The Information of Researcher of Medical Device Clinical Trials Should Be Informed:Current Situation, Ethical Defense and Policy Suggestion
10.12026/j.issn.1001-8565.2017.12.15
- VernacularTitle:医疗器械临床试验研究者信息应该告知——现状、伦理辩护与政策建议
- Author:
Xiaomin XING
1
;
Rui DENG
Author Information
1. 山西医科大学人文社会科学学院
- Keywords:
Medical Device Clinical Trials;
Researcher Information;
Ethical Defense
- From:
Chinese Medical Ethics
2017;30(12):1517-1521
- CountryChina
- Language:Chinese
-
Abstract:
The technological level of medical device trials researchers directly affects the validity and risk of trials,but now almost all the research programs and informed consents don't have designate researchers.The analyses of the contents of three informed consents suggested that "researcher information" was that the subjects paid great attention to and had the right to know;in order to respect the subject autonomy,maintain the justice of research,reduce the harm and maintain social harmony,the information of researchers of medical device clinical trials with significant risk involved operation should be informed to subjects.In this regard,policy and ethical review should make clear requirements in practice.