4. INVESTIGATOR 研究者
4.8 Informed Consent of Trial Subjects
试验对象的知情同意
4.8.15 In emergency situations, when prior consent of the subject is not possible, the consent of the subject's legally acceptable representative, if present, should be requested. When prior consent of the subject is not possible, and the subject’s legally acceptable representative is not available, enrolment of the subject should require measures described in the protocol and/or else where,with documented approval/favourable opinion by the IRB/IEC, to protect the rights, safety and well-being of the subject and to ensure compliance with applicable regulatory requirements. The subject or the subject's legally acceptable representative should be informed about the trial as soon as possible and consent to continue and other consent as appropriate (see 4.8.10)should be requested.
在紧急情况下，不可能事先得到受试对象的知情同意时，应该请求受试对象的合法可接受代表(如果在场)的同意。当受试对象的接纳需要按方案和/或其他文件中描述的、得到IRB/IEC的书面批准/赞成意见的方法进行，以保护受试对象的权利、安全和健康，并保证依从适用的管理要求。应尽可能地通知受试对象或受试对象地合法可接受代表关于试验的事，并应得到他们继续参加试验和其他事项(见4.8.10)的知情同意。
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往期目录
临床试验听听看 ▎ICH GCP 2-3部分目录
临床试验听听看 ▎ICH-GCP 4.1
临床试验听听看 ▎ICH-GCP 4.2
临床试验听听看 ▎ICH-GCP 4.3
临床试验听听看 ▎ICH-GCP 4.4
临床试验听听看 ▎ICH-GCP 4.5
临床试验听听看 ▎ICH-GCP 4.61-4.63
临床试验听听看 ▎ICH-GCP 4.64-4.66
临床试验听听看 ▎ICH-GCP 4.7
临床试验听听看 ▎ICH-GCP 4.81
临床试验听听看 ▎ICH-GCP 4.8.2-4.84
临床试验听听看 ▎ICH-GCP 4.8.5-4.8.7
临床试验听听看 ▎ICH-GCP 4.8.8-4.8.9
临床试验听听看 ▎ICH GCP 4.8.10
临床试验听听看 ▎ICH GCP 4.8.10（continued）
临床试验听听看 ▎ICH GCP 4.8.11-4.8.13
临床试验听听看 ▎ICH GCP 4.8.14
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