Risks and prevention for ethical review of drug clinical trials
10.3760/cma.j.issn.1000-6672.2011.09.015
- VernacularTitle:药物临床试验伦理审查中的风险与防范
- Author:
Chen WANG
;
Tienan YAO
;
Caizhen BAI
- Publication Type:Journal Article
- Keywords:
Drug clinical trial;
Ethical review;
Risk;
Prevention
- From:
Chinese Journal of Hospital Administration
2011;27(9):684-688
- CountryChina
- Language:Chinese
-
Abstract:
The authors presented in the paper the following subjects: a description of risk exposures commonly found in drug clinical trials; risk types in terms of the personnel organization of ethical review boards, and the composition of the ethical review board members, as well as ethical training, ethical review procedures and supervising of the ethical review. To avoid these risks, an analysis is made on the causes of ethical review risks, and recommendations are proposed on international certification, reform of ethical review board setup, greater efforts on training, introduction of ethical supervision and ethical acceptance procedure.
