Policies Regarding the Inclusion of Individuals with Limited English Proficiency: A Cross‐Institutional Analysis

ABSTRACT Individuals with limited English proficiency (LEP) are a rapidly growing social group in the United States, yet they have been historically under‐included in clinical research. This is partly due to the fact that research team members typically conduct the informed consent process in English. While some institutions have policies for how to conduct an informed consent process with individuals who have LEP, many lack structured instructions for consent of LEP participants. Our study investigated whether the human research protection programs and institutional review boards at the top 50 institutions that receive funding from the National Institutes of Health have policies about the inclusion of individuals with LEP in research. We investigated whether they have an inclusion statement, specifications around minimal risk and direct benefit studies, requirements regarding translation of study materials, and provisions for funding the translation of consent forms into non‐English languages. We found variation in policies across institutions. Our findings serve as a benchmark to assess the changing landscape regarding the inclusion of individuals with LEP in clinical research, which has the potential to alter care for LEP patients.