Informed consent: assessment of comprehension.
OBJECTIVE
The authors designed and evaluated a structured and rigorous informed consent procedure involving subjects with schizophrenia.


METHODS
Informed consent forms were read and explained to 49 schizophrenic patients participating in ongoing clinical treatment research trials. The subjects answered a questionnaire relating to each research protocol. Protocol procedures were reiterated until the patients answered 100% of the questions correctly. Subjects were asked the same questions 7 days later to ascertain how much of the information they had retained.


RESULTS
The patients' median score on the first trial of the informed consent questionnaire was 80% correct. To achieve 100% correct responses, 53% of the patients required a second trial of the questionnaire, and 37% of them required three or more trials. Scores improved between the first trial and the trial on day 7. Ninety-six percent of the subjects felt adequately informed, 66% reported participating in the research protocol for personal reasons, and 34% reported participating at the suggestion of others.


CONCLUSIONS
These findings demonstrate that when adequate informed consent procedures are established, schizophrenic research subjects are able to understand and retain critical components of informed consent information.
Wirshing
D A
DA
Department of Psychiatry, West Los Angeles VA Medical Center, CA 90073, USA.
Wirshing
W C
WC
Marder
S R
SR
Liberman
R P
RP
Mintz
J
J
D000328:Adult; D001290:Attitude; D002985:Clinical Protocols; D003071:Cognition; D032882:Comprehension; D032962:Consent Forms; D004311:Double-Blind Method; D005260:Female; D005555:Forensic Psychiatry; D006801:Humans; D007258:Informed Consent; D008297:Male; D016743:Mental Competency; D028642:Persons with Psychiatric Disorders; D008875:Middle Aged; D035842:Research Subjects; D012189:Retrospective Studies; D012559:Schizophrenia / Q000175:diagnosis* / Q000188:drug therapy; D012565:Schizophrenic Psychology; D011795:Surveys and Questionnaires