样本库受试者隐私保护管理的现状分析
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摘要
总结了国内外样本库隐私保护方面的法规和指南,分析了国内样本库隐私保护方面的受试者是否从真正意义上"去标识化"和隐私是否会被泄露等问题。在此基础上,结合我国国情提出相应的建议,以期通过建立完善的去标识化流程,加强访问权限以及生物样本库系统的监管,并加强对研究者隐私规则的培训,加强相关监督和质控管理等措施改善目前的状况。
This paper summarized the domestic and foreign laws and guidelines of privacy protection in sample bank and analyzed the problems that whether the subjects were in the real sense of "no identification" and whether the privacy would be leaked.Based on this and combined with Chinese conditions,it put forward the corresponding suggestions to improve the current situation,through establishing a thorough process of no identification,strengthening the access permission and the supervision of biological sample bank system,strengthening the training of researchers' privacy rules,strengthening the related supervision and management of quality control,and so on.
This paper summarized the domestic and foreign laws and guidelines of privacy protection in sample bank and analyzed the problems that whether the subjects were in the real sense of "no identification" and whether the privacy would be leaked.Based on this and combined with Chinese conditions,it put forward the corresponding suggestions to improve the current situation,through establishing a thorough process of no identification,strengthening the access permission and the supervision of biological sample bank system,strengthening the training of researchers' privacy rules,strengthening the related supervision and management of quality control,and so on.
引文
[1]董哲君,肖飞,郭健.生物样本库建立现况及进展[J].中华检验医学杂志,2013,36(10):130-135.
[2]谷丽华.欧美国家健康信息隐私保护立法情况探析及对我国立法的启示[J].中国卫生信息管理杂志,2013,10(6):520-524.
[3]Paula Lobato de Faria,Joao Valente Cordeiro.Health data privacy and confidentiality rights:Crisis or redemption[J].Rev port saudepublica,2014,32(2):123-133.
[4]刘克新,郑琳,王莹,等.生物样本库的现状及研究进展[J].中国病案,2014,15(9):32-36.
[5]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.
[6]GuidoZuccon,Daniel Kotzura.De-identification of health records using Anonym:Effectiveness androbustnessacrossdatasets[J].Artificial Intelligence in Medicine,2014(61):145-151.
[7]Khaled EL Emam,Sam Rodgers,Bradley Malin.Conceptsand Methodsfor De-identifying Clinical Trial Data[J].BMJ,2015,350:h1139.
[8]曾令烽,刘军,潘建科,等.生物样本研究数据环境与受试者隐私保护伦理问题[J].世界科学技术——中医药现代化探索,2015,17(7):1567-1575.
[9]徐永国,周学迅,郭爱华,等.生物样本库的安全管理措施[J].转化医学杂志,2013,2(2):103-105.
[10]刘夕宁,汪秀琴.涉及人体医学研究中关于隐私的保护[J].世界中西医结合杂志,2010,5(2):167-168.
[11]周凤娟,邱琇.剖析生物样本库建设中的伦理问题[J].中国医学伦理学,2014,27(4):479-481.
[12]郭爱华,张翠,余永国,等.二维码技术在生物样本库编码中的应用与评价[J].中国医药生物技术,2012,7(4):306-308.
[2]谷丽华.欧美国家健康信息隐私保护立法情况探析及对我国立法的启示[J].中国卫生信息管理杂志,2013,10(6):520-524.
[3]Paula Lobato de Faria,Joao Valente Cordeiro.Health data privacy and confidentiality rights:Crisis or redemption[J].Rev port saudepublica,2014,32(2):123-133.
[4]刘克新,郑琳,王莹,等.生物样本库的现状及研究进展[J].中国病案,2014,15(9):32-36.
[5]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.
[6]GuidoZuccon,Daniel Kotzura.De-identification of health records using Anonym:Effectiveness androbustnessacrossdatasets[J].Artificial Intelligence in Medicine,2014(61):145-151.
[7]Khaled EL Emam,Sam Rodgers,Bradley Malin.Conceptsand Methodsfor De-identifying Clinical Trial Data[J].BMJ,2015,350:h1139.
[8]曾令烽,刘军,潘建科,等.生物样本研究数据环境与受试者隐私保护伦理问题[J].世界科学技术——中医药现代化探索,2015,17(7):1567-1575.
[9]徐永国,周学迅,郭爱华,等.生物样本库的安全管理措施[J].转化医学杂志,2013,2(2):103-105.
[10]刘夕宁,汪秀琴.涉及人体医学研究中关于隐私的保护[J].世界中西医结合杂志,2010,5(2):167-168.
[11]周凤娟,邱琇.剖析生物样本库建设中的伦理问题[J].中国医学伦理学,2014,27(4):479-481.
[12]郭爱华,张翠,余永国,等.二维码技术在生物样本库编码中的应用与评价[J].中国医药生物技术,2012,7(4):306-308.