研究者发起的临床研究的风险评估及伦理审查

发布时间：2018-04-20 10:57

本文选题：研究者发起的临床研究 + 生物医学研究　；参考：《中国新药杂志》2017年22期

【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。
[Abstract]:The clinical research initiated by the researchers is inadequate in the operational level of supervision and management. At present, most institutions are approved by the ethics committee to assess the risks and protect the subjects. The subjects were exposed to the risks of physical and psychological harm, privacy invasion and personal information leakage, and economic aggression when they participated in clinical studies. The risk was not greater than the minimum risk and the low risk. Moderate risk and high risk 4 grades. The ethics committee should make an assessment based on the risk, consider the risk of the research content and the research operation, from the qualification of the researcher, the selection of the subjects, the basis of the previous research, Comprehensive evaluation of intervention factors and emergency rescue plan. In this paper, the study of drug use in the supermanual, the clinical study of special population, Clinical application of new medical technology and clinical research with no greater than minimum risk: an analysis of how the Ethics Committee conducts a risk-based ethical review of clinical research initiated by researchers.
【作者单位】：中国人民解放军总医院药物临床研究中心;
【分类号】：R95

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