| 临床试验的伦理审查:知情同意 |
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| 引用本文： | 汪秀琴,熊宁宁,刘沈林,李七一,蒋萌,刘芳,邹建东,卜擎燕,高维敏.临床试验的伦理审查:知情同意[J].金属学报,2004,9(1):117-120. |
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| 作者姓名： | 汪秀琴 熊宁宁 刘沈林 李七一 蒋萌 刘芳 邹建东 卜擎燕 高维敏 |
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| 作者单位： | 南京中医药大学附属医院国家药品临床研究基地, 南京 210029, 江苏 |
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| 基金项目： | 科技部“ 临床试验关键技术及平台研究” 项目(NO.2002AA2Z341i) |
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| 摘 要： | 知情同意是人体生物医学研究的主要伦理要求之一。知情同意的伦理审查一般要考虑以下要点:信息的充分性, 语言表达, 知情同意过程, 知情同意的文件, 知情同意的例外, 隐瞒信息和欺骗, 随机化、双盲和安慰剂对照临床试验, 重新获取知情同意。
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| 关 键 词： | 医学伦理学 临床试验 伦理委员会 伦理审查 知情同意 |
| 收稿时间： | 2003-06-11 |
| 修稿时间： | 2003-07-13 |
Ethic review in clinical research:informed consent |
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| WANG Xiu-Qin,XIONG Ning-Ning,LIU Shen-Lin,LI Qi-Yi,JIANG Meng,LIU Fang,ZOU Jian-Dong,BO Qing-Yan,GAO Wei-Min.Ethic review in clinical research:informed consent[J].Acta Metallurgica Sinica,2004,9(1):117-120. |
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| Authors: | WANG Xiu-Qin XIONG Ning-Ning LIU Shen-Lin LI Qi-Yi JIANG Meng LIU Fang ZOU Jian-Dong BO Qing-Yan GAO Wei-Min |
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| Affiliation: | National Base for Drug Clinical Trial, Affiliated Hospital of Nanjing University of Traditional Chinese Medicine, Nanjing 210029, Jiangsu, China |
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| Abstract: | Informed consent is one of the primary ethical requirements underpinning biomedical research involving human subjects.The general IRB considerations regarding informed consent are as follow:adequacy of the information, language expressed, consent procedure, documentation, exempt from consent, withholding information and deception, randomization double-masked and placebos clinical trials, and renewing consent. |
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| Keywords: | medicinal ethic clinical research institutional review board ethic review informed consent |
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