The result analysis of initial clinical research ethics review in a hospital
10.3760/cma.j.issn.1006-1924.2016.06.020
- VernacularTitle:某院临床研究伦理初始审查结果分析
- Author:
Zhongguang YU
;
Yanfen CHEN
;
Zongping CHANG
;
Lin LI
;
Xu YAN
;
Ruihua SUN
- Keywords:
Clinical research;
Ethics;
Initial review
- From:
Chinese Journal of Medical Science Research Management
2016;29(6):477-480
- CountryChina
- Language:Chinese
-
Abstract:
Objective In this paper,we analyzed the initial review projects of clinical research during past five years in a hospital,which aims to summarize the experience and analysis existent problems,in order to provide a reference for the future hospital ethics review.Methods Summarizing and analyzing the meeting records during past five years,which were also in the field of the initial review projects of clinical research.Results Clinical trials of drug and divice,and clinical research projects exist in varying degrees of problems,which express in these two aspects:research design and ethical rational.Conclusions Ethics Committee should stengthen review the following two parts,the scientific of research project and the informed consent form.Improve their own system constantly,and ensure the efficient operation of the Ethics Committee.
