儿童生物医学研究中简单干预措施的最小风险评估标准研究  

Study on the Minimal Risk Evaluation Criteria for Simple Interventions in Pediatric Biomedical Research

作　　者：杨红荣[1] 唐燕[1] 奚益群[1] 

机构地区：[1]上海市儿童医院/上海交通大学附属儿童医院伦理委员会,上海200062

出　　处：《中国医学伦理学》2018年第2期224-229,共6页Chinese Medical Ethics

摘　　要：目的收集儿童生物医学研究中的简单干预措施并分析风险情况,构建最小风险评估标准,为儿童生物医学研究伦理审查提供科学方法。方法开展儿童生物医学研究简单干预措施最小风险评估专家咨询,选取来自全国11家开展儿童临床研究医疗机构的25名专业人员,开展2轮专家咨询。结果回收有效问卷25份,调研对象积极性系数为100%;对相关问题的判断和熟悉或关注程度系数为0.764;确定4个维度25个简单干预措施的最小风险评估标准。结论采用德尔菲法科学确定了儿童生物医学研究中简单干预措施最小风险评估标准,且研究结果具有可靠性,可为儿童生物医学研究伦理审查提供参考依据。Objective： To collect the simple interventions in pediatric biomedical research and analyze the risk condition, to establish the minimal risk evaluation criteria, thus to provide the scientific method for the ethical re- view of pediatric biomedical research. Methods： The expert consultation was carried out on the minimal risk evalu- ation of the simple interventions for pediatric biomedical research, and 25 experts from 11 medical institutions car- rying out children＇ s clinical research were selected to conduct 2 rounds of expert consultation. Results ： 25 valid questionnaires were collected, and the positive coefficient of the respondents was 100%. The judgment and famili- arity or degree of attention on the related problems was 0.764. The minimal risk evaluation criteria of 25 simple in- terventions in 4 dimensions were determined. Gonclusion： We determine the minimal risk evaluation criteria for simple interventions in pediatric biomedical research using the Delphi method, and the research results were relia- ble and could provide a reference for the ethical review of pediatric biomedical research.

关 键 词：儿童生物医学研究 简单干预措施 最小风险 评估标准 

分 类 号：R174[医药卫生—妇幼卫生保健]