• 中国科学学与科技政策研究会
  • 中国科学院科技政策与管理科学研究所
  • 清华大学科学技术与社会研究中心
ISSN 1003-2053 CN 11-1805/G3

科学学研究 ›› 2019, Vol. 37 ›› Issue (4): 577-581.

• 科学学理论与方法 •    下一篇

我国基因检测伦理监管政策法规研究 ——基于精准医学的视角

王群1,丁心蕊1,段佳莹1,李磊2,孟令宇1,王国豫3   

  1. 1. 大连理工大学
    2.
    3. 复旦大学
  • 收稿日期:2018-07-09 修回日期:2019-01-15 出版日期:2019-04-15 发布日期:2019-04-24
  • 通讯作者: 王国豫
  • 基金资助:

    国家重点研发计划“精准医学研究”重点专项:精准医疗伦理、政策法规框架研究

A study of China’s policies and regulations on ethical supervision of genetic testing ——Based on the perspective of precision medicine

  • Received:2018-07-09 Revised:2019-01-15 Online:2019-04-15 Published:2019-04-24
  • Contact: WANG Guoyu
  • Supported by:

    The national key research and development program "Ethics, Policies and Regulation of Precision Medicine"

摘要: 精准医学在数据安全与共享、隐私保护、临床应用和服务的操作程序及监督规范、遗传咨询这四方面提出了伦理监管挑战。本研究以基因检测为例,运用政策文本分析方法,分析我国基因检测伦理监管的政策法规现状与精准医学伦理监管内在要求之间的差距。基于政策文本分析结果,本研究提出为应对精准医学所带来的伦理挑战,我国的基因检测伦理监管应首先在现有政策法规基础上进行适当扩展及修正,并在这一过程中注重基因检测伦理监管政策法规的适应性、灵活性、敏感性。此外,本研究还建议我国应加强对相关从业人员的精准医学伦理培训。

Abstract: Precision medicine poses ethical supervision challenges in four aspects: data security and sharing, privacy protection, operational procedures and supervision norms of clinical applications, and genetic counseling. Taking genetic testing as an example, this study uses the method of document analysis to analyze the gap between the current situation of policies and regulations of genetic testing’s ethical supervision in China and the inherent requirements of precision medicine’s ethical supervision. Based on the results of document analysis, this study proposes to deal with the challenges brought by ethical supervision of precision medicine, the ethical supervision of genetic testing in China should first be appropriately extended and revised on the basis of existing policies and regulations, then focus on the adaptability, flexibility, and sensitivity of ethical supervision’s policies and regulations on genetic testing, and strengthen precision medical ethics training for relevant practitioners.