INFORMED CONSENT AND THE THERAPEUTIC MISCONCEPTION

研究表明，临床研究对象往往未能 理解他们知情同意的重要因素， “治疗性误解”“治疗上的误解 涉及患者/受试者无法理解 参与临床研究项目，并接受普通 临床护理 我们不知道如何：1）普遍存在，2）与 个人和情境变量的治疗误解是 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 患者参与研究的经历和5）它如何影响 临床研究的招募率和辍学率。 这 建议的目的是弥补这些缺乏知识的采访， 深入10个不同临床研究项目的200名受试者，然后 在他们完成参与后， 项目 这将促进获得同意的新方法， 减少公众对临床研究不满的潜在来源。

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.