Assessing decisional capacity for research participation in psychiatric patients and their relatives

A cross-sectional study among adult inpatients with non-organic psychiatric disorders, and among their key relatives, assessed their comprehension and recall of key information in consent forms. It also assessed their capacity to consent to participate in two hypothetical randomised controlled trials (RCTs) with different potential risks and burdens, using structured questionnaires and recorded interviews. Of the 24 participants (12 patient–key relative dyads), seven patients (58%) and three key relatives (25%) were clinically judged to lack the capacity to consent. Of the remaining 14 participants s, less than half the patients (2/5; 40%) or relatives (3/9; 33%) accurately recalled 50% of the key information on both trials. Among the eight participants (3 patients, 5 relatives) independently assessed on the MacArthur Competence Assessment Tool for Clinical Research, the proportions judged competent for each trial varied with the criteria for defining competence. No one fulfilled the stringent competence criteria for both trials. Routine assessments of the capacity of psychiatric research participants, and of relatives providing proxy consent, appear to be warranted. However, neither suboptimal understanding of consent forms, nor incompetence determined by the use of formal assessment tools, necessarily denote an incapacity to consent to research if detailed clinical assessments indicate otherwise. Research into incorporating participants’ health literacy and clinical status in formal assessments may help determine the optimal standards for defining competence.

Participation in randomised controlled trials: perspectives of psychiatric patients and key relatives

This study assessed the perspectives of adults who had acute nonorganic psychiatric disorders and were admitted in a private, not for- profit medical college hospital, and also of their key relatives, on randomised controlled trials (RCTs). Structured questionnaires and audio-recorded interviews were used for the purpose. We explored their willingness and motivation to participate in two hypothetical RCTs with different risks and burdens. The transcripts of the interviews were analysed using the principles of grounded theory and framework analysis. Of the 24 consenting participants (12 patient and key-relative dyads), the 20 who completed the interviews had largely positive attitudes towards research and RCTs. However, 50% of those interviewed declined to participate in either of the hypothetical RCTs. The refusal to participate seemed to be influenced by a lack of education; forgetfulness, which impeded the process of making informed decisions; unfavourable benefit–risk–burden ratios; practical difficulties; dependence on treating doctors and relatives for decision-making; and the wish to exercise one’s choice regarding treatment options. The factors that motivated the patients and relatives were trust in doctors and organisations, altruism, expectation of personal benefits and favourable risk–benefit ratios. These observations indicate that while the respondents in this study valued research, they were discerning about whether or not to participate in the trials; their decision-making was influenced by individualised assessments of risks and burdens and pragmatic considerations, rather than only by the benefits they would obtain.