BackgroundThe nature of the relationship between a clinical investigator and a research subject has generated considerable debate because the investigator occupies two distinct roles: clinician and scientist. As a clinician, the investigator has duties to provide the patient with optimal care and undivided loyalty. As a scientist, the investigator has duties to follow the rules, procedures and methods described in the protocol.Results and conclusionIn this article, I present a contextual approach to the investigator-subject relationship. The extent of the investigator's duty (...) to provide the patient/subject with clinical care can vary from one situation to the next, as a function of several factors, including: the research design, benefits and risks of the research; the subject's reasonable expectations, motivations, and vulnerabilities; the investigator's ability to benefit the subject; and the investigator's prior relationship with the subject. These and other factors need to be considered when determining the clinical investigator's obligations to provide clinical care to human research subjects. In some research contexts, the investigator has extensive clinical obligations to the patient/subject; in others, the investigator has minimal ones. (shrink)

Fair Play in Sport presents a critical re-working of the classic ideal of fair play and explores its practical consequences for competitive sport. By linking general moral principles and practical cases, the book develops a contemporary theory of fair play.

Scholars and policymakers continue to struggle over the meaning of the word “vulnerable” in the context of research ethics. One major reason for the stymied discussions regarding vulnerable populations is that there is no clear distinction between accounts of research vulnerabilities that exist for certain populations and discussions of research vulnerabilities that require special regulations in the context of research ethics policies. I suggest an analytic process by which to ascertain whether particular vulnerable populations should be contenders for additional regulatory (...) protections. I apply this process to two vulnerable populations: the cognitively vulnerable and the economically vulnerable. I conclude that a subset of the cognitively vulnerable require extra protections while the economically vulnerable should be protected by implementing existing regulations more appropriately and rigorously. Unless or until the informed consent process is more adequately implemented and the distributive justice requirement of the Belmont Report is emphasized and operationalized, the economically disadvantaged will remain particularly vulnerable to the harm of exploitation in research. (shrink)

The precautionary principle is frequently referred to in various momentous decisions affecting human health and the environment. It has been invoked in contexts as diverse as chemicals regulation, regulation of genetically modified organisms, and research into life-extending therapies. Precaution is not an unknown concept in medical contexts. One author even cites the Hippocratic Oath as a parallel to the precautionary principle.

In this paper I explore the politics of trust in the clinical testing of pharmaceuticals in the US. Specifically, I analyze trust in terms of its institutional manifestations in the pharmaceutical clinical trials industry. In the process of testing new drugs, pharmaceutical companies must (1) protect their proprietary information from the clinicians who conduct their studies, and (2) find a way to ensure human subjects’ compliance to study protocols. Concern with these two critical issues leads drug companies to approach clinicians (...) and research subjects with an attitude of mistrust and the desire to exert control over their activities. This orientation results in an institutionalization of mistrust that structures the relationships and activities required for the clinical development of new pharmaceutical products. (shrink)

Many drugs have therapeutic off-label uses for which they were not originally designed. Some drugs designed to treat neuropsychiatric and other disorders may enhance certain normal cognitive and affective functions. Because the long-term effects of cognitive and affective enhancement are not known and may be harmful, a precautionary principle limiting its use seems warranted. As an expression of autonomy, though, competent individuals should be permitted to take cognition- and mood-enhancing agents. But they need to be aware of the risks in (...) chronic use of these agents and to take responsibility for their effects. A reasonable middle ground between these positions is to warn those who choose to enhance that doing so entails risks. (shrink)

This chapter analyzes the ethical issues that arise in the context of the use of physical enhancement techniques, i.e.techniques that aim at enhancing one or more physical functions of human beings. First, it discusses the different types of physical enhancement and points doping in sports is only a minor part of the whole enhancement field. Considerable attention is devoted to enhancement in sports, primarily because of the extensive extant literature. Then, the chapter moves on to problematize the concept of enhancement. (...) It shows that deciding whether something should count as an enhancement is not a matter for pure personal decision. The chapter engages with the ethical arguments put forward in the enhancement debate, showing that the validity of both the pro‐ and the anti‐enhancement arguments is context‐dependent and the growth hormone treatment can only be justifiably claimed if it aims at giving someone a height in the normal range. (shrink)