赵心刚,徐萍,马维骏,沈毅,王丽萍.规范和完善我国干细胞研究与临床应用的伦理审查和过程监管机制势在必行[J].中国科学院院刊,2012,(4):432-438.

赵心刚
中国科学院生命科学与生物技术局
Zhao Xingang
Bureau of Life Sciences and Biotechnology,CAS 100864 Beijing
徐萍
中国科学院上海生命科学信息中心
Xu Ping
Shanghai Information Center for Life Sciences,CAS 200031 Shanghai
马维骏
中国科学院上海生命科学研究院健康科学研究所
Ma Weijun
Institute of Health Sciences,Shanghai Institute for Biological Sciences,CAS 200025 Shanghai
沈毅
中国科学院生命科学与生物技术局
Shen Yi
Bureau of Life Sciences and Biotechnology,CAS 100864 Beijing
王丽萍
中国科学院生命科学与生物技术局
Wang Liping
Bureau of Life Sciences and Biotechnology,CAS 100864 Beijing

         干细胞研究;伦理审查;过程监管

        stem cell;ethical review;supervision

        干细胞研究涉及伦理问题,在将相关研究成果转化为临床应用的过程中,还会使患者面临一系列的风险。为规范干细胞研究和应用,世界各国的相应机构推出了一系列的伦理审查规范和监管法规,对相关行为进行严格的控制,从而在不影响干细胞研究和应用发展的前提下,最大限度地保护各方权益。本文旨在为规范和完善我国干细胞研究和临床应用的伦理审查和监管体系提供参考。在对主要国家的干细胞的伦理审查和监管情况进行调研的基础上,重点选取美国和英国的干细胞监管体系进行深入剖析,总结这两个国家在干细胞监管体系中的做法,并对我国干细胞研究和应用的监管情况进行分析,针对存在的问题提出建议。

        Ethical issues are involved in stem cell research.The clinical applications of stem cells also make patients face a series of risks.A number of ethical review standards and supervision regulations have been launched by the appropriate agencies of the countries around the world to strictly limit on the relevant events in order to maximize the protection of interests for all under the premise to benefit people’s health from the application and research of stem cells.This paper aims to provide a reference to standardize and improve ethical review and supervision system for stem cells research and its clinical applications.Based on the investigations on the stem cells ethical review and regulatory measures carried out by the major countries,we thoroughly analyze stem cells regulatory system of U.S.and the UK,summarize the practices implemented by these two countries in the stem cells regulatory system,and provide recommendations on current regulatory status of stem cells research and application in our country.