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Original research
How should China set ethical guardrails for medical research?
  1. Jingyi Xu1,
  2. Zhongxuan Liu2,
  3. Jiayou Shi3,
  4. Yue Wang4
  1. 1Department of Medical Ethics and Law, School of Health Humanities, Peking University, Beijing, China
  2. 2Law School, Sichuan University, Chengdu, Sichuan, China
  3. 3Law School, Renmin University of China, Beijing, China
  4. 4School of Health Humanities, Peking University, Beijing, China
  1. Correspondence to Professor Jiayou Shi, Law School, Renmin University of China, Beijing, People's Republic of China; jiayoushi{at}ruc.edu.cn; Professor Yue Wang, Department of Medical Ethics and Law, School of Health Humanities, Peking University, Beijing, People's Republic of China; wangyues{at}bjmu.edu.cn

Abstract

‘Ethics first’ reform in China significantly changes the governance framework for the research of emerging technologies. The misapplication of human genome editing technology reflects the urgent need to reform the governance framework. Strengthening ethics governance in medical research has become a consensus in China, where legal and ethical reforms are proceeding in parallel. The protection of human dignity, the prevention of biosafety risks, as well as the regulation of technological crimes are at the core of the legal system, which has been embodied in numerous fundamental legislations following the CRISPR-babies incident. Establishing a national ethics committee to coordinate ethics governance, and reinforcing ethics review and external oversight are significant steps in ethical reform. Essentially, ethics governance requires implementing the basic concept of ‘ethics first’, focusing on forward-looking and preventive governance rather than delayed intervention, while maintaining openness and collaboration.

  • Ethics
  • Legislation
  • Policy

Data availability statement

Data sharing not applicable as no datasets generated and/or analysed for this study.

https://doi.org/10.1136/jme-2023-109621

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    Data availability statement

    Data sharing not applicable as no datasets generated and/or analysed for this study.

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    Footnotes

    • JX, ZL and JS are joint first authors.

    • JS and YW are joint senior authors.

    • JX, ZL and JS contributed equally.

    • Contributors JX, ZL and JS: drafting and editing. JS: funding. YW and JS: conceptualising and reviewing. JS is the guarantor of this article. JX, ZL and JS: joint first authors and contributed equally to this work. JS and YW: joint corresponding authors. All authors read and approved the manuscript.

    • Funding This study was funded by Study on Chinese Legislations on Human Germline Genome Editing funded by Chinese Ministry of Justice. (No. 19SFB2035), Legal and Ethical Governance for Emerging Biotechnologies in China funded by Global Partnerships Fund of British Embassy in China. (no grant number).

    • Competing interests None declared.

    • Provenance and peer review Not commissioned; externally peer reviewed.