Has the biobank bubble burst? Withstanding the challenges for sustainable biobanking in the digital era.
Has the biobank bubble burst? Withstanding the challenges for sustainable biobanking in the digital era.
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DOI：
10.1186/s12910-016-0124-2
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发表时间：
2016-07-12
影响因子：
2.7
通讯作者：
Whitton T
中科院分区：
文献类型：
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作者：
Chalmers D;Nicol D;Kaye J;Bell J;Campbell AV;Ho CW;Kato K;Minari J;Ho CH;Mitchell C;Molnár-Gábor F;Otlowski M;Thiel D;Fullerton SM;Whitton T
生物库已被誉为将生物医学研究转化为实践的重要工具，推动精准医学改善全球医疗治疗和服务的途径。许多国家建立了具体的治理制度，以促进研究并解决这些制度所带来的复杂的道德、法律和社会挑战，但这并没有导致全世界的统一。尽管在应对生物库的伦理、法律和社会影响方面取得了重大进展，但操作、可持续性和资金方面的挑战仍在继续出现。目前还没有确定解决这些问题的连贯战略。鉴于维持生物库运行所需的大量资源，这使生物库的总体可行性和有用性受到质疑。这篇综述阐述了生物库社区自21世纪初成立以来必须克服的挑战。第一部分简要概述了澳大利亚、德国、日本、新加坡、台湾、英国和美国七个国家的生物库和监管架构的多样性。然后，文章讨论了应对生物库挑战的四种浪潮。这篇文章是在英国牛津健康、法律和新兴技术中心(Helex)会议上关于生物库的一次讨论中产生的，该会议由塔斯马尼亚大学法律和遗传学中心共同主办。本文旨在提供与生物库实践和治理相关的问题的回顾，以期为大规模和较小规模生物库的未来发展提供参考。
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.