Recognize the significant impact of language-based exclusions in clinical trials, including how these exclusions have increased over time, limiting the generalizability of results, and contributing to health disparities.  Differentiate between various definitions of Limited English Proficiency (LEP) and their implications for research, recognizing that LEP can manifest differently across diverse groups. Identify the ethical and regulatory requirements for fair subject selection and the inclusion of individuals with Limited English Proficiency (LEP), considering both language and literacy to ensure ethical practices and compliance with guidelines. Develop practical strategies to address language barriers and promote health literacy in clinical trials by providing language assistance and translating research materials to meet the needs of diverse participants.