Development of a Framework for the Enrollment of Children and Families in Emergency Department Research.

Objectives: There remains a need to establish best practices for ethical and inclusive enrollment of children in emergency settings outside of established research networks. We aimed to develop a stakeholder-informed framework for enrolling children and families in emergency department (ED) research. Methods: We conducted a cross-sectional mixed-methods study using a convergent parallel design. Data collection tools were formulated by a multidisciplinary team. We approached caregivers of pediatric ED patients at a single site to complete a tablet-based questionnaire. We conducted 4-item structured interviews with (1) clinicians in a single pediatric ED and (2) pediatric ED researchers from across the United States. We calculated descriptive statistics for quantitative data and conducted a content analysis of qualitative data. These data were merged to develop a framework to support research recruitment and enrollment in the pediatric ED. Results: The questionnaire was completed by 225 caregivers (61% response). Caregivers' likelihood of participating in research was high but varied by type of research, perceived importance, and the clinical context. Researchers (n = 11) and clinicians (n = 8) identified barriers to and facilitators of research recruitment in the ED at the caregiver, clinician, and systems level. Merging these data, we developed a framework of 5 principles: (1) high-quality communication is essential; (2) discussions about research participation cannot be coercive; (3) partnership with clinical teams is necessary; (4) research teams must adapt to unpredictability; and (5) participation in research may be viewed as an opportunity by families. Conclusion: Our framework provides key considerations for conducting ED research with children and families.