Allocation of very scarce medical interventions such as organs and vaccines is a persistent ethical challenge. We evaluate eight simple allocation principles that can be classiﬁed into four categories: treating people equally, favouring the worst-oﬀ, maximising total beneﬁts, and promoting and rewarding social usefulness. No single principle is suﬃcient to incorporate all morally relevant considerations and therefore individual principles must be combined into multiprinciple allocation systems. We evaluate three systems: the United Network for Organ Sharing points systems, quality-adjusted life-years, and (...) disability-adjusted life-years. We recommend an alternative system—the complete lives system—which prioritises younger people who have not yet lived a complete life, and also incorporates prognosis, save the most lives, lottery, and instrumental value principles. (shrink)
In this book, Alan Wertheimer seeks to identify when a transaction or relationship can be properly regarded as exploitative--and not oppressive, manipulative, or morally deficient in some other way--and explores the moral weight of taking ...
: Bioethicists have failed to understand the pervasively paternalistic character of research ethics. Not only is the overall structure of research review and regulation paternalistic in some sense; even the way informed consent is sought may imply paternalism. Paternalism has limits, however. Getting clear on the paternalism of research ethics may mean some kinds of prohibited research should be reassessed.
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.
Introduction -- Facing up to paternalism in research ethics -- Preface to a theory of consent transactions in research : beyond valid consent -- Should we worry about money? -- Exploitation in clinical research -- The interaction principle.
When does a woman give valid consent to sexual relations? When does her consent render it morally or legally permissible for a man to have sexual relations with her? Why is sexual consent generally regarded as an issue about female consent? And what is the moral significance of consent? These are some of the questions discussed in this important book, which will appeal to a wide readership in philosophy, law, and the social sciences. Alan Wertheimer develops a theory of consent (...) to sexual relations that applies to both law and morality in the light of the psychology of sexual relations, the psychology of perpetrators, and the psychology of the victims. He considers a wide variety of difficult cases such as coercion, fraud, retardation, and intoxication. We can all agree that 'no' means 'no'. This book suggests that the difficult question is whether 'yes' means 'yes'. (shrink)
It is universally accepted that participants in biomedical research have the right to withdraw from participation at any time, except, perhaps, when withdrawal would constitute a threat to their health or the health of others. The right to withdraw is encoded in nearly every document on the requirements for ethical conduct of research on humans, including the U.S. Code of Federal Regulations governing all federally-funded research, the Common Rule (45 CFR 46); the Declaration of Helsinki (WMA 2008); the 2002 research (...) guidelines of the Council for International Organizations of Medical Sciences (CIOMS 2002); and the Belmont Report (National Commission 1979). Presumably, if codification of the right in these .. (shrink)
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)
In this short response to Kerstein and Bognar, we clarify three aspects of the complete lives system, which we propose as a system of allocating scarce medical interventions. We argue that the complete lives system provides meaningful guidance even though it does not provide an algorithm. We also defend the investment modification to the complete lives system, which prioritizes adolescents and older children over younger children; argue that sickest-first allocation remains flawed when scarcity is absolute and ongoing; and argue that (...) Kerstein and Bognar are mistaken to base their allocation principles on differences in personhood. (shrink)
There is a good deal of biomedical research that does not produce scientifically useful data because it fails to recruit a sufficient number of subjects. This fact is typically not disclosed to prospective subjects. In general, the guidance about consent concerns the information required to make intelligent self-interested decisions and ignores some of the information required for intelligent altruistic decisions. Bioethics has worried about the ‘therapeutic misconception’, but has ignored the ‘completion misconception’. This article argues that, other things being equal, (...) prospective subjects should be informed about the possibility of non-completion as part of the standard consent process if it is or should be anticipatable that there is a non-trivial possibility of non-completion and that information is likely to be relevant to a prospective subject's decision to consent. The article then considers several objections to the argument, including the objection that disclosing non-completion information would make recruitment even more difficult. (shrink)
Policy makers are understandably interested—for both political and moral reasons—in following Thaler and Sunstein's recommendation to use ‘choice architecture’ , or other ‘nudges’, to promote desirable behaviour in ways that are allegedly compatible with personal freedom.1 Yashar Saghai's intricate analysis shows that simply maintaining the target's choice-set is insufficient to preserve the target's freedom when the nudge bypasses the target's deliberative capacities—as it is specifically designed to do.2 In his friendly amendment to Thaler and Sunstein's project, Saghai advances a more (...) robust account of nudges in which fewer policies would count as nudges, but those that do count as nudges would be less troublesome. In this commentary, I briefly discuss several issues raised by Saghai's project, some of which go beyond the topic of nudges. How important is definitional salvaging? If a ‘substantially controlling’ influence were more efficacious in promoting healthy behaviours, we would have a trade-off between the efficacy of a policy and its compatibility with freedom. Saghai states that an influence can be morally permissible even if it is ‘substantially controlling’ and, therefore, does not qualify as a nudge. So even on Saghai's definitional project it is not clear how much work it does in distinguishing the morally permissible from the morally impermissible. The …. (shrink)
This article has two broad purposes. First, as a political philosopher who has been interested in the concepts of coercion and exploitation, I want to consider just what the analysis of the concept of consent can bring to the question, what sexually motivated behavior should be prohibited through the criminal law? Put simply, I shall argue that conceptual analysis will be of little help. Second, and with somewhat fewer professional credentials, I shall offer some thoughts about the substantive question itself. (...) Among other things, I will argue that it is a mistake to think that sexual crimes are about violence rather than sex and that we need to understand just why the violation of sexual autonomy is a serious wrong. I shall also argue that the principle that “no means no” does not tell us when “yes means yes,” and that it is the latter question that poses the most interesting theoretical difficulties about coercion, misrepresentation, and competence. In addition, I shall make some brief remarks concerning two questions about consent and sexual relations that lie beyond the criminal law: What “consent compromising behaviors” should be regarded as indecent, although not criminal? When should someone consent to sexual relations within an enduring relationship? (shrink)
What I call ‘the standard view’ claims that IRBs should not regard financial payment as a benefit to subjects for the purpose of risk/benefit assessment. Although the standard view is universally accepted, there is little defense of that view in the canonical documents of research ethics or the scholarly literature. This paper claims that insofar as IRBs should be concerned with the interests and autonomy of research subjects, they should reject the standard view and adopt ‘the incorporation view.’ The incorporation (...) view is more consistent with the underlying soft-paternalist justification for risk-benefit assessment and demonstrates respect for the autonomy of prospective subjects. Adoption of the standard view precludes protocols that advance the interests of subjects, investigators, and society. After considering several objections to the argument, I consider several arguments for the standard view that do not appeal to the interests and autonomy of research subjects. (shrink)
The Standard View in research ethics maintains that, under certain conditions, investigators may deceive subjects and may enroll subjects without their consent. In contrast, it is always impermissible to coerce subjects to enroll, even when the same conditions are satisfied. This view raises a question that, as far as we are aware, has received no attention in the literature. Why is it always impermissible to undermine the validity of subjects’ consent through coercion, but it can be permissible to undermine the (...) validity of subjects’ consent through deception, and it can be permissible to enroll subjects without any consent at all? The present analysis suggests that the answer traces to the conditions on the appropriate treatment of subjects. This conclusion suggests that some requirements for human subjects research, and for valid consent more generally, trace not to the protection of subjects per se but to the proper behavior of agents. (shrink)
What is the basis for arguing that a volunteer army exploits citizens who lack civilian career opportunities? How do we determine that a doctor who has sex with his patients is exploiting them? In this book, Alan Wertheimer seeks to identify when a transaction or relationship can be properly regarded as exploitative--and not oppressive, manipulative, or morally deficient in some other way--and explores the moral weight of taking unfair advantage. Among the first political philosophers to examine this important topic from (...) a non-Marxist perspective, Wertheimer writes about ordinary experience in an accessible yet philosophically penetrating way. He considers whether it is seriously wrong for a party to exploit another if the transaction is consensual and mutually advantageous, whether society can justifiably prohibit people from entering into such a transaction, and whether it is wrong to allow oneself to be exploited.Wertheimer first considers several contexts commonly characterized as exploitive, including surrogate motherhood, unconscionable contracts, the exploitation of student athletes, and sexual exploitation in psychotherapy. In a section outlining his theory of exploitation, he sets forth the criteria for a fair transaction and the point at which we can properly say that a party has consented. Whereas many discussions of exploitation have dealt primarily with cases in which one party harms or coerces another, Wertheimer's book focuses on what makes a mutually advantageous and consensual transaction exploitive and analyzes the moral and legal implications of such exploitation. (shrink)
Gesundheit and colleagues offer dramatic examples of the medical treatment of terrorists but then pose the suggestion that those who engage in terrorism forfeit their right to medical care, and, consequently, that physicians have no obligation to treat them. Their argument presupposes that a physician’s obligation to provide medical care depends on the patients’ right to health care. Therefore, someone who commits heinous and abhorrent acts thereby waives the right to health care and the physicians’ duty to provide health care (...) might consequently be absolved. This view may appeal to physicians who have experienced the complexity and discomfort of treating someone whose morality or even humanity they question, such as a rapist, a serial killer, or a perpetrator of genocide. However we have grounds to believe that the duty of physicians to treat is not based on the moral worth of patients, but rather on the duties that physicians have, and this notion renders any concern about the unacceptability of any person’s behavior irrelevant in determining whether to provide treatment. We will first argue that not all duties are directly derived from rights, and then illustrate how deontological views, along with common views on the role morality of physicians, provide a basis for offering indiscriminate medical care. Second, we will discuss the physician’s role in the context of war, and offer one compelling moral reason on the basis of which warfare norms do indeed obligate physicians to extend their duty to care toward enemies, terrorists included, independently of whatever right they maintain. (shrink)
This article considers the principles that underlie the claim that some contracts are unconscionable and that such contracts should not be enforceable. It argues that it is much more difficult to explain unconscionability than is often supposed, particularly in cases where the contract is mutually advantageous or Pareto superior. Among other things, the article considers whether unconscionability is a defect in process or result, whether the gains in an unconscionable contract are disproportionate, whether there is a strong link between the (...) use of standard forms and unconscionability, and whether the principle of inequality of bargaining power can account for unconscionability. After rejecting several standard explanations of unconscionability, I consider several alternative ways in which it might be explained. (shrink)
The intentional punishment of the innocent is ordinarily claimed to be a special problem for utilitarian theories of punishment. The unintentional punishment of the innocent is a problem for any theory of punishment which holds that the guilty should be punished. This paper examines the criteria that are relevant to a determination of the appropriate probability of punishment mistakes for a society, and argues that this is the kind of moral problem for which utilitarian judgments, as opposed to considerations of (...) justice, are most appropriate. To illustrate some of the trade-offs involved, the paper employs some hypothetical data. (shrink)
The view that research with competent adults requires valid consent to be ethical perhaps finds its clearest expression in the Nuremberg Code, whose famous first principle asserts that “the voluntary consent of the human subject is absolutely essential.” In a similar vein, the United Nations International Covenant on Civil and Political Rights states that “no one shall be subjected without his free consent to medical or scientific experimentation.” Yet although some formulations of the consent principle allow no exceptions, others hold (...) that informed consent is not always strictly necessary for ethical research. The U.S. federal regulations known as the “Common Rule,” which govern research with human subjects, lists several conditions for waiving consent. However, neither guidance documents on the ethics of clinical research nor the literature in bioethics contains a general justification of research without consent. The purpose of this paper is to advance a justificatory framework that will explain why research without consent is permissible in paradigmatic cases and that can be useful in analyzing cases about which there is disagreement. We argue that research without consent can be justified on two grounds: if it stands to infringe no right of the participants and obtaining consent is impracticable, or if the gravity of the rights infringement is minor and outweighed by the expected social value of the research and obtaining consent is impracticable. (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.
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)
Using payment to recruit research subjects is a common practice, but it raises ethical concerns that coercion or undue inducement could potentially compromise participants’ informed consent. This is the first national study to explore the attitudes of IRB members and other human subjects protection professionals concerning whether payment of research participants constitutes coercion or undue influence, and if so, why. The majority of respondents expressed concern that payment of any amount might influence a participant’s decisions or behaviors regarding research participation. (...) Respondents expressed greater acceptance of payment as reimbursement or compensation than as an incentive to participate in research, and most agreed that subjects are coerced if the offer of payment makes them participate when they otherwise would not or when the offer of payment causes them to feel that they have no reasonable alternative but to participate . Views about undue influence were similar. We conclude that human subjects protection professionals hold expansive and inconsistent views about coercion and undue influence that may interfere with the recruitment of research participants and impede valuable research. (shrink)
As Sarah Conly notes in the précis of her important new book, there is considerable evidence that human beings are prone to make decisions that do not advance their own ends.1 Whereas some have argued for forms of libertarian paternalism such as ‘nudges,’2 ,3 Conly defends a more expansive use of straightforwardly coercive paternalism beyond such uncontroversial policies such as seat belt laws and requiring prescriptions for drugs. We should seriously consider banning trans fats and large portions in restaurants and (...) a total ban on cigarettes.I am largely sympathetic with Conly's project although it is doubtful that preventing people from harming themselves is ‘equally’ permissible with preventing people from harming others. It need only be permissible enough. I am also sympathetic with an underlying thesis of Conly's book, namely, that the justifiability of policies turns largely on empirical considerations of costs and benefits rather than appeals to abstract moral principles. But a commentator's job is not to praise or express sympathy. And so I do.First, Conly's book focuses on coercive paternalism by the state. She does not discuss paternalistic interventions that are not coercive or undertaken by individuals. And these are a central concern in medical ethics. Is it …. (shrink)
It is widely assumed that it is ethical to conduct research with human subjects only if the research has social value. There are two standard arguments for this view. The allocation argument claims that public funds should not be devoted to research that lacks social value. The exploitation avoidance argument claims that subjects are exploited if research has no social value. The primary purpose of this article is to argue that these arguments do not succeed. The allocation argument has little (...) relevance to commercial research. Social value is not necessary to avoid exploitation if subjects benefit from participation. Although the standard arguments for a social value requirement do not succeed, that view might be justified in a different way. It might be justified by appeal to the importance of social trust or the integrity of physician investigators. It is possible but doubtful that these arguments succeed. (shrink)