关于医疗机构伦理委员会审查中值得注意的几个问题

Issues in Ethics Review Committee in Medical Institutions

为了维护受试者/患者的权益,创建和谐的医患环境和宽松的科研环境,保护国家的生物医学资源,促进临床研究和临床试验的正常进行,我们对伦理审查中经常遇到的问题(如临床试验样本的使用及管理问题、损害赔偿等)进行分析,从而提出了一些用于提高医疗机构伦理委员会审查质量的有效措施,包括加强管理、提高认识,建议国家行政管理部门出台和完善相应的管理办法,加强各级伦理委员会的监督和相关人员的生命伦理学及法规教育,提倡开展临床试验及研究项目伦理盲审法,保证伦理委员会专家的审阅时间、施行有记名投票等方法 。

To safeguard the rights of patients/subjects, create harmonious medical surroundings and liberal environment for scientific research, protect our national biomedical resources, promote the normal for clinical research and clinical experiments, we analyzed the encounter problems of ethical review （ such as the use and management of clinical test samples, compensation of damages and so on ）. Then we put forward a series of medical institutions for higher ethical committees review of the effective measures, include strengthen the management of recognition, suggest the state administrative authorities issue and improve relevant management measures, strengthen the supervision of all ethical committees and the education of the ethics and relevant laws and regulations, promote ethical blind review for clinical research and clinical experiments, ensure ethical committee of experts for review and so on.