Melbourne Law School - Research Publications

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    Trends and Challenges in Biobanking
    Kaye, J ; Bell, J ; Prictor, M ; Munsie, M ; Freckelton, I ; Petersen, K (Federation Press, 2017)
    The last twenty years have seen the emergence of the phenomena of biobanks, which are now regarded as essential research infrastructure in most countries around the world. However, the very nature of biobanks, as long-term repositories of sample and data that are used for many different research purposes continues to challenge many of the legal requirements for medical research, both in the UK and Australia. This chapter will provide an overview of biobanking and discuss some of the legal challenges that these activities raise by discussing and comparing the UK and Australian legal landscapes.
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    Consent for Data Processing under the General Data Protection Regulation: Could ‘Dynamic Consent’ be a Useful Tool for Researchers?
    Prictor, M ; Teare, H ; Bell, J ; Taylor, M ; Kaye, J (Henry Stewart Publishing, 2019)
    The General Data Protection Regulation (GDPR) sets the bar high for consent for the processing of personal data. In the UK, researchers have been directed to rely on legal bases other than consent for processing personal data for research purposes. Informed consent, nonetheless, and despite certain shortcomings, holds a central position in ethical research practice, as well as at common law, and in a range of other legislation dealing with research involving humans. This paper evaluates the place of informed consent in research following the GDPR’s implementation, arguing that a fresh approach to consent — specifically the concept known as ‘dynamic consent’ — could provide a way for researchers to meet the new European regulatory requirements for data processing while adhering to the highest ethical standards for research conduct. It analyses dynamic consent according to specific GDPR requirements and reflects on practical examples that could inform future implementation of the approach, while remaining aware of the need for further empirical research.
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    Dynamic Consent and Biobanking: A Means of Fostering Sustainability
    Kaye, J ; Prictor, M ; Minssen, T ; Herrmann, JR ; Schovsbo, J (Edward Elgar Publishing Ltd, 2019)
    Biobanks are rich repositories of biological materials (such as DNA) and other health and demographic data, often collected over a long period, that can be used for a variety of research purposes to improve the health of individuals and populations. It is important that the value of biobanks is maximized, but at this point in time there are a number of challenges to achieving this. There is continued debate over the most appropriate mode of gaining consent from people who contribute tissue samples and data to biobanks, which will uphold high ethical standards and enable autonomous decisionmaking.
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    Health Data Linkage for UK Public Interest Research: Key Obstacles and Solutions.
    Mourby, MJ ; Doidge, J ; Jones, KH ; Aidinlis, S ; Smith, H ; Bell, J ; Gilbert, R ; Dutey-Magni, P ; Kaye, J (Swansea University, 2019-04-02)
    INTRODUCTION: Analysis of linked health data can generate important, even life-saving, insights into population health. Yet obstacles both legal and organisational in nature can impede this work. APPROACH: We focus on three UK infrastructures set up to link and share data for research: the Administrative Data Research Network, NHS Digital, and the Secure Anonymised Information Linkage Databank. Bringing an interdisciplinary perspective, we identify key issues underpinning their challenges and successes in linking health data for research. RESULTS: We identify examples of uncertainty surrounding legal powers to share and link data, and around data protection obligations, as well as systemic delays and historic public backlash. These issues require updated official guidance on the relevant law, approaches to linkage which are planned for impact and ongoing utility, greater transparency between data providers and researchers, and engagement with the patient population which is both high-profile and carefully considered. CONCLUSIONS: Health data linkage for research presents varied challenges, to which there can be no single solution. Our recommendations would require action from a number of data providers and regulators to be meaningfully advanced. This illustrates the scale and complexity of the challenge of health data linkage, in the UK and beyond: a challenge which our case studies suggest no single organisation can combat alone. Planned programmes of linkage are critical because they allow time for organisations to address these challenges without adversely affecting the feasibility of individual research projects.
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    The Governance Structure for Data Access in the DIRECT Consortium: An Innovative Medicines Initiative (IMI) Project
    Teare, HJA ; de Masi, F ; Banasik, K ; Barnett, A ; Herrgard, S ; Jablonka, B ; Postma, JWM ; McDonald, TJ ; Forgie, I ; Chmura, PJ ; Rydzka, EK ; Gupta, R ; Brunak, S ; Pearson, E ; Kaye, J (Springer, 2018)
    Biomedical research projects involving multiple partners from public and private sectors require coherent internal governance mechanisms to engender good working relationships. The DIRECT project is an example of such a venture, funded by the Innovative Medicines Initiative Joint Undertaking (IMI JU). This paper describes the data access policy that was developed within DIRECT to support data access and sharing, via the establishment of a 3-tiered Data Access Committee. The process was intended to allow quick access to data, whilst enabling strong oversight of how data were being accessed and by whom, and any subsequent analyses, to contribute to the overall objectives of the consortium.
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    From single biobanks to international networks: developing e-governance
    Kaye, J (SPRINGER, 2011-09)
    The future holds the possibility to link and network biobanks, existing biorepositories and reference databases for research purposes in ways that have not been possible before. There is the potential to develop 'research portals' that will enable researchers to access these research resources that are located around the globe with the click of a mouse. In this paper, I will argue that our current governance system for research is unable to provide all of the oversight and accountability mechanisms that are required for this new way of doing research that is based upon flows of data across international borders. For example, our current governance framework for research is nationally based, with a complex system of laws, policies and practice that can be unique to a jurisdiction. It is also evident that many of the nationally based governance bodies in this field do not have the legal powers or expertise to adjudicate on the complex issues, such as privacy and disclosure risks that are raised by cross-border data sharing. In addition, the conceptual underpinning of this research governance structure is based on the "one researcher, one project, one jurisdiction" model. In the conclusion of this paper, I lay out some preliminary ideas as to how this system has to change to accommodate research that is based on networks. I suggest that a move to digital governance mechanisms might be a start to making research governance systems more appropriate for the 21st century.
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    A P3G generic access agreement for population genomic studies
    Knoppers, BM ; Chisholm, RL ; Kaye, J ; Cox, D ; Thorogood, A ; Burton, P ; Brookes, AJ ; Fortier, I ; Goodwin, P ; Harris, JR ; Hveem, K ; Kent, A ; Little, J ; Riegman, PHJ ; Ripatti, S ; Stolk, RP (NATURE PUBLISHING GROUP, 2013-05)
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    Implementing a successful data-management framework: the UK10K managed access model
    Muddyman, D ; Smee, C ; Griffin, H ; Kaye, J (BIOMED CENTRAL LTD, 2013-11-15)
    This paper outlines the history behind open access principles and describes the development of a managed access data-sharing process for the UK10K Project, currently Britain's largest genomic sequencing consortium (2010 to 2013). Funded by the Wellcome Trust, the purpose of UK10K was two-fold: to investigate how low-frequency and rare genetic variants contribute to human disease, and to provide an enduring data resource for future research into human genetics. In this paper, we discuss the challenge of reconciling data-sharing principles with the practicalities of delivering a sequencing project of UK10K's scope and magnitude. We describe the development of a sustainable, easy-to-use managed access system that allowed rapid access to UK10K data, while protecting the interests of participants and data generators alike. Specifically, we focus in depth on the three key issues that emerge in the data pipeline: study recruitment, data release and data access.
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    Towards a data sharing Code of Conduct for international genomic research
    Knoppers, BM ; Harris, JR ; Tasse, AM ; Budin-Ljosne, I ; Kaye, J ; Deschenes, M ; Zawati, MH (BMC, 2011)
    Data sharing is increasingly regarded as an ethical and scientific imperative that advances knowledge and thereby respects the contributions of the participants. Because of this and the ever-increasing amount of data access requests currently filed around the world, three groups have decided to develop data sharing principles specific to the context of collaborative international genomics research. These groups are: the international Public Population Project in Genomics (P3G), an international consortium of projects partaking in large-scale genetic epidemiological studies and biobanks; the European Network for Genetic and Genomic Epidemiology (ENGAGE), a research project aiming to translate data from large-scale epidemiological research initiatives into relevant clinical information; and the Centre for Health, Law and Emerging Technologies (HeLEX). We propose seven different principles and a preliminary international data sharing Code of Conduct for ongoing discussion.
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    Direct-to-consumer genetic testing for predicting sports performance and talent identification: Consensus statement
    Webborn, N ; Williams, A ; McNamee, M ; Bouchard, C ; Pitsiladis, Y ; Ahmetov, I ; Ashley, E ; Byrne, N ; Camporesi, S ; Collins, M ; Dijkstra, P ; Eynon, N ; Fuku, N ; Garton, FC ; Hoppe, N ; Holm, S ; Kaye, J ; Klissouras, V ; Lucia, A ; Maase, K ; Moran, C ; North, KN ; Pigozzi, F ; Wang, G (BMJ PUBLISHING GROUP, 2015-12)
    The general consensus among sport and exercise genetics researchers is that genetic tests have no role to play in talent identification or the individualised prescription of training to maximise performance. Despite the lack of evidence, recent years have witnessed the rise of an emerging market of direct-to-consumer marketing (DTC) tests that claim to be able to identify children's athletic talents. Targeted consumers include mainly coaches and parents. There is concern among the scientific community that the current level of knowledge is being misrepresented for commercial purposes. There remains a lack of universally accepted guidelines and legislation for DTC testing in relation to all forms of genetic testing and not just for talent identification. There is concern over the lack of clarity of information over which specific genes or variants are being tested and the almost universal lack of appropriate genetic counselling for the interpretation of the genetic data to consumers. Furthermore independent studies have identified issues relating to quality control by DTC laboratories with different results being reported from samples from the same individual. Consequently, in the current state of knowledge, no child or young athlete should be exposed to DTC genetic testing to define or alter training or for talent identification aimed at selecting gifted children or adolescents. Large scale collaborative projects, may help to develop a stronger scientific foundation on these issues in the future.