2016年版CIOMS伦理准则关于健康数据研究的伦理规范
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摘要
国际医学科学组织理事会于2016年联合世界卫生组织制定发布了新版《涉及人的健康相关研究国际伦理准则》。新版准则的应用范围覆盖了利用健康相关数据开展的研究。通过分析新版准则提出的健康相关研究中数据的收集、储存和使用的伦理规范(准则12)、如何使用网络环境和数字化工具获取的数据的伦理指导(准则22);并结合上述内容,分享解读两则真实的伦理审查案例:(1)利用公共数据库开展的研究;(2)利用企业自建数据库开展的研究。以期引起学界对新版准则及相关问题的关注。
In 2016, the Council for International Organizations of Medical Sciences revised its International Ethical Guidelines for Health-related Research Involving Humans in collaboration with World Health Organization. The new guidelines now cover research with health-related data. The authors explore new ethical guidance provided in the guidelines for collection, storage and use of data in health-related research and for use of data obtained from the online environment and digital tools. In this respect, the authors examine two cases reviewed in the past: one involves public database, and the other one involves private database.
In 2016, the Council for International Organizations of Medical Sciences revised its International Ethical Guidelines for Health-related Research Involving Humans in collaboration with World Health Organization. The new guidelines now cover research with health-related data. The authors explore new ethical guidance provided in the guidelines for collection, storage and use of data in health-related research and for use of data obtained from the online environment and digital tools. In this respect, the authors examine two cases reviewed in the past: one involves public database, and the other one involves private database.
引文
[1] Wikipedia.Council for International Organizations of Medical Sciences[EB/OL].[2019-05-06].https://en.wikipedia.org/wiki/Council_for_International_Organizations_of_Medical_Sciences.
[2] KALKMAN S,MOSTERT M,GERLINGER C,et al.Responsible data sharing in international health research:A systematic review of principles and norms[J].BMC Med Ethics,2019,20(1):21.
[3] DOVE E S,JOLY Y,TASSé A M,et al.Genomic cloud computing:Legal and ethical points to consider[J].Eur J Hum Genet,2015,23(10):1271-1278.
[4] VAN DELDEN J J,VAN DER GRAAF R.Revised CIOMS International Ethical Guidelines for Health-Related Research Involving Humans[J].JAMA,2017,317(2):135-136.
[5] SáNCHEZ M C,SARRIA-SANTAMERA A.Unlocking data:Where is the key?[J].Bioethics,2019,33(3):367-376.
[6] Council for International Organizations of Medical Sciences.涉及人的健康相关研究国际伦理准则[M].朱伟,译.胡庆澧,审校.上海:上海交通大学出版社,2019.
[7] World Health Organization.WHO Data Policy[EB/OL].(2019-04-30)[2019-04-30].https://www.who.int/publishing/datapolicy/en/.
[8] BRIDGE Health.The BRIDGE Health Project[EB/OL].(2019-05-20)[2019-05-20].https://www.bridge-health.eu.
[9] Food and Drug Administration.Use of Electronic Health Record Data in Clinical Investigations Guidance for Industry[EB/OL].(2019-05-20)[2019-05-20].https://www.fda.gov/regulatory-information/search-fda-guidance-documents /use-electronic-health-record-data-clinical-investigations-guidance-industry.
[10] BALLANTYNE A,SCHAEFER G O.Consent and the ethical duty to participate in health data research[J].J Med Ethics,2018,44(6):392-396.
[11] European Commission.2018 reform of EU data protection rules[EB/OL].(2019-05-20) [2019-05-20].https://europa.eu/dataprotection.
[12] IENCA M,FERRETTI A,HURST S,et al.Considerations for ethics review of big data health research:A scoping review[J].PLoS One,2018,13(10):e0204837.
[2] KALKMAN S,MOSTERT M,GERLINGER C,et al.Responsible data sharing in international health research:A systematic review of principles and norms[J].BMC Med Ethics,2019,20(1):21.
[3] DOVE E S,JOLY Y,TASSé A M,et al.Genomic cloud computing:Legal and ethical points to consider[J].Eur J Hum Genet,2015,23(10):1271-1278.
[4] VAN DELDEN J J,VAN DER GRAAF R.Revised CIOMS International Ethical Guidelines for Health-Related Research Involving Humans[J].JAMA,2017,317(2):135-136.
[5] SáNCHEZ M C,SARRIA-SANTAMERA A.Unlocking data:Where is the key?[J].Bioethics,2019,33(3):367-376.
[6] Council for International Organizations of Medical Sciences.涉及人的健康相关研究国际伦理准则[M].朱伟,译.胡庆澧,审校.上海:上海交通大学出版社,2019.
[7] World Health Organization.WHO Data Policy[EB/OL].(2019-04-30)[2019-04-30].https://www.who.int/publishing/datapolicy/en/.
[8] BRIDGE Health.The BRIDGE Health Project[EB/OL].(2019-05-20)[2019-05-20].https://www.bridge-health.eu.
[9] Food and Drug Administration.Use of Electronic Health Record Data in Clinical Investigations Guidance for Industry[EB/OL].(2019-05-20)[2019-05-20].https://www.fda.gov/regulatory-information/search-fda-guidance-documents /use-electronic-health-record-data-clinical-investigations-guidance-industry.
[10] BALLANTYNE A,SCHAEFER G O.Consent and the ethical duty to participate in health data research[J].J Med Ethics,2018,44(6):392-396.
[11] European Commission.2018 reform of EU data protection rules[EB/OL].(2019-05-20) [2019-05-20].https://europa.eu/dataprotection.
[12] IENCA M,FERRETTI A,HURST S,et al.Considerations for ethics review of big data health research:A scoping review[J].PLoS One,2018,13(10):e0204837.