解读《涉及人的生命科学和医学研究伦理审查办法》发展负责任研究与创新

Interpretation of the Measures for Ethical Review of Life Sciences and Medical Research Involving Humans developing responsible research and innovation

《涉及人的生命科学和医学研究伦理审查办法》的出台,回应了科学技术、社会和伦理发展引发的伦理审查新问题,以及法律法规对伦理审查的要求,适应了科技创新研究投入持续加大和生物技术发展的趋势,扩展了伦理审查制度适用机构和研究类型。面对涉及人的生命科学和医学研究,伦理审查是负责任研究与创新的保障形式之一。因此,要建立并完善伦理审查制度,落实涉及人的生命科学和医学研究的“主体责任”,开展分类分层次的生命伦理教育,增强科研人员、研究管理人员和学生的负责任研究与创新的意识。

The Measures for Ethical Review of Life Sciences and Medical Research Involving Humans responded to the new issues faced by ethical review arising from the development of science and technology,society,and ethics,as well as the requirements of laws and regulations for ethical review.It adapted to the continuous increase of investment in scientific and technological innovation research and the development of biotechnology in China,and expanded the applicable institutions and research types of the ethical review system.Facing the ethical review of life sciences and medical research involving humans is one of the practical forms of responsible research and innovation.Therefore,it is necessary to establish and improve the ethical review system,implement the“subject responsibility”of life sciences and medical research involving humans,carry out classified and hierarchical bioethics education,and enhance the consciousness of researchers,research managers,and students in responsible research and innovation.