Title

Why is therapeutic misconception so prevalent?

UMMS Affiliation

Department of Psychiatry; Systems and Psychosocial Advances Research Center

Date

4-1-2015

Document Type

Article

Disciplines

Bioethics and Medical Ethics | Health Services Research | Law and Psychology | Psychiatry | Psychiatry and Psychology

Abstract

Therapeutic misconception (TM)-when clinical research participants fail to adequately grasp the difference between participating in a clinical trial and receiving ordinary clinical care-has long been recognized as a significant problem in consent to clinical trials. We suggest that TM does not primarily reflect inadequate disclosure or participants' incompetence. Instead, TM arises from divergent primary cognitive frames. The researchers' frame places the clinical trial in the context of scientific designs for assessing intervention efficacy. In contrast, most participants have a cognitive frame that is personal and focused primarily on their medical problems. To illustrate this, we draw on interview material from both clinical researchers and participants in clinical trials. We suggest that reducing TM requires encouraging subjects to adjust their frame, not just add information to their existing frame. What is necessary is a scientific reframing of participation in a clinical trial.

Rights and Permissions

Citation: Camb Q Healthc Ethics. 2015 Apr;24(2):231-41. doi: 10.1017/S096318011400053X. Link to article on publisher's site

Related Resources

Link to Article in PubMed

Keywords

therapeutic misconception, informed consent, clinical trials, research ethics