LAUSR

Informed consent is the foundation of modern biomedical research and it is vital for assuring the safety of vulnerable individuals, like those with psychotic disorders (e.g. schizophrenia, schizoaffective disorder, schizophreniform disorder, etc.). All individuals who are involved in clinical research must have consented to participate or had surrogate consent from a representative. As individuals with psychotic disorders may not always have capacity to consent, assessment of capacity before research participation is vital but there is little research on how these assessments are conducted in clinical research. The authors conducted a systematic review of high-risk trials, defined as randomized medication or device trials that specifically recruited individuals with psychotic disorders, to understand the use of capacity to consent assessment and their reporting. A total of 646 articles, which mostly recruited participants with schizophrenia and were medication trials, were coded using a standardized questionnaire on consent practices and ethical reporting of research. Only 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 had capacity to provide informed consent in the study inclusion/exclusion criteria. Additionally, 66 (10.2%) of the articles did not have a statement about IRB approval and 134 (20.7%) had no statements about potential conflicts of interest. Though limitations to the review exist, it is clear that both in conducting high-risk research with individuals with psychotic disorders and when reporting research findings, there are ethical issues that must be addressed.