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Equitable Clinical Trials 

By Nicole Rodriguez

Did you know that the most common medication prescribed to manage asthma symptoms is ineffective at improving lung function within the Puerto Rican pediatric population despite significantly improving symptoms in other communities? This case represents one of many health disparities that have emerged due to a lack of participant diversity within clinical trials. During a clinical trial, a novel medical intervention is tested on human participants to see if the medication is safe and effective. If the intervention passes several iterations of clinical trials, it is approved for clinical use and can be prescribed to patients. The availability, safety, and potency of an emerging medical intervention is determined based on the reactions of the couple of thousands of participants enrolled in the intervention’s precursory clinical trial. Therefore, when this participant group is homogenous, the clinical trials may fail to identify group-level treatment effects, and the generalizability of the results becomes questionable. This is how we get widespread marketing of medications that are highly effective in some patients and inert, or even harmful, in others. To make emerging medical treatments equitable for everyone, future clinical trials must commit to recruiting more diverse participant groups. This effort will undoubtedly require the recruitment of lingually diverse participants, specifically participants with limited English proficiency (LEP). 

The first step in recruiting any person for a clinical trial is gaining informed consent. Informed consent is a legally and ethically required step in all clinical studies and is designed to protect a person’s right to autonomy over their body. Informed consent is a process between a potential participant and the research team and manifests into a document that is signed by both groups. For the resulting document to be valid, the informed consent process must include the following three elements. First, the person must understand that their participation in the trial, at all points, is voluntary, and their decision to participate should be made free of third-party coercion. Second, researchers must disclose sufficient information about the study so that the person understands the goals, procedure, risks, and benefits of the current study. Furthermore, the researchers must explain the alternative care options available and their associated risks and benefits. Finally, the participant must demonstrate sufficient understanding of the trial design and its associated consequences to ensure that their decision to participate is based on accurate information. Furthermore, researchers must uphold informed consent continuously throughout the duration of the study. Therefore, researchers are required to reiterate the voluntary nature of participation, disclose new information about the study and alternative options of care, and assess participants’ understanding throughout the length of the study. Fulfilling the requirement of informed consent can be difficult, but the language barrier that accompanies LEP participation can make achieving validated consent increasingly complex. Within the current research landscape, there are several obstacles to achieving informed consent with LEP participants. Through identifying and addressing these difficulties, the scientific community creates an avenue for the equal and prudent inclusion of LEP participants within research. 

Some notable challenges to obtaining proper informed consent from LEP participants include the lack of guidelines available to researchers, associated costs of inclusion, and a failure to address participants’ cultural differences. Foremost, there are federal and institutional rules that describe how to conduct the informed consent process, and researchers are legally and ethically expected to follow these directions. Unfortunately, federal directives elaborate little on how to obtain informed consent from LEP participants and only specify that the process be conducted in a language comprehensible by the participant. The vague explanation at the federal level has led to a sundry of interpretations by institutions, resulting in the creation of consent procedures that range in specificity. A review of consent procedures from 134 different health centers revealed that only 78% included directions for enrolling LEP participants, only 53% specified how to translate documents, only 32% specified fluency requirements for personnel obtaining consent. Shockingly, some health centers had guidelines that included language that discouraged the recruitment of LEP participants. It is important to highlight that many of the guidelines that detail LEP participant informed consent focus on the initial recruitment process and do not provide expectations on how to maintain informed consent throughout the research project, or specify what research-related documents and directions require translation. Research groups may be apprehensive about enrolling LEP participants due to the lack of federal and institutional directions on how to do so prudently.  

In addition to the scarcity of guidelines on how to recruit LEP participants, researchers may be deterred from recruiting LEP participants due to the additional cost of translating materials and hiring personnel to complete clinical interpreting. One study found that, of 33 clinical studies that explicitly excluded LEP participants, researchers cited the cost of translating research materials, the cost of hiring bilingual personnel, and translating participant responses to English as prominent reasons for this exclusion criteria. Even in studies dedicated to recruiting LEP participants, associated costs still arise as a barrier. A clinical study dedicated to recruiting Spanish-speaking participants disclosed that the cost of translating consent forms, approximately $3,300 per recruitment site, hindered the study’s ability to make translated forms proactively available to potential LEP participants. Finally, the current approach toward recruiting LEP participants emphasizes bridging language gaps within the informed consent process by using interpretation and translation services while ignoring the importance of addressing cultural differences. One case study found that LEP participants still had trouble understanding the nature of the research study during the informed consent process even when an interpreter was present. Additionally, the same case study found that both researchers and interpreters cited regional differences in accents, word usage, and connotations as barriers to communication with LEP participants. However, dialect differences are not the only cultural differences that can impede on accurate clinical interpretation. The mere recoding of the researcher’s message into a language comprehensible by the participant can still lead to incomplete understanding when cultural differences between the participant and research team, such as alternative religious outlooks, perceptions of health care organizations, and awareness of the scientific method, are not addressed. The purpose, benefits, risks, and voluntary nature of research participation may be lost when the translation and interpretation of research content is a static process that ignores cultural differences beyond language. 

Identifying the current shortcomings in the LEP participant informed consent process should inspire actionable change. The fact that scarcity of guidelines and financial concerns are common motives for the exclusion of LEP persons reveals the systemic insensitivity toward the recruitment of these participants. LEP individuals represent a growing proportion of the population, and it is time that institutions acknowledge this fact by explicitly recognizing and protecting LEP participants within their research guidelines. All institutions should develop clear guidelines on how to acquire LEP participant informed consent, which define the appropriate method for translating documents, the credentials of auxiliary personnel, what research content requires translations, and directions on how to sustain informed consent throughout the study. By codifying these rules, researchers will no longer have to assume the burden of interpreting ambiguous directions and will feel more supported in including LEP participants within their research. Likewise, researchers should factor in the cost of LEP participation whilst designing the research study rather than considering this expense only when there is a budget surplus. Grant-awarding organizations, federal agencies, and research institutions can encourage the intentional inclusion of LEP participants by favoring research proposals that include the cost of translation and interpretation services within their estimated budget. Similarly, these organizations should require that researchers provide an explanation for the exclusion of LEP participants when such costs are not indicated within their research proposal. Furthermore, the financial cost of recruiting LEP participants should be shared between individual research groups and their supporting institutions. Institutions should consider founding an office dedicated to the recruitment of LEP participants that provides internal translation services and medical interpreters that are disposable to assist in LEP participant informed consent appointments. Finally, researchers should depend on interpreters to not only convert their message into one understood by the LEP participant but to actively engage the participant’s cultural beliefs to construct an accurate and collective meaning of the research content. This inherently involves exploring the LEP participant’s attitudes and beliefs, forming connections to the research content, and clarifying questions using terms and concepts readily available to the participant. This is a very personalized form of meaning construction that cannot be done using written documents, instead requiring dynamic conversation between the participant, interpreter, and the research group. To do so, researchers should schedule longer appointments for LEP participant recruitment to allow this discussion to occur calmly. Additionally, it may be helpful for interpreters to have some understanding of the LEP participants, such as country of origin, age, and gender, before the time of the appointment to review cultural phenomena that may influence a participant’s understanding of the study. Finally, research groups should consider having an advisory board composed of LEP community representatives that can provide insight into what cultural beliefs may cause misunderstanding between participants and research groups and how to negotiate these beliefs. 

The strive toward equitable clinical research and therapeutics calls for greater visibility of LEP participants within clinical studies and better methods for attaining their informed consent. The most urgent barriers to LEP participant informed consent indicate that the restructuring of both the institutional and researcher attitudes and infrastructure is required to safeguard and promote LEP participants. It is imperative that future research cease to treat LEP participation as a haphazard incidental occurrence and rather embark on their investigations from the perspective of making LEP participation accessible and viable.