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)

We argue that charging people to participate in research is likely to undermine the fundamental ethical bases of clinical research, especially the principles of social value, scientific validity, and fair subject selection.

The therapeutic misconception has been seen as presenting an ethical problem because failure to distinguish the aims of research participation from those receiving ordinary treatment may seriously undermine the informed consent of research subjects. Hence, most theoretical and empirical work on the problems of the therapeutic misconception has been directed to evaluate whether, and to what degree, this confusion invalidates the consent of subjects. We argue here that this focus on the understanding component of informed consent, while important, might be (...) too narrow to capture the ethical complexity of the therapeutic misconception. We show that concerns about misplaced trust and exploitation of such trust are also relevant, and ought to be taken into account, when considering why the therapeutic misconception matters ethically. (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)

When seriously ill patients for whom existing treatments are inadequate are invited to participate in clinical trials that offer a new treatment, should those persons be considered “vulnerable”? And if so, what additional protections should they be accorded? This article attempts to provide some answers.

The recent TeGenero phase I trial of a novel monoclonal antibody in healthy volunteers produced a drastic inflammatory reaction in participants receiving the experimental agent. Commentators on the ethics of the research have focused considerable attention on the role of financial considerations: the for-profit status of the biotechnology company and Contract Research Organization responsible respectively for sponsoring and conducting the trial and the amount of monetary compensation to participants. We argue that these financial considerations are largely irrelevant and distort ethical (...) appraisal of this tragic research. Except for administering the antibody to all 6 participants nearly simultaneously, the trial appears to fulfill all of the critical ethical requirements for clinical research—social value, scientific validity, fair subject selection, favorable risk-benefit ratio, independent review, informed consent, and respect for enrolled participants. (shrink)

Background A topic of great concern in bioethics is the medical research conducted in poor countries sponsored by wealthy nations. Western drug companies increasingly view Latin America as a proper place for clinical research trials. The region combines a large population, modern medical facilities, and low per capita incomes. Participants from developing countries may have little or non alternative means of treatment other than that offered through clinical trials. Therefore, the provision of a valid informed consent is important. Methods To (...) gain insight about some aspects of the informed consent procedure in a major cancer centre in Mexico, we conducted a three-step evaluation process: 1) a ten point multiple choice survey questionnaires, was used to explore some aspects of the patients' experiences during the informed consent process, 2) researchers' knowledge about specific aspects of the informed consent was evaluated in this study using survey questionnaires; and 3) the comprehensibility, readability and number of pages of the consent forms were analysed. The socioeconomic and educational level of the patients, were also considered. Results were reported using a numerical scale. Results Thirty five patients, 20 doctors, and 10 individuals working at the hospital agreed to participate in the study. Eighty three percent of the patients in the study were classified as living in poverty; education level was poor or non existent, and 31% of the patients were illiterate. The consent forms were difficult to understand according to 49% of the patients, most doctors agreed that the forms were not comprehensible to the patients. The average length of the IC documents analysed was 14 pages, and the readability average score was equivalent to 8TH Grade. Conclusion The results presented in this work describe some relevant characteristics of the population seen at public health care institutions in Mexico. Poverty, limited or no education, and the complexity of the information provided to the patients may question the validity of the informed consent procedure in this group of patients. (shrink)

Though abortion is legal in Canada, policies currently in place at various levels of the health care system, and the individual actions of medical professionals, can inhibit access to abortion. This paper examines the various extra-legal barriers to abortion access that exist in Canada, and argues that these barriers are unjust because there are no good reasons for the restrictions on autonomy that they present. The paper then outlines the various policy measures that could be taken to improve access.

1. The opinions expressed are the author's own. They do not reflect any position or policy of the National Institutes of Health, Public Health Service, Department of Health and Human Services, or any of the authors affiliated organizations.

This paper presents the case of a young man with a diagnosis of schizophrenia, who agreed to inpatient treatment primarily to avoid being formally detained. I draw on Peter Breggin's early critique of coercion of informal patients to supply an updated discussion of the ethical issues raised. Central questions are whether the admission was coercive, and if so, whether unethical. Whether or not involuntary admission would be justified, moral discomfort surrounds its appearance as a threat. This arises in part from (...) ambivalence about autonomy: although a ‘choice’ is made, the threat of detention impinges on the patient's choice. Recent legal developments provide some experience of safeguarding those whose consent is not obtained. This highlights the lack of safeguards in this ‘gap’ and suggests that we have the tools with which to begin to deal with the problem. (shrink)