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

Don Chalmers,Tess Whitton,Kazuto Kato,Stephanie M Fullerton,Margaret Otlowski,Daniel Thiel,Alastair V Campbell,Colin Mitchell,Jusaku Minari,Calvin W L Ho,Chih-Hsing Ho,Jessica Bell,Fruzsina Molnár-Gábor,Dianne Nicol,Jane Kaye

doi:10.1186/s12910-016-0124-2

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.

Highlights

Over the past 20 years, there has been considerable investment in biobanking and research infrastructure in scientifically- advanced countries because of the perceived research benefits they provide
This article looks prospectively to a future ‘fourth wave’, where we propose that technological developments and new strategies for community engagement could coalesce and, where complex infrastructures and financial burdens are minimised without compromising the research value of biobanking or public trust in the biobanking enterprise
This article does not propose that the biobank bubble has burst, but it suggests that there are challenges that require mechanisms to be put in place to transform current practices

Summary

Introduction

Over the past 20 years, there has been considerable investment in biobanking and research infrastructure in scientifically- advanced countries because of the perceived research benefits they provide. These research-focused biobanks comprise collections of human tissue linked with genetic, genealogical, health and other personal information, which can be used for a number of research purposes and from which a multitude of different datasets can be extracted [3, 4]. They are seen to accelerate the research effort because researchers do not have to expend valuable time and funds on the collection, storage and curation of Chalmers et al BMC Medical Ethics (2016) 17:39 human tissue samples and data. The greatest value comes from these rich resources if they can be combined together in the form of ‘Big Data’ [5] for use in addressing research questions of global significance

Objectives

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Conclusion