| 药物临床试验的伦理审查几个要点 |
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| 引用本文： | 杜彦萍,汪朝晖,杨忠奇,黄可儿,洗绍祥.药物临床试验的伦理审查几个要点[J].中国医学伦理学,2007,20(4):95-96. |
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| 作者姓名： | 杜彦萍 汪朝晖 杨忠奇 黄可儿 洗绍祥 |
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| 作者单位： | 广州中医药大学第一附属医院,广东,广州,510407 |
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| 摘 要： | 药物临床试验中,为充分保护受试者权益,在伦理审查中要特别重视受试者参加风险和受益,力求风险最小和受益最大,保证受试者充分了解临床试验后知情同意,注意特殊受试人群保护,避免发生利益冲突。
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| 关 键 词： | 医学伦理学 药物 临床试验 |
| 文章编号： | 1001-8565（2007）04-0095-02 |
| 收稿时间： | 2007-05-19 |
| 修稿时间： | 2007-05-192007-06-19 |
The Several Points in Ethic Review in Drug Clinical Trials |
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| DU Yan-ping,WANG Zhao-hui,YANG Zhong-qi,HUANG Ke-er,XIAN Shao-xiang.The Several Points in Ethic Review in Drug Clinical Trials[J].Chinese Medical Ethics,2007,20(4):95-96. |
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| Authors: | DU Yan-ping WANG Zhao-hui YANG Zhong-qi HUANG Ke-er XIAN Shao-xiang |
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| Institution: | The First Hospital of Guangzhou University of Traditional Chinese Medicine Guangzhou ,510407, China |
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| Abstract: | In order to protect the trial subjects' rights and benefits in drug clinical trials,we must pay special attention to the risk and benefit of the trial subjects(striving to minimize the risk and maximize the benefit),ensure the trial subjects' complete realization of the clinical trials and the successive informed consent,pay special attention to the protection of the specific trial subjects,and avoid the conflict of interests. |
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| Keywords: | Medical Ethics Drugs Clinical Trials |
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