FDA的知情同意书信息表指出，“当研究的受试者人群包括非英语人群，或临床研究者或IRB预计知情同意谈话将以英语以外的语言进行时，IRB应要求准备一份知情同意的翻译件，并确保翻译准确。“FDA是否有任何标准要求IRB适用于知情同意书的翻译以及该翻译的准确性保证（例如，使用“经过认证翻译人员”和/或官方翻译证书）

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：在最近对这个问题的非正式答复中，FDA的GCP计划中指出，“IRB如何确保‘译文准确’，完全取决于IRB。换言之，IRB可以自由确定自己对译文的要求和翻译文件的可接受性，例如要求‘经过认证翻译人员’或官方证书。然而，具体的做法完全取决于他们，因为我们没有任何关于该事项的具体的规定。”

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.”