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FDA的知情同意書信息表指出，“當(dāng)研究的受試者人群包括非英語人群，或臨床研究者或IRB預(yù)計知情同意談話將以英語以外的語言進(jìn)行時，IRB應(yīng)要求準(zhǔn)備一份知情同意的翻譯件，并確保翻譯準(zhǔn)確?！癋DA是否有任何標(biāo)準(zhǔn)要求IRB適用于知情同意書的翻譯以及該翻譯的準(zhǔn)確性保證（例如，使用“經(jīng)過認(rèn)證翻譯人員”和/或官方翻譯證書）

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)?

回答：在最近對這個問題的非正式答復(fù)中，F(xiàn)DA的GCP計劃中指出，“IRB如何確?！g文準(zhǔn)確’，完全取決于IRB。換言之，IRB可以自由確定自己對譯文的要求和翻譯文件的可接受性，例如要求‘經(jīng)過認(rèn)證翻譯人員’或官方證書。然而，具體的做法完全取決于他們，因為我們沒有任何關(guān)于該事項的具體的規(guī)定。”

In a recent informal response to this question, the FDA’s Good Clinical Practice Program noted, “how the IRB assures ‘that the translation is accurate’ is really up to the IRB. In other words, the IRB is free to establish its own requirements for translations and the acceptability of translated documents, for example by requiring ‘certified translators,’ or an official certificate. However, the particulars of doing so are really up to them, since we do not have any specific regulations about this.”