Informed consent: Assessment of comprehension

Donna A. Wirshing, William C. Wirshing, Stephen R. Marder, Robert P. Liberman, Jim Mintz

Research output: Contribution to journalArticle

162 Citations (Scopus)

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.

Original languageEnglish (US)
Pages (from-to)1508-1511
Number of pages4
JournalAmerican Journal of Psychiatry
Volume155
Issue number11
StatePublished - 1998
Externally publishedYes

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Informed Consent
Research
Research Subjects
Consent Forms
Schizophrenia
Surveys and Questionnaires
Therapeutics

ASJC Scopus subject areas

  • Psychiatry and Mental health

Cite this

Wirshing, D. A., Wirshing, W. C., Marder, S. R., Liberman, R. P., & Mintz, J. (1998). Informed consent: Assessment of comprehension. American Journal of Psychiatry, 155(11), 1508-1511.

Informed consent : Assessment of comprehension. / Wirshing, Donna A.; Wirshing, William C.; Marder, Stephen R.; Liberman, Robert P.; Mintz, Jim.

In: American Journal of Psychiatry, Vol. 155, No. 11, 1998, p. 1508-1511.

Research output: Contribution to journalArticle

Wirshing, DA, Wirshing, WC, Marder, SR, Liberman, RP & Mintz, J 1998, 'Informed consent: Assessment of comprehension', American Journal of Psychiatry, vol. 155, no. 11, pp. 1508-1511.
Wirshing DA, Wirshing WC, Marder SR, Liberman RP, Mintz J. Informed consent: Assessment of comprehension. American Journal of Psychiatry. 1998;155(11):1508-1511.
Wirshing, Donna A. ; Wirshing, William C. ; Marder, Stephen R. ; Liberman, Robert P. ; Mintz, Jim. / Informed consent : Assessment of comprehension. In: American Journal of Psychiatry. 1998 ; Vol. 155, No. 11. pp. 1508-1511.
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