| 浅议试药导致损害的侵权责任 |
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| 引用本文： | 周天保.浅议试药导致损害的侵权责任[J].山西省政法管理干部学院学报,2011,24(4):32-34. |
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| 作者姓名： | 周天保 |
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| 作者单位： | 江苏省盱眙县人民法院,江苏盱眙,211700 |
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| 摘 要： | 《药品临床试验质量管理规范》规定了我国药物临床试验的主要制度,但对试药导致损害的救济立法上不甚明确。建议通过侵权责任的方式对受试者的损害进行救济。试药人身损害的责任可适用过错推定责任原则,其构成要件应由损害后果、加害行为、因果关系、过错四部分组成。
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| 关 键 词： | 试药 侵权责任 归责原则 构成要件 |
On Tort Liability of Damage Caused by Drug Test |
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| ZHOU Tian-bao.On Tort Liability of Damage Caused by Drug Test[J].Journal of Shanxi Politics and Law Institute for Administrators,2011,24(4):32-34. |
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| Authors: | ZHOU Tian-bao |
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| Institution: | ZHOU Tian-bao(Xuyi County People's Court,Xuyi Jiangsu 211700,China) |
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| Abstract: | ＂Regulations for Quality Management in Clinical Drug Trials＂ stimulates the main system of clinical drug trials of our country,but it is not clear about reparation for damage caused by drug test in legislation.It is suggested that the testees damaged by drug test should be relieved through the tort liability.The responsibility of damage caused by drug test can be applied with the principle of presumption of fault liability,whose constituent elements consist of consequences of the damage,tortious action,causal relationship,and fault. |
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| Keywords: | drug test tort liability principle of attribution constituent elements |
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