Novel approach to parental permission and child assent for research: improving comprehension.

OBJECTIVE: The aim of this research was to test a multimedia permission/assent (P/A) process. The overall hypothesis was that children and their parents exposed to a multimedia P/A process would have better comprehension compared with those exposed to a text-based process. METHODS: Traditional and multimedia P/A processes were created by using an innovative learning-objective approach. A total of 194 parent-child dyads (children aged 11-14 years) were enrolled: 24 dyads in a prestudy testing P/A components for preference and effect on comprehension and 170 dyads in a randomized trial of a multimedia or paper P/A process for a hypothetical study. Participants were predominantly white and were from a metropolitan area served by a tertiary care pediatric hospital and outpatient facility. Comprehension of 8 essential elements of the P/A process was assessed. RESULTS: The majority of prestudy subjects preferred the video version of the dual-energy radiograph absorptiometry description over the animated and paper versions combined (41 of 48 [85%]; P < .0001), and there were similar results for the abdominal ultrasound description (38 of 47 [81%]; P < .0001). Children exposed to the novel process showed significantly better overall comprehension compared with the paper P/A process (P = .0009), and there were highly significant differences in understanding of study procedures (P = .0002) and risks (P < .0001). The parental multimedia group had significantly better overall comprehension (P = .03). CONCLUSIONS: Multimedia approaches to the research P/A process may improve overall understanding of research participation for children and parents. Improved understanding of study-specific research components (rather than research rights) may improve overall comprehension.

Ethical considerations in research involving children.

Ethical concerns and medical advances unique to children and adolescents make pediatric research an evolving endeavor. The child's changing physiology from infancy to maturity requires understanding of the benefits and risks of medical therapies currently available, but often not tested in children, as well as the risks and benefits of inclusion of children in clinical research. Recent mandates from the US Food and Drug Administration (FDA) require that drugs be tested for safety and efficacy in children. Growing concern for the prevalence of chronic disorders and increasing understanding of distinct phenotypes of these disorders points to a likely need for unique interventions matched to specific phenotypes. All contribute to the increasing complexity of ethical considerations in pediatric research.