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。

关键词: 医学伦理, 伦理规范, 医学论文, 动物实验, 临床试验, 调查, 案例

Abstract:

[Purposes] This paper aims to survey the ethical guidelines which involve animal experiment papers and clinical trial papers, and to analyze the representative cases published in Journal of Third Military Medical University recently after a period of ethical guidelines practice.[Methods] Through CNKI or journal survey, animal experiment papers and clinical trial papers (including prospective study, retrospective study, human sample study and human population survey study) were retrieved and 20 papers were selected, respectively, to survey the ethical guidelines. The representative 5 papers published recently in Journal of Third Military Medical University were selected as typical cases to analyze the ethical statements of authors.[Findings] The survey results showed that the ethical statements of clinical trial were more normative than animal experiment. Some of the animal experiment papers lacked ethics committee approved number. Some of the clinical trial papers also did not have written informed consent from the patients, the ethics committee approved number or registered number. After a period of ethical guidelines practice, the ethical statements of selected 5 papers were more normative.[Conclusions] The ethical awareness of authors and editors has been strengthened after a period of ethical guidelines practice. But we still need to guide authors to standardize the ethical statements.

Key words: Medical ethics, Ethical guidelines, Medical papers, Animal experiment, Clinical trial, Survey, Case