研究者发起的临床研究的风险评估及伦理审查  

Risk evaluation and ethical review of investigator-initiated trials

作　　者：江学维[1] 曹江[1] 梁蓓蓓[1] 蔡芸[1] 王瑾[1] 王睿[1] 白楠[1] 

机构地区：[1]中国人民解放军总医院药物临床研究中心,北京100853

出　　处：《中国新药杂志》2017年第22期2714-2718,共5页Chinese Journal of New Drugs

摘　　要：研究者发起的临床研究在监督管理的操作层面存在不足,目前大多数机构由伦理委员会进行审批、评估风险从而保护受试者。受试者在参加临床研究时会受到来自身体生理伤害、心理精神危害、隐私侵犯与个人信息资料泄露以及经济侵犯的风险,风险存在不大于最小风险、低风险、中度风险和高风险4个等级。伦理委员会在审查时应基于风险进行评估,考虑研究内容和研究操作所带来的风险,从研究人员资质、受试人群的选择、前期研究基础、干预因素及应急抢救预案等方面综合评估。本文从超说明书用药研究、特殊人群的临床研究、医疗新技术临床应用和不大于最小风险的临床研究4个方面浅析伦理委员会如何对研究者发起的临床研究进行基于风险的伦理审查。There exist defects in the supervision and conduction of investigator-initiated clinical trials,because they are mainly reviewed and approved by ethics committees/institutional review boards（EC/IRB）. And the mission of EC/IRB is to evaluate risk and protect participants. Subjects who attend clinical studies will suffer potential psychological harm,privacy/legal harm,financial harm and health/physical harm. The risks are classed into four grades,which are not more than minimum risk,minor increase over minimal risk,moderate risk and high risk. The ethics committees should have a risk-based review when reviewing investigator-initiated trials,consider the possible risks brought by the research contents and interventions,and comprehensively evaluate the research risks from the perspectives such as investigators＇ qualification,subject selection,foundation laid by previous work,interventions and emergency plans. This article explored how ethics committees perform risk-based review on investigator-initiated trials including off-label use drug research,clinical research in special populations,clinical application of new medical technologies and clinical research of no less than the minimum risk.

关 键 词：研究者发起的临床研究 生物医学研究 风险评估 伦理审查 

分 类 号：R969.4[医药卫生—药理学]