title: Why is therapeutic misconception so prevalent?
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.
authors.forename: Charles W
authors.initials: CW
authors.lastname: Lidz
authors.forename: Karen
authors.initials: K
authors.lastname: Albert
authors.forename: Paul
authors.initials: P
authors.lastname: Appelbaum
authors.forename: Laura B
authors.initials: LB
authors.lastname: Dunn
authors.forename: Eve
authors.initials: E
authors.lastname: Overton
authors.forename: Ekaterina
authors.initials: E
authors.lastname: Pivovarova
mesh_terms: D002986:Clinical Trials as Topic / Q000941:ethics*; D032882:Comprehension; D003695:Delivery of Health Care / Q000941:ethics*; D032984:Ethics, Research; D006805:Human Experimentation / Q000941:ethics*; D006801:Humans; D007258:Informed Consent / Q000941:ethics; D035842:Research Subjects; D055990:Therapeutic Misconception
keywords: research ethics