title: Decisional capacity to consent to research among patients with bipolar disorder: comparison with schizophrenia patients and healthy subjects.
abstract: OBJECTIVE
  Although clinical trials are needed to advance treatments for bipolar disorder, there has been little empirical research on the capacity of bipolar patients to consent to research. The aim of the present study was to evaluate levels of decisional capacity of bipolar patients compared with those of schizophrenia patients and healthy comparison subjects, as well as to examine whether symptom and neurocognitive deficits correlate with patients' decisional abilities.
  
  
  METHODS
  Participants were 31 outpatients with bipolar disorder, 31 outpatients with schizophrenia, and 28 healthy comparison subjects; each participant's decisional capacity was evaluated with the MacArthur Competence Assessment Tool for Clinical Research. Patient participants were also evaluated with standardized clinical rating scales and neurocognitive tests. Data were collected from April 2002 through November 2005.
  
  
  RESULTS
  Bipolar patients had worse understanding than healthy comparison subjects, and their level of decisional capacity did not differ from that of schizophrenia patients. Within the combined patient sample, neurocognitive deficits and negative symptoms were significantly correlated (p < .05) with the level of decisional capacity (particularly, understanding of disclosed information). Repeating the missed information improved the level of understanding in all groups.
  
  
  CONCLUSIONS
  The presence of bipolar disorder appears to be a risk factor for impaired understanding of information disclosed under standard consent procedures but should not be equated with a lack of competence to consent. The observed improvement in understanding with redisclosure of information suggests that enhanced consent procedures may be useful during enrollment of bipolar patients in research.
authors.affiliation: Department of Psychiatry, University of California, San Diego, Veterans Affairs San Diego Healthcare System, Calif 92161, USA. bpalmer@ucsd.edu
authors.forename: Barton W
authors.initials: BW
authors.lastname: Palmer
authors.forename: Laura B
authors.initials: LB
authors.lastname: Dunn
authors.forename: Colin A
authors.initials: CA
authors.lastname: Depp
authors.forename: Lisa T
authors.initials: LT
authors.lastname: Eyler
authors.forename: Dilip V
authors.initials: DV
authors.lastname: Jeste
mesh_terms: D000328:Adult; D000368:Aged; D001714:Bipolar Disorder / Q000523:psychology*; D002986:Clinical Trials as Topic; D003072:Cognition Disorders; D003657:Decision Making; D005260:Female; D006801:Humans; D007258:Informed Consent; D008297:Male; D016555:Matched-Pair Analysis; D008875:Middle Aged; D012565:Schizophrenic Psychology