250. Research Involving Persons Who Do Not Speak English

Updated July 2, 2021

It is important to involve participants in research who are not fluent in spoken or written English:

• to ensure the burdens and benefits of research are justly distributed, and
• to address research topics that are specific to such populations (e.g., international research, research targeting immigrant populations).

Regardless of the reasons for involving individuals with minimal or no English-language skills in research, University and affiliate researchers must design recruitment and consent processes to ensure prospective participants comprehend what is being asked of them and voluntarily agree to participate. The researcher must communicate to the IRB on the IRB Application if the study involves human participants who are not fluent in English. In these studies, the researcher must explain how the participants who are not fluent in English will be accommodated. Researchers should also be aware that there are cultural concerns and appropriateness for language that may need to be addressed. For example, certain words or phrases may not translate well (or at all) in each language. Having cultural competency with the population or working with a certified translator who has cultural competency with the population, can be very useful - but this may be costly and time consuming for some research projects. Researchers may need to develop a strategy to address these cultural concerns and appropriateness for language if words and/or phrases do not translate well for the study population.

Federal regulations require consent documents to be in language understandable to the participant.

• For research posing greater than minimal risk, researchers must obtain legally effective signed consent from each participant in accordance with DHHS requirements for informed consent (at 45 CFR 46.116) and for documentation of informed consent (at §46.117), which includes use of a short form written consent document (see the IRB Policy Manual for information about short form consent process).
• For minimal risk research, researchers may use simplified information scripts/sheets and oral consent in lieu of a consent form, including a short form consent document. NOTE: For minimal risk research that is conducted or supported by federal funds, or that involves prisoners or incomplete disclosure/deception, the IRB must approve an alteration of informed consent (at §46.116(2)) and a waiver of the requirement to obtain a signed consent form (at §46.117(c)(1) or (2)).

Using Interpreters

Ideally, the research team will include individuals fluent in the language spoken by prospective participants.

If researchers and participants are not fluent in the same language, interpreters are needed for recruitment and consent, and for interviews, focus groups, or other verbal interactions with participants. Interpreters must:

• have sufficient knowledge about the research to correctly respond to questions from prospective participants;
• must demonstrate a basic understanding of the importance of voluntary participation; and
• agree to limit their comments to the information provided in the IRB-approved consent materials.

Considerations for Selecting Interpreters

Investigators must consider the relationship of the interpreter to the interviewee and to the community:

• Family members may have conflicting interests related to the research study or may not be able to fully explain the study's risks and benefits to a prospective participant.
• Family members or others with relationships with individuals in the community may limit the privacy and confidentiality that can be promised to participants, and may prevent some participants from speaking freely, which could affect data integrity.
• To enhance participant privacy, the IRB recommends that whenever possible investigators engage interpreters who are unfamiliar to individual participants and who may be from outside the immediate community.

Interpreters must be willing to respect the privacy of individual participants and maintain the confidentiality of the information provided by the participant.

• PIs using interpreters must provide training related to privacy rights and protections, including when these are specific to a community, and processes for ensuring data confidentiality.
• PIs may consider requiring interpreters to sign a confidentiality agreement.

In some research, the sensitivity of research data may preclude use of a local interpreter. For example, collection of data of interest to factions in violent conflicts may make it difficult to ensure the confidentiality of information provided through an interpreter.

Translating Study Documents

When research involves individuals, who do not speak English, recruitment, consent, and assessment and intervention scripts/materials must be translated and conveyed in the languages used by prospective and enrolled participants.

To ensure the accuracy of translations, the University IRB requires investigators to use the services of a certified translator or to submit "back-translations" of all translated documents.

• When using certified translators, PIs must submit documentation of certification of the translations or the translators' credentials.
• A back-translation is the document that results when a person other than the original translator translates a document from the translated (i.e., foreign) language back to English.

Considerations for Translated Materials

• The translator must have an adequate understanding of the purpose of the document and the technical points addressed in the document.
• Translations should consider regional dialects.
• Due to dialectal differences, "textbook" translations may not be easily understood by participants.
• On-line translation programs are not always accurate.
• On-line translation programs may not be appropriate for research-related documents due to the use of technical terms and the need to accurately communicate complex ideas.
• The investigator is responsible for the cost of translating study materials.

Recommendations for Submitting Translated Materials for Review

The IRB understands that it may be preferable to delay having study documents translated until after the English versions are approved. This way, IRB-requested changes to the English versions would be incorporated into the documents before these are forwarded for translation, thus allowing researchers to avoid the costs and inconveniences of having study materials translated multiple times.

The PI would request an amendment to submit the translated versions for review and approval.