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Toward better governance of human genomic data

Nature Genetics volume 53, pages 2–8 (2021)Cite this article

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Here, we argue that, in line with the dramatic increase in the collection, storage and curation of human genomic data for biomedical research, genomic data repositories and consortia have adopted governance frameworks to both enable wide access and protect against possible harms. However, the merits and limitations of different governance frameworks in achieving these twin aims are a matter of ongoing debate in the scientific community; indeed, best practices and points for consideration are notably absent in devising governance frameworks for genomic databases. According to our collective experience in devising and assessing governance frameworks, we identify five key functions of ‘good governance’ (or ‘better governance’) and three areas in which trade-offs should be considered when specifying policies within those functions. We apply these functions as a benchmark to describe, as an example, the governance frameworks of six large-scale international genomic projects.

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Acknowledgements

K.C.O.D. is supported by the Canadian Institutes of Health Research and the Social Sciences and Humanities Research Council. H.B.B. is supported by the Research Council of Norway grant number 238999 and NordForsk grant number 81105. P.B. is funded through Horizon 2020 project euCanSHare (an EU–Canada joint infrastructure for next-generation multi-study heart research, project number 825903). M.M.B. is supported by the Canadian Institutes of Health Research, the Social Sciences and Humanities Research Council, the National Science Foundation, the Patient-Centered Outcomes Research Institute and the Research Council of Norway. J.D.V. is supported by the National Human Genome Research Institute of the National Institutes of Health under Award number 1U54HG009790 and by the Wellcome Trust under award number 219600_Z_19_Z. E.J. is supported by the National Human Genome Research Institute of the US National Institutes of Health under award number R01HG010661. K.K. is supported by the Japan Agency for Medical Research and Development (AMED) under grant number JP19kk0205012. B.M.K. is funded by Genome Canada, Genome Québec and the Canada Research Chair in Law and Medicine. B.A.K. is supported by the Eunice Kennedy Shriver National Institute of Child Health and Human Development and the National Human Genome Research Institute of the National Institutes of Health under award number U19HD077627. S.M.M. is supported by the National Center on Minority Health and Health Disparities, National Institutes of Health 1U54MD011240 and National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health 1P30DK092923. A.L.M. is supported by NIH-NCI R01CA237118 (to R. Cook-Deegan and A.L.M.) and NIH-NHGRI R01HG008918 (to A.L.M. and R. Cook-Deegan). D.N., L.E. and D.C. are supported by Australian Research Council DP 180100269. A.T. is supported by Genome Canada, Genome Québec and the Canadian Institutes of Health Research.

Author information

Authors and Affiliations

  1. Department of Psychology, University of Guelph, Guelph, Ontario, Canada

    Kieran C. O’Doherty

  2. Metamedica, Faculty of Law and Criminology, Ghent University, Ghent, Belgium

    Mahsa Shabani

  3. School of Law, University of Edinburgh, Edinburgh, UK

    Edward S. Dove

  4. Center for Medical Ethics, Faculty of Medicine, University of Oslo, Oslo, Norway

    Heidi Beate Bentzen

  5. Department of Public Health and Primary Care, KU Leuven, Leuven, Belgium

    Pascal Borry

  6. School of Population and Public Health, University of British Columbia, Kelowna, British Columbia, Canada

    Michael M. Burgess & Kimberlyn M. McGrail

  7. Faculty of Law, University of Tasmania, Hobart, Tasmania, Australia

    Don Chalmers, Lisa Eckstein & Dianne Nicol

  8. Department of Medicine, University of Cape Town, Cape Town, South Africa

    Jantina De Vries

  9. Department of Bioethics and Humanities, University of Washington, Seattle, WA, USA

    Stephanie M. Fullerton

  10. Department of Social Medicine, University of North Carolina, Chapel Hill, NC, USA

    Eric Juengst

  11. Graduate School of Medicine, Osaka University, Osaka, Japan

    Kazuto Kato

  12. Faculty of Law, University of Oxford, Oxford, UK

    Jane Kaye

  13. Centre of Genomics and Policy, McGill University, Montreal, Québec, Canada

    Bartha Maria Knoppers & Adrian Thorogood

  14. University of California, San Francisco, San Francisco, CA, USA

    Barbara A. Koenig

  15. Colorado School of Public Health, University of Colorado, Aurora, CO, USA

    Spero M. Manson

  16. Center for Medical Ethics and Health Policy, Baylor College of Medicine, Houston, TX, USA

    Amy L. McGuire

  17. Council of Canadian Academies, Ottawa, Ontario, Canada

    Eric M. Meslin

  18. Department of Political Science, University of Vienna, Vienna, Austria

    Barbara Prainsack

  19. Department of Global Health & Social Medicine, King’s College London, London, UK

    Barbara Prainsack

  20. Genetic Alliance, Washington, DC, USA

    Sharon F. Terry

  21. Department of Bioethics and Humanities, University of Washington, Seattle, WA, USA

    Wylie Burke

Authors
  1. Kieran C. O’Doherty
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  2. Mahsa Shabani
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  14. Bartha Maria Knoppers
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  15. Barbara A. Koenig
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  19. Eric M. Meslin
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  20. Dianne Nicol
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  21. Barbara Prainsack
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  22. Sharon F. Terry
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  23. Adrian Thorogood
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  24. Wylie Burke
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Corresponding author

Correspondence to Edward S. Dove.

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Competing interests

E.S.D. is co-chair of the Regulatory and Ethics Work Stream of the Global Alliance for Genomics and Health (GA4GH). J.D.V. is a member of the H3Africa Steering Committee. The remaining authors declare no competing interests.

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Peer review information Nature Genetics thanks Dina Paltoo and the other, anonymous, reviewer(s) for their contribution to the peer review of this work. Peer reviewer reports are available.

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O’Doherty, K.C., Shabani, M., Dove, E.S. et al. Toward better governance of human genomic data. Nat Genet 53, 2–8 (2021). https://doi.org/10.1038/s41588-020-00742-6

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