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Taken from the NEW Good Clinical Practice: A Question & Answer Guide 2015.

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Question: The FDA’s Information Sheet on informed consent notes that, “when the study subject population includes non-English speaking people or the clinical investigator or the IRB anticipates that the consent interviews will be conducted in a language other than English, the IRB should require a translated consent document to be prepared and assure that the translation is accurate.” Does the FDA have any standards that IRBs should apply to the translation of informed consent documents and the assurance of the accuracy of this translation (e.g., the use of a “certified translator” and/or an official certificate of translation)?

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