Peer-reviewed article
Equitable Language Access in Neonatal Research.
Green S, Boyle C, Backes CH ·
Summary
Written by AI, not yet AICS's view · claude-haiku-4-5-20251001This paper examines language-based exclusion in neonatal research trials, particularly how non-English-speaking families are underrepresented in randomized controlled trials. The authors review neonatal research protocols and consent materials to identify barriers to language access and propose strategies including stronger regulations, improved translation services, and community engagement. The work argues that language equity is essential for scientific validity and ensuring research benefits reach all infants and families.
Key points
- Language-based exclusion in neonatal research remains inadequately examined despite focus on racial and ethnic diversity
- Systematic review of NICHD Neonatal Research Network protocols (1991-2020) and ClinicalTrials.gov (2018-2025) identified language barriers
- Regulatory, institutional, and structural factors contribute to language exclusion in research
- Recommended strategies include strengthened federal regulations, investment in language access services, and language-inclusive study design
- Language equity in research is critical for representation, scientific validity, and ensuring benefits extend to all infants and families
Limitations
This is a perspective paper synthesizing evidence and reviewing protocols rather than conducting an empirical evaluation of an intervention. It does not provide quantitative data on health outcomes for children or measure the effectiveness of proposed strategies.
Abstract
Participation in neonatal randomized controlled trials (RCTs) is associated with improved or equivalent outcomes for infants and is widely viewed as a cornerstone of high-quality neonatal care. Equitable access to research participation is therefore essential to scientific validity, ethical integrity, and generalizability. Although substantial efforts have focused on improving the representation of racial and ethnic minority groups in neonatal research, the inclusion of families who speak languages other than English remains inadequately examined. In this perspective, we synthesize existing evidence on language-based exclusion in pediatric research and present findings from systematic reviews of neonatal RCT protocols and informed consent materials from the National Institute of Child Health and Human Development Neonatal Research Network (1991-2020) and ClinicalTrials.gov (2018-2025). We discuss regulatory, institutional, and structural factors contributing to language exclusion and highlight actionable strategies to promote language-inclusive research, including strengthened federal regulations, investment in equitable language access, language-inclusive study design, systematic documentation of participant language, and meaningful community engagement. Advancing language equity in neonatal research is critical to improving representation, strengthening scientific validity and ensuring that the benefits of research extend to all infants and families.