药品、保健品人体试验法律问题思考

发布时间：2018-03-20 07:52

本文选题：人体试验　切入点：立法现状　出处：《广西大学》2017年硕士论文　论文类型：学位论文

【摘要】：从近代以来,随着科学技术的不断发展,医疗卫生科技水平也得到了长远的进步,许多疑难杂症得到了痊愈的治疗,其中人体试验功不可没。由于人体试验本身具备的未知性和风险性,以及近些年来不断曝光的人体试验案件都反映了当前人体试验发展的严峻形势。如何利用法律手段来规范它显得尤为重要,因此我们必须在这方面进行详细研究,找出解决之道。论文包括五个部分的内容,前言,正文三章内容以及结束语。前言部分介绍了论文选题的背景意义,本文采用的主要研究方法的论述,以及论文的创新点和独到新颖之处。第一章是人体试验的概述。首先阐述了人体试验概念,分类,人体试验的相关主体以及申办者研究者和受试者的权利义务,国际规范《纽伦堡法典》和《赫尔辛基宣言》所规定的人体试验应当遵守的基本伦理原则;其次阐述了人体试验的发展历程,包括中国古代和近现代的人体试验,二战中日本和德国的人体试验,二战后各盟国的人体试验,;最后通过对比国内和国外关于人体试验的立法现状,得出国外立法模式给我国的借鉴和启示。第二章是人体试验立法存在的问题以及原因分析。首先从整体上阐述了我国人体试验立法存在的问题,从受试者的知情同意,人体试验的伦理审查和相关法律责任三个方面进行问题分析。其次是从本文的侧重点药品和保健食品方面,论述其存在的问题。最后从国内和国外两个角度,分析了我国人体试验出现问题的具体原因。第三章是完善我国人体试验立法的对策和建议。提出建立人体试验法和完善现有法律规范两种解决路径,并详细从受试者的告知义务,伦理审查机构,救济手段等方面阐述了具体对策。并提出了对于药品和保健食品人体试验立法的相关建议。
[Abstract]:Since modern times, with the continuous development of science and technology, the level of medical and health science and technology has also made long-term progress. Many difficult and complicated diseases have been cured. Among them, the human body test can not be ignored. Due to the unknown and risky nature of the human body test itself, And the human trial cases that have been continuously exposed in recent years all reflect the grim situation of the current development of human experiments. How to use legal means to regulate it is particularly important. Therefore, we must study this aspect in detail. The paper includes five parts, preface, three chapters and the conclusion. The preface introduces the background significance of the topic, the main research methods used in this paper. The first chapter is an overview of human trials. Firstly, the concept, classification, relevant subjects of human trials and the rights and obligations of the applicants and subjects are described. The basic ethical principles which should be observed in human body tests as stipulated in the Nuremberg Code and the Helsinki Declaration; secondly, the development of human body tests, including ancient and modern human trials in China, is described. Human trials in Japan and Germany during World War II, and human trials in allies after World War II. Finally, by comparing domestic and foreign legislation on human trials, The second chapter is the analysis of the problems and causes of the human body experiment legislation. Firstly, the problems of the human body experiment legislation in our country are expounded, and the informed consent of the subjects is discussed. The ethical review and related legal liability of human body test are analyzed in three aspects. Secondly, the existing problems are discussed from the aspects of important drugs and health food in this paper. Finally, from the domestic and foreign perspectives, This paper analyzes the concrete reasons of the problems in human body test in China. Chapter three is the countermeasures and suggestions to perfect the legislation of human body test in our country. The author puts forward two ways to solve the problem: establishing the method of human body test and perfecting the existing laws and regulations. The specific countermeasures are discussed in detail from the aspects of the subjects' obligation of informing, the organization of ethics review, the means of relief and so on, and the relevant suggestions on the legislation of human body test for medicine and health food are put forward.
【学位授予单位】：广西大学
【学位级别】：硕士
【学位授予年份】：2017
【分类号】：D922.16

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