Alan Wertheimer

(1942 - 2015)

This chapter examines the fair transaction model of informed consent as an alternative to autonomous authorization by research participants. Prevailing ethical thinking about informed consent to clinical research is characterized by theoretical confidence and practical disquiet. On one hand, bioethicists are confident that informed consent is a fundamental norm. On the other hand, they are uneasy about the quality of consent in practice. One major source of this disquiet is substantial evidence of the “therapeutic misconception”—the tendency of patient-subjects in clinical trials to think that participation in research means receiving personalized medical care. This tension between theory and practice relating to informed consent has given rise to a lack of clarity about, and incoherence in, application of theory to practice. This chapter argues that this prevailing pattern of theoretical and practical thinking about informed consent in bioethics is fundamentally flawed. It attributes the problem to the idea that consent is valid only if it constitutes autonomous authorization. It then describes the fair transaction model and highlights its advantages over autonomous authorization.

This chapter explores the moral obligations of medical researchers in “correcting injustice” and “avoiding exploitation” when conducting scientific studies in less-developed countries (LDCs). The latter concern is the focus, as it can be done on a small scale. The argument addresses the issues of obtaining proper morally transformative consent from subjects participating in medical research, and providing them with reasonable compensation for their trouble. Or at the very least, this chapter provides an enlightening look into the “interaction principle,” and how they can be revised or omitted in the larger context of global justice.

This chapter argues that the basic features of research ethics and regulation are based on a fundamentally paternalistic foundation—one that is reasonable in view of the nature of clinical research. The paternalistic roots of research ethics and regulation are obscured by the antipathy to paternalism within bioethics, which began with a critique of traditional medical paternalism and championed the autonomy of patients and research subjects. Nevertheless, there would be no rationale for independent committee review and oversight, deploying the key subject-protection task of risk-benefit assessment, if research subjects in the aggregate were capable of protecting their interests by means of consent. This chapter explains and justifies the prevailing approach to research ethics and regulation in terms of “group soft paternalism.” Even the requirement for informed consent has a paternalistic justification since a process of information disclosure is not required as a condition of valid consent in many other areas of social life.

This chapter discusses the ethical issues raised by the film _Outbreak_ (1995), specifically the conflict between protecting public health versus respecting the rights of the individual. The film tells the story of an outbreak caused by a deadly virus carried to the United States by an African monkey shipped to California. At one point, it appears necessary to obliterate an entire town to prevent the virus from escaping and endangering the entire population of the United States. The virus is cast as an agent of war, justifying the use of force and citing that the flu pandemic of 1918 killed more people than did World War I. The film asks, in effect, whether it is morally acceptable to use force against those who carry the virus even when they are essentially innocent victims.

It is generally thought to be permissible to enroll people in research only if subjects give their voluntary consent. Much biomedical research takes place in low- and middle-income countries where people participate because they expect to receive medical or financial benefits that exceed the risks and burdens of participation. It may be claimed that people cannot give voluntary consent when they believe they have no reasonable alternative but to consent. The chapter argues that we must either reject the view that having no reasonable alternative makes one’s consent involuntary or that we must reject the view that valid consent must be voluntary. There are good reasons to allow people to consent to beneficial transactions even when they have no reasonable alternative.

This chapter focuses on the question of when a person's consent to sexual relations is morally transformative. For example, if one consents while intoxicated or after one has been deceived, is it permissible for the other party to proceed? It develops a general account of the criteria of moral transformative consent (CMT), a set of criteria that itself can take two forms: the criteria of morally transformative consent for the law (CMT L ) and the criteria of morally transformative consent for morality (CMT M ). Both versions of CMT are moral criteria, but the criteria that indicate when consent should—as a moral matter—be regarded as legally permissible are not identical to the criteria that indicate when a person's consent renders another's action morally permissible.

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.

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.

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

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.

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.

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

The current prevailing view is that participation in biomedical research is above and beyond the call of duty. While some commentators have offered reasons against this, we propose a novel public goods argument for an obligation to participate in biomedical research. Biomedical knowledge is a public good, available to any individual even if that individual does not contribute to it. Participation in research is a critical way to support an important public good. Consequently, all have a duty to participate. The current social norm is that individuals participate only if they have a good reason to do so. The public goods argument implies that individuals should participate unless they have a good reason not to. Such a shift would be of great aid to the progress of biomedical research, eventually making society significantly healthier and longer lived.

Prevailing ethical thinking about informed consent to clinical research is characterized by theoretical confidence and practical disquiet. On the one hand, bioethicists are confident that informed consent is a fundamental norm. And, for the most part, they are confident that what makes consent to research valid is that it constitutes an autonomous authorization by the research participant. On the other hand, bioethicists are uneasy about the quality of consent in practice. One major source of this disquiet is substantial evidence of the “therapeutic misconception”—the tendency of patient-subjects in clinical trials to confuse participating in research with receiving personalized medical care. This ..

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 …

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'.