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Laws & Regulations

International Documents

  • Declaration of Helsinki, 2013
  • The Universal Declaration of Human Rights Preamble(UNESCO, 2005)
  • Guidance for Ethics Review of Health-Related Research with Human Participants (WHO, 2011)
  • International Ethical Guidelines for Health-related Research Involving Humans (CIOMS, 2016)

Domestic Documents

  • 《干细胞临床研究管理办法(试行)》(国卫科教, 2015)
  • 《关于深化审评审批制度改革鼓励药品医疗器械创新的意见》(两办, 2017)
  • 《人胚胎干细胞研究伦理指导原则》(科技部卫生部联合, 2003)
  • 《涉及人的生物医学研究伦理审查办法》(国家卫计委, 2016)
  • 《涉及人的生物医学研究伦理审查规范》(上海地标, 2015)
  • 《体外诊断试剂临床试验技术指导原则》(国家食药监, 2014)
  • 《细胞治疗产品研究与评价技术指导原则(试行)》(国家食药监, 2017)
  • 《药物临床试验伦理审查工作指导原则》(国家食药监, 2010)
  • 《药物临床试验质量管理规范》(国家药监局, 2020)
  • 《医疗器械临床试验质量管理规范》(国家食药监, 2016)
  • 《涉及人的生命科学和医学研究伦理审查办法》(国家卫科教, 2023)

Contact Us

18F, Building A, No. 380 Fenglin Road (Fenglin International Center)
021-33676001 021-33676247 (Office Tel)
021-33676540 (For Research Complaints)
seccr@scrcnet.org (Attachment less than 20MB)
scrciec2008@163.com (Attachment larger than 20MB)

Links

  • Shanghai Clinical Research Center
  • Shanghai Municipal Health Commission
  • National Health Commission of the People's Republic of China
  • Council for International Organizations of Medical Sciences (CIOMS)
  • European Network for Research Ethics and Integrity (ENERI)
  • Public Responsibility in Medicine and Research (PRIM&R)
  • National Institute of Health and Medical Research (INSERM)
  • HUST Center for Bioethics
  • 中国人民大学生命伦理学研究所

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