伦理审查平台的应用探索  

Application and exploration of ethics review platform

作　　者：郝梅[1] 王方 丛翠翠 王力华[1] 

机构地区：[1]北京大学人民医院医学信息中心,北京100044 [2]北京大学人民医院科研处,北京100044

出　　处：《中国临床药理学杂志》2017年第23期2468-2470,共3页The Chinese Journal of Clinical Pharmacology

基　　金：国家高技术研究发展计划(863计划)基金资助项目(2012AA02A611)

摘　　要：传统伦理审查采用纸质文件审查方式和人工管理模式,由于审查信息无法及时共享,导致沟通效率低下、协同工作困难,难以适应新时期药学伦理委员会的发展要求。依据国际通用规则和医院标准操作规程,构建了信息化伦理审查协同工作平台。经过1年的实际应用,平台稳定运行,对规范审查流程,提升审查能力,提高审查效率,保护受试者权益,保证审查质量具有重要意义。Traditional ethic review,characterized by paper-management and artificial mode has a lot of shortcomings,such as ineffective administration, lacks of information sharing and collaborative management,which makes it difficult to meet the requirements of drug ethics committee in new period. According to current international rules and standard operation procedure in hospital,the ethic review platform is been designed and applied. It was proved that the system was feasible and applied,which normalized the process, enhanced the ability,improved the efficiency,protectd rights of subjects and guaranteed the quality of ethic review.

关 键 词：伦理审查 协同工作平台 信息化 伦理委员会 受试者保护 

分 类 号：R97[医药卫生—药品]