There is a need to develop (1) a library of validated audio-visual and text materials to educate children about their particular health condition, the clinical research process in general, and specific experiences they may have in a proposed clinical trial; and (2) exemplary instructional materials, guidelines, and best practice recommendations for researchers in selecting and employing these tools. Based on research conducted among pediatric patients and their parents, there is consensus that these tools should be designed for use on an electronic device.
Accessing a platform of such materials will expedite the enrollment of children in trials of potentially life-saving and health-enhancing devices and drugs. Our research team will continue interviewing experts, collecting and characterizing guidelines and materials currently in use for obtaining assent, and conducting a stakeholders’ workshop. The team will produce a report for applying guidelines for obtaining assent, a peer-reviewed article on our findings, and a roadmap for developing additional education materials as needed.
Each stage of this project will be guided by input and feedback from children through The International Children’s Advisory Network (ICAN). The project will benefit those in all stages of clinical research, from subjects to researchers and their institutions, to sponsors and site managers. Clinical researchers and their institutions and Internal Review Boards (IRBs) will have guidelines to follow for obtaining assent, thereby facilitating more clinical trials for innovative products. Research sponsors and site managers should experience more streamlined assent processes, supporting more timely completion of clinical trials. And children, perhaps the most important part of the process, will receive age-appropriate and condition-specific information necessary for providing assent for participation in clinical studies as informed as possible.