临床试验听听看 ▎ICH-GCP 4.8.8-4.8.9

药物临床试验网 · 公众号 · 药品 · 2017-07-05 17:45

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4. INVESTIGATOR 研究者
4.8 Informed Consent of Trial Subjects
试验对象的知情同意
4.8.8 Prior to a subject’s participation in the trial, the written informed consent form should be signed and personally dated by the subject or by the subject's legally acceptable representative, and by the person who conducted the informed consent discussion.
在受试对象参加试验之前，受试对象或受试对象的合法可接受代表以及执行知情同意讨论的人应亲自签署知情同意书并注明日期。
4.8.9 If a subject is unable to read or if a legally acceptable representative is unable to read, an impartial witness should be present during the entire informed consent discussion. After the written informed consent form and any other written information to be provided to subjects, is read and explained to the subject or the subject’s legally acceptable representative, and after the subject or the subject’s legally acceptable representative has orally consented to the subject’s participation in the trial and, if capable of doing so, has signed and personally dated the informed consent form, the witness should sign and personally date the consent form. By signing the consent form, the witness attests that the information in the consent form and any other written information was accurately explained to, and apparently understood by, the subject or the subject's legally acceptable representative, and that informed consent was freely given by the subject or the subject’s legally acceptable representative.
如果一名受试对象不能阅读，或一位合法可接受的代表不能阅读，在整个知情同意讨论期间必需有一位公正的见证人在书面的知情同意书和其他文件资料交给受试对象后，向受试对象或受试对象的合法可接受代表进行阅读并解释，在受试对象或受试对象的合法可接受代表已经口头同意受试对象参加试验、并且如果可能的话在知情同意书上签字并注明日期。见证人通过签署知情同意书证明，知情同意书和其他文字资料已被准确的向受试对象或受试对象的合法可接受代表作了解释，受试对象或受试对象的合法可接受代表显然懂得这些解释，知情同意是受试对象或受试对象的合法可接受代表自由给出的。