Charles W Lidz1, Paul S Appelbaum. 1. Department of Psychiatry, University of Massachusetts Medical School, Worcester, Massachusetts, USA. chuck.lidz@umassmed.edu
Abstract
BACKGROUND: 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. OBJECTIVES: 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. RESEARCH DESIGN: A conceptual analysis of informed consent to research and a review of the empirical literature are undertaken. RESULTS: 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. DISCUSSION: 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.
BACKGROUND: 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. OBJECTIVES: 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. RESEARCH DESIGN: A conceptual analysis of informed consent to research and a review of the empirical literature are undertaken. RESULTS: 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. DISCUSSION: 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.
Entities:
Keywords:
Biomedical and Behavioral Research; Empirical Approach
Authors: Neelam S Joglekar; Swapna S Deshpande; Seema Sahay; Manisha V Ghate; Robert C Bollinger; Sanjay M Mehendale Journal: Int Health Date: 2012-12-30 Impact factor: 2.473