Diagonal convergences: genetic testing, governance, and globalisation

Accepted Manuscript of a book chapter published by Routledge in Knowing New Biotechnologies: Social Aspects of Technological Convergence, March 2015, available online: http://www.tandfebooks.com/isbn/9781315776781The actual and sometimes quite unexpected uses to which individuals put new technologies can undermine social norms. Governments therefore often try to control access to new technologies. Beyond that, the notion of Converging Technologies (CT) stands for government programmes that not only monitor and regulate a new technology but plan and steer the convergence of emerging technologies and their future potential uses. In the early 2000s the U.S. and Europe set up government programmes to induce and configure the convergence of the nano-, bio-, information- and cognitive sciences (NIBC) into technologies that will alter humanity’s ways of being. CT is a form of meta-level governance that aims to control not only individual technological developments but also the ways in which scientific and technical innovations might intersect and cause social and economic change. This paper treats CT as an especially ambitious and precarious instance of governance because it aims to predetermine future science, future technologies, their intersections and resulting societal changes. Drawing on examples of a convergence that is well underway, I aim to demonstrate some of the problems of such prospective policy-making and argue that it draws on an understanding of the power and means of national governments that is already technologically overcome. National or local CT policies represent what Foucault called governmentality, an overreliance on manageability, regarding the formation of new platforms for decision-making that is happening alongside and irrespective of such government programmes. This situation demands new ways of policy-making of certain social values are to be protected

Can harmonized regulation overcome intra-European differences? Insights from a European Phase III stem cell trial

This is the author accepted manuscript. The final version is available from Future Medicine via the DOI in this record.Harmonized regulation of research with human stem cells in Europe has shaped innovation in regenerative medicine. Findings from a Phase III academic clinical trial of an autologous cell procedure illustrate the obstacles a multinational trial faces. A typology of the obstacles encountered, may help other teams embarking upon trials. The findings throw light on the situation of clinician-scientists in clinical innovation, as the expertise to run scientific trials is very complex. The innovation route of clinical translation takes insufficient account of the interdependencies between multiple social and cultural factors from outside the laboratory and the clinic. For ethical reasons, however, academic and business routes to stem cell treatments ought to be enabled by the regulators. Suggestions arise: how academics can prepare for trials, that academic research needs better institutional support, and that new models of medical innovation may need to be developed for regenerative medicine.This research was funded by the European Commission under the Seventh Framework Programme, HEALTH, Grant agreement number 278967

Care Ethics and Care Contexts: Contributions from Feminist Philosophy

This is the author accepted manuscript. The final version is available from Duke University Press via the DOI in this recor

Between the Local and the Global: Evaluating European regulation of stem cell regenerative medicine

This is the author accepted manuscript. The final version is available from Johns Hopkins University Press via the DOI in this record.Current European regulations hinder the compilation of the evidence that would be required to bring safe and effective autologous stem cell–based interventions (SCBIs) into standard clinical care. European agencies have expanded their regulations to cover all new SCBIs and research. They establish demanding conditions for cell retrieval, processing, and application. Drawing on empirical sociological findings from observing the implementation of the first phase III stem cell clinical trial in 2 Europe, this article teases out some ethical problems effected by that policy. They include that because of the costs of bringing treatments to market, new autologous SCBs may remain untested and that this plays in favour of the growing direct-to-consumer market. Furthermore, that the research pathways in regenerative medicine and the role of clinician-scientists in developing new treatments is restricted, because the regulations are biased to enable specific SCBI’s that are of interest to industry. This present situation contradicts the moral and social concerns in favour of new treatments and patient interests, which the regulations supposedly safeguard. To align aims and effects of policy better, European regulatory authorities should reconfigure their regulations to advance a fair and effective governance regime that allows pursuit of all promising SCBIs.This research was funded through the European Union’s Seventh Framework Programme for research, technological development, and demonstration under grant agreement No. 27896

Assets, Commodities and Biosocialities. Multiple Biovalues in Hybrid Biobanking Practices

This is the final version. Available on open access from STS Italia via the URL in this record.Biobanks are crucial institutions in the infrastructure of contemporary life sciences. They depend on the participation of donors who give tissues and data. Through their participa-tion, donors can build identities and form biosociality. Biobanks are key sites in the cur-rent bioeconomy, that enable the generation of value from those tissues and bioinfor-mation, transformed into assets or commodities. We define biobanks as hybrid zones of heterogeneous practices that blur the boundaries between institutional sectors and ways of producing economic values. On that basis we introduce a novel empirical, realist approach to the analysis of biobanking economies, explaining the different economic and social biovalues that emerge from the practices of valuing and interacting between the research-ers, biobank staff and donor participants in specific banking activities. We discuss why STS studies on biobanking should explore the concrete practices through which multiple biovalues as well as biosocialities are produced simultaneously and in configurations of mutual interdependence

Translational research: an imperative shaping the spaces in biomedicine

This is the final version of the article. Available from STS Italia via the link in this record.In this paper we recapitulate the history of the conceptual entwinement of biomedicine and translation and argue that a translational imperative (still peripheral to the practices that order the fields unified under the term biomedicine) has come to dominate public and institutional perceptions of biomedical research. We show this by first delineating a brief history of the conceptual developments in the sociology of science and technology, in particular in relation to translation and the complex multiagent social interactions contributing to the structure of this field. We then report the findings from our studies of translational spaces and how the actors in them conceive of the imperatives. At least in the field of cell therapy research, the push toward translational research from funding and science policy institutions seems not to have altered greatly the established practices of validation and merit that organise the complexes that form cell therapy biomedical research today.The authors gratefully acknowledge the Economic and Social Research Council (ESRC) as funder of both the project Stem Cell Research in Context (Project No. RES-349-25-0002) and the ESRC Centre for Genomics in Society in Exeter, which was part of the ESRC Genomics Network. The Corresponding Author, Jean Harrington, also acknowledges the support of the NIHR Biomedical Research Centre at Guy’s and St Thomas’ NHS Foundation Trust and King’s College London

De las sombras a la luz, los psicodélicos y los poderes institucionales

This is the final version. Available from Universidad Nacional Autónoma de México via the DOI in this record. The objective of this essay is to analyze the limits and ethical problems underlying the process of medicalization of psychedelics, the paradoxes found in psychedelic psychotherapy are also analyzed, as well as the institutional powers that have led psychedelics to the verge of becoming a very lucrative industry. In order to carry out this analysis, we have taken into account the Critical Theory proposal developed by the Frankfurt School, as well as the philosophical proposal of Michel Foucault

Standards, Harmonization and Cultural Differences: Examining the Implementation of a European Stem Cell Clinical Trial

This is the author accepted manuscript. The final version is available from Taylor & Francis via the DOI in this record.A complex set of European regulations aims to facilitate regenerative medicine, harmonizing good clinical and manufacturing standards and streamlining ethical approval procedures. The sociology of standardization has elaborated some of the effects of regulation but little is known about how such implementation works in practice across institutions and countries in regenerative medicine. The effects of transnational harmonization of clinical trial conduct are complex. A long-term ethnographic study alongside a multinational clinical trial finds a range of obstacles. Harmonization standardizes at one level, but implementing the standards brings to the fore new layers of difference between countries. Europe-wide harmonization of regulations currently sdisadvantages low-cost clinician-lead research in comparison to industry-sponsored clinical trials. Moreover, harmonized standards must be aligned with the cultural variations in everyday practice across European countries. Each clinical team must find its own way of bridging harmonized compulsory practice with how things are done where they are, respecting expectations from both patients and the local hospital ethics committee. Established ways of working must further be adapted to a range of institutional and cultural conventions that affect the clinical trial such as insurance practices and understandings of patient autonomy. An additional finding is that the specific practical roles of team members in the trial affect their evaluation of the importance of these challenges. Our findings lead to conclusions of wider significance for the sociology of standards concerning how regulation works and for medical sociology about how trial funding and research directions in stem cell medicine intersect.The BAMI Project is partially funded by the European Commission under the 7th Framework Programme (Grant agreement number 278967)

İkilikleri Altüst Etmek ve Dayanışmayı Hayata Geçirmek

This is the final version. Available on open access from Feminist Tahayyül via the link in this recor

Judith Butler, Das Unbehagen der Geschlechter

This is the author accepted manuscript. The final version is available from Suhrkamp Verlag via the link in this record.Aus heutiger Sicht bereitet Butlers Kritik an Theorien der Ontogenese des vergeschlechtlichten Subjekts und seines Begehrens die Grundlage für eine neue Ethik der Intersubjektivität sowie des zwischenmenschlichen Handelns vor. Diese Ethik ist eine der wechselseitigen Abhängigkeit, in der das Individuum sich selbst notwendig als verletzlich und fragil erlebt, angewiesen auf die Anerkennung und das Vertrauen anderer (Hauskeller 2006). Die Leistung Butlers ist, dass sie die Fragilität des einzelnen Individuums und der Beziehungen im sozialen Raum durch kompromisslose Analysen von Theorien, aber auch politischen Macht- und Gewaltbeziehungen aufzeigt. Zu diesem Zweck verbindet sie Einsichten aus der Sprachphilosophie, des poststrukturalistischen Denkens und der frühen Frankfurter Schule. Unter Bedingungen zunehmender Globalisierung und neuer Kommunikationsformen scheint das selbstbewusste und handlungsfähige Subjekt der westlichen Moderne ideologischer und problematischer denn je. Butler diskutiert, wie körperliche und psychische Gewalt mit gesellschaftlichen Machtkonstellationen verschränkt sind. In diesem Zusammenhang konzentriert sich Das Unbehagen der Geschlechter speziell auf die Analyse bestimmter Annahmen über Geschlecht, insbesondere derjenigen, dass das körperliche Geschlecht eine Naturgegebenheit sei, die das Sein der Individuen präformiert. Die Verknotung von Epistemologie, das heißt dem, was gedacht und begründet werden kann, Normen und begründbaren Forderungen im sozialpolitischen Raum ist dabei zentral für ihre Argumentationsweise, die argumentationslogisch an Michel Foucault anschließ