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

ABSTRACT: 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

SUBMITTER: Weissinger GM 

PROVIDER: S-EPMC11520818 | biostudies-literature | 2019 Sep

REPOSITORIES: biostudies-literature