Pediatric Emergency Department Research Participation: The Influence of Study Design Across Race and Ethnicity

The underrepresentation of racial and ethnic minorities in clinical research limits the generalizability of findings. This study examined how specific study design elements, such as follow-up requirements, stipends, and research procedures, were associated with participation refusal rates across racial and ethnic groups in a pediatric emergency department setting.

This retrospective cohort study analyzed recruitment outcomes from prospective studies conducted between 2012 and 2022 in a pediatric emergency department with approximately 70,000 annual visits. Studies requiring informed consent were included, excluding those targeting specific racial or ethnic groups. Demographic data were abstracted from the electronic health record using standard categories obtained by self-report during ED registration. Logistic regression assessed associations between study design elements and consent likelihood across racial and ethnic subgroups.

Among 14,500 encounters, the median age was 12 years; 14.0% identified as Hispanic, 41.6% as Black, 55.7% as White, and 2.0% as Asian. Recruitment was successful in 71.5% of cases, with a 25.4% refusal rate. Moderate enrollment procedure time (6 to 15 min) were associated with higher consent odds for all groups, while very short (<6 min) or prolonged durations (>30 min) were linked to lower consent odds. High stipends (>$135) were associated with reduced likelihood of consent across all groups. Requirements for biobanking and lab work were more likely to be linked with refusal among Black and Asian participants. Hispanic participants were more likely to consent to medication trials (OR: 1.74, P =0.003). Follow-up requirements were associated with lower consent odds among Hispanic and White participants, with a stronger association for Hispanic participants (OR: 0.39, P =0.002).

Study design elements were significantly associated with recruitment outcomes, with notable variation across racial and ethnic groups. Transparent communication, culturally responsive engagement, and logistical flexibility may help reduce participation barriers and promote equity in pediatric clinical research.