Ensuring Ethical Informed Consent for Research Participants with Limited English Proficiency

October 2025 Issue

Author(s):

  • Matt Ogrodnik, MS, CIP, OHRA Director

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Introduction

When your study involves conducting an informed consent process with participants, ensuring that these potential participants are given the opportunity to clearly understand the study’s purpose, procedures, risks, benefits, alternatives, and participant rights is a fundamental component of ethical research. This is true regardless of whether the researchers and the potential participant speak the same language. This month’s Feature Article discusses the inclusion of individuals with limited English proficiency (LEP), and how to ensure that these individuals are given the opportunity to make a fully informed and autonomous decision about whether participating in a research study is right for them.

*Please note: this Feature Article accompanies the release of the Spanish consent form templates:

Researchers are encouraged to use these templates to facilitate the enrollment of Spanish-speaking participants.

 

Planning Ahead for Enrollment of Individuals with Limited English Proficiency

When you expect to enroll people who do not speak English fluently (referred to in the HRPP Policies and Procedures as “Subjects with Limited English Proficiency (LEP)”, you must carefully plan how to communicate with them, both during the informed consent process, as well as throughout the life of the study. This plan needs to be part of your initial study submission to the BMC/BUMC IRB.

The plan includes:

  • Translating the full consent form into the anticipated non-English languages; and
  • When appropriate, requesting to use the short form consent process for unanticipated languages; and
  • Describing how you will conduct consent conversations in these languages, including how emergencies will be handled (note: if the study involves more than minimal risk, provisions must be established to respond to concerns or questions of ALL subjects 24/7); and
  • Arranging for interpreters during study visits if necessary; and
  • Making sure all other participant-facing study materials are also translated.

Adhering to all aspects of this plan ensures that participants can understand the study in their own language, allowing them to make truly informed decisions. The submission information in your IRB application will need to include all of these details, as described in Section 7.2.2.12.6  Subjects with Limited English Proficiency Information.

 

Limited English Proficiency and Fully Translated Consent Forms

Whenever possible, potential participants should receive a written consent form translated into their language. If you will be enrolling participants who speak an anticipated language (for example, Spanish and Haitian Creole are nearly always considered anticipated at BMC), then fully translating the consent form is an IRB requirement, as outlined in Section 8.4.5      Informed Consent for Subjects with Limited English Proficiency.

To do this, after you obtain IRB approval for English versions of initial and revised versions of the consent forms and other study materials, you must have the document(s) translated by a qualified translator. The translation could be done by a commercial vendor, or by someone who is both fluent in the language and has the requisite expertise. If you use a qualified translator who is not a commercial vendor, then you must submit a Translator Qualification form which is found on the IRB website. To determine whether the translator has adequate qualifications, the IRB review will take into consideration what medical background, if any, would be appropriate based on the risks and complexities of study interventions; and based on whether any of the study procedures require additional consent when performed for clinical care.

There is one exception to the policy requiring IRB review of fully translated consent forms and other study materials. If your study is conducted internationally, and you confirm that the local ethics committee(s) will review and approve accurate translations of the materials, then the translated documents do not need to be submitted to the BMC/BUMC IRB.

 

Using a Short Form for Unexpected Situations

Researchers can be unprepared when LEP individuals who speak an unanticipated language(s) wish to join the study, for which there is not an approved translated consent form.  In these unexpected cases, the IRB may allow you to use the “short form” consent process. The short form consent process involves providing the participant with a simpler, shorter written document in their language, combined with an oral explanation of the study in their language. This “short form” contains a listing of the elements of informed consent, and asks the LEP participant to attest that all elements of the consent form have been adequately explained to them. The short form is not study-specific; the same template language is used for the short form in all available languages. Rather, the study-specific document is the written English narrative that is translated to the potential participant. This English narrative is almost always the entire IRB-approved English consent form.

The short form process also requires that an impartial witness be present during the consent conversation. The witness must be fluent in both languages. This is described in more detail in the next section.

Following IRB approval of the short form process, the IRB staff will upload copies of the approved short form(s) in the appropriate language(s) into the study submission in the INSPIR electronic system, accompanied by a supplementary signature page for the witness and consent administrator. This documentation is printed, signed, and appended to the English narrative distributed to the participant. A copy of all consent-related documents (whether translated consent forms, or short forms and narratives) must be provided to the participant for their records.

 

The Importance of Interpreters and Witnesses

As discussed, it is imperative that the informed consent process be conducted in a language that potential participants can understand. This requirement extends equally to parents or legal guardians providing permission, and to legally authorized representatives providing consent. This comprehension is facilitated by the involvement of interpreters, and formally documented by the use of impartial witnesses present throughout the consent process.

When employing the short form consent process, a witness must be present throughout the entire consent discussion to ensure that the information is communicated accurately. If the individual conducting the consent discussion also provides the verbal translation in the language of the LEP individual, then an independent witness fluent in both languages (and not otherwise affiliated with the study) is required. Alternatively, if an interpreter who is not affiliated with the study is used, then that interpreter may also fulfill the role of impartial witness.

The IRB reviews the qualifications of interpreters, including deliberations on whether adult family members can serve in this role. The decision considers factors such as medical or dental knowledge pertinent to the study’s risk level and complexity, and whether study procedures overlap with clinical care activities that require additional consent. Importantly, minors are prohibited from serving as interpreters under any circumstances.

At Boston Medical Center, hospital policy prohibits the use of untrained individuals as interpreters during medical encounters. Professional interpreters provided by Boston Medical Center and the Henry M. Goldman School of Dental Medicine (including those accessible via a contracted telephone interpreter service) are deemed sufficiently trained and qualified for studies involving medical or dental procedures.

 

Written Consent for Subjects with Limited English Proficiency

Except in instances where documentation of consent is formally waived, the fully translated consent form must be signed by both the participant and the individual conducting the consent process.

When using the short form process, the participant and the witness sign the short form written in the non-English language; while the witness and consent administrator sign the English narrative describing the study. In cases where the telephone interpreter service is utilized, the interpreter may instruct the consent administrator to record interpreter identification in lieu of a signature.

Copies of all signed documents, whether full translations or short forms, must be offered to the participant for their records.

 

Summary

Ensuring the ethical inclusion of LEP participants in research necessitates the implementation of robust processes and procedures aimed at safeguarding their comprehension and voluntariness during the consent process. Given the complexities inherent in cross-language communication, the policies described in this Feature Article must be followed when including LEP participants in your study. You must develop a consent process that adequately addresses linguistic barriers and preserves the integrity of the informed consent process. This includes providing consent materials in accessible formats, utilizing qualified interpreters or translators, and establishing mechanisms for ongoing communication during the life of the study. Adhering to these plans will support more inclusive participant recruitment, thus helping to ensure BMC/BUMC research better represents the communities we serve, and by enhancing the generalizability of study findings.