| 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]. 中国临床药理学与治疗学, 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(№ 2 0 0 2AA2Z3 41i) |
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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 |
| 文章编号： | 1009-2501(2004)01-0117-04 |
| 修稿时间： | 2003-06-11 |
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 National Base for Drug Clinical Trial,Affiliated Hospital of Nanjing University of Traditional Chinese Medicine,Nanjing ,Jiangsu,China. Ethic review in clinical research:informed consent[J]. Chinese Journal of Clinical Pharmacology and Therapeutics, 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 National Base for Drug Clinical Trial Affiliated Hospital of Nanjing University of Traditional Chinese Medicine Nanjing Jiangsu China |
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| Affiliation: | 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 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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