Translating Materials for Non-English Speakers

Federal regulations mandate that information given to potential research participants or their representatives be in a language that they can understand. Translation of research documents, thus, is necessary to comply with such regulations in order to effectively engage non-English speaker populations in research and address some of the barriers to participation.

IRB Review Process for Translated Research Documents

All research materials 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 Modification 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. 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, individuals with impaired decision-making capacity, economically/educationally disadvantaged persons, or where there may be more than minimal risk to human subjects, the PI will be asked to verify through certification or attestation that the 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. The IRB will indicate if a professional is required given the level of risk to human subjects in the study. Researchers can use the Certification of Translation Form to verify and certify the translation of study documents.

Certificate of Translation

Translations for Minimal Risk Research

For projects involving minimal risk to participants (no foreseeable risks involved in participating in this research beyond those experienced in everyday life), the qualifications of the translator should be provided (e.g. native speaker, academic degrees, certified translator, etc.) to the IRB, using the Translation Certification form, when foreign language versions of project documents are provided. The translations should be consistent to the English versions in both content and format. Translators must sign the Translation Certification form indicating that they have carried out the translation to the best of their ability.

Translations for More than Minimal Risk Research

For projects involving greater than minimal risk to participants, the IRB requires that the researchers either use certified translators (with a letter of certification from the translator or translation service) or that a back-translation by a different translator than the one who performed the original translation be provided. The back translation (back into English) serves to ensure that the non-English version contains all of the key elements of the English version. The translated documents (forward and back), as well as documentation of the qualifications of each translator, must be submitted to the IRB for final approval.