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
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摘要
精准医学在数据安全与共享、隐私保护、临床应用的操作程序及监管规范、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。
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.
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.
引文
[1] White House.Remarks by the president in state of the union address[EB/OL].https://obamawhitehouse.archives.gov/the-press-office/2015/01/20/remarks-president-state-union-address-january-20-2015.2015-01-20 / 2018-3-28.
[2] Frizzo-Barker J,Chow-White P A,Charters A,et al.Genomic big data and privacy:Challenges and opportunities for precision medicine[J].Computer Supported Cooperative Work,2016,25(2-3):115-136.
[3] Nicol D,Bubela T,Chalmers D,et al.Precision medicine:Drowning in a regulatory soup[J].Journal of Law and the Biosciences,2016,3(2):281-303.
[4] Precision Medicine Initiative Working Group.The precision medicine initiative cohort program-building a research foundation for 21st century medicine[R].Washington:National Institutes of Health,2015:1-103.
[5] Collins F S,Varmus H.A new initiative on precision medicine[J].New England Journal of Medicine,2015,372(9):793-795.
[6] Rusk N.Deep learning[J].Nature Methods,2016,13(1):35.
[7] 王晓敏,刘星.基因导向个体化医疗中的伦理问题研究[J].伦理学研究,2017,(2):100-104.
[8] 周元,蔡善荣,邓甬川.基因检测应用的社会伦理问题[J].中国医学伦理学,2008,21(2):102,119.
[9] 孙福伯,刘利丹.DTC基因检测的伦理思考[J].医学与哲学,2013,34(8):45-47.
[10] Millum J,Wendler D,Emanuel E J.The 50th anniversary of the declaration of Helsinki:Progress but many remaining challenge[J].Jama-Journal of the American Medical Association,2013,310(20):2143-2144.
[2] Frizzo-Barker J,Chow-White P A,Charters A,et al.Genomic big data and privacy:Challenges and opportunities for precision medicine[J].Computer Supported Cooperative Work,2016,25(2-3):115-136.
[3] Nicol D,Bubela T,Chalmers D,et al.Precision medicine:Drowning in a regulatory soup[J].Journal of Law and the Biosciences,2016,3(2):281-303.
[4] Precision Medicine Initiative Working Group.The precision medicine initiative cohort program-building a research foundation for 21st century medicine[R].Washington:National Institutes of Health,2015:1-103.
[5] Collins F S,Varmus H.A new initiative on precision medicine[J].New England Journal of Medicine,2015,372(9):793-795.
[6] Rusk N.Deep learning[J].Nature Methods,2016,13(1):35.
[7] 王晓敏,刘星.基因导向个体化医疗中的伦理问题研究[J].伦理学研究,2017,(2):100-104.
[8] 周元,蔡善荣,邓甬川.基因检测应用的社会伦理问题[J].中国医学伦理学,2008,21(2):102,119.
[9] 孙福伯,刘利丹.DTC基因检测的伦理思考[J].医学与哲学,2013,34(8):45-47.
[10] Millum J,Wendler D,Emanuel E J.The 50th anniversary of the declaration of Helsinki:Progress but many remaining challenge[J].Jama-Journal of the American Medical Association,2013,310(20):2143-2144.