【摘要】：本文旨在以受試者權益保護為視角,運用現(xiàn)有的侵權行為法理論,研究新藥臨床試驗致人損害的侵權責任的獨立性,從理論上明確其歸責原則和構成要件及其認定,以期對將來的法律完善和司法審判實踐提供借鑒。本文將從法律淵源出發(fā),分析目前國內(nèi)外對新藥臨床試驗和受試者法律保護的現(xiàn)狀,收集國內(nèi)與新藥臨床試驗侵權責任相關的案例,結合新藥臨床試驗的要求、法律淵源和侵權行為法理論等對案例進行研究,同時采用文獻研究、案例研究、法學理論解釋和邏輯推理等方法,以期對新藥臨床試驗致人損害的侵權責任的獨立性進行研究,并從理論上明確其歸責原則和構成要件及其認定。全文主要分為六個部分,其內(nèi)容分別如下： 第一部分,將梳理研究新藥臨床試驗和受試者權益保護的法律淵源及存在的問題,并以此引出本論文研究具有的現(xiàn)實意義,以及研究的范圍和目的。 第二部分,將研究新藥臨床試驗中侵權責任與合同責任的競合,分析在出現(xiàn)兩種責任競合時,在很多方面以侵權責任優(yōu)先更有利于保護受試者權益的原因。第三部分,將研究新藥臨床試驗與常規(guī)醫(yī)療行為的區(qū)分,包括兩者在含義、目的和行為 性質、行為特點以及法律關系上的區(qū)分,以明確新藥臨床試驗致人損害的侵權責任的獨立性。 第四部分,將研究新藥臨床試驗中侵權責任的歸責原則。包括對各歸責原則進行概述；對3個相關案例進行詳細分析并研究我國司法審判實踐中和現(xiàn)行法律法規(guī)下適用的歸責原則;并以受試者權益保護為視角,對獨立的新藥臨床試驗侵權責任的歸責原則適用進行理論研究,以期從理論上明確其歸責原則。 第五部分,將研究新藥臨床試驗中侵權責任的構成要件及其認定。包括根據(jù)對獨立的新藥臨床試驗侵權責任歸責原則的理論研究,明確各主體侵權責任認定的構成要件,以及對其認定中的過錯認定標準、侵權行為表現(xiàn)形式、因果關系認定標準、損害事實認定進行理論研究,以期以受試者權益保護為視角,從理論上對構成要件及其認定進行明確。 第六部分,對全文進行總結歸納。
[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.
【學位授予單位】：成都中醫(yī)藥大學
【學位級別】：碩士
【學位授予年份】：2014
【分類號】：D923;R969.4

【參考文獻】

相關期刊論文 前10條

1 曹永高;;論完善我國人體藥物試驗法律制度的幾個問題[J];法律與醫(yī)學雜志;2006年04期

2 周建松;;淺論試藥所致醫(yī)療糾紛及救濟[J];四川省干部函授學院學報;2009年04期

3 沈毅,吳殿源,張步振,郭海,王以平,黨寶麗;“舉證責任倒置”對臨床試驗的考驗[J];解放軍醫(yī)院管理雜志;2004年05期

4 周曄;宋民憲;;藥物臨床試驗中侵權責任的歸責原則探析[J];中藥與臨床;2014年01期

5 吳軍;湯權;;新藥人體試驗致人損害民事賠償訴訟中的法律問題[J];人民司法;2007年23期

6 周天保;;淺議試藥導致?lián)p害的侵權責任[J];山西省政法管理干部學院學報;2011年04期

7 滿洪杰;;論醫(yī)學人體試驗中的侵權責任——以比較法為視角[J];法學論壇;2012年05期

8 陳煒;;無過錯責任原則在臨床試驗受試者保護中的適用[J];西北醫(yī)學教育;2006年05期

9 邵蓉,宋乃鋒;臨床研究中受試者權益保護問題探討[J];南京醫(yī)科大學學報(社會科學版);2002年02期

10 梁偉雄;;藥物臨床試驗中受試者損害補償問題探討(一)[J];中國臨床藥理學與治療學;2006年10期

，

本文編號：2312480