Precaution, governance and the failure of medical implants: the ASR(TM) hip in the UK

Hip implants have provided life-changing treatment, reducing pain and improving the mobility and independence of patients. Success has encouraged manufacturers to innovate and amend designs, engendering patient hopes in these devices. However, failures of medical implants do occur. The failure rate of the Articular Surface Replacement metal-on-metal hip system, implanted almost 100,000 times world-wide, has re-opened debate about appropriate and timely implant governance. As commercial interests, patient hopes, and devices’ governance converge in a socio-technical crisis, we analyse the responses of relevant governance stakeholders in the United Kingdom between 2007 and 2014. We argue that there has been a systemic failure of the governance system entrusted with the safety of patients fitted with medical implants. Commercial considerations of medical implants and the status quo of medical implant governance have been given priority over patient safety despite the availability of significant failure data in an example of uncertainty about what constitutes appropriate precautionary action

Governing anticipatory technology practices. Forensic DNA phenotyping and the forensic genetics community in Europe

Forensic geneticists have attempted to make the case for continued investment in forensic genetics research, despite its seemingly consolidated evidentiary role in criminal justice, by shifting the focus to technologies that can provide intelligence. Forensic DNA phenotyping (FDP) is one such emerging set of techniques, promising to infer external appearance and ancestry of an unknown person. On this example, I consider the repertoire of anticipatory practices deployed by scientists, expanding the concept to not only focus on promissory but also include epistemic and operational aspects of anticipatory work in science. I explore these practices further as part of anticipatory self-governance efforts, attending to the European forensic genetics community and its construction of FDP as a reliable and legitimate technology field for use in delivering public goods around security and justice. In this context, I consider three types of ordering devices that translate anticipatory practices into anticipatory self-governance

Socio-technical disagreements as ethical fora: Parabon NanoLab’s forensic DNA Snapshot™ service at the intersection of discourses around robust science, technology validation, and commerce

DNA profiling and databasing technologies have become integral to criminal justice practices in many countries, and their reliability is now rarely challenged. However, a new set of forensic genetics technologies has emerged, one of which is forensic DNA phenotyping (FDP). FDP aims to infer a person’s visible traits from DNA, and to predict biogeographical ancestry, in order to provide intelligence for difficult investigations. Debates around FDP have been largely academic and legal, but in some countries they have become of public interest. Here, many scientists and practitioners tend to avoid publically articulating disagreement about the limitations of such technologies. This paper attends to a rare public disagreement about technoscientific practices in the wider forensic genetics community about a commercial forensic service called Snapshot™ which utilises FDP. Its analysis of scientists’ ethical reasoning about the development and use of this set of technologies contributes to understanding the political economy of forensic genetics, at the intersection of scientific ethics, forensic practice, and commercial resources that make visible and enable further scientific research in the field. More widely, this paper proposes that attending to public ethical debates such as this offers much-needed insight into the various intersecting stakes that co-constitute emerging technologies

‘Crisis’, control and circulation: Biometric surveillance in the policing of the ‘crimmigrant other’

Automated facial recognition, the use of dactyloscopic data and advanced forensic DNA analyses are becoming dominant technological surveillance means for ‘crimmigration’ control. ‘Crimmigration’ describes the increasing criminalisation of migration, based on a perceived ‘crisis’ of mass migration and its assumed negative impact on national stability and welfare, materialising in overlapping crime and migration control regimes. We analyse the policing of migration through biometric technologies as the reproduction of social practices of security against crime. By combining concepts of social practices and ethical regimes, we suggest that biometric ethical regimes are constituted by social practices working towards legitimising the use of biomaterials and biodata. This analytical synthesis supports us in exploring how biometric technologies deployed in the policing of crime circulate into the policing of migration and vice versa. First, technologies as materials (DNA, fingerprints, facial images, analysis kits, databases, etc.) are inscribed with assumptions about validating identity and suspicion, and are increasingly made accessible as data across policy domains. Second, forensic competence moves in abstracted forms of expertise independent of context and ethics of application, creating challenges for reliable and legitimate technology deployment. Third, biometric technologies, often portrayed as reliable, useful, accurate policing tools, travel from crime into migration control with meanings that construct generalised criminal suspicion of migrants. To evidence the complexity and difficulty of achieving accountability and responsibility for the ethical governance of biometric technologies in policing, we trace how the goals, risks, benefits and values of biometric technologies are framed, and how the legitimacy of their deployment in policing of migration is constructed and negotiated.info:eu-repo/semantics/publishedVersio

Value beyond scientific Validity: Let’s RULE (Reliability, Utility, LEgitimacy)

My perspective piece contributes to social studies of biometric technologies, and to studies on values and valuation within debates of responsible innovation. I reflect on innovation as social practice where values are temporary settlements of considerations around validity, operability, and social compatibility of socio-technical innovations. As such, I propose a practice-based approach to testing values in new technologies and their respective emerging practice and governance arrangements around Reliability, Utility and LEgitimacy (RULE). These three values combine scientific with operational and social aspects of innovation as centre-points around which deliberative engagement can be facilitated between different societal perspectives, offering the opportunity to develop greater awareness of diverse and at times competing understandings of value. On the case study of forensic genetics – the use of genetic material and data for policing purposes in security and justice contexts – I make the case for multi-perspectival, cross-disciplinary, community-grounded deliberation based on RULE

An Analysis of the Learning Health System in Its First Decade in Practice: Scoping Review

Background: In the past decade, Lynn Etheredge presented a vision for the Learning Health System (LHS) as an opportunity for increasing the value of health care via rapid learning from data and immediate translation to practice and policy. An LHS is defined in the literature as a system that seeks to continuously generate and apply evidence, innovation, quality, and value in health care. Objective: This review aimed to examine themes in the literature and rhetoric on the LHS in the past decade to understand efforts to realize the LHS in practice and to identify gaps and opportunities to continue to take the LHS forward. Methods: We conducted a thematic analysis in 2018 to analyze progress and opportunities over time as compared with the initial Knowledge Gaps and Uncertainties proposed in 2007. Results: We found that the literature on the LHS has increased over the past decade, with most articles focused on theory and implementation; articles have been increasingly concerned with policy. Conclusions: There is a need for attention to understanding the ethical and social implications of the LHS and for exploring opportunities to ensure that these implications are salient in implementation, practice, and policy efforts

Was this an Ending? The Destruction of Samples and Deletion of Records from the UK Police National DNA Database

Between December 2012 and September 2013 the United Kingdom government oversaw one of the largest destructions of a collection of human-derived samples ever conducted. Approximately 7,753,000 DNA samples and 1,766,000 DNA computerized profiles associated with the UK’s policing National DNA Database (NDNAD) were destroyed or deleted. This paper considers this moment of exceptional erasure and the consequent implementation of new processes for routinely discarding and keeping samples and their associated computer records. It is divided into two parts. The first discusses the rapid growth of the NDNAD, the changing legal, ethical and political landscape within it was promoted and contested, and the developments that led to the decision to limit its scope. The second shifts focus to the operational challenge of implementing the destruction of samples and deletion of records. The NDNAD case allows us to examine the labour and continuing uncertainties involved in erasure of biological data and the emerging norms and practices associated with collecting DNA in differing formats. It also sheds new light on the importance, interconnection and on-going instability of the ethical and practical biovalue of genetic collections: as the paper argues, far from ending the NDNAD, a more rigorous regime of erasure has helped for the moment at least to secure its future

Promissory Ethical Regimes: Publics and Public Goods in Genome Editing for Human Health

This paper analyses promissory discourse for genome editing and human health in the UK, attending to the articulation of public goods and their beneficiary publics. Focusing on promissory reasoning about an emerging technology field as anticipatory and ethical considerations as integral to such debates, the notion of ethical regime as a mode of governance is applied to the concept of promissory regime. By analyzing key documents and interviews with opinion leaders—thus focusing on the discursive dimension—an enabling promissory ethical regime for genome editing and its contestation are identified. This regime posits scientific knowledge production now, and improved treatment or prevention of hereditary diseases later, as key goods of genome editing for human health and as a sociotechnical project worthy of support. Specific publics are created as beneficiaries. These publics and goods play out as ethical rationales for the promissory governance of the emerging field of human genome editing

Interdisziplinäre Überlegungen zu Erweiterten DNA-Analysen (Interdisciplinary considerations about new and emerging forensic DNA analyses)

Due to a change in law in December 2019, the use of "Forensic DNA Phenotyping“, i.e. technologies for the prediction of skin, hair and eye color as well as age, is now permitted in the context of criminal investigations. This article discusses the reliability, usefulness and legitimacy of such extended DNA technologies and thus the framework conditions for their application in Germany. It is revealed how complicated, error-prone, demanding, ambitious and sensitive the use of these technologies in investigations can be if appropriate precautions are not taken and if they are not limited to prudently supervised individual cases. Finally, based on this analysis, measures for the application and regulation of extended DNA technologies in Germany are proposed