INFORMED CONSENT AND THE THERAPEUTIC MISCONCEPTION

研究表明，临床研究对象往往不能 感谢他们知情同意的重要内容，因为 “治疗误区”。治疗上的误区 涉及患者/受试者未能掌握 参与一项临床研究项目并获得普通 临床护理。我们不知道：1)它是如何流行的，2)它是如何 个人和情景变量治疗误会是 相关，3)这种误解对其他方面的影响有多严重 参与研究的决定，4)它的影响是什么 患者参与研究的体验和5)它如何影响 临床研究的招募和退出率。这 一项旨在弥补这些知识缺乏的提案通过在 对来自10个不同临床研究项目的200名受试者进行深度调查 在他们完成参与 项目。这将促进获得同意的新方法，并 通过临床研究减少公众不满的潜在来源。

Research suggests that clinical research subjects often fail to appreciate significant elements of what their informed consent because of the "therapeutic misconception." The therapeutic misconception involves patient/subjects failing to grasp the difference between participating in a clinical research project and receiving ordinary clinical care. We do not know how: 1) prevalent it is, 2) with which personal and situational variables the therapeutic misunderstanding is associated, 3) how seriously this misconception affects other aspects of a decision to participate in research, 4) what its effects are on patients' experience of research participation and 5) how it affects the rate of recruitment to, and dropout from clinical research. This proposal aims to remedy these lacks of knowledge by interviewing in depth 200 subjects from 10 different clinical research projects and then reinterviewing them after they have completed their participation in the project. This will facilitate new approaches to gaining consent and reduce potential sources of public disaffection with clinical research.