title: Determining when impairment constitutes incapacity for informed consent in schizophrenia research.
abstract: BACKGROUND
  Although people with schizophrenia display impaired abilities for consent, it is not known how much impairment constitutes incapacity.
  
  
  OBJECTIVE
  To assess a method for determining the categorical capacity status of potential participants in schizophrenia research.
  
  
  METHODS
  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.
authors.affiliation: Department of Psychiatry, Bioethics Program, and Center for Behavioral and Decision Sciences in Medicine, University of Michigan, 300 North Ingalls, Ann Arbor, MI 48109-0429, and Massachusetts General Hospital, Boston, USA. scottkim@umich.edu
authors.forename: Scott Y H
authors.initials: SY
authors.lastname: Kim
authors.forename: Paul S
authors.initials: PS
authors.lastname: Appelbaum
authors.forename: Jeffrey
authors.initials: J
authors.lastname: Swan
authors.forename: T Scott
authors.initials: TS
authors.lastname: Stroup
authors.forename: Joseph P
authors.initials: JP
authors.lastname: McEvoy
authors.forename: Donald C
authors.initials: DC
authors.lastname: Goff
authors.forename: Dilip V
authors.initials: DV
authors.lastname: Jeste
authors.forename: J Steven
authors.initials: JS
authors.lastname: Lamberti
authors.forename: Adrian
authors.initials: A
authors.lastname: Leibovici
authors.forename: Eric D
authors.initials: ED
authors.lastname: Caine
mesh_terms: D000328:Adult; D016022:Case-Control Studies; D003657:Decision Making; D005260:Female; D006801:Humans; D007258:Informed Consent / Q000592:standards*; D007406:Interview, Psychological / Q000592:standards; D008297:Male; D016743:Mental Competency / Q000592:standards*; D011594:Psychometrics; D012372:ROC Curve; D012015:Reference Standards; D012559:Schizophrenia / Q000175:diagnosis*; D012565:Schizophrenic Psychology