Federal regulations require that information provided to a potential research participant be presented to the participant or their legally authorized representative “in a language understandable to the subject or the legally authorized representative” (45 CFR § 46.116(a)(3)).
If the research participants do not fluently speak, read, or understand English, all research materials (e.g., recruitment materials, informed assent and consent documents, data collection tools, and other documents used with the human subjects) must be translated from English to a language that is understandable to the participants and / or their legally authorized representative (e.g., parents or guardians in the case of participants who are minors).
IRB Review Process for Translated Research Documents
The researcher should contact their IRB Representative to discuss plans to include non-English speaking participants in their research. The Principal Investigator (PI) should clearly explain in the IRB application how the participants who are not fluent in English will be accommodated.
All research documents (e.g., recruitment materials, informed assent and consent documents, data collection tools, and other documents used with the human subjects) must be presented in English with the initial application to the IRB. The IRB will review the initial application and may require changes or edits to the application or the research documents. Once all research documents are reviewed and approved in English, the PI can have the materials translated in the language(s) appropriate for the research participants.
The PI should then submit a study Modification application with the non-English documents attached. The IRB may request that the PI provide information regarding who translated the documents and their qualifications for doing so (see below). Once the IRB approves this Modification, the PI can begin recruiting non- English speaking research participants.
Certification of Translated Research Documents
Exempt studies and most studies involving minimal risk generally do not require certification of translated documents. However, in all studies involving federally designated vulnerable populations, pregnant persons, fetuses, children and prisoners (45 CFR § 46.111(b)), as well as individuals with impaired decision-making capacity, or economically or educationally disadvantaged persons, or in studies where there may be more than minimal risk to human subjects (i.e., Full Board and some Expedited reviews), the PI will be asked to verify through certification or attestation that research documents have been translated accurately.
Translations must be a complete translation of the documents provided to the IRB in English, and may not omit or contain information that is not presented within the context of the English versions. There are various ways to validate translations. The researcher may choose to contract a professional translation company or a professional translator. A member of the research team who is fluent in both languages may be able to certify or attest to that accuracy of the translation of research materials. The IRB will indicate if a professional is required given the level of risk to human subjects in the study. Researchers can use the form, “Certification of Translation,” which is found on the USD IRB website under Forms, to verify and certify the translation of study documents.
Professional translation of research materials can be costly, and it is the responsibility of the researcher to cover these costs. Please DO NOT translate any materials into another language until the USD IRB has approved the study based on the English language materials.