BackgroundConsent for data research in acute and critical care is complex as patients become at least temporarily incapacitated or die. Existing guidelines and regulations in the European Union are of limited help and there is a lack of literature about the use of data from this vulnerable group. To aid the creation of a patient-centred framework for responsible data research in the acute setting, we explored views of patients and next-of-kin about the collection, storage, sharing and use of genetic and (...) health-related data for observational research.MethodsWe conducted qualitative interviews (n = 19) with Dutch sudden cardiac arrest survivors who donated clinical and socio-economic data and genetic samples to research. We also interviewed their next-of-kin. Topics were informed by ethics literature and we used scenario-sketches to aid discussion of complex issues.ResultsSudden cardiac arrest survivors displayed limited awareness of their involvement in health data research and of the content of their given consent. We found that preferences regarding disclosure of clinically actionable genetic findings could change over time. When data collection and use were limited to the medical realm, patients trusted researchers to handle data responsibly without concern for privacy or other risks. There was no consensus as to whether deferred consent should be explicitly asked from survivors. If consent is asked, this would ideally be done a few months after the event when cognitive capacities have been regained. Views were divided about the need to obtain proxy consent for research with deceased patients’ data. However, there was general support for the disclosure of potentially relevant post-mortem genetic findings to relatives.ConclusionsSudden cardiac arrest patients’ donation of data for research was grounded in trust in medicine overall, blurring the boundary between research and care. Our findings also highlight questions about the acceptability of a one-time consent and about responsibilities of patients, researchers and ethics committees. Finally, further normative investigation is needed regarding the (continued) use of participants’ data after death, which is of particular importance in this setting. Our findings are thought to be of relevance for other acute and life-threatening illnesses as well. (shrink)

Contemporary, technoscientific capitalism is characterized by the configuration of a range of “things” as assets or capitalized property. Accumulation strategies have changed as a result of this assetization process. Rather than entrepreneurial strategies based on commodity production, technoscientific capitalism is increasingly underpinned by rentiership or the appropriation of value through ownership and control rights, monopoly conditions, and regulatory or market devices and practices. While rentiership is often presented as a negative phenomenon in both neoclassical and Marxist political economy literatures—and much (...) in between—in this paper, I conceptualize rentiership as a technoeconomic practice and process framed by insights from science and technology studies. So, rather than a problematic “side effect” of capitalism, the concept of rentiership enables us to understand how different forms of value extraction constitute, and are constituted by, different forms of technoscience. This allows STS to contribute a distinctive analytical approach to ongoing debates in political economy about economic rents and rent-seeking. (shrink)

Throughout the Global North, policymakers invest in large-scale integration of health-data infrastructures to facilitate the reuse of clinical data for administration, research, and innovation. Debates about the ethical implications of data repurposing have focused extensively on issues of patient autonomy and privacy. We suggest that it is time to scrutinize also how the everyday work of healthcare staff is affected by political ambitions of data reuse for an increasing number of purposes, and how different purposes are prioritized. Our analysis builds (...) on ethnographic studies within the Danish healthcare system, which is internationally known for its high degree of digitalization and well-connected data infrastructures. Although data repurposing ought to be relatively seamless in this context, we demonstrate how it involves costs and trade-offs for those who produce and use health data. Even when IT systems and automation strategies are introduced to enhance efficiency and reduce data work, they can end up generating new forms of data work and fragmentation of clinically relevant information. We identify five types of data work related to the production, completion, validation, sorting, and recontextualization of health data. Each of these requires medical expertise and clinical resources. We propose that the implications for these forms of data work should be considered early in the planning stages of initiatives for large-scale data sharing and reuse, such as the European Health Data Space. We believe that political awareness of clinical costs and trade-offs related to such data work can provide better and more informed decisions about data repurposing. (shrink)

This article provides an ethnographic account of how Big Data biology is produced, interpreted, debated, and translated in a Big Data-driven cancer clinical trial, entitled “Personalized OncoGenomics,” in Vancouver, Canada. We delve into epistemological differences between clinical judgment, pathological assessment, and bioinformatic analysis of cancer. To unpack these epistemological differences, we analyze a set of gazes required to produce Big Data biology in cancer care: clinical gaze, molecular gaze, and informational gaze. We are concerned with the interactions of these bodily (...) gazes and their interdependence on each other to produce Big Data biology and translate it into clinical knowledge. To that end, our central research questions ask: How do medical practitioners and data scientists interact, contest, and collaborate to produce and translate Big Data into clinical knowledge? What counts as actionable and reliable data in cancer decision-making? How does the explicability or translatability of genomic Big Data come to redefine or contradict medical practice? The article contributes to current debates on whether Big Data engenders new questions and approaches to biology, or Big Data biology is merely an extension of early modern natural history and biology. This ethnographic account will highlight how genomic Big Data, which underpins the mechanism of personalized medicine, allows oncologists to understand and diagnose cancer in a different light, but it does not revolutionize or disrupt medical oncology on an institutional level. Rather, personalized medicine is interdependent on different styles of thought, gaze, and practice to be produced and made intelligible. (shrink)

In this article, we use the theory of Information Ethics to argue that deceased people have a prima facie moral right to privacy in the context of health data research, and that this should be reflected in regulation and guidelines. After death, people are no longer biological subjects but continue to exist as informational entities which can still be harmed/damaged. We find that while the instrumental value of recognising post-mortem privacy lies in the preservation of the social contract for health (...) research, its intrinsic value is grounded in respect for the dignity of the post-mortem informational entity. However, existing guidance on post-mortem data protection is available only in the context of genetic studies. In comparing the characteristics of genetic data and other health-related data, we identify two features of DNA often given as arguments for this genetic exceptionalism: relationality and embodiment. We use these concepts to show that at the appropriate Level of Abstraction, there is no morally relevant distinction between posthumous genetic and other health data. Thus, genetic data should not automatically receive special moral status after death. Instead we make a plea for ‘contextual exceptionalism’. Our analysis concludes by reflecting on a real-world case and providing suggestions for contextual factors that researchers and oversight bodies should take into account when designing and evaluating research projects with health data from deceased subjects. (shrink)

New data-driven ideas of healthcare have increased pressures to reform existing data infrastructures. This article explores the role of data governing institutions during a reform of both secondary health data infrastructure and related legislation in Finland. The analysis elaborates on recent conceptual work on data journeys and data frictions, connecting them to institutional and regulatory issues. The study employs an interpretative approach, using interview and document data. The results show the stark contrast between the goals of open and Big Data (...) inspired reforms and the existing institutional realities. The multiple tensions that emerged during the process indicate how data frictions emanate to the institutional level, and how mundane data practices and institutional dynamics are intertwined. The article argues that in the Finnish case, public institutions acted as sage-guards of public interest, preventing more controversial parts from passing. Finally, it argues that initiating regulatory and infrastructural reforms simultaneously was beneficial for solving the tensions of the initiative and analysing either side separately would have produced misleading accounts of the overall initiative. The results highlight the benefits of analysing institutional dynamics and data practices as connected issues. (shrink)

For years, attempts at ensuring the social sustainability of digital solutions have focused on ensuring that they are perceived as helpful and easy to use. A smooth and seamless work experience has been the goal to strive for. Based on document analysis and interviews with 15 stakeholders, we trace the setting up of a data infrastructure in Danish General Practice that had achieved just this goal – only to end in a scandal and subsequent loss of public support. The ease (...) of data access made it possible for data to be extracted, exchanged and used by new actors and for new purposes – without those producing the data fully realizing the expansion of the infrastructure. We suggest that the case has wider relevance for a still more data-intensive healthcare sector and a growing data economy: when those who produce the data are not made aware of new uses of data, it makes it more difficult to resolve potential conflicts along the way. In the Danish case, conflicting views on legitimate data use led to the collapse of the infrastructure. Therefore, while seamlessness may be a solution to the old problem of a poor fit between user and technology, this celebrated virtue may also involve new problems relating to social instability. As digital solutions tend to be integrated still more seamlessly in still more of our activities, we need to develop political mechanisms to define and protect the rights and obligations of both data suppliers and users in order to ensure the long-term sustainability of digital infrastructures. (shrink)

This article draws on research undertaken by the authors as part of the Administrative Data Research Centre in England. Between 2014 and 2017, we conducted four case studies on government administrative data for education, transport, energy and health. The purpose of the research was to examine stakeholder perspectives about the sharing, linking and re-use of government administrative data. In relation to the role and nature of consent given by data subjects for re-use, our study revealed significant variations in data provider (...) and researcher attitudes. Although our study setting was England, we believe that the findings have wider resonance. Our analysis identified six factors which might account for the variations around consent: the specificities of the legislative framework governing the collection and processing of particular data; the type of data being collected and the relational context in which it is created; the broader information governance framework in which the data resides; the creating organization's approach to data release; the relative levels of risk aversity within the creating organization; and public perceptions and social attitudes. In conclusion, we consider whether consent is still the best mechanism available for data re-use, or whether a social contract model of data sharing should be developed. (shrink)

There is a long history in science and technology studies of tracking problematic objects, such as controversies, matters of concern, and issues, using various digital tools. But what happens when public problems do not play out in these familiar ways? In this paper, we will think through the methodological implications of studying “problems” in relation to recent events surrounding the sharing of patient data in the National Health Service in the United Kingdom. When a data sharing agreement called care.data was (...) announced in 2013, nearly 1.5 million citizens chose to opt out. Yet, in subsequent years, there has been little evidence of a robust public mobilising around data sharing. We will attempt to track this elusive ‘non problem’ using some digital tools developed in STS for the purpose of mapping issues and problem definitions within science. Although we find these digital tools are unable to capture the “problem,” the process of searching helps us map the terrain of the case and forces us to consider wider definitions. (shrink)