Common Issues in the Initial Review of the Clinical Trial Ethics Committee / 中国医学伦理学
Chinese Medical Ethics
; (6): 47-49, 2015.
Article
in Chinese
| WPRIM (Western Pacific)
| ID: wpr-461588
Responsible library:
WPRO
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.
Full text:
Available
Database:
WPRIM (Western Pacific)
Type of study:
Practice guideline
Aspects:
Ethical aspects
Language:
Chinese
Journal:
Chinese Medical Ethics
Year:
2015
Document type:
Article