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Adherence to oral pre-exposure prophylaxis (PrEP) is challenging for adolescent males who have sex with males (AMSM). Once adult trials comparing oral to longer lasting injectable PrEP are completed, there will be a need for adolescent studies. However, lack of data on adolescent consent capacity may sustain guardian permission requirements identified as a barrier to AMSM participation in prior PrEP trials. This online study assessed AMSM's (14–17 years) consent capacity for these trials, comparing performance to MSM (18–19 years) for whom guardian permission is not required. Applying the MacCAT-CR, participants (N = 214) viewed a video and mock consent form followed by open-ended and yes/no items. Cognitive diagnostic models and means testing analyses supported AMSM capacity to consent to these trials: 16–17 and most 14–15 year-olds, demonstrated consent understanding, appreciation and reasoning at 18–19 year-old levels. Data also identified vulnerabilities requiring attention during informed consent. [ABSTRACT FROM AUTHOR]

Abstract Background The process of assessing the decision-making capacity of potential subjects before their inclusion in clinical trials is a legal requirement and a moral obligation, as it is essential for respecting their autonomy. This issue is especially important in psychiatry patients (such as those diagnosed with schizophrenia). The primary purpose of this article was to evaluate the degree of impairment in each dimension of decision-making capacity in schizophrenia patients compared to non-mentally-ill controls, as quantified by the (MacCAT-CR) instrument. Secondary objectives were (1) to see whether enhanced consent forms are associated with a significant increase in decision-making capacity in schizophrenia patients, and (2) if decision-making capacity in schizophrenia subjects is dependent on the age, gender, or the inpatient status of the subjects. Methods We systematically reviewed the results obtained from three databases: ISI Web of Science, Pubmed, Scopus. Each database was scrutinised using the following keywords: “MacCAT-CR + schizophrenia”, “decision-making capacity + schizophrenia”, and “informed consent + schizophrenia.” Results We included 13 studies in the analysis. The effect size between the schizophrenia and the control group was significant, with a difference in means of −4.43 (−5.76; −3.1, p

Background: Identifying correlates of capacity to provide informed consent among individuals with bipolar disorder is essential for patient protection. As part of a clinical trial involving approved, standard treatments, we investigated relationships between clinical characteristics and capacity to provide informed consent in adults with bipolar disorder using the MacArthur Competence Assessment Tool for Clinical Research (MacCAT-CR). After administering the MacCAT-CR, continuing participants in the trial were capable of and provided informed consent.Methods: Trained, board-certified psychiatrists administered the MacCAT-CR to potential study participants (N = 50) after they provided informed consent, but prior to initiation of study procedures.Results: Higher Schedule for Assessment of Positive Symptoms (SAPS) scores were significantly correlated with worse MacCAT-CR Understanding and Appreciation (p < 0.04) subscale scores; lower Hamilton Depression Rating Scale (HDRS) scores and higher Clinical Global Impression-Severity (CGI-S) scores were significantly correlated with worse Reasoning and Understanding subscale scores (p < 0.03); and patients with comorbid substance use disorders (SUD) had better Appreciation and Reasoning subscale scores (p < 0.05).Limitations: The MacCAT-CR identifies areas where participants need explanation. However, there is not a predetermined score to indicate understanding of study procedures and therefore input from a trained clinician is needed to determine capacity to provide informed consent.Conclusions: Our findings suggest that certain measures of illness severity are associated with lower levels of capacity to provide informed consent among adults with bipolar disorder. This study provides important information for clinicians and researchers to consider when obtaining informed consent in this population. [ABSTRACT FROM AUTHOR]

Background: The process of assessing the decision-making capacity of potential subjects before their inclusion in clinical trials is a legal requirement and a moral obligation, as it is essential for respecting their autonomy. This issue is especially important in psychiatry patients (such as those diagnosed with schizophrenia). The primary purpose of this article was to evaluate the degree of impairment in each dimension of decision-making capacity in schizophrenia patients compared to non-mentally-ill controls, as quantified by the (MacCAT-CR) instrument. Secondary objectives were (1) to see whether enhanced consent forms are associated with a significant increase in decision-making capacity in schizophrenia patients, and (2) if decision-making capacity in schizophrenia subjects is dependent on the age, gender, or the inpatient status of the subjects. Methods: We systematically reviewed the results obtained from three databases: ISI Web of Science, Pubmed, Scopus. Each database was scrutinised using the following keywords: "MacCAT-CR + schizophrenia", "decision-making capacity + schizophrenia", and "informed consent + schizophrenia." Results: We included 13 studies in the analysis. The effect size between the schizophrenia and the control group was significant, with a difference in means of -4.43 (-5.76; -3.1, p < 0.001) for understanding, -1.17 (-1.49, -0.84, p < 0.001) for appreciation, -1.29 (-1.79, -0.79, p < 0.001) for reasoning, and -0.05 (-0.9, -0.01, p = 0.022) for expressing a choice. Conclusions: Even if schizophrenia patients have a significantly decreased decision-making capacity compared to non-mentally-ill controls, they should be considered as competent unless very severe changes are identifiable during clinical examination. Enhanced informed consent forms decrease the differences between schizophrenia patients and non-mentally-ill controls (except for the reasoning dimension) and should be used whenever the investigators want to include more ill patients in their clinical trials. Increased age, men gender and an increased percentage of inpatients might increase the differential of decision-making incompetence compared to nonmentally- ill subjects in various dimensions of the decision-making competence as analysed by the MacCAT-CR scale, but the small number of subjects did not allow us (except for one instance) to reach statistical significance. [ABSTRACT FROM AUTHOR]

Objectives: To assess the cognitive capacity of early, middle, and late adolescents, and their parents or guardians to provide informed consent to a population-based cohort study.Study Design: adolescent-parent/guardian dyads including 40 early (N = 80; 10-14 years), 20 middle (15-17 years), and 20 late (18-19 years) adolescents were recruited from the Rakai Community Cohort Study (RCCS), an open demographic cohort in Uganda. Participants were administered the MacArthur Competence Assessment Tool for Clinical Research (MacCAT-CR), a structured open-ended assessment; interviews were recorded and transcribed. Twenty transcripts were scored independently by two coders; the intraclass correlation coefficient (ICC) was 0.89. The remaining interviews were scored individually. We compared mean scores for early and middle/late adolescents using a one-sided t-test and score differences between parent/guardian and adolescent dyads using two-sided paired t-tests.Results: Early adolescents (mean score, 95% confidence interval (CI)) (28.8, 27.1-30.5) scored significantly lower (p<.01) than middle/late adolescents (32.4, 31.6-33.1). In paired dyad comparisons, we observed no statistically significant difference in scores between parents/guardians and middle/late adolescents (difference=-0.2, 95% CI=-1.0-0.6). We found a statistically significant difference in scores between parents/guardians and early adolescents (difference=3.0, 95% CI=1.2-4.8).Conclusions: The capacity of adolescents-of different ages and in diverse settings-to comprehend risks, benefits, and other elements of informed consent is a critical but understudied area in research ethics. Our findings support the practice of having middle and late adolescents provide independent informed consent for sexual and reproductive health studies. Early adolescents may benefit from supported decision-making approaches. [ABSTRACT FROM AUTHOR]

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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., (Copyright © 2014 L’Encéphale, Paris. Published by Elsevier Masson SAS. All rights reserved.)