摘要
目的旨在剖析目前我国干细胞临床研究管理中面临的难题,探讨如何提高干细胞研究管理建设能力,推进干细胞临床研究健康有序地发展。方法通过检索我国干细胞临床研究相关政策法规,以问题为导向,分析在政策法规层面、具体管理机构层面和研究者层面亟需解决的问题,探讨加强医疗机构干细胞临床研究管理建设的对策建议。结果干细胞的临床应用存在着不确定性和高风险,在推进干细胞临床研究和应用转化的过程中充满机遇和挑战,在政策法规层面存在管理规范不够细化、具体管理机构层面存在内部制度不健全和研究者层面存在法规和伦理概念缺乏等诸多亟需解决的问题。结论干细胞研究作为一项前沿新兴科学技术,具有非常广阔的医疗前景。干细胞临床研究的管理需要政府部门和机构管理部门的共同努力,共同探讨和建立干细胞临床研究管理体系,同时也需要研究者、干细胞企业和受试者的积极参与,共同促进干细胞临床研究的健康有序发展。
Objective To analyze the current problems in the management of stem cell clinical research in China,explore how to improve the construction ability of stem cell research and management,and promote the well development of stem cell clinical research.Methods By searching the relevant laws and policies of stem cell clinical research in China,identifying prob lems that need to be.solved at the regulatory levels institutional level and individual research personnel,proposing countermeas ures and suggestions on strengthening the construction of stem cell clinical research management in medical institutions.Results There are uncertainties and high risks in the clinical application of stem cells,which is full of opportunities and challenges in the process of promoting the clinical research and application transformation of stem cells.There are many problems to be solved,such as the lack of detailed management standards,the imperfect internal system at the level of specific management in stitutions»and the lack of regulations and ethical concepts at the researcher level.Conclusions Stem cell research is one of the promising new frontiers of science and technology.The management of stem cell clinical research needs the joint efforts of government departments and institutional management departments to discuss and establish the management system of stem cell clinical research.At the same time,it also needs the active engagement of stakeholder,such as researchers^stem cell enterpri ses and human subjects to work together in promoting the well development of stem cell clinical research.
作者
黄小慧
黄凯琪
许颖君
彭亮
Huang Xiaohui;Huang Kaiqi;Xu Yingjun;Peng Liang(Clinical Medicine Research Center,The Third Affiliated Hospital of Sun Yat-sen University Guangzhou 510630,Guang dong Province,China;Guangdong Provincial Key Laboratory of Liver Research,the Third Affiliated Hospital of Sun Yat-sen University,Guangzhou 510630,Guangdong Province China;Infectious Disease Department The Third Affilia ted Hospital of Sun Yut-sen University,Guafigzhou 510630,Guangdong Province,China)
出处
《中华医学科研管理杂志》
2020年第6期465-469,共5页
Chinese Journal of Medical Science Research Management
基金
中山大学附属第4医院管理科研基金资助项目(2O19GLMS06)。
关键词
干细胞
临床研究
管理
Stem cell
Clinical research
Management
