LOYOLA UNIVERSITY CHICAGO

Institutional Review Board Policy for Documentation of Informed Consent of Participants Who Do Not Speak English

For studies 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 when foreign language versions of consent forms are provided.  The translations should be consistent to the English versions in both content and format.  Translators must sign a statement indicating that they have carried out the translation to the best of their ability.

For studies involving greater than minimal risk to participants, the Board 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.  

Regardless of the level of risk, it is recommended that English versions of consent forms be approved prior to translating, minimizing the number of iterations of translations.


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