临床试验听听看 ▎ICH GCP 4.8.11-4.8.13

药物临床试验网 · 公众号 · 药品 · 2017-07-14 15:50

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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
4.8.11 Prior to participation in the trial, the subject or the subject's legally acceptable representative should receive a copy of the signed and dated written informed consent form and any other written information provided to the subjects. During a subject's participation in the trial, the subject or the subject’s legally acceptable representative should receive a copy of the signed and dated consent form updates and a copy of any amendments to the written information provided to subjects.
在参加试验前，受试对象或受试对象的合法可接受代表应收到一份已签署并注明日期的书面知情同意书的复印件和其他提供给受试对象的书面资料。受试对象参加试验期间，受试对象或受试对象的合法可接受代表应收到已签署并注明日期的知情同意书的更新的复印件和提供给受试对象的书面资料的修改文本。
4.8.12 When a clinical trial (therapeutic or non-therapeutic) includes subjects who can only be enrolled in the trial with the consent of the subject’s legally acceptable representative (e.g., minors, or patients with severe dementia), the subject should be informed about the trial to the extent compatible with the subject’s understanding and, if capable, the subject should sign and personally date the written informed consent.
当一个临床试验(治疗的或非治疗的)包括那些只能由其合法可接受代表表示进入试验的受试对象时(如未成年人，或严重痴呆病人)，应当在受试对象能理解的程度告知受试对象关于试验的信息。如果可能，受试对象应当亲自签署书面的知情同意并注明日期。
4.8.13 Except as described in 4.8.14, a non-therapeutic trial (i.e. a trial in which there is no anticipated direct clinical benefit to the subject), should be conducted in subjects who personally give consent and who sign and date the written informed consent form.
除非如4.8.14所描述的情况外，一个非治疗试验(如对于受试对象没有可预期的直接临床好处的试验)应当在那些亲自同意并在书面的知情同意书上签字和注明日期的受试对象中进行。