Informed Consent: Assessment of Comprehension

TLDR

In schizophrenia research, most participants feel adequately informed and report personal motivation, indicating that proper informed consent procedures enable understanding and retention. The authors designed a structured informed consent protocol for 49 schizophrenic patients, administering repeated questionnaires until 100% correct responses were achieved and reassessing retention after seven days. Participants achieved a median 80% correct on the initial consent questionnaire, 53% required a second trial and 37% needed three or more, yet scores improved by day 7, confirming that rigorous consent procedures enable comprehension and retention among schizophrenic subjects.

Abstract

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