Informed consent: assessment of comprehension.
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.
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ABSTRACT: Résumé En recherche biomédicale, le recueil d'un consentement éclairé chez les sujets sains peut parfois s'avérer délicat. Cette question peut se complexifier de manière extrême, lorsque l'on s'intéresse aux patients souffrant de schizophrénie. Les échelles dédiées (MacCAT-CR notamment) mettent en évidence une diminution de la capacité à consentir des patients présentant une schizophrénie par rapport à la population générale. Cependant, ces patients constituent un groupe extrêmement hétérogène. Les patients dont l'insight est faible, de même que ceux manifestant des symptômes cognitifs marqués, semblent plus à risque de présenter une capacité à consentir diminuée, ceci en lien avec des difficultés de prise de décision. Il est pos-sible de mettre en place un certain nombre de mesures afin d'augmenter la capacité à consentir des patients les plus vulnérables. Parmi elles, les stratégies s'appuyant sur les nouvelles tech-nologies de la communication et de l'information semblent particulièrement prometteuses. Cependant, d'autres études sont nécessaires afin d'exploiter, au mieux, ces techniques. Enfin, le soutien des associations de famille et d'usagers, telles que l'UNAFAM, est fondamental pour faciliter la participation des patients à la recherche dans les meilleures conditions. Summary Context. — Informed consent to research remains a complex issue, while sometimes staying difficult to obtain, even in the general population. This problem may be maximized with patients suffering from schizophrenia. Objective. — This paper summarizes available data in the literature about informed consent for research involving patients suffering from schizophrenia. Method. — Medline and Google Scholar searches were conducted using the following MESH terms: schizophrenia, informed consent and research. * Auteur correspondant.L Encéphale 08/2014; DOI:10.1016/j.encep.2014.07.004 · 0.60 Impact Factor
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ABSTRACT: CONTEXT: Informed consent to research remains a complex issue, while sometimes staying difficult to obtain, even in the general population. This problem may be maximized with patients suffering from schizophrenia. OBJECTIVE: This paper summarizes available data in the literature about informed consent for research involving patients suffering from schizophrenia. METHOD: Medline and Google Scholar searches were conducted using the following MESH terms: schizophrenia, informed consent and research. RESULTS: Studies using dedicated standardized scales (e.g. MacCAT-CR) revealed a decrease in the capacity to consent of patients with schizophrenia when compared with healthy individuals. Keeping in mind that schizophrenia is an heterogeneous disorder, patients with the lowest insight as well as those with the most severe cognitive symptoms appeared more impaired in their capacity to consent. Such a poor capacity to understand and consent to trials was shown linked with alterations in decision-making. For these specific patients, interventions may be set up to increase their capacity to consent. Various strategies were proposed: enhanced consent forms, extended discussion, test/feedback method or multimedia interventions. Among them, interventions relying on communication and the growing field of information technologies (e.g. web-based tools) seem promising. Finally, associations grouping families and patients (like the French Association UNAFAM) may facilitate the involvement of patients in research programs with safer conditions. CONCLUSION: Patients suffering from schizophrenia appear able to consent to research programs when suitable interventions are proposed. Further studies are now needed to optimize and individualize such interventions.
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ABSTRACT: This study examined the efficacy of corrected feedback for improving consent recall throughout the course of an ongoing longitudinal study. Participants (N = 135) were randomly assigned to either a corrected feedback or a no-feedback control condition. Participants completed a consent quiz 2-weeks after consenting to the host study and at months 1, 2, and 3. The corrected feedback group received corrections to erroneous responses and the no-feedback control group did not. The feedback group displayed significantly greater recall overall and in specific content areas (i.e., procedures, protections, risks/benefits). Results support the use of corrected feedback for improving consent recall.Ethics & Behavior 10/2010; 20(5):387-399. DOI:10.1080/10508422.2010.491767 · 0.78 Impact Factor