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Am J Psychiatry. 1998 Nov;155(11):1508-11.

Informed consent: assessment of comprehension.

Author information

1
Department of Psychiatry, West Los Angeles VA Medical Center, CA 90073, USA.

Abstract

OBJECTIVE:

The authors designed and evaluated a structured and rigorous informed consent procedure involving subjects with schizophrenia.

METHOD:

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.

PMID:
9812110
DOI:
10.1176/ajp.155.11.1508
[Indexed for MEDLINE]

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