Second, undue influence involves more than making a decision that leads to objectively unreasonable risk exposure (Resnik 2015a). Many scholars worry that payment may be more attractive to individuals of lower SES, and thus offering payment for participation may result in unfair distribution of research benefits and burdens across the general population (e.g., Maclin 1981, 1989; Faden and Beauchamp 1986; Ackerman 1989; McNeill 1997; Grady 2005; Dickert and Grady 2008; Gelinas et al. In clinical research, access to treatment will usually be sufficient to achieve this goal, except when the subjects are healthy volunteers, in which case ensuring that payment is adequate would be important for avoiding exploitation (Shamoo and Resnik 2006). A history and theory of informed consent. Strategies for recruitment and retention of participants in clinical trials. Payment and reimbursement to research subjects. How payment for research participation can be coercive. A systematic review shows that less than half of trials achieve their original recruitment target goal in time (Campbell et al. The research subject as wage earner. The .gov means its official. The potential for exploitation also varies considerably in research. Sully Ben G, Julious Steven A, Nicholl Jon A. (2013) found that 43% of subjects failed to disclose concurrent enrollment in another study, 28% did not disclose prescription drug use, 25% admitted to exaggerating symptoms, and 14% said they had pretended to have a health problem they did not have. The lure of money might cause some people, especially those who are socioeconomically disadvantaged, to take unreasonable risks for financial gain (Macklin 1981; McNeill 1997) or to lie to investigators about important health information to qualify for enrollment (Dresser 2013). The remaining ethical principles constitute a skeleton of morally sound payment practices by providing additional moral reasons for offering or not offering certain types of payments to research participants. These categories are distinguished by a different impact each of them has on the participants economic position as evaluated ex post. National Health and Medical Research Council. Having clarified basic terminological and conceptual issues, we can move on and explore the ethical anatomy of payment for research participants. The office is open 8:00AM - 8:00PM M-F Eastern Time. Campbell, Marion K., Claire Snowdon, David Francis, Diana R. Elbourne, Alison M. McDonald, Resemary C. Knight, Vikki Entwistle, Jo Garcia, Ian Roberts, and STEPS Group. To report or not to report: Exploring healthy volunteers rationales for disclosing adverse events in Phase I drug trials. Disclaimer. We dont expect people to always be altruists in their other endeavors, including risky work.. 2010; Roche et al. Bioethicists and institutional review boards (IRBs) often worry that paying human subjects too much money for research participation might compromise informed consent by coercing or unduly influencing individuals to enroll in studies against their better judgment ( Grady 2001, 2005; Klitzman 2013, 2015; Largent et al. Additionally, an offer of payment could convince to participation persons who believe that their private or professional time is particularly valuable (for example due to their unique responsibilities, competences, or skills), and, therefore, they should not allot it to alternative causes without an adequate remuneration. For example, Dickert and Grady (1999) argue that studies that recruit healthy volunteers should pay research subjects roughly the amount of money that is typically earned for unskilled labor involving some risks. 2013; Largent and Lynch 2017a). Clinical trials: The challenge of recruitment and retention of participants. While this third justification is more convincing that the first two, it also has some problems. Devine Eric G, Knapp Clifford M, Sarid-Segal Ofra, O'Keefe Sean M, Wardell Cale, Baskett Morgan, Pecchia Ashley, Ferrell Katie, Ciraulo Domenic A. 2019). People who are unduly swayed by lure of money are likely to underestimate the risks of research and overestimate their personal benefits. Exploiting a research underclass in phase 1 clinical trials. Association between financial incentives and participant deception about study eligibility, Payment and Reimbursement to Research Subjects - Information Sheet. Yet community members expressed the opposite view, according to the results of a recent study.1. 2015). In contrast to most publications on the ethics of paying research subjects, which start by identifying and analyzing major ethical concerns raised by the practice (in particular, risks of undue inducement and exploitation) and end with a set ofmore or less well-justifiedethical recommendations for using payment schemes immune to these problems, this paper offers a systematic, principle-based ethical analysis of the practice. Money would be a corrupting influence when it affects people this way. We show that rejection of research exceptionalism with respect to payment helps settle open debates about both how best to define coercion and undue influence, and how to understand the relation between these concepts and offers of payment. Phase I oncology trials: Why the therapeutic misconception will not go away. Such recompenses lead to differential payments between participantsindividuals who receive higher wages get higher recompense; those who are lower paid by employeeslower recompense, and those who are unemployedno recompense at all. And there is nothing essentially unfair in allowing researchers and altruistically motivated participants to engage in scientifically and socially valuable biomedical research. government site. To some extent, I think that the view of financial compensation as inherently exploitative comes from within the research establishment, Devlin offers. Paying Research Participants: The Outsized Influence of "Undue For example, in the movie Indecent Proposal, a financially struggling married couple encounter a billionaire at a casino in Las Vegas, Nevada, who offers them one million dollars if the woman will spend a night with him and have sex. Unsuccessful trial accrual and human subjects protections: An empirical analysis of recently closed trials. 2 4 6 Although most people agree that paying participants is an inducement, the amount at which it becomes an "undue inducement" is debatable. 2019). Thus, the reimbursement of direct costs has a potential to enhance justice in research not only by reducing inequities in access to research for those who otherwise could not afford it, but also by contributing to the fair distribution of clinical benefits associated with participation. Carlisle Benjamin, Kimmelman Jonathan, Ramsay Tim, MacKinnon Nathalie. The principle of respect for autonomy is a cornerstone of modern research ethics (National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research 1979; Faden and Beauchamp 1986; Emanuel et al. The cial and in-kind support provided to research participants.1 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". A minimum threshold of physical and mental capacities is necessary (though not sufficient) for an individual to be able to pursue her particular life goals, plans, and projects that express her vision of a good life. This principle constitutes an ethical spine of the practice. As payment for participation of vulnerable groups can be exploitative, the amount and distribution should be carefully assessed Reference Schonfeld, Brown, Weniger and Gordon (10).One problem, particularly with high levels of payment, is the possibility that a person will ignore the potential risks involved in a study and participate when they would not have done . More to the point, why do so many people think that subjects require special protections from the influence of money on judgment and decision-making that we do not usually apply to competent adults outside the research context? Trapped by the ambiguous language of compensation, they frame remuneration as recompense for losses, arguing that participants' time, as well as their assumption of research-related burden and inconvenience are critical contributions experienced as losses by participants; they are giving up or accepting unfavorable as a result of participation. It argues that many concerns about offers of payment to research participants can be attributed to the misguided view that such offers ought to be treated differently than offers of payment in other contexts, a form of "research exceptionalism." Instead of exploring the ethical foundations of payments systematically, scholars and public-policy makers rather focus on payment-related ethical concerns, in particular of undue inducement and exploitation, andfrom this perspectiverecommend or discourage certain forms, schedules and timings of payment commonly used in research practice (e.g., Macklin 1981; Dickert and Grady 1999; Grady 2001, 2005; Gelinas et al. sharing sensitive information, make sure youre on a federal To pay or not to pay? 2016. It only mentions that information on incentives for subjects must be contained in the study protocol (par. Just compensation: Paying research subjects relative to the risks they bear. 2012), but this way of thinking about the issue rests on a conceptual mistake. Association between financial incentives and participant deception about study eligibility. London, Alex J. But these offers would likely have no impact on recruitment of individuals who are better-off, i.e., who have better paid jobs or capacity to make more money outside research context, thus potentially biasing the subjects recruitment. It's not often I'm drawn to comment on a BMJ article, but the BMJ piece titled "Misrepresentation, coercion and undue influence: the dangers of paying research participants" (BMJ 2023;380:p686 . Glannon William. What makes clinical research ethical? In some situations, remuneration merits special scrutiny because the recipients might not have the capacity to make wise choices involving money, due to their age, mental disability, or socioeconomic circumstances. A critique of clinical equipoise: Therapeutic misconception in the ethics of clinical trials. Many people believed it was exploitative not to compensate people for their role in the study. Why does paying people money for research participation seem ethically suspect to so many commentators and IRB members? As a result, payment practices vary. Rhodes Rosamond. 2017, https://www.fda.gov/RegulatoryInformation/Guidances/ucm126429.htm?utm_campaign=FDA%20clarifies%20information%20about%20payment%20and%20reimbursement%20to%20research%20subject&utm_medium=email&utm_source=Eloqua. (2018) provides data that has some relevance to the issue of undue inducement in research, it does not show that paying people too much money for participation increases the risk of deception. Recompenses, when full and adequate, make the research participation cost-free for subjects, andas shown abovethey can remove at least some entrance barriers for patients to potentially clinically beneficial studies. Check out some of the speakers' slide presentations below! 2017; Resnik 2018). If not, consider one of the subscription options below. 2017a). As Wilkinson and Moore note, denying people the option of taking inducements reduces their freedom, since it removes an option that they prefer to the alternatives (Wilkinson and Moore 1997, p. 377). Additionally, the obligation to pay research participants may be overridden by justified research budget constraints. McCann Sharon K, Campbell Marion K, Entwistle Vikki A. Federal government websites often end in .gov or .mil. 2018, 2020; Persad et al. Devlin was inclined to agree that high payments were problematic. Acts that would be "labor" or . The main pragmatic reason (Largent and Lynch 2017a, p. 77 fn. This mistake originates from the fact that the former two categories of payments are defined by the payment impact on the subject baseline economic position, the latter is based on the researchers intention. The Oxford Handbook of Clinical Research Ethics, Facing up to paternalism in research ethics. Then, she started working with Temple Health: Block by Block, a long-standing cohort study conducted in North Philadelphia. In contrast, those in favour of paying research participants argue that payment rightly recognizes the contribution individuals make to research outcomes and that without such financial recognition the number of participants opting to be involved in research would be insufficient to achieve statistically robust results; payment is viewed as a . Walker Rebecca L, Fisher Jill A. Inducement in research. access to 500+ CME/CE credit hours per year, and access to 24 yearly Offering payments, reimbursement and incentives to patients - PubMed Largent EA, Grady C, Miller FG, Wertheimer A. Money, coercion, and undue inducement: a survey of attitudes about payments to research participants. One way of understanding this concept is to view undue influence as a type of influence that compromises or distorts a persons judgment or decision-making so that he or she makes a choice contrary to his or her best interests or values (Resnik 2015a; Largent and Fernandez Lynch 2017b). 2000; Miller and Brody 2003).While there are studies which have a potential of direct therapeutic benefits for the participants, it is neither the goal of research practice, nor a requirement that research should be beneficial for participants. For the sake of the analysis to come, it is assumed that paid participation in biomedical research is a form of paid bodily services, and it should be no more worrisome to commodify a persons labor [bodily serviceJR] as a research subject than to commodify a persons labor in other contexts, which happens all the time (Lynch 2014, p. 159). 2019a, Unger et al. The recruitment of normal healthy volunteers: A review of the literature on the use of financial incentives. However, the same principle justifies the claim that payment for participation should not be overly attractive. Payment in challenge studies: Ethics, attitudes and a new payment for risk model. Bethesda, MD 20894, Web Policies Exploitation in payments to research subjects. The obligation to participate in biomedical research. Financial toxicity and equitable access to clinical trials. Outside the research context, people are free to take many kinds of risks without external oversight (Edwards et al. Equal time, efforts, burdens and risks associated with participation deserve equal remuneration (measured in market value, rather than in nominal value in case of multi-site studies conducted in different settings). Get unlimited access to our full publication and article library. Consent is important for respecting the individuals autonomy and promoting his or her welfare (Resnik 2018). 1.3.). However, there was no significant association between the amount of money offered and divergence the from baseline vaccination rate. The groups were offered $25, $100 or $1,000 for participation. Third, most countries have extensive regulations that protect human subjects from exploitation (Emanuel 2004, Resnik 2018), and there is no need for additional protections that focus specifically on remuneration. What this argument means in practice is that offering human subjects money for their participation should not be regarded as ethically suspect, absent substantial evidence to the contrary. Researchers interviewed 58 participants (many of whom were Black women) about their attitudes on financial compensation for research participants. Recruitment criteria should reflect the scientific purpose of the study, not target populations which are considered easy to recruit simply because of their easy availability, their compromised position, or their manipulability (National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. Bethesda, MD 20894, Web Policies Recruitment and retention of participants are both critical for the success of trials, yet both remain significant problems. Food and Drug Administration. The site is secure. To ensure that individuals can make free choices concerning research participation, consent should take place under conditions that minimize the potential for coercion or undue influence (Grady 2001; Department of Homeland Security et al.