Common Issues in the Initial Review of the Clinical Trial Ethics Committee
- VernacularTitle:临床试验伦理委员会初始审查中的主要问题
- Author:
Ting QUAN
;
Daiwen ZENG
;
Yousong YANG
;
Jing ZOU
;
Shengxi HAN
- Publication Type:Journal Article
- Keywords:
Ethics Committee;
Clinical Trial;
Ethical Review;
Initial Review
- From:
Chinese Medical Ethics
2015;(1):47-49
- CountryChina
- Language:Chinese
-
Abstract:
Objective:To analyze that if the quality of ethics review is closely related to the protection of human subjects' right and interest. Methods:This article has analyzed all the issues raised by local Ethics Committee in the process of review in recent two years since guideline of ethical review of drug clinical trials was published, summed up the most common problems occurred in protocols and informed consents. Results:Total 94 new drug or medical device clinical trial projects were reviewed by the local ethics committee, among which 29 projects were ap-proved through regular full board meeting, the approval rate in the initial review was 31%. The most common prob-lems in protocols include: the research backgrounds, design, and risk-benefit ratio; Main issues raised on in-formed consent focused on the contents, language and signature terms. Conclusions:The protection of subjects needs more improvement of capability of investigator, sponsor, drug clinical trial institution and the ethics commit-tee.
