儿童生物医学研究最小风险评估的路径研究  

Research on Evaluation Path of Minimal Risk in Pediatric Biomedical Research

作　　者：唐燕[1] 杨红荣[1] 奚益群[1] TANG Yan;YANG Hongrong;XI Yiqun(Ethics Office,Shanghai Children＇s Hospital,Shanghai 200062,China)

机构地区：[1]上海市儿童医院伦理办公室,上海200062

出　　处：《中国医学伦理学》2018年第9期1170-1174,共5页Chinese Medical Ethics

基　　金：上海市医院协会医院管理研究基金:建立涉及儿童的临床试验最小风险评估模型的研究(2014006);上海申康医院发展中心临床科技创新项目:支撑临床大数据应用的个人隐私信息保护的制度框架研究(SHDC 2015643)

摘　　要：目的确定儿童生物医学研究最小风险评估的影响因素并判定重要程度,建立最小风险评估路径,为儿童生物医学研究的伦理审查提供科学评价工具。方法运用德尔菲法,选择全国8个省市的11所医院的25位专家,开展两轮专家咨询。结果确定6个儿童生物医学研究最小风险评估的主要影响因素,结合儿童生物医学研究简单干预措施最小风险评估标准的构建,建立多层级维度的儿童生物医学研究最小风险评估路径。结论基于德尔菲法建立的儿童生物医学研究最小风险评估路径,具有较强的科学性和伦理合理性,为儿童生物医学研究最小风险评估提供了较为完善、全面的评估架构。Objective： To determine the impact factors of the minimal risk evaluation of pediatric biomedical research and determine the importance,establish minimal risk evaluation path,so as to provide scientific evaluation tools for ethical review of pediatric biomedical research. Methods： Using Delphi method,25 experts from 11 hospitals in 8 provinces and cities were selected to carry out two rounds of expert consultation. Results： The 6 main impact factors of minimal risk evaluation of pediatric biomedical research were determined. The multi-layer dimension minimal risk evaluation path of pediatric biomedical research was constructed combined with the construction of minimal risk evaluation criteria of pediatric biomedical research simple intervention. Conclusion： The minimal risk evaluation path of pediatric biomedical research based on Delphi method has a strong scientific and ethical rationality,which provides a more complete and comprehensive evaluation framework for minimal risk evaluation of pediatric biomedical research.

关 键 词：儿童生物医学研究 风险评估 最小风险 

分 类 号：R-052[医药卫生]