本文選題：臨床試驗(yàn) + 責(zé)任險(xiǎn)　； 參考：《復(fù)旦大學(xué)》2013年碩士論文

【摘要】：隨著醫(yī)學(xué)事業(yè)的不斷發(fā)展,新藥、新器械以及新醫(yī)療技術(shù)的不斷運(yùn)用,各類臨床研究項(xiàng)目數(shù)量逐漸增加,隨之而來(lái)的各種各樣的不安全事件層出不窮,臨床研究造成嚴(yán)重傷害的例子也屢見不鮮。藥物臨床試驗(yàn)責(zé)任險(xiǎn)起源于西方醫(yī)療發(fā)達(dá)國(guó)家,主要用于分?jǐn)傄蛩幬锱R床試驗(yàn)進(jìn)行過(guò)程中,受試者出現(xiàn)不良反應(yīng)后引起的一系列風(fēng)險(xiǎn),對(duì)于這些受試者的生命和財(cái)產(chǎn)安全給予保障。目前國(guó)內(nèi)臨床試驗(yàn)責(zé)任險(xiǎn)的認(rèn)知程度和重視程度還不夠,由此產(chǎn)生了一系列的醫(yī)療糾紛問(wèn)題。本文的研究目的是通過(guò)查閱資料、專家訪談和問(wèn)卷調(diào)查等方式了解我國(guó)臨床研究責(zé)任險(xiǎn)的現(xiàn)狀及需求,從申辦者、研究者和受試者三方面對(duì)我國(guó)臨床研究責(zé)任險(xiǎn)的認(rèn)識(shí)程度進(jìn)行初步的了解,分析國(guó)內(nèi)臨床研究責(zé)任險(xiǎn)無(wú)法推進(jìn)的原因,對(duì)比其他發(fā)達(dá)國(guó)家,尋找出差距和不足,為加強(qiáng)我國(guó)臨床研究過(guò)程中受試者的保護(hù)、規(guī)范倫理委員會(huì)對(duì)于研究方案及知情同意書中有關(guān)責(zé)任險(xiǎn)的審查,以及最終將臨床研究責(zé)任險(xiǎn)作為國(guó)家相關(guān)法律法規(guī)政策的一部分提供決策依據(jù)和幫助。研究?jī)?nèi)容主要分為以下幾個(gè)方面：①通過(guò)查閱文獻(xiàn)的方法了解近年來(lái)國(guó)內(nèi)臨床試驗(yàn)及責(zé)任險(xiǎn)的現(xiàn)狀；②通過(guò)資料查閱的方法了解本市某三級(jí)甲等醫(yī)院(A醫(yī)院)臨床試驗(yàn)開展情況,了解臨床試驗(yàn)責(zé)任險(xiǎn)的分布以及責(zé)任險(xiǎn)的具體內(nèi)容；③通過(guò)問(wèn)卷調(diào)查的方式從A醫(yī)院中選取研究者、受試者和申辦者,了解他們對(duì)責(zé)任險(xiǎn)的認(rèn)知與需求；④歸納分析臨床試驗(yàn)責(zé)任險(xiǎn)的種類與特點(diǎn)；⑤臨床研究責(zé)任險(xiǎn)對(duì)受試者、申辦方及研究者保護(hù)的作用；⑥臨床試驗(yàn)責(zé)任險(xiǎn)存在的問(wèn)題與困難,通過(guò)問(wèn)卷及訪談專家、領(lǐng)導(dǎo)了解目前責(zé)任險(xiǎn)推廣存在的難點(diǎn)及困難；⑦探尋影響臨床試驗(yàn)責(zé)任險(xiǎn)推進(jìn)的影響因素；⑧通過(guò)總結(jié)歸納提出臨床試驗(yàn)責(zé)任險(xiǎn)的發(fā)展方向。從研究結(jié)果得知,臨床試驗(yàn)責(zé)任險(xiǎn)在我國(guó)的臨床研究中所占比較比較低,臨床試驗(yàn)責(zé)任險(xiǎn)的認(rèn)知程度存在明顯差異,對(duì)于臨床試驗(yàn)責(zé)任險(xiǎn)的概念和含義的理解存在誤區(qū)。對(duì)于臨床試驗(yàn)責(zé)任險(xiǎn)的需求三類人群普遍較高,需求客觀存在。對(duì)比其他發(fā)達(dá)國(guó)家和地區(qū),希望我國(guó)的臨床試驗(yàn)責(zé)任險(xiǎn)能夠盡早規(guī)范起來(lái),通過(guò)法律法規(guī)等途徑,真正做到保護(hù)好受試者的權(quán)益。
[Abstract]:With the continuous development of medical cause, the application of new drugs, new devices and new medical technology, the number of clinical research projects is increasing gradually, and all kinds of unsafe events emerge in endlessly. Cases of serious injury caused by clinical research are also common. The liability insurance for drug clinical trials originated in western medical developed countries and is mainly used to distribute a series of risks caused by adverse reactions in the course of drug clinical trials. The safety of the subjects' lives and property was guaranteed. At present, the degree of cognition and importance of liability insurance in clinical trials in China is not enough, which has caused a series of medical disputes. The purpose of this study is to find out the current situation and needs of clinical research liability insurance in China through consulting materials, expert interviews and questionnaires, from the applicants. The researchers and subjects made a preliminary understanding of the degree of understanding of the liability insurance in clinical research in China, analyzed the reasons why the liability insurance in clinical research in China could not be advanced, and compared with other developed countries, to find out the gaps and deficiencies. In order to strengthen the protection of subjects in the course of clinical research in China, the Ethics Committee has regulated the review of liability insurance in research programs and informed consent letters. And ultimately clinical research liability insurance as part of the relevant national laws and regulations to provide decision-making basis and help. The content of the study is divided into the following aspects: 1 through the method of literature review to understand the current situation of clinical trials and liability insurance in China in recent years; (2) to understand the development of clinical trial, the distribution of liability insurance and the specific content of liability insurance in a Grade 3A hospital in this city. By means of questionnaire investigation, we selected the researchers, subjects and applicants from Hospital A to find out their cognition and demand for liability insurance. 4. Summarize and analyze the types and characteristics of liability insurance in clinical trials. Problems and difficulties of liability insurance in clinical trials, through questionnaires and interviews with experts, the leaders understand the difficulties and difficulties existing in the promotion of liability insurance at present; (7) to explore the factors influencing the promotion of liability insurance in clinical trials and to put forward the development direction of liability insurance in clinical trials by summing up and summing up. The results show that the clinical trial liability insurance is relatively low in clinical research in China, and there are obvious differences in the cognition of clinical trial liability insurance, and there are some misunderstandings about the concept and meaning of clinical trial liability insurance. The demand for liability insurance for clinical trials is generally high, and the demand is objective. Compared with other developed countries and regions, it is hoped that the liability insurance of clinical trials in China can be standardized as soon as possible, and the rights and interests of the subjects can be really protected by means of laws and regulations.
【學(xué)位授予單位】：復(fù)旦大學(xué)
【學(xué)位級(jí)別】：碩士
【學(xué)位授予年份】：2013
【分類號(hào)】：F842.69;R969.4

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本文編號(hào)：1933382