Survey and Suggestion for Ethical Review of Paediatric Clinical Trials
- VernacularTitle:某院儿科临床试验伦理审查的调研及建议
- Author:
Ru DUAN
;
Lan CHEN
;
Qing HE
;
Zhipeng ZHANG
- Publication Type:Journal Article
- Keywords:
Pediatrics Department;
Ethical Review;
Clinical Trial;
Informed Consent
- From:
Chinese Medical Ethics
2015;(4):628-631
- CountryChina
- Language:Chinese
-
Abstract:
This article surveyed the protocols and informed consent forms of 15 paediatric clinical trials which had been reviewed by the hospital′s institutional research board from 2008 to 2013 .This survey reevaluated and made suggestions on the protocols and informed consent forms, focusing on the risk level, protocol design back-ground, risk minimization measures, the required elements as well as the language expressions of informed consent forms and finding out the shortage of informed consent and give appropriate advices.
