临床试验听听看 ▎ICH-GCP 4.8.5-4.8.7

药物临床试验网 · 公众号 · 药品 · 2017-07-03 17:10

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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
4.8.5 The investigator, or a person designated by the investigator, should fully inform the subject or, if the subject is unable to provide informed consent, the subject's legally acceptable representative, of all pertinent aspects of the trial including the written information and the approval/ favourable opinion by the IRB/IEC.
研究者或由研究者指定的人，至少应当告诉受试对象，或如果受试对象不能提供知情同意时告诉受试对象的合法可接受代表，所有与试验相关的方面，包括文字资料和IRB/IEC的批准/赞成意见。
4.8.6 The language used in the oral and written information about the trial, including the written informed consent form, should be as non-technical as practical and should be understandable to the subject or the subject's legally acceptable representative and the impartial witness, where applicable.
关于试验的口述和书面资料，包括书面知情同意书，所用的语言应当是非技术术语性的实用语言，对于受试对象或受试对象的合法可接受代表或公正的见证人应当是易懂的。
4.8.7 Before informed consent may be obtained, the investigator, or a person designated by the investigator, should provide the subject or the subject's legally acceptable representative ample time and opportunity to inquire about details of the trial and to decide whether or not to participate in the trial. All questions about the trial should be answered to the satisfaction of the subject or the subject's legally acceptable representative.
在可能得到知情同意之前，研究者或研究者指定的人应当让受试对象或受试对象的合法可接受代表有充足的时间和机会询问关于试验的详细情况和决定是否参加试验。应当回答所有问题，让受试对象或受试对象的合法可接受代表满意。