【摘要】：近代以來(lái),隨著生物醫(yī)學(xué)知識(shí)的發(fā)展與進(jìn)步,人類的健康得到極大的保護(hù)和提高,許多以前無(wú)法治愈的疾病得到了有效的治療和抑制,而藥品人體試驗(yàn)在這其中發(fā)揮了極大的作用。其實(shí),藥品人體試驗(yàn)存在已久,但是由于較少的曝光率,使人們淡忘了其的存在,直到黃金大米事件’的曝光,人體試驗(yàn)又重新走入人們的視線并引起極大的關(guān)注。 作為發(fā)展中國(guó)家,由于缺乏對(duì)人體試驗(yàn)的關(guān)注,導(dǎo)致相關(guān)立法不夠完善,監(jiān)管也不到位,這些原因致使我國(guó)在開(kāi)展藥品人體試驗(yàn)的過(guò)程中存在諸多法律問(wèn)題,例如藥品準(zhǔn)入監(jiān)管問(wèn)題、倫理委員會(huì)建構(gòu)問(wèn)題以及受試者權(quán)利保護(hù)問(wèn)題等。這些法律問(wèn)題的存在嚴(yán)重阻礙人體試驗(yàn)的健康運(yùn)行,最終影響人類健康事業(yè)的發(fā)展。因此,解決人體試驗(yàn)中存在的法律問(wèn)題變得極為迫切。 由于發(fā)達(dá)國(guó)家的人體試驗(yàn)有著更為悠久的歷史,其相關(guān)立法和配套制度都比較完善,因此,借鑒國(guó)外先進(jìn)做法與經(jīng)驗(yàn)對(duì)解決我國(guó)藥品人體試驗(yàn)存在的問(wèn)題有很大的幫助。 人體試驗(yàn)作為一項(xiàng)科學(xué)行為,其無(wú)論在理論上,還是實(shí)踐中都十分具有存在的必要性,因此調(diào)整和完善人體試驗(yàn)制度顯得有為重要。本文希望通過(guò)解決藥品人體試驗(yàn)存在的問(wèn)題,盡可能完善該制度,使使這項(xiàng)科學(xué)行為健康發(fā)展,最終造福于全人類。2 全文包括六部分：前言、正文共4章、結(jié)束語(yǔ)。 前言部分介紹了“人體試驗(yàn)”的概念以及分類,并且對(duì)做為本文研究對(duì)象的“藥品人體試驗(yàn)”的概念進(jìn)行了描述,同時(shí)還對(duì)參與藥品人體試驗(yàn)的主體進(jìn)行了簡(jiǎn)要介紹。 第一章主要闡述藥品人體試驗(yàn)的一般理論； 第二章主要闡述藥品人體試驗(yàn)國(guó)內(nèi)外立法狀況； 第三章主要闡述藥品人體試驗(yàn)引發(fā)的法律問(wèn)題及原因分析； 第四章主要闡述如何完善我國(guó)的藥品人體試驗(yàn)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.
【學(xué)位授予單位】：廣西大學(xué)
【學(xué)位級(jí)別】：碩士
【學(xué)位授予年份】：2014
【分類號(hào)】：D922.16

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