论我国临床试验侵权责任的归责原则

发布时间：2018-08-12 13:33

【摘要】：自神农尝百草以来,人类孜孜不倦的研究治愈疾病的方法。经历数千年的摸索,人类的医学水平得到显著提高。特别是16世纪后,西方自然科学的新起,牛痘疫苗的发明,青霉素的发现使得人类死亡率大幅降低。进入20世纪后,人类生物医学更是飞速发展,克隆技术的发明、基因图谱的制作使得医学技术上了新的台阶。不可否认的是临床试验为人类医学的进步发挥了不可替代的作用,但同时,临床试验中不合乎伦理规范、侵害受试者权利的行为,引起人们的广泛关注。由于我国对临床试验侵权责任立法的缺失,导致临床试验侵权案件难以得到合理的解决。本文主要研究的就是临床试验侵权责任的归责原则,而归责原则决定着责任构成要件、举证责任负担、免责条件、损害赔偿的原则和方法、减轻责任的依据,因此确立合适的归责原则具有重要意义。本文通过以下几部分对这个问题进行分析。首先,是对临床试验侵权责任的概述。界定了临床试验,与普通医疗行为进行区分,并介绍了临床试验的分类与分期。然后分别临床试验侵权侵害的权益,表现形式和责任承担者。其次,通过对典型国家临床试验侵权责任立法的研究,得到了一些对我国临床试验侵权责任的借鉴。然后分析了我国临床试验侵权责任立法、司法上的现状,指出了我国目前存在的一些问题。最后,本文根据临床试验侵权的特殊性,对临床试验侵权责任进行类型化分类。非治疗性临床试验侵权采用无过错原则更符合法理,并且能较好保护受试者;治疗性临床试验侵权采用过错推定原则,能平衡有治疗利益的受试者与研究机构之间利益。
[Abstract]:Since Shennong tasted hundred herbs, human beings have worked tirelessly to find ways to cure diseases. After thousands of years of exploration, human medical standards have been significantly improved. Especially after the 16th century, the new rise of western natural science, the invention of vaccinia vaccine and the discovery of penicillin have greatly reduced the human mortality rate. After entering the 20th century, human biomedicine is developing rapidly. The invention of cloning technology and the making of gene map make medical technology to a new level. It is undeniable that clinical trials have played an irreplaceable role in the progress of human medicine, but at the same time, the behaviors of clinical trials which are not in accordance with ethical norms and violate the rights of the subjects have aroused widespread concern. Due to the lack of legislation on tort liability of clinical trials in China, it is difficult to solve the tort cases of clinical trials reasonably. This article mainly studies the principle of liability for tort liability in clinical trials, and the principle of imputation determines the constitutive elements of liability, burden of proof, exemption conditions, principles and methods of compensation for damages, and the basis for lightening liability. Therefore, it is of great significance to establish appropriate imputation principle. This article carries on the analysis to this question through the following several parts. First, the summary of tort liability in clinical trials. The clinical trial is defined, and the classification and staging of the clinical trial are introduced. Then clinical trial infringement of the rights and interests, manifestations and duty bearers. Secondly, through the research on tort liability legislation of clinical trial in typical countries, some references to tort liability of clinical trial in China are obtained. Then it analyzes the current situation of tort liability legislation and judicature of clinical trial in China, and points out some problems existing in our country. Finally, according to the particularity of clinical trial tort, this paper classifies the tort liability of clinical trial. The principle of no-fault in non-therapeutic clinical trials is more consistent with the principle of law and can better protect the subjects. The tort of therapeutic clinical trials adopts the principle of presumption of fault which can balance the interests between the subjects with therapeutic interests and the research institutions.
【学位授予单位】：华中科技大学
【学位级别】：硕士
【学位授予年份】：2015
【分类号】：D923

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