Ethic review on clinical experiments of medical devices in medical institutions.
- Author:
Wanjun SHUAI
1
;
Yong CHAO
;
Ning WANG
;
Shining XU
Author Information
1. Department of Medical Engineering, First Affiliated Hospital to General Hospital of PLA, Beijing 100048, China. smallshuai2002@hotmail.com
- Publication Type:Journal Article
- MeSH:
Biomedical Research;
ethics;
Equipment and Supplies;
ethics;
Ethical Review;
Humans
- From:Chinese Journal of Medical Instrumentation
2011;35(4):274-276
- CountryChina
- Language:Chinese
-
Abstract:
Clinical experiments are always used to evaluate the safety and validity of medical devices. The experiments have two types of clinical trying and testing. Ethic review must be done by the ethics committee of the medical department with the qualification of clinical research, and the approval must be made before the experiments. In order to ensure the safety and validity of clinical experiments of medical devices in medical institutions, the contents, process and approval criterions of the ethic review were analyzed and discussed.
