BULLETIN TWO - SUMMER 2007
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Parliamentary Bill
At the end of July, a Joint Committee of both UK Houses of Parliament produced a detailed report that comments on the government’s draft Human Tissue and Embryos Bill which is being used as a vehicle to update the law on assisted human reproduction. The Bill carries various amendments to the Human Fertilisation and Embryology Act 1990 (HFEAct) and the Human Tissue Act 2004 (HTAct). One of the principal proposals it makes is the proposed merger of the HFEA and the HTA to form the Regulatory Authority for Tissue and Embryos (RATE) and legislation relating to interspecies embryos (ISE), such as cytoplasmic hybrids or ‘cybrids’. The Bill contains various proscriptions as well as enablements for ISEs, under licence and according to new regulations. While welcoming the draft bill in broad terms, the Joint Committee has raised a number of objections to what are actually the core aspects of the proposed legislation. The proposal to establish RATE is rejected after hearing evidence from research councils and other stakeholders against it, as are the proposals relating to ISE, which are seen to define prematurely and so in a pre-emptive way what these might comprise ahead of the science. Instead the Committee prefers a more open-ended definition that allows regulatory discretion in the future:
‘legislation should provide a general definition that the regulator can interpret and apply to individual research applications within the principles set out by Parliament. This contrasts with the Government's approach to try to define now in legislation new types of inter-species embryos that may emerge in the future’
The ESRC’s SCI network has been exploring these issues for some time especially through the work we are doing on regulation within and outside of the UK . The Joint Committee’s comments on the Draft Bill are highly predictable in the British science policy making context which has a long-established tradition of trying to avoid new legislative instruments if possible and encompass scientific developments within existing provisions, and simultaneously avoiding overly-prescriptive procedures and definitions. It is then somewhat ironic to see at the same time a strong lobby among the science community calling for an end to ‘over-regulation’. Paradoxically, the regulatory regime in the UK which has been developed over recent years in fields such as stem cells has been highly enabling of science precisely because it has established a strong platform through which developments can be monitored and approved. The Draft Bill is clearly regarded as a shift away from this regulatory tradition of ‘flexibility’, and hence the quite vehement opposition to it. The Joint Committee calls for the retaining of an important additional feature of the British policy-making culture, the free vote in Parliament, reflecting what it regards as being difficult ethical dimensions to the debate. Indeed, it also recommends the establishing of a new Joint Committee on Bioethics.
As we reported in e-Bulletin (I) various ESRC-funded projects are tracing the management of uncertainty in the field and how this effects regulation, governance and innovation In the Research Updates section below, this latest e-Bulletin reports on a number of projects that explore these issues at an international level. They range from the new work of a PhD student (Liverani), a postdoc Fellow (Harvey) to more experienced researchers (Wainwright and Kraft).
The move towards a Joint Bioethics Committee is a development that would mirror similar initiatives within EU member states and the US (the National Bioethics Advisory Committee). If this is agreed, it will be important that, unlike elsewhere, a UK version does not marginalise competing voices from within the civic-sector: typically, and this has been found especially in the US, such Committees tend to endorse the authority of science, while at the same time acting more prescriptively (especially in the wider EU). A new Joint Committee may well in fact act as contrary to the interests of the UK regulatory model which has depended on a more pragmatic and, indeed flexible, framework through which the science/society relationship has developed. The SCI’s work on ethics, public engagement and accountability will be an important evidence-based resource on which parliament should draw.
UKSCN update
The UK Stem Cell Network announced that its first national research conference will be held at the Edinburgh Conference Centre at Heriot-Watt University, 9-11 April 2008.
Over 300 delegates are expected to congregate in Edinburgh to hear UK leaders in stem cell science present the latest stem cell research highlights and findings. High profile international stem cell researchers will be invited to deliver keynote speeches at the conference. The conference will represent the diversity and quality of stem cell research in the UK, with a focus on up and coming young investigators. The ESRC’s SCI will be involved and we will have a umber of younger researchers from the social science network giving papers at the meeting
The conference will become an annual feature of the scientific calendar, visiting a different UK centre of excellence in stem cell science each year. It will not only be an outstanding opportunity to learn about the latest advances, but will also function as a unique forum for developing improved co-ordination of research efforts across the natural and social sciences in this field.
We present four brief reports updating work on the international aspects of stem cell science especially in relation to translational and governance-focused research. Liverani’s work (based at Egenis in Exeter) examines patterns of scientific cooperation across EU-based labs. This has significance for questions of regulation inasmuch as scientists build such ‘collaboratories’ across distinct regulatory arenas. Harvey’s postdoc work examines an even wider geographical space – the globalisation of the stem cell economy – and the ways in which individual states respond to the challenges that are posed by this highly uneven, rapidly expanding market which is paralleled by an uneven moral economy. This raises questions for any putative Joint Bioethics Committee in terms of precisely where it locates the UK within the global regulatory universe?
Wainwright reports on his Fellowship that explores another space – that within which we see the translation of research from the lab to the clinic. He shows how different paradigms (cell transplantation models and lines as vehicles through which to understand disease per se) relating to the ways in which the contribution of stem cells is likely to be made underpin very different approaches to the field. Again, these different paradigms will be likely to cast the regulatory and ethical prospects and dilemmas of embryonic stem cells in quite different ways. Such paradigms would, for example, have different implications for the role of ISEs in research, with disease models regarding ISEs perhaps as more appropriate (and safer) models through which translational research might be tested.
Finally, Kraft raises the whole question of what ‘translational’ research actually means, and her project paper will be worth reading when it appears in the not too distant future for it will endeavour to determine how genuinely novel this concept is.
Marco Liverani (Egenis, University of Exeter)
My PhD project in sociology at Egenis (EU Stem Cell: A Case Study in Scientific Cooperation) investigates the patterns of collaboration between stem cell laboratories which are involved in EU funded international consortia. In particular, the project aims to explore issues such as group formation, knowledge transfer, the circulation of biological material, and the role of both national and European regulations in affecting the organizational structure of such consortia. These are important concerns not only for the practical need of enhancing European integration in one of the most promising fields of biomedicine, but also for the broader issue of understanding scientific practice in contemporary society. Indeed, biomedical research is increasingly being reshaped in terms of transnational networks. In Europe this development has long been fostered by a number of initiatives aimed to forge stronger links across national boundaries between universities, institutions and private companies (e.g. Joint Research Centre, Framework Programmes, and European Research Area). However, this process is far from being straightforward. Important differences between national regulations are counteracting the establishment of a uniform platform for European research in the life sciences. In addition, issues of intellectual property, recognition of priority in scientific discoveries, and national self-interest are further complicating the picture. In this respect, stem cell research is a particularly interesting case study due to the fragmented regulatory landscape and the controversial cultural and political implications.
The research design includes a detailed mapping of projects involving stem cells which have been sponsored by the 6th Framework Programme (2002-2006) and the in-depth study of three collaborative networks through qualitative analysis and interviews with key participants. The project builds upon previous works in the sociology of science, political theory and social network analysis. Ultimately, it seeks to contribute to these fields by shedding some light on the interplay between ongoing political developments in European society and the production of scientific knowledge.
Dr Olivia Harvey (UEA/ KingsCollegeLondon (from September 1 2007)
This one-year postdoctoral Fellowship awarded under Phase II of the SCI is designed to complement the Phase I SCI project ‘The global biopolitics of stem cell research’ underway at the Biopolitics Research Group at the University of East Anglia, Norwich. The Fellowship draws upon the resources, networks and empirical material of ‘The global biopolitics of stem cell research’ project to examine the role of the state in the global stem cell bioeconomy.
In working to enhance their global competitive position within the stem cell bioeconomy, states may introduce a range of policies to support and develop stem cell science. Some of these might include: investment in basic and translational science, strategic co-ordination of science, public-private partnerships between science and industry, regulation to maintain public trust, and incentives to encourage private investment. Precisely what strategy is adopted depends on the interplay of various social, cultural, economic and regional factors within each state.
The Global Biopolitics Research Group has produced two papers in relation to this project (see www.ioh.uea.ac.uk/biopolitics). The first, ‘State strategies and speculative innovation in regenerative medicine: the global politics of uncertain futures’ (Salter, 2007) examines the different types of states and the strategies they might adopt in light of the uncertainty of the global bioeconomy. The second paper ‘STS perspectives on the components of innovation: A US-case study’ (Harvey, 2007) details the stem cell innovation system in the US and how current science and technology studies scholarship on the social studies of stem cells illuminates this process.
Material from these papers and others will be presented at the seminar ‘Government strategies and commercial models: interdisciplinary perspectives on innovation in stem cell science’ at the Royal Society of Medicine, London, on Friday 21 st of September, 2007.
Professor Steve Wainwright (CBAS, Kings College London)
The project develops our ESRC research on stem cell transplantation for diabetes and liver disease, which explored the sociological themes of ethics, expectations, the body, and science studies. This new research focuses on 'disease in a dish' approaches to stem cell translation (ie stem cells as tools for unravelling mechanisms of disease and for drug development) in the fields of neuroscience and diabetes, through a programme of research with six interrelated objectives which:
Outcomes from the research to date include talks in Edinburgh, Berlin, Vienna, and Sydney; and two posters at the International Society of Stem Cell Research (ISSCR) Conference in Cairns, Australia. These presentations form the basis for two papers: ‘Outline of a geography of science approach to human embryonic stem cell research and diabetes’; and ‘Shifting paradigms? Reflections on regenerative medicine, embryonic stem cells and pharmaceuticals’, which examines how the sociology of expectations, Bourdieu’s concepts, and our notion of ‘expectational capital’ illustrate the tensions between ‘cell transplantation’ and ‘disease in a dish’ models of hES cell research in diabetes and neuroscience.
Dr Alison. Kraft (University of Nottingham)
In July 2004, the US-based Journal of Clinical and Laboratory Medicine added a new ‘tag line’ to its title/front cover, proclaiming anew its role as a ‘Forum for Translational Research’. Two years later – and some eighty years after its inception - the journal changed its name to Translational Research and amended its instructions for authors in order to make explicit that ‘translational research’ was part of its scope. This Fellowship and a forthcoming paper asks whether these changes in terminology have more than superficial significance. In a sense, the term ‘translation’ can be seen as merely a new label for something that has long preoccupied those concerned with improving the efficiency of medical innovation: the interaction between lab and clinic, between bench scientist and clinician. But the journal’s insistence that translational medicine is ‘coming of age as a discipline in its own right’, and its accompanying editorial conceptualising the ‘transitional’ space between lab and clinical research as a Zwischenzone, emphasizing the multi-directional flow of information within this ‘translational setting’, may really signal new approaches that will bring about changes in practice. These moves by a leading journal in the field and the new concern with translation which they express also reflect various recent policy initiatives. Most notably, perhaps, was the added kudos and impetus accorded translation in 2003 when the newly-appointed NIH Chief, Elias A. Zerhoudi, made it a priority in his ‘Road Map’ for future policy at the NIH.
Drawing on the concept of a Zwischenzone, Kraft’s work explores the meaning(s) of translation, its emergence as a distinctive domain within contemporary biomedicine and the various forces that have driven it to the top of the policy agenda in the US , the UK and elsewhere. Its focus is a case study of translation with regard to the field of stem cell innovation. Translation gained currency in policy circles and became a strategic priority amongst funding bodies just as stem cell biology moved to the forefront of biomedical research. Her paper will ask whether the much-vaunted new conceptualizations and new approaches to translation have made any difference to medical innovation involving the haematopoietic stem cell (HSC). In order to assess changes over time in the interactions between scientific researchers and clinicians, the paper adopts an historical perspective. This perspective is possible in the case of the HSC because of its long-standing clinical use: it therefore provides a distinctive case through which to explore translation past and present. By placing these developments in broader historical context, the paper seeks to build historically informed policy-relevant insights that contribute new understanding of the problems that attend translation per se, and of those that are particular to stem cell innovation.
Centre for Biomedicine & Society (CBAS) Workshop on:
Selling Science? Academy-Industry Interactions in Stem Cell Research
Friday 14 September 2007, King's College London
This workshop is the result of an ESRC SCI International Visiting Stem Cell Fellowship awarded to Professors Clare Williams, Steven Wainwright and Christopher Scott. It is designed to encourage multidisciplinary dialogue between different groups of researchers interested in the university-industry interface and stem cell research. More information here - pdf.
Innovation Cafe: Stem Cell Futures
4 October 2007, University of York
Organised by the SCI office at York, this is a new type of workshop taylor-made of industrialists to provide them with the most up to date research from social science and an opportunity to secure information on the social, political, economic and cultural factors affecting scientific research and technological innovation today. Further information here - html
Future development of haematopoietic stem cell (HSC) science and technology
29 October 2007, Wellcome Trust Conference Centre, London.
The workshop will focus on the current development and future expectations about how research in haematopoietic stem cells will be translated into commercial products and clinical applications.
Contact Richard Tutton for further information. See Paul Martin's project group page for further information about the project.
BBSRC Cross Council Stem Cell Workshop
12-13 December, University of Warwick
A dedicated social science session is being planned for this event. Further information will be posted on the Events page in due course.
Regenerative Bodies – Seminar Series
www.uwe.ac.uk/hlss/research/regenbodies/index.shtml
This interdisciplinary seminar series funded by the Economic & Social Research Council (ESRC) aims to bring together clinicians, health professionals, social scientists, bioscientists, and tissue engineers to explore aspects of the emerging technologies for ‘regenerating bodies’.
Julie Kent has organised this series as part of her fellowship.
The first event is Tissue collecting and tissue donation 11 th October 2007 with presentations from Professor Naomi Pfeffer ( London Metropolitan University ) - Old for new: recycling bodies and body parts; and Glenda Cornwell (Nurse Co-ordinator, Kings College London) – Sourcing embryos in the IVF clinic.
Genomics Forum Seminar Series and Short Courses
Genomics Forum has been awarded funding to develop a workshop series of capacity building, networking and outreach activities as well as to organise a short course for young stem cell scientists.
The objective of the workshop series is
-- to build on the work of the ESRC funded stem cell research community by bringing together social science researchers with scientists, policy makers, regulators as well as representatives of industry and civil society,
-- to advance existing work, encourage interdisciplinary insights and collaboration,
-- identify and explore current and emerging policy issues,
-- exposing the significance of ESRC stem cell research to a wider audience.
The short course aims specifically at young (post-doc) natural scientists in the area of stem cells. Looking at stem cell science from the perspective of the social sciences, young scientists will get an insight into the reactions of the public, politics and individuals to the science that they do. The short course's objective is
-- to discuss the societal aspects of stem cell research in general and of their work in particular,
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to provide an introduction to social scientific research on issues raised by stem cell science and technology,
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to build capacity for the appreciation, reception, and use of social science amongst natural scientists
The Forum has already run one successful even on the 'The science and sociology of stem cells' , back in May 2007. Their next event covering the legal aspects of stem cell science is planned for late October/early November 2007.
There are a few copies remaining of New Technologies in Health Care: Challenge, Change and Innovation Edited by Andrew Webster, available at £20 each, including P&P (normal price £55). Please contact Stephanie for a copy.
Hardback, 288 pages, ISBN 1403991308
Description
A unique, pathbreaking collection that provides the first, detailed and comprehensive analysis of the implications of new health technologies for society, the delivery of health care, and the very meaning of health itself. It is based on new, critical social science research integrated according to core themes, making it accessible and engaging. It will be of especial value to students and researchers in Social Science, Health Studies and medical schools.
Contents
New Technologies in Health Care: Opening the Black Bag: A.Webster
PART 1: GENETIC RISK, REPRODUCTION AND IDENTITY
The Genetic Iceberg: Risk and Uncertainty: A.Bharadwaj, L.Prior, P.Atkinson, A.Clarke & M.Worwood
Navigating the Troubled Waters of Prenatal Testing Decisions: G.Lewando-Hundt, J.Green, J.Sandall & J.Hewison
Genetic Ambivalence: Expertise, Uncertainty, and Communication in the Context of New Genetic Technologies: A.Kerr & S.Franklin
PART 2: INFORMATION AND EMPOWERMENT
'Pathways to the Doctor' in the Information Age: The Role of ICTS in Contemporary Lay Referral Systems; S.Nettleton & G.Hanlon
Desperately Seeking Certainty: Bone Densitometry, The Internet and Healthcare Contexts; E.Green, F.Griffiths, F.Henwood & S.Wyatt
Telemedicine, Telecare, and the Future Patient: Innovation, Risk And Governance; T.Finch, C.May, M.Mort & F.Mair
Patient 'Expertise' and Innovative Health Technologies; K.Ward, M.Davis & P.Flowers
Making Sense of Mediated Information: Empowerment and Dependency; J.Cullen & S.Cohn
PART 3: INNOVATION, CONTEXT AND MEANING
Time, Place and Settings: Negotiating Birth, Childhood and Death; J.Seymour, E.Ettorre, J.Heaton, G.Lankshear, D.Mason & J.Noyes
Replacing Hips and Lenses: Surgery, Industry and Innovation in Post War Britain ; J.S.Metcalfe & J.Pickstone
Access, Agency and Normality: The Wheelchair and the Internet as Mediators of Disability; S.Parr, N.Watson & B.Woods
PART 4: REGULATION AND EVALUATION OF IHTS
Understanding the 'Productivity Crisis' in the Pharmaceutical Industry: Over-Regulation or Lack of Innovation?; P.Martin, J.Abraham, C.Davis & A.Kraft
Regulating Hybridity: Policing Pollution in Tissue Engineering and Transpecies Transplantation; N.Brown, A.Faulkner, J.Kent & M.Michael
Cultural Politics and Human Embryonic Stem Cell Science; B.Salter
Regulation and the Positioning of Complementary and Alternative Medicine; J.Chatwin & P.Tovey
Evaluation as an Innovative Health Technology; D.Armstrong