Alex John London, Patrick Bodilly Kane, Jonathan Kimmelman
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Varieties of Community Uncertainty and Clinical Equipoise.
The judgments of conscientious and informed experts play a central role in two elements of clinical equipoise. The first, and most widely discussed, element involves ensuring that no participant in a randomized trial is allocated to a level of treatment that everyone agrees is substandard. The second, and less often discussed, element involves ensuring that trials are likely to generate social value by producing the information necessary to resolve a clinically meaningful uncertainty or disagreement about the relative merits of a set of interventions. The distribution of judgments in expert communities can take many forms, each with important implications for whether a trial satisfies one or both elements of clinical equipoise. In this article we use a graphical approach to represent three ways in which expert community uncertainty can vary: by spread, modality, and skew. Understanding these different distributions of expert judgment has three important implications: it helps to make operational the requirement of social value, it shows that some conditions for initiating studies to promote social value diverge from common assumptions about clinical equipoise, and it has important implications for how trials should be designed and monitored, and what patients should be told during informed consent.
期刊介绍:
The Kennedy Institute of Ethics Journal offers a scholarly forum for diverse views on major issues in bioethics, such as analysis and critique of principlism, feminist perspectives in bioethics, the work of the Advisory Committee on Human Radiation Experiments, active euthanasia, genetics, health care reform, and organ transplantation. Each issue includes "Scope Notes," an overview and extensive annotated bibliography on a specific topic in bioethics, and "Bioethics Inside the Beltway," a report written by a Washington insider updating bioethics activities on the federal level.