新药临床试验伦理学问题探讨
新药,,新药；临床试验；伦理问题,1相关的法律、法规,2伦理委员会的职责,3临床试验的知情同意,4受试者的权益,【参考文献】
【摘要】 新药临床试验必须保障受试者的安全与权益，因而必须考虑医学伦理学问题。受试者的权益已经日益受到重视。目前国内临床研究基地对临床试验已进行了规范，也有相应的保障受试者安全与权益的法规和措施，但仍然存在一些问题值得临床试验工作者思考和重视。本文主要对存在于相关的法律、法规方面，伦理委员会的职责方面，临床试验知情同意以及受试者权益方面的一些问题及对策进行探讨，力求使临床试验中受试者的安全与权益得到更加有效的保障，以促进我国临床试验规范化、科学化、法制化建设。【关键词】 新药；临床试验；伦理问题
【Abstract】 In order to protect subjects safety,legal rights and interestings,it is necessary to consider the problems about medical ethical issues.Now the legal rights and interestings have been much attentive day and day.Though,at present clinical trials have been standardized,laws and measurements to protect subjects safe,legal rights and interestings have been set up at clinial trials bases in our country,there are still some problems worth clinical trials workers to consider and pay attentiion.In order to effectively protect subjects safety,leagal right and interesting,promote the development of clinical trials standardization,scientific regulation and legal system building of our country,in this article writers discusse about relative laws and regulations of medicine ethics,duties of ethics committee,consent of patients being informed about clinical trials and leagal rights and interestings of subjects and tries to find the ways to deal with these situations. ......
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