Authors
Lidz, Charles W.Albert, Karen
Appelbaum, Paul S.
Dunn, Laura B.
Overton, Eve
Pivovarova, Ekaterina
Document Type
Journal ArticlePublication Date
2015-04-01Keywords
therapeutic misconceptioninformed consent
clinical trials
research ethics
Bioethics and Medical Ethics
Health Services Research
Law and Psychology
Psychiatry
Psychiatry and Psychology
Metadata
Show full item recordAbstract
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.Source
Camb Q Healthc Ethics. 2015 Apr;24(2):231-41. doi: 10.1017/S096318011400053X. Link to article on publisher's siteDOI
10.1017/S096318011400053XPermanent Link to this Item
http://hdl.handle.net/20.500.14038/45511Related Resources
Link to Article in PubMedae974a485f413a2113503eed53cd6c53
10.1017/S096318011400053X