重视建立人体研究保护体系对促进临床研究各环节管理的影响  

Establishing human research protection program and its influence on promoting the whole process management of clinical research

作　　者：白彩珍[1] 徐贝贝[2] 任佩娟[2] 肖淑萍[1] Bai Caizhen;Xu Beibei;Ren Peijuan;Xiao Shuping(Hospital Office,Beijing Tiantan Hospital Affiliated to Capital Medical University,Beijing 100070,China;Scientific Research Department,Beijing Tiantan Hospital Affiliated to Capital Medical University,Beijing 100070,China)

机构地区：[1]首都医科大学附属北京天坛医院医院办公室,100070 [2]首都医科大学附属北京天坛医院科技处,100070

出　　处：《中华医学科研管理杂志》2021年第1期69-72,共4页Chinese Journal of Medical Science Research Management

摘　　要：目的 提高临床研究各环节工作质量,保护人体受试者.方法 介绍医院人体研究保护体系的运行操作和管理经验.结果 建立人体研究保护体系可以促进临床研究相关部门直接的沟通与协作,加强对临床研究各环节的管理.结论 医疗机构建立全方位的人体研究规范体系与制度,对促进医院临床研究的高质量发展具有积极的推进作用.Objective Improve the quality of clinical research at different stages for better protection of human subject.Methods Introduce the operational and the administrative experiences of establishing the human research protection program in our hospital.Results Establish human research protection program can promote the direct communication and cooperation among relevant departments of clinical research,strengthen the whole process management of clinical research.Conclusions Developing comprehensive human research protection program and related policies play a positive role in promoting the high-quality development of clinical research in hospitals.

关 键 词：人体研究保护体系 临床研究 体系内定期评估 

分 类 号：R197.323[医药卫生—卫生事业管理]