People in the United States communicate in over 350 languages. While the majority of the population speaks English fluently, many millions of Americans do not, are not fully comfortable in English, and/or process information more easily in other languages. Everyone has experienced the stress of a health scare (for oneself or a family member) or an unfamiliar health environment (e.g., new doctor, new facility, new paperwork), and this anxiety and frustration are compounded when the information being communicated is not clear. It is difficult to trust the front-desk staff, healthcare provider, or clinical research team, and even more challenging to try to make decisions about what to do. In any clinical trial, before signing on to participate, there is a required process called informed consent, in which the researchers discuss the details of the trial (e.g., risks, benefits, tasks, expectations, privacy protections) with the potential participant. The “informed” part of this consent process is critical, and that means research teams must communicate in ways that are clear and understandable for the participant.
While translated materials and the use of interpreters are common practices in clinical care, these are not as commonly provided in clinical research. The MRCT Center has been working with sites, research teams, and sponsors to better understand best practices for translation and use of interpreters in all aspects of clinical trials (e.g., patient portals, informed consent documents, medication instruction, help desks). This is an evolving project as we learn from existing trials and institutional policies.
Related Assets
- Pediatric Research, Muthukumar et al. (2025) publication, “Persistent exclusion of non-English speakers in Pediatric research: a national analysis using ClinicalTrials.gov.”
- US Department of Health and Human Services (HHS) Language Access Plan (Note: Not an MRCT Center asset, but relevant)
- Evaluating the frequency of English language requirements in clinical trial eligibility criteria: A systematic analysis using ClinicalTrials.gov
- Limited English Proficiency and Translation of Study Materials
Please note: The tools listed above are living documents and will be improved with use. We welcome feedback, suggestions, useful references, resources, and concerns.
Acknowledgments
Many thanks to everyone who has so thoughtfully collaborated on these projects. Members who have chosen to be publicly acknowledged are listed in the links below, with the titles and organizational affiliations that they had at the time of the product launch. Please note that each member served in their individual capacity, and the views and findings expressed in project materials are those of the authors and do not imply endorsement or reflect the views or policies of the U.S. Food and Drug Administration or the affiliated organization or entity of any member who contributed to this work.
