伦理审查视角下非注册临床研究方案常见问题刍议——基于某三甲医院近十年伦理审查样本的分析

Preliminary Discussion on Common Problems of Non-Registered Clinical Research Programs from the Perspective of Ethical Review:An Analysis of Ethical Review Samples in a Third-Class A Hospital in the Past Ten Years

对某三甲医院2008年至2017年伦理审查的非注册临床研究方案进行了分析,发现方案的常见问题主要集中在纳排标准不严谨、样本量的确定缺少依据、观察指标设置不合理、研究背景不充分,缺乏必要的立题依据、隐私和保密条款缺如等方面。原因在于研究人员伦理意识淡薄,临床研究方案设计能力不足,对方案制定的重视度不够。建议临床研究人员在方案制定上多下功夫,在夯实科研基础的同时正确处理好科研与伦理的关系。

This paper analyzed the non-registered clinical research program of ethical review in a third-class hospital from 2008 to 2017,and found that the common problems of the program mainly focused on the imprecise standards of inclusion and exclusion,the lack of basis for determining sample size,the unreasonable setting of observation indicators,the insufficient research background,the lack of necessary basis for topic setting,and the lack of privacy and confidentiality provisions.The reasons were as follows:the lack of ethical awareness of researchers,inadequate ability to design clinical research programs,and insufficient attention to program formulation.It is suggested that clinical researchers should pay more attention to the formulation of the program,and properly handle the relationship between scientific research and ethics while consolidating the foundation of scientific research.