Analysis and research about the management of ethical post approval review in human subject research
10.3760/cma.j.issn.1006-1924.2018.06.001
- VernacularTitle:涉及人的临床研究伦理跟踪审查管理的分析与研究
- Author:
Xue HONG
1
;
Xiaohong WANG
;
Lijun LIANG
;
Yaqin LEI
;
Chun ZHANG
Author Information
1. 100191,北京大学第三医院科研处
- Keywords:
Human-involved clinical research;
Tracking review;
Ethical management
- From:
Chinese Journal of Medical Science Research Management
2018;31(6):401-403
- CountryChina
- Language:Chinese
-
Abstract:
Objective Ethical review is an important safeguard for the development of human subject research.The post approval review during the research process is particularly vital because it is the core method in the ethical review to protect participants' safety and right.In this article,current problems about post approval review were analyzed deeply to explore how to improve the mechanism of post approval review from the combination of management and technical aspect,particularly for the plan of not-for-cause visit.Methods According to the work experiences,literature review,identifying problems,to explore the collaboration to strengthen post approval review with experts,pharmacological institutions and scientific research management department.Results There are more and more frequent ethical issues during the implementation process,besides continuing strengthen the passive continuing review,continuing review guidelines and more detailed active continuing review screening and implementation mechanism should be developed.Conclusions It will prevent the occurrence of injury through establishing more optimal post approval review mechanism and a forehand active prevention strategy,which play an important role in the ethical review of human subject research.
