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      Has the biobank bubble burst? Withstanding the challenges for sustainable biobanking in the digital era

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          Abstract

          Biobanks have been heralded as essential tools for translating biomedical research into practice, driving precision medicine to improve pathways for global healthcare treatment and services. Many nations have established specific governance systems to facilitate research and to address the complex ethical, legal and social challenges that they present, but this has not lead to uniformity across the world. Despite significant progress in responding to the ethical, legal and social implications of biobanking, operational, sustainability and funding challenges continue to emerge. No coherent strategy has yet been identified for addressing them. This has brought into question the overall viability and usefulness of biobanks in light of the significant resources required to keep them running. This review sets out the challenges that the biobanking community has had to overcome since their inception in the early 2000s. The first section provides a brief outline of the diversity in biobank and regulatory architecture in seven countries: Australia, Germany, Japan, Singapore, Taiwan, the UK, and the USA. The article then discusses four waves of responses to biobanking challenges. This article had its genesis in a discussion on biobanks during the Centre for Health, Law and Emerging Technologies (HeLEX) conference in Oxford UK, co-sponsored by the Centre for Law and Genetics (University of Tasmania). This article aims to provide a review of the issues associated with biobank practices and governance, with a view to informing the future course of both large-scale and smaller scale biobanks.

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          Most cited references 45

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          Biology: The big challenges of big data.

           Vivien Marx (2013)
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            Rare variant discovery by deep whole-genome sequencing of 1,070 Japanese individuals

            The Tohoku Medical Megabank Organization reports the whole-genome sequences of 1,070 healthy Japanese individuals and construction of a Japanese population reference panel (1KJPN). Here we identify through this high-coverage sequencing (32.4 × on average), 21.2 million, including 12 million novel, single-nucleotide variants (SNVs) at an estimated false discovery rate of <1.0%. This detailed analysis detected signatures for purifying selection on regulatory elements as well as coding regions. We also catalogue structural variants, including 3.4 million insertions and deletions, and 25,923 genic copy-number variants. The 1KJPN was effective for imputing genotypes of the Japanese population genome wide. These data demonstrate the value of high-coverage sequencing for constructing population-specific variant panels, which covers 99.0% SNVs of minor allele frequency ≥0.1%, and its value for identifying causal rare variants of complex human disease phenotypes in genetic association studies.
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              Broad Consent for Research With Biological Samples: Workshop Conclusions.

              Different types of consent are used to obtain human biospecimens for future research. This variation has resulted in confusion regarding what research is permitted, inadvertent constraints on future research, and research proceeding without consent. The National Institutes of Health (NIH) Clinical Center's Department of Bioethics held a workshop to consider the ethical acceptability of addressing these concerns by using broad consent for future research on stored biospecimens. Multiple bioethics scholars, who have written on these issues, discussed the reasons for consent, the range of consent strategies, and gaps in our understanding, and concluded with a proposal for broad initial consent coupled with oversight and, when feasible, ongoing provision of information to donors. This article describes areas of agreement and areas that need more research and dialogue. Given recent proposed changes to the Common Rule, and new guidance regarding storing and sharing data and samples, this is an important and timely topic.
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                Author and article information

                Contributors
                Don.Chalmers@utas.edu.au
                Dianne.Nicol@utas.edu.au
                Jane.Kaye@law.ox.ac.uk
                Jessica.Bell@dph.ox.ac.uk
                Alastair_V_Campbell@nuhs.edu.sg
                Calvin_Ho@nuhs.edu.sg
                Kato@eth.med.osaka-u.ac.jp
                Minari@eth.med.osaka-u.ac.jp
                chihho@sinica.edu.tw
                Colin.Mitchell@law.ox.ac.uk
                Fruzsina.Molnar-Gabor@adw.uni-heidelberg.de
                Margaret.Otlowski@utas.edu.au
                dbthiel@umich.edu
                Smfllrtn@uw.edu
                Tess.Whitton@utas.edu.au
                Journal
                BMC Med Ethics
                BMC Med Ethics
                BMC Medical Ethics
                BioMed Central (London )
                1472-6939
                12 July 2016
                12 July 2016
                2016
                : 17
                Affiliations
                [ ]Centre for Law and Genetics, Faculty of Law, University of Tasmania, Hobart, Tasmania Australia
                [ ]Centre for Health, Law and Emerging Technologies (HeLEX), Nuffield Department of Population Health, University of Oxford, Oxford, UK
                [ ]Centre for Biomedical Ethics, Yong Loo Lin School of Medicine, National University of Singapore, Singapore, Singapore
                [ ]Department of Biomedical Ethics and Public Policy, Graduate School of Medicine, Osaka University, Osaka, Japan
                [ ]Heidelberg Academy of Sciences and Humanities, Heidelberg, Germany
                [ ]Department of Health, Management and Policy, School of Public Health, University of Michigan, Ann Arbor, Michigan USA
                [ ]Department of Bioethics and Humanities, University of Washington, Seattle, WA USA
                [ ]Academia Sinica, Taipei, Taiwan
                Article
                124
                10.1186/s12910-016-0124-2
                4941036
                27405974
                © The Author(s). 2016

                Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License ( http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver ( http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.

                Funding
                Funded by: Australian Research Council Discovery Grant
                Award ID: DP110100694
                Award Recipient :
                Funded by: Australian Research Council Discovery Grant
                Award ID: DP110100694
                Award ID: DP110100694
                Award Recipient :
                Funded by: FundRef http://dx.doi.org/10.13039/100004440, Wellcome Trust;
                Award ID: 096599/2/11/2
                Award Recipient :
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                © The Author(s) 2016

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