Standardizing Reporting of Pediatric Assent in Clinical Trials

Despite longstanding ethical consensus on the importance of pediatric assent, documentation of how assent is obtained, waived, or overridden remains sparse and inconsistent in clinical research. This article examines the systemic underreporting of assent practices in pediatric trials, drawing on a review of trial registries, informed consent forms, and published studies in pediatric oncology. Our findings reveal that assent is often embedded within parental consent processes, rarely documented in detail, and inconsistently interpreted across studies. Without minimal reporting standards, it is impossible to evaluate whether children were informed, involved in decisions, or given opportunities to dissent. This lack of transparency compromises ethical accountability and prevents researchers, ethics committees, and policymakers from learning from prior practice. Drawing on international examples, we propose a practical recommendation for change: that trial registries and journals adopt minimal reporting requirements to include who assented, whether disagreement occurred, and how it was addressed. Better documentation-through standardized, developmentally appropriate practices-can help ensure that children's voices are respected and their participation in research is ethically sound. Importantly, documenting assent is not only relevant to research but also extends to pediatric clinical care, in which everyday care decisions offer opportunities to engage children, foster trust, and respect their voices.