我国临床试验责任险的现状与需求分析

发布时间：2018-05-25 14:03

本文选题：临床试验 + 责任险　；参考：《复旦大学》2013年硕士论文

【摘要】：随着医学事业的不断发展,新药、新器械以及新医疗技术的不断运用,各类临床研究项目数量逐渐增加,随之而来的各种各样的不安全事件层出不穷,临床研究造成严重伤害的例子也屡见不鲜。药物临床试验责任险起源于西方医疗发达国家,主要用于分摊因药物临床试验进行过程中,受试者出现不良反应后引起的一系列风险,对于这些受试者的生命和财产安全给予保障。目前国内临床试验责任险的认知程度和重视程度还不够,由此产生了一系列的医疗纠纷问题。本文的研究目的是通过查阅资料、专家访谈和问卷调查等方式了解我国临床研究责任险的现状及需求,从申办者、研究者和受试者三方面对我国临床研究责任险的认识程度进行初步的了解,分析国内临床研究责任险无法推进的原因,对比其他发达国家,寻找出差距和不足,为加强我国临床研究过程中受试者的保护、规范伦理委员会对于研究方案及知情同意书中有关责任险的审查,以及最终将临床研究责任险作为国家相关法律法规政策的一部分提供决策依据和帮助。研究内容主要分为以下几个方面：①通过查阅文献的方法了解近年来国内临床试验及责任险的现状；②通过资料查阅的方法了解本市某三级甲等医院(A医院)临床试验开展情况,了解临床试验责任险的分布以及责任险的具体内容；③通过问卷调查的方式从A医院中选取研究者、受试者和申办者,了解他们对责任险的认知与需求；④归纳分析临床试验责任险的种类与特点；⑤临床研究责任险对受试者、申办方及研究者保护的作用；⑥临床试验责任险存在的问题与困难,通过问卷及访谈专家、领导了解目前责任险推广存在的难点及困难；⑦探寻影响临床试验责任险推进的影响因素；⑧通过总结归纳提出临床试验责任险的发展方向。从研究结果得知,临床试验责任险在我国的临床研究中所占比较比较低,临床试验责任险的认知程度存在明显差异,对于临床试验责任险的概念和含义的理解存在误区。对于临床试验责任险的需求三类人群普遍较高,需求客观存在。对比其他发达国家和地区,希望我国的临床试验责任险能够尽早规范起来,通过法律法规等途径,真正做到保护好受试者的权益。
[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.
【学位授予单位】：复旦大学
【学位级别】：硕士
【学位授予年份】：2013
【分类号】：F842.69;R969.4

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