中国医学伦理学
中國醫學倫理學
중국의학윤리학
CHINESE MEDICAL ETHICS
2015年
4期
628-631
,共4页
段茹%陈岚%贺晴%张志鹏
段茹%陳嵐%賀晴%張誌鵬
단여%진람%하청%장지붕
儿科%伦理审查%临床试验%知情同意书
兒科%倫理審查%臨床試驗%知情同意書
인과%윤리심사%림상시험%지정동의서
Pediatrics Department%Ethical Review%Clinical Trial%Informed Consent
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。
迴顧調查瞭某院臨床試驗機構倫理委員會2008年至2013年審查的兒科臨床試驗的15箇項目的方案和知情同意書，分彆對風險級彆、方案設計依據、風險最小化措施，知情同意書告知要素、語言等方麵進行瞭攷察，找齣方案和知情同意書存在的不足，併給予適噹的建議。
회고조사료모원림상시험궤구윤리위원회2008년지2013년심사적인과림상시험적15개항목적방안화지정동의서，분별대풍험급별、방안설계의거、풍험최소화조시，지정동의서고지요소、어언등방면진행료고찰，조출방안화지정동의서존재적불족，병급여괄당적건의。
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.
