【摘要】：本文旨在以受試者權(quán)益保護(hù)為視角,運(yùn)用現(xiàn)有的侵權(quán)行為法理論,研究新藥臨床試驗(yàn)致人損害的侵權(quán)責(zé)任的獨(dú)立性,從理論上明確其歸責(zé)原則和構(gòu)成要件及其認(rèn)定,以期對(duì)將來的法律完善和司法審判實(shí)踐提供借鑒。本文將從法律淵源出發(fā),分析目前國(guó)內(nèi)外對(duì)新藥臨床試驗(yàn)和受試者法律保護(hù)的現(xiàn)狀,收集國(guó)內(nèi)與新藥臨床試驗(yàn)侵權(quán)責(zé)任相關(guān)的案例,結(jié)合新藥臨床試驗(yàn)的要求、法律淵源和侵權(quán)行為法理論等對(duì)案例進(jìn)行研究,同時(shí)采用文獻(xiàn)研究、案例研究、法學(xué)理論解釋和邏輯推理等方法,以期對(duì)新藥臨床試驗(yàn)致人損害的侵權(quán)責(zé)任的獨(dú)立性進(jìn)行研究,并從理論上明確其歸責(zé)原則和構(gòu)成要件及其認(rèn)定。全文主要分為六個(gè)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(yàn)和受試者權(quán)益保護(hù)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(shí)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(yàn)中侵權(quán)責(zé)任與合同責(zé)任的競(jìng)合,分析在出現(xiàn)兩種責(zé)任競(jìng)合時(shí),在很多方面以侵權(quán)責(zé)任優(yōu)先更有利于保護(hù)受試者權(quán)益的原因。第三部分,將研究新藥臨床試驗(yàn)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(zhì)、行為特點(diǎn)以及法律關(guān)系上的區(qū)分,以明確新藥臨床試驗(yàn)致人損害的侵權(quán)責(zé)任的獨(dú)立性。 第四部分,將研究新藥臨床試驗(yàn)中侵權(quán)責(zé)任的歸責(zé)原則。包括對(duì)各歸責(zé)原則進(jìn)行概述；對(duì)3個(gè)相關(guān)案例進(jìn)行詳細(xì)分析并研究我國(guó)司法審判實(shí)踐中和現(xiàn)行法律法規(guī)下適用的歸責(zé)原則;并以受試者權(quán)益保護(hù)為視角,對(duì)獨(dú)立的新藥臨床試驗(yàn)侵權(quán)責(zé)任的歸責(zé)原則適用進(jìn)行理論研究,以期從理論上明確其歸責(zé)原則。 第五部分,將研究新藥臨床試驗(yàn)中侵權(quán)責(zé)任的構(gòu)成要件及其認(rèn)定。包括根據(jù)對(duì)獨(dú)立的新藥臨床試驗(yàn)侵權(quán)責(zé)任歸責(zé)原則的理論研究,明確各主體侵權(quán)責(zé)任認(rèn)定的構(gòu)成要件,以及對(duì)其認(rèn)定中的過錯(cuò)認(rèn)定標(biāo)準(zhǔn)、侵權(quán)行為表現(xiàn)形式、因果關(guān)系認(rèn)定標(biāo)準(zhǔn)、損害事實(shí)認(rèn)定進(jìn)行理論研究,以期以受試者權(quán)益保護(hù)為視角,從理論上對(duì)構(gòu)成要件及其認(rèn)定進(jìn)行明確。 第六部分,對(duì)全文進(jìn)行總結(jié)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(xué)位授予單位】：成都中醫(yī)藥大學(xué)
【學(xué)位級(jí)別】：碩士
【學(xué)位授予年份】：2014
【分類號(hào)】：D923;R969.4

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