对《涉及人的生物医学研究伦理审查办法》的解读

Interpretation on “The Regulations of Ethical Reviews of Biomedical Research Involving Human Subjects”

解读国家卫生和计划生育委员会《涉及人的生物医学研究伦理审查办法》出台背景及特点,分析该办法强制要求有关医疗机构设立伦理委员会后,带来离体样本及信息的生物医学研究难题、伦理有关人才的需求增加而任职标准缺位、政府多部门的沟通协作有待推进、医疗机构之间的多中心伦理审查及医疗机构内部的伦理体系构建等实施问题,期待多方合力,加强沟通,落实监管,完善医学伦理组织建设,推动医学研究的长远发展。

This paper discussed the background and characteristics of ＂The Regulations of Ethical Reviews of Biomedical Research Involving Human Subjects＂ issued by National Health and Family Planning Commission of the People＇s Republic of China. The authors addressed some practical problems brought by this regulation with the compulsory requirement of the establishment of ethics committee in medical institutions conducting biomedical research involving human subjects, including challenges of research involving in vitro samples and information, the absence of enrollment standards of ethics committee members with the increasing demand of ethics experts, inadequate communication and cooperation between different government sectors, and necessity of construction of multi center ethical review and ethical system in medical institutions, etc. The efforts should be made to strengthen communication, implement oversight, improve the organizational construction of medical ethics committee, and promote the long-term sound development of medical research.