医学论文中涉及动物实验和临床试验的伦理规范调查及案例分析

发布时间：2018-08-28 07:47

【摘要】：【目的】调查涉及动物实验和临床试验论文的伦理规范,并对《第三军医大学学报》在践行中遇到的典型案例进行分析。【方法】利用中国知网或通过期刊调查方式,分别检索并选取动物实验研究和涉及人的临床试验研究(包括前瞻性研究、回顾性研究、取自人体标本研究、人群调查研究)各20篇,以调查其伦理规范。挑选《第三军医大学学报》最近发表的有代表性的5篇论文作为典型案例,对作者的伦理表述规范程度进行审查和分析。【结果】调查结果显示:作者对涉及人的临床试验研究伦理声明的规范程度明显强于动物实验,动物实验存在伦理委员会审批缺失,临床试验论文也存在患者知情同意、伦理委员会审批或临床试验注册的缺失。从挑选的最近发表的5篇论文来看,在初步践行伦理规范之后,作者的伦理表述规范程度明显增强。【结论】对动物实验及临床试验伦理规范的初步践行,强化了作者的出版伦理意识,但仍需要编辑不断引导作者规范伦理声明。
[Abstract]:[objective] to investigate the ethical norms related to the articles on animal experiments and clinical trials, and to analyze the typical cases encountered in the practice of Journal of the third military Medical University. 20 animal experimental studies and 20 clinical trials involving human beings (including prospective studies, retrospective studies, human specimen studies, and population-based studies) were retrieved and selected to investigate their ethical norms. Five representative papers recently published in the Journal of the third military Medical University were selected as typical cases. A review and analysis of the author's ethical statements was made. [results] the results showed that the author's ethical statements concerning clinical trials involving human beings were significantly stronger than those of animal experiments. There is a lack of ethics committee approval, clinical trial papers, patients' informed consent, ethics committee approval or clinical trial registration. From the selected five recently published papers, it is found that after the initial practice of the ethical norms, the author's ethical expression norms are significantly enhanced. [conclusion] the preliminary practice of the ethical norms of animal experiments and clinical trials, It strengthens the author's consciousness of publishing ethics, but it still needs the editor to guide the author to regulate the ethical statement.
【作者单位】：《第三军医大学学报》编辑部;第三军医大学西南医院临床研究中心;
【分类号】：G353.1;R-052

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