研究者发起临床研究的人类遗传资源管理初探  

Human genetic resources management of the Investigator-Initiated Clinical Trials

作　　者：邬凡[1] 王丹蕾[1] 梁公文[1] 韩娜[1] Wu Fan;Wang Danlei;Liang Gongwen;Han Na(Peking University People′s Hospital,Beijing 100044,China)

机构地区：[1]北京大学人民医院,100044

出　　处：《中华医学科研管理杂志》2022年第3期171-174,共4页Chinese Journal of Medical Science Research Management

基　　金：北京大学科研管理课题。

摘　　要：目的为了鼓励医学科技创新,规范研究者发起的临床研究活动,分析医疗机构人类遗传资源管理所面临的问题以及对应采取的管理措施。方法结合现有法律规章等管理制度以及医院管理实际,对研究者发起临床研究的人遗管理存在问题进行梳理。结果存在监管机制不完善、政策解读不透彻、研究者对人遗政策的认识不充分以及如何在人遗管理的范畴内支持创新等问题。结论医疗机构应建立完善监管体系,强化IIT全流程管理;精准解读文件,提高申报效率;提升研究者人遗认知度,避免漏报错报;搭建保藏平台,鼓励合法合规利用人类遗传资源开展高水平IIT创新。Objective To encourage the innovation of medical science and technology,regulate the Investigator Initiated Clinical Trials(IIT),this paper analyzed the problems faced by the management of human genetic resources in medical institution,and the corresponding management measures.Methods Existing problems of human genetic resource management in IIT were discussed and summarized,taking into consideration of regulatory requirements and daily practices in the hospital.Results Problems identified include imperfect supervision mechanism,incomplete policy interpretation,insufficient understanding of human genetic resources management policies by researchers,and how to support innovation with human gentic resources and so on.Conclusions Medical institutions should establish and improve the supervision system and strengthen the whole process management of IIT.Accurately interpret regulatory requirements to improve application efficiency.Improve researchers′recognition of human genetic resources to avoid omission and misrepresentation.Build a biobank to encourage legal and compliant use of human genetic resources to carry out high-quality IIT.

关 键 词：研究者发起临床研究 医学科技创新 人类遗传资源管理 

分 类 号：R394[医药卫生—医学遗传学]