: we call it theft” is against schemes that can deepen social inequalities, lead (2019, p. 1), thus suggesting that this is exactly what happens to unfair social distribution of research burdens and benefits when participants are not fairly paid for their contribution to or exploitation. the common good. Despite its rhetorical attractiveness, this What should research subjects be paid for and in which claim cannot be accepted as it rests on two mistakes. Firstly, amount to make payment consistent with demands of jus- it ignores the power of consent. Valid consent of a prospec- tice? Firstly, justice-related considerations provide an ethi- tive subject for using her body for research purposes trans- cal justification for paying research subjects a recompense forms theft into gift, lease, rent, work or other consensual for direct costs related to research participation. By making relation with a researcher. Second, it forgets that it takes two participation in research a cost-free activity, recompense willing parties to change provision of goods or services into removes—at least some—economic barriers for participa- transaction, i.e., exchange of goods and services in return for tion, thus equalizing opportunities for all willing individu- money. Thus, when a researcher is unable (e.g., due to budg- als to contribute to the development of science, no matter etary constraints) or uninterested in offering payment for their SES. Moreover, as studies already referred to suggest prospective participants (e.g., due to availability of sufficient (Unger et al. 2013, 2016, 2019; American Cancer Society number of unpaid subjects), or when a prospective partici- Cancer Action Network 2018; Nipp et al. 2019b; Chino and pant is genuinely willing to contribute to the development of Zafar 2019), reimbursement of direct expenses may improve science without any remuneration and reimbursement, there access to potentially beneficial studies for patients, who is no ground for transaction. And there is nothing essentially otherwise would not be able to participate due to their low unfair in allowing researchers and altruistically motivated SES or disease-caused greater sensitivity to economic bur- dens associated with research. Thus, the reimbursement of 1 3 The ethical anatomy of payment for research participants 457 direct costs has a potential to enhance justice in research not Health Research Authority 2014, par. 3.4; Council for only by reducing inequities in access to research for those International Organizations of Medical Sciences 2016, p. who otherwise could not afford it, but also by contributing 53; Food and Drug Administration 2018; National Health to the fair distribution of clinical benefits associated with and Medical Research Council 2019, par. 1.1). Only a few, participation. however, mention the level of research risks among factors Secondly, the principle of justice provides a strong which should be taken into consideration when determining ethical reason for disallowing recompenses for the loss of an adequate amount of payment. Moreover, those that do so reasonably expected profits, especially lost wages. Such provide conflicting instructions on this matter. For example, recompenses lead to differential payments between par - the CIOMS Guidelines expressis verbis state that “the level ticipants—individuals who receive higher wages get higher of compensation should not be related to the level of risk recompense; those who are lower paid by employees—lower that participants agree to undertake” (2016, Commentary on recompense, and those who are unemployed—no recom- Guideline 13). In contract, the Australian National Health pense at all. This is consistent with a norm of equity, as and Medical Research Council’s guideline reads: “In cases it makes participation a revenue-neutral activity for all, no where risk may be considered as a factor in determining matter how much they earn. Nevertheless, it is very likely payment, payment of participants based on the degree of to reinforce unfair distribution of research risks and ben- risk associated with the research is not prohibited, so long efits between different social strata by prompting research- as there is evidence that a participant’s ability to provide ers to make savings by drawing research participants from valid consent is not likely to be compromised” (2019, par. “cheaper” populations, especially from the unemployed and 1.3.). Also the UK Health Research Authority “sympathises the low-paid (Dickert and Grady 1999; Resnik 2015). with the view that not to allow payments on the basis of risk Thirdly, justice supports remuneration for participants’ would be unduly paternalistic in the absence of evidence that contributions to the development of science and society, pro- the participants’ ability to provide valid consent would be vided it is fair, i.e., equitable, adequate, and non-exploitive. compromised” (2014, par. 3.1.). Remuneration is equitable when it does not violate the norm These regulatory variations mirror the lack of consen- “equal pay for equal work” (Dickert and Grady 1999; Resnik sus regarding risk-based payments among research ethicists 2015; Gelinas et al. 2018, 2020; Persad et al. 2019). Equal (Grady 2001; Menikoff 2001; Jones and Liddell 2009; Saun- time, efforts, burdens and risks associated with participa- ders 2009; Grimwade et al. 2020; Lynch and Largent 2020; tion deserve equal remuneration (measured in market value, Jamrozik and Selgelid 2020). Although a detailed analysis rather than in nominal value in case of multi-site studies of this issue goes beyond the scope of this analysis, three conducted in different settings). However, when different following arguments provide strong reasons for arguing groups of participants in a study are expected to make die ff r - that adequate remuneration for research subjects should be ent contributions, equitable remuneration should reflect dif- proportionate also to the level of risk involved in participa- ferences in their input (Persad et al. 2019). This is consistent tion: (i) an argument from consistency, which notices that with equal respect and concern for each and every individual risk-based remuneration is accepted in many non-research and it prevents discrimination. contexts, e.g., in high-risk professions (Menikoff 2001; Remuneration is adequate when it is proportionate in Jones and Liddell 2009); (ii) an argument from the nature value to the value of participants’ contribution to the study. of human “guinea pigging” which claims that the assump- The latter necessarily depends on various factors which tion of risk is often an essential contribution of research determine how time- and effort-consuming, burdensome and participants (Menikoff 2001; Różyńska 2018; Malmqvist risky give research project is. For example, when a study 2019); (iii) an argument for public trust, which argues that involves 2 visits, each lasting 60-min and requires filling a paying proportionally to the incurred risk meets expectations questionnaire and giving a blood sample for further analysis, regarding the fair treatment of a significant portion of pro- and another project involves 4 visits of the same length and spective subjects as well as researchers, REC/IRB members, level of associated risks and burdens, participants of the lat- and other members of the research community (Czarny et al. ter study—ceteris paribus—should be offered remuneration 2010; Ripley et al. 2010; Largent et al. 2012; Grimwade of double the remuneration offered to the participant of the et al. 2020), thereby enhances public trust in research at first project. large. All guidelines and regulatory documents referred to Finally, remuneration is non-exploitive when it is not above follow this normative logic by recommending or lower than a socially accepted payment which is (or would permitting paying research participants an “appropriate” be) offered for a similarly time- and effort-consuming, bur - or “proportionate” or “just and fair” remuneration for the densome and risky activity, outside research context in time spent and other inconveniences resulting from the the same setting (Gelinas et al. 2018; Largent and Lynch study participation (Council of Europe 2005b, sec. 64; 2017b). Although space does not permit discussing in 1 3 458 J. Różyńska details how a proper amount of such defined payment injustices, e.g., racial biases or class differences (Persad should be calculated, a proposal widely advocated in the et al. 2019). literature should be mentioned here, namely a minimum hourly wage benchmark. Numerous authors and guidelines Individual beneficence and payment suggest that the amount should be based on the minimum hourly wage in the region or country as a point of refer- The principle of individual beneficence is rarely invoked in ence (Council for International Organizations of Medical the discussion on ethical payment practices. Most probably, Sciences 2016, Commentary to Guideline 15, 53; National it is because research is about advancing the interests of sci- Health and Medical Research Council 2019, Appendix 1, ence and society, not the interests of individual participants 7) with augmentations for particularly burdensome proce- (Emanuel et al. 2000; Miller and Brody 2003).While there are dures (Ackerman 1989; Dickert and Grady 1999; Grady studies which have a potential of direct therapeutic benefits for 2005; Gelinas et al. 2020), risks involved (Menikoff 2001), the participants, it is neither the goal of research practice, nor a and even other additional benefits (cf. Anderson and Wei- requirement that research should be beneficial for participants. jer 2002). This proposal has three advantages. It is rela- Moreover, all canonical guidelines on human research eth- tively easy to implement as it provides a clear method of ics exclude non-direct and non-medical benefits to research setting the baseline amount of reimbursement for research subjects, such as payment, from the risk–benefit analysis, participants. It allows for keeping payments sensitive to thereby forbidding IRBs/RECs to take payment into account specific features of the project and subjects’ contributions as a benefit to counterbalance research risks (Emanuel et al. by accepting relevant payment augmentations. And—since 2010; contra Wertheimer 2013). it sets the reference value of an non-exploitive remunera- Nevertheless, despite the above normative premises, in tion relatively low—“more researchers could afford to pay fact, individuals treat money as a benefit when considering an a fair wage and fewer would be inconvenienced by a pro- offer to participate, and deciding on entering the study (Abadie hibition on unfairly low wages” (Phillips 2011a, p. 219). 2010; Czarny et al., 2010; Stunkel and Grady 2011; Grady However, it also faces challenges. Offers of payment calcu- et al. 2017; Fisher et al. 2018; Manton et al. 2019). For an lated in such a way would be attractive for prospective sub- individual prospective participant, the payment is a part of jects with low SES, who have no reasonable alternatives to an equation for the overall attractiveness of a research pro- get engaged in better paid activities. But these offers would ject. Recompenses, when full and adequate, make the research likely have no impact on recruitment of individuals who participation cost-free for subjects, and—as shown above— are better-off, i.e., who have better paid jobs or capacity they can remove at least some entrance barriers for patients to make more money outside research context, thus poten- to potentially clinically beneficial studies. Remunerations— tially biasing the subjects’ recruitment. In contrast, the whether calculated as a reward or as a price—may constitute average-wage benchmark for non-exploitive remuneration, a gain for subjects, thereby making participation in research mentioned by some authors (Phillips 2011a) would seem overall beneficial from their personal perspective. fairer as it would make payment offers reasonably attrac- Thus, the principle of individual beneficence provides addi- tive to both individuals of SES and to those better-off, thus tional support for oe ff ring money to research subjects. How - promoting a fair distribution of research risks and benefits ever, the same principle justifies the claim that payment for between different social strata. participation should not be overly attractive. There is some Fourthly, the principle of justice does not prohibit remu- evidence that too attractive remuneration may increase the risk nerations going beyond what constitutes equitable, adequate, of jeopardizing subjects’ health by encouraging them to con- and minimally non-exploitive payment—i.e., remunerations ceal or misrepresent information important for their safety in driven by a market-driven forces. Although such payments order to ensure recruitment or continued participation in paid are conceptualized as “price” for desired services, in order research (Bentley and Thacker 2004; Devine et al. 2013, 2015; to avoid exploitation, they should not be lower than remu- Lee et al. 2018; Lynch et al. 2019). Such a deceptive behavior neration viewed as “reward”. They may, however, be higher by participants may take various forms (e.g., nondisclosure of than “rewards” and they may vary within the same study on concurrent enrollment in other studies, concealment of tobacco the basis of salient characteristics of particular groups of use, alcohol consumption, or illicit substance abuse, conceal- participants (i.e., their age, sex, race, ethnicity, rare clinical ment of pre-existing medical conditions, falsification of cur - status etc.). Offering disproportionally high and/or differ - rent health status, over-reporting of a study protocol adher- ential remuneration does not violate requirements of jus- ence, etc.), and it may result in severe adverse events or even tice insofar as the payment is designed to help the study to subjects’ death (Lee et al. 2018). 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 1 3 The ethical anatomy of payment for research participants 459 Table 1 The ethical anatomy of payment for research participants Recompense for reasonable Recompense for loss of reasonably Remuneration conceptualized as a reward for Remuneration conceptualized as a price driven expenses expected profits (e.g., wages) contribution (time, affords, burdens, risks) by supply-demand market forces Subject to the reservations listed below, payment for research participants is prima facie obligatory as it promotes the realization of a common good (socially valuable knowledge). Principle of social Enhances recruitment and retention Enhances recruitment and retention Enhances recruitment and retention rates by meeting participants’ financial needs, expectations, and beneficence rates by removing economic entry rates by making participation a aspirations. barriers. revenue-neutral activity. Reservation: When inadequate to contribution Reservation: When overly attractive, may increase and excessive may increase risk of biasing risk of biasing research data by encouraging research data by encouraging subjects to deceive subjects to deceive in order to be recruited and/or in order to be recruited and/or kept in research. kept in research. When inadequate to contribution and scant When unattractive or scant decreases the inducing decreases the inducing potential of payment. potential of payment. Subject to the reservations listed below, ethical payment promotes participants’ autonomy. Principle of Enables realization of an Enables realization of an individual’s Respects individuals’ ability and right to make autonomous choices regarding what profitable activities respect for individual’s free will to participate free will to participate in research by to engage in and what risks to undertake for money. autonomy in research by removing economic making participation a revenue-neutral Reduces risk of therapeutic misconception, thereby making decision to participate in research better entry barriers. activity. informed and more autonomous. Reservation: When excessive and/or overly attractive for other reasons may increase risk of impairing individuals’ judgment or their voluntariness (undue inducement). Subject to the reservations listed below, ethical payment makes participation en bloc more beneficial to participants. Principle of Reduces risk of participation having Reduces risk of participation having a Constitutes an economic gain which makes participation in research – from the subject’s perspective – individual a negative impact on the subject’s negative impact on the subject’s (more) beneficial. beneficence economic position (welfare) by economic position (welfare) by making Reservation: When excessive and/or overly attractive for other reasons may increase risk of making participation a cost-free participation a revenue-neutral activity. jeopardizing subjects’ health by encouraging them to conceal or misrepresent important information on activity. their health or health-related behaviors in order to be recruited and/or kept in research. Improves access to potentially beneficial research for patients with low SES. Subject to the exclusion and reservations listed below, ethical payment promotes fair distribution of research risks and benefits. Principle of Reduces inequality of opportunities UNACCEPTABLE: Promotes fair distribution of research risks and Does not violate the principle of justice, provided it justice to for individuals with low SES by benefits, provided it is equitable, adequate and is non-exploitive and does not reinforce wider Reinforces unfair distribution of removing economic entry barriers. non-exploitive. social injustices and inequalities research risks and benefits between social strata by prompting sponsors to Reservation: When unequitable, inadequate Reservation: When exploitive and/or based on draw participants from populations of and/or exploitive reinforces unfair distribution of background social injustices and inequalities low SES (the unemployed and the low- research risks and benefits between social strata reinforces unfair distribution of research risks and paid). as well as between researchers and participants. benefits between social strata as well as between researchers and participants. remuneration conceptualized as a market-driven price, Conclusions provided (i) the remuneration is necessary and designed to help the study achieve its social and scientific goals, The paper argues that the ethical anatomy of paying (ii) it does not reinforce wider social injustices and ine- research participants is built upon four basic principles qualities; (iii) it meets the requirement of non-exploita- of research ethics (and bioethics in general). The ethical tion; (iv) it is not overly attractive (as defined above). “spine” of the practice is the principle of social benefi- cence, which requires the maximization of the common good—in the case of research practice—socially valu- Obviously, a proper application of this ethical “skel- able scientific knowledge. This principle grounds a gen- eton” into research practice requires investigators and eral prima facie moral obligation of offering payment to RECs/IRBs to take into account “the nature of the study, research subjects. The remaining ethical principles con- the nature of participants contributions and vulnerabilities, stitute a “skeleton” of morally sound payment practices institutional and organizational guidelines, and local and by providing additional moral reasons for offering or not cultural norms” (Grady 2005, p. 1686). Moreover, to make offering certain types of payments to research participants. the proposed scheme fully helpful in determining whether As discussed above and presented in Table 1, the princi- any particular offer of payment is not overtly attractive ples argue for offering research participants: and whether it meets standards of not equality, adequacy and non-exploitation, further detailed analyses of these • recompense for reasonable expenses, but not for lost standards are needed. The proposed scheme should also wages (or loss of other reasonably expected profits); be tested against and enriched by further empirical stud- • remuneration conceptualized as a reward for their valu- ies about payment, especially about how money impacts able contribution, provided (i) the remuneration meets subjects’ decision-making processes and behaviors. standards of equality, adequacy and non-exploitation, and (ii) it is not overly attractive, i.e., it does not con- stitute undue inducement for participation or retention, Funding This analysis was supported by a grant of the National Sci- and does not encourage deceptive behaviors; ence Centre, Poland, No. 2015/17/B/HS1/02390. 1 3 460 J. Różyńska Data availability Not applicable. in clinical research. Journal of Clinical and Translational Sci- ence 5 (1): e159. https:// doi. org/ 10. 1017/ cts. 2021. 816. Caldwell, Patrina H., Sana Hamilton, Alvin Tan, and Jonathan C. Code availability Not applicable. Craig. 2010. 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"Medicine, Health Care and Philosophy" – Springer Journals

Published: Sep 1, 2022

Keywords: Research ethics; Payment for research participants; Social beneficence; Autonomy; Justice/fairness; Undue inducement; Exploitation

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The ethical anatomy of payment for research participants

The ethical anatomy of payment for research participants

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The ethical anatomy of payment for research participants

The ethical anatomy of payment for research participants

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