Drawing the line on physician assistance in physician-assisted death continues to be a contentious issue in many legal jurisdictions across the USA, Canada and Europe. PAD is a medical practice that occurs when physicians either prescribe or administer lethal medication to their patients. As more legal jurisdictions establish PAD for at least some class of patients, the question of the proper scope of this practice has become pressing. This paper presents an argument for restricting PAD to the terminally ill that (...) can be accepted by defenders as well as critics of PAD for the terminally ill. The argument appeals to fairness-based paternalism and the social meaning of medical practice. These two considerations interact in various ways, as the paper explains. The right way to think about the social meaning of medical practice bears on fair paternalism as it relates to PAD and vice versa. The paper contends that these considerations have substantial force when directed against proposals to extend PAD to non-terminally ill patients, but considerably less force when directed against PAD for the terminally ill. The paper pays special attention to the case of non-terminally ill patients who suffer from treatment-resistant depression, as these patients present a potentially strong case for extending PAD beyond the terminally ill. (shrink)

Unrealistic optimism is a bias that leads people to believe, with respect to a specific event or hazard, that they are more likely to experience positive outcomes and/or less likely to experience negative outcomes than similar others. The phenomenon has been seen in a range of health-related contexts—including when prospective participants are presented with the risks and benefits of participating in a clinical trial. In order to test for the prevalence of unrealistic optimism among participants of early-phase oncology trials, we (...) conducted a survey with patients over 18 years of age who were enrolled in a phase I, phase I/II, or phase II clinical cancer trial in the New York City area between August 2008 and October 2009. Participants in our study were asked to compare their own chances of experiencing a range of risks and benefits related to the trial they were enrolled in with the chances of the other trial participants. We found a significant optimistic bias in their responses. Respondents tended to overestimate the benefits of the trial they were enrolled in and underestimate its risks. In addition, we found no significant relationship between respondents’ understanding of the trial’s purpose and how susceptible they were to unrealistic optimism. Our findings suggest that improving the consent process for oncology studies requires more than addressing deficits in understanding. (shrink)

In this paper, we defend the ethics of clinical research against the charge of paternalism. We do so not by denying that the ethics of clinical research is paternalistic, but rather by defending the legitimacy of paternalism in this context. Our aim is not to defend any particular set of paternalistic restrictions, but rather to make a general case for the permissibility of paternalistic restrictions in this context. Specifically, we argue that there is no basic liberty-right to participate in clinical (...) research and that considerations of distributive fairness justify some paternalistic protections of research subjects. (shrink)

The ethical standards that regulate clinical research have multiple rationales. Among them is the need to protect potential subjects from making imprudent decisions, which extends beyond the soft paternalistic concern to protect people from making uninformed decisions to participate in trials. This article argues that a plausible risk/benefit restriction on clinical trials is presumptively justified by hard paternalism, which in turn is supported by a deeper fairness-based rationale. This presumptive case for hard paternalism in research is not defeated by the (...) alleged right to participate in clinical trials, by concerns about insult or status, by the need to conduct early phase trials that promise little to no benefit to participants, or by the recognition that some potential subjects are altruistically motivated. (shrink)

Recent years have witnessed a growing concern that terminally illpatients are needlessly suffering in the dying process. This has ledto demands that physicians become more attentive in the assessment ofsuffering and that they treat their patients as `whole persons.'' Forthe most part, these demands have not fallen on deaf ears. It is nowwidely accepted that the relief of suffering is one of the fundamentalgoals of medicine. Without question this is a positive development.However, while the importance of treating suffering has generally (...) beenacknowledged, insufficient attention has been paid to the question ofwhether different types of terminal suffering require differnt responsesfrom health care professionals. In this paper we introduce a distinctionbetween two types of suffering likely to be present at the end of life,and we argue that physicians must distinguish between these types if theyare to respond appropriately to the suffering of their terminally illpatients. After introducing this distinction and explaining its basis,we further argue that the distinction informs a (novel) principle ofproportionality, one that should guide physicians in balancing theircompeting obligations in responding to terminal suffering. As weexplain, this principle is justified by reference to the intereststerminally ill patients have in restoration, as well as in therelief of suffering, at the end of life. (shrink)

: "Clinical pragmatism" is an important new method of moral problem solving in clinical practice. This method draws on the pragmatic philosophy of John Dewey and recommends an experimental approach to solving moral problems in clinical practice. Although the method may shed some light on how clinicians and their patients ought to interact when moral problems are at hand, it nonetheless is deficient in a number of respects. Clinical pragmatism fails to explain adequately how moral problems can be solved experimentally, (...) it underestimates the relevance and importance of judgment in clinical ethics, and it presents a questionable account of the role that moral principles should play in moral problem solving. (shrink)

: Some commentators have recently proposed that "clinical equipoise," although widely accepted, is not necessary for morally acceptable research on human subjects. If this concept is rejected, however, we may find that trials not in the best medical interests of their subjects--bad deal trials--could be justified. To avoid exploiting participants, we must find a way to distribute the risks fairly, even if it means embracing radical changes in the way clinical research is conducted.

The term “exploitation” has gained wide currency in recent discussions of biomedical and research ethics. This is due in no small measure to the influence of Alan Wertheimer’s path-breaking work on the topic (Wertheimer 1999, 2011). Wertheimer presented a clear and compelling non-Marxist account of the concept of exploitation—one that stressed the connection between exploitation and unfair distributive outcomes. On this account, when one party exploits another, she takes advantage of the other to gain unfairly. A number of contemporary bioethicists (...) have accepted Wertheimer’s account of exploitation and have proceeded to apply it to a range of issues in research ethics (Hawkins and Emanuel 2008; Miller and Brody .. (shrink)

Purpose Recent research has found unrealistic optimism among patient-subjects in early-phase oncology trials. Our aim was to investigate the cognitive and motivational factors that evoke this bias in this context. We expected perceptions of control to be a strong correlate of unrealistic optimism. Methods A study of patient-subjects enrolled in early-phase oncology trials was conducted at two sites in the USA. Respondents completed questionnaires designed to assess unrealistic optimism and several risk attribute variables that have been found to evoke the (...) bias in other contexts. Results One hundred and seventy-one patient-subjects agreed to be interviewed for our study. Significant levels of perceived controllability were found with respect to all nine research-related questions. Perceptions of control were found to predict unrealistic optimism. Two other risk attribute variables, awareness of indicators and mental image, were correlated with unrealistic optimism. However, in multivariate regression analysis, awareness and mental image dropped out of the model and perceived controllability was the only factor independently associated with unrealistic optimism. Conclusion Patient-subjects reported that they can, at least partially, control the benefits they receive from participating in an early-phase oncology trial. This sense of control may underlie unrealistic optimism about benefiting personally from trial participation. Effective interventions to counteract unrealistic optimism may need to address the psychological factors that give rise to distorted risk/benefit processing. (shrink)

We are currently in the midst of a revival of interest in thevirtues. A number of contemporary moral philosophers havedefended a virtue-based approach to ethics. But does thisrenewal of interest in the virtues have much to contributeto medical ethics and medical practice? This paper criticallydiscusses this question. It considers and rejects a number ofimportant arguments that purport to establish the significanceof the virtues for medical practice. Against these arguments,the paper seeks to show that while the virtues have a genuinerole to (...) play in medical ethics, it is a limited role, one thatis subordinate to the role that other moral concepts such asrules and principles play. (shrink)

There is broad agreement among research ethicists that investigators have a duty to obtain the informed consent of all subjects who participate in their research trials. On a common view, the duty to obtain this informed consent follows from the need to respect persons and their autonomous decisions. However, the nature of informed consent and the demands it places on investigators are open to dispute and recently have been challenged. Respect for persons, it has been claimed, does not require investigators (...) to guarantee that the subjects enrolled in their trials comprehend the risk/benefit information disclosed to them or even that they appreciate the difference between research and therapy. According to this critique, the significance of defects in informed consent, like therapeutic misconception or unrealistic optimism, has been greatly exaggerated. This article reevaluates informed consent in clinical research in light of this critique. It not only rebuts the main points the critics raise, but also shows that other points they raise can be accepted by a doctrine of informed consent that resembles the common view in maintaining that autonomous authorization is central to informed consent. (shrink)

What standard or principle should guide decisionmaking concerning the permissibility of allowing children to be organ donors? For a long time, it has been widely assumed that the best interest of the child is the appropriate standard. But recently, several critics have charged that this standard fails to give due weight to the interests of the family and the intimate relationships that the family makes possible.1,2 This article reviews and rejects both the best-interest standard and the alternative standard recommended by (...) the critics. I then propose a new standard to help parents, healthcare professionals, and judges decide when it is and is not permissible for children to serve as organ donors. This new standard modifies and broadens the best-interest standard to allow it to account adequately for the contribution that intimate relationships make to the well-being of children. (shrink)

Recent empirical work on the concept of intentionality suggests that people’s assessments of whether an action is intentional are subject to uncertainty. Some researchers have gone so far as to claim that different people employ different concepts of intentional action. These possibilities have motivated a good deal of work in the relatively new field of experimental philosophy. The findings from this empirical research may prove to be relevant to medical ethics. In this article, we address this issue head on. We (...) first describe a study we conducted on intention ascription. Drawing on recent work in experimental philosophy, we investigated the possibility that the ascription of intentions to clinical actors in clinical settings is influenced by prior judgments about the goodness or badness of the consequences of the action in question. Our study was modeled on experimental studies in other contexts that have shown that people, when presented with a range of scenarios, are more likely to classify a side effect of an action as intended if the side effect is negative or reflects poorly on the actor than if it is positive or reflects well on the actor. We investigated whether this asymmetry in intention ascriptions was also present among physicians who were asked to ascribe intentions to clinical actors in certain well-defined clinical scenarios. After describing the study and its results, we discuss its implications for medical ethics. (shrink)

In recent years, a number of writers have proposed voluntary stopping of eating and drinking as an alternative to physician-assisted suicide. This paper calls attention to and discusses some of the ethical complications that surround the practice of voluntary stopping of eating and drinking. The paper argues that voluntary stopping of eating and drinking raises very difficult ethical questions. These questions center on the moral responsibility of clinicians who care for the terminally ill as well as the nature and limits (...) of the authority they exercise over them. (shrink)

We are currently in the midst of a revival of interest in thevirtues. A number of contemporary moral philosophers havedefended a virtue-based approach to ethics. But does thisrenewal of interest in the virtues have much to contributeto medical ethics and medical practice? This paper criticallydiscusses this question. It considers and rejects a number ofimportant arguments that purport to establish the significanceof the virtues for medical practice. Against these arguments,the paper seeks to show that while the virtues have a genuinerole to (...) play in medical ethics, it is a limited role, one thatis subordinate to the role that other moral concepts such asrules and principles play. (shrink)

Informed consent is a central concept in the literature on the ethics of clinical care and human subjects research. There is a broad consensus that ethical practice in these domains requires the informed consent of patients and subjects. The requirements of informed consent in these domains, however, are matters of considerable controversy. Some argue that the requirements of informed consent have been inflated, others that they have not been taken seriously enough. This essay argues that both sides are partly right. (...) To advance this argument, the essay distinguishes a general doctrine of informed consent from what it characterizes as “models of informed consent.” A general doctrine articulates a set of requirements for informed consent and then adjusts these requirements to fit the context in which they are to be applied. In contrast, different models of informed consent impose different requirements in different contexts. The essay contends that different models of informed consent are needed for clinical care and clinical research. It outlines these two models, articulates the rationale for distinguishing them, and considers and rebuts the objection that clinical care and clinical research are too deeply intertwined in contemporary medicine for the models approach to apply to them. (shrink)

While tens of thousands of people across the United States serve on hospital and other healthcare ethics committees , almost no carefully prepared educational material exists for HEC members. Ethics by Committee is a one volume collection of chapters developed exclusively for this educational purpose. Experts in bioethics, clinical consultation, health law, and social psychology from across the country contribute chapters on ethics consultation, education, and policy development.

Physicians treating newly incapacitated patients often must navigate surrogate decision-makers through a difficult course of treatment decisions. Such a process can be complex. Physicians must not only explain the medical facts and prognosis to the surrogate, but also attempt to ensure that the surrogate arrives at decisions that are consistent with the patient's own values and wishes. Where these values and wishes are unknown, physicians must help surrogates make decisions that reflect the patient's best interests.

Ethical research on human subjects requires that subjects, if they have the capacity to do so, give free and informed consent to participate in the trials in which they are enrolled. This requirement, which is commonly referred to as the principle of informed consent, was prominently endorsed by the authors of the Belmont Report in 1978, and it remains widely accepted today. Yet while the principle of informed consent is by now almost universally accepted, the responsibilities that it imposes on (...) those who conduct research on human subjects is a more contentious matter. New challenges to securing informed consent have emerged since the publication of the Belmont Report, and responding to these challenges requires... (shrink)

Death in the Clinic fills a gap in contemporary medical education by explicitly addressing the concrete clinical realities about death with which practitioners, patients, and their families continue to wrestle. Visit our website for sample chapters!

Physicians treating newly incapacitated patients often must navigate surrogate decision-makers through a difficult course of treatment decisions. Such a process can be complex. Physicians must not only explain the medical facts and prognosis to the surrogate, but also attempt to ensure that the surrogate arrives at decisions that are consistent with the patient's own values and wishes. Where these values and wishes are unknown, physicians must help surrogates make decisions that reflect the patient's best interests.