Strategies to Promote Inclusion and Decrease Language Barriers in Spanish Speaking Participants

Ariana Berrios, EMT, Thomas Jefferson University

Abstract: This paper was developed from our discussions about inclusion of non-English speakers in clinical research. We presented a poster on this topic at the 2022 SOCRA Annual Conference. We believe that Spanish-speaking individuals are often excluded from clinical research studies because of language barriers. While some language services have been established for clinical use, those services are often unavailable and are generally not standardized for clinical research purposes. This paper calls attention to current language barriers and provides an overview of the shortcomings of Spanish language services in clinical research. The authors propose strategies to promote research that is inclusive of Spanish-speaking participants. While the emphasis of this paper is focused on improving inclusion of Spanish-speaking participants in clinical research; the solutions we propose could be applied to other participants whose first language is not English.

Introducing Spanish Language Barriers

The 2020 United States census reports the Hispanic population as the largest ethnic minority group, making up approximately 17% of the total population—a percentage which is expected to rise in the coming years (See Figure 1). Despite the growing Hispanic population, only 8% of clinical trial participants identify as being Hispanic (Byrne et al., 2021).

One of the challenges the authors faced, while searching the literature, was identifying the scope of Spanish-speaking persons who may not be represented in clinical research. In the collection of research demographics, Hispanic/Latino is often viewed as an ethnicity and not a as a race. The demographic data reported in the literature and in reports to regulatory authorities do not show whether the enrolled subjects of a race or ethnicity were enrolled in studies that only used English language documents and systems. The utilization of efforts for inclusion like translation services and/or translated documents and short form consent documents is often not published in the literature and is not presented in publicly accessible (in English) research results on sites like clinicaltrials.gov.

While translation services and bilingual staff are often available in a clinical setting, we believe that language services are provided inconsistently or are lacking in clinical research settings. From the development of the research concept to project planning and budgeting to the execution and closing of a study, the authors believe there is significant room for improvement in the language services offered for Spanish speaking and other non-English speaking research participants.

One of the goals of clinical research is to generate results that can be applied as a representative sample of the population being studied.  Excluding individuals from a study because of a language barrier negatively impacts the quality of the research being conducted. A greater degree of generalizability correlates to greater study validity. Research cannot be generalizable to the general population if accurate representation is not achieved. Underrepresentation of minority groups can also skew the results of research. This is the foundation that population-based research is built upon, that is exemplified by the principle of justice in the Belmont Report, and why, the authors believe, research subject accrual needs to be diverse. Research subject accrual must be adaptable to language barriers and sensitive to the diverse population it attempts to enroll.

We believe that translation (text-based) and interpreter (speech-based) services can help combat the low representation of Spanish-speaking Hispanics in clinical research. While other barriers, such as concerns about research misconduct, pose a harder challenge to overcome, there are practices that can be implemented to address inclusion.

The 2020 census revealed that almost 16 million persons over the age of 5 speak Spanish at home and/or speak English less than “very well” (See Figure 2). Only 8.5% of investigators are Hispanic, and research teams often lack the resources necessary to provide interpretation services or to hire bilingual staff (Research Investigator Demographics, 2022). Because of this, Spanish-speaking participants are not usually able to speak directly with a research team; creating a divide between the research team and the participant. We believe that language barriers can contribute to lower Hispanic enrollment in clinical studies.

Promoting Inclusive Practices

Establishing a diverse multi-lingual research team is one way to build rapport with non-English speaking research participants. When proficient bilingual clinicians are able to communicate directly with their patients, patients report feeling more satisfied and have better understanding of their care, diagnoses, and treatments (Diamond et al., 2012). Research has shown that being able to communicate directly with a Spanish speaking professional improves overall experience and retention (Steinberg et al., 2016) of Spanish speaking research subjects.

When communicating with a potential participant in a clinical or research setting, it is necessary for both the participant and research personnel to know exactly what the other person intends to say. It is imperative that the participant and researcher and/or provider understand one another. Inaccurate interpretations occur in nearly 30% of interactions, resulting from untrained interpreters and unfamiliarity with medical terminology (Nápoles et al., 2015). Those who use informal interpreters, such as relying on the patient’s friends or family to translate, are more likely to experience errors in communication and understanding when compared to those who utilize professional interpreters (Diamond et al., 2012). Although well-meaning, friends and family who facilitate interpretation, are not the research subject. Impromptu interpreters are more likely to substitute words or omit information.  These interpreters could change the meaning of what is being said to or by the patient, thus contributing to ethical concerns related to the subject’s participation (Diamond et al., 2012).

Just as representatives are provided for individuals who are legally unable to give consent, a similar approach could be utilized to promote inclusion of Spanish speakers in the form of medically and research-trained language interpreters. This means seeking and hiring bilingual staff and training them to be accurate interpreters or finding appropriate interpretation services.

Sanossian et al., 2017, implemented approaches to increase enrollment through the use of a Spanish phone line to a bilingual investigator. Their results revealed a 10% increase in Hispanic recruitment and brought forth new information regarding a potential difference in the pathology of strokes in Hispanics versus non-Hispanics. Persons from different demographic backgrounds may have different reactions to certain medications or have different disease development. A Spanish-language phone line can allow researchers to better serve and represent their community, as well as to note any important findings.

Linguistic Access

Individuals who do not speak English often are unaware of how to participate in research. Recruitment efforts are conducted primarily in English and thus exclude the potential for a diverse non-English speaking population right from the beginning. Many documents and instructions given to research participants during consenting or while on-study are also only available in English. Studies may avoid translating documents entirely by establishing an English-only study participant pool. Translating documents relevant to consenting can be time consuming and may omit essential information.

The consenting process can be a difficult task in English, with no language barriers, especially with complex studies, and can be even more difficult when conducting informed consent with non-English speakers. Some studies may implement the use of short form consent documents.  While these forms are helpful (and quicker to translate), the authors note that short form consent documents are not equivalent to the full consent document presented to persons in language a subject understands—as required by the Common Rule (45 CFR 46.116 (a)(5)(i-ii)).  Gabler et al., 2021, asserted that when research tools are found to be incompatible with their English versions it can be perceived as discriminatory.

One of the difficulties associated with document translation is that some words are just not directly translatable from English into other languages. The translation of some words or complex procedures may be avoided or changed altogether. A solution to this is to be mindful of word choice when developing the summaries provided to the participants. Working closely with a translator who is research-competent may also be beneficial in creating a document that is easily translatable into a variety of languages.

The University of Utah sought to address the issue of document translation by creating the Research Participant Advocacy (RPA) program. The RPA addressed two aspects in consenting: translating documents related to consent, and incorporating a trained interpreter to assist in the informed consent process. The documents approved by the University of Utah Institutional Review Board (IRB) were translated to ensure that participants could make fully-informed decisions. The RPA’s practices included employing a native Spanish speaker to proofread translations and oversee language use. The program culminated in the creation of a portfolio of IRB-approved forms available in multiple languages. The RPA program translated over 500 documents and has been used over 1000 times in over 8 months (Gabler et al., 2021).

Cultural Considerations

Translation and interpretation aside, there are other barriers that must be addressed. Establishing trust is key in retaining participants. Being able to establish rapport with the potential participants and then being sensitive to their needs can help increase retention rates. It is also important to keep cultural differences in mind. People in different countries may perceive culturally specific concepts differently.  

Occa et al., 2018  found that being as transparent as possible throughout study procedures can help maintain retention and address some of the fears participants’ may have. This could mean going the extra step to explain procedures, and to clarify actions being taken, such as when drawing blood or when administering a drug. The way in which something is explained to someone plays an important role in how the information is received (Occa et al., 2018).

Conclusion

Both the U.S. Code of Federal Regulations (CFR) and the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) require that information provided to the participants or their legally authorized representatives be available to them in a language they can understand. This can be found in Title 45 of the U.S. Code of Federal Regulations(45 CFR  46.116 (a)(3), also known as the Common Rule, and in the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines (ICH E6 (R2): 1.37, 4.8). Spanish and other language documents such as consent forms, assessments, and study advertisements should be readily available and equivalent to their English counterparts. While a very few institutions have such a level of linguistic access available for non-English speaking participants, the RPA from the University of Utah has shown it can be done and, the authors believe, ought to be considered.

An important juxtaposition to note is that the Common Rule in the Code of Federal Regulations is scarcely available in languages other than English. The authors could only find an unofficial Spanish-translated version of the pre-2018 Common Rule on the website of the Office for Human Research Protections (OHRP). However, it is tagged with the caveat that it serves only as “a convenience to the public” and may vary from the English version “due to the difficulties of translating” (OHRP, 2022). While changes in practice on a study-to-study basis is important, systemic change should also be an immediate goal.

Language barriers continue to be prevalent in the recruitment of Hispanic populations in clinical research. Diversity among research teams and participants ought to reflect the cultural and racial demographics of the general population. Bilingual staff can work closely with Spanish speaking study participants and make them feel more comfortable. Training Spanish speaking staff to be medically and culturally competent avoids inaccurate interpreting and may help to account for cultural differences in language or dialect. Similarly, some translation services do not offer clinically or research trained translators, so choosing a service that is well versed in clinical research terminology is important. Utilizing bilingual staff or research trained translators aids in establishing rapport with research participants. We believe that when participants feel that they can trust the research team, retention rates go up—regardless of language.

We have found that without addressing language barriers, a substantial percentage of the population is excluded from study involvement and thus the scope of the research being conducted is limited. Many studies have shown that implementing strategies to address language barriers increases diverse recruitment and retention, improves patient experience, and leads to richer study results. Changing the standard and expectation for inclusion in clinical research will improve research practices, not only for Spanish speaking individuals, but all those who encounter language barriers in research participation.

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