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Background: Since 1991, The Common Rule has provided regulation to protect humans participating in biomedical or social research.1 Despite clear protocols to obtain informed consent from adults, there is limited information on how to incorporate developmental factors such as simplified language, formative assessment, and feedback into youth assent practices. Adolescence, an important period for developing behaviors that impact health throughout the lifespan, is also a time when developmental capabilities vary greatly among peers of the same chronological age. Meaningfully engaging youth in research begins with an assent that integrates developmental factors and promotes the health literacy of youth. Operationalizing this approach narrows the gap between regulation and research practices. Methods: To quantify the language complexity of two assent templates, 3 trained speech-language pathologists used Language Sample Analysis; the results were compared. To assess the usefulness of incorporating development into assent, a developmental approach to assent was designed. This approach was implemented with a randomized sample of 50 youth participating in the Children And Teens Study (CATS). A data capture system was utilized to present simplified assent language in segments and ask 6 questions assessing comprehension. For individuals with incorrect answers, feedback was provided, and the same question was presented a second time. To incorporate youth priorities, values, and strengths into assent resources, demographics, educational experiences, exposure to racism, and resiliency data were analyzed. To evaluate the feasibility of shifting institutional assent practices, semi-structured interviews were conducted, assessing the importance of assent, understanding of a developmental approach, its acceptability, the practicality of requiring it, and the resources needed for Principal Investigators (PIs), to be successful. To design a toolkit of operational resources, the knowle