| 台湾地区人体试验法律制度对大陆医疗技术人体试验立法的启示 |
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| 引用本文： | 陈小嫦. 台湾地区人体试验法律制度对大陆医疗技术人体试验立法的启示[J]. 中国医院管理, 2009, 29(1): 42-45 |
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| 作者姓名： | 陈小嫦 |
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| 作者单位： | 广东医学院,广东,东莞,523808 |
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| 基金项目： | 教育部2005年人文社会科学研究项目 |
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| 摘 要： | 处于人体试验阶段的医疗技术的安全性和有效性处于未知状态，极易侵害公民的生命权和健康权，并给生态安全、伦理、法律等带来冲击，有必要对其实行行政许可制度。考察台湾地区有关新医疗技术人体试验的法律制度，并与大陆地区的《人体器官移植条例》、《特殊医疗技术临床应用管理办法（征求意见稿）》和《医疗技术临床应用管理办法（征求意见稿）》进行比较，对医疗技术的人体试验立法提出建议。
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| 关 键 词： | 医疗技术 人体试验 伦理审查 知情同意 |
The implication to the mainland by the law of human subject research of Taiwan |
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| CHEN Xiao-chang. The implication to the mainland by the law of human subject research of Taiwan[J]. Chinese Hospital Management, 2009, 29(1): 42-45 |
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| Authors: | CHEN Xiao-chang |
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| Affiliation: | CHEN Xiao-chang(Guangdong Medical College, Dongguan, Guangdong, 523808, China) |
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| Abstract: | The uncertainty of medical technology experimenting on human being is a threat to our life, health, zoology, ethics and law. The employment of Admittance System is necessary. This essay analyses the laws of medica technology experimenting on human being of Taiwan puts forward suggestions for lawmaking for medical technology experimenting on human being of China. |
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| Keywords: | medical technology human subjects independent review informed-consent |
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