Interprestation of the key review points of human genetic resources application

VernacularTitle:人类遗传资源审批申请书审核要点解析
Author: Lijue WANG ¹ ; Mingfeng WU ; Danlei WANG ; Huaying FAN ; Zhenwei XIE ; Danjie GUO ; Hua ZHANG ; Tianbing WANG ; Hao WANG
Author Information

1. 北京大学人民医院科研处 100044
Keywords: Human genetic resources; Drug clinical trial; Check points
From: Chinese Journal of Medical Science Research Management 2019;32(6):479-480,封3
CountryChina
Language:Chinese
Abstract: Objective To strengthen human genetic resource management in clinical trials.Methods This article analyzes the common problems in the process of reviewing human genetic resources application by the drug clinical trial institute in our hospital,and proposes solutions for solving the problems.Results Common questions are also the key points for future review of human genetic resources applications,including the collection of sample and consistency with clinical trial plan,ethical review and informed consent,intellectual property rights etc.Conclusions Strictly reviewing applications of human genetic resources,as well as strengthen the management of human genetic resources in clinical trials,are not only make traceability of human genetic resources traceable,but also have important significance for the authenticity and scientific validity of trial results.