| 临床试验的伦理审查:利益冲突 |
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| 引用本文： | 汪秀琴,熊宁宁,刘沈林,高维敏,蒋萌,刘芳,邹建东,卜擎燕.临床试验的伦理审查:利益冲突[J].金属学报,2004,9(3):358-360. |
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| 作者姓名： | 汪秀琴 熊宁宁 刘沈林 高维敏 蒋萌 刘芳 邹建东 卜擎燕 |
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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(№2002AA2Z341i) |
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| 摘 要： | 研究的客观性是科学研究的本质和公众信任的基石。利益冲突是指个人的利益与其职责之间的冲突, 即存在可能过分影响个人履行其职责的经济或其他的利益。临床试验的利益冲突主要有研究者的利益冲突, 伦理委员会成员的利益冲突, 受试者监护人的利益冲突, 与公开研究结果有关的利益冲突。处理利益冲突的策略主要包括公开、审查、限制以及伦理道德培训等。
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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 利益冲突 |
| 收稿时间： | 2003-12-02 |
| 修稿时间： | 2004-01-17 |
Ethic review in clinical research:conflicts of interest |
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| WANG Xiu-Qin,XIONG Ning-Ning,LIU Shen-Lin,GAO Wei-Min,JIANG Meng,LIU Fang,ZOU Jian-Dong,BO Qing-Yan.Ethic review in clinical research:conflicts of interest[J].Acta Metallurgica Sinica,2004,9(3):358-360. |
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| Authors: | WANG Xiu-Qin XIONG Ning-Ning LIU Shen-Lin GAO Wei-Min JIANG Meng LIU Fang ZOU Jian-Dong BO Qing-Yan |
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| Affiliation: | National Base for Drug Clinical Trial, Affiliated Hospital of Nanjing University of Traditional Chinese Medicine, Nanjing, 210029, J iangsu, China |
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| Abstract: | The objectivity of researchers is an essential value in scientific research and the basis for public trust.Conflict of interest refers to a conflict between an individual's private or personal interest and his or her duty, which could unduly influence one's position in fulfilling his or her duty.Conflicts of interest in clinical trial mainly consist of the conflicts of interest for investigators, for IRB members, for guardians of the subjects and those related with publishing scientific work.Strategies for dealing with conflicts of interest include disclosure, review, limiting and ethic training, etc. |
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| Keywords: | medical ethic clinical research institutional review board ethic review conflicts of interest |
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