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 language | English (US) |
|---|---|
| Pages (from-to) | 1508-1511 |
| Number of pages | 4 |
| Journal | American Journal of Psychiatry |
| Volume | 155 |
| Issue number | 11 |
| State | Published - 1998 |
| Externally published | Yes |
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ASJC Scopus subject areas
- Psychiatry and Mental health
Cite this
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 journal › Article
}
TY - JOUR
T1 - Informed consent
T2 - Assessment of comprehension
AU - Wirshing, Donna A.
AU - Wirshing, William C.
AU - Marder, Stephen R.
AU - Liberman, Robert P.
AU - Mintz, Jim
PY - 1998
Y1 - 1998
N2 - 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.
AB - 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.
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UR - http://www.scopus.com/inward/citedby.url?scp=0031731188&partnerID=8YFLogxK
M3 - Article
C2 - 9812110
AN - SCOPUS:0031731188
VL - 155
SP - 1508
EP - 1511
JO - American Journal of Psychiatry
JF - American Journal of Psychiatry
SN - 0002-953X
IS - 11
ER -