某院儿科临床试验伦理审查的调研及建议

摘要

回顾调查了某院临床试验机构伦理委员会2008年至2013年审查的儿科临床试验的15个项目的方案和知情同意书，分别对风险级别、方案设计依据、风险最小化措施，知情同意书告知要素、语言等方面进行了考察，找出方案和知情同意书存在的不足，并给予适当的建议。%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.