The ethical dilemma of excluding patients from clinical trials based on language preference

Patients who prefer a language other than English (LOE) are underrepresented in clinical research trials. The reasons for lower enrollment are multi-faceted, and the literature lacks a good understanding of these causes or how to address them. Our objective is to examine the ethical implications of language-based exclusion from clinical trials, particularly through the lens of the Belmont Report, and to propose practical strategies to support language-concordant informed consent. The lack of translation and interpretation services and the lack of training for research sponsors and staff on trial enrollment for patients who prefer a LOE are key barriers. While short-form consents provide an alternative to traditional long-form consents and reduce the amount of translated material needed, short-form consents rely more on provider and interpreter communication skills and require robust translation support. Here we suggest strategies for increasing enrollment for patients who prefer a LOE onto oncology clinical trials by encouraging enhanced federal and state policy to incentivize translation and interpretation services, requirements for sponsor-funded translation and interpretation services, and augmented training for research staff to improve the process of enrolling patients who prefer a LOE in a language-concordant and culturally-appropriate manner. These strategies aim to align clinical trial conduct with the Belmont principles by ensuring that patients who prefer a LOE can meaningfully access and benefit from clinical research.