The Information of Researcher of Medical Device Clinical Trials Should Be Informed:Current Situation, Ethical Defense and Policy Suggestion / 中国医学伦理学

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.