中国医学伦理学Issue(4)：628-631,4.
某院儿科临床试验伦理审查的调研及建议
Survey and Suggestion for Ethical Review of Paediatric Clinical Trials
段茹 1陈岚 1贺晴 1张志鹏2
作者信息
- 1. 南京医科大学附属无锡市人民医院药物临床试验机构伦理委员会，江苏 无锡 214023
- 2. 苏州大学药学院，江苏 苏州 215123
- 折叠
摘要
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.关键词
儿科/伦理审查/临床试验/知情同意书Key words
Pediatrics Department/Ethical Review/Clinical Trial/Informed Consent分类
医药卫生引用本文复制引用
段茹,陈岚,贺晴,张志鹏..某院儿科临床试验伦理审查的调研及建议[J].中国医学伦理学,2015,(4):628-631,4.
