Practice and consideration on the management of human genetic resources in drug clinical research under new regulations
NI Qi
LIU Yi
Abstract：Human genetic resources are an important strategic resources for the development of science and technology.The scientific research on human genes not only holds significant potentials for development and utilization value but also poses biological safety risks.In order to implement the"Regulations of the People's Republic of China on the Management of Human Genetic Resources"(hereinafter referred to as"the Regulations"),further improve the standardization level of human genetic resources management in China,strengthen the management of human genetic resources,and promote the effective protection and rational use of human genetic resources,the Ministry of Science and Technology of the People's Republic of China(hereinafter referred to as"Ministry of Science and Technology")issued the"Implementing Rules of the Regulations on the Management of Human Genetic Resources"(hereinafter referred to as the"Implementation Rules")and has successively released several notifications regarding the administrative approval management of human genetic resources,and adjusted relevant approval processes.How to optimize the supervision and application process of clinical trials and scientific research projects on the basis of standardized management has become an extremely important issue to hospital management.This article is set against the backdrop of"the Regulations"and the"Implementation Rules".It summarizes,based on the characteristics of the review process at various stages of actual application,the management mechanisms for human genetic resources,related system construction,and declaration situation at the Dermatology Hospital of Chinese Academy of Medical Sciences over the past four years.Focusing on several aspects of human genetic resources collection,preservation,international cooperation in scientific research,and the provision or open use of information to the outside world,the paper summarizes the main problems found in the process of project declaration and puts forward targeted improvement measures in order to promote the standardized management of clinical research,in order to provide reference suggestions for medical institutions in strengthening human genetic resources management.
Keywords：human genetic resourcesmanagementstandardizationclinical trialsscientific research
Publication Date：2025-10-15
Online Publishing Date：2026-08-14(First online date of this platform, not the publication date of the document)
Pages：5( 2036-2040 )