研究者发起的临床研究的风险评估及伦理审查.doc

研究者发起的临床研究的风险评估及伦 理审查 江学维曹江 梁禧禧蔡芸王瑾王睿白楠 中国人民解放军总医院药物临床研究中心 ： 研究者发起的临床研究在监督管理的操作层面存在不足，口前大多数机构由伦 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 方而综合评估。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。 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; ：江学维，男，本科，主要从事I期临床研究及伦理委员会工作。联系 电话：(010) E-ma订:i jiangxuewei@163. como ：白楠，女，博士研究生，副主任药师，主要从事I期临床研究及伦理 委员会工作。联系电话：(010) :bain-an82@126. como :2017-09-18 Risk evaluation and ethical review of investigator~initiated trials JIANG Xue-wei CAO Jiang LIANG Bei-bei CAI Yun WANG Jin WANG Rui BAI Nan Center of Drug Clinical Research, Chinese PLA General Hospital; Abstract： 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/TRB is to evaluate risk and protect participeints. 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 ethies committees should have a risk-based review when reviewing investigator-initieitcd trials, considcr 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