Ethical Review Gist of Clinical Trials Regarding Medical Apparatus and Instruments
10.12026/j.issn.1001-8565.2017.07.14
- VernacularTitle:医疗器械临床试验的伦理审查要点
- Author:
Wei SUO
;
Kexu YANG
;
Yang LIN
- Keywords:
Medical Apparatus and Instruments;
Clinical Trial;
Institutional Review Board;
Ethical Review
- From:
Chinese Medical Ethics
2017;30(7):856-858
- CountryChina
- Language:Chinese
-
Abstract:
Objective:To explore the principles and elements of ethical review of clinical trials regarding medical apparatus and instruments.Methods:This paper introduced Beijing Anzhen Hospital's requirements on considerations for the vulnerable,acquisition of informed consent,the researchers' qualification and experiment design,during ethical review of clinical trials regarding medical apparatus and instruments.Results:Institution review board of Beijing Anzhen Hospital designed principles and standard operating procedures for ethical review of clinical trials regarding medical apparatus and instruments.Conclusion:Ethical review of clinical trials regarding medical apparatus and instruments now is more scientifically standardized,and has become an important approach for the protection of subjects' rights and interests.
