干细胞再生生物学研究悖论及相关法律问题探讨  

Discuss of Stem Cell Regenerative Biology Research Paradox and Problems Related Law

作　　者：杨荣华[1] 李忠光[1] 崔婧[1] 王荣荣[1] 王春慧[1] 牟玉莲[2] Hiroshi Takeshima MengMeng Xu 刘万红[5] William Isaacs 徐学红[1] 

机构地区：[1]陕西师范大学生命科学学院,西安710119 [2]中国农业科学院北京畜牧兽医研究所,北京100193 [3]Kyoto University,Kyoto,Japan [4]MSTP,Duke University Medical Center,Durham,NC,USA [5]武汉大学基础医学院,武汉430072 [6]Johns Hopkins University,Baltimore,MD,USA

出　　处：《医学与社会》2016年第7期44-46,共3页Medicine and Society

基　　金：US Maryland Stem Cell Research Fund,编号为2009MSCRFE008300;国家自然科学基金面上项目,编号为31371256;教育部中央高校团队项目,编号为GK20130100;教育部外事局“海外名师”项目,编号为MS2014SXSF038;国家重大科学研究计划项目,编号为2015CB943100;秦巴山区持续发展中心项目,编号为CIC-QBRSD

摘　　要：干细胞可分化为构成人体的250余种细胞,这一特性为彻底攻克人类疾病带来了极大的希望,然而,现阶段也存在大量亟待解决的问题。干细胞基础研究结果应用于临床试验还有许多问题没有解决,仍然需要包括动物实验等中间试验在内的数据积累。干细胞应用前期的临床试验面临的科研人员职业道德的挑战、科学实验立论不够严谨、急功近利的虚假研究报道等问题必须坚决杜绝,在此基础上才能加快干细胞再生生物学从基础及临床试验走向临床应用的步伐。中国干细胞临床应用相关的法律法规必须借鉴发达国家的经验,组建至少包括法律界资深学者、医学伦理学专家、再生生物学领域的一线科研工作者和政治政策的制定者在内的干细胞应用相关法律委员会,颁布符合国情的法律。Stem cells have a pluripotency to develop to over 250 different cells composed of human body. This characteristic makes a great promise for human being to conquer life threatening diseases entirely and meanwhile brings rigorous challenging. Uncertainty on stem cell research needs more solid data from animal pre- clinic experiments. Issues on challenge of scientific medical workers＇ ethics,inexact scientific experiments argument and dishonest research reports etc need to be put an end to so as to speed up the pace of stem cell regenerative biology from basic and clinical trials to cure patients. The formulation of related laws and regulations of stem cells clinical application must learn from the experience of developed countries and set up legal committees related stem cell application at least including senior scholars of legal profession,experts on medical ethics,front- line researchers of regenerative biology and policy makers. It is urgent to promulgate legal provisions in accordance with the national conditions.

关 键 词：干细胞再生生物 研究悖论 法律法规 

分 类 号：R19-019[医药卫生—卫生事业管理] R163.2[医药卫生—公共卫生与预防医学]