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Toward better governance of human genomic data

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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.

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Correspondence to Edward S. Dove.

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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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