我国干细胞临床研究现状与伦理问题分析

Analysis on Current Situation and Ethical Problems of Stem Cell Clinical Research in China

在干细胞临床研究中如何趋利避害,发挥技术的优势造福人类,是值得深思的。通过对干细胞临床研究现状分析,包括技术及相关管理办法;提出进行干细胞研究存在的主要问题,诸如技术不确定带来的风险、研究与治疗的模糊、过度治疗还是技术创新等;进而探讨中国干细胞临床研究的伦理、法律风险,主要涉及法律法规建设滞后、行政主管部门的监管挑战大、研究者的伦理意识有待进一步提升、没有关照到公平公正原则、医疗机构的研究平台建设不到位及受试者保护体系不完善、伦理委员会组织建设和审查能力仍有一定欠缺等。

It is worth pondering how to seek advantages and avoid disadvantages in stem cell clinical research and give full play to the advantages of technology for the benefit of mankind.Through the analysis of the status of stem cell clinical research,including technology and related management methods,proposed the main problems existing in stem cell research,such as the risks of technological uncertainty,ambiguity between research and treatment,over-treatment and technological innovation.Then this paper discussed the ethical and legal risks of stem cell clinical research in China,mainly related to the problems that the construction of laws and regulations is lagging behind,the regulatory challenges of administrative departments are large,the ethical awareness of researchers needs to be further improved,the principle of fairness and justice is not taken into account,the research platform construction of medical institutions is not in place and the protection system of subjects is imperfect,and the organization construction and review capacity of the ethics committee is still lacking.