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.

Balancing the Local and the Universal in Maintaining Ethical Access to a Genomics Biobank

“…Sustainability questions also arise in relation to the wider data sharing environment and the existence of cost free alternatives to accessing genotype and phenotype data [19] broadly similar to that in GS. For example, access can be sought to resources via routine academic collaboration with the Principal Investigator of different cohorts, or from genomics data resources such as the EGA [33].…”

“…We argue that data sharing raises issues relating to the role of the repository in future governance and ethical oversight and how expectations and preferences of participants will be interpreted in future scenarios, for example within consortia [18]. Whilst issues of sustainability could be viewed as separate from ethical and governance considerations, we aim to show that they are inseparable in relation to access [19].…”

Introduction to the article collection ‘Translation in healthcare: ethical, legal, and social implications’

“…Providing a comparative international perspective, Chalmers et al offer a review of biobanking governance through the lens of the diverse regulatory contexts of seven countries. The authors chart four waves of biobanking management and policy that have resulted in response to the challenges of ensuring informed consent, standardization, sustainability and public trust [27]. Addressing similar concerns by drawing attention to the lack of regulatory oversight of unauthorized secondary uses of health data and samples, O’Doherty et al argue that without building ethical oversight in tandem with the proliferation of health data collections intended for research, unintended negative consequences are likely to result [28].…”

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“…real] affordances". 14 Although Norman is not approaching the question primarily with the underlying instrumentality of software (as opposed to visual) design in mind, his comment hints at an important truth about the power of the designer to control users' 11 Ibid., p. 13. In an interesting discussion of robotics and artefact-artefact affordances, Maier and Fadel discuss how non-organic agents can be afforded support by a surface, without 'knowing' (perceiving) it.…”

“…Derivative works include user-generated content (UGC), 11 which is, in turn, broader in scope than parodies. faith.…”