Informed consent and ethical reporting of research in clinical trials involving participants with psychotic disorders.

Informed consent is critical for protecting vulnerable individuals interested in research participation, like those with psychotic disorders (e.g. schizophrenia, schizoaffective disorder, schizophreniform disorder, etc.). Individuals with psychotic disorders may have fluctuating capacity to consent and capacity assessment prior to research participation can help determine decisional status. However, there is little research on how, or if, these assessments are conducted in clinical research. A systematic review of randomized medication or device trials that specifically recruited individuals with psychotic disorders to understand the use and reporting of capacity assessment to consent was conducted. A total of 646 articles were reviewed using a developed questionnaire on ethical reporting of consent practices and capacity assessment. Less than 10% (n = 34; 5.3%) of the studies reported an assessment of capacity to provide informed consent and less than half of those used a standardized assessment. Sixty-four (9.9%) of the articles reported capacity to provide informed consent in the study's inclusion and exclusion criteria. Additionally, 66 (10.2%) of the articles did not provide a statement about institutional review board (IRB) approval; and given the large number of medication and device trials, one out of five articles (n = 134; 20.7%) reported no statement about potential conflicts of interest. Future research should continue to examine these issues and to better understand the benefits and challenges of research participation with psychotic individuals and their decisional capacity in this context.