Inclusion of Non-English Speaking Persons in Research

Background: The Belmont Report, drafted in US in 1979 by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, provides ethical principles and general guidelines for the protection of human subjects. One of the three basic ethical principles outlined in this report is the principle of “justice”, which discusses the equality of selection of human subjects to ensure appropriate and equal distribution of the benefits and burdens of research participation.

When selecting a target population for a research project, the investigators must provide sufficient justification for either the inclusion or the exclusion of non-English speakers in the research protocol.

  • An example of a justification for inclusion is if the patient population targeted for a clinical trial includes a certain percentage of non-English speakers who are eligible for participation.
  • An example of a justification for exclusion is a high risk, no benefit intervention study where the ability to provide informed consent is questioned due to the fact that the subject does not speak English.

Research studies should not systematically exclude non-English speakers if appropriate for study participation merely because inclusion would be inconvenient for the investigators. In contrast, research studies should not systematically target non-English speakers merely because they are a population of convenience.

University Hospitals IRB requirements

An investigator who intends to include non-English speakers must provide sufficient detail in the research protocol regarding the plan for inclusion, including the plan for obtaining informed consent and HIPAA Authorization and additional provisions made during the conduct of the study.

Informed Consent: Federal regulations pertaining to human subject protections (45 CFR 46) mandate that informed consent must be presented “in language understandable to the subject” and, in most situations, that informed consent be documented in writing (45 CFR §46.116 and §46.117). As such, if an investigator intends to enroll subjects who speak a language other than English, a translated version of the informed consent form must be submitted to the IRB for approval prior to use. A person who is fluent in both English and the patient’s language must conduct the informed consent process. If the person authorized to obtain informed consent in the research protocol is not fluent in the patient’s language, a translator or translator service may be obtained (see below for additional information regarding translators).

Short form informed consent: For subjects who may be eligible to be enrolled in a research protocol where there may not be sufficient time to obtain a fully translated version of the written consent form in the subject’s native language, a “short-form” informed consent may be approved for use by the IRB. The short form informed consent is a brief document that affirms that all the required elements of informed consent (45 CFR 46.116) were presented orally to the subject or the subject’s legally authorized representative. The short form informed consent is written in the subject’s native language.

When using the short form informed consent, the following process should be followed:

  • Submit an amendment to the UH IRB requesting approval of a short form informed consent written in the subject’s native language. The UH IRB has a several versions of a short form informed consent available for download on the UH IRB website.
  • A person fluent in English and the subject’s native language must present the information in the IRB approved version of the long form English consent form.
    • If the person obtaining informed consent is not fluent in the subject’s native language, a translator or translator service must be obtained to assist with the translation. Family members, friends etc. may not act as an official translator for the purposes of enrollment.
    • If the person obtaining informed consent is fluent in the subject’s native language, an additional witness (also fluent in English and the subject’s native language) must be present during the consent process. Family members, friends, etc. may act as a witness to the oral presentation.
  • The IRB approved short form informed consent is signed by the subject.
  • The IRB approved version of the long form English consent form (the summary that is used to orally present the study to the subject) must be signed by the person obtaining informed consent (as per the IRB approved protocol).
    • If the person obtaining informed consent is also the “translator”, then both the short form document and the long form English consent form should be signed by a “witness” to the consent process.
    • If an official translator is used, the person authorized to obtain consent may sign the English consent form and the translator may sign both the short form and the English consent form.

Study visits/other study documentation: Other study related documents that will be filled out by the participant (e.g., log sheets, data collection forms, self-assessment tools) must also be translated into the subject’s native language. If the study involves more than one study visit, a plan must be developed to ensure that an appropriate party is available to conduct all study visits in the subject’s native language. IMPORTANT NOTE: If the participant will spend the night in the Hospital, there should be an appropriate round-the-clock plan for the duration of the planned hospitalization. This may be a combination of in-person interpretation and the telephone language line service. The plan should take into account the risk level of the research protocol, and also the ability to plan in advance. For example, a participant in a Phase I clinical trial will need to have a very strong plan to report side effects that may not be anticipated, but the visits can probably be planned well in advance.

HIPAA Authorization: Similar to the informed consent document, the subject must also be presented with a HIPAA Authorization form in a language understandable to the subject. The translated form must be approved for use by the Research Privacy Board (RPB). [discuss use of this with short form consent]

Translation and Interpretation services: Obtaining translation and interpretation services are the investigator’s responsibility. Any cost incurred from obtaining such services are the investigator’s responsibility. Investigators may obtain assistance from any of the following:

  • Publicly available certified translation services
  • UH’s Language Line (phone translation services available for clinical practice): UH extension 4-INTE or 800-874-9426. Include the six-digit client classification identification number (212223), organization’s name (UH) and your department’s phone number [see UH Policy 3.19 for additional information regarding use]
  • Study investigators fluent in both English and the subject’s native language; or
  • Other UH clinicians/researchers who speak the subject’s native language (call the UH Clinical Research Center for additional assistance if necessary).

Study related documents that will be read or used by the participant (informed consent form, HIPAA Authorization, assessment tools, etc) must be translated from English into the subject’s native language. The translated version of the documents must receive IRB approval prior to use.

  • If a professional translation service is used to obtain the translation, the investigator must submit the translated documents along with a certificate of translation from the agency. The IRB will accept professionally translated documents without the need for additional back translation as long as a certificate of translation is provided.
  • If the document is translated by someone who is not a certified professional translator, the investigator must provide information regarding the translator and his/her credentials. Upon receipt, the IRB will obtain a consultant to affirm the accuracy of the translation. Once the accuracy of the translation is affirmed, the IRB may proceed with the approval process.

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