Human genetic resources management of the Investigator-Initiated Clinical Trials
10.3760/cma.j.cn113565-20211207-00192
- VernacularTitle:研究者发起临床研究的人类遗传资源管理初探
- Author:
Fan WU
1
;
Danlei WANG
;
Gongwen LIANG
;
Na HAN
Author Information
1. 北京大学人民医院 100044
- Keywords:
Investigator-Initiated Clinical Trial;
Innovation of medical science and technology;
Human genetic resources management
- From:
Chinese Journal of Medical Science Research Management
2022;35(3):171-174
- CountryChina
- Language:Chinese
-
Abstract:
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.
