The need for language inclusivity in clinical research

Nearly 22% of the U.S. population prefers to speak a language other than English (PLOE) at home, a figure that has nearly tripled since 1980. Despite this rapid growth, non-English speaking populations remain underrepresented in clinical research, contributing to significant health disparities. This gap not only limits our understanding of how medical conditions and treatments affect diverse populations but also exacerbates health inequities.

For example, language barriers are linked to increased rates of medical errors, serious adverse events and, in some cases, increased mortality. However, clinical research continues to exclude participants who speak a language other than English. One systematic review of three pediatric research journals (JAMA Pediatrics, Pediatrics, and the Journal of Pediatrics) found that of 5,008 articles screened, only 469 (9%) included participants who prefer a non-English language. Of those, Spanish was the most common language (75%), leaving other linguistic groups underrepresented or entirely excluded. This highlights the urgent need to advocate for language inclusivity in clinical research and to examine why this issue continues to be a barrier.

The role of federal policy in language inclusivity

The “Common Rule” (45 CFR 46) protects human subjects in research. Section 46.116(a)(3) requires that the information provided to participants must “be in a language understandable to the subject or legal authorized representative.” However, this policy is vague and lacks explicit guidance on how to effectively include participants who speak a language other than English in clinical research. As a result, Institutional Review Boards (IRBs) across different institutions have developed inconsistent policies. Studies evaluating IRB policies have found significant variability in consent processes for patients who speak another language, including the use of in-person versus virtual interpreters and varying definitions of “qualified interpreters.”

Researchers generally have two options when obtaining consent from participants who prefer a language other than English:

• Short–form: a brief document stating that the essential elements of informed consent were explained verbally to the participant in their preferred language. A witness fluent in the participant’s language (but not part of the study team) must sign the form. At Baylor College of Medicine, this form is available and translated into multiple languages, and an in-person interpreter may serve as the witness.
• Long–form: a detailed document that includes information about the study, risks, and benefits; requiring translation into the participant’s preferred language with no witness required.

Ethical and practical implications

It can be difficult to recruit participants who speak less common languages, as finding a qualified witness may be challenging. Additionally, the financial burden of translating documents and hiring professional interpreters can average $3,000 per research protocol. While some institutions absorb these costs, many researchers must bear the financial burden themselves. These logistical and financial challenges often discourage researchers from including non-English-speaking participants, despite the clear ethical and scientific need to do so.

Excluding participants from clinical research based on the language they speak not only limits the generalizability of findings but also undermines the ethical principle of justice. Research that fails to include diverse populations risks producing data that is not applicable to the broader public, particularly immigrant and ethnic minority groups, which make up a significant portion of our community in Houston. Without robust data on the health needs of non-English-speaking communities, we cannot make informed decisions about treatments, drug efficacy or preventative measures for these populations.

Furthermore, excluding these groups from research can erode trust in the healthcare system. Immigrant and non-English speaking groups already face barriers to care, and exclusion from research may further alienate them from seeking necessary care or participating in future studies.

Moving toward inclusivity: Policy change and advocacy

To ensure more equitable healthcare for all, we must advocate for meaningful policy change at both the federal and institutional levels. Clear guidance from regulatory bodies is needed to help include non-English speaking populations. Additionally, institutions should consider adopting technological advances by researchers, such as allowing virtual interpreters to provide secure e-signatures for research consent forms.

Institutions must also prioritize funding for translation services and compensation for qualified interpreters to ease the financial burden on researchers. For researchers without institutional financial support, we encourage the inclusion of translation costs in grant proposals. Finally, we must advocate for the inclusion of preferred language as a variable in national databases (i.e. PHIS network) to promote language equity research and make data collection more feasible.

Researchers should also consider the cultural needs of participants throughout the entire research process, from study design to data collection and interpretation. As we care for a diverse patient population in Houston, we have the opportunity to lead by example and advocate for language equity in research, setting a standard for other institutions to follow.

By Drs. Amanda Macias, a second-year pediatric hospital medicine fellow, and Marina Masciale, assistant professor of pediatrics, associate director of research, division of pediatric hospital medicine, assistant program director, pediatric hospital medicine fellowship, Baylor College of Medicine/Texas Children’s Hospital