Determining when impairment constitutes incapacity for informed consent in schizophrenia research.

Journal Article (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

International Standard Serial Number (ISSN)

  • 0007-1250

Digital Object Identifier (DOI)

  • 10.1192/bjp.bp.106.033324


  • eng

Conference Location

  • England