医疗器械临床试验的伦理审查要点

摘要

目的 分析医疗器械临床试验的伦理审查原则与要素.方法 介绍北京安贞医院临床研究伦理委员会在医疗器械临床试验伦理审查过程中关注弱势群体、知情同意过程、研究者资质、试验设计方面的伦理审查要求.结果 北京安贞医院临床研究伦理委员会制定了医疗器械临床试验的伦理审查原则与标准操作规程.结论 伦理委员会对医疗器械临床试验伦理审查更加科学规范,成为保护受试者权益的重要手段.%Objective:To explore the principles and elements of ethical review of clinical trials regarding medical apparatus and instruments.Methods:This paper introduced Beijing Anzhen Hospital's requirements on considerations for the vulnerable,acquisition of informed consent,the researchers' qualification and experiment design,during ethical review of clinical trials regarding medical apparatus and instruments.Results:Institution review board of Beijing Anzhen Hospital designed principles and standard operating procedures for ethical review of clinical trials regarding medical apparatus and instruments.Conclusion:Ethical review of clinical trials regarding medical apparatus and instruments now is more scientifically standardized,and has become an important approach for the protection of subjects' rights and interests.