Peer-reviewed article

Caregiver decision-making on pediatric research participation in congenital heart disease in western China: a qualitative study.

Peng M, Ding Y, Li Z, Shao S, Cui Y et al. · 23 Jun 2026

Abstract

Background High-quality pediatric clinical research depends on effective and ethically robust recruitment, yet participation can be difficult for families of children with congenital heart disease (CHD), particularly in resource-constrained and culturally diverse settings. In western China, long-distance care-seeking, financial strain, family-centered decision-making, and evolving pediatric research protections may shape how caregivers understand and negotiate research participation. Methods We conducted a qualitative descriptive study at a tertiary pediatric referral center in western China between June and December 2025. Caregivers of children with CHD participated in one-to-one semi-structured interviews. Interviews explored practical burden, perceptions of research and treatment, therapeutic misconception, trust, child assent, and strategies to improve recruitment. Audio-recordings were transcribed verbatim, anonymized, and analyzed using qualitative content analysis. Results Thematic saturation was reached after 22 interviews. Four overarching themes were identified: (1) families' real-world constraints and the costs of research participation; (2) cognitive biases and tensions surrounding therapeutic misconception; (3) trust anchors and views on assent, insurance, and institutional protection under a changing policy context; and (4) strategies for optimizing recruitment. Caregivers commonly weighed research participation against treatment-related burdens, especially travel distance, accommodation costs, wage loss, and repeated hospital visits. Decisions were further shaped by collective family decision-making, culturally mediated concerns about bodily integrity, confusion between research and individualized treatment, and strong reliance on physician recommendation. Participation was generally more acceptable when procedures were non-invasive or integrated into routine care, whereas extra venipuncture was often resisted. Caregivers also emphasized the value of plain-language, visual, dialect-adapted, and child-friendly communication. Conclusions Caregivers' decisions about pediatric clinical research participation in western China are shaped by structural disadvantage, family-centered norms, therapeutic misconception, and trust in physicians and institutions. Recruitment should reduce burden, improve comprehension, support family communication, and accommodate children's developing role in research decisions.