B14 - Research With Children—Parental Permission and Assent and Child-Centric Trial Education

This session will review the Subpart D requirements, and their historical and ethical basis. Presenters will discuss the particular complexities of assessing the consent process in research with youth and present strategies for thinking through the parental permission requirement and the challenge and protection offered by the option for waiver. Speakers will also discuss common IRB pitfalls related to youth assent and creating a meaningful assent process, and offer practical suggestions for implementing effective assent in research with children. This session is intended to provide a foundation for developing materials by and for youth that explain various aspects of clinical trial participation. Through sharing the processes involved in developing these materials, attendees will become familiar with an inclusive approach to material development Before attending this session, attendees should be familiar with the criteria for the inclusion of children in research.