Schaefer et al. Bethesda, MD 20894, Web Policies Socially valuable human biomedical research is critically dependent on successful enrolment and retention of a sufficient number of appropriate participants, and on their willingness to comply with study procedures and conditions. Half of the members of the experimental groups were told that receiving an influenza vaccine within the last six months was required for eligibility, and half were told that not receiving the vaccination was required. Inclusion in an NLM database does not imply endorsement of, or agreement with, According to Wertheimer (1999), an exploitative relationship involves at least one of three conditions: harm, compromised consent (including lack of consent), and unfair distribution of benefits. Many people believed it was exploitative not to compensate people for their role in the study. both enjoyable and insightful. For the sake of this analysis, I use all these terms interchangeably, as is frequently done in the literature. Moreover, contrary to views of some commentators, the commutative justice per se does not require offering payments to research subjects. For example, one might argue that some companies that operate clothing factories in developing nations exploit workers by paying them extremely low wages because the owners of these companies and their stockholders derive far more benefits from these relationships than the laborers. Central to the ethical challenges in financially compensating participants in research is that money may unduly induce people to take part. Informative inducement: Study payment as a signal of risk. Second, it is not clear that avoiding excessive payments to participants is an essential or even effective means of promoting public trust. Couldn't make it to the event? The trusted source for healthcare information and CONTINUING EDUCATION. Unger Joseph M, Vaidya Riha, Hershman Dawn L, Minasian Lori M, Fleury Mark E. Systematic review and meta-analysis of the magnitude of structural, clinical, and physician and patient barriers to cancer clinical trial participation. Biomedical research is social practice aimed at generating such a common goodgeneralizable scientific knowledge that may contribute to the improvement of healthcare interventions and public health measures, thus leading to the advancement of human health (cf. 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. Stunkel Leanne, Grady Christine. Finally, remuneration is non-exploitive when it is not lower than a socially accepted payment which is (or would be) offered for a similarly time- and effort-consuming, burdensome and risky activity, outside research context in the same setting (Gelinas et al. If risk is the main reason for worrying about the influence of money on research subjects, we should be concerned about paying people to participate in high-risk, non-beneficial studies and have few qualms about paying people to participate in low-risk studies. Food and Drug Administration. good which has two characteristics: it is non-exhaustible (one persons use does not diminish anothers use)and is beneficial for all or almost all members of a society.2. Ethics reviewers tend to look at the dollar amount in a vacuum, Devlin notes. Dunn Laura B, Gordon Nora E. Improving informed consent and enhancing recruitment for research by understanding economic behavior. 2019). However, empirical evidence does not support the widely held view that money often unduly influences research participation decisions, and there are significant ethical problems related to underpayment, such as exploitation and failure to meet study enrollment goals. If we want to claim that paying individuals for research participation can sometimes compromise their free choice, we should express this idea in terms of concerns about undue influence rather than coercion (Grady 2005; Wertheimer and Miller 2008; Largent et al. Payment for participation in research: a pursuit for the poor? Menikoff Jerry. In contract, the Australian National Health and Medical Research Councils guideline reads: In cases where risk may be considered as a factor in determining payment, payment of participants based on the degree of risk associated with the research is not prohibited, so long as there is evidence that a participants ability to provide valid consent is not likely to be compromised (2019, par. 2007; Abadie 2010; McCann et al. Since progress in biomedical science and healthcare is not ethically discretionary, this section argues that neither efficient enrolment nor payment for research subjects, being conductive to the latter, are value-neutral practices. Resnik David B. Bioethical issues in providing financial incentives to research articipants. In contrast, those in favour of paying research participants argue that payment rightly recognizes the contribution indi-viduals make to research outcomes and that without such financial recognition the Gelinas L, Largent EA, Cohen IG, Kornetsky S, Bierer BE, Fernandez Lynch H. 2018. One of the factors which adds to this confusion is the diversity and ambiguity of terminology used in the literature and guidelines on research payment. Several writers have argued that paying research subjects too little money could lead to exploitation (Shamoo and Resnik 2006; Resnik 2015; Largent and Fernandez Lynch 2017a, 2017b). 2020; Bierer et al. Strategies to minimize risks and exploitation in phase one trials on healthy subjects. What this 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. and transmitted securely. Association between financial incentives and participant deception about study eligibility, Payment and Reimbursement to Research Subjects - Information Sheet. Largent Emily A, Grady Christine, Miller Franklin G, Wertheimer Allan. 2013, 2015; Lee et al. An official website of the United States government. 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. 2005; Fry et al. The strength of the obligation to offer payment for participation grows in relation to studies which are urgently needed, e.g., to address acute public-health emergencies (such as a dire pandemic), or when there is strong evidence that without payment recruitment, retention and completion of socially valuable studies would be doomed or severely compromised. Health, health care and the problem of intrinsic value. 1This is an improved version of the payment typology presented in Ryska (2021). Unable to load your collection due to an error, Unable to load your delegates due to an error. 2010; Stunkel and Grady 2011; Grady et al. Surprisingly, these questions have been rarely the subject of in-depth discussions in the literature. 1 Yet there is a tension between researchers' use of payment as an incentive and the aim of institutional review boards (IRBs) to protect research participants by determining the ethical . Why does paying people money for research participation seem ethically suspect to so many commentators and IRB members? Third, most countries have extensive regulations that protect human subjects from risks, including oversight by government agencies and IRBs or similar committees (Emanuel 2004, Resnik 2018). Emanuel Ezekiel J, Wendler David, Grady Christine. Monetary offers do not involve the use of force, intimidation or threats. Largent Emily A, Lynch Holly Fernandez. U.S. Food and Drug Administration: Office of the Commissioner, Office of Clinical Policy and Programs, Office of Clinical Policy, Office of Good Clinical Practice. Financial compensation acts as a motivator in many other areas, such as employment. Underpayment of human subjects could lead to exploitation if research sponsors, institutions and investigators reap most of the financial benefits from a study and the human participants receive very little economic or other benefits in return (Resnik 2003). This paper also leaves aside payments to participants unable to give consent, because those raise additional, substantive issues, as well as recompenses for research-related injuries as they would require in-depth legal analysis. Schaefer G. Owen, Emanuel Ezekiel J, Wertheimer Alan. Paying Research Participants: The Outsized Influence of "Undue Having clarified basic terminological and conceptual issues, we can move on and explore the ethical anatomy of payment for research participants. National Research and Ethics Advisors' Panel. Manton Kerry J, Gauld Cassandra S, White Katherine M, Griffin Paul M, Elliott Suzanne L. Qualitative study investigating the underlying motivations of healthy participants in phase I clinical trials. Payment in challenge studies: Ethics, attitudes and a new payment for risk model. Gul Raisa B, Ali Parveen A. Nipp Ryan D, Hong Kessely, Paskett Electra D. Overcoming barriers to clinical trial enrollment. Commentators continue to justify payment across many types of studies and have called for paying higher amounts in order to mitigate exploitation or make research participation fairer (Gelinas et al. There are two problems with Emanuels critique of the unreasonable risk view. I am grateful to Michael Fessler for helpful comments on the manuscript. Thus, the idea that research subjects require special protections from the influence of money because of the risks they face does not stand up to scrutiny. The payment may attract people who would be otherwise discouraged from the participation by the necessity of taking unpaid leave from work and resulting loss of wages. gifts, failure to pay f or them is a problem: we call it theft" (2019, p. 1), thus suggesting that this is exactly what happens . However, the ethical concerns expressed by commentators and IRB members about the influence of money on research participation seem to apply to both high-risk and low-risk research alike. 2018). 2021; MacKay and Walker 2021). 5,28-30 One study found that the level of payment is associated with the perception of risk: participants judged higher-paying studies to be riskier than lower-paying studies . 2009, p. 70). FOIA Keep in mind that we are all reasonably influenced by money every day, Fernandez Lynch says. Many commentators argue that IRBs should carefully review payments to avoid the potential for coercion or undue influence (Dickert and Grady 2005, Grady 2005, Gelinas et al. 2010). Such a mistake affects all typologies of research payments which, alongside recompenses and remunerations, distinguish incentives or inducements payments. Before For the sake of brevity, we can refer to this as the unreasonable risks view. Offering disproportionally high and/or differential remuneration does not violate requirements of justice insofar as the payment is designed to help the study to meet its social and scientific goals by enhancing recruitment and retention of the necessary category of subjects, and it does not reproduce or reinforce wider social inequities and injustices, e.g., racial biases or class differences (Persad et al. 2010; Largent and Lynch 2017a; Fisher et al. Participation as commodity, participation as gift. Research regulations and guidelines require that the risks to human subjects must be justified in terms of expected benefits to the subjects or society, i.e., the value of knowledge gained (Department of Homeland Security et al. It presumes that any discussion on ethically sound payment practice should be preceded by a clear statement of ethical reasons for paying research participants, their deontic nature and mutual relations. An official website of the United States government. Failure to recruit or retain participants may lead to invalid or inconclusive research data, it may result in premature termination of a study, increase research costs, andwhat is the most importantdelay or even hinder scientific progress and the anticipated development of safer and more effective diagnostic, prophylactic and therapeutic interventions (Altman 1980; Halpern et al. 2011; Kwiatkowski et al. Anderson and Weijer 2002). 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. 2017; Fisher et al. . We dont expect people to always be altruists in their other endeavors, including risky work.. PROBLEMS WITH PAYING PARTICIPANTS Four potential problems with payment of research subjects were clearly identified (table 3). 2015). 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. 2019). Wertheimer Alan, Miller Franklin G. Payment for research participation: A coercive offer? The paper argues that the ethical anatomy of paying research participants is built upon four basic principles of research ethics (and bioethics in general). Emanuel Ezekiel J. Are Payments to Human Research Subjects Ethically Suspect? Money for research participation: does in jeopardize informed consent? The latter necessarily depends on various factors which determine how time- and effort-consuming, burdensome and risky give research project is. Largent and Fernandez Lynch (2017a, 2017b) have written extensively about issues related to paying people to participate in research. Nevertheless, such payment remains the source of substantial debate, in particular about whether or the extent to which offers of payment coerce and/or unduly induce individuals to participate. A national survey of investigators and IRB chairpersons. Although there is still a substantial disagreement in the literature about whether an offer of payment may be perceived as coercion, what exactly constitutes undue inducement, and whether money can distort or compromise autonomous decision-making (Macklin 1981, 1989; Wilkinson and Moore 1997; Grady 1999, 2001, 2005; Grant and Sugarman 2004; Emanuel 2004, 2005; Wertheimer and Miller 2008; Klitzman 2013; Largent et al. 2008 May;34(5):389-92. doi: 10.1136/jme.2007.021857. Page, Emily Haozous, Angelica Solares, Carla N. Cordova, and Richard S. Larson. 1979). 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. Remunerationswhether calculated as a reward or as a pricemay constitute a gain for subjects, thereby making participation in research overall beneficial from their personal perspective. Consider one of the subscription options below to receive full access to this article and many more. Our All Access Subscription provides unlimited access to our entire publication Dickert Neal W. Enrollment of economically disadvantaged participants in clinical research. However, there was no significant association between the amount of money offered and divergence the from baseline vaccination rate. Gelinas Luke, White Sarah A, Bierer Barbara E. Economic vulnerability and payment for research participation. 2017; Fisher et al. Glannon William. 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. What are the ethical principles or values which constitute an ethical rationale for paying research subjects? Bierer Barbara E, White Sarah A, Gelinas Luke, Strauss David H. Fair payment and just benefits to enhance diversity in clinical research. Fernandez Lynch H, Joffe S, Thirumurthy H, Xie D, Largent EA. Bethesda, MD 20894, Web Policies However, it also faces challenges. Since individuals still play a key role in safeguarding their own welfare, it is important to ensure that their decision-making regarding research participation is not unduly influenced by money. Most probably, it is because research is about advancing the interests of science and society, not the interests of individual participants (Emanuel et al. 2019. 2014. The use of incentives to target participants and trial staff has been proposed as one solution. Providing participants with enough compensation helps investigators do this (Largent and Fernandez Lynch 2018). For many of them accepting an offer of unfairly low but still en bloc beneficial payment for participation might be a reasonable choice. Thus, even if an offer of money might impact an individuals decision to enroll in a study, it cannot constitute undue influence because participating in the research would not expose the individual to unreasonable risks (Emanuel 2004). Making the case for completion bonuses in clinical trials. Justice for the professional guinea pig. Also, the U.S. Common rule (Department of Health and Human Services 2018) and the European Union Clinical Trial Regulation (2014) offer very limited guidance on payment for participants. Recent statistics published by the Center for Information and Study on Clinical Research Participation show that information about potential costs and their reimbursement as well as information about compensation for time off from work are among the most important factors influencing a decision to participate in research forrespectively58% and 40% potential subjects (2019). Why is it the case that concerns about undue influence have had a disproportionate impact on bioethical thinking about paying research subjects? 2019a; Largent and Lynch 2018; Bierer et al. 1 The amount of payment varies considerably, depending on the type of research, the amount of time spent performing research activities, and the procedures involved in the research. American Society of Clinical Oncology Educational Book. Paying Research Participants: The Outsized Influence of "Undue The ethical anatomy of payment for research participants Lee CP, Holmes T, Neri E, Kushida CA. It might be the case that SES affects willingness to participate or risk assessment, but further research is needed to ascertain whether this occurs (Klitzman 2005; Largent and Fernandez Lynch 2017a, 2017b). This efficiency-driven (Phillips 2011a) rationale is widely acknowledged. Grady Christine. McManus Lisa, Fisher Jill A. Those who choose the path of deception might have a sound grasp of the risks of research, yet still act against their values by doing something (e.g., lying or withholding important information) that they would not otherwise do. Resnik David B. In contrast, the average-wage benchmark for non-exploitive remuneration, mentioned by some authors (Phillips 2011a) would seem fairer as it would make payment offers reasonably attractive to both individuals of SES and to those better-off, thus promoting a fair distribution of research risks and benefits between different social strata. Remuneration is adequate when it is proportionate in value to the value of participants contribution to the study. 2018). While some ethicists (e.g. Ethical Issues in Research Involving Participants With Opioid Use Such a deceptive behavior by participants may take various forms (e.g., nondisclosure of concurrent enrollment in other studies, concealment of tobacco use, alcohol consumption, or illicit substance abuse, concealment of pre-existing medical conditions, falsification of current health status, over-reporting of a study protocol adherence, etc. At the same time, applying the logic of remuneration, they reject compensating participants based on their opportunity costs, noting that rather, research compensation is an acknowledgement of participants contributions to research, which leads to the conclusion that there generally should be equal pay for equal work (Lynch et al. 2017a). 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. Bioethicists and institutional review boards 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. A study that fails to meet its enrollment goals might yield data and results that are not significant and therefore potentially useless. IRBs also can justify any concerns raised about payment amounts. Sully Ben G, Julious Steven A, Nicholl Jon A. sharing sensitive information, make sure youre on a federal IRB Ethics Hum Res. Williams Rebecca J, Tse Tony, DiPiazza Katelyn, Zarin Deborah A. (2013) found that a significant percentage of respondents admitted that they had lied to investigators or withheld information to qualify for enrollment in a study. Salman, Rustam A. S. Elaine Beller, Jonathan Kagan, Elina Hemminki, Robert S. Phillips, Julian Savulescu, Malcolm Macleod, Janet Wisley, and Iain Chalmers. These categories are distinguished by a different impact each of them has on the participants economic position as evaluated ex post. Biomedical and behavioral research necessary to improve human health and medical care depends on the participation of human subjects. J Clin Res Best Pract. Most of the ethical debate has focused on issues related to paying people too much money rather than paying people at all (Largent and Fernandez Lynch 2017b). These regulatory variations mirror the lack of consensus regarding risk-based payments among research ethicists (Grady 2001; Menikoff 2001; Jones and Liddell 2009; Saunders 2009; Grimwade et al. The https:// ensures that you are connecting to the Thus, societies have a prima facie moral obligation to promote the conduct of biomedical research, including research involving human subjects. Research enterprise should not entrench or exacerbate these background social injustices. On the contrary, they are ethically grounded in and governed by the principle of social beneficence that calls for maximization of a common good, i.e. Shamoo Adil E, Resnik David B. Finally, what is rarely observed, the principle of respect for autonomy provides a general support for public policies which allow remuneration of research subjects for their contributionsboth in the form of reward and priceas it calls for respecting peoples right to decide freely in what practices and activates they what to engage in for the sake of earning their living. Recompense amends to research participants for financial and non-financial losses or injuries resulting from their participation in research. 2019). Health is highly valued by all individuals and societies primarily because of what it enables us to do (Duncan 2010, p. 321). [emailprotected]. While this third justification is more convincing that the first two, it also has some problems. As a library, NLM provides access to scientific literature. 2016. PDF Ethical and practical considerations of paying research participants Moreover, in order to fully understand their consequences for ethics of paying research subjects, it is essential to note two things. permitting paying research participants an "appropriate" Likewise, Mantzari et al. 1.3.). The Professional Guinea Pig: Big Pharma and the Risky World of Human Subjects, The influence of risk and monetary payment on the research participation decision making process, Participation as commodity, participation as gift. 2010). Thirdly, justice supports remuneration for participants contributions to the development of science and society, provided it is fair, i.e., equitable, adequate, and non-exploitive. Paying research participants: Regulatory uncertainty, conceptual confusion, and a path forward. The proposal was against their best interests or values because it would undermine marital fidelity.
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