药品人体试验法律问题研究

发布时间：2019-06-19 22:26

【摘要】：近代以来,随着生物医学知识的发展与进步,人类的健康得到极大的保护和提高,许多以前无法治愈的疾病得到了有效的治疗和抑制,而药品人体试验在这其中发挥了极大的作用。其实,药品人体试验存在已久,但是由于较少的曝光率,使人们淡忘了其的存在,直到黄金大米事件’的曝光,人体试验又重新走入人们的视线并引起极大的关注。作为发展中国家,由于缺乏对人体试验的关注,导致相关立法不够完善,监管也不到位,这些原因致使我国在开展药品人体试验的过程中存在诸多法律问题,例如药品准入监管问题、伦理委员会建构问题以及受试者权利保护问题等。这些法律问题的存在严重阻碍人体试验的健康运行,最终影响人类健康事业的发展。因此,解决人体试验中存在的法律问题变得极为迫切。由于发达国家的人体试验有着更为悠久的历史,其相关立法和配套制度都比较完善,因此,借鉴国外先进做法与经验对解决我国药品人体试验存在的问题有很大的帮助。人体试验作为一项科学行为,其无论在理论上,还是实践中都十分具有存在的必要性,因此调整和完善人体试验制度显得有为重要。本文希望通过解决药品人体试验存在的问题,尽可能完善该制度,使使这项科学行为健康发展,最终造福于全人类。2 全文包括六部分：前言、正文共4章、结束语。前言部分介绍了“人体试验”的概念以及分类,并且对做为本文研究对象的“药品人体试验”的概念进行了描述,同时还对参与药品人体试验的主体进行了简要介绍。第一章主要阐述药品人体试验的一般理论；第二章主要阐述药品人体试验国内外立法状况；第三章主要阐述药品人体试验引发的法律问题及原因分析；第四章主要阐述如何完善我国的药品人体试验制度。
[Abstract]:Since modern times, with the development and progress of biomedical knowledge, human health has been greatly protected and improved, many previously incurable diseases have been effectively treated and suppressed, and drug human trials have played a great role in it. In fact, drug human trials have existed for a long time, but because of less exposure, people forget its existence, until the exposure of golden rice incident, human experiments have come back into people's attention and attracted great attention. As a developing country, due to the lack of attention to human trials, the relevant legislation is not perfect and the supervision is not in place. These reasons lead to many legal problems in the process of carrying out drug human trials in our country, such as drug access supervision, ethics committee construction and subject rights protection. The existence of these legal problems seriously hinders the healthy operation of human experiments and ultimately affects the development of human health. Therefore, it is very urgent to solve the legal problems existing in human experiments. Because the human trials in developed countries have a longer history and their relevant legislation and supporting systems are relatively perfect, it is of great help to solve the problems existing in the human trials of drugs in our country by drawing lessons from the advanced practices and experiences of foreign countries. As a scientific behavior, human experiment is necessary both in theory and in practice, so it is important to adjust and perfect the human test system. This paper hopes to improve the system as much as possible by solving the problems existing in the human trial of drugs, so that the scientific behavior can develop healthily and benefit all mankind. 2 the full text consists of six parts: preface, the main body consists of four chapters, and the conclusion is made. In the preface, the concept and classification of "human body test" are introduced, and the concept of "drug human test", which is the object of this study, is described, and the main body involved in the human trial of drugs is also briefly introduced. The first chapter mainly expounds the general theory of drug human body test; the second chapter mainly expounds the legislative situation of drug human body test at home and abroad; the third chapter mainly expounds the legal problems and causes caused by drug human body test; the fourth chapter mainly expounds how to perfect the drug human body test system in our country.
【学位授予单位】：广西大学
【学位级别】：硕士
【学位授予年份】：2014
【分类号】：D922.16

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