Skip to main content
Translating Materials for Non-English Speakers
Summary
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.
Full Description
What is Required in Your IRB Submission
Exempt, Non-Federally Funded Projects: Researchers may include translated materials, but they are not required to attach them. Only the English versions must be attached to the protocol application.
Non-Exempt Projects (regardless of funding source): Researchers must include translated materials along with a certificate of translation. The English and translated versions must be attached to the protocol application either during initial review or as a modification after the English versions have been approved.
All Federally Funded Projects (exempt and non-exempt): Researchers must include translated materials along with a certificate of translation. The English and translated versions must be attached to the protocol application either during initial review or as a modification after the English versions have been approved.
IRB Review Process for Translated Research Documents
All research materials must be presented in English when submitted 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 into the language(s) appropriate for the research participants.
It is recommended that the PI wait for approval of the English materials prior to translating the documents. If the project is non-exempt or federally funded, the PI should submit a Modification via SPARCS and attach any non-English documents. The IRB may request that the PI provide information about who translated the documents and their qualifications. Once the IRB approves this Modification, the PI can begin recruiting non-English speaking research participants.
Certification of Translation
A "Certificate of Translation" may be required when documents require translation during the review and/or approval of a project involving human participants or human subjects determinations. Non-exempt and/or federally funded projects must have the certificate attached.
Translations must be complete translations of the documents provided to the IRB in English and may not omit or include information not presented in the English versions. The IRB will indicate whether a professional is required, based on 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.
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 with 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 researchers either use certified translators (with a letter of certification from the translator or translation service) or provide a back-translation by a different translator than the one who performed the original translation. The back translation (back into English) helps ensure that the non-English version contains all the key elements of the English version. The translated documents (forward and backward), along with documentation of each translator's qualifications, must be submitted to the IRB for final approval.