摘要
目的探讨我国干细胞研究产生的伦理学问题,提出规范干细胞研究的对策。方法分析干细胞在监管体系、来源渠道、生产过程、存储行业、临床研究等方面产生的伦理学问题。结果结合当前干细胞研究伦理现状及笔者单位实践探索,从形成科学有效的干细胞伦理监管体制、构建公开透明的干细胞溯源机制、打造符合GMP标准的干细胞生产平台、选择合法合规的干细胞存储机构、开展符合伦理规范的干细胞临床研究等5个方面提出应对干细胞研究伦理学问题的对策。结论加强干细胞研究的伦理建设,规范干细胞转化研究,对推动干细胞产业健康发展具有重大现实意义。
Objective To explore the ethical issues arising from stem cell research in China and propose countermeasures to regulate stem cell research.Methods This article analyzed the ethical issues arising from stem cells in terms of regulatory systems,source channels,production processes,storage industries,and translational applications.Results Combining the current ethical situation of stem cell research and the practical exploration of the authors'unit,we proposed countermeasures to address the ethical issues of stem cell research in five aspects,including forming a scientific and effective stem cell ethical regulatory system,building an open and transparent stem cell traceability mechanism,creating a GMP-compliant stem cell production platform,selecting a legal and compliant stem cell storage institution,and conducting ethical stem cell clinical research.Conclusions It is of great practical significance to strengthen the ethical construction of stem cell research and regulate stem cell transformation research to promote the healthy development of the stem cell industry.
作者
李佳潞
赵庆辉
汤红明
刘中民
Li Jialu;Zhao Qinghui;Tang Hongming;Liu Zhongmin(Translational Medical Center for Stem Cell Therapy&Institute for Regenerative Medicine,Shanghai East Hospital,Tongji University School of Medicine National Stem Cell Translational Resource Center,Shanghai Institute of Stem Cell Research and Clinical Translation,Shanghai Engineering Research Center for Stem Cell Clinical Treatment,Shanghai 200123,China)
出处
《中华医学科研管理杂志》
2023年第2期95-98,共4页
Chinese Journal of Medical Science Research Management
基金
上海高校Ⅳ类高峰学科建设资助
上海市卫生健康委员会科研项目(202150023)。
关键词
干细胞研究
伦理学
对策探讨
Stem cell research
Ethics
Countermeasure exploration
