(108) Inter-center Variation in Human Subjects Protections During Research Informed Consent Processes for Subjects with Non-english Language Preferences at Centers Training Pediatric Medical Geneticists

Background: According to the U.S. Census Bureau, over the past 40 years, the foreign-born population has increased from 6.2% to 13.9%. Similarly, the percentage of people who speak a language other than English at home has doubled, from 11.0% (1980) to 22.0% (2019). Despite this increase in diversity across the U.S., there remains a lack of diverse representation in genomics datasets: participants of European descent accounted for 94.5% of subjects in the Genome-Wide Association Studies Catalog in 2024. The inclusion of diverse populations in genomics research is particularly important, as there are differences in disease burden and allele frequency across ancestrally diverse populations.
Members of immigrant communities often originate from populations under-represented in genomics research. Inclusion of new Americans in genomics research in the U.S. can be a powerful way to enhance representation in this research. Unfortunately, language may act as a barrier to inclusion. The Urban Institute’s Children of Immigrants Data Tool shows that 4.9% of children in the U.S. had limited English proficiency in 2023 and 15.4% of children had at least one limited English proficient parent. While multiple studies have demonstrated the inconsistency of research consent practices for non-English-speaking subjects, no study has examined these practices at pediatric centers with an academic focus on genomics.

Objectives: The objective of this study is to describe the IRB policies related to consenting subjects with non-English language preferences (NELP) at institutions with ACGME-approved pediatrics-medical genetics and genomics (PMGG) residency training programs. We aim to better understand the prevalence and nature of policies which might encourage or inhibit the enrollment of diverse populations in pediatric genomics studies, as well as institutional-level factors which might drive differences.

Design/Methods: This is a cross-sectional survey of the IRB policies at the 27 U.S. institutions with PMGG programs. The policies related to consent and enrollment of subjects with NELP were obtained from IRB websites, email and/or live interviews with IRB staff. The categories of information we examine include statements of inclusion, short and long form consents, document translations and interpreters, and pediatric considerations. Policies are compared between institutions and analyzed by institutional and local factors.

Results:

Conclusions: