| 对临床试验中"受试者知情同意权"法律保护的研究 |
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| 引用本文： | 沈秀芹,曹永福.对临床试验中"受试者知情同意权"法律保护的研究[J].中国医学伦理学,2005,18(5):36-37. |
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| 作者姓名： | 沈秀芹 曹永福 |
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| 作者单位： | 山东大学医学院人文医学研究中心,山东,济南,250012 |
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| 摘 要： | 知情同意权作为患者的一项权利已经得到普遍认同.但现在医患双方都比较注重诊疗实践中一般的知情同意,而对临床试验中受试者这一特殊群体的"知情同意"没有引起足够的重视,导致在实践中这项权利常被侵犯,为医疗纠纷埋下了隐患.本文通过介绍国际上把伦理原则上升为法律规范,加强对受试者知情同意权利保护的经验,初步分析和探讨了我国法律对临床试验中受试者知情同意权保护中存在的问题以及完善措施.
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| 关 键 词： | 临床试验 受试者 知情同意权 |
| 文章编号： | 1001-8565（2005）05-0036-02 |
| 收稿时间： | 2005-08-20 |
| 修稿时间： | 2005年8月20日 |
Study on Legal Protection of Subject′s Right of Informed Consent in Clinical Trial |
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| Shen Xiuqin,Cao Yongfu.Study on Legal Protection of Subject′s Right of Informed Consent in Clinical Trial[J].Chinese Medical Ethics,2005,18(5):36-37. |
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| Authors: | Shen Xiuqin Cao Yongfu |
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| Affiliation: | Humanism Medicine Department of Medical School, Shandong University, Jinan, 250012, China |
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| Abstract: | As a patient's right,informed consent has been acknowledged universally.Both hospital and patients attach great importance to normal informed consent during clinic.But the subjects' right in clinical trial didn't draw enough attention,which leads to encroachment of the subjects' right and even the clinical disputes.The law and rule,based on the ethics principle,can enhance the protection of the subject's right of informed consent.In this article,the problem on the legal protection against the infringement of the subject's right and the corresponding counter-measures are discussed. |
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| Keywords: | Clinical trial Subject Informed consent |
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