Kennedy Institute of Ethics journal
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The idea of a "learning health care system"--one that systematically integrates clinical research with medical care--has received considerable attention recently. Some commentators argue that under certain conditions pragmatic comparative effectiveness randomized trials can be conducted ethically within the context of a learning health care system without the informed consent of patients for research participation. In this article, we challenge this perspective and contend that conducting randomized trials of individual treatment options without consent is neither necessary nor desirable to promote and sustain learning health care systems. Our argument draws on the normative conception of personal care developed by Charles Fried in a landmark 1974 book on the ethics of randomized controlled trials.
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Kennedy Inst Ethics J · Sep 2014
Fat stigma and public health: a theoretical framework and ethical analysis.
This paper proposes a theoretical framework for understanding fat stigma and its impact on people's well-being. It argues that stigma should never be used as a tool to achieve public health ends. Drawing on Bruce Link and Jo Phelan's 2001 conceptualization of stigma as well as the works of Hilde Lindemann, Paul Benson, and Margaret Urban Walker on identity, positionality, and agency, this paper clarifies the mechanisms by which stigmatizing, oppressive conceptions of overweight and obesity damage identities and diminish moral agency, arguing that the use of obesity-related stigma for public health ends violates the bioethics principles of nonmaleficence, autonomy, and justice.
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Clinical research with patient-subjects was routinely conducted without informed consent for research participation prior to 1966. The aim of this article is to illuminate the moral climate of clinical research at this time, with particular attention to placebo-controlled trials in which patient-subjects often were not informed that they were participating in research or that they might receive a placebo intervention rather than standard medical treatment or an experimental treatment for their condition. An especially valuable window into the thinking of clinical investigators about their relationship with patient-subjects in the era before informed consent is afforded by reflection on two articles published by psychiatric researchers in 1966 and 1967, at the point of transition between clinical research conducted under the guise of medical care and clinical research based on consent following an invitation to participate and disclosure of material information about the study. Historical inquiry relating to the practice of clinical research without informed consent helps to put into perspective the moral progress associated with soliciting consent following disclosure of pertinent information; it also helps to shed light on an important issue in contemporary research ethics: the conditions under which it is ethical to conduct clinical research without informed consent.