title: Has the biobank bubble burst? Withstanding the challenges for sustainable biobanking in the digital era.
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.
authors.affiliation: Centre for Law and Genetics, Faculty of Law, University of Tasmania, Hobart, Tasmania, Australia. Don.Chalmers@utas.edu.au.
authors.forename: Don
authors.initials: D
authors.lastname: Chalmers
authors.affiliation: Centre for Law and Genetics, Faculty of Law, University of Tasmania, Hobart, Tasmania, Australia.
authors.forename: Dianne
authors.initials: D
authors.lastname: Nicol
authors.affiliation: Centre for Health, Law and Emerging Technologies (HeLEX), Nuffield Department of Population Health, University of Oxford, Oxford, UK.
authors.forename: Jane
authors.initials: J
authors.lastname: Kaye
authors.affiliation: Centre for Health, Law and Emerging Technologies (HeLEX), Nuffield Department of Population Health, University of Oxford, Oxford, UK.
authors.forename: Jessica
authors.initials: J
authors.lastname: Bell
authors.affiliation: Centre for Biomedical Ethics, Yong Loo Lin School of Medicine, National University of Singapore, Singapore, Singapore.
authors.forename: Alastair V
authors.initials: AV
authors.lastname: Campbell
authors.affiliation: Centre for Biomedical Ethics, Yong Loo Lin School of Medicine, National University of Singapore, Singapore, Singapore.
authors.forename: Calvin W L
authors.initials: CW
authors.lastname: Ho
authors.affiliation: Department of Biomedical Ethics and Public Policy, Graduate School of Medicine, Osaka University, Osaka, Japan.
authors.forename: Kazuto
authors.initials: K
authors.lastname: Kato
authors.affiliation: Department of Biomedical Ethics and Public Policy, Graduate School of Medicine, Osaka University, Osaka, Japan.
authors.forename: Jusaku
authors.initials: J
authors.lastname: Minari
authors.affiliation: Academia Sinica, Taipei, Taiwan.
authors.forename: Chih-Hsing
authors.initials: CH
authors.lastname: Ho
authors.affiliation: Centre for Health, Law and Emerging Technologies (HeLEX), Nuffield Department of Population Health, University of Oxford, Oxford, UK.
authors.forename: Colin
authors.initials: C
authors.lastname: Mitchell
authors.affiliation: Heidelberg Academy of Sciences and Humanities, Heidelberg, Germany.
authors.forename: Fruzsina
authors.initials: F
authors.lastname: Molnár-Gábor
authors.affiliation: Centre for Law and Genetics, Faculty of Law, University of Tasmania, Hobart, Tasmania, Australia.
authors.forename: Margaret
authors.initials: M
authors.lastname: Otlowski
authors.affiliation: Department of Health, Management and Policy, School of Public Health, University of Michigan, Ann Arbor, Michigan, USA.
authors.forename: Daniel
authors.initials: D
authors.lastname: Thiel
authors.affiliation: Department of Bioethics and Humanities, University of Washington, Seattle, WA, USA.
authors.forename: Stephanie M
authors.initials: SM
authors.lastname: Fullerton
authors.affiliation: Centre for Law and Genetics, Faculty of Law, University of Tasmania, Hobart, Tasmania, Australia.
authors.forename: Tess
authors.initials: T
authors.lastname: Whitton
mesh_terms: D026688:Bioethical Issues; D018070:Biological Specimen Banks / Q000191:economics / Q000941:ethics / Q000331:legislation & jurisprudence; D035843:Biomedical Research / Q000191:economics / Q000941:ethics / Q000331:legislation & jurisprudence; D005378:Financial Support; D006801:Humans; D057285:Precision Medicine; D012926:Social Control, Formal
keywords: Biobanks; Comparative review; Genetics and genomics; Medical research ethics; Personalised medicine; Precision medicine; Sustainable biobanking