Incorporating Patient Voices in Pediatric Assent Forms

This white paper outlines the redesign of pediatric assent forms by Fortrea to better incorporate the voices of children. The objective is to create templates that are engaging, understandable, and appropriate for young children participating in clinical trials. The paper discusses the importance of pediatric research and the assent process, which allows children to actively engage in decision-making regarding their participation in clinical trials. It details findings from a survey conducted in collaboration with the International Children’s Advisory Network (iCAN), which aimed to assess the effectiveness of redesigned assent forms that included cartoons compared to previous versions with photographs. Key findings indicate that imagery can aid understanding, but it must correspond to the text and be age-appropriate. The paper emphasizes the need for a thoughtful balance between realistic and non-scary images and suggests the potential use of technology to enhance patient education. The insights gained from the survey have led to further improvements in the design of assent materials.