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评估治疗性误解。

Evaluating the therapeutic misconception.

作者信息

Miller Franklin G, Joffe Steven

机构信息

Department of Clinical Bioethics, National Institutes of Health, Bethesda, MD, USA.

出版信息

Kennedy Inst Ethics J. 2006 Dec;16(4):353-66. doi: 10.1353/ken.2006.0025.

Abstract

The "therapeutic misconception", described by Paul Appelbaum and colleagues more than 20 years ago, refers to the tendency of participants in clinical trials to confuse the design and conduct of research with personalized medical care. Although the "therapeutic misconception" has become a term of art in research ethics, little systematic attention has been devoted to the ethical significance of this phenomenon. This article examines critically the way in which Appelbaum and colleagues formulate what is at stake in the therapeutic misconception, paying particular attention to assumptions and implications that clinical trial participation disadvantages research participants as compared with receiving standard medical care. After clarifying the ethical significance of the therapeutic misconception with respect to the decision making of patients, we offer policy recommendations for obtaining informed consent to participation in clinical trials.

摘要

20多年前,保罗·阿佩尔鲍姆及其同事所描述的“治疗性误解”,指的是临床试验参与者倾向于将研究的设计与实施和个性化医疗护理混为一谈。尽管“治疗性误解”已成为研究伦理领域的一个术语,但对于这一现象的伦理意义却很少有系统的关注。本文批判性地审视了阿佩尔鲍姆及其同事阐述治疗性误解中利害关系的方式,尤其关注与接受标准医疗护理相比,参与临床试验会使研究参与者处于不利地位的假设和影响。在阐明治疗性误解对于患者决策的伦理意义之后,我们就获得参与临床试验的知情同意提出了政策建议。

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