Christine Hauskeller

Genes, genomes and identity. Projections on matter

This paper aims to show that references to genes and genomes are counterproductive in legal and political understandings of what it is to be human and a unique individual. To support this claim, I will give a brief overview of the many incompatible meanings the term ‘identity’ has gathered in reference to genes or genome in the contexts of biology and family ancestry, personal identity, species identity. One finds various and incompatible understandings of these expressions. While genetics is usually considered to deliver definitive knowledge about history and the future, genomics seems to work with more complicated relations between DNA, inheritance and phenotype. In genomics, ‘identity’ is no longer about identification and status markers but about individualization. Regulatory and legal documents project from traits to genomes, implying that the individuality is at least represented, if not created, in a unique genome. Boundaries between humans and other animals, between different ‘kinds’ of humans, and between all individual humans are re‐established via reference to the chemical matter of DNA. My analysis will show how this trend is a reactionary response to modern understandings of identities as social products and that it ignores new biomedical understandings of human bodies.

The consensus of the Task Force of the European Society of Cardiology concerning the clinical investigation of the use of autologous adult stem cells for the treatment of acute myocardial infarction and heart failure: update 2016

In 2006, the Task Force of the European Society of Cardiology published its consensus document on the use of autologous cell therapy for repair of the heart. Since then, there have been numerous clinical trials and analyses performed to establish the role of autologous cell therapy in the treatment of both acute and chronic cardiac disease. The majority of these studies have been Phase II clinical trials. Phase III clinical trials of autologous cell therapy have been launched (e.g. BAMI), which marks the successful progression of clinical investigation of autologous cell therapy in heart disease. The Task Force has reviewed its 2006 recommendations and the developments in this area of research and proposes updated recommendations for the future of autologous cell therapy in the heart. This article does not duplicate the many reviews on stem cells and the heart but gives considered recommendations based on the experience from the last 10 years (Table 1).

“A Faustian bargain?” Public voices on forensic DNA technologies and the National DNA Database

This article draws on the idea of the “forensic imaginary” (Williams 2010) to explore UK public perspectives on the place, role and significance of forensic DNA technologies, both independent of and in relation to other genetic applications. Using correspondents’ replies to the Spring 2006 Mass Observation Directive “Genes, Genetics and Cloning,” the analysis focuses on continuities and tensions in their discursive repertoires. The argument examines (1) the ways in which knowledge is made sense of in these accounts; and (2) the discrepancy between an appreciation of the benefits of using DNA identification techniques in police work and a more critical attitude towards a wider national DNA database. The conclusion reflects on the need for a wider scope in research on public understandings of science, which looks beyond targeted consultations and specific publics, and provides more textured data to document collective views on the development and governance of forensic DNA technologies.

Genetics and the Sociology of Identity

In 1990, an international coalition of scientists successfully argued for huge public investment to support their work to sequence the human genome. Proponents of the Human Genome Project described it at the time as ‘one of mankind’s greatest odysseys. It is a quest that is leading to a new understanding of what it means to be a human being’ (Bodmer and McKie, 1994: vii). According to its advocates, the resulting knowledge of human genetic make-up would not only impact on basic science, the practice of medicine and the delivery of healthcare; it would also do much to explain human behaviour, elucidating and even offering solutions to social problems and reshaping how humans think of themselves and relate to others. The Human Genome Project spurred renewed claims by scientists to speak authoritatively about what makes us who we are, challenging the position held by the social sciences, and in particular by sociology, since the end of the Second World War. Over the past two decades, social scientists from different traditions – sometimes in alliance with sympathetic scientists – have risen to this challenge in two distinct but related ways: first, by engaging with and critiquing claims about the explanatory power of genetics; and second, by studying the myriad ways in which actors draw upon and interpret genetic knowledge as part of their identity-making practices. This latter programme of research and reflection has been particularly fruitful as a source of insights into the sociology of identity. Early fears that genetics would lend itself to a process of reification and standardisation of identities (Flower and Heath, 1993) have been superseded by a growing appreciation of the extent to which ‘individuals resist, appropriate, or accommodate themselves to genetic power/knowledge in line with diverse identity politics, not schemes of centralized or capillary control’ (Brodwin, 2005: 142). Social scientists have accordingly assembled a rich and multifaceted empirical literature on the ways in which identities are formed where genetics comes to be involved. The articles in this Special Issue contribute to this sociological understanding of genetic knowledge and identity practices in two key respects. On the one hand, they emphasise just how deeply genetics has penetrated into many realms of social life. On the other, they illustrate the diversity of the ways in which identities are negotiated between self, others and institutions, and how the language and practices of genetics – and heredity more generally – have been integrated into those negotiations. Before discussing the contributions of the individual articles in this Special Issue, we briefly revisit the wider sociological literature on identity in order to specify the particular challenges raised by these new empirical analyses.

Travelling cells: harmonized European regulation and the BAMI stem cell trial

Harmonized regulation of clinical trials seems necessary in order to speed up approval processes and the time from bench to bedside for novel stem cell treatments. Europe is comprised of countries with diverse regulatory and health-care systems, and the regulators’ aim to unify practice across them provides an opportunity to study the effects of harmonization through regulation and novel institutions. We report findings from a long-term study alongside the first multinational European stem cell clinical trial that applied the harmonized approval procedures and follows the regulations in stem cell clinical trial practice standards introduced over the past decade. Adapting to this regulatory environment was costly in terms of trial implementation and caused delays in patient recruitment. That the stem cells for autologous use had to be transported all over Europe for processing in licensed centres stands out among the costly complications the teams had to address. We conclude that academic trials with little industry support are currently hampered by harmonized regulation. Such trials depend on complex cross-area expertise for implementation. The academic and public sectors have insufficient access to such information. In order to facilitate all promising routes towards a future stem cell medicine, a central support institution bundling expertise in handling the technicalities of implementing multinational trials in Europe is needed.

Cardiac stem cell research: regulation and practice in the UK and Germany

Debates on the regulation of stem cell research (SCR) tend to center on the governance of ethically contested stem cells (i.e. human embryonic), focus on the macro-dynamics of science development and the role of legislative bodies, and rely on documentary resources. They also largely ignore regulatory dynamics in adult SCR, where clinical trials have brought SCR closer to application. This article examines the contextual elaboration of novel medical treatment regulation in relation to stem cell therapies for heart repair using adult stem cells, in two European countries, the UK and Germany. It presents some of the challenges regulation poses in practice for both regulators and clinical teams, and discusses how the tension between the creation and maintenance of standards and the development of new treatments is understood by the regulators themselves. The conclusion evaluates the significance of regulatory practices in the production of new stem cell therapies in particular and innovative treatments more generally.

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

ABSTRACT 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 disadvantages 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.

Hybrid practices in cord blood banking. Rethinking the commodification of human tissues in the bioeconomy

The STS and bioethical literature on umbilical cord blood (UCB) banking nowadays discusses the field as divided into opposite institutional arrangements, public versus private banking. Public banks represent a model-sharing economy; private banks represent a market economy that capitalizes hopes and tissues, and new hybrid forms that are emerging. We challenge that this distinction is analytically valuable for understanding the various forms of marketization, commodification and biovalue production that mark the UCB economy. Our analysis of current UCB banking practices, especially hybrid ones, and their inherent visions of the future, shows that hybrid UCB banking criss-crosses the different economic models and concepts of commodification. The private, public, hybrid distinction is thus inadequate for a critical analysis of the complex UCB bioeconomies. Drawing on the perspective of social welfare systems analysis, however, the tripartite distinction emphasizes an important ethical and biopolitical commitment to equality in current and future health care.

Von der Grundlagenforschung in die Klinik

Translation from the laboratory to the clinic is one of the key problems of stem cell research. One reason for this is that stem cell science is ethically charged and therefore its successful therapeutic application would support its social legitimacy and further funding. We discuss translation both theoretically and with reference to an example, namely efforts regarding the creation of cardiomyocytes from embryonic stem cell lines with the aim to regenerate a patients myocardium post trauma. Using this case we explain the facts that need to be established scientifically and the subsequent steps that need to be taken in order to develop and implement clinical application. We also discuss aspects of current scientific development related to the moral charge of the research, in particular emerging methods aimed at the derivation of pluripotent cells, such as the hybridization of human DNA and animal egg cells, or the genetic modification of adult somatic cell nuclei in culture to induce pluripotency.ZusammenfassungDer Übergang von der Laborforschung in die klinische Anwendung ist ein Schlüsselproblem der Stammzellforschung. Die Forschung selbst ist ethisch umstritten, jedoch aufgrund der therapeutischen Nutzbarkeit ihrer Ergebnisse gerechtfertigt. Im vorliegenden Beitrag soll theoretisch und anhand eines Beispiels auf den Übergangsprozess von der Forschung in die Klinik eingegangen werden: Dargestellt wird die Entwicklung von Herzzellen aus embryonalen Stammzellen (ES-Zellen) mit dem Ziel, diese zur Regeneration von Herzgewebe bei Infarktpatienten zu nutzen. Zunächst werden Erkenntnisse aus der Forschung erläutert, anschließend wird auf die erforderlichen Schritte hin zu einer klinischen Anwendung eingegangen. Außerdem werden einige neue Entwicklungen in der Stammzellforschung diskutiert, d. h. 2 neue Methoden zur Gewinnung pluripotenter Zellen diskutiert: die Hybridisierung menschlicher Zellkern-DNA mit Kuheizellen und die genetische Manipulation adulter somatischer Zellen im Labor zum Zwecke der Herstellung von Pluripotenz.AbstractTranslation from the laboratory to the clinic is one of the key problems of stem cell research. One reason for this is that stem cell science is ethically charged and therefore its successful therapeutic application would support its social legitimacy and further funding. We discuss translation both theoretically and with reference to an example, namely efforts regarding the creation of cardiomyocytes from embryonic stem cell lines with the aim to regenerate a patient’s myocardium post trauma. Using this case we explain the facts that need to be established scientifically and the subsequent steps that need to be taken in order to develop and implement clinical application. We also discuss aspects of current scientific development related to the moral charge of the research, in particular emerging methods aimed at the derivation of pluripotent cells, such as the hybridization of human DNA and animal egg cells, or the genetic modification of adult somatic cell nuclei in culture to induce pluripotency.

Von der Grundlagenforschung in die KlinikFrom basic research to the clinic. Obstacles and options for stem cell therapies

Translation from the laboratory to the clinic is one of the key problems of stem cell research. One reason for this is that stem cell science is ethically charged and therefore its successful therapeutic application would support its social legitimacy and further funding. We discuss translation both theoretically and with reference to an example, namely efforts regarding the creation of cardiomyocytes from embryonic stem cell lines with the aim to regenerate a patients myocardium post trauma. Using this case we explain the facts that need to be established scientifically and the subsequent steps that need to be taken in order to develop and implement clinical application. We also discuss aspects of current scientific development related to the moral charge of the research, in particular emerging methods aimed at the derivation of pluripotent cells, such as the hybridization of human DNA and animal egg cells, or the genetic modification of adult somatic cell nuclei in culture to induce pluripotency.ZusammenfassungDer Übergang von der Laborforschung in die klinische Anwendung ist ein Schlüsselproblem der Stammzellforschung. Die Forschung selbst ist ethisch umstritten, jedoch aufgrund der therapeutischen Nutzbarkeit ihrer Ergebnisse gerechtfertigt. Im vorliegenden Beitrag soll theoretisch und anhand eines Beispiels auf den Übergangsprozess von der Forschung in die Klinik eingegangen werden: Dargestellt wird die Entwicklung von Herzzellen aus embryonalen Stammzellen (ES-Zellen) mit dem Ziel, diese zur Regeneration von Herzgewebe bei Infarktpatienten zu nutzen. Zunächst werden Erkenntnisse aus der Forschung erläutert, anschließend wird auf die erforderlichen Schritte hin zu einer klinischen Anwendung eingegangen. Außerdem werden einige neue Entwicklungen in der Stammzellforschung diskutiert, d. h. 2 neue Methoden zur Gewinnung pluripotenter Zellen diskutiert: die Hybridisierung menschlicher Zellkern-DNA mit Kuheizellen und die genetische Manipulation adulter somatischer Zellen im Labor zum Zwecke der Herstellung von Pluripotenz.AbstractTranslation from the laboratory to the clinic is one of the key problems of stem cell research. One reason for this is that stem cell science is ethically charged and therefore its successful therapeutic application would support its social legitimacy and further funding. We discuss translation both theoretically and with reference to an example, namely efforts regarding the creation of cardiomyocytes from embryonic stem cell lines with the aim to regenerate a patient’s myocardium post trauma. Using this case we explain the facts that need to be established scientifically and the subsequent steps that need to be taken in order to develop and implement clinical application. We also discuss aspects of current scientific development related to the moral charge of the research, in particular emerging methods aimed at the derivation of pluripotent cells, such as the hybridization of human DNA and animal egg cells, or the genetic modification of adult somatic cell nuclei in culture to induce pluripotency.