新药临床试验中的侵权责任研究
发布时间：2018-11-05 15:21
【摘要】：本文旨在以受试者权益保护为视角,运用现有的侵权行为法理论,研究新药临床试验致人损害的侵权责任的独立性,从理论上明确其归责原则和构成要件及其认定,以期对将来的法律完善和司法审判实践提供借鉴。本文将从法律渊源出发,分析目前国内外对新药临床试验和受试者法律保护的现状,收集国内与新药临床试验侵权责任相关的案例,结合新药临床试验的要求、法律渊源和侵权行为法理论等对案例进行研究,同时采用文献研究、案例研究、法学理论解释和逻辑推理等方法,以期对新药临床试验致人损害的侵权责任的独立性进行研究,并从理论上明确其归责原则和构成要件及其认定。全文主要分为六个部分,其内容分别如下： 第一部分,将梳理研究新药临床试验和受试者权益保护的法律渊源及存在的问题,并以此引出本论文研究具有的现实意义,以及研究的范围和目的。 第二部分,将研究新药临床试验中侵权责任与合同责任的竞合,分析在出现两种责任竞合时,在很多方面以侵权责任优先更有利于保护受试者权益的原因。第三部分,将研究新药临床试验与常规医疗行为的区分,包括两者在含义、目的和行为 性质、行为特点以及法律关系上的区分,以明确新药临床试验致人损害的侵权责任的独立性。 第四部分,将研究新药临床试验中侵权责任的归责原则。包括对各归责原则进行概述；对3个相关案例进行详细分析并研究我国司法审判实践中和现行法律法规下适用的归责原则;并以受试者权益保护为视角,对独立的新药临床试验侵权责任的归责原则适用进行理论研究,以期从理论上明确其归责原则。 第五部分,将研究新药临床试验中侵权责任的构成要件及其认定。包括根据对独立的新药临床试验侵权责任归责原则的理论研究,明确各主体侵权责任认定的构成要件,以及对其认定中的过错认定标准、侵权行为表现形式、因果关系认定标准、损害事实认定进行理论研究,以期以受试者权益保护为视角,从理论上对构成要件及其认定进行明确。 第六部分,对全文进行总结归纳。
[Abstract]:The purpose of this paper is to study the independence of tort liability in clinical trials of new drugs from the perspective of the protection of the rights and interests of the subjects, using the existing theory of tort law, and to clarify the principle of liability, the constitutive requirements and the determination of the liability in theory. In order to improve the law and judicial practice in the future to provide reference. Starting from the legal origin, this paper will analyze the current situation of clinical trials of new drugs and legal protection of subjects at home and abroad, collect domestic cases related to tort liability of clinical trials of new drugs, and combine the requirements of clinical trials of new drugs. The sources of law and the theory of tort law are used to study cases, and the methods of literature study, case study, legal theory interpretation and logical reasoning are used to study the independence of tort liability caused by new drug clinical trials. And from the theory clear its imputation principle, the constitution essential element and the confirmation. The full text is divided into six parts, the contents are as follows: the first part, will comb the new drug clinical trial and the subject's rights and interests protection legal origin and the existence question, and thus leads to this thesis research has the realistic significance. And the scope and purpose of the study. In the second part, we will study the coincidence of tort liability and contract liability in clinical trials of new drugs, and analyze the reasons why tort priority is more beneficial to the protection of the rights and interests of the subjects in many aspects. The third part will study the distinction between clinical trials of new drugs and routine medical behaviors, including their meanings, purpose and nature of behavior, behavioral characteristics and legal relations. To clarify the independence of tort liability for damage caused by clinical trials of new drugs. The fourth part, will study the new drug clinical trial tort liability imputation principle. Including an overview of the principles of attribution; This paper makes a detailed analysis of three related cases and studies the principle of imputation applied in judicial practice and current laws and regulations in our country. From the perspective of the protection of the rights and interests of the subjects, this paper makes a theoretical study on the application of the principle of liability for tort liability in clinical trials of independent new drugs, in order to clarify the principle of liability in theory. The fifth part will study the constitutive elements of tort liability and its determination in clinical trials of new drugs. Including according to the theoretical research on the principle of tort liability attribution of independent new drug clinical trial, it clarifies the constituent elements of each subject's tort liability, as well as the criterion of fault identification and the form of tort behavior. The criterion of causality and the identification of damage facts are studied theoretically in order to clarify the constitutive elements and their cognizance theoretically from the perspective of the protection of the rights and interests of the subjects. The sixth part summarizes the full text.
【学位授予单位】：成都中医药大学
【学位级别】：硕士
【学位授予年份】：2014
【分类号】：D923;R969.4
本文编号：2312480
[Abstract]:The purpose of this paper is to study the independence of tort liability in clinical trials of new drugs from the perspective of the protection of the rights and interests of the subjects, using the existing theory of tort law, and to clarify the principle of liability, the constitutive requirements and the determination of the liability in theory. In order to improve the law and judicial practice in the future to provide reference. Starting from the legal origin, this paper will analyze the current situation of clinical trials of new drugs and legal protection of subjects at home and abroad, collect domestic cases related to tort liability of clinical trials of new drugs, and combine the requirements of clinical trials of new drugs. The sources of law and the theory of tort law are used to study cases, and the methods of literature study, case study, legal theory interpretation and logical reasoning are used to study the independence of tort liability caused by new drug clinical trials. And from the theory clear its imputation principle, the constitution essential element and the confirmation. The full text is divided into six parts, the contents are as follows: the first part, will comb the new drug clinical trial and the subject's rights and interests protection legal origin and the existence question, and thus leads to this thesis research has the realistic significance. And the scope and purpose of the study. In the second part, we will study the coincidence of tort liability and contract liability in clinical trials of new drugs, and analyze the reasons why tort priority is more beneficial to the protection of the rights and interests of the subjects in many aspects. The third part will study the distinction between clinical trials of new drugs and routine medical behaviors, including their meanings, purpose and nature of behavior, behavioral characteristics and legal relations. To clarify the independence of tort liability for damage caused by clinical trials of new drugs. The fourth part, will study the new drug clinical trial tort liability imputation principle. Including an overview of the principles of attribution; This paper makes a detailed analysis of three related cases and studies the principle of imputation applied in judicial practice and current laws and regulations in our country. From the perspective of the protection of the rights and interests of the subjects, this paper makes a theoretical study on the application of the principle of liability for tort liability in clinical trials of independent new drugs, in order to clarify the principle of liability in theory. The fifth part will study the constitutive elements of tort liability and its determination in clinical trials of new drugs. Including according to the theoretical research on the principle of tort liability attribution of independent new drug clinical trial, it clarifies the constituent elements of each subject's tort liability, as well as the criterion of fault identification and the form of tort behavior. The criterion of causality and the identification of damage facts are studied theoretically in order to clarify the constitutive elements and their cognizance theoretically from the perspective of the protection of the rights and interests of the subjects. The sixth part summarizes the full text.
【学位授予单位】：成都中医药大学
【学位级别】：硕士
【学位授予年份】：2014
【分类号】：D923;R969.4
【参考文献】
相关期刊论文 前10条
1 曹永高;;论完善我国人体药物试验法律制度的几个问题[J];法律与医学杂志;2006年04期
2 周建松;;浅论试药所致医疗纠纷及救济[J];四川省干部函授学院学报;2009年04期
3 沈毅,吴殿源,张步振,郭海,王以平,党宝丽;“举证责任倒置”对临床试验的考验[J];解放军医院管理杂志;2004年05期
4 周晔;宋民宪;;药物临床试验中侵权责任的归责原则探析[J];中药与临床;2014年01期
5 吴军;汤权;;新药人体试验致人损害民事赔偿诉讼中的法律问题[J];人民司法;2007年23期
6 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年04期
7 满洪杰;;论医学人体试验中的侵权责任——以比较法为视角[J];法学论坛;2012年05期
8 陈炜;;无过错责任原则在临床试验受试者保护中的适用[J];西北医学教育;2006年05期
9 邵蓉,宋乃锋;临床研究中受试者权益保护问题探讨[J];南京医科大学学报(社会科学版);2002年02期
10 梁伟雄;;药物临床试验中受试者损害补偿问题探讨(一)[J];中国临床药理学与治疗学;2006年10期
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