某大型医院研究者发起的临床研究人类遗传资源管理探索  

Exploration of Investigator-Initiated Clinical Trials human genetic resource administration in a large hospital

作　　者：邢荔函 左旭 李悦[1] 崔焱[2] Xing Lihan;Zuo Xu;Li Yue;Cui Yan(Science and Technology Department,Beijing Friendship Hospital,Capital Medical University,Beijing 100050,China;Office of Drug Clinical Trials Institution,Beijing Friendship Hospital,Capital Medical University,Beijing 100050,China)

机构地区：[1]首都医科大学附属北京友谊医院科技处,北京100050 [2]首都医科大学附属北京友谊医院药物临床试验机构办公室,北京100050

出　　处：《中华医学科研管理杂志》2022年第3期175-179,共5页Chinese Journal of Medical Science Research Management

基　　金：2018年度消化内科学科协同发展中心协作创新项目(XXX0105)。

摘　　要：目的目前大型医院利用人类遗传资源开展研究者发起临床研究(IIT)的管理体系尚不完善。本研究旨在梳理大型医院IIT中人类遗传资源管理现存问题,分析某大型医院管理的实践方法,为IIT中人类遗传资源的规范管理提供借鉴。方法通过文献分析梳理大型医院IIT中人类遗传资源管理现存问题,分析某大型医院自院人遗办成立以来的管理实践活动,提出大型医院IIT人类遗传资源管理建议。结果大型医院IIT人类遗传资源管理问题集中在研究者和管理者对管理的认知不足、重视程度不高、过程监管缺乏、遗传资源的投入与产出不对等方面。某大型医院通过落实人员和制度建设、强化节点管控、建设培训体系,2021年科技部人遗行政审批、备案项目较上一年度同比增长52.69%。结论大型医院应从实际出发,多部门联动共同构建人类遗传资源管理体系,完善管理流程,加强质量控制,加大培训力度,提升研究者和管理者的专业能力和素质,促进IIT高质量、高水平和有序开展。Objective The management system of Investigator Initiated Clinical Trials(IIT)using human genetic resources in large hospitals is still not optimal.The purpose of this study is to sort out the existing problems of human genetic resources management in IIT of large hospitals,analyze the management practices,and provide reference for the standardized management of human genetic resources in IIT.Methods The existing problems of human genetic resources management in IIT of large hospitals were sorted out by literature analysis,and the management practices since the establishment of human genetic resources management office were analyzed,and suggestions were put forward.Results The problems of human genetic resources management in IIT of large hospitals mainly focused on the lack of awareness and attention of investigators and managers,the lack of process supervision,and the imbalance between input and output of genetic resources.A large hospital has implemented personnel and system construction,strengthened node management and control,and developed a training system.The approval rate of administrative approval and archival projects of human genetic resources of the Ministry of Science and Technology in 2021 increased by 52.69%compared with the previous year.Conclusions Large hospitals should proceed from the actual situation,establish the human genetic resource management system jointly through multi-department linkage,improve management process,strengthen quality control,increase training efforts,improve the professional capacity and quality of researchers and managers,promote the high-quality,high-level and well development of IIT.

关 键 词：人类遗传资源 研究者发起的临床研究 大型医院 

分 类 号：R394[医药卫生—医学遗传学]