Opposition to inducement payments for research subjects is an international orthodoxy amongst writers of ethics committee guidelines. We offer an argument in favour of these payments. We also critically evaluate the best arguments we can find or devise against such payments, and except in one very limited range of circumstances, we find these unconvincing.

In this classic text, Kant sets out to articulate and defend the Categorical Imperative - the fundamental principle that underlies moral reasoning - and to lay the foundation for a comprehensive account of justice and human virtues. This new edition and translation of Kant's work is designed especially for students. An extensive and comprehensive introduction explains the central concepts of Groundwork and looks at Kant's main lines of argument. Detailed notes aim to clarify Kant's thoughts and to correct some common (...) misunderstandings of his doctrines. (shrink)

The practice of paying research subjects for participating inclinical trials has yet to receive an adequate moral analysis.Dickert and Grady argue for a wage payment model in whichresearch subjects are paid an hourly wage based on that ofunskilled laborers. If we accept this approach, what follows?Norms for just working conditions emerge from workplacelegislation and political theory. All workers, includingpaid research subjects under Dickert and Grady''s analysis,have a right to at least minimum wage, a standard work week,extra pay for overtime hours, (...) a safe workplace, no faultcompensation for work-related injury, and union organization.If we accept that paid research subjects are wage earners likeany other, then the implications for changes to current practiceare substantial. (shrink)

Both international and federal regulations exist to ensure that scientists perform research on human subjects in an environment free of coercion and in which the benefits of the research are commensurate with the risks involved. Ensuring that these conditions hold is difficult, and perhaps even more so when protocols include the issue of monetary compensation of research subjects. The morality of paying human research subjects has been hotly debated for over 40 years, and the grounds for this debate have ranged (...) from discussion of legal rights, economic rights, philosophical principles of vulnerability and altruism to bioethical concepts of consent, best-interest determination, and justice theory. However, the thought surrounding these issues has evolved over time, and the way we think about the role of the human research subject today is markedly different than the way we thought in the past. Society first thought of the research subject as an altruist, necessarily giving of his time to benefit society as a whole. As time progressed, many suggested that the subject should not need to sacrifice himself for research: if something goes wrong, someone should compensate the subject for injuries. The concept of redress evolved into a system in which subjects were offered money as an inducement to participate in research, sometimes merely to offset the monetary costs of participation, but sometimes even to mitigate the risks of the study. This article examines ethical and legal conversations regarding compensation from the 1960s through today, examining theories of the ethics of compensation both comparatively and critically. In conclusion, we put forward an ethical framework for treating paid research subjects, with an attempt to use this framework as a means of resolving some of the more difficult problems with paying human subjects in research. (shrink)

On November 14, 1996, an in-depth report on the recruiting and testing practices of Lilly Pharmaceuticals appeared in the Wall Street Journal. Laurie Cohen reported that most pharmaceutical companies had difficulty recruiting healthy subjects to participate in testing of “untried and potentially dangerous” drugs. These companies often had to pay subjects up to $250 a day to ensure adequate enrollment, and some even gave referral bonuses to doctors who sent potential subjects their way. Cohen then exposed how Lilly was able (...) to keep costs down: by recruiting homeless alcoholics to serve as research guinea pigs. “In many ways,” Cohen reported, “the practice is mutually beneficial. For Lilly, it is efficient and limits the risk that subjects will sue if harmed by an experiment or divulge particulars of a drug.” And the subjects “get several weeks or months of free room and board, and in interviews they express voluble gratitude for what they often call easy money.”. (shrink)

Volume 19, Issue 9, September 2019, Page 32-34.

The evaluation of labour markets and of particular jobs ought to be sensitive to a plurality of benefits and burdens of work. We use the term 'the goods of work' to refer to those benefits of work that cannot be obtained in exchange for money and that can be enjoyed mostly or exclusively in the context of work. Drawing on empirical research and various philosophical traditions of thinking about work we identify four goods of work: 1) attaining various types of (...) excellence; 2) making a social contribution; 3) experiencing community; and 4) gaining social recognition. Our account of the goods of work can be read as unpacking the ways in which work can be meaningful. The distribution of the goods of work is a concern of justice for two conjoint reasons: First, they are part of the conception of the good of a large number of individuals. Second, in societies without an unconditional income and in which most people are not independently wealthy, paid work is non-optional and workers have few, if any, occasions to realize these goods outside their job. Taking into account the plurality of the goods of work and their importance for justice challenges the theoretical and political status quo, which focuses mostly on justice with regard to the distribution of income. We defend this account against the libertarian challenge that a free labour market gives individuals sufficient options to realise the goods of work important to them, and discuss the challenge from state neutrality. In the conclusion, we hint towards possible implications for today’s labour markets. (shrink)

To later generations, much of the moral philosophy of the twentieth century will look like a struggle to escape from utilitarianism. We seem to succeed in disproving one utilitarian doctrine, only to find ourselves caught in the grip of another. I believe that this is because a basic feature of the consequentialist outlook still pervades and distorts our thinking: the view that the business of morality is to bring something about . Too often, the rest of us have pitched our (...) protests as if we were merely objecting to the utilitarian account of what the moral agent ought to bring about or how he ought to do it. Deontological considerations have been characterized as “side constraints,” as if they were essentially restrictions on ways to realize ends. More importantly, moral philosophers have persistently assumed that the primal scene of morality is a scene in which someone does something to or for someone else. This is the same mistake that children make about another primal scene. The primal scene of morality, I will argue, is not one in which I do something to you or you do something to me, but one in which we do something together. The subject matter of morality is not what we should bring about, but how we should relate to one another. If only Rawls has succeeded in escaping utilitarianism, it is because only Rawls has fully grasped this point. His primal scene, the original position, is one in which a group of people must make a decision together. Their task is to find the reasons they can share. (shrink)

Payment for research participation has raised ethical concerns, especially with respect to its potential for coercion. We argue that characterising payment for research participation as coercive is misguided, because offers of benefit cannot constitute coercion. In this article we analyse the concept of coercion, refute mistaken conceptions of coercion and explain why the offer of payment for research participation is never coercive but in some cases may produce undue inducement.

Volume 19, Issue 9, September 2019, Page 44-45.

Volume 19, Issue 9, September 2019, Page 37-39.

Each year thousands of individuals enrol in clinical trials as healthy volunteers to earn money. Some of them pursue research participation as a full-time or at least a part-time job. They call themselves professional or semiprofessional guinea pigs. The practice of paying healthy volunteers raises numerous ethical concerns. Different payment models have been discussed in literature. Dickert and Grady argue for a wage-payment model. This model gives research subjects a standardised hourly wage, and it is based on an assumption that (...) research participation is morally indistinguishable from other forms of unskilled labour. In this paper, I will challenge this assumption. I will argue that human guinea pigging has particular characteristics which taken together make it significantly different from other forms of labour. Participation in research is skill-independent. Healthy volunteers are valuable not because they are skilful persons, but because they are human bodies. The role of research volunteers is mainly passive. They are not asked to produce goods or deliver services. They are paid for enduring unpleasant, painful and risky interventions performed by investigators. Research volunteering involves inherent risks and uncertainties, and subjects have little or no control over their minimisation and materialisation. I conclude that participation in clinical research is a specific kind of activity. It is more like renting out one’s body to strangers, than working. Thus, research participation should not be treated on par with other forms of employment. (shrink)

Volume 19, Issue 9, September 2019, Page 48-50.

Phase 1 healthy volunteer clinical trials—which financially compensate subjects in tests of drug toxicity levels and side effects—appear to place pressure on each joint of the moral framework justifying research. In this article, we review concerns about phase 1 trials as they have been framed in the bioethics literature, including undue inducement and coercion, unjust exploitation, and worries about compromised data validity. We then revisit these concerns in light of the lived experiences of serial participants who are income-dependent on phase (...) 1 trials. We show how participant experiences shift attention from discrete exchanges, behaviors, and events in the research enterprise to the ongoing and dynamic patterns of serial participation in which individual decision-making is embedded in collective social and economic conditions and shaped by institutional policies. We argue in particular for the ethical significance of structurally diminished voluntariness, routine powerlessness in setting the terms of exchange, and incentive structures that may promote pharmaceutical interests but encourage phase 1 healthy volunteers to skirt important rules. (shrink)

Volume 19, Issue 9, September 2019, Page 52-54.

Volume 19, Issue 9, September 2019, Page 46-48.

Phase I clinical trials are the first stage of testing new pharmaceuticals in humans. The majority of these studies are conducted under controlled, inpatient conditions using healthy volunteers who are paid for their participation. This article draws on an ethnographic study of six phase I clinics in the United States, including 268 semistructured interviews with research staff and healthy volunteers. In it, I argue that an institutional banalization of risk structures the perceptions of research staff and healthy volunteers participating in (...) the studies. For research staff, there are three mechanisms by which risk becomes banal: a perceived homogeneity of studies, Fordist work regimes, and data-centric discourse. For healthy volunteers, repeat study participation contributes to the institutional banalization of risk both through the process of desensitization to risk and the formation of trust in the clinics. I argue that the institutional banalization of risk also renders invisible ethical concerns about exploitation of underprivileged groups in pharmaceutical research. (shrink)

Offering cash payments to research subjects is a common recruiting method, but this practice continues to be controversial because of its potential to compromise the protection of human subjects. Some critics question whether researchers should be allowed to offer money at all, citing concerns about commodification of the research subject, invalidation of study results, and increased risks to subjects. Other critics are comfortable with the idea of monetary payments but question how much researchers can pay their subjects, citing concerns about (...) undue inducement, crowding out, and monetary exploitation. Focusing only on the amount researchers can pay their subjects, this paper argues that the federal regulations and guidelines should implement a standard payment formula. It argues for a wage payment model, and critically examines three candidates for a base wage: the nonfarm production wage, the FLSA minimum wage, and a living wage. (shrink)

Volume 19, Issue 9, September 2019, Page 41-43.

Volume 19, Issue 9, September 2019, Page 50-52.

A growing literature documents the existence of individuals who make a living by participating in phase I clinical trials for money. Several scholars have noted that the concerns about risks, consent, and exploitation raised by this phenomenon apply to many (other) jobs, too, and therefore proposed improving subject protections by regulating phase I trial participation as work. This article contributes to the debate over this proposal by exploring a largely neglected worry. Unlike most (other) workers, subjects are not paid to (...) produce or achieve anything but to have things done to them. I argue that this passivity is problematic for reasons of distributive justice. Specifically, it fails to enable subjects to realize what Gheaus and Herzog call “the goods of work”—a failure not offset by adequate opportunities to realize these goods outside of the research context. I also consider whether granting subjects worker-type protections would accommodate this concern. (shrink)

What, if anything, is wrong with taking advantage of people’s unjust circumstances when they both benefit from and consent to the exchange? The answer, some believe, is that such exchanges are wrongfully exploitative. I argue that this answer is incomplete at best, and I elaborate a different one: to take advantage of injustice is to become complicit in its reproduction. I also argue that the case for third-party interference with mutually beneficial and consensual exchanges, while normally considered weak, is strengthened (...) once these exchanges are understood as implicated in broader unjust structures. (shrink)

Volume 19, Issue 9, September 2019, Page 35-36.

Research subjects do not always conform to research requirements. When their personal interests conflict with the demands of participation, some subjects surreptitiously break the rules. These subjects are subversive — they undermine the research endeavor. In rejecting the restrictions research imposes, subversive subjects diminish the value of research results. From one vantage point, subversive subjects engage in unethical behavior. They create risks to themselves and others; they also disregard ethical responsibilities to adhere to research agreements and tell the truth. At (...) the same time, subversive subjects expose ethical problems in the design and conduct of clinical trials. Features of the research environment create fertile ground for subject subversion. Intensified policing and guidance are two common strategies for reducing subject subversion, but collaborative reforms are more consistent with the partnership model of clinical research. (shrink)

Scientific reports about clinical research appear objective and straightforward. They describe a study's findings, methods, subject population, number of subjects, and contribution to existing knowledge. The overall picture is pristine: the research team establishes the requirements of study participation and subjects conform to these requirements. Readers are left with the impression that everything was done correctly, by the book.In other places, however, one finds a different and messier picture of clinical research. In this picture, research subjects deviate from the prescribed (...) plan. One author contrasted the “tidy graphics” and “crisp prose” of the New England Journal of Medicine's HIV/AIDS trial publications with reports that subjects shared medications and broke other trial rules. Awareness of this behavior, he wrote, could lead insiders to “conclude that knowledge was resting on something rather less solid than bedrock.”. (shrink)

Volume 19, Issue 9, September 2019, Page 39-41.

Volume 19, Issue 9, September 2019, Page 62-64.