临床试验听听看 ▎ICH GCP 4.8.10

药物临床试验网 · 公众号 · 药品 · 2017-07-07 17:08

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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
4.8.10 Both the informed consent discussion and the written informed consent form and any other written information to be provided to subjects should include explanations of the following:
知情同意讨论和提供给受试对象的书面的知情同意书以及其他文字资料应当包括以下问题的解释：
a) That the trial involves research.
试验涉及的研究
b) The purpose of the trial.
试验目的
c) The trial treatment(s) and the probability for random assignment to each treatment.
试验治疗和随机分配到各种治疗的可能性
d) The trial procedures to be followed, including all invasive procedures.
试验运行的程序，包括所有侵袭性程序
e) The subject's responsibilities.
受试对象的责任
f) Those aspects of the trial that are experimental.
试验的实验方面性
g) The reasonably foreseeable risks or inconveniences to the subject and, when applicable, to an embryo, fetus, or nursing infant.
带给受试对象、可能时带给胚胎、胎儿或哺乳婴儿的合理预见的危险或不方便。
h) The reasonably expected benefits. When there is no intended clinical benefit to the subject, the subject should be made aware of this.
可合理预见的受益。不存在预期的临床受益时，受试对象应当知道这一点。
i) The alternative procedure(s) or course(s) of treatment that may be available to the subject, and their important potential benefits and risks.
受试对象可能得到的可替代治疗程序或过程，以及这些治疗的重要潜在受益和风险。
j) The compensation and/or treatment available to the subject in the event of trial-related injury.
在与试验相关的伤害事件中受试对象可获得的补偿和/治疗。