One of the most important questions in the ethics of human clinical research asks what obligations investigators owe the people who enroll in their studies. Research differs in many ways from standard care - the added uncertainties, for instance, and the nontherapeutic interventions such as diagnostic tests whose only purpose is to measure the effects of the research intervention. Hence arises the question whether a physician engaged in clinical research has the same obligations toward research subjects that he owes his (...) medical patients, or whether they differ in any fundamental way.Perhaps the most common answer is that the relationship is the same. Investigators, like physicians, are said to be fiduciaries of the volunteers who enroll in research trials. Each owes the best available medical care, which means that a physician can only justify enrolling his patient in research if the study meets the requirements of clinical equipoise, namely, that there is legitimate disagreement within the medical community as to whether the standard treatment or the investigational intervention is superior. (shrink)

One of the most important questions in the ethics of human clinical research asks what obligations investigators owe the people who enroll in their studies. Research differs in many ways from standard care - the added uncertainties, for instance, and the nontherapeutic interventions such as diagnostic tests whose only purpose is to measure the effects of the research intervention. Hence arises the question whether a physician engaged in clinical research has the same obligations toward research subjects that he owes his (...) medical patients, or whether they differ in any fundamental way.Perhaps the most common answer is that the relationship is the same. Investigators, like physicians, are said to be fiduciaries of the volunteers who enroll in research trials. Each owes the best available medical care, which means that a physician can only justify enrolling his patient in research if the study meets the requirements of clinical equipoise, namely, that there is legitimate disagreement within the medical community as to whether the standard treatment or the investigational intervention is superior. (shrink)

Some authors argue that the ethics of medical care and the ethics of research differ, and that it is a mistake to conflate the two. They propose “that medical research and medical treatment are two distinct forms of activities, governed by different ethical principles.” This raises the question of whether physicians who are also clinical investigators may separate their role as physician from that of researcher when they are involved in clinical trials, thereby avoiding the obligations required in the physician-patient (...) relationship. Miller and Brody suggest that medical training is to blame for what they believe is the physicians’ tendency to confound the obligations of research and practice. “Physician-investigators, after all, went to medical school” they explain. They believe that considering research with patients outside the ethical framework of the physician-patient relationship may be “difficult and threatening” to physicians who have “psychological needs” to consider the ethical obligations flowing from their relationship with their patients. (shrink)

The medical profession contains five “spheres of morality”: clinical care, clinical research, scientific knowledge, population health, and the market. These distinct sets of normative commitments require physicians to act in different ways depending on the ends of the activity in question. For example, a physician-scientist emphasizes patients’ well-being in clinic, prioritizes the scientific method in lab, and seeks to maximize shareholder returns as a board member of a pharmaceutical firm. Physicians increasingly occupy multiple roles in healthcare and move between them (...) frequently, creating the possibility of conflict between the ethical obligations of their various roles. This paper examines the entire moral landscape of medicine through the lens of role morality. It develops a novel framework that helps physicians recognize how their moral commitments depend on the nature and context of the situation, clarifies ethical conflicts that physicians face, and concludes with ideas for resolving these conflicts. (shrink)