Lidz Charles W, Appelbaum Paul S
Department of Psychiatry, University of Massachusetts Medical School, Worcester, Massachusetts, USA.
Med Care. 2002 Sep;40(9 Suppl):V55-63. doi: 10.1097/01.MLR.0000023956.25813.18.
The therapeutic misconception occurs when a research subject fails to appreciate the distinction between the imperatives of clinical research and of ordinary treatment, and therefore inaccurately attributes therapeutic intent to research procedures. The therapeutic misconception is a serious problem for informed consent in clinical research.
This paper analyzes the nature and origins of the therapeutic misconception and suggests some ways in which researchers can overcome this problem when obtaining a subject's consent to participation in research.
A conceptual analysis of informed consent to research and a review of the empirical literature are undertaken.
Research and clinical care involve different standards for how the patient/subject is to be treated. The confusion of the two often leads to profound misunderstandings on the part of the patient/subject.
A method for describing to patients/subjects the differences between research and treatment is proposed as a potential solution to the therapeutic misconception. Research is needed to determine whether this or any other change in the nature of the disclosure is effective in reducing the therapeutic misconception.
当研究对象未能认识到临床研究的要求与普通治疗的要求之间的区别,从而错误地将治疗意图归因于研究程序时,就会出现治疗性误解。治疗性误解是临床研究中知情同意的一个严重问题。
本文分析了治疗性误解的性质和根源,并提出了一些研究人员在获得受试者参与研究的同意时可以克服这一问题的方法。
对研究的知情同意进行概念分析,并对实证文献进行综述。
研究和临床护理涉及对患者/受试者治疗方式的不同标准。两者的混淆常常导致患者/受试者产生深刻的误解。
提出了一种向患者/受试者描述研究与治疗之间差异的方法,作为解决治疗性误解的一种潜在方案。需要进行研究以确定这种披露性质的改变或任何其他改变是否能有效减少治疗性误解。