Research Equity and Enrolling Non-English Speakers
Informed consent, a cornerstone of ethical research, involves describing important elements of research in a way that permits participants or potential participants to comprehend those elements and make a voluntary choice about research participation. For individuals who speak languages other than English, or who possess limited English proficiency (LEP), informed consent may require an interpreter and a translated consent form.
Facilitating enrollment of individuals with LEP gives the research community an important chance to foster clinical trial diversity and inclusion. However, careful forethought is needed to anticipate logistical challenges and balance the importance of fostering diversity with the costs of translation services.
Regulatory Parameters and the Challenge of Inclusion
Both Food and Drug Administration (FDA) and Health and Human Services (HHS) regulations state during informed consent, “the information that is given to the subject or the representative shall be in language that is understandable to the subject or representative.” FDA further advises, “When the study subject population includes non-English speaking people or the clinical investigator or the IRB anticipates that the consent interviews will be conducted in a language other than English, the IRB should require a translated consent document to be prepared and assure that the translation is accurate.”
Because translation and interpreter services incur costs and can be time-consuming, sponsors and sites may choose to limit enrollment to people with English proficiency, rather than providing translation services. Indeed, there are several empirical studies supporting the conclusion that people with LEP are excluded from research participation at surprisingly high rates—often through an explicit requirement stating participants must read and/or understand English.
While the costs and feasibility of translation services are important considerations, there are a number of factors that make exclusion of people with LEP less than optimal and important practical solutions that should be explored first.
Access, Justice, and Scientific Value
From an ethical and participant-centered perspective, considerations of access and justice support the inclusion of people with LEP in research, which are reflected in the regulatory requirement for institutional review boards (IRBs) to ensure equitable participant selection (21 CFR 50.27 (b)(2)). Underlying this principle is the idea of sharing the benefits of research equitably across groups and members of society, and that people should not be denied access to research based on medically or scientifically irrelevant characteristics, such as limited proficiency in English.
Another consideration stems from the importance of enrolling diverse and representative study populations, which ensures that the research conclusions can be generalized widely across all segments of society. While LEP is not itself a scientifically relevant variable, it can overlap with such features, including increased co-morbidities and polypharmacy, due to the unfortunate fact that individuals with LEP are more likely to be economically vulnerable and more susceptible to negative social determinants of health.
Sponsors and investigators should anticipate which non-English speaking populations they are likely to encounter for enrollment and proactively translate consent materials into those languages. Indeed, consent materials may always merit translation into prominent non-English languages, such as Spanish. The IRB should confirm translation accuracy, which may be done via an attestation from a third-party translation service or another certified translator. Researchers may also want to check with their IRB of record to ensure they understand any other IRB translation requirements.
US regulations also make specific provision for unanticipated situations where study-specific translated consent materials are unavailable. In these cases, researchers may use what is known as a “short form” consent in tandem with an oral interpreter to conduct the consent process (21 CFR 50.27 (b)(2), 45 CFR 46.117 (b)(2)). The short form consent is a document containing general, key elements of research translated into the participant’s native language. Since the short form consent does not contain study-specific information, it is best practice for participants enrolled in this way to receive the full consent document translation as soon as it is available.
An Opportunity for the Research Community
As the research community pays greater attention to access and equity considerations, facilitating the inclusion of individuals with LEP is a concrete way to advance these goals. Including people with LEP will require commitment from sponsors and researchers, both in terms of facilitating informed consent at enrollment and ensuring non-English speaking participants can adequately communicate with study staff and complete study requirements as the study unfolds.
While inclusion of individuals with LEP may carry operational costs, these costs can be justified by the goods of ensuring fair access to clinical trial opportunities for people with LEP and diversifying clinical trial samples. Excluding people from research based on the language they speak is, in many cases, ethically questionable, especially when regulatory provisions exist to minimize the burdens of translation. The research community has an excellent opportunity to advance diversity and inclusion in practice by finding ways to facilitate the enrollment of people with LEP.