The payment of human subjects is an area where Institutional Review Boards have wide discretion. Although the “Common Rule” requires the provision of full information to human research participants to secure valid consent, the Rule is silent on the issue of payment. Still, some federal agencies offer guidance on the matter. For example, the National Science Foundation cautions that high payments for risky research “may induce a needy participant to take a risk that they normally would prefer not to take.” (...) For research under its purview, the Food and Drug Administration guidance provides that “[a]dvertisements may state that subjects will be paid, but should not emphasize the payment or the amount to be paid, by such means as larger or bold type.” One might read the FDA guidance to permit the advertisement for human subjects to state the specific amount of payment, as long as it is not emphasized. (shrink)

Some maintain that voluntariness is a value-neutral concept. On that view, someone acts involuntarily if subject to a controlling influence or has no acceptable alternatives. I argue that a value-neutral conception of voluntariness cannot explain when and why consent is invalid and that we need a moralized account of voluntariness. On that view, most concerns about the voluntariness of consent to participate in research are not well founded.

John McMillan's article raises numerous important points about the ethics of surgical castration of sex offenders.1 In this commentary, we focus solely on and argue against the claim that the offer of release from detention conditional upon surgical castration is a coercive offer that compromises the validity of the offender's consent. We take no view on the question as to whether castration for sex offenders is ethically permissible. But, we reject the claim that it is ethically permissible only if competing (...) ethical considerations outweigh worries about coercion. For in the situation described, the proposal is not coercive at all.McMillan states that if offenders agree to castration because they fear long-term detention, then ‘it seems, intuitively, as if agreeing to be castrated under these conditions makes the decision coerced in some way.’1 He adds that if castration is ‘the only way that they will be released back into the community, the status of this decision as a genuine expression of their autonomy is questionable.’1 In defence of his claim, he uses two analogies that he borrows from Joel Feinberg. First, if a governor offers to commute a death sentence if the prisoner agrees to participate in a medical experiment, then ‘it's clear that the governor is coercing the prisoner.’1 Second, if a millionaire offers to give a woman $1 000 000 …. (shrink)

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)

Incentivising has shown to improve participation in clinical trials. However, ethical concerns suggest that incentives may be coercive, obscure trial risks and encourage individuals to enrol in cli...

BackgroundTo assess ethical concerns associated with participation in a financial incentive programme to help adolescents with type 1 diabetes improve diabetes self-management.MethodsFocus groups with 46 adolescents with type 1 diabetes ages 12–17 and 38 of their parents were conducted in the Seattle, Washington metropolitan area. Semistructured focus group guides addressed ethical concerns related to the use of FI to promote change in diabetes self-management. Qualitative data were analysed and emergent themes identified.ResultsWe identified three themes related to the ethical issues adolescents (...) and parents anticipated with FI programme participation. First, FI programmes may variably change pressure and conflict in different families in ways that are not necessarily problematic. Second, the pressure to share FIs in some families and how FI payments are structured may lead to unfairness in some cases. Third, some adolescents may be likely to fabricate information in any circumstances, not simply because of FIs, but this could compromise the integrity of FI programmes relying on measures that cannot be externally verified.ConclusionsMany adolescents with type 1 diabetes and their parents see positive potential of FIs to help adolescents improve their self-management. However, ethical concerns about unfairness, potentially harmful increases in conflict/pressure and dishonesty should be addressed in the design and evaluation of FI programmes. (shrink)

Using the case of Ebola Virus Disease as an example, this paper shows why patients at high risk for death have a defensible moral claim to access unregistered medical interventions, without having to enrol in randomized placebo controlled trials.A number of jurisdictions permit and facilitate such access under emergency circumstances. One controversial question is whether patients should only be permitted access to UMI after trials investigating the interventions are fully recruited. It is argued that regulatory regimes should not prioritise trial (...) recruitment over patient access, even if this results in drug research and development delays.We describe how the moral duty to rescue impacts on others' duties to oblige patients seeking emergency access to unregistered medical interventions. The view that eligible patients are owed the provision of access to UMI regardless of their willingness to enrol in a randomised controlled trial is defended. (shrink)

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 aprima faciemoral 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). (shrink)

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)

Background Payment of research participants helps to increase recruitment for research studies, but can pose ethical dilemmas. Research ethics committees (RECs) have a centrally important role in guiding this practice, but standardisation of the ethical approval process in Ireland is lacking. Aim Our aim was to examine REC policies, experiences and concerns with respect to the payment of participants in research projects in Ireland. Method Postal survey of all RECs in Ireland. Results Response rate was 62.5% (n=50). 80% of RECs (...) reported not to have any established policy on the payment of research subjects while 20% had refused ethics approval to studies because the investigators proposed to pay research participants. The most commonly cited concerns were the potential for inducement and undermining of voluntary consent. Conclusions There is considerable variability among RECs on the payment of research participants and a lack of clear consensus guidelines on the subject. The development of standardised guidelines on the payment of research subjects may enhance recruitment of research participants. (shrink)

Volume 19, Issue 9, September 2019, Page 56-58.

Governments and policy-makers have of late displayed renewed attention to behavioural research in an attempt to achieve a range of policy goals, including health promotion. In particular, approaches which could be labelled as ‘nudges’ have gained traction with policy-makers. A range of objections to nudging have been raised in the literature. These include claims that nudges undermine autonomy and liberty, may lead to a decrease in responsibility in decision-making, lack transparency, involve deception, and involve manipulation, potentially occasioning coercion. In this (...) article I focus on claims of coercion, examining nudges within two of the main approaches to coercion—the pressure approach and the more recent enforcement approach. I argue that coercion entails an element of control over the behaviour of agents which is not plausibly displayed by the kinds of serious examples of nudges posited in the literature. (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)

Ethical review of applications to conduct research projects continues to be a focus of scrutiny and controversy. We argue that attention to the actual practices of ethical review has the potential to inform debate. We explore how research ethics committees (RECs) establish their position and authority through the texts they use in their correspondence with applicants. Using a discursive analysis applied to 260 letters, we identify four positions of particular interest: RECs positioned as disinterested and responsible; as representing the interests (...) of potential participants; as facilitating ethically sound, high-quality research; and as engaged in dialogue. These positions are used strategically to deflect criticism or complaint. This analysis has implications for reducing contestation between researchers and RECs, suggesting that more dialogic rather than hierarchical approaches to positioning might be helpful. (shrink)

Hospital systems commonly face the challenge of determining just ways to allocate scarce drugs during national shortages. There is no standardised approach of how this should be instituted, but principles of distributive justice are commonly used so that patients who are most likely to benefit from the drug receive it. As a result, clinical indications, in which the evidence for the drug is assumed to be established, are often prioritised over research use. In this manuscript, we present a case of (...) a phase II investigational trial of intravenous thiamine for delirium prevention in patients undergoing haematopoietic stem cell transplantation to emphasise several shortcomings in the overarching prioritisation of clinical over research uses of scarce drugs. Specifically, we present the following considerations: clinical use may not have stronger evidence than research use; a strong scientific rationale for research use may outweigh the claim for clinical indications in which there is weak evidence; treatment within the context of a clinical trial may be the standard of care; and research use may not only benefit patients receiving the treatment but also offers the prospect of improving future clinical care. In summary, we argue against allocation schemes that prohibit all research uses of scarce drugs and instead recommend that allocation schemes include a balanced approach that weighs risks and benefits of access to scarce drugs irrespective of the research versus clinical use designation. (shrink)

The idea that payment for research participation can be coercive appears widespread among research ethics committee members, researchers, and regulatory bodies. Yet analysis of the concept of coercion by philosophers and bioethicists has mostly concluded that payment does not coerce, because coercion necessarily involves threats, not offers. In this article we aim to resolve this disagreement by distinguishing between two distinct but overlapping concepts of coercion. Consent-undermining coercion marks out certain actions as impermissible and certain agreements as unenforceable. By contrast, (...) coercion as subjection indicates a way in which someone’s interests can be partially set back in virtue of being subject to another’s foreign will. While offers of payment do not normally constitute consent-undermining coercion, they do sometimes constitute coercion as subjection. We offer an analysis of coercion as subjection and propose three possible practical responses to worries about the coerciveness of payment. (shrink)

The European Committee for the Prevention of Torture and Inhuman or Degrading Treatment or Punishment have conducted visits and written reports criticising the surgical castration of sex offenders in the Czech Republic and Germany. They claim that surgical castration is degrading treatment and have called for an immediate end to this practice. The Czech and German governments have published rebuttals of these criticisms. The rebuttals cite evidence about clinical effectiveness and point out this is an intervention that must be requested (...) by the sex offender and cannot occur without informed consent. This article considers a number of relevant arguments that are not discussed in these reports but which are central to how we might assess this practice. First, the article discusses the possible ways in which sex offenders could be coerced into castration and whether this is a decisive moral problem. Then, it considers a number of issues relevant to determining whether sex offenders are harmed by physical castration. The article concludes by arguing that sex offenders should not be coerced into castration, be that via threats or offers, but that there is no reason to think that this is occurring in the Czech Republic or Germany. In some cases, castration might be useful for reconfiguring a life that has gone badly awry and where there is no coercion, the European Committee for the Prevention of Torture and Inhuman or Degrading Treatment or Punishment are mistaken about this being degrading treatment. (shrink)

In my reply to Wertheimer and Miller's paper on coercive offers and payment for research participation1 I claim that ‘… it's not unreasonable to suppose that there is another normative aspect to these cases, over and above the voluntariness of consent. While the parents of children at Willowbrook and the millionaire's mistress might have given consent that was voluntary and informed, they are still wronged by taking up this offer…’2 Furthermore, nowhere in my paper on surgical castration do I claim (...) that coercive offers invalidate consent,3 and I suggest that Bomann-Larsen has come closest to cashing this out correctly with her idea that ‘the wrongness of these coercive offers has more to do with the wilful creation of choices that take advantage of others vulnerabilities…’.4 So, it is puzzling that they object to my analysis of coercion and castration because coercive offers are not readily unpacked as a problem with consent. …. (shrink)

Concepts such as ‘coercion’ and ‘inducement’ are often used within bioethics without much reflection upon what they mean. This is particularly so in research ethics where they are assumed to imply that payment for research participation is unethical. Wertheimer and Miller advance our thinking about these concepts and research ethics in a significant way, specifically by questioning the possibility of genuine offers ever being coercive. This commentary argues that they are right to question this assumption, however, more needs to be (...) said about the plausible coercive offer cases and to explain the normativity of these cases. (shrink)

In this paper we analyze the non-coercive ways in which researchers can use knowledge about the decision-making tendencies of potential participants in order to motivate them to consent to research enrollment. We identify which modes of influence preserve respect for participants’ autonomy and which disrespect autonomy, and apply the umbrella term of manipulation to the latter. We then apply our analysis to a series of cases adapted from the experiences of clinical researchers in order to develop a framework for thinking (...) through the ethics of manipulating people into research participation. All manipulation disrespects autonomy and is therefore pro tanto wrong. However, only deceptive manipulation invalidates the consent that results from it. Use of the other forms of manipulation can be permissible, but only if the outcome of using manipulation is sufficiently good and if the research cannot be carried out using ethically preferable means to obtain consent. (shrink)

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)

The Patient Protection and Affordable Care Act turns to a nontraditional mechanism to improve public health: employer -provided financial incentives for healthy behaviors. Critics raise questions about incentive programs' effectiveness, employer involvement, and potential discrimination. We support incentive program development despite these concerns. The ACA sets the stage for a broad-based research and implementation agenda through which we can learn to structure incentive programs to not only promote public health but also address prevalent concerns.

Individuals can often take steps to preserve or improve their own health. They can eat appropriate quantities of healthy foods, exercise, and refrain from smoking. They can obtain preventive care and adhere to their physicians’ advice about how best to manage their health. But they often fail to take these steps.A widespread failure to adopt healthy behaviors can significantly erode public health while increasing health care costs. Obesity, for example, increases the risk of heart disease, stroke, liver disease, and certain (...) cancers. By one estimate, it is responsible for almost 10 percent of medical spending in the United States, or about $147 billion per year. Smoking increases the risk of heart disease, stroke, lung disease, and cancer; it accounts for nearly 20 percent of deaths each year in the United States and about $96 billion in health care expenditures. (shrink)

Volume 19, Issue 9, September 2019, Page 1-4.

Payment to recruit research subjects is a common practice but raises ethical concerns relating to the potential for coercion or undue influence. We conducted the first national study of IRB members and human subjects protection professionals to explore attitudes as to whether and why payment of research participants constitutes coercion or undue influence. Upon critical evaluation of the cogency of ethical concerns regarding payment, as reflected in our survey results, we found expansive or inconsistent views about coercion and undue influence (...) that may interfere with valuable research. In particular, respondents appear to believe that coercion and undue influence lie on a continuum; by contrast, we argue that they are wholly distinct: whereas undue influence is a cognitive distortion relating to assessment of risks and benefits, coercion is a threat of harm. Because payment is an offer, rather than a threat, payment is never coercive. (shrink)

Background Increase in global health research undertaken in resource poor settings in the last decade though a positive development has raised ethical concerns relating to potential for exploitation. Some of the suggested strategies to address these concerns include calls for providing universal standards of care, reasonable availability of proven interventions and more recently, promoting the overall social value of research especially in clinical research. Promoting the social value of research has been closely associated with providing fair benefits to various stakeholders (...) involved in research. The debate over what constitutes fair benefits; whether those that addresses micro level issues of justice or those focusing on the key determinants of health at the macro level has continued. This debate has however not benefited from empirical work on what stakeholders consider fair benefits. This study explores practical experiences of stakeholders involved in global health research in Kenya, over what benefits are fair within a developing world context. Methods and results We conducted in-depth interviews with key informants drawn from within the broader health research system in Kenya including researchers from the mainstream health research institutions, networks and universities, teaching hospitals, policy makers, institutional review boards, civil society organisations and community representative groups. The range of benefits articulated by stakeholders addresses both micro and macro level concerns for justice by for instance, seeking to engage with interests of those facilitating research, and the broader systemic issues that make resource poor settings vulnerable to exploitation. We interpret these views to suggest a need for global health research to engage with current crises that face people in these settings as well as the broader systemic issues that produce them. Conclusion Global health research should provide benefits that address both the micro and macro level issues of justice in order to forestall exploitation. Embracing the two is however challenging in terms of how the various competing interests/needs should be balanced ethically, especially in the absence of structures to guide the process. This challenge should point to the need for greater dialogue to facilitate value clarification among stakeholders. (shrink)

DNA databases have significant commercial value. Direct-to-consumer genetic testing companies have built databanks using samples and information voluntarily provided by customers. As the price of genetic analysis falls, there is growing interest in building such databases by paying individuals for their DNA and personal data. This paper maps the ethical issues associated with private companies paying for DNA. We outline the benefits of building better genomic databases and describe possible concerns about crowding out, undue inducement, exploitation, and commodification. While certain (...) objections deserve more empirical and philosophical investigation, we argue that none currently provide decisive reasons against using financial incentives to secure DNA samples. (shrink)

BackgroundProfessional guidelines have addressed ethical dilemmas posed by a few types of nontraditional procreative arrangements, but many questions arise regarding how providers view and make decisions about these and other such arrangements.MethodsThirty-seven ART providers and 10 patients were interviewed in-depth for approximately 1 h each. Interviews were systematically analyzed.ResultsProviders faced a range of challenges and ethical dilemmas concerning both the content and the process of decisions about requests for unconventional interfamilial and other reproductive combinations. Providers vary in how they respond (...) — what they decide, who exactly decides, and how — often undergoing complex decision-making processes. These combinations can involve creating or raising the child, and can shift over time — from initial ART treatment through to the child’s birth. Patients’ requests can vary from fully established to mere possibilities. Arrangements may also be unstable, fluid, or unexpected, posing challenges. Difficulties emerge concerning not only familial but social, combinations. These arrangements can involve blurry and confusing roles, questions about the welfare of the unborn child, and unanticipated and unfamiliar questions about how to weigh competing moral and scientific concerns — e.g., the autonomy of the individuals involved, and the potential risks and benefits. Clinicians may feel that these requests do not “smell right”; and at first respond with feelings of “yuck,” and only later, carefully and explicitly consider the ethical principles involved. Proposed arrangements may, for instance, initially be felt to involve consanguineous individuals, but not in fact do so. Obtaining and verifying full and appropriate informed consent can be difficult, given implicit familial and/or cultural expectations and senses of duty. Social attitudes are changing, yet patients’ views of these issues may also vary, based on their cultural backgrounds.ConclusionsThese data, the first to examine how clinicians make decisions about unconventional reproductive arrangements, highlight several critical ethical questions and ambiguities, and variations in clinicians’ responses. While several professional guidelines exist, the current data highlight additional challenges, and have vital implications for improving future guidelines, practice, education and research.Trial registrationNot applicable. (shrink)

Introduction Scholars have debated how to define coercion and undue influence, but how institutional review boards (IRBs) view and make decisions about these issues in actual cases has not been explored. Methods I contacted the leadership of 60 US IRBs (every fourth one in the list of the top 240 institutions by National Institutes of Health funding), and interviewed 39 IRB leaders or administrators from 34 of these institutions (response rate=55%), and 7 members. Results IRBs wrestled with defining of ‘coercion’ (...) and ‘undue inducement’, most notably in deciding about participant compensation. IRBs often use these terms synonymously and define undue inducement in varying ways, often wrestling with these issues, relying on ‘gut feelings’, and seeking compromises. Ambiguities arose, partly reflecting underlying tensions: whether subjects should ‘get paid’ versus ‘volunteer’ (ie, whether subjects should be motivated by compensation vs altruism), and whether subjects should be paid differently based on income, given possible resultant selection bias. Lack of consistent standards emerged between and even on single IRBs. Questions arose concerning certain aspects and types of studies; for example, how to view and weigh providing free care in research, whether and how recruitment flyers should mention compensation, and how to avoid coercion in paediatric, developing world, or students research. Conclusions These data, the first to probe qualitatively how IRBs view and approach questions about coercion, undue influence and participant compensation, and to examine how IRBs have reviewed actual cases, reveal several critical ambiguities and dilemmas, and have vital implications for future practice, education, policy and research. (shrink)

Controlled Human Infection Model (CHIM) research involves the infection of otherwise healthy participants with disease often for the sake of vaccine development. The COVID-19 pandemic has emphasised the urgency of enhancing CHIM research capability and the importance of having clear ethical guidance for their conduct. The payment of CHIM participants is a controversial issue involving stakeholders across ethics, medicine and policymaking with allegations circulating suggesting exploitation, coercion and other violations of ethical principles. There are multiple approaches to payment: reimbursement, wage (...) payment and unlimited payment. We introduce a new Payment for Risk Model, which involves paying for time, pain and inconvenience and for risk associated with participation. We give philosophical arguments based on utility, fairness and avoidance of exploitation to support this. We also examine a cross-section of the UK public and CHIM experts. We found that CHIM participants are currently paid variable amounts. A representative sample of the UK public believes CHIM participants should be paid approximately triple the UK minimum wage and should be paid for the risk they endure throughout participation. CHIM experts believe CHIM participants should be paid more than double the UK minimum wage but are divided on the payment for risk. The Payment for Risk Model allows risk and pain to be accounted for in payment and could be used to determine ethically justifiable payment for CHIM participants.Although many research guidelines warn against paying large amounts or paying for risk, our empirical findings provide empirical support to the growing number of ethical arguments challenging this status quo. We close by suggesting two ways (value of statistical life or consistency with risk in other employment) by which payment for risk could be calculated. (shrink)

Incentives are typically conceived as a form of trade, and so voluntariness appears to be the only ethical concern. As a consequence, incentives are often considered ethically superior to regulations because they are voluntary rather than coercive. But incentives can also be viewed as one way to get others to do what they otherwise would not; that is, as a form of power. When incentives are viewed in this light, many ethical questions arise in addition to voluntariness: What are the (...) responsibilities of the powerful in using incentives? Can incentives be manipulative or exploitative, even if people are free to refuse them? Like all other forms of power, incentives can be abused. This paper develops criteria for distinguishing their legitimate from their illegitimate uses, viz. legitimacy of purpose, voluntariness, and effect on character. The criteria are then applied to three cases: plea bargaining, recruiting medical research subjects, and motivating children to learn. Thinking of incentives in terms of.. (shrink)

The idea of coercion is one that has played, and continues to play, at least two importantly distinct moral-theoretic roles in our thinking. One, which has been the focus of a number of recent influential treatments, is a primarily deontic role in which claims of coercion serve to indicate relatively weighty prima facie wrongs and excuses. The other, by contrast, is a primarily axiological or eudaimonic role in which claims of coercion serve to pick out instances of some distinctive kind (...) of pro tanto human bad (such as unfreedom or interpersonal subjection). I argue that this turns out not to be a simple case of one idea put to two different uses, but rather a case of two subtly distinct ideas in need of separate philosophical treatment. Moreover, although often relatively neglected, the primarily eudaimonic idea of coercion is of enduring importance to both liberal-perfectionist and socialist political moralities, as well as to personal ethics. This paper aims to elucidate it and to examine its relationship to its better-theorised deontic cousin. In addition, the paper seeks to show how a better understanding of these aspects of the concept can enable us to resolve certain important and long-standing theoretical disagreements, such as the dispute over whether coercion is an ‘essentially moralised’ concept and the dispute over whether (genuine) offers can be coercive. (shrink)

Current orthodoxy in research ethics assumes that subjects of clinical trials reserve rights to withdraw at any time and without giving any reason. This view sees the right to withdraw as a simple extension of the right to refuse to participate all together. In this paper, however, I suggest that subjects should assume some responsibilities for the internal validity of the trial at consent and that these responsibilities should be captured by contract. This would allow the researcher to impose a (...) penalty on the subject if he were to withdraw without good reason and on a whim. This proposal still leaves open the possibility of withdrawing without penalty when it is in the subject's best interests to do so. Giving researchers recourse to legal remedy may now be necessary to protect the science, as existing methods used to increase retention are inadequate for one reason or another. (shrink)

The practice of paying prisoners to for their participation in research has long been debated, and the controversy is reflected in the differing policies in the U.S. prison systems. Empirical study of financial payments to inmates who enroll in research has focused on whether this practice is coercive. In this study, we examined whether monetary incentives have the potential to be unduly influential among fifty HIV‐positive prisoners. The majority of prisoners surveyed believed that inmates should receive some compensation for their (...) involvement in research and disagreed with statements suggesting that the offer of payment constitutes undue influence. However, a sense of potentially being susceptible to undue influence was significantly higher among participants who had spent a longer time in prison and had less education. Overall, our findings suggest that most prisoners feel that they would be able to make a decision about research enrollment that is not solely based on an offer of monetary payment. (shrink)

In 2011, Frank Van Den Bleeken became the first detainee to request euthanasia under Belgium’s Euthanasia Act of 2002. This article investigates whether it would be lawful and morally permissible for a doctor to accede to this request. Though Van Den Bleeken has not been held accountable for the crimes he committed, he has been detained in an ordinary prison, without appropriate psychiatric care, for more than 30 years. It is first established that VDB’s euthanasia request plausibly meets the relevant (...) conditions of the Euthanasia Act and that, consequently, a doctor could lawfully fulfill it. Next, it is argued that autonomy-based reasons for euthanizing VDB outweigh complicity-based reasons against doing so, and that, therefore, it is also morally permissible for a doctor to carry out the euthanasia request. (shrink)

Given that the concept of coercion remains a central concern for bioethics, Quigley's (Monash Bioethics Rev 32:141–158, 2014) recent article provides a helpful analysis of its frequent misapplication in debates over the use of ‘nudges’. In this commentary I present a generally sympathetic response to Quigley’s argument while also raising several issues that are important for the larger debates about nudges and coercion. I focus on several closely related topics, including the definition of coercion, the role of empirical research, and (...) the normative concerns at the core of these disputes. I suggest that while a degree of precision is certainly required when deploying the relevant concepts, perhaps informed by empirical data, we need to continue to push these debates towards more pressing normative considerations. (shrink)

As a 2006 Institute of Medicine report highlights, surprisingly little empirical attention has been paid to how prisoners arrive at decisions to participate in modern research. With our study, we aimed to fill this gap by identifying a more comprehensive range of factors as reported by prisoners themselves during semistructured interviews. Our participants described a diverse range of motives, both favoring and opposing their eventual decision to join. Many are well-recognized considerations among nonincarcerated clinical research participants, including a desire for (...) various forms of personal benefit, altruism, and concern about study risks and inconveniences. However, a number of influences seem unique to prisoners. Participants did not report that they were not coerced into enrolling, and they have even been under pressure not to enroll. However, many sought to enroll in order to obtain access to better health care, raising a concern about whether they were unfairly exploited. (shrink)

Concerns that people would be disinclined to voluntarily undergo moral enhancement have led to suggestions that an incentivised programme should be introduced to encourage participation. This paper argues that, while such measures do not necessarily result in coercion or undue inducement (issues with which one may typically associate the use of incentives in general), the use of incentives for this purpose may present a taboo tradeoff. This is due to empirical research suggesting that those characteristics likely to be affected by (...) moral enhancement are often perceived as fundamental to the self; therefore, any attempt to put a price on such traits would likely be deemed morally unacceptable by those who hold this view. A better approach to address the possible lack of participation may be to instead invest in alternative marketing strategies and remove incentives altogether. (shrink)

Volume 19, Issue 9, September 2019, Page 54-56.

The American Board of Internal Medicine (ABIM) Foundation has recently initiated a campaign called “Choosing Wisely,” which is aimed at reducing “low-value” care services. Lists of low-value care services are being developed and the ABIM Foundation is urging the American Medical Association and other organizations to get behind the lists, disseminate them, and implement them. Yet, there are many ethical questions that remain about the development, dissemination, and implementation of these low-value care lists. In this paper I argue for conceptual (...) clarity with respect to the label “low-value care.” Thus far it has not been precisely defined, and I argue that there are actually 10 distinct categories of low-value care. I discuss the ethical challenges and considerations associated with each category. I also provide arguments that can be used to justify the reduction of some of these categories of low-value care. These arguments rely on Rawlsian and Hegelian notions of justice, as well as on concepts about the fiduciary obligations of physicians. Finally, I outline the various mechanisms that could be utilized for the reduction of low-value care (i.e., incentives, punishments, nonrational influences such as appeals to social norms, emotions, or ego, and creation of conditions that make avoidance easy such as defaults and reminders). I provide normative guidelines for the use of each. (shrink)

ABSTRACTThis paper begins with the assumption that it is morally problematic when people in need are offered money in exchange for research participation if the amount offered is unfair. Such offers are called ‘coercive’, and the degree of coerciveness is determined by the offer's potential to cause exploitation and its irresistibility. Depending on what view we take on the possibility to compensate for the sacrifices made by research participants, a wish to avoid ‘coercive offers’ leads to policy recommendations concerning payment (...) for participation. For sacrifices considered compensable, we ought to offer either no payment or payment at a level deemed fair, while for sacrifices deemed incompensable, we always ought to offer no payment because as compensation appears and increases, so too does coercion. This article provides a model for thinking of the way in which degrees of exploitativeness, irresistibility, and coerciveness interact with the size of the reward for compensable and incompensable cases. T... (shrink)

In 2022, students at North American universities with third-dose COVID-19 vaccine mandates risk disenrolment if unvaccinated. To assess the appropriateness of booster mandates in this age group, we combine empirical risk-benefit assessment and ethical analysis. To prevent one COVID-19 hospitalisation over a 6-month period, we estimate that 31 207–42 836 young adults aged 18–29 years must receive a third mRNA vaccine. Booster mandates in young adults are expected to cause a net harm: per COVID-19 hospitalisation prevented, we anticipate at least (...) 18.5 serious adverse events from mRNA vaccines, including 1.5–4.6 booster-associated myopericarditis cases in males (typically requiring hospitalisation). We also anticipate 1430–4626 cases of grade ≥3 reactogenicity interfering with daily activities (although typically not requiring hospitalisation). University booster mandates are unethical because they: (1) are not based on an updated (Omicron era) stratified risk-benefit assessment for this age group; (2) may result in a net harm to healthy young adults; (3) are not proportionate: expected harms are not outweighed by public health benefits given modest and transient effectiveness of vaccines against transmission; (4) violate the reciprocity principle because serious vaccine-related harms are not reliably compensated due to gaps in vaccine injury schemes; and (5) may result in wider social harms. We consider counterarguments including efforts to increase safety on campus but find these are fraught with limitations and little scientific support. Finally, we discuss the policy relevance of our analysis for primary series COVID-19 vaccine mandates. (shrink)

Volume 19, Issue 9, September 2019, Page 58-60.

Purposeful infection of healthy volunteers with a microbial pathogen seems at odds with acceptable ethical standards, but is an important contemporary research avenue used to study infectious diseases and their treatments. Generally termed ‘controlled human infection studies’, this research is particularly useful for fast tracking the development of candidate vaccines and may provide unique insight into disease pathogenesis otherwise unavailable. However, scarce bioethical literature is currently available to assist researchers and research ethics committees in negotiating the distinct issues raised by (...) research involving purposefully infecting healthy volunteers. In this article, we present two separate challenge studies and highlight the ethical issues of human challenge studies as seen through a well-constructed framework. Beyond the same stringent ethical standards seen in other areas of medical research, we conclude that human challenge studies should also include: independent expert reviews, including systematic reviews; a publicly available rationale for the research; implementation of measures to protect the public from spread of infection beyond the research setting; and a new system for compensation for harm. We hope these additions may encourage safer and more ethical research practice and help to safeguard public confidence in this vital research alternative in years to come. (shrink)

This paper argues that there are two irreducibly distinct negative concepts of liberty: freedom as non-prevention, and freedom as non-coercion. Contemporary proponents of the negative view, such as Matthew Kramer and Ian Carter, have sought to develop the Hobbesian idea that freedom is essentially a matter of physical non-prevention. Accordingly, they have sought to reduce the freedom-diminishing effect of coercion to that of prevention by arguing that coercive threats function to diminish freedom by preventing people from performing certain combinations of (...) actions. Against this, this paper argues that coercion diminishes people’s freedom in ways that cannot be fully captured in terms of prevention. Focusing on two types of case, those involving coercive threats and those involving coercive preference manipulation, it argues that non-coercion and physical non-prevention are importantly different goods. It concludes that a complete negative account of liberty must draw not only on the (Hobbesian) ‘non-prevention’ strand of the negative tradition but also on its (Hayekian) ‘non-coercion’ strand. (shrink)