problems with paying research participants

Ethics in human subjects research: Do incentives matter? Although people often complain that top corporate executives or professional athletes make too much money, these moral qualms about overpayment have to do with unfairness rather than coercion or undue influence. Schaefer et al. 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. Most probably, it is because research is about advancing the interests of science and society, not the interests of individual participants (Emanuel et al. Infamous abuses of human research subjects, such as the Nazi experiments on concentration camp prisoners, the Tuskegee syphilis study, and the US governments secret radiation experiments, have involved exploitation. FOIA access to 500+ CME/CE credit hours per year, and access to 24 yearly 2019). Sage Open. Dickert Neal W. Concealment and fabrication: The hidden price of payment for research participation? $100 bonus for successful infection with yellow fever. 2018. From a broader perspective, it is useful in fulfilling societys obligation to meet the essential [health-related] needs of its members (Ackerman 1989, p. 1). However, it is neither designed for nor capable of actively fighting them, especially against participants poverty, unemployment or lack of access to high-quality healthcare (Fisher 2019). 2017) indicate that financial incentives affect willingness to participate but do not unduly influence the risk assessment, they have some limitations. 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. Ryska Joanna. 2019a; Largent and Lynch 2018; Bierer et al. Despite the widespread practice of paying research participants, doing so remains ethically controversial; how much, when, and what to pay participants has been much debated (Beckford & Broome . Understanding worries about payments to research participants. I was shocked by the findings. The https:// ensures that you are connecting to the To restore and safeguard the publics trust, researchers should follow rules and norms for protecting the rights and welfare of human subjects that provide more protection than people ordinarily have outside the research context (Miller and Wertheimer 2007; Resnik 2015b, 2018). Many different factors contribute to the low participation and retention rates. 2020; Lynch and Largent 2020; Jamrozik and Selgelid 2020). The study found that the amount of payment affected willingness to participate but did not have a negative impact on risk assessment (Cryder et al. Although research regulations do not define coercion, we can view coercion as the use of force, intimidation or threats to compel someone to do something (Wertheimer 1999; Wertheimer and Miller 2008, Gelinas et al. 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." How payment for research participation can be coercive. Money may remove participation barriers for those individuals who are unable or unwilling to cover direct costs associated with research, such as costs of traveling, lodging or hiring a babysitter. 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. When this happens, the study population might consist mostly of people who can afford to participate without a great deal of compensation, i.e., people with higher SES. Secondly, by rejecting the termcompensation, the proposed typology avoids conceptual and normative confusion stemming from ambiguity of this notion in legal terminology, where it stands for both money received in return for services rendered, especially salaries or wages, and for payment of damages for loss or injury (Ryska 2021). Second, it forgets that it takes two willing parties to change provision of goods or services into transaction, i.e., exchange of goods and services in return for money. 2018. 3.4; Council for International Organizations of Medical Sciences 2016, p. 53; Food and Drug Administration 2018; National Health and Medical Research Council 2019, par. Is It a Problem to Pay Research Participants? Macklin 1981) have adopted a similar view of the potential impact of money on informed consent for research participation. Paying research participants | The BMJ 2023 Apr 22;14(1):2325. doi: 10.1038/s41467-023-38068-6. 2019). (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. Emanuel Ezekiel J, Wendler David, Grady Christine. 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. Paying research participants: Regulatory uncertainty, conceptual confusion, and a path forward. Largent Emily A, Lynch Holly Fernandez. National Library of Medicine Should healthy volunteers in clinical trials be paid according to risk? It only mentions that information on incentives for subjects must be contained in the study protocol (par. It is, therefore, unsurprising that investigators and Institutional Review Boards (IRBs) experience confusion about how to evaluate offers of payment, and lean toward conservative approaches. et al. Offering payments, reimbursement and incentives to patients and family 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. Following Christine Gradys terminology (2005), the authors separate reimbursement, compensation, and incentive. Payment expectations for research participation among subjects who tell the truth, subjects who conceal information, and subjects who fabricate information. 2019. Clinical labor: tissue donors and research subjects in the global bioeconomy. Attachment A addressing ethical concerns offers of payment to research participants, Policies Support Clinicians if Asked to Provide Inappropriate Care, Changing Practice Models in Healthcare Raise Some Ethical Concerns. On the alleged right to participate in high-risk research. Participants 21 315 participants . Scientific research and the public trust. The first related to bias in study results: "If people are only doing research to get paid, I would have to question the accuracy of their results". Thus, the same justifications applicable to reimbursement applied here (Lynch et al. 2010; Largent et al. Money for research participation: Does it jeopardize informed consent? In: Emanuel Ezekiel J, Crouch Robert A, Grady Christine C, Lie Reidar K, Miller Franklin G, Wendler David D., editors. The continuing unethical conduct of underpowered clinical trials. The best way to promote the rights and welfare of adult human research subjects is to treat them as autonomous agents who have the capacity to make wise choices involving money, and not like children or mentally disabled individuals who need to be protected from its influence. 2014. JCI - Payment of clinical research subjects Ethical considerations for researchers developing and testing minimal-risk devices. 22) for offering payment to research participants is to boost recruitment and retention rates. 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). The paper deals with the widespread practice of paying research participants in exchange for their valuable service without determining whether the service should be treated as an unskilled labor, regular work, body renting, or a unique sui generis endeavor (cf. Phase I oncology trials: Why the therapeutic misconception will not go away. 2019). By continuing to use our site, you consent to the use of cookies outlined in our Privacy Policy. Bioethical Issues in Providing Financial Incentives to Research Grady Christine, Dickert Neal, Jawetz Tom, Gensler Gary, Emanuel Ezekiel J. Such a concealment, fabrication or falsification by participants create risks for participants, but also for research resources and the integrity of research data as it can bias the results and undermine the validity of a study (Lee et al. publications. On the contrary, it is considered at least as good as engaging in any other socially valuable and risky service or work. Payment of clinical research subjects - PMC - National Center for Federal government websites often end in .gov or .mil. Unsuccessful trial accrual and human subjects protections: An empirical analysis of recently closed trials. History provides ample evidence of the potential for exploitation in research with human subjects. Couldn't make it to the event? 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. Thus, payment is not, as some scholars and guidelines suggest, a demand of justice or fairness (Gelinas et al. I shall now consider three justifications one might offer for special concern about the impact of money on research participation. 2021) or requirement of non-maleficence and beneficence for an individual subject (Bierer et al. Ryska Joanna. Council for International Organizations of Medical Sciences. . For an individual prospective participant, the payment is a part of an equation for the overall attractiveness of a research project. Bierer Barbara E, White Sarah A, Gelinas Luke, Strauss David H. Fair payment and just benefits to enhance diversity in clinical research. 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. government site. My body is one of the best commodities: Exploring the ethics of commodification in phase i healthy volunteer clinical trials. Chambers 2001) argue that any form of payment for research participation is ethically suspect because people should enroll in studies for altruistic motives, most ethicists agree that some form of remuneration is acceptable (Largent and Fernandez Lynch 2017a). All participants were asked if they had received an influenza vaccine in the last six months. Fernandez Lynch et al. Since all liberal and democratic societies share a fundamental moral (and political) commitment to protecting and respecting each persons right to lead her life in accordance with her personal views of what is valuable in human life, they also share a moral obligation to encourage forms of social collaboration useful in fulfilling basic health needs of their members (London 2003, 2006; Rawls 1971; Nussbaum 2013). 2018). Valid consent of a prospective subject for using her body for research purposes transforms theft into gift, lease, rent, work or other consensual relation with a researcher. Strategies for recruitment and retention of participants in clinical trials. We conclude that payment raises all kinds of ethical difficulties, but that reimbursementwhilst not completely unproblematicis an ethical requirement. Remuneration is adequate when it is proportionate in value to the value of participants contribution to the study. Largent E, Grady C, Miller FG, Wertheimer A. Bioethics. McNeill Paul. Although such payments are conceptualized as price for desired services, in order to avoid exploitation, they should not be lower than remuneration viewed as reward. To estimate the prevalence of deception among professional research subjects, Devine et al. 2011; Kwiatkowski et al. Barriers to clinical trial enrollment in racial and ethnic minority patients with cancer. However, empirical research does not support the hypothesis that payments adversely impact judgment and decision-making concerning research participation (Gelinas et al. Ryska Joanna. Research regulations and ethical guidelines require that IRBs (or similar oversight committees) determine that risks are reasonable in relation to benefits to the subjects or to the value of the knowledge that might be gained, prior to approving a research proposal (Department of Homeland Security et al. (2014) surveyed 275 university faculty and students and found that the amount of money offered influenced the decision to participate in a hypothetical study involving ingestion of an experimental medication but did not affect information processing concerning risks. The research subject as wage earner. Here's why this must change. Anderson and Weijer 2002). Deception by human subjects is a serious problem, especially in clinical research, because it can place participants at risk and undermine the integrity of the data (Dresser 2013, Resnik and McCaan 2015). For example, the International ethical guidelines for health-related research involving humans of the Council for International Organizations of Medical Sciences (CIOMS) make a distinction between reimbursement for reasonable direct costs incurred by research subjects and compensation for the time spent and other inconveniences resulting from study participation (2016, Guideline 13 and Commentary). Paying people to participate in research: Why not? The latter necessarily depends on various factors which determine how time- and effort-consuming, burdensome and risky give research project is. 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. MacKay Douglas, Walker Rebecca L. Paying for fairness? 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. Accessibility Print 2023 Mar. Fundamentally, the problem is that "research participation" is a classificatory label for an experience that can be understood in a number of ways. Moreover, in order to fully understand their consequences for ethics of paying research subjects, it is essential to note two things. A living wage for research subjects. And there is nothing essentially unfair in allowing researchers and altruistically motivated participants to engage in scientifically and socially valuable biomedical research. Are payments to human research subjects ethically suspect? The recruitment of normal healthy volunteers: A review of the literature on the use of financial incentives. These justifications emphasize differences between paying money for research participation and paying people money for other types of labor or activity. 2014). This principle constitutes an ethical spine of the practice. For these people, money does not corrupt their judgment or decision-making by causing them to act against their values, because they are already prone to engage in deceptive acts to earn money. 2019). They all indicate that although the payment is not the only reason why people agree to participate in biomedical research, it is definitely one of the top motivates for enrollment, especially among healthy volunteers (Tishler and Bartholomae 2002; Almeida et al. Payment and reimbursement to research subjects. 2012, Largent and Fernandez. In this article, I argue that our ethical qualms about the negative impact of money on decisions concerning research participation are largely unfounded and reflect more general concerns about the need to avoid repeating abuses of human subjects that occurred in the past. 1.1). Therefore, commodification concerns against research payment, raised by some commentators (Macklin 1989; Chambers 2001; Abadie 2010, 2015; Cooper and Waldby 2014; Walker and Fisher 2019) will not be explored here.
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