Translation of Study Documents

  1. Study-related information that is given to a subject or a subject’s legally authorized representative (LAR) must be in a language understandable to the subject or representative.
  2. Translated documents provided to subjects must be approved by the IRB prior to use.
  3. For new studies enrolling only Non-English speakers, study approval will not be granted until the translated documents are reviewed and approved.
  4. Base the translations on IRB approved English versions.
  5. Language and reading level should be culturally sensitive to the population to whom the documents are being presented.
  6. The IRB-approved and validated English documents must be translated into the language/dialect of the participant population and/or legally authorized representatives.
  7. The translated material should then be back-translated into English to confirm that the meaning has not been changed (not required if a professional translation service is used).
  8. A member of the research team may perform either the forward or back-translation; however, if a member of the research team performs the forward translation then the back-translation must be done by someone independent and vice-versa.
  9. When back-translating, it is important to only use the non-English translated version when translating the document back into English. Back-translators should not have access to the approved English version. One or both of the translators should then compare the back-translation to the approved English version and reconcile the translation if needed.
  10. Electronic translator applications (such as Google Translate) are not appropriate for generating forward or back-translations.
  11. It is recommended that the cost of forward and back-translation be included in the study budget.
  12. Please note that in addition to documents provided to subjects, letters that are not written in English, such as international ethics committee letters, are to be accompanied by an English translation when submitted to the IRB. It is acceptable for a research team member to provide the English translation, and generally a back-translation is not needed for such documents.
  13. Submit the following to the IRB for review and approval:
    1. IRB approved English version
    2. Forward translation (into foreign language)
    3. One of the following:
      1. HRP-215-FORM-Certification of Translation/Back Translation (A letter/email from the translator may be accepted in lieu of a signature on the completed HRP-215 form) and back-translated documents (from non-English language back into English to confirm the translation is accurate).

        Or
         
      2. If using a professional translation service, provide a formal letter from the translation service that certifies the translation. If applicable, provide documentation of quality assurance procedures utilized by the professional translation service.