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
10.12026/j.issn.1001-8565.2019.03.14
- VernacularTitle: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
- Author:
Jing YANG
1
;
Xiuqin CHEN
;
Lucan JIANG
;
Yongchuan CHEN
Author Information
1. 陆军军医大学第一附属医院伦理委员会
- Keywords:
Ethical Review;
Non-Registered Clinical Research Programs;
Sample Analysis
- From:
Chinese Medical Ethics
2019;32(3):345-349
- CountryChina
- Language:Chinese
-
Abstract:
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.
