Ensuring Language Access and Linguistic Competence: A Guide for Researchers

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  • Overview and Purpose

    Persons with limited English proficiency (LEP), those who have low literacy skills or are not literate, persons with disabilities, and those who are deaf or hard of hearing, are less likely to be included in clinical studies. This guide is designed to provide researchers and study teams with practical information on enhancing the capacity for meaningful inclusion of members from these populations and communities in their studies. The guide provides rationales, demographic data, legal requirements and guidance, guiding values, action steps and strategies, and key definitions for linguistic competence. The guide is intended to minimize barriers to participation in research caused by language, culture, and associated attitudinal barriers within the research community about people who speak languages other than English and those who have other communication needs. This guide was developed by Tawara Goode, a member of the GHUCCTS Community Engagement Team and Director of the Georgetown University National Center for Cultural Competence.

  • Why Ensuring Language Access and Linguistic Competence are Essential in the Conduct of Clinical Research
      1. It’s the law.
      2. Respond to current and emergent demographic trends in the DMV metropolitan area
      3. Promote equity in research participation
      4. Enhance capacity to address health literacy
      5. Enhance capacity to include individuals with disabilities
      6. Address implicit biases
      7. Add to the body of knowledge on clinical research for LEP populations and those with other communication needs.
    1. Guiding Values for Language Access and Linguistic Competence
      Research institutions and researchers should identify and reach consensus on guiding values for conducting research for LEP populations and those with other communication needs. The Georgetown University National Center for Cultural Competence offers the following values that are adapted for clinical research for discussion, consideration, and modification.

      • Research is conducted in the preferred language of the study participants.
      • Written materials are translated, adapted, and/or provided in alternative formats based on the needs and preferences of the study participants.
      • Interpretation and translation services comply with all relevant federal, state, and local mandates governing language access and assistance services.
      • People with disabilities are provided accommodations to participate in studies.
      • Translated documents are tested prior to using with participants with LEP.
      • Researchers use processes to assure the quality of language access services.
    2. Probing Questions to Confront Conscious or Explicit Bias in Research

      Researchers and research team members, such as study coordinators, are not immune to explicit or implicit biases simply by their membership in the helping professions. Bias is often associated with negative thoughts or behaviors; however, bias is simply a preference for one thing, person, or group over another. Bias is a cognitive tendency among humans to make systematic decisions in certain circumstances based on cognitive factors rather than evidence. We as human beings all have biases. Bias is only a concern when it becomes a prejudice against certain people or groups in ways that are unfair and lead to marginalization or discrimination41.

      There is a robust body of literature on biases in medicine and health care and its detrimental effects on diverse patient populations42-49. This literature also describes myriad biases including studies of individuals with LEP. It illustrates that these biases are present not only among researchers and other research team members, also with Institutional Review Boards (IRBs)49. The following questions were adopted for this resource guide from a course, Conscious and Unconscious Biases in Health Care (Georgetown University National Center for Cultural Competence)50. They are provided to spur self-reflection and probe the extent to which explicit and implicit biases affect the conduct of research.

      Explicit Bias

      As you contemplate each question, consider how factors such as race, ethnicity, culture, English language proficiency, disability, and literacy affect your research.

      • Do my biases:
        • Impact questions and the populations I select for research (e.g., additional level of effort to include some populations, how much accommodations cost to include people with disabilities, the complexities of including populations in study design, implementation, and data analysis)?
        • Influence how I communicate with potential or actual research participants?
        • Interfere with my capacity to interact positively with culturally and linguistically diverse research participants?
        • Hamper my capacity to feel and express empathy toward research participants and the communities in which they live?
      • Do you ever perceive that you are less comfortable with research participants who are of a different race, ethnicity, or culture than you?
      • Do you believe that recruitment of people with limited English proficiency and/or those with disabilities would be too difficult, burdensome, or costly?
      • Do you know whether (or believe that) your colleagues and other staff with whom you routinely interact think that your attitudes and behaviors negatively affect your studies? If so, are you open to discussing these issues and the implications for your research with them?
      • Have you elicited the views of community partners about perceived biases?
      • Have research participants or their families, directly or through satisfaction surveys, raised concern about your attitude or the way you communicate with them?
      Answering yes to any of these questions indicates that you could benefit from interventions to mitigate the impact of explicit bias.
    3. Six Interventions to Tackle Unconscious or Implicit Bias

      The following six interventions represent the evolving body of knowledge of ways to address implicit bias. These interventions, initially designed for health care practitioners, are adapted for health researchers50.

      1. Acknowledge and accept the existence of implicit bias, its manifestations, and its impact on the conduct of research.
      2. Assume individual responsibility to address implicit bias in your work.
      3. Engage in self-reflection and self-assessment on an ongoing basis.
      4. Make good use of neuroscientific methods to combat “hard wiring” in our brains that labels those who are not like us as “the other.”
      5. Collect and use data effectively and perform self-monitoring.
      6. Incorporate cultural and linguistic competence in your research and practice.
    4. Ensuring Language Access and Linguistic Competence: Action Steps and Strategies for Researchers

      “The policy of NIH is to provide individuals
      with limited English proficiency meaningful
      access to NIH conducted programs and
      activities, in accordance with the agency’s
      needs, capacity assessment, and this Plan.” 53

      Know the Law and the Policies

      • Be familiar with the policies and practices of your institution’s Language Access Implementation Plan. This plan is a requirement for all institutions receiving federal financial assistance. It describes policy, procedures, and processes to ensure effective communication with persons and communities that are non-English speaking and those with LEP.
      • Be familiar with and adhere to the policies of NIH and other HHS funding sources specifically related to the participation of persons with LEP in clinical research51-52.
      • Be familiar with, and adhere to, federal and state policies governing accessibility of public health related research to people with disabilities and those who are deaf or hard of hearing54.

      Know Your Population

      • Determine the number of individuals or segment of the population requiring assistance or accommodations
        to participate in a study that:
        • Speaks languages other than English
        • Are neither literate in English nor their language of origin
        • Have low health literacy
        • Have disabilities that require communication assistance55-56
        • Are deaf or hard of hearing

      Plan for Language Access & Health Literacy

      • Determine, plan for, and incorporate the provision of interpretation services for all phases of research to ensure the participation of LEP populations.
      • Attend to cultural differences regarding the use of language among populations that speak the same language.
      • Determine translation services that will be needed during all phases of research.
      • Test the accuracy and readability of translated documents with a sample of the LEP population that will be included in the study.
      • Determine and respond to the health literacy needs of potential and enrolled participants, including written and oral communication.
      • Determine and incorporate culturally appropriate images and culturally relevant examples in print documents, web-based, and other media when communicating about the study.

      Plan your budget accordingly

      • Ensure budgets include the cost of language access and linguistic competence services necessary to conduct
        the study. This may include but is not limited to:
        • Salaries for bilingual or multilingual staff who have been vetted, received specialized training, or certified by an accredited organization to provide interpreter or translation services.
        • Sub-contracts with certified professional interpreters; designated budget line items for professional translators;
        • Resources for ethnic media and community organizations that serve linguistically diverse populations;
        • Focus groups with LEP populations to test translated documents;
        • Resources to include people with disabilities who may require accommodations to ensure effective communication;
        • Resources for ASL for people who are deaf or hard of hearing.

      Plan for dissemination

      • Plan and implement dissemination strategies in partnership with the study population to ensure that research
        findings are:
        • Accessible in languages other than English.
        • Written at the appropriate literacy level.
        • Offered in venues and formats that the populations are likely to access (e.g. ethnic print, television, radio media; faith-based publications and conferences; health fairs; civic organizations; town hall meetings; social media platforms).
        • Accessible to people with disabilities.
        • Specified in the budget and budget narrative including the provision of interpretation, translation, and other communication methods to ensure dissemination to diverse audiences, stakeholders, and constituents.
    5. Key Definitions or Glossary of Terms

      American Sign Language (ASL) Interpretation

      ASL is the most prominent type of interpreting used in the United States. Interpretation occurs between two distinct languages—ASL and English.


      The process of understanding and analyzing a spoken or signed message and re-expressing that message
      faithfully, accurately, and objectively in another language, taking the cultural and social context into account.


      The oral restating in one language of what has been said in another language; should accurately convey
      the tone and meaning of the information given in the original language.

      The process of understanding and analyzing a spoken or signed message and re-expressing that message faithfully, accurately, and objectively in another language, taking the cultural and social context into account. Interpretation and translation are often incorrectly used interchangeably. The term translation is used for the process of converting written messages from one language to another.


      A person who renders a message spoken or signed in one language into a second language. Interpreters strive to render the message accurately, conveying the content and spirit of the original message, taking into consideration the cultural context. Professional interpreters bide by a code of ethics. The terms interpreter and translator are often mistakenly used interchangeably.

      Language Assistance Services

      Language assistance services are mechanisms used to facilitate communication with individuals who do not speak English, those who have limited English proficiency, and those who are deaf or hard of hearing. These services can include in-person interpreters, bilingual staff, or remote interpreting systems such as telephone or video interpreting. Language services also refer to processes in place to provide translation of written materials or signage, sign language, or Braille materials.

      Limited English Proficiency

      As defined by federal legislation, and delineated in policy guidance, limited English proficiency (LEP) refers to individuals who do not speak English as their primary language and who have a limited ability to read, speak, write, or understand English.

      Linguistic Competence

      There are several definitions of linguistic competence in the health literature. This guide features the conceptual framework and definition of linguistic competence developed by the Georgetown University National Center for Cultural Competence. Linguistic competence is the capacity of an organization and its personnel to communicate effectively, and convey information in a manner that is easily understood by diverse groups including persons of limited English proficiency, those who have low literacy skills or are not literate, individuals with disabilities, and those who are deaf or hard of hearing. Linguistic competence requires organizational and provider capacity to respond effectively to the health and mental health literacy needs of populations served. The organization must have policy, structures, practices, procedures, and dedicated resources to support this capacity.

      • Goode, T.D. & Like, R.C. (2012). Advancing and sustaining cultural and linguistic competence in the American health
        system: Challenges, strategies, and lessons learned. In D. Ingle, A. Chiarenza, I. Kotsioni, and W. Devillé (Eds.), Inequalities in Health Care for Migrants and Ethnic Minorities. COST Series on Health and Diversity Volume II, Antwerp: Garant.
      • Goode, T., Wells, N., & Kyu, Rhee (2009). Family-Centered, Culturally and Linguistically Competent Care: Essential Components of the Medical Home. In Turchi, R. & Antonelli, R. (Eds.) Pediatric Annals Special Supplement on the Medical Home. Thoroughfare, NJ: Slack Incorporated.

      Plain Language

      Plain language, also called plain writing or plain English, is communication your audience can understand the first time they read or hear it. Written materials are in plain language if the intended audience can: 1) find what they need, 2) understand what they find, and 3) use what they find to meet their needs. Plain language is characterized by writing that is clear, concise, well-organized, and follows other best practices appropriate to the subject or field and intended audience.

      Sign Language Interpreter

      An interpreter is a specially trained professional whose job is to convey the messages of people who do not share the same language, culture, or mode of communication. The purpose of providing an interpreter is to allow hearing, deaf, and hard of hearing people equal access to information and interactions.

      The written conversion of written materials from one language to another; a process in which text is transferred from the source language to another language.


      A translator is a professional that converts written materials from one language into another language, while maintaining the meaning and cultural nuances of the original written document.

    6. References

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    7. Access the Guide & Watch our Webinar

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