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Download/ 18.235F40c212384f2ca668000177/1340207439890/Biobanks 2008 10.Pdf, Accessed 25 July 2014 Original Article Detaching data from the state: Biobanking and building big data in Sweden Alison Cool Department of Anthropology, University of Colorado, 1350 Pleasant St. Boulder, Boulder, CO 80309-0233, USA. Abstract LifeGene, a biobank and research infrastructure, is Sweden’s largest biomedical pro- ject. Designed for research on gene–environment interactions, the project aimed to collect data and biological samples from 500 000 individuals. The directors pointed to Sweden’s universal health-care system, national registries and pro-science citizenry as indicative of the nation’s unique suitability for this ambitious project. As researchers explained, in Sweden, large-scale national collection of per- sonal data has generally proceeded with little debate. In this view, the historical legacy of social engineering and close ties between science and the state has led to a popular sense of trust in the state to collect and use information in the best interest of the population.Proof However, LifeGene is more than just a continuation of information-gathering-as-usual in a country where the government has long kept track of its population’s health and social characteristics. With LifeGene, the construction of surrounding research infrastructures, and a reworking of national data protection legislation, Swedish researchers and authorities are now purposely building a framework for moving from data- as-usual to Big Data and the Big Value it promises to deliver. Drawing on ethnographic fieldwork with Swedish researchers and data managers, this article will examine the legal, social and infra- structural challenges of Sweden’s bid for Big Data. BioSocieties (2015) 0, 1–19. doi:10.1057/biosoc.2015.25 Keywords: Big Data; Sweden; biobanks; medical research; infrastructure LifeGene,Revised Sweden’s most ambitious national health and biobank project, began as a pilot study in 2009, and was launched in 2010. Designed to facilitate large-scale prospective epidemiological research by collecting high-quality lifestyle and genomic data, LifeGene was coordinated by the Karolinska Institute. The goal of the project, funded through a public– private partnership, was to enroll 500 000 individuals across Sweden, who would be given a comprehensive web-based questionnaire, and from whom biosamples and physical mea- surements would be taken.1 The questionnaire, measurements and samples would be repeated at 5-year intervals for at least the next 20 years. Participants in the project were 1 Funders include the Swedish Research Council, the Karolinska Institute, AFA Insurance, and the Ragnar and Torsten Söderberg Foundations. © 2015 Macmillan Publishers Ltd. 1745-8552 BioSocieties Vol. 00, 0, 19 www.palgrave-journals.com/biosoc/ Cool asked to give consent to LifeGene for the processing of personal data collected specifi- cally for the study, the storage of their blood and urine samples in a biobank, and access to personal data from medical records and health-relevant data in Sweden’snational registries (Maeurer, 2010; Almqvist et al, 2011; Regeringens Proposition, 2013). LifeGene was part of a larger Swedish initiative creating comprehensive research infra- structures to enable the collection and storage of data on an unprecedented scale, and developing technological platforms for analyzing these data sets to discover patterns and associations. Thus, I argue, LifeGene can be seen as part of a national push toward Big Data in biomedical research and across multiple domains of health and social welfare (Regeringens Proposition, 2008; SRC, 2012; SRC, 2014). For purposes of this article, I define Big Data as the analysis of data contained in very large – and often mixed – databases. Big Data projects, including LifeGene, require the development of elaborate, novel infrastructures – in particular when researchers want to access or combine data across research domains, jurisdictions, and, potentially, national borders. In 2009–2010, when the LifeGene project was introduced, and when I conducted fieldwork, the term Big Data was not widely used in Sweden. References to Big Data (the English term has been adopted in Swedish usage) can be found in research reports beginning around 2012 (for example, Görnerup et al, 2012) and in the popular press around 2013, following the revelations of NSA surveillance in the United States and Sweden’s FRA’s (National Radio Defense Establishment) cooperation (Dagens Nyheter, 2013;Proof Kielos, 2013; Rebas, 2013). As Big Data entered the popular lexicon in Sweden in 2013 and 2014, the term began to be used to describe LifeGene and other large-scale research databases (for example, Lagerwall, 2013; Jonsson, 2014). Here, I will trace the development of LifeGene, the construction of surrounding research infrastructures, and the reworking of national data protection legisla- tion over the period from 2009 to 2014 as an example of how Swedish researchers and authorities are actively working to move from data-as-usual, as it has been understood in the Swedish context, to Big Data and the Big Value – the seemingly limitless knowledge and economic growth – it promises to deliver. In Sweden, as elsewhere, the rhetoric of Big Data draws on a sense of its technological novelty and its perceived ability to produce novel forms of social and scientific knowledge and economic value. Big Data is also often characterized as perpetually in flux: accumulating, growing and moving beyond existing capacities for containing and processing data (Mayer-Schönberger and Cukier, 2013). These ways of imagining Big Data as both mobile and anticipatory came into play in Swedish discussions of the LifeGene project,Revised and, I will argue, helped to produce a crisis of legitimacy that led to the temporary shutdown of LifeGene in 2011 by the Swedish Data Inspection Authority (DIA). In 2013, a new law was passed to allow LifeGene’s work to continue, resolving the 2-year period of legal uncertainty. The DIA’s2011decisionandthesubsequentdebates revealed how the detachment of health data collection and storage from existing social welfare state infrastructures and oversight mechanisms emerged as an obstacle for LifeGene, raising the question of whether the possibility of participating in Big Data can be reconciled with national data as it has been framed in the context of the Swedish social welfare state. Paradoxically, LifeGene aimed to build on qualities imagined as uniquely Swedish while standardizing data protocols to facilitate seamless linkage with research data worldwide and 2 © 2015 Macmillan Publishers Ltd. 1745-8552 BioSocieties Vol. 00, 0, 1–19 Detaching data from the state creating a large-scale database that stands apart from Sweden’s traditional state-managed and nationally bounded model of data collection. Thus, I will argue, LifeGene is emblematic of a larger tension in Swedish biomedical research in which the particular history of the Swedish welfare state and the related longstanding and widespread usage of personnummer (personal identification numbers) has produced an unusually rich trove of national data, but at the same time, the value of Swedish data increasingly depends on its use for producing knowledge about human health and behavior more generally, indeed, through what is identified as global data. This longstanding tension has been amplified as Sweden, like many other nations worldwide, works to build not only the technological infrastructure for Big Data, but also to adapt governance structures to the social and legal challenges of collecting and using data in new ways. Sweden, which has long been known for its detailed national demographic and medical databases and its progressive social welfare state, offers an especially interesting context for exploring the rescaling of ethical concerns in light of profound changes in data technologies and practices. Methodology In this article, I draw on ethnographic fieldwork conducted in Stockholm, Sweden with researchers and database managers over 15 months betweenProof 2009 and 2010, including 30 tape-recorded, semi-structured interviews. This ethnographic research focused on research- ers from a range of disciplinary backgrounds, all of whom studied on genetic and environ- mental influences on behavior and used data from the Swedish Twin Registry, housed at the Department of Medical Epidemiology and Biostatistics at the Karolinska Institute. The LifeGene project includes an oversampling of data from twins in the Swedish Twin Registry, and its development was described to me by researchers affiliated with both projects as one of the priorities of the Swedish Twin Registry. In addition to researchers affiliated with Karolinska, I also interviewed researchers at Stockholm University, the Swedish Institute of Financial Research, the Stockholm School of Economics, and Uppsala University, and database managers at Statistics Sweden. I conducted participant-observation at lectures, seminars, dissertation defenses, conferences, meetings and in social gatherings with infor- mants. Tape-recorded interviews were conducted in English, while participant-observation took place in both Swedish and English. I also draw on archival research and textual analysis of Swedish newspaper and popular scientific mediaRevised reports about LifeGene and Big Data; academic publications by researchers affiliated with LifeGene; Swedish legislation concerning personal data, biobanks, and science and research policy; Swedish government reports; policy documents and reports published by public authorities including the
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