Promoting Health Literacy by Operationalizing a Developmental Approach to Assent

Abstract

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 knowledge from implementing a developmental approach, analyzing youth data, and conducting the feasibility study was applied. Results: The simplified assent conveyed the same number of key study details as the more complex assent. 100% of the 6 questions were answered accurately by participants. The cross-section of the youth represented a diverse mix of demographics with 72% reporting comorbidities that impact language, learning, mental, and chronic health. Ninety-eight percent indicated an awareness of racism while 16% had encountered it directly. Youth valued education/knowledge and prioritized flexibility, agency, and autonomy. They demonstrated strengths such as cooperation, connection, and belonging. PIs indicated that assent was important and incorporating a developmental approach was acceptable. They did not believe it would be practical to require this approach. Key barriers were identified as securing buy-in from researchers, addressing time constraints, and gaining institutional support. Resources that strengthen capacity, provide examples, and allow for flexibility, were identified as a need by researchers. A toolkit of resources that reflected youth awareness, priorities, values, and strengths while meeting researcher requests was developed and made available in the resources section of the University of Arizona (UArizona) Institutional Review Board (IRB) website. Conclusion: The results suggest that integrating a developmental approach was useful in communicating key study elements and reinforced the necessity for inclusive assent practices that align with youth awareness. Incorporating developmental factors into assent empowers youth to exercise health literacy. Providing operational assent resources that reflect the values of diverse youth communities and strengthen the capacity of PIs is the first of many strategies to meaningfully engage youth in research.