Clinical Research Policies for Inclusion of Subjects With Limited English Proficiency: A Cross-Institution Analysis

Patients with limited English proficiency (LEP) often experience barriers in communication in clinical care and suffer worse healthcare outcomes, especially in emergency departments. However, these findings are limited by the historical exclusion of LEP subjects in clinical research with some estimates showing that less than 2% of studies indicate language as a primary variable and only 10% specify inclusion of LEP subjects. This project investigates LEP inclusion policies from the most highly funded NIH Institutions and serves as a marker of the national landscape.

The NIH Research Portfolio Online Reporting Tools (RePORT) was used to find the top 50 research institutions by funding in the US in 2023. Each institution’s Program of the Protection of Human Subjects (PPHS) office and IRB websites were reviewed to search for a policy regarding language interpretation for subjects with LEP. If nothing was found on these public resources, they contacted the director of the IRB program allowing two weeks for a response before sending a follow-up. In two weeks, "no response" was recorded.

Of the 50 institutions that we sought to analyze, the researchers were able to locate policies for 46 met the criteria for participation. Sixteen out of 46 of the IRB policies had codified specific statements preventing “exclusion” indicating that the institution or the investigators will not systematically exclude LEP in clinical research. Nineteen out of 46 of the policies made specific determinations for consenting LEP subjects in studies that were minimal risk. Twelve out of 46 of the policies made mention of direct benefit either in stating that LEP patients must be included if there is a potential for direct benefit or lessening the consenting requirements, such as using a short consent form, when the study had direct benefit for participants. Twenty eight out of 46 policies explicitly required researchers to translate study of recruitment materials. None of the 46 institutions indicated that the institution would be financing the translation fees.

There is significant variability in the policies for consenting LEP subjects across institutions which affects information on clinical measures and outcomes for LEP patients in emergency departments. Policy recommendations to address this issue should begin with increased transparency.