肠道微生物样本库:伦理考量和管理规范
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摘要
人体微生物组与健康和疾病的关系是重要的科学问题。而人体微生物样本库的建立是人体微生物组研究的重要基础,这个新兴领域迫切要求对已建立的价值体系和伦理规范进行调整和变革。本文讨论人体微生物样本库建设中的知情同意、样本和数据的所有权、隐私和风险等;并以粪菌库和粪菌移植为典型案例,分析选择"最佳"、"健康"供体所面临的医学和伦理困难;提出了人体微生物样本库监管的政策建议。
Human microbiome research and its relationship with health and disease have increasingly become a hot area in biomedical science.Biobanking human microbiome is fundamental for the development of human microbiome research.However,human microbiome research and biobank are facing many serious ethical,social and regulatory challenges that must be addressed.In this article,we examine three core ethical and social issues,i.e.,informed consent,ownership,privacy and risks.Next,we employ fecal microbiota bank and fecal microbiota transplantation as a case study to discuss how to determine a suitable healthy donor.We conclude the article by providing some regulatory and governance suggestions for policy makers to develop successful policy response.
Human microbiome research and its relationship with health and disease have increasingly become a hot area in biomedical science.Biobanking human microbiome is fundamental for the development of human microbiome research.However,human microbiome research and biobank are facing many serious ethical,social and regulatory challenges that must be addressed.In this article,we examine three core ethical and social issues,i.e.,informed consent,ownership,privacy and risks.Next,we employ fecal microbiota bank and fecal microbiota transplantation as a case study to discuss how to determine a suitable healthy donor.We conclude the article by providing some regulatory and governance suggestions for policy makers to develop successful policy response.
引文
[1]马永慧,杨云生.人体微生态研究伦理:生命伦理学的新领域[J].中国医学伦理学,2017,30(7):814-822.Ma Yonghui,Yang Yunsheng.Ethics of human microbiome research:New field for bioethics[J].Chinese Medical Ethics Journal,2017,30(7):814-822.
[2]Lederberg J.The microbe's contribution to biology—50 years after[J].International Microbiology:The Cfficial Journal of the Spanish Societyfor Microbiology,2006,9(3):155-156.
[3]Cambon-Thomsen A,Rial-Sebbag E,Knoppers B M.Trends in ethicaland legal frameworks for the use of human biobanks[J].The EuropeanRespiratory Journal,2007,30(2):373-382.
[4]董尔丹,胡海,俞文华.生物样本库是生物医学研究的重要基础[J].中国科学:生命科学,2015,45:359-370.Dong Erdan,Hu Hai,Yu Wenhua.Biobank is important foundation forbiomedical research[J].China Science:Life Science,2015,45:359-370.
[5]朱伟.知情同意:定义、模式和挑战[J].生命科学2012,24(11):1243-1249.Zhu Wei.Informed Consent:definition,paradigm,and challenges[J].Life Science,2012,24(11):1243-1249.
[6]刘闵,翟晓梅,邱仁宗.生物信息库的知情同意问题[J].中国医学伦理学,2009,22(2):31-33.Liu Min,Zhai Xiaomei,Qiu Renzong.Informe consent issues in biobank[J].Chinese Medical Ethics Journal,2009,22(2):31-33.
[7]Hawkins A K,O'Doherty K C."Who owns your poop":Insights regard-ing the intersection of human microbiome research and the ELSI as-pects of biobanking and related studies[J].BMC Medical Genomics,2011,4:72.
[8]Mc Guire A L,Colgrove J,Whitney S N,et al.Ethical,legal,and socialconsiderations in conducting the Human Microbiome Project[J].Ge-nome Research,2008,18(12):1861-1864.
[9]Hallinan D,Friedewald M.Open consent,biobanking and data protec-tion law:Can open consent be'informed'under the forthcoming dataprotection regulation[J].Life Sciences,Society and Policy,2015,11:1.
[10]Steinsbekk K S,Kare Myskja B,Solberg B.Broad consent versus dy-namic consent in biobank research:Is passive participation an ethicalproblem[J].European Journal of Human Genetics,2013,21(9):897-902.
[11]Mello M M,Wolf L E.The Havasupai Indian tribe case-lessons for re-search involving stored biologic samples[J].New England Journal ofMedicine,2010,363(3):204-207.
[12]Gligorov N,Frank L,Schwab A P,et al.Privacy,confidentiality,andnew ways of knowing more in the human microbiome:Ethical,legaland social concerns[M].New York:Oxford University Press,2013:109-111.
[13]Schwab A P,Brenner B,Goldfarb J,et al.Biobanks and the humanmicrobiome in the human microbiome:ethical,legal and social con-cerns[M].New York:Oxford University Press 2013,183-184.
[14]Rhodes R.Gligorov N,Schwab A P.The human microbiome:Ethical,legal and social concerns[M].New York:Oxford University Press2013:9-11.
[15]Rhodes R.Ethical issues in microbiome research and medicine[J].BMC Medicine,2016,14(1):156.
[16]曾令烽,刘军,潘建科,等.人体微生物研究和样本库建设中的伦理问题及对策[J].中国医学伦理学,2015,28(2):162-166.Zeng Lingfeng,Liu Jun,Pan Jianke,et al.Ethical issues andresolutions in human microbiome reearch and bibank[J].ChineseMedical Ethics Journal,2015,28(2):162-166.
[17]Franzosa E A,Huang K,Meadow J F,et al.Identifying personal mi-crobiomes using metagenomic codes[J].Proceedings of the NationalAcademy of Sciences,2015,112(22):2930-2938.
[18]Tridico S R,Murray D C,Addison J,et al.Metagenomic analyses ofbacteria on human hairs:A qualitative assessment for applications inforensic science[J].Investigative Genetics,2014,5(1):1-13.
[19]马永慧,许鸿志,肖传兴,等.粪菌移植的伦理、社会问题探讨[J].中华消化杂志,2016,36(12):861-863.Ma Yonghui,Xu Hongzhi,Xiao Chuanxing,et al.Ethical and socialissues in fecal microbiota transplantation[J].Chinese DigestiveJournal,2016,36(12):861-863.
[20]Terveer E M,van Beurden Y H,Goorhuis A,et al.How to establishand run a stool bank[J].Clinical Microbiology and Infection,2017,doi:cmi.2017.05.015.
[21]Ma Y,Yang J,Cui B,et al.How Chinese clinicians face ethical andsocial challenges in fecal microbiota transplantation:A questionnairestudy[J].BMC Medical Ethics,2017,18(1):1-11.
[22]Paramsothy S,Borody T J,Lin E,et al.Donor recruitment for fecal mi-crobiota transplantation[J].Inflammatory Bowel Diseases,2015,21(7):1600-1606.
[23]Ma Y,Liu J,Rhodes C,et al.Ethical issues in fecal microbiota trans-plantation in practice[J].The American Journal of Bioethics,2017,17(5):34-45.
[24]Bakken J S,Borody T,Brandt L J,et al.Fecal microbiota transplanta-tion workgroup:Treating clostridium difficileinfection with fecal micro-biota transplantation[J].Clinical Gastroenterology&Hepatology,2011,9(12):1044-1049.
[25]Relman D,Rustgi A K,Vender R J,et al.Joint society letter to FDA-current consensus guidance on donor screeningand stool testing forFMT.2013.http://ww.gastro.org/research/Joint_society-FMT_guidance.pdf.
[26]Smits L P,Bouter K E,de Vos W M,et al.Therapeutic potential of fe-cal microbiota transplantation[J].Gastroenterology,2013,145(5):946-953.
[2]Lederberg J.The microbe's contribution to biology—50 years after[J].International Microbiology:The Cfficial Journal of the Spanish Societyfor Microbiology,2006,9(3):155-156.
[3]Cambon-Thomsen A,Rial-Sebbag E,Knoppers B M.Trends in ethicaland legal frameworks for the use of human biobanks[J].The EuropeanRespiratory Journal,2007,30(2):373-382.
[4]董尔丹,胡海,俞文华.生物样本库是生物医学研究的重要基础[J].中国科学:生命科学,2015,45:359-370.Dong Erdan,Hu Hai,Yu Wenhua.Biobank is important foundation forbiomedical research[J].China Science:Life Science,2015,45:359-370.
[5]朱伟.知情同意:定义、模式和挑战[J].生命科学2012,24(11):1243-1249.Zhu Wei.Informed Consent:definition,paradigm,and challenges[J].Life Science,2012,24(11):1243-1249.
[6]刘闵,翟晓梅,邱仁宗.生物信息库的知情同意问题[J].中国医学伦理学,2009,22(2):31-33.Liu Min,Zhai Xiaomei,Qiu Renzong.Informe consent issues in biobank[J].Chinese Medical Ethics Journal,2009,22(2):31-33.
[7]Hawkins A K,O'Doherty K C."Who owns your poop":Insights regard-ing the intersection of human microbiome research and the ELSI as-pects of biobanking and related studies[J].BMC Medical Genomics,2011,4:72.
[8]Mc Guire A L,Colgrove J,Whitney S N,et al.Ethical,legal,and socialconsiderations in conducting the Human Microbiome Project[J].Ge-nome Research,2008,18(12):1861-1864.
[9]Hallinan D,Friedewald M.Open consent,biobanking and data protec-tion law:Can open consent be'informed'under the forthcoming dataprotection regulation[J].Life Sciences,Society and Policy,2015,11:1.
[10]Steinsbekk K S,Kare Myskja B,Solberg B.Broad consent versus dy-namic consent in biobank research:Is passive participation an ethicalproblem[J].European Journal of Human Genetics,2013,21(9):897-902.
[11]Mello M M,Wolf L E.The Havasupai Indian tribe case-lessons for re-search involving stored biologic samples[J].New England Journal ofMedicine,2010,363(3):204-207.
[12]Gligorov N,Frank L,Schwab A P,et al.Privacy,confidentiality,andnew ways of knowing more in the human microbiome:Ethical,legaland social concerns[M].New York:Oxford University Press,2013:109-111.
[13]Schwab A P,Brenner B,Goldfarb J,et al.Biobanks and the humanmicrobiome in the human microbiome:ethical,legal and social con-cerns[M].New York:Oxford University Press 2013,183-184.
[14]Rhodes R.Gligorov N,Schwab A P.The human microbiome:Ethical,legal and social concerns[M].New York:Oxford University Press2013:9-11.
[15]Rhodes R.Ethical issues in microbiome research and medicine[J].BMC Medicine,2016,14(1):156.
[16]曾令烽,刘军,潘建科,等.人体微生物研究和样本库建设中的伦理问题及对策[J].中国医学伦理学,2015,28(2):162-166.Zeng Lingfeng,Liu Jun,Pan Jianke,et al.Ethical issues andresolutions in human microbiome reearch and bibank[J].ChineseMedical Ethics Journal,2015,28(2):162-166.
[17]Franzosa E A,Huang K,Meadow J F,et al.Identifying personal mi-crobiomes using metagenomic codes[J].Proceedings of the NationalAcademy of Sciences,2015,112(22):2930-2938.
[18]Tridico S R,Murray D C,Addison J,et al.Metagenomic analyses ofbacteria on human hairs:A qualitative assessment for applications inforensic science[J].Investigative Genetics,2014,5(1):1-13.
[19]马永慧,许鸿志,肖传兴,等.粪菌移植的伦理、社会问题探讨[J].中华消化杂志,2016,36(12):861-863.Ma Yonghui,Xu Hongzhi,Xiao Chuanxing,et al.Ethical and socialissues in fecal microbiota transplantation[J].Chinese DigestiveJournal,2016,36(12):861-863.
[20]Terveer E M,van Beurden Y H,Goorhuis A,et al.How to establishand run a stool bank[J].Clinical Microbiology and Infection,2017,doi:cmi.2017.05.015.
[21]Ma Y,Yang J,Cui B,et al.How Chinese clinicians face ethical andsocial challenges in fecal microbiota transplantation:A questionnairestudy[J].BMC Medical Ethics,2017,18(1):1-11.
[22]Paramsothy S,Borody T J,Lin E,et al.Donor recruitment for fecal mi-crobiota transplantation[J].Inflammatory Bowel Diseases,2015,21(7):1600-1606.
[23]Ma Y,Liu J,Rhodes C,et al.Ethical issues in fecal microbiota trans-plantation in practice[J].The American Journal of Bioethics,2017,17(5):34-45.
[24]Bakken J S,Borody T,Brandt L J,et al.Fecal microbiota transplanta-tion workgroup:Treating clostridium difficileinfection with fecal micro-biota transplantation[J].Clinical Gastroenterology&Hepatology,2011,9(12):1044-1049.
[25]Relman D,Rustgi A K,Vender R J,et al.Joint society letter to FDA-current consensus guidance on donor screeningand stool testing forFMT.2013.http://ww.gastro.org/research/Joint_society-FMT_guidance.pdf.
[26]Smits L P,Bouter K E,de Vos W M,et al.Therapeutic potential of fe-cal microbiota transplantation[J].Gastroenterology,2013,145(5):946-953.