Determining when impairment constitutes incapacity for informed consent in schizophrenia research.
Published
Journal Article
BACKGROUND: Although people with schizophrenia display impaired abilities for consent, it is not known how much impairment constitutes incapacity. AIMS: To assess a method for determining the categorical capacity status of potential participants in schizophrenia research. METHOD: Expert-judgement validation of capacity thresholds on the sub-scales of the MacArthur Competence Assessment Tool-Clinical Research (MacCAT-CR) was evaluated using receiver operating characteristic (ROC) analysis in 91 people with severe mental illness and 40 controls. RESULTS: The ROC areas under the curve for the understanding, appreciation and reasoning sub-scales of the MacCAT-CR were 0.94 (95% CI 0.88-0.99), 0.85 (95% CI 0.76-0.94) and 0.80 (95% CI 0.70-0.90). These findings yielded negative and positive predictive values of incapacity that can guide the practice of investigators and research ethics committees. CONCLUSIONS: By performing such validation studies for a few categories of research with varying risks and benefits, it might be possible to create evidence-based capacity determination guidelines for most schizophrenia research.
Full Text
Duke Authors
Cited Authors
- Kim, SYH; Appelbaum, PS; Swan, J; Stroup, TS; McEvoy, JP; Goff, DC; Jeste, DV; Lamberti, JS; Leibovici, A; Caine, ED
Published Date
- July 2007
Published In
Volume / Issue
- 191 /
Start / End Page
- 38 - 43
PubMed ID
- 17602123
Pubmed Central ID
- 17602123
International Standard Serial Number (ISSN)
- 0007-1250
Digital Object Identifier (DOI)
- 10.1192/bjp.bp.106.033324
Language
- eng
Conference Location
- England