27-28 May 2010
2010
the Royal Tropical Institute, Amsterdam International Scientific Conference 2009
2008
2007
Ten Years After Mapping the Societal Genomics Landscape
2006
2005
2004
2003
2002
2001
26 June 2000 the White House, Washington DC Press Conference presenting the results of the Human Genome Project
www.society-genomics.nl/conference
2000
Programme overview Conference organisation
Thursday 27 May 2010 Organising Committee
9.15 – 9.30 Plenary Opening lecture on ‘Mapping’
Maria-Lucia Cantore (conference secretariat)
by Hub Zwart, Scientific Director of
Kristy van Lammeren (communication)
the Centre for Society and Genomis
Gijs van der Starre (management)
9.30 – 10.15 Keynote lecture by Bartha Knoppers:
Hub Zwart (chair)
‘The « What If » Question: An (Un)
Maud Radstake (coordination)
Ethical Trump Card?’ 10.15 – 10.45
Tea/Coffee break
10.45 – 12.15
Parallel session I
Hub Zwart (chair), Radboud University Nijmegen / CSG
12.15 – 14.00
Lunch
Michael Arribas-Ayllon, Cesagen, Cardiff University / EGN Network, UK
14.00 – 15.30
Parallel session II
Jacqueline Broerse, Athena Institute, VU University Amsterdam / CSG
15.30 – 16.00
Tea/Coffee break
David Castle, University of Ottawa / VALGEN, Canada
16.00 – 17.00 Interview with Karen-Sue Taussig
Programme Committee
Martina Cornel, VU University Medical Center Amsterdam / CSG
about her book ‘Ordinary Genomes.
Bart Gremmen, Wageningen University
Science, citizenship and genetic identities’
Michiel Korthals, Wageningen University / CSG Patricia Osseweijer, Delft University of Technology / CSG Maud Radstake, Radboud University Nijmegen / CSG
17.00 – 18.00
Poster session
18.30 – 19.30
Drinks in Artis
19.30 – 24.00 Dinner in Artis including a dinner
Gijs van der Starre, Radboud University Nijmegen / CSG
speech by George Gaskell and the
Arend Jan Waarlo, Utrecht University / CSG
CSG Prize Ceremony
Guido de Wert, Maastricht University / CSG
Conference book
Friday 28 May 2010
Kristy van Lammeren, Radboud University Nijmegen / CSG
All correspondence should be directed to the conference secretariat Maria-Lucia Cantore Centre for Society and Genomics PO box 9010 6500 GL Nijmegen, The Netherlands + 31 (0)24 365 27 33 e-mail: cantore@society-genomics.nl www.society-genomics.nl
Design Hannie van den Bergh (www.studio-hb.nl)
Frans van Dam, Radboud University Nijmegen / CSG
9.00 – 9.45
Poster session including breakfast
9.30 – 11.00
Parallel session III
11.00 – 11.30
Tea/Coffee break
11.30 – 12.15 Keynote lecture by Mike Jetten: ‘Impact of ecogenomics - discovering the hidden majority and their role in global element cycles’ 12.15 – 13.30
Lunch
13.30 – 15.00
Parallel session IV
15.00 – 15.30
Break
15:30 – 16:00
Future EU-funding possibilities
16:00 – 16:15
Announcement Poster Prize
16:15 – 17:15
Grand Finale Ten Years from Now
Day 1, 27 May 2010
Parallel session I 10:45 - 12:15
The promise of biobanks
Genetics and genomics in health care: access and insurance
International developments in plant genomics
Safety and sustainability: identifying issues in industrial genomics
Biobanks, Biocapital and the Political Economies of Promise Tutton
Politics of Provision – A Comparative Analysis of Access to Genetic Technologies Aarden
Varietal, agro-ecological and social aspects of drought tolerance in rice farming in West Africa Nuijten
Bio-based economy
Integration of genomic technologies into Canadian healthcare framework Stoklosa
The Changing Landscape of International Genetic Resources Governance Rhodes
Exploring future scenarios for the role of genomics in health insurance Broerse
Detrimental Social and Trade Impacts due to Adventitious Presence (AP): case study of GM Flax Ryan
Cornel
Korthals
Biobanks and their societal outreach Meijer Putting genomics’ promises into biobanking practice: a genealogy of ambitions Boeckhout
Chair
Parallel session II 14:00 – 15:30
Radstake
Looking back: The role of societal valued promises in the development of toxicogenomics Pijnappel Interaction for Sustainability Sleenhoff
Van der Starre
Biobanks: genetic profiles in perspective
Shifting perspectives in medical genomics application, regulation and governance
Engaging with ecological genomics
Industrial biotechnology: inside views on innovation
Harmonizing 50 Large Bioclinical Studies: the DataSHaPER approach Fortier
The emergence of ELSA research Wieser
Mapping and assessing the emerging landscape of ecogenomics: a voyage of discovery Van der Hout
Industrial biotechnology and the Place of ELSA Research Castle
Genomic Sovereignty Hardy Ethical Aspects of Storing and Using Tissue from Minors for Genetic Research Hens
Chair
Asveld
De Wert
The network of influences between ethics, law and practices in regulation of genomic information: a 10 years overview Rial-Sebbag
Ecological genomics & society in interaction: the challenge of learning Roelofsen
The Dilemmas of Life Cycle Assessments in Industrial Biotechnology Flipse
Genetic testing, governance, and the family in the PRC Sleeboom
Military pollution, microbes, and genomics: engaging the public on messy issues O’Doherty
Safe ice cream innovation: The many safeties of ice structuring protein Penders
Radstake
Zwart
Osseweijer
Day 2, 28 May 2010 Parallel session III 09:30 - 11:00
Biobanks: governing tissue terrains
Changing landscapes of genetic screening and testing
Animals, plants and seeds: genomics technologies in the rural zone
Genomic sources: routes and strategies
Clinical waste and regulatory wastelands: governing the use of human residual tissue Geesink
The changing landscape of genetic screening I: Learning to inhabit new territories Van El
The landscape of animal diseases Bruce
Mapping emerging stabilization in the genomics landscape Nahuis
Biobanking cancer tissue – Patients consider excised (tumour) tissue to be ‘connective tissue’ Vermeulen
The changing landscape of genetic screening II. Governing the balance between ‘duty to protect’ and ‘right to test’ Cornel
StemCell Banks and Registries: Governance Issues and Challenges in a Comparative Perspective Isasi
Lay and professional perceptions of predictive testing for diabetes based on DNA test results or family history assessment: a focus group study Wijdenes
Perspectives for the use of molecular markers in plant breeding for organic agriculture De Vriend
Open Source and Drug Development: A Feasible Route to Access? Marden
Becoming Public-Private: Emergent Technologies, the Private Sector, and the Sideshadows of Apomixis Technoscience Hodges
Hacking genomes – A study of open source biotech ethos Delfanti
Castle
Gremmen
Barriers to Genetic Testing: Provider Perspectives Darmonkow
Chair
Parallel session IV 13:30 – 15:00
Knoppers
Genes, race and ethnicity
Personalisation and pharmacogenomics
Trends in the governance of agricultural genomics
Promises and expectations of ecogenomics research
Tracing the Use of Racial Terminology in Representations of Genomic Research Rachul
The remaking of genomic medicine: shifting regimes in genetic research and the promise of personalised medicine Martin
Designing engagement for policy development in agricultural genomics: a policy cycle approach Rayner
Zooming in on the web of life – Ecogenomics contribution to an ecological ethics Drenthen
The Societal Landscape of Future Genomics
Why change a winning horse… or bug? Reflecting on structural aspects of six years of Ecogenomics Consortium Kloet
Physicians in the United States Attitudes about the Use of Ethnicity and Race in the Understanding Human Genetic Variation in Clinical Care Bonham
Chair
De Wert
Unravelling genetic profiling: Test characteristics and ELSA Bunnik
The Persistence of Race in Biotech Patenting and Drug Development Kahn
New modes of governing pharmacovigilance for genomicsbased drugs: supporting and balancing safety and innovation Boon
Cornel
Arribas-Ayllon
Saner Reporting Genozymes: Mapping a Deliberative Model of Science Journalism Walmsley
Osseweijer
Rules for the animal park: genome management as a life-line for endangered species in an era of mass extinction Zwart
Broerse
Table of contents
Ten years after - Mapping the societal landscape of genomics is organised by the Centre for Society and Genomics (the Netherlands), in collaboration with the ESRC Genomics Network (United Kingdom) and VALGEN (Canada). About the Centre for Society and Genomics The Centre for Society and Genomics (CSG) analyses, assesses and improves the relationship between society and genomics research. By doing so, CSG improves the way in which genomics meets the expectations and needs of society. Many of CSG’s research projects are conducted in close co-operation with the 15 genomics centres of the Netherlands Genomics Initiative (NGI). In addition, CSG closely monitors international developments. CSG maps out the social, legal and ethical issues surrounding genomics. As many as 50 researchers at ten universities and institutes take part in CSG’s research programme. Communication activities and research go hand-in-hand. Dialogue between researchers and social or business parties forms part of the initial stages of every project. Society thus occupies a central position in the CSG research and ensures that the CSG researchers stay abreast of contemporary issues and concerns. In all its activities, including research, CSG seeks contact with society for interaction, dialogue and education. Insights gained from research are used to improve and renew public communication and education. CSG works together closely with other science centres and educational institutions to firmly embed these communication forms.
Genomics as map-making, and the Human Genome Sequence as a Map, Hub Zwart ‘I try to stay ahead of the science’ – Interview with Bartha Knoppers
www.society-genomics.nl
About the ESRC Genomics Network The ESRC Genomics Network is a multi-million pound investment by the UK’s Economic and Social Research Council (ESRC), dedicated to examining the development and application of genomic science and technologies. The EGN spans five of the UK’s leading universities, and involves over a hundred researchers, from professors to PhD students, as well as an international cast of visiting research fellows. It is one of the largest social science investments in the ESRC’s current portfolio, and is growing into the largest concentration of social scientific research on genomics in the world. The activities of the EGN span the whole field of genomics, covering areas as diverse as plant and animal genetics, embryonic stem cell research, and associated health applications. The EGN includes Cesagen (Lancaster University and Cardiff University), Egenis (Exeter University), Innogen (University of Edinburgh and the Open University) and Genomics Forum (Edinburgh). www.genomicsnetwork.ac.uk FULL COLOUR
About VALGEN Amidst the opportunities in applied genomics for bioproducts and crops, deep governance challenges exist. The Value Addition Through Genomics and GE3LS project (VALGEN) is a four year project supported by Genome Canada and managed by Genome Prairie that responds to these challenges by assembling a team of researchers to study how Canada can benefit from applying genomic research to agriculture. Using current research methods in the social sciences, humanities and legal scholarship, VALGEN researchers examine three contexts from which barriers to innovation in agricultural biotechnology research and development arise: intellectual property management and technology transfer, regulation and governance, and democratic engagement. The VALGEN team includes researchers and partnering institutions from across Canada and international partners in the UK, US, The Netherlands and France. www.valgen.ca
PANTONE COOL GREY 8
50% BLACK
PANTONE 282
C100 M72.16 Y0 K56.08
PANTONE 1805
C0 M91 Y100 K23
5 9 14 17 19 20
Keynote speakers, day 1 Conference dinner Keynote speaker, day 2 Poster competition Urban zone, parallel sessions I Urban zone, parallel sessions II Urban zone, parallel sessions II Urban zone, parallel sessions IV Urban zone, posters
22 31 40 51 59
Industrial zone, parallel session I Industrial zone, parallel session II Industrial zone, parallel session III Industrial zone, posters
80 85 89 93
Environmental zone, parallel session II Environmental zone, parallel session IV Environmental zone, posters
96 100 104
Rural zone, parallel session I Rural zone, parallel session III Rural zone, parallel session IV Rural zone, posters
108 113 118 122
Author index
124
TWO COLOUR
BLACK & WHITE
REVERSE
ONE COLOUR
General
Conference Venue
Conference Venue
The Royal Tropical Institute, Amsterdam
Introduction Hub Zwart
General
Hub Zwart
Genomics as map-making, and the Human Genome Sequence as a Map Dear participant, Welcome to the seventh international conference on society and genomics, organised by the Centre for Society and Genomics (CSG, the Netherlands) in collaboration with the ESRC Genomics Network (United Kingdom) and VALGEN (Canada). By way of introduction, I devote a few words to the title of our Conference, Ten Years After.
Photography Royal Tropical Institute
On June 26 2000 President Clinton, together with Francis Collins and Craig Venter, solemnly announced, from the East Room of the White House, that the grand effort to sequence the human genome was rapidly nearing its completion. During this Press Conference, a whole series of metaphors was used to indicate what the human sequence means. Our genome was baptised as the “language of life”, our “genetic code”, “the working blueprint of mankind”, the “book of life”, our “instruction book”, our “common inheritance”, our “essence”. A whole train of metaphors, each with its own history of rise and decline, was thus assembled with the key human actors present. Yet, the most dominant metaphor that won the day, introduced with remarkable emphasis right at the beginning of the ceremony, was the map metaphor. Indeed, rereading the protocol of the Conference “ten years after”, it is quite striking how President Clinton, after a number of formal acknowledgements of human individuals, suddenly proceeds to announce the human genome sequence in the form of a map:
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“Nearly two centuries ago, in this room, on this floor, Thomas Jefferson and a trusted aide spread out a magnificent map – a map Jefferson had long prayed he would see in his lifetime. The aide was Meriwether Lewis and the map was the product of a courageous expedition across the American frontier, all the way to the Pacific. It was a map that defined the contours and forever expanded the frontiers of our continent and our imagination. Today, the world is joining us here in the East Room to behold a map of even greater significance. We are here to celebrate the completion of the first survey of the entire human genome. Without a doubt, this is the most important, most wondrous map ever produced by humankind.” Map-making The decision to present the human genome sequence as a map was a deliberate, but also a highly controversial one. First of all, what is a map? Map-making can be defined 5
General
Introduction Hub Zwart
as a technique for organising and representing information concerning geographical regions and their populations, human or otherwise, a technique for making the diffuse (the real) tangible, accessible and discrete. Maps are conscious simplifications that become increasingly sophisticated and refined. A map is not only a description of a landscape, but always a representation of relationships as well. Maps allow us to represent our relationships with our various environments in various ways. They allow us to make visible the various layers of a landscape, as a whole typology of maps is possible (maps focusing on geographical structure, on land use, industrial development, pollution, infrastructure, wild life habitats, populations, etc.). Diffuse boundary zones will be represented as clear demarcations, and pure symbolical or virtual borders will be presented as solid and real. That a map is never to be regarded a simple and straightforward representation of a particular landscape or site is clear from the fact that styles and techniques of map-making tend to change over time, thus reflecting particular ideologies and concerns and that, even at one particular point in time, a plethora of maps are possible. Interestingly, maps combine descriptive and normative functions. They “mirror” a landscape as reliable and accurately and “objectively” as possible, but at the same time impose a particular kind of order on what in itself remains fluid and unstable and often contested. As soon as it is printed, moreover, a map is already outdated. Quite often, maps give voice to concerns, as representations of “problems” (such as maps that depict the disappearance of rain forest over time). Lewis & Clark map This also goes for the Lewis & Clark map that resulted from the Lewis and Clark expedition funded by the US government (1804-1806). At first glance this map seems as accurate and objective as was technically possible at the time. Nonetheless it is clear that it was something of a political statement, a first decisive step towards the colonisation and usurpation of the West, not in the least by presenting the landscape almost as if it was uninhabited and unclaimed (virgin territory). The West was depicted as an abiotic region. By focusing on the physical properties of the landscape, everything else (including First Nation inhabitants) was virtually erased from / ignored by the map.1 And this anticipated, as it were, the fact that native inhabitants (together with buffalo, prairie grasses and other “landscape elements”) were subsequently virtually decimated in real life. The Lewis & Clark map more or less anticipated this whole process and made it possible. It depicted the gold-rush region and made the goldrush possible. Thus the map visualised a relationship between a particular area and a political entity (the United States of America) guided by a political and ideological programme. Maps are never only about landscapes as “objects”, but always also on 1. One has to study the map in detail, to pore over it with a looking-glass as it were, in order to come across tiny references to human presence, almost “in passing”, minuscule notes conveying a minimum of demographic information (such as: “Wa-pa toone, a Tribe of Sioux 1000 souls”; “Wa-pa too-ta, a band of Sioux 600 souls”, etc.). Even the numbers mentioned suggest that inhabitation is marginal, compared to the huge numbers of US citizens, eager to push the frontiers of Western civilisation further West.
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how we relate to them in terms of politics (borders) or policies (land use, infrastructure, environmental concerns, etc.). Therefore, the conscious and deliberate decision to present the human genome sequence as a revivification, as it were, of the (both famous and notorious) Lewis & Clark map, was not all that unproblematic. Map-making had become a key technology for emerging nation-states, not only in the sense that maps allow to impose and define borders, but also in the sense that maps, by mapping opportunities and issues of concern, became tools for biopolitics. The presentation of the Human Genome as a “kind of” Lewis & Clark map was something of a risk. Was it, once again, an anticipation of a process of usurpation, with human inhabitants consciously left out of the picture? What kind of practices would be supported and made possible by this new “map”? Was a second gold rush (a massive effort towards patenting genes for instance) awaiting us? A 2010 map In 2010 we want to address this question by once again producing and presenting a map. This time, however, the map will very consciously and explicitly depict emerging networks and relationships rather than “purely physical” features. The CSG conference will invite experts from genomics science, humanities and social science, policy, society and media to join in a collective map-making effort that will allow us to indicate and assess collectively (as a research community) how the genomics landscape has evolved, has become populated, inhabited and organised, and what is to be done to govern and improve this process. Four zones In the urban zone, individuals are allowed, now and in the near future, both by clinical centres and by web-based companies, an increasingly detailed glance at the map of their personal genome in order to assess their opportunities, weaknesses and strengths when it comes to settling themselves in bio-informed societies. They are invited to take an entrepreneurial stance and to become the managers of their own life and health, their “genomic capital”. This is likely to have major consequences for how personal biographies, but also health care and population surveillance will be organised and structured in the future. Will it lead to new dividing lines between neighbourhoods inhabited by those who are willing and able to use these new forms of information for improving their health and societal prospects, versus those who are unable or unwilling to do so? Between neighbourhoods characterised by healthy ageing versus neighbourhoods characterised by afflictions associated with life style such as obesity and diabetes? Or will it rather enhance new forms of social mobility and traffic, new creative uses of opportunities by various strata of society? In the rural zone, tensions between more traditional versus genomics-based forms of land use may emerge, for instance in the context of the biofuel debate. Similarly, genomics and microbial genomics is affecting the industrial landscape, while metagenomics is 7
General
Introduction Hub Zwart
analyzing biodiversity and evolution, contributing to bioremediation and to “genome management” of endangered species in wild life parks. Governance A whole variety of landscape elements is coming into view, for instance in terms of infrastructure. Roads, by-passes and traffic networks are designed in order to make funding and valorisation of genomics feasible. But also various forms of social regulation and landscape management are introduced. Thus, the conference will summarise important outcomes of ten years of societal research (ELSA Genomics) on analysing and improving the emerging societal landscape of genomics. Our research is not only about what forms of knowledge genomics research produces and how this is affecting society, but also on how to organise and distribute knowledge and applications in such a way that society may optimally benefit and genomics research may become optimally embedded. Maps are not only functional when it comes to depicting actual situations or the actual state of affairs, but also when it comes to planning and governing trajectories towards the future, - in the end a map is basically a governance tool. The map will structure not only the agenda for the conference, but will also allow us to present and organise the outcomes of the conference in a comprehensive way. When we organised our previous Amsterdam Conference two years ago, the CSG and the EGN centres had recently been awarded their second stage of funding (2008-2012). Currently, we are exploring the landscape beyond 2012. What are the opportunities and challenges for ELSA life sciences research looming at the horizon, during the so-called post-genomics era? Developing future agendas for ELSA life sciences research as a collective endeavour will be furthered by drawing the map of what has been achieved so far. Many people have been working very hard, both on stage and behind the scenes, to make this conference possible. I would like to thank the programme committee and CSG staff members but also the conference participants for their time and effort. I believe we are looking forward to a milestone conference. Hub Zwart Scientific Director CSG Chair of the Programme Committee
Interview with Bartha Knoppers
General
Interview with Bartha Knoppers*
‘I try to stay ahead of the science’
‘Hello, what is newborn screening?’ That’s what Bartha Knoppers asked 26 years ago, when a clinical geneticist called her about a meeting to discuss the subject. At that time, she was a lawyer completing her thesis on legislation concerning reproductive medicine in Great Britain, the United States, Canada and France. Genetics had not yet entered her field of vision. She used the three months before the meeting to learn more about the subject. Looking back, she recognises the telephone call as the start of her ‘genetic life’, as she calls it. The anecdote, and the fact that she tells it with a smile, is characteristic of Bartha Knoppers. Seated opposite to us is a scientist with an impressive CV. But there’s not a hint of arrogance. She is friendly, accessible and highly driven. Indeed, Bartha Knoppers has a mission: she wants to motivate genomics researchers worldwide to cooperate and to share information with one another, all for the public interest.
The various subjects that Bartha Knoppers has focused on during her career reflect the evolution of the ‘genomics landscape’. At the same time, she has helped to shape and keeps on shaping this landscape as a scientist. This interview with Knoppers gives an insight into the activities and visions of a leading scientist. Yet it also offers a sketch of the history and possible future of the genomics research field. From individual to population Bartha Knoppers summarises her CV in four phases which - perhaps not entirely coincidentally - are all more or less equally long. ‘Every seven years you like to change.’ Her academic career picked up speed in the mid-70s when she was studying legislation on reproductive technology. Such technology was far removed from the public eye: ‘this was before Louise Brown was born, the first IVF baby’. After the telephone call by the clinical geneticist, she redirected her attention to medical research into infant diseases. ‘I really enjoyed learning. At the time, I had no idea what a chromosome was.’ But she quickly realised that there were many parallels between these two areas of
* Director of the Centre of Genomics and Policy, McGill University & Distinguished Visiting Scientist (Netherlands Genomics Initiative, on behalf of the Centre for Medical Systems Biology and the Centre for Society and Genomics).
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General
Interview with Bartha Knoppers
research. Bartha Knoppers is someone who likes to base her research on ‘comparison’. Her original specialisation is in comparative law, i.e., comparing legal systems with one another. Such comparisons clarify how the application of laws and regulations to new technologies can differ between countries, and how improvements or changes can be made in this respect. A significant difference appeared to exist between reproductive medicine and neonatal screening. In the case of reproductive medicine, the legal issues primarily concerned individuals: ‘what do I want, what do I need, what about my children?’ In neonatal screening, however, the moral questions are about the consequences for populations: ‘what is in the interest of children who look like they are healthy when they are born, but are at risk and can be treated right away.’ Approaching legal and ethical questions from a societal perspective remains one of Knoppers’ specialties. Biomedical research must of course respect the individual rights of research participants. That comes up time and again in discussions on privacy and informed consent. But at the same time, it is important to give researchers enough room to explore the opportunities offered by their efforts to improve the health of large groups of people. Biobanks That challenge, enabling research into public health while maintaining respect for the individual, plays a crucial role in biobanking, a topic that has the enthusiastic support of Knoppers. Biobanks enable epidemiological research into genetic and environmental factors that play a role in health or common diseases. Such research shows how these diseases arise and develop, and raise possibilities for prevention and treatment. Public health can benefit greatly from this. In that sense, research of this type has a public function. According to Bartha Knoppers, participants of a biobank run only a minor risk of privacy violation, for example. The public interest of research must therefore take precedence, provided a strong governance and security framework is in place. Heritage In 1992, Knoppers became a member of the International Ethics Committee of the Human Genome Organisation (HUGO), the organisation that was responsible for coordinating the Human Genome Project. She was appointed chairman of the committee in 1996. She advised on ‘many, many subjects’, such as DNA sampling, cloning, stem cells and genetic databases. Those recommendations were a lot more pioneering than she was used to from her legal background. ‘It was less day to day issues like in the context of reproduction, genetic testing, and more about building a scientific map, a tool that could be used by anyone, everywhere.’ The statements formulated by this committee raised the debate on ethical and legal issues as regards subjects like cloning, DNA sampling and gene therapy to a higher level: instead of provisional, often nationally formulated guidelines, such matters are now discussed internationally with a long-term perspective in mind. In that sense, the ethical work was as groundbreaking as the Human Genome Project was for biologists: it led to 10
intensive cooperation between ethicists and lawyers active in the world of genomics. Also, there was absolutely no sense of competition between members of the committee: it was ‘a constellation of free scientists, people who want to work together (...) We believe in doing collaborative science.’ As a member of the International Bioethics Committee of the United Nations (UNESCO), Knoppers was one of the co-authors of the Universal Declaration on the Human Genome and Human Rights. It is laid down in the Declaration that the human genome is ‘in a symbolic sense, [] the heritage of humanity’. This is a heritage that we must treat with utmost care. The identity and physical integrity of future generations are leading. The Declaration therefore rallies against discrimination on the basis of hereditary properties and against certain applications such as the cloning of people and germ-line gene therapy, which can have an impact on human reproduction itself. Sharing of information After her work for HUGO and UNESCO, Knoppers became involved in the ethical programme of HapMap, a study into patterns in the genetic variation between people. She was then funded by Genome Canada and Genome Québec, counterparts of the Netherlands Genomics Initiative, to lead CARTaGENE. CARTaGENE is a large-scale, longterm epidemiological study for which genetic material and data on disease, health, living environment and lifestyle are being gathered. The material and data are stored in a biobank. Thus started the fourth phase of her career. ‘From then on, most of my effort then went into building the Canadian scientific infrastructure for fundamental science.’ CARTaGENE is part of the efforts Knoppers devoted to population genomics, a challenge she describes as ‘something that’s difficult and yet I’m proud of.’ Bartha Knoppers tells that she soon understood that while the biobank would represent a very valuable collection, it would never suffice on its own. Population genomics requires huge numbers of samples to book statistically and socially significant results. CARTaGENE could not function as a standalone project. Epidemiologists and statisticians require major quantities of samples and specimens: 10.000 of this, 20.000 of that.’ What’s more, Knoppers realised that nobody, in no country, can gather enough experimental subjects on their own. International collaboration, the exchange of bodily samples and other data between research projects, is thus the only solution. That exchange must be organised with care, however. ‘The ultimate value depended on being able for CARTaGENE to share with other projects, and for other projects to share with CARTaGENE – and that’s why I founded the international Public Population Project in Genomics (P3G) at the same time.’ 50 research projects from 18 countries participated in the first worldwide P3G study, which was intended to gauge the possibilities for harmonisation and collaboration between various research efforts. The first results were published in April 2010.
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General
Interview with Bartha Knoppers
Different roles Bartha Knoppers combines several functions and tasks: she is a manager, director and researcher at the same time. For her, that combination of tasks goes without saying. The fact that she also performs research is vital to Knoppers in her role as a member of a committee. After all, it is from research that you draw your ideas for policy. ‘You have to do your research. You can’t invent policy. It’s not a field of good intentions, it is a field of inquiry and discussion. A good policy should be good for at least a decade.’ Combining academic and policy work is not a problem as long as you always keep in mind what the purpose of the policy is. ‘You have to keep a critical eye and keep your intellectual curiosity, otherwise you’d just be a consultant.’ She also sees it as her ‘duty’ to contribute towards the formulation of new policy. ‘I learn from the field as much as I give.’ Genomics landscape The intellectual development of Bartha Knoppers runs parallel to the evolution of the genomics landscape. Since the start of the Human Genome Project, funds are structurally made available for research into the ethical, legal and social consequences of developments in the area of genomics. Knoppers’ career traces the shift in main themes from a focus on individuals to issues that are relevant to populations. An example is the emergence of biobanks like CARTaGENE. The results of biobank research will initially prove their value in terms of public health, rather than for the participants themselves. Bartha Knoppers says that she regularly finds herself ahead of current scientific reality. Her vision of population genomics is an example. The fact that she, as a social scientist, was approached to lead a large life sciences project like CARTaGENE, was - in her opinion - surprising. The sensitivity that some social parties feel towards biobank research might have played a role. Financiers of the project were concerned about potential social and political issues that might arise. A social scientist of her standing would be better placed to explain the importance of the project to a broader public. Getting the message across to the general public proved relatively easy, however. What was far more difficult was to gain support for biobanks and population genomics among medical ethics committees. In total, 18 committees commented on her proposal. One of the main reasons for this amount of comments, according to Knoppers, was that the guidelines for research proposals continue to place more emphasis on individual rights (such as privacy and informed consent) than on the public interest – to her surprise. ‘I’ve always thought that people could see that it’s different, that it’s not a clinical trial, that it’s not the same kinds of risks and that the opportunities are mainly at a social, health systems level. The public understands, participants understand, but ethics committees are quite frightened of the idea of data sharing and collecting samples and data over a period of, say, 50 years.’ She sighs. ‘It’s something new, so I guess it’s maybe a matter of climatisation, and a matter of building trust.’ 12
What’s more, Bartha Knoppers calls herself a ‘firm believer’ in open source and open science. She greatly enjoyed working together on shared problems within HUGO. But she thinks that also within biomedical research the focus should be on ‘free and unfettered search for truths’, instead of revolving around who has acquired the most patents. At the same time, she is by no means ‘anticommercial’; industry is more than welcome to join in on the search for knowledge, especially if companies are prepared to fulfil a social role. Netherlands Bartha Knoppers will regularly visit the Netherlands as a ‘Distinguished Visiting Scientist’ during the next two years. Her intentions are to meet with Dutch researchers and establish a working relationship, instead of a long-distance relationship between peers. This mean she also wants involve them in the development of ideas about partnership and new projects. She is, at present, unable to say what these would look like. ‘Everyone knows what they’re doing now, but it’s just as much about what we want to do – what gets us excited!’ Knowing that is at least as important if you want to start up something new. Bartha Knoppers is thus eager to learn of the ‘dreams’ of Dutch researchers. www.humgen.org/int/team.cfm?Id=9 www.cartagene.qc.ca Yrrah Stol & Martin Boeckhout*
* Yrrah Stol and Martin Boeckhout are connected to the Philosophy Department of the Humanities Faculty, University of Amsterdam. Yrrah conducts research into whether and how biobank-ELSI are context linked, and whether specification is required. Martin studies issues pertaining to public and political engagement in biobank governance. Both studies form part of the CSG programme.
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Keynote speakers Thursday, 27 May 2010
Thursday, 27 May 2010
Keynote speakers
Opening address Hub Zwart Biography Hub Zwart studied philosophy (cum laude) and psychology (cum laude) at Radboud University Nijmegen. He worked as research associate at the Centre for Bioethics (Maastricht, 1988-1992) and defended his thesis on consensus formation in a pluralistic society in 1993 (cum laude). He was appointed as research director of the Centre for Ethics (Nijmegen, 1992-2000) and acted as editor-inchief of the Dutch Journal Tijdschrift voor Geneeskunde en Ethiek. In 2000 he became full professor of philosophy at the Faculty of Science. He was European lead of the EU Canada exchange programme Coastal Values (1999-2003). In 2004 he became director of the Centre for Society and Genomics, funded by the Netherlands Genomics Initiative and established at his department. The focus of his research is on epistemological and ethical issues in the life sciences: biomedicine (1988-1996), research with animals (1996-2003), environmental research (1998-2003) and genomics (2003-present). His current research concerns: the epistemological profile of genomics; philosophical implications of the Human Genome Project; epistemological profile of ecogenomics; challenges of macro-ethics (the ethics of bio-information); scientific authorship and comparative epistemology (literary imagination as a research tool). Hub Zwart teaches introduction to philosophy and ethics of life sciences, visible scientists and science & literature.
Bartha Maria Knoppers “The « What If » Question : An (Un)Ethical Trump Card?” An autonomous and informed consent has long been the hallmark of ethical research. Like respect for privacy, however the interpretation and application of such principles if treated as absolute may themselves produce ethical anomalies. This is particularly true in the context of research in population genomic databases where both the issues of broad consent and that of possible identifiability serve to thwart the creation and uses of such infrastructures.
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This use of perilous hypotheticals – “what if one day …?” has two sources: 1) the continued equation of the person, human tissue, and, data as constitutive of the person and 2) the paternalism of ethics committees who wish to “protect” the person and so limit free choice. Between sacralisation and reification of tissue and data, what principled policies can be constructed that are both workable and in the public interest? Biography Bartha Maria Knoppers, PhD, is Director of the Centre of Genomics and Policy, Faculty of Medicine, Department of Human Genetics, McGill University and the Canada Research Chair in Law and Medicine. She held the Chair d’excellence Pierre Fermat (France: 2006-2008) was named Distinguished Visiting Scientist (Netherlands Genomics Initiative) (2009- ). A graduate of McMaster University (B.A.), University of Alberta (M.A.), McGill University (LL.B., B.C.L.), Cambridge University, U.K., (D.L.S.), Sorbonne Paris I) (Phd.) she was admitted to the Bar of Québec in 1985 and named Governor and Advocatus Emeritus. Professor Knoppers was the Chair of the International Ethics committee of the Human Genome Organization (HUGO), (1996-2004), and member of the International Bioethics Committee of the United Nations, Educational, Scientific and Cultural Organization (UNESCO) which drafted the Universal Declaration on the Human Genome and Human Rights (1993-1997). Co-Founder of the International Institute of Research in Ethics and Biomedicine (IIREB) (2000 – 2009), she founded the international Population Project in Genomics (P3G) and CARTaGENE a Quebec population study in 2003. From 2000-2006 she served on the Board of Genome Canada, became Chair of the Ethics Working Party of the International Stem Cell Forum, Co-Chair of the Sampling/ELSI Committee of the 1000 Genomes Project (2008- ) and a member of the Scientific Steering Committee of the International Cancer Genome Consortium (ICGC) (2009- ). Professor Knoppers has received four Doctorates Honoris Causa, is Fellow of the American Association for the Advancement of Science, of The Hastings Center (Bioethics) and the Canadian Academy of Health Sciences (CAHS). She is an Officer of the Order of Canada.
Interview with Karen-Sue Taussig Ordinary Genomes. Science, citizenship and genetic identities Karen-Sue Taussig will be interviewed about her book Ordinary Genomes. Science, citizenship and genetic identities (Duke University Press, 2009) Biography Karen-Sue Taussig is an Associate Professor of Anthropology at 15
General
Keynote speakers Thursday, 27 May 2010
the University of Minnesota. She received her Ph.D. in Anthropology at The Johns Hopkins University. She has previously taught in the Department of the History of Science at Harvard University where she also held a two year post-doctoral position in the Department of Social Medicine. She is the author of Ordinary Genomes: Science, Citizenship, and Genetic Identities.
Conference dinner Thursday, 27 May 2010
Thursday, 27 May 2010
Conference dinner
Venue: Artis Zoo, Artis Party-and Conference Centre*
Her current project, Genetics and Its Publics: Crafting Scientific and Medical Literacies in the New Age of Biotechnology, examines the diverse future building activities set in to motion by the explosion of knowledge in the life sciences, particularly efforts to develop a molecular medical clinic. She has also recently begun a new project examining questions related to the role of the idea of “potential” in relation to humanness in the context of the new life sciences. Editors review Ordinary Genomes is an ethnography of genomics, a global scientific enterprise, as it is understood and practiced in the Netherlands. Karen-Sue Taussig’s analysis of the Dutch case illustrates the broader phenomenon of the entwining of scientific knowledge and culture: genetics may transform society, but society also transforms genetics. Taussig argues that in the Netherlands, ideas about genetics are shaped by two highly valued and sometimes contradictory Dutch social ideals: a desire for ordinariness and a commitment to tolerance. They are also influenced by Dutch history and concerns about immigration and European unification. Taussig contends that the Dutch enable a social ideal of tolerance by demarcating and containing difference so as to minimise its social threat, and that it is within this particular ideal of tolerance that they construct and manage the meaning of genetic difference. Illuminating the connections between biology, citizenship, and identity, Taussig traces the everyday experiences of Dutch people as they encounter genetics in research labs, clinics, the media, and elsewhere. She explains the institutional framework--involving clinics, research and diagnostic laboratories, and counseling offices--within which human genetic knowledge and practices are produced in the Netherlands. Through her vivid descriptions of specific diagnostic processes, Taussig illuminates the open and evolving nature of genetic categories, the ways that abnormal genetic diagnoses are “normalised,” and the ways that race, ethnicity, gender, and religion inform diagnoses. Addressing broader concerns about the interconnections among science, technology, bodies, and the nation, she examines how the Dutch people attempted to come to terms with a transgenic bull (a bull with a gene from another species incorporated into its genome). Taussig’s analysis of how genomics is understood and practiced in the Netherlands challenges monolithic notions of Western modernity and of genetics. Ordinary Genomes. Science, citizenship and genetic identities, Duke University Press (October 1, 2009), 264 pages, ISBN-10: 0822345161, ISBN-13: 978-0822345169 At the conference dinner, the CSG prize will be awarded and George Gaskell will give a dinner speech. 16
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18.30 - 19.30 Drinks 19.30 - 24.00 Dinner * Address: Plantage Middenlaan 41A-43, 1018 DC Amsterdam
CSG Prize for most relevant publication in society & genomics: awarding ceremony The prize will be awarded to a publication that has most successfully translated ‘society & genomics’ research to an audience of outsiders. Those can be professionals, users, patients, consumers, citizens, school pupils, scientists or others affected by genomics in any way. Participating publications appeared between January 1, 2008 and January 1, 2010. A total of 21 publications were submitted and have been judged by the jury, composed of: - Wilma van Donselaar, manager Operations and Public Affairs, Netherlands Genomics Initiative - Ingrid Geesink, senior researcher Technology Assessment, Rathenau Institute, NL - Niki Korteweg, science journalist, NL Jury secretary and organiser: Maud Radstake, CSG.
Dinner speech George Gaskell Biography George Gaskell studied psychology at University College London and is now professor of Social Psychology and pro-director of the London School of Economics (LSE). His interest in science, technology and society started in 1993 as a member of the steering committee for the 1st UK National Consensus Conference on Plant Biotechnology. Since then he has coordinated the series of Eurobarometer surveys on 17
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Conference dinner Thursday, 27 May 2010
biotechnology and the life sciences – the latest will be published in June 2010. At the core of his research is the notion that representation, the meaning of an object, is the outcome of communication. Modern biotechnology provided a vehicle for theorising and empirical research on social representations leading, with his colleague Martin Bauer to the ‘toblerone model’. In parallel findings of the research, published in edited books and journals such as Science and Nature, articulated both the public’s support for and reservations over particular developments of biotechnology. He is chair of CSG’s International Advisory Committee; a member of the European Food Safety Authority’s advisory committee on risk communication and coordinator of a EC 7th Framework Programme project on ‘Sensitive Technologies and European Public Ethics.
Keynote speaker Friday, 28 May 2010
General
Friday, 28 May 2010
Keynote speaker
Mike Jetten Impact of ecogenomics - discovering the hidden majority and their role in global element cycles Biography Mike Jetten has been a Full Professor of Microbial Ecology at Radboud University Nijmegen since 2000 and director of the Institute of Water and Wetland Research since 2005. He is an expert in the ecology, physiology and application of anaerobic micro-organisms using metagenomic approaches. Prof. Jetten is editor of the leading journals in the field of Environmental Microbiology. He has published more than 200 papers, and his work is cited over 7.000 times. His work was awarded with many prizes; most notably in 2008 he received the prestigious Advanced Investigator Grant from the European Research Council. Outline Microbes are the main catalysts of the biogeochemical cycles on Earth, but the major microbial players in most ecosystems are not known today. This is demonstrated by the recent spectacular discoveries of new microbial species involved in the nitrogen and methane cycles, and by the results of metagenome sequencing projects of selected ecosystems that have added billions of new DNA-sequence to the public domain. In addition, more than 1.000 microbial genomes have been completed to date. Based on these data sets we have the ability to explore the heart of the matter and try to understand how microbial communities function. Similar to other fields anthropogenic effects on the environment call for an integrated approach in microbial ecology. It is essential to understand how microbial ecosystem functions and interact with higher organisms, and how these ecosystems respond and adapt to environmental changes and stress factors.
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Poster competition
urban zone
Thursday, 27 May & Friday, 28 May 2010
Poster competition
• biobanks • health care • genes, race and ethnicity • genetic screening and testing • personalised health
Delegates’ posters will be put on display throughout the whole conference. During two 30’ sessions, presenters will pitch their posters on: Thursday, 27 May, 17.00 – 18.00 Friday, 28 may, 9.00 – 9.30 The jury consists of: Paul Martin (chair), University of Nottingham, UK Jacqueline Broerse, Athena Institute, VU University Amsterdam / CSG, NL Martina Cornel, VU University Medical Center Amsterdam / CSG, NL Bart Penders, Radboud University Nijmegen / CSG, NL The winning poster will be announced on Friday, 28 May, 16.00.
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Session
I-A
urban zone - The promise of biobanks
Urban zone – Parallel session I-A
Thursday, 27 May, 10.45 – 12.15
The promise of biobanks Author(s) Institution(s) Title
R Tutton CESAGen, Lancaster University, UK Biobanks, Biocapital and the Political Economies of Promise
Introduction The year of 2009 illustrated well both the promise and volatility that has characterized the field of biobanking in the first decade of the twenty first century. Time magazine listed biobanking as number eight in its list of ten ideas that are currently changing the world, UK Biobank invited royalty to officially open its archive in Manchester that boasts the world’s largest human blood and urine freezer, then, deCODE Genetics Inc., after months of speculation, finally filed for chapter 11 bankruptcy in the US with debts of US$300m. In places such as Scotland, Spain, Denmark, Iceland, United Kingdom, Estonia, Latvia, and elsewhere, actors ranging from government agencies, universities, charities, and industry have invested in biobanks in expectation that these initiatives will have a future value to academic and industry research on the causes of common, complex diseases that will enhance efforts to prevent their occurrence and to develop new personalized diagnostics and therapies to benefit patients. In tandem with these expectations, the potential of biobanks to produce economic benefits has been emphasized in different ways in a number of national contexts. Conceptual framework Drawing on work in the sociology of expectations, this paper examines the political economies of biobanking in the twenty-first century through a study of different initiatives in Europe and Asia, discussing both the economic promise of biobanks and their experience of volatility in the search for viable business models. Method The paper draws on analysis of individual biobank websites, other public and promotional documents as well as media coverage. Results From my analysis I draw out the insights this study gives us into understanding the processes of innovation and investment in biobanking as a promissory technology of contemporary biocapital. 22
Author(s) Institution(s) Title
I Meijer Technopolis Group, Amsterdam, NL Biobanks and their societal outreach
Introduction Population surveys and biobanking are key resources in providing researchers with material and data. Research can help us understand the interactions between genes, the environment, lifestyle and disease, and then translate that knowledge into clinical practice quickly through innovative diagnostics, therapeutics and preventative treatment strategies. Through the genetic assessment of both healthy and diseasespecific biospecimens obtained from biobanks, the potential for personalized medicine is becoming realized. Demonstrating the socio-economic impact of a biobank is thought to be crucial in order to make biobanking sustainable. Sustainability depends on stable funding, which in turn requires outreach to public and private parties (i.e. society), other than scientists, to involve them in activities. The concept of outreach refers to the activities that are carried out by a biobank facility to reach out and engage with the lay public, patients, medical professionals, policy makers or funders. The goal of outreach to society is primarily to inform, share, and get support from the public on the benefits of biobanking, in order to serve societal accountability, which in turn may serve sustainability of biobanks. The question is whether biobanks in Europe, and their European coordinating structure, have organised their outreach activities and included them in strategic plans. Conceptual framework For this study we have chosen the logical framework model as a starting point. Logical frameworks can be used to support evaluation of policies/programmes, and are built with objectives that respond to needs, problems or issues identified by society. Once needs and challenges are identified and objectives are defined, implementation of such programmes can be viewed as a process whereby “inputs” (resources) are transformed into “outputs”. It is expected that these outputs will lead to results for the direct beneficiaries of the programmes and, hopefully, that these will lead in future to an impact on society at large. The transformation of inputs into outputs is called the implementation process and usually includes ‘activities’. When the objective is to create health and economic impacts, then it is important to define activities relating to these objectives, which can be operational or strategic. Health impact and economic impact involve different target groups; likewise they require different types of activities that are externally-oriented, i.e. outreach. Method The study is more specifically focusing on the BBMRI (Biobanking and Biomolecular 23
Session
I-A
urban zone - The promise of biobanks
Resources Research Infrastructure) that aims to build a coordinated, large-scale European infrastructure of biomedically- relevant, quality-assessed, biological samples (linked to related clinical information), to enhance therapy and prevention of common and rare diseases. The study uses a logical framework to describe the mission and objectives of BBMRI in a detailed way and links the objectives to activities and expected outputs and results. In addition, we have studied 10 individual biobanks or biobanking networks, located all over Europe, which are all very diverse. The information was gathered using semi-structured interviews. The case studies were used to investigate the objectives from the logical framework. So part of the individual case studies focused on outreach activities, or the way in which a particular biobank engages with a community it might want to serve. Results From the BBMRI logical framework it was concluded that the majority of the activities of BBMRI currently focus on internally-oriented operational activities such as the ICT infrastructure, access, and ELSI matters. The activities to engage with society are fairly limited, both at the level of BBMRI and at the level of individual biobanks. We have used information on the number of samples and information on the number of samples distributed and used for scientific studies as a measure for the external orientation of biobanks, and their strategic orientation in outreach. In only 3 out of 10 case studies outreach strategy, activities and outputs are documented or easily retrieved when requested. From these three, 2 are biobanks that are initiated and/or supervised by patient organisations having outreach strategies that also systematically monitor and document their societal outreach. The third case is a biobank operating under a funding scheme that requires specific numbers and data to account for the funding. For the other 7 cases, outreach activities are limited and when present, they are defined by the audience served. In fact, in most of these 7 cases, societal outreach is not very well documented, if at all; instead the emphasis is on scientific excellence and research. From this we conclude that when BBMRI as a whole and individual biobanks in particular strive for a sustainable funding situation, there should be more timely emphasis and attention for societal outreach strategies. Author(s)
M Boeckhout of Philosophy, Faculty of Humanities, University of Amsterdam/ CSG, NL Title Putting genomics’ promises into biobanking practice: a genealogy of ambitions Institution(s) Department
Introduction Biobanking, the organization of large-scale, long-term collection of data, blood and 24
tissue for genomic research, is considered to be of great importance for delivering on the promises of genomics and related genetic technologies through enabling, for instance, personalized and translational medicine. However, the ambitions as well as the means by which these are said to be achieved through biobanks are diverse. How have requirements for fulfilling genomic promises changed over time? How can we make sense of the work necessary to align these various requirements? Conceptual framework Biobanking is a field of particular interest to investigate how models, visions and expectations of biomedical research relate to and co-shape the societal genomics landscape (Brown 2003; Brown & Michael 2003; Borup et al. 2006), because of its central role in governing contemporary genomic life (Rose 2006, Gottweis & Petersen 2008). Expectations related to biobanks are constitutive of programmes of action which provide the conditions for fulfilling particular (health-related) ambitions (Van Lente 1993) as well as for changing conceptions of (inter-)disciplinary objects of research constituted through such programmes (De Vries 2007). Biobanks embody diverse conceptualisations of the object of research, the goals such research is meant to achieve, and the ways in which participants’ role is construed. Therefore, they provide a view on the dynamics of expectations in terms of changes in the organisational means and research populations required to achieve genomics’ varying promises. Method The emergence of biobanking is characterised by evolving ways of thinking about how large-scale biomedical research repositories may contribute to the fulfilment of the prospects of genomics. This emergence will be analysed by drawing on primary as well as secondary sources, using methods of discourse analysis as well as more formal methods of semantic network analysis. Results The analysis shows that the field of biobanking incorporates a number of different models of how health-related expectations of genomics can be fulfilled. Differences in these models relate, notably, to various disciplinary traditions, such as the fields of bioinformatics, epidemiology, clinical genetics and pathology. Some of these practices aim at attaining the goods of genomic research by contributing to epidemiological understandings of disease. Others are aligned with attempts at putting the tools of genomic analysis to work for pharmacological risk profiling. These various modes of organizing the object of genomic medicine, moreover, are increasingly intertwined. ‘Biobanking’ is a label signifying a diverse and growing number of research practices. Even though these share a number of problematics, most notably related to ethical, legal and social aspects, diverse understandings of what biobanks are aiming for and what the role for participants in them should be still co-exist. Therefore, current efforts 25
Session
I-A
urban zone - The promise of biobanks
to standardise and harmonise biobanks do not just raise issues over organisational and technical alignment, but will also involve struggles over the entanglement of biomedical research in realignments and transformations of genomic conceptions of (public and private) health.
urban zone - Genetics and genomics in health care: access and insurance
I-B Session
Urban zone – Parallel session I-B
Thursday, 27 May, 10.45 – 12.15
Genetics and genomics in health care: access and insurance Author(s)
E Aarden
Institutions(s) Department
of Health, Ethics & Society, Faculty of Health, Medicine and Life Sciences, Maastricht University, NL Title Politics of Provision – A Comparative Analysis of Access to Genetic Technologies.
Developments in genetic technologies are expected to have far-reaching implications for health care. While many of these implications have extensively been studied and debated, the question what genetic technologies mean for health care access has so far largely been absent. This is particularly the case in the context of European public arrangements for the provision of medical care. Nevertheless, European health care arrangements have historically developed highly particular approaches to the incorporation of medical procedures in their benefit packages – which means that the way genetic technologies figure in health care and the way they affect medicine is locally specific as well. In this paper I will present results from a study of how three European countries – Germany, the Netherlands and the UK – have incorporated some specific genetic technologies in health care provision and how this required a mutual adaptation of technology and health care organization. In my analysis I concentrate on two aspects of providing new medical technologies; the inclusion of procedures in the reimbursement schemes on the one hand, and the distribution of access to these procedures on the other. This shows how deeply embedded distributive mechanisms in health care contribute to the shape genetic technologies take in different countries. I will conclude this paper by discussing the implications of genetic technologies in the light of my analysis of health care provision, with a particular focus on health care distribution. Moreover, I will propose some issues that deserve further attention on the basis of my study.
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Session
I-B
urban zone - Genetics and genomics in health care: access and insurance
Author(s)
A Stoklosa Institution(s) University of Toronto, Canada Title Integration of genomic technologies into Canadian healthcare framework Introduction New technologies resulting from our investment in the Human Genome Project (HGP) have the potential to tremendously improve healthcare. However, the challenges associated with integrating these technologies into healthcare – particularly a publicly funded system, such as Canada’s – are also considerable. While it is recognised that careful policy planning is required here (Gwinn and Khoury, 2006), it remains unclear how to appropriately conduct this integration (Farmer and Godard, 2007). My focus is on the issues surrounding the integration of one particular post-HGP technology: genetic testing for diseases. Over 1300 genetic tests are presently available, and these are expected both to proliferate further, and play an increasing role in treatment (Guttmacher and Collins, 2002). Arguments for or against their integration into publicly funded healthcare systems frequently rest on the tests’ clinical utility, although what is meant by ‘clinical utility’ is unclear, as various definitions underpin discussion in the literature (Munafo, 2009; Grosse and Khoury, 2006). My aim here is to argue for a conceptually sound definition of ‘clinical utility’ and to assess clinical utility of genetic tests in four testing scenarios, thereby laying groundwork for robust policy regarding public funding of genetic tests. Conceptual framework Genetic tests can be categorised into two types. Diagnostic tests are carried our on symptomatic patients, to confirm whether they are suffering from a particular disease, e.g. Cystic Fibrosis, or Tay-Sachs. Predictive tests are carried out on asymptomatic patients, to ascertain whether they are at risk for a particular disease, such as Alzheimer’s, PKU or Huntington’s (Ashcroft, 1999). Ability to genetically test for a disease, however, does not imply the existence of its treatment: while treatment is available for PKU, this is not the case for many other diseases, including, e.g., Huntington’s (McPherson, 2006). Clinical utility has been narrowly defined as “the ability of a test to prevent or ameliorate adverse health outcomes” (Genetic Testing Task Force, 1998) and, more broadly, to encompass any outcomes considered relevant to the patient (e.g. reproductive planning) (Grosse and Khoury, 2006). Definitions falling somewhere in-between have also been offered (Khoury, 2003; Munafo, 2009). Breadth of the definition of clinical utility that is adopted will impact the assessment of the value of genetic tests, and thus affect the arguments regarding their inclusion in a publicly funded health framework. 28
Method A systematic review of academic literature, as well as government reports (primarily Canadian and Australian) was conducted on the subject of genetic testing, in order to generate a range of definitions of ‘clinical utility’ currently in use. Results I examine the definitions of ‘clinical utility’ offered in literature. Next, I argue for a definition of clinical utility that can capture both the scientific and ethical complexity of genetic testing. I then assess the clinical utility in four genetic testing scenarios: (1) diagnostic testing where treatment is available; (2) diagnostic testing where treatment is not available; (3) predictive testing where treatment is available; (4) predictive testing where treatment is not available. I close by considering the implications of these assessments for integration of genetic testing into Canadian publicly funded healthcare framework. Author(s)
J Broerse1,3, W Boon2, J van de Kraats1 Institution(s) Athena Institute, VU University Amsterdam, NL 2 Department of Innovation Studies, Utrecht University, NL 3 Centre for Society and Genomics, NL Title Exploring future scenarios for the role of genomics in health insurance 1
Introduction Scientific developments in human genomics have resulted in the widening of possibilities for screening, prevention, diagnostics and therapy over the last ten years. Genomics will have an impact on health insurance. Therefore, the Dutch Health Care Insurance Board (CVZ) became interested in exploring the future role of genomics in health insurance. In answer to this, this paper deals with the following questions: which scenarios describe possible futures between now and ten years for Dutch health insurance in which genomics play a large role? Which dilemmas are encountered in these scenarios? And which repercussions do these dilemmas and trends have on the tasks and responsibilities of the Board? Conceptual framework This scenario research builds on previous future-oriented studies by Van Rijswoud and others in which scenarios for public health care, commercial care providers and physicians are explored. Like these authors, the scenarios explicitly build on the present situation and trends that are discerned. Based on this a possible (and not necessarily the most probable) future is sketched in a controlled way. The emphasis lies on uncovering complex interactions between actors, factors and (technological and societal) developments. These pictures can then be translated into questions and dilemmas, which need to be taken into account by stakeholders while they prepare for the future. 29
Session
I-B
urban zone - Genetics and genomics in health care: access and insurance
urban zone - Biobanks: genetic profiles in perspective
Method The methodology owes to the Interactive Learning and Action approach (Bunders, Broerse). Firstly, a desk study was performed and a series of exploratory interviews was conducted with experts within the organisation as well as an external genomics expert. Secondly, members of the Board were asked to participate in several meetings: 1) two focus groups in which the participants were asked to reflect on the current state of science, to name the possible opportunities and repercussions for the health insurance practice, and to sketch a social map; 2) a workshop in which the participants developed scenarios based on the results of the focus groups and the interviews; and 3) a feedback workshop in which the participants discussed the results of the analysis.
Urban zone – Parallel session ii-A
Results The results from the desk study, interviews, focus groups and workshops are presented in this paper. More specifically, the scenarios are presented, which follow different developments of genomics, related dilemmas and potential consequences for the Health Care Insurance Board.
Author(s)
II-A Session
Thursday, 27 May, 14.00 – 15.30
Biobanks: genetic profiles in perspective I Fortier1, 2, D Doiron1, F L’Heureux1, M Deschesne1, P Burton3 Institution(s) Public Population Project in Genomics (P3G), Canada 2 Université de Montréal, Canada 3 University of Leicester, UK Title Harmonizing 50 Large Bioclinical Studies: the DataSHaPER approach 1
Introduction To properly understand the role and interaction of genetic, lifestyle, environmental and social factors in modulating the risk and/or progression of chronic diseases, a vast number of study participants is often required [1-2]. Even the largest cohort studies generate only enough subjects to investigate common complex diseases and simple etiological architectures. Given financial, technical, and temporal constraints, the benefits of sharing high quality data to generate the required sample sizes are clear. Major technical, ethico-legal and scientific challenges must still be faced, but information pooling is therefore increasingly important. This presentation will explore the potential of the DataSHaPER (Data Schema and Harmonization Platform for Epidemiological Research) tool to facilitate data sharing between 50 large populationbased studies (>5.5M participants). Conceptual Framework The DataSHaPER (www.datashaper.org) provides a flexible, but structured, approach to support harmonization and pooling of high quality and inferentially equivalent information between studies [3]. A DataSchema includes a core set of variables serving as a central reference for prospective and retrospective harmonization in a given scientific setting. Development of the Harmonization Platform subsumes: (1) creation of formal “pairing” rules to evaluate the potential for each individual study to generate each variable in the DataSchema; (2) construction of tables indicating which variables can be generated by each study – using the “pairing” rules; (3) development and implementation of processing algorithms enabling studies to generate the DataSchema variables to achieve pooling.
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Session
II-A
urban zone - Biobanks: genetic profiles in perspective
Method The “Generic DataSHaPER” aims to support the construction of general purpose baseline questionnaires and physical measures for use in large cohorts enrolling middle-aged participants. Its DataSchema contains a core set of 150 reference variables which were selected in a series of international consensus meetings (2006-2008) involving multidisciplinary experts from 15 countries. A total of 50 large populationbased studies (each ≥10 000 participants) from around the world are now part of this major harmonization initiative.
population resources. In an effort to capture the value of these investments and promote an equal stake in international collaborations, a few of these countries have either developed or proposed guidelines and laws to protect local human genomic material as a sovereign resource. Critics suggest that this approach will impede international collaborations – reducing access to external funding which can be vital in these countries. The debate is important, as the knowledge generated from these large-scale studies may need to be interpreted in larger international collaborative efforts before it can lead to health benefits.
Results The presentation will outline the overall potential of the 50 studies to successfully construct the DataSchema variables. Pairing quality will be described on a three level scale: “complete”, “partial” or “impossible”. Key features in study design and important characteristics of individual variables will be identified that influence the potential for harmonization. As illustrative examples, “Occurrence of high blood pressure” and “Occurrence of diabetes” can reliably be recreated by 90% of participating studies while “Level of physical activity”, “Current use of alcohol” and “Occurrence of stroke” can be created by 80%. But, real analysis demands multiple variables: if “Systolic and diastolic blood pressure”, “Body mass index”, “Level of physical activity”, “Current use of alcohol”, “Current quantity of cigarettes smoked” and “Post-secondary education” are considered jointly, 15 studies (>1.5M participants) can recreate all of the variables required. Based on these results, and if it is paired with complementary informatics, statistical and ethical tools, the DataSHaPER has the potential to contribute substantially to harmonization and pooling between major studies.
Conceptual Framework The research described here is an in-depth study of the theme, genomic sovereignty, through an exploration of the empirical and theoretical understandings of the concept. The focus is on how it may contribute to each country’s aim of achieving health equity through investments in genomics, its relation to heritage, pride and patrimony, and its potential limitations.
1. Burton et al, Int J Epidemiol, 2009. 38(1):263-73. 2. Spencer et al, PLoS Genet, 2009. 5(5): p. e1000477. 3. Fortier et al, Int J Epidemiol, 2010:submitted. Author(s)
B-J Hardy1, B Séguin1,2, P Singer1,3, A Daar1,3 Institution(s) McLaughlin-Rotman Centre for Global Health, University Health Network and University of Toronto, Canada 2 Leslie Dan Faculty of Pharmacy, University of Toronto, Canada 3 McLaughlin Centre for Molecular Medicine, Toronto, Canada Title Genomic Sovereignty
Methods The primary data source consists of 75 in-depth, semi-structured interviews conducted with key informants collected during several field trips conducted between 2007 and 2009. Transcribed interviews, field notes and key documents were coded using thematic-content analysis, exploring the following: drivers and barriers, translation, commercialization and ethical, legal social implications. These results were triangulated with the analysis of relevant academic papers, policy documents, laws, and government reports. The theme of genomic sovereignty is further interpreted through an in-depth literature review of sovereignty and the ownership and sharing of genomic materials and data. Results Ultimately we hope this research will result in a resource that can be built on by other groups studying how infrastructure and capacity are being established around genotyping initiatives in emerging and developing countries.
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Introduction In recent years, governments in Mexico, India, South Africa and Thailand have funded or proposed to fund large-scale human genotyping initiatives. These countries provide compelling reasons for pursuing these studies: the potential to address local health needs and reduce health care costs; the opportunity to stimulate economic development through investments in genomic sciences, and the availability of unique 32
Author(s)
K Hens, K Dierickx for Biomedical Ethics and Law, Faculty of Medicine, Katholieke Universiteit Leuven, Belgium Title Ethical Aspects of Storing and Using Tissue from Minors for Genetic Research
Institution(s) Centre
Introduction & Conceptual framework Many biobanks deliberately do not include tissue from children in their collection. This may be due to the fact that storage and use of human tissue in human biobanks has been largely framed in terms of the research subject’s rights, with an emphasis 33
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on informed consent [1]. But not including children in biobank research poses different challenges. As we have already stated above, for research in general, and as pointed out by Williams (2005) for biobanks, this could lead to the situation that genetic research that may result in treatment is not carried out. For example, scientists now acknowledge the influence of early childhood and prenatal environmental factors on gene expression later in life. The proliferation of diseases such as allergies, asthma, food intolerances, diabetes and obesity is attributed to a combination of genetic and environmental factors. To thoroughly understand this interaction, and to develop preventive measures, epidemiological research using genetic databases coupled with environmental and medical data may be appropriate. For more traditional purposes, such as the study of genetic factors of certain childhood cancers, DNA samples from children with that condition could be needed.
• Williams, Genomics, Society and Policy 1(2) (2005) 50-65. • Hens, Am J of Med Genetics Part A 149A(10) (2009) 2346-2358. • Hens, Eur J Hum Genet 17(2009) 979-990.
Method This talk gives an overview and the results of our PhD project, with which we aimed to investigate the ethical issues related to genetic research on stored tissue samples from minors. Based on this investigation, we try to provide answers and recommendations that can be used by researchers, policy makers, and ethics committees. An ethical inquiry and subsequent recommendations are based on four steps. First, a state-of-the-art overview is needed of the concepts and themes in current literature and guidelines about the concept under investigation. Second, the current ethos needs to be understood and checked against the theoretical state-of-the-art. An investigation of the ethos is best done through systematic empirical research. Third, concepts and themes that arose from the first and second part need to be elaborated, investigated and checked for consistency in in-depth normative/theoretical reflections. Finally, based on the cumulative experiences from the previous parts, recommendations can be formulated. Results In a first part, we investigated the themes discussed in guidelines and recommendations and the ethical literature (Hens, 2009; Hens, 2009). We found that basic themes were consent and assent and issues surrounding minimal risks and group benefits. In a second part we performed focus group research with lay people and professionals. We found that a major issue was the fact that non-therapeutic research should not burden children (e.g. through extra vene punctures). We also found that both with the lay people and professionals, the genetic aspect of the research was not seen as too problematic, contrary to some more theoretical literature. In a third part we provided a normative/theoretical framework based on our previous findings. We provided recommendations for return of results in pediatric biobanks. We sketched a framework of ‘burden and group benefit’ rather than the usual concept of minimal risk in pediatric research. We also described a framework for assent/dissent and the need to recontact people when they reach the age of competence.
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urban zone - Shifting perspectives in medical genomics application, regulation and governance
Urban zone – Parallel session ii-B
Thursday, 27 May, 14.00 – 15.30
Shifting perspectives in medical genomics application, regulation and governance
Method For this purpose, I draw on qualitative interview data I have collected during the past seven years of ELSA research and which I have analysed using a discourse analysis approach. From a methodological point of view it is crucially important to reflect on the broader context in which ELSA research is carried out when interpreting such interview data.
Author(s)
Results In conclusion I argue that ELSA research is not merely reflexive. A new form of social science and philosophical analysis emerges: researchers cannot any longer claim to be disengaged observers. They are themselves actors in the field they strive to investigate. These findings challenge classical understandings of science and call for a conceptual framework that does justice to the complex circumstances in which ELSA research is carried out.
Institution(s) Title
B Wieser IFF/IFZ, Graz, Austria The emergence of ELSA research
Introduction With this presentation, I aim to allocate a specific policy strategy to govern genome research within the “emerging societal landscape of genomics” and to discuss its methodological and conceptual implications. Governments have devoted huge amounts of public resources to genome research. What justifies an investment of this scale? Already during the Human Genome Project genome research was closely related to economic prospects of a promising bio-economy to come. On the other hand, ethical and social concerns were also articulated. However, it is not only revealing to examine arguments made on this account, but also to analyse the strategies deployed in order to communicate these arguments to the public. Conceptual framework In order to analyse the specific function of ELSA research in the interplay between genome science, politics and the public I draw on a number of well-known STS concepts. Using the “mode 2” literature allows me to address the ways in which ELSA research contributes to make genome research socially more robust (Gibbons et al. 1994, Nowotny, Scott, & Gibbons 2001). Accountability is a key element in this regard. In recent years, policy makers have encouraged scientists to disseminate their findings more broadly and thereby to engage with the public. In such a way decision-makers passed on the task to account for public investment to those who received such funding (Maasen & Lieven 2006). Philosophers and social scientists are also enrolled in this science policy framework. It is their job to study the ethical, legal, and social aspects of genome research. By no means is ELSA research merely contemplative when it is expected to deliver policy relevant findings. This assignment influences the relationship between social scientist and genome researcher as it becomes apparent during the research interview. I use Thomas Gieryn’s “boundary work” (Gieryn 1999) 36
to analyse such communication and therewith highlight the strategic nature of the encounter between social scientist and genome researcher.
Author(s)
E Rial-Sebbag, A Pigeon, A Cambon-Thomsen INSERM, France Title The network of influences between ethics, law and practices in regulation of genomic information: a 10 years overview Institution(s)
Introduction Rapid developments in genomics and efforts to sequence the human genome and to study its variation were accompanied by evolving related ethical and legal issues and regulation. Conceptual framework The main issues initially considered were related to the uses of genetic tests in a clinical context of monogenic diseases and the potential misuse of genetic information. Present challenges anchored in new developments of biobanks and genetic databases concern high throughput techniques generating large amount of data not only for clinical applications, data sharing, uncertainty on clinical significance of many genetic data, incidental findings in genetic research, limits of confidentiality and patentability, assessment of clinical utility, direct to consumer tests, return of results to research participants, and avoiding hype. Methodology We analysed over a period of 10 years (2000 – 2009) the content and process of development of various international and European legal and soft law instruments, professional guidelines and relevant specialised literature. As a case study we looked 37
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at how the EU project Gen2Phen had used those various instruments to construct an internal research ethics policy. Results Professionals working with genomics data are applying in various ways, international, European and national relevant instruments; professional guidelines and practices are also influencing the redaction of those instruments with different weights. For instance, OECD published in October 2009 its Recommendation on Human Biobanks and Genetic Research Databases, which aims to provide guidance for the establishment, governance, management, operation, access, use and discontinuation of human biobanks and genetic research databases. This recommendation which is a non-binding instrument is nevertheless fully relevant for the creation of ethical and legal policies for professionals. Nevertheless, in few issues the literature pointed out a lack of appropriate regulation particularly concerning data coming from minors, or direct to consumer genetic testing, where collaboration between professionals and lawyers is recommended to assess those issues. New networks of actors of regulation are appearing.
minorities in the republic; (2) The history of genetics and biomedical ethics on the basis of twenty-five textbooks on biomedical ethics for students and professionals in the life sciences; (3) A study of twenty handbooks for eugenic and foetal education in China. Results While government policies on genetic testing still view the Chinese nation as one big family, data on actual practices reveal a concept of the family that is increasingly diverse. Many couples choose to abort abnormal foetuses, denying the applicability of state eugenics, making the concept of laissez-faire eugenics look apt. But often, individual choice is moulded by a constellation of pressures unique to China and different from those in Western Europe, denying the aptness of understanding genetic testing in China in terms of neo-liberalism. Although socialist in name, China’s healthcare provisions are unevenly shared compared to most countries in Western Europe. A lack of financial support and welfare institutions, as in many developing countries, limits the couples’ ability of raising a child with a birth defect and looking after handicapped grown-ups, providing a Chinese meaning to the term biological citizenship regarding genetic testing in China.
Author(s) Institutions(s) Title
M Sleeboom-Faulkner Department of Anthroplogy, University of Sussex, UK Genetic testing, governance, and the family in the PRC
Introduction Western concepts of biocitizenship, eugenics and neoliberal governance are often used to discuss genetic testing in the People’s Republic of China (PRC) as well. China’s population policy has a reputation for condoning eugenic practices and for ruthless family planning policies, but the recent reforms, together with the revival and development of traditional religions and beliefs have complicated the discussion on Chinese family planning. In this context, the introduction of genetic testing in China has been linked to state eugenics as well as post-reform neo-liberalist governance. This presentation investigates whether genetic testing in China can be understood in terms of eugenics and liberal governance.
Main references • C hinese Ministry of Health (2003). Guidelines for genetic counselling [Jiyin zixun guifan]. Source. Available from: http://www.healthychildren.org.cn/actionplan/ fagui/fagui.htm • Chinese Population and Family Planning Law (Zhongguo renkou yu jihua shengyu fa) (2002). articles 2 and 30, 1st September 2002. • Dikötter, F. (1998). Imperfect Conceptions. Medical Knowledge, Birth Defects and Eugenics in China. London: C. Hurst & Co. • Greenhalgh, S. (2008). Just One Child. Science and Policy in Deng’s China. Berkeley, Los Angeles, London: University of California Press. • Kipnis, A. (2007). Neoliberalism Reified: Sushi Discourse and Tropes of Neoliberalism in the PRC. Journal of the Royal Anthropological Institute, 13, 383–400. • Rose, N. & Novas, C (2005). Biological Citizenship. In Aihwa Ong & S. Collier (eds.) Global Assemblages (pp 439-465). Malden & Oxford: Blackwell.
Conceptual framework Basic concepts: genetic testing, China, neo-liberalism, biocitizenship, eugenics population policies, premarital testing, Chinese family household, reproductive choice, quality of offspring Research methods This study draws on a combination of studies that explore genetic testing and reproductive decision-making in China. Fieldwork (interviews, participant observation) in Guangzhou, Shanghai, Wuhan, Changsha, Haikou, Kunming, Shanghai and Beijing. Archival and literature studies related to: (1) Population policies regarding ethnic 38
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urban zone - Biobanks: governing tissue terrains
Urban zone – Parallel session iII-A
Friday, 28 May, 9.30 – 11.00
Biobanks: governing tissue terrains
Author(s)
I Geesink, C Steegers Technology Assessment unit, Rathenau Institute, NL Title Clinical waste and regulatory wastelands: governing the use of human residual tissue Institution(s)
Introduction Human biological material is increasingly being used instrumentally in clinical practice. Tissues and cells have become starting materials for innovative (therapeutic) products, transplants and diagnostic devices. Technological innovation has enhanced possibilities to derive, process, modify and store human biological materials, while more (valuable) information can be obtained from these processes and bio-entities. Conceptual framework Regulatory frameworks have been put in place to govern the increased mobility of human bodily materials. Most developed nations have informed consent procedures for donation and use of human organs, blood, tissues and cells. Consent and conditions of use for residual tissue is an exception to the rules – at least in the Netherlands. With looming international controversy over potential illicit or ‘inappropriate’ use of human biological material, in the Netherlands debate has been ongoing over regulating conditions and use of this ‘waste’ tissue. We conclude our presentation by reviewing recent legal activity and policy initiatives and reflect on ways of providing some public perspective on the horizon of the current regulatory wasteland. Method Our study reports on the regulatory wasteland of secondary use of human tissue. Our analysis includes attitudes and implications of secondary use of these samples for different purposes. We present data from a large-scale public survey (N=1038), clinical intervention study in a Dutch cancer hospital (NKI) and socio-legal analysis of governance frameworks for (re-use of) human tissue.
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Results While millions of human tissue samples are routinely banked in hospitals each year, most patients (73%) and citizens (76%) are not aware of storage and re-use of their tissue for diagnostic purposes, scientific research or product development. Our research reveals that 91% has never been informed of potential re-use of their tissue by a clinician or health professional. This is problematic, given the high percentage of patients that would like to receive verbal information (81%) from their health professional before treatment takes place. Our clinical intervention study in a cancer hospital demonstrates that this particular informed consent procedure can be easily integrated in daily practice. In addition to information, respondents would also like to have the option to give consent for the particular purpose of re-use of tissue. Scientific research is regarded considerably less problematic than commercial use. While most people are positive about re-use of residual tissue, and levels of trust in clinical practice are high, we argue for the need to take into account both public and patient views in relation to active informed consent. This is especially important given recent legal activities in the Netherlands, and longtime debate about new regulations to cover human tissue issues. Author(s)
E Vermeulen
Institution(s) Section Community Genetics, Department of Clinical Genetics/EMGO
Institute for Health and Care Research, VU University Medical Center, Amsterdam/ CSG, NL Title Biobanking cancer tissue – Patients consider excised (tumour) tissue to be ‘connective tissue’ Introduction Excised tissues are routinely stored in hospitals for future diagnostic use. These tissues are also important for scientific research. In the Netherlands these ‘residual tissues’ are registered in a central pathological registry (PALGA), which makes this collection, consisting of millions of samples, a very large biobank. In the current legal context written informed consent for the use of these tissues in medical research is not required. Patients can declare they do not want their residual tissue used according to an opt-out regime but patients may not be aware of tissue storage and research and the possibility to opt-out. Currently, a proposal for a Dutch ‘Human Tissue Act’ (‘Wet Zeggenschap Lichaamsmateriaal’) (1), which includes information about the consent procedure, is discussed among stakeholders. This presentation elucidates and analyses the underlying attitude of patients towards medical research with excised tissues and focuses on the use of the tissue in genetic medical research. Concepts of ownership in the context of increasing (commercial) value of tissues are discussed.
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Methods The study is based on mixed methods design combining quantitative data (questionnaires) with qualitative data (transcripts from interviews) and observations during an intervention study at the Netherlands Cancer Institute. In total 260 patients were interviewed, 61% of 426 patients who completed a written questionnaire. Results Most patients were unaware of medical research with residual tissue and preferred to be informed about research with this tissue. Therefore the current procedure to inform patients is insufficient. Patients endorse medical research with this tissue, only a few (2%) object to research with residual tissue (2;3). Most patients (62%) do not consider themselves to be owner of residual tissue and 57% do not consider DNA in the residual tissue to be a personal possession. Patients consider the tissue to be of special value however. For patients the stored tissue is a hypercollective good (the value of the good increases with its use) that should remain in the public sphere (i.e. not available for commercial research) in order to facilitate use of the tissue in research. The tissue connects patients to relatives and other patients, the hospital and scientific community. Respondents prefer an ongoing relationship with the tissue holder. Patients expect to be reciprocated by the tissue holder and to be informed about findings of the research. Conclusion Dutch cancer patients endorse research with residual tissue. Information about medical research with residual tissue should be improved. A more participatory and reciprocal model of research with residual tissue and biobanking is required. References 1 Wet Zeggenschap Lichaamsmateriaal (concept), Staatssecretaris van VWS, (2010). 2 Vermeulen E, Schmidt MK, Aaronson NK, Kuenen M, Baas-Vrancken Peeters MJ, van der PH, et al. A trial of consent procedures for future research with clinically derived biological samples. Br J Cancer 2009 Nov 3;101(9):1505-12. 3 Vermeulen E, Schmidt MK, Cornel MC, Knoppers BM, van Leeuwen FE, Aaronson NK. Connective tissue. Cancer patients’ attitudes towards medical research using excised (tumour) tissue. Submitted 2010. Author(s)
R Isasi
Institution(s) Centre
of Genomics and Policy, McGill University and Génome Québec Innovation Centre, Canada Title Stem Cell Banks and Registries: Governance Issues and Challenges in a Comparative Perspective
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Introduction and Conceptual Framework The expansion of national and international research efforts in stem cell (SC) research is increasingly paired with the trend of establishing SC banks and registries (e.g. UKSCB, NIH Registry, Spanish National SC Bank, European hESC registry, UMASS International SC Registry, etc.). In jurisdictions crossing the spectrum of restrictive to liberal SC policies (Isasi, 2006), banks are emerging as an essential resource for transnational access to quality controlled and ethically sourced SC lines from different origins (e.g. embryonic, adult, SCNT) and grades (e.g. research, clinical) (International Stem Cell Banking Initiative, 2009). However, a critical discussion about appropriate mechanisms for both domestic and international governance is yet to take central stage. The emergence of SC banks represents a fairly new phenomenon, and therefore it is still debatable whether their conceptual framework and governance structure fits neatly within the traditional biobanking paradigm (Cambon-Thomsen, 2007). What is clear however is that SC research (particularly embryonic research) raises distinct socioethical and legal concerns as compared to other areas of biomedical research (International Stem Cell Forum Ethics Working Party, 2006). For one, the origin of the SC line, among others, creates challenges in terms of informed consent, commodification and protections of confidentiality and privacy given the requirement of traceability and the potential for donor identifiability (Isasi, 2006). Method This presentation will focus on the results of the International Stem Cell Banking Initiative’s (ISCBI) survey on the governance frameworks of 20 SC banks in 14 jurisdictions (Isasi, 2009). To that end, convergence and divergence in issues surrounding policy approaches, governance mechanisms and trans-national resource sharing will be developed. Furthermore, we will identify prospective strategies for the adoption of governance frameworks that will foster the scientific and ethical integrity of SC banks. Finally, while our analysis is focused on embryonic SC banks, the lessons to be gleaned from this examination will encourage further analysis and research into the issues raised in the banking of other sources of human tissues and cells (Zarzeczny, 2009). Conclusion While it is recognized that SC research “is a global enterprise that begins at the local level” (O’Rourke, 2008), the majority of current and emerging national SC banks are not adopting a global and prospective strategy. What is of heightened concern is the fact that despite these platforms being built with the goal of maximizing the reproducibility, comparability, and transparency of the field (European Group of Ethics in Science and New Technologies, 2007), they often lack a comprehensive and transparent governance framework. In this study, we have identified central issues, convergence points, and gaps in the adoption of such a framework, as well as 43
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urban zone - Changing landscapes of genetic screening and testing
III-B Session
demonstrated the increasing need for the adoption of both domestic and international policies providing ethical and scientific guidance.
Urban zone – Parallel session iII-B
Yet, several international initiatives seeking harmonization of policies and standardization of scientific practices are emerging (e.g., ISSCR, ISCF). They all seek global leadership so as to complement the role of national SC banks. What is more, giving the proliferation of national banks, these international initiatives aim to achieve the important goal of interconnecting national efforts in order to facilitate international collaboration. Whether these transnational attempts will succeed, or whether a global governance framework will emerge from them, remains to be seen.
Changing landscapes of genetic screening and testing
Friday, 28 May, 9.30 – 11.00
Author(s)
C van El1, T Pieters2, E Vermeulen1, M Cornel1 Institution(s) Section Community Genetics, Department of Clinical Genetics/EMGO Institute for Health and Care Research, VU University Medical Center, Amsterdam/ CSG, NL 2 Department of Medical Humanities, EMGO Institute for Health and Care Research, VU University Medical Center, Amsterdam / CSG, NL Title The changing landscape of genetic screening I: Learning to inhabit new territories 1
Introduction In the Netherlands in the past three decades remarkable changes have occurred regarding population genetic screening. In the year 2000 no routine prenatal genetic screening to detect Down syndrome or neural tube defects was offered to pregnant women under 36 years of age. By 2010 governmental restraint in reproductive screening, based on an enduring emphasis on treatability as a screening criterion, has given way to prenatal screening being available to all pregnant women. Neonatal screening has expanded dramatically, from 3 to 17 disorders. Methods Based on interviews, literature research, and results from a witness seminar (a group discussion with experts from the Health Council, the Ministry of Health, geneticists, obstetricians, patient organizations, a politician, et cetera, that have witnessed and influenced policy and debate over the past 30 years) we will highlight three mechanisms that can put these changes into perspective. Results Widening circles In the 1980s and 1990s the pros and cons of prenatal genetic testing on medical indication were known and weighed by a small circle of experts and health professionals. With the introduction of new techniques, making it possible to screen all pregnant women, wider circles (in society and Parliament) were confronted with ethical issues. Whenever circles widen ethical issues have to be assessed anew. 44
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Differentiating between screening aims Where population screening is seen as a public health instrument (aiming for health gain by prevention or treatment through early detection) it is ill at ease with genetic screening providing reproductive options. Depending on the screening aim, consent regimes and outcome measures (such as uptake, reduced morbidity or having made an informed choice regarding reproductive options) vary. Countries differ in their solutions to differentiate these two screening domains. In the Netherlands prenatal screening for Down syndrome is not offered to women under 36 years of age; they have to pay for the test themselves. In addition, the government tries to reduce potential pressure on pregnant women to have a test by giving adequate information on prenatal screening, while stressing explicitly that women may refuse to receive information or to have a test. However, in both prenatal and neonatal screening new technology (such as the foetal anomaly scan and tandem mass spectrometry respectively) make it difficult to differentiate between screening aims in practice. Providing adequate information about screening goals and obtaining informed consent pose major new challenges. Balancing protection and autonomy Traditional screening policy emphasized the protection of citizens against harmful or unsound screening, as is laid down in the Dutch Population Screening Act (1996). In practice this law made it difficult to introduce certain types of screening, most notably prenatal screening. In the age of preventive genomics more tests and possibilities for screening are developed and the demand for tests increases. These developments call for transparent alternatives to create a new balance between protection and autonomy. Author(s)
M Cornel, T Pieters, E Vermeulen, C van El VU University Medical Centre, Amsterdam/ CSG, NL Title The changing landscape of genetic screening II. Governing the balance between ‘duty to protect’ and ‘right to test’ Institution(s)
In the previous century the availability of genetic testing and screening was governed by public health authorities and medical professionals. Many diagnostic and relatively few predictive and screening tests were available. Increasingly other actors got involved, such as prevention services and commercial parties. While on the one hand people have become freer to decide for them whether they want to order their genetic risk test, on the other hand, lack of expertise, lack of counselling, or incorrect results may lead to disappointment or may prove harmful. The quality of genetic services is no longer guaranteed by existing regulations. Integration of genetic knowledge in predictive and preventive healthcare turns out to be a huge challenge.
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In a recent report the Netherlands Health Council discusses three types of screening: (1) useful and cost effective, potentially part of national program, (2) utility less clear, no harm foreseen (3) potentially harmful or misleading. A quality certificate is proposed, enabling consumers to discern responsible from less responsible screening. Some other recommendations, especially concerning direct-to-consumer testing, call for stricter control, for instance by recommending that the test be offered by a qualified health professional. To guarantee informed decision making, the public needs to have access to high quality information (trusted websites). Education and communication are needed to inform the public at large on pros and cons of genetic screening. Policy makers should engage with patient and consumer organisations. Especially for complex diseases translational research is needed. Adequate pre-market evaluation needs to be debated and implemented. The European certificate CE marking should guarantee analytical validity and clinical validity. Assessment of clinical utility, relating to the availability of effective interventions, should be performed for new forms of testing and screening for low risk populations and high as well as intermediate and low-risk gene variants. References • G rosse SD, Rogowski WH, Ross LF, Cornel MC, Dondorp WJ, Khoury MJ. Population Screening for Genetic Disorders in the 21st Century: Evidence, Economics, and Ethics. Public Health Genomics 2010;13:106–115. • Health Council of the Netherlands. Screening: between hope and hype. The Hague: Health Council of the Netherlands, 2008; publication no. 2008/05E. • Ministerie van Volksgezondheid, Welzijn en Sport. Kaderbrief Screening. 4 juli 2008. • Patch C, Sequeiros J, Cornel MC. Genetic horoscopes: is it all in the genes? Points for regulatory control of direct-to-consumer genetic testing. Eur J Hum Genet. 2009;17:857-9. • Van Ommen GB, Cornel MC. Recreational genomics? Dreams and fears on genetic susceptibility screening. Eur J Hum Genet 2008; 16:403-4. Van Rijswoud E, Stemerding D, Swierstra T. Genetica, genomics en gezondheidszorg. Een toekomstverkenning. Centre for Society and Genomics, 2008. Author(s) M Wijdenes–Pijl1, W
Henneman
Dondorp2, D Timmermans1, M Cornel1,3, L
1,3
Institution(s) 1Department
of Public and Occupational Health, EMGO Institute for Health and Care Research, VU University Medical Center, Amsterdam/ CSG, NL 2 Department of Health, Ethics and Society, Research Institute CAPHRI, University Maastricht, Maastricht/ CSG, NL 3 Department of Clinical Genetics, section Community Genetics, EMGO Institute for Health and Care Research, VU University Medical Center,
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Amsterdam/ CSG, NL and professional perceptions of predictive testing for diabetes based on DNA test results or family history assessment: a focus group study
Title Lay
Introduction The aim of this study is to explore lay and professional perceptions of issues surrounding genetic risk assessment for multifactorial diseases based on DNA test results versus family history assessment. Type 2 diabetes is used as an example. Genetic risk assessment for multifactorial diseases might not raise the same ethical, legal, and social issues as testing for monogenic diseases. Method Eight focus group interviews were conducted among 45 people aged 35-70 years with (n=3) and without (n=1) a family history of diabetes, mixed groups of these two (n=2), and diabetes patients (n=2). Individual interviews were held with professionals (n=13) of multidisciplinary backgrounds. Results Themes such as privacy, discrimination and psychological harm were only briefly mentioned for both tests. Lay participants believed that genetic risk assessment would be useful for identifying people at risk for diabetes and to motivate preventive behaviour, but only for high-risk individuals. They, in particular patients, also believed that genetic risk information can be useful to warn or consciously raise children. Professionals, however, stressed that DNA tests still have a low predictive value. Participants argued that a family history assessment can both strengthen and distort family relations. They also thought that respect for autonomy was a more important issue with regard to DNA testing than for family history assessment. Drawbacks of a DNA test were: diabetes is not severe enough, lack of trust in testing. For the family history assessment these were: there is no use for people without a family history, and the family history may be unknown. Conclusions These results indicate that participants see a value for genetic risk assessment in diabetes prevention, but indicate points to consider before using these tests. Issues for multifactorial diseases seem to be more related to public health issues, whereas classic issues that are important in testing for monogenic disorders seem to be regarded as less relevant.
Author(s)
V Darmonkow, F Brunger Health and Humanities, Faculty of Medicine, Memorial University of Newfoundland, Canada Barriers to Genetic Testing: Provider Perspectives
Institution(s) Community Title
Introduction This research examines barriers to the provision of genetic services from the perspectives of genetics professionals working in the province of Newfoundland and Labrador, Canada. It assesses the current structure and capacity of the Provincial Genetic Services Program, the referral process, and the protocols followed, as well as providers’ opinions on barriers to accessing services. The intent is to examine the social, historical, and cultural factors shaping accessibility to and uptake of genetic services from the perspectives of those who provide the services. Conceptual Framework This study constitutes part of the Genomic Ethical, Economic, Environmental, Legal and Social (GE3LS) analysis of the broader Atlantic Medical Genetics and Genomics Initiative (AMGGI). The AMGGI project is an interdisciplinary endeavour to identify genes and genetic mutations underlying familial monogenic disorders arising in populations and communities throughout the Atlantic provinces as well as to develop genetic tests for specific genetic conditions. Within the AMGGI project, GE3LS researchers collaborate with scientists and clinical investigators to ensure that the translation of genetic research from lab to clinical practice to health policy is appropriate, from the perspectives of the end users. This sub-study focuses on the perspectives of those who provide genetic services. Method This study is based on open-ended semi-structured key informant interviews. For the purposes of this study, “genetic professional” is defined as a professional with specialized training in genetics who provides genetic services to patients and their families. This definition encompasses medical/clinical geneticists as well as genetic counsellors. Genetic researchers were also invited as key informants. Although researchers do not formally provide genetic services, they are often the initial contact that patients have with the system and they work closely with individuals, families and, in some cases, entire communities affected by a genetic disease. Interviews focused on perceptions of barriers to accessibility and uptake of genetics services for the four major genetic conditions examined within the broader AMGGI project (hereditary colon cancer, hereditary deafness, hereditary blindness and sudden cardiac death syndrome). Results Barriers identified by the genetics professionals were of two broad types: systemic
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urban zone - Changing landscapes of genetic screening and testing
and psychosocial. Systemic barriers included geography of the area amplified by the lack of adequate and equally distributed resources as well as deficiencies in genetic competences among non-geneticists who typically refer patients to the services. Psychosocial barriers discussed by the service providers included patients’ guilt, fear of social discrimination, fear of loss of insurability, and lack of education including genetic literacy. The findings of this research aim to inform improvements in the organizational structure and the resource/expertise allocation needed for the efficient and timely delivery of genetic services. Further, the study provides a source for strategic direction to healthcare decision makers and health policy makers regarding short and long-term investments in genetic screening and testing in the region. As well, this study discerns new questions emerging from the inquiry and links them to issues that have come forward in both the academia and the broader community.
urban zone - Genes, race and ethnicity
IV-A Session
Urban zone – Parallel session IV-A
Friday, 28 May, 13.30 – 15.00
Genes, race and ethnicity
Author(s)
C Rachul, T Caulfield Health Law Institute, University of Alberta, Canada Title Tracing the Use of Racial Terminology in Representations of Genomic Research Institution(s)
Introduction In the pursuit of personalized medicine, the concept of race remains a contentious aspect of population-based genomic research. Media representations of this genomic research further complicate the debate. Racial terminology in the context of genomic research raises concerns about legitimizing biological views of race, increasing racist attitudes, and giving rise to poor health outcomes. Racial terminology introduces methodological issues and lacks standardized definitions that often rely on cultural or political notions of race. Popular representations of genomics research, i.e. press releases and newspaper articles, give rise to issues with definitions that can hold different meanings dependent on geographic, social, historical and personal context. Conceptual Framework While we recognize that there is clearly biological variation between populations, we believe that the simplistic historical social categories of race have little biological legitimacy. A lot of work has been done on this issue (e.g., Koenig, et al., 2008; Caulfield, et al., 2009). However, it is not clear who is using which kinds of racial terminology, where the language emerges in the communication process and how it is being framed. An exploratory, mixed methods study allows us to answer these questions. Understanding how racial terms are used should help to inform science communication policy and efforts to ensure the consistent and accurate use of population terminology. Method Based on a corpus of 36 complete data sets which included newspaper articles, press releases and journal articles, racial terminology in each article was analysed for statistical significance of frequency and the terms were traced to determine changes in language and frequency from journal article to press release to newspaper article. A 50
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qualitative textual analysis was then conducted on a sample of the data sets to shed further light on the use and source of racial terminology in this context. Results Results indicated a wide variation in the frequency and terminology of racial language used by genomics researchers and the media. The qualitative textual analysis highlighted differences in the use and the framing of racial terminology between scientific literature and media representations, specifically in the use of citations and references, definitions of scientific terms, and exclusion of terms. Based on these results, the use of racial categories in genomics research raises questions about the efficacy of using race as a research category and questions about the social, scientific, and clinical implications of “race” in genomics research. A commitment to providing personalized medicine includes a responsibility to accurately define research terms and research populations in both the scientific literature and in media representations of genomics research. • K oenig BA, Lee SS, Richardson SS, editors (2008) Revisiting race in a genomic age. New Jersey: Rutgers University Press. 368p. • Caulfield T, Fullerton SM, Ali-Khan SE, Arbour L, Burchard EG, et al. (2009) Race and ancestry in biomedical research: exploring the challenges. Genome Medicine 1: 8.1-8.8. Author(s)
V Bonham, D Wayman and Behavioral Research Branch, Division of Intramural Research, National Human Genome Research Institute, National Institutes of Health, Bethesda, Maryland, USA Title Physicians in the United States Attitudes about the Use of Ethnicity and Race in the Understanding Human Genetic Variation in Clinical Care Institution(s) Social
Introduction As medicine enters the genomic age, fundamentally altering the course of disease in individuals may become possible. While the application of genomic information to address common diseases is still in its infancy, the use of race and ethnicity as a surrogate marker in research on human genetic variation is becoming common. Understanding how physicians think about the intersection of race, health and genetics is important to the translation of genomics to clinical care. This study explored United States physicians’ attitudes about the relevance of race in clinical care and their views of the relationships among race, genetics and disease.
genetic testing in clinical practice. The Physicians’ Understanding of Human Genetics Variation (PUHGV) study seeks to investigate how physicians in the U.S. understand and use genetics in clinical practice, specifically, this study was conducted to measure physicians’ knowledge and understanding of human genetic variation and use of race and ethnicity in clinical decisions. Methods We conducted a mixed method study with a random sample of primary care physicians. In the first phase of this study, we conducted 10 racially and ethnically concordant focus groups of primary care physicians in five metropolitan areas in the U.S. In the second phase of this study, we conducted a web-based survey with a random sample of primary care physicians. Physicians’ knowledge of human genetic variation, beliefs about biologic and genetic differences based upon their patients’ race and ethnicity, and use of these constructs in their clinical decision making were measured using the Human Genetic Variation-Health Professionals’ Scales (HGV-HP). Results Data from the study suggested that physicians believe patients’ ethnic and racial background is medically relevant; however, physicians had different opinions as to why these characteristics are relevant. While the data also indicated that physicians believe genomics has a limited role today, it showed that physicians are excited about the future of genomic medicine and believe that the main benefit will be the potential to improve the safety and efficacy of commonly used drugs. In the second phase of this study, 364 physicians responded to the web-based preliminary data collection. Of these physicians, the majority believed that biological differences between racial and ethnic groups affect health outcome differences (83% and 77%, respectively). Conclusion Our study suggests that race in the clinical setting is a confusing and poorly defined construct. While most physicians believed patients’ race had important clinical implications, no consensus emerged regarding why race was useful in the clinical encounter. This wide variation in physicians’ attitudes suggests that patients may be treated differently depending on their physicians’ views of “race” and “ethnicity”. Increasing physicians’ ability to discuss ancestry, race and ethnicity with patients in the examination room could help make physicians’ clinical decision-making more transparent to patients and enhance patient satisfaction as we enter an era of personalized and genomic medicine. Author(s)
Conceptual Framework In the coming years, primary care physicians will be responsible for the translation of new genomic knowledge, including the use of pharmacogenomic and multiplex 52
Institution(s) Title
J Kahn Hamline University School of Law, USA The Persistence of Race in Biotech Patenting and Drug Development
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urban zone - Genes, race and ethnicity
Introduction In 2005 the FDA approved BiDil, the first drug ever to include a race-specific indication on its label – to treat heart failure in a “black” patient. BiDil soon became a poster-child to advertise the progress of pharmacogenomics. In the aftermath of this controversial approval and subsequent marketing of the drug, many have wondered whether BiDil was an anomaly or a harbinger of things to come. Conceptual Framework This presentation explores these concerns in light of specific developments subsequent to the approval of BiDil and considers how similar yet distinct models are developing for the exploitation of race in pharmacogenomic practice and product development. It will explore the tensions embedded in the persistent use of racial categories even as specific genetic variations linked to particular drug responses are identified. It will first consider an emerging phenomenon of the rapidly rising use of racial categories in biotech patent applications. It will then consider more specifically several cases of new drugs and diagnostic genetic tests that present direct examples of some of the new strategies being employed to exploit race under the guise of pharmacogenomic advancement. Here race is used to distinguish products and obtain market share in the increasingly competitive arena of biotechnology. Method This presentation will be built around a close analysis of the case of warfarin, a widely prescribed anti-coagulant drug that has been described by Francis Collins, (the current director of the US National Institutes of Health) as a “poster child” for pharmacogenomics. It will focus in particular on the development of a new genetic dosing algorithm published in 2009 in the New England Journal of Medicine by the International Warfarin Pharmacogenomics Consortium. It will consider how race remains a salient category in the algorithm despite its being rendered insignificant by the incorporation of gene-specific dosing information. Results The presentation will argue that the promise of leaving race “behind” as more refined “personalized” genetic medicine develops is a fantasy that has enabled the continued, indeed, expanding use of race as a quasi-genetic category in biomedical research and product development. Race, indeed, has continued to be used because it serves commercial purposes independent of any biomedical utility it is purported to have.
Personalisation and pharmaco-genomics
IV-B Session
Urban zone – Parallel session iV-B
Friday, 28 May, 13.30 – 15.00
Personalisation and pharmacogenomics Author(s)
P Martin
Institution(s) Institute
for Science and Society, School of Sociology and Social Policy, University of Nottingham, UK Title The remaking of genomic medicine: shifting regimes in genetic research and the promise of personalised medicine Introduction The development of genomic medicine was originally driven by the search for single genes directly involved in the causation of common diseases, such as cancer. This approach was embodied in the emergence of functional genomics and the first genetic association studies in the 1990s. The discovery of the BRCA mutations, although based on more traditional methods, gave weight to the idea that common conditions could be genetically dissected into nosological sub-types. However, whilst the last decade has seen massive investment in the search for such genetic markers, most notably through the use of Genome Wide Association Studies (GWAS), few that significantly predict the risk of common diseases have been found. At the same time, a more complex model of the relationship between multiple genetic interactions, environmental factors and disease risk has started to emerge and has been embodied in the search for new diagnostic biomarkers using SNP panels, gene expression profiling or novel molecular signatures, such as DNA methylation. This shift has also been accompanied by the rise of the vision of personalised medicine in which individual disease risk profiling can be accomplished through a combination of biomarkers and information technology. This paper will attempt to map and analyse the broad contours of these transformations in the meaning of genomics using examples from the field of cancer diagnostics. Conceptual framework Conceptually the paper uses ideas from both science and technology studies and medical sociology that look at the career, problematisation and (re)construction of emerging technologies. In particular, it will draw on the sociology of expectations and the notion of socio-technical regimes to explore the way in which genomics as a field has been shaped by both the history of human genetics and different visions of the future of medicine.
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Method The data for the paper is drawn from a number of empirical qualitative studies conducted by the author and collaborators in recent years, including work on the impact of genomics on pharmaceutical innovation, the clinical and commercial development of pharmacogenetics and current work on diagnostics. Results Data will be presented to show how the original vision of the role of genetic factors in common diseases, based on the well established monogenic regime, was initially replaced by a more complex genetic model that still conceived of genes as determining disease. However, in the light of the failure of this paradigm, a new socio-technical regime associated with the discourse of personalised medicine has started to emerge in which the very idea and meaning of genomics is being fundamentally transformed. This regime can be thought of as an attempt to reconfigure the relationship between the state, medical profession and patients/ consumers, open up the field of genomics to social and environmental factors, whilst at the same time entrenching a new vision of molecular medicine. Author(s) Institution(s) Title
E Bunnik, M Schermer, C Janssens Erasmus Medical Centre Rotterdam/ CSG, NL Unravelling genetic profiling: Test characteristics and ELSA
Introduction Genetic profiling is the construction of risk profiles on the basis of genetic testing for multiple genetic variants simultaneously. It is used for the prediction of complex, polygenic traits, in particular of multifactorial diseases. Internet-based personal genome testing companies are currently offering genetic profiles directly-to-consumer for dozens of multifactorial diseases within one genome-wide analysis. The advent of genetic profiling is affecting the traditional debate on the ethical, legal and societal aspects (ELSA) of genetic testing: it gives rise to new or slightly different ethical issues, and, conversely, it causes some classical issues to lose part of their relevance. In this presentation, I will focus on the relationships between test characteristics of genetic profiling and ELSA thereof.
testing, and neither do they have similar implications for family members. The low level of clinical validity partly undermines classical ELSA-issues regarding privacy protection, discrimination and stigmatization on the basis of genetic information. Contrarily, there are other psychological and health risks involved specifically in genetic profiling of low clinical validity. Concurrently, part of the ELSA-debate focuses on regulatory issues. In this presentation, I will distinguish four positions with regard to the need and justifiability of regulation in relation to different conceptions of clinical validity and related risks. Thirdly, the notion of clinical utility is being expanded in the present-day ELSA-debate to encompass more personal approaches towards the utility of genetic testing. I will show how different notions of utility will impact the ethical evaluation of genetic profiling differently. Finally, personal genome testing is a form of non-targeted testing. Therewith, it generates an enormous and problematic amount of information. Moreover, personal genome testing companies tend to update their risk profiles as new associations between genetic variants and diseases are being discovered, which causes test outcomes to change over time. Not only fluidity, but also complexity and incompleteness of genetic information further exacerbate the ELSA-issue of information in genetic profiling. This problem occurs both at the instant of informed consent and at the instant of delivery of test results. Method Literature review combined with interviews with ELSA-experts, including ethicists, psychologists, and experts of health care law. Results Key test characteristics of genetic profiling are targeted/non-targeted testing, analytical validity, clinical validity, and clinical utility. Variability of these test characteristics lead to variability in psychological risks, health risks and social risks, and subsequent ELSA. Among the primary ELSA-issues is the problem of information: How to inform the consumer? How to do so adequately especially with regard to the limitations of personal genome testing? I will present the outline of a resolution.
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Conceptual framework Firstly, since genetic profiling is increasingly based on genome-wide scanning technology with high accuracy and reliability, and performed in high-quality laboratories, the test characteristic analytical validity has moved away from the centre of the ELSA-debate surrounding direct-to-consumer genetic testing.
Author(s)
W Boon1, E Moors1, A Meijer2 Institution(s) Innovation Studies, Utrecht University, NL 2 Utrecht School of Governance, Utrecht University, NL Title New modes of governing pharmacovigilance for genomics-based drugs: supporting and balancing safety and innovation
Secondly, however, present-day genetic profiles are of limited clinical validity. Therefore, they do not entail psychosocial risks to the same extent as does traditional genetic
Introduction The need for fast drug innovation and the public demand for risk-free drugs create
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a dilemma for regulatory authorities: rapid market access conflicts with uncertainty about benefit/risk profiles of new drugs. Frameworks for post-marketing surveillance of safety and efficacy, or pharmacovigilance, have been developed. There is a governance problem: these present arrangements fall short in maintaining the delicate balance between innovation speed and safety. This is especially imminent with drugs based on the principles of pharmacogenomics. They are characterised by high levels of off-label use and market segmentation. Moreover, these drugs are often ‘conditionally approved’, i.e. intended for a disease for which no treatment is readily available and therefore granted early market access.
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Therefore, the aim of this paper is to increase the understanding of pharmacovigilance governance arrangements for pharmacogenomics drugs, in order to enrich the societal landscape of genomics and contribute to more responsible pharmaceutical innovation.
Author(s)
Conceptual framework This paper borrows its theoretical background from two strands of thinking about regulation and innovation. Firstly, the conceptualisation of post-marketing surveillance as a crucial element in the process of innovation is based upon theories in the field of innovation studies that stress the involvement of multiple stakeholders. Secondly, ideas about new forms of regulation are adapted from the growing field of governance studies.
Introduction One major development accelerating the Human Genome project, and accelerated by it, is the use of informatics tools in biology, resulting in bioinformatics as a new academic discipline. Ten years after the presentation of the HGP, this discipline has a major influence on the way biological information is processed in all genomicsand related fields and has as such changed the entire genomics landscape, and the knowledge production within this landscape. In my poster I will present how I plan to investigate material semiotic changes of embodied identities in the context of bioinformatics.
Method Empirical results are presented from two completed case studies on conditionallyapproved pharmacogenomics oncology medicines (Gleevec and Iressa). The results are based on interviews and extensive desk research, complemented with the results of an expert workshop. Results These cases show, amongst others, that pharmacovigilance and market segmentation strategies are heavily intertwined, and that these strategies rely on off-label use of these drugs. These two strategies can reinforce each other and in this way increase the innovative potential and safety of these drugs. This can be done by combining conditionally approving pharmacogenomics drugs with rigorous post-marketing surveillance and stepwise extension of the indication area. Furthermore, different stakeholders play distinct roles in relation to these strategies. Lastly, the cases illustrate that current pharmacovigilance practices are unable to deal with off-label use and conditional approvals.
Posters
Thursday, 27 May & Friday, 28 May
Posters
Institution(s) Title
J van Baren Faculty of Science, Radboud University Nijmegen / CSG, NL Bioinformation and material identities
Conceptual framework Drawing authors like Kay, Haraway, Barad and Thacker I link (bio)information to identity on a material as well as discursive level. Both concepts are often framed as nonmaterial. In my project I make the link between the inseparability of the discursive and the material in both concepts, showing how the materiality of information contributes significantly to shifts in embodied identities. Method I will investigate the shifts in a number of genomics discourses in order to find an answer to the question what being human means in the context of the informatisation of biology, more specifically in the context of bioinformatics as constituting practice of this informatisation process. Author(s)
L Bitsch
Institution(s) Department
of Science, Technology and Policy Studies (STePS), University of Twente / CSG, NL Title Genomics and new options for innovation in asthma: tracing emerging innovation journeys
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Introduction With the Human Genome Project (HGP), promises and expectations of a future with personalized medicine have been introduced. According to these visions, the HGP will, first of all, bring new understandings of disease. Secondly, these new understandings will be translated into new clinical practices, with diagnosis, treatment and therapy targeted to the individual. The implications of such changes for society, in terms of organization of healthcare and the experience of the individual, were and are contested territory. On my poster I will explore, in more detail, how genomic knowledge is being created and embedded within medical research, and how, in this process, implications for future healthcare practices might be taking shape. Focusing on the intersection of asthma and genomics, I aim to answer the main question: how is genomics creating new opportunities for innovation in asthma research? Conceptual framework I see these new opportunities for innovation as starting points for particular ‘innovation journeys’ in the emerging landscape of medical genomics and healthcare. The concept of innovation journey refers to emerging irreversibilities being shaped by the dynamics of expectations, agendas and actor arrangements (Rip & Schot, 2002; Van de Ven et al., 1999; Van Merkerk & Van Lente, 2005). By tracing these dynamics in the field of asthma genetics, I will show how genomic knowledge manages to recast the definition of disease, the explanatory model of disease, empirical research methods, and evaluations of possible applications. In this process, new opportunities for genome-based innovation journeys emerge. Method To analyze the dynamics of expectations, agendas and actor arrangements, I draw on a qualitative approach. By focusing on statements linking asthma and genomics, a body of literature was identified, consisting of 13 review papers in the period 1999 to 2008. In addition, 7 semi-structured interviews were conducted with Dutch and US researchers involved in asthma and/or genomics research. Results In this process, a convergence at the level of expectations, agendas and actor arrangements can be observed. This convergence points to the emergence of specific innovation journeys, involving large-scale collaborations, with the aim to produce knowledge that will facilitate active intervention in disease trajectories. • R ip, A., Schot, J. W. (2002). Identifying Loci for Influencing the Dynamics of Technological Development. In R. Williams, Soerensen K. (Ed.), Shaping Technology. Guiding Policy; concepts Spaces and Tools (pp. 158-176). Cheltenham: Edward Elgar. • Van de Ven, A., Douglas, A. H., Polley, E., Garud, R., Venkataraman, S. (1999). The Innovation journey. New York, Oxford: Oxford University Press. • Van Merkerk, R. O., & Van Lente, H. (2005). Tracing emerging irreversibilities in 60
emerging technologies: The case of nanotubes. Technological Forecasting and Social Change, 72(9), 1094-11 Author(s)
A Bredenoord, J van Delden Center for Health Sciences and Primary Care, dep Medical Humanities, University Medical Center Utrecht, NL Title Disclosure of individual genetic data to research participants in the genomic era: the debate revisited
Institution(s) Julius
Introduction A debate has evolved in recent years regarding the question of whether individual genetic research results should be disclosed to research participants in genetic/ genomic research, and if so, which data, and by whom. In this poster, we present the first results of our research project, which is aimed at (1) rethinking the appropriate standard of disclosure for medical scientific research involving human participants in the genomics era, and (2) developing guidelines for researchers and research ethics committees regarding the disclosure of individual genetic data to research participants in genomics research. Conceptual framework Ethics; genetic research ethics; disclosure of genetic data; GWAS; whole genome sequencing. Methods Literature review, focus groups, normative analysis. Results By “genetic research results”, we refer to a broad category of information, including validated and non-validated, highly and poorly predictive, and more or less probabilistic genetic data generated by a medical scientific study with human participants (Renegar et al, 2006). On the one end of the spectrum, it is argued that giving individual feedback to research participants is ethically imperative (Fernandez et al, 2003). On the other end of the spectrum, it is argued that no individual genetic research results should be disclosed whatsoever (Forsberg et al, 2009). An intermediate position is defended by those who opt for a ‘qualified disclosure’. Although the majority of commentators and also most guidelines adopted a variant of this latter position, their underlying argumentation and the conditions for disclosure varies widely. Some argue that the deciding factor is the relationship between participant and researcher; for example, the more intense this relationship, the stronger the obligation to disclose would be. This, however, has been criticized because it would involve a blurring of research and clinical care and thereby promote the so-called ‘therapeutic misconception’ (Dressler and Juengst, 2006). Others argue that individual genetic data 61
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should be disclosed to research participants when these data are of analytic validity and of clinical relevance - i.e. preventive or therapeutic measures are available (Ravitsky and Wilfond, 2006). This position raises the question of what we should deem ‘data of clinical utility’, e.g. whether risk information should be included. Currently, there still exists a lack of clarity regarding when and how to disclose individual genetic data to research participants in studies with a genetic component. If guidance is already available, then this is not shaped with the changing (genetic) landscape in mind, such as the current genome-wide association studies, the impending whole genome sequencing-studies and the upcoming commercial activities in this field (Kaye et al, 2009). In this poster, we present the results of our systematic search and explore whether and when individual genetic data should be returned to research participants. References • D ressler LG and Juengst ET (2006) Thresholds and Boundaries in the Disclosure of Individual Genetic Research results. Am J Bioethics 6(6):18-20 • Fernandez CV, Kodish E, Weijer C (2003) Informing study participants of research results: an ethical imperative. IRB: Ethics Hum Res 25:12-19 • Forsberg JS, Hanson MG, Eriksson S (2009) Changing perspectives in biobank research: from individual rights to concerns about public health regarding the return of results. Eur J Hum Genet 17(12):1544-9 • Kaye J, Boddington P, De Vries J, Hawkins N, Melham K (2009) Ethical implications of the use of whole genome methods in medical research. Eur J Hum Genet advance online publication, 4 November 2009; doi:10.1038/ejhg.2009.191 • Ravitsky V and Wilfond BS (2006) Disclosing Individual Genetic Results to Research Participants. Am J Bioethics 6(6):8-17 • Renegar G, Webster CJ, Stuerzebecher S, Harty L, Ide SE, Balkite B, Rogalski-Salter TA, Cohen N, Spear BB, Barnes DM, Brazell C (2006) Returning genetic research results to individuals: points-to-consider. Bioethics 20(1):24-26 Author(s)
A de Jong1,3, W Dondorp1,2, G de Wert1,2,3 Institution(s) Maastricht University. Faculty of Health, Medicine and Life Sciences. Department of Health, Ethics & Society and Research Institute GROW, NL 2 Maastricht University, Research Institute CAPHRI, NL 3 Centre for Society and Genomics, NL Title The scope of prenatal testing: broad or narrow? Ethical reflections 1
Introduction Current prenatal screening strategies include risk-assessment and subsequent invasive diagnostic testing. Replacing the present diagnostic test (karyotyping) with a test 62
with a more narrow scope (rapid aneuploidy diagnosis: RAD) is internationally under discussion. Aim Assessment of the moral implications of the choice between karyotyping and RAD, including evaluations of the concept of reproductive autonomy, the aim of prenatal screening, the logic of the screening strategy and the overall cost-effectiveness and justice of prenatal screening. Methods Theoretical: Ethical analysis of relevant literature and empirical data. Empirical: In-depth interviews with professionals (n=7), focus groups with professionals (n=30) and (future) parents (n=11). Results While RAD generates fewer so-called unexpected findings, it misses some abnormalities that may be found by karyotyping. These implications of RAD can be valued in different ways. The avoidance of unclear findings might be seen as facilitating informed consent and as alleviating the burden of choice. Furthermore, RAD would be in keeping with the narrow scope of the preceding risk-assessment, which currently serves as the gateway to prenatal diagnostic testing. Conversely, missing clinically relevant findings might be deemed to unjustly restrict autonomous reproductive choice. The opposing opinions may partly be informed by various views on the principle of autonomy: is the emphasis on maximizing reproductive options or on optimizing the process of decision-making? Depending on the view taken, the use of tests with a broader scope than karyotyping (e.g. array-CGH) may be supported as well. The maximizing view may be reinforced by the opinion that invasively-obtained fetal material must be put to optimal use, to counterbalance the risk of the procedure (i.e. iatrogenic miscarriage). An alternative may be to enable women themselves to choose between RAD and karyotyping on the basis of their own evaluation of what they regard as relevant aspects. On a societal level, considerations of justice should also be taken into account. This pertains to the use of scarce resources, but also to (un)equal access to testing. Finally, the aim of prenatal screening is an important consideration, both as a point of reference with regard to the issues mentioned and as a question in its own right. Changing the scope of prenatal testing implies normative choices and needs justification. Views of professionals and lay stakeholders should inform the moral assessment. References • d e Jong A, Dondorp WJ, de Wert GMWR. The scope of prenatal diagnostic testing for 63
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chromosomal aberrations: broad or narrow? Ethical considerations on the choice of tests. Ned Tijdschr Geneeskd. 2009;153:A1060. (In Dutch). • Ogilvie CM, Yaron Y, Beaudet AL. Current controversies in prenatal diagnosis 3: For prenatal diagnosis, should we offer less or more than metaphase karyotyping? Prenat Diagn. 2009;29:11-4. Author(s)
A Dijkstra, L Gudde, R Pin, J Gutteling of Twente, Department of Behavioural Sciences, Institute ELAN, Enschede, NL Title Experts’ visions on public acceptance of successful implementation of nutrigenomics applications Institution(s) University
Introduction and conceptual framework In the past years, developments in gene technology have brought about a lot of public indignation, just as food technologies always have been a hot topic for public concern and interest. Public acceptance is important in making a technological innovation develop successfully, but people worry about the impact of human genetics on natural integrity, privacy and the control of sensitive information (Frewer, Howard, & Shepherd, 1998). Nevertheless, it should be noted that the way people perceive the risks and benefits of a new technology cannot be generalized, as every (potential) hazard will be judged on the basis of its own particular context, resulting from various social, cultural and institutional processes (Pidgeon, 1998). To successfully implement nutrigenomics in society, it is important to understand how related risks are represented and communicated, and how they are framed by social processes in this specific context. Regarding the implementation process of a new technology, experts generally have an initiating role in framing the content of its policies. However, it has been demonstrated that experts have difficulties accepting the different ways of risk assessment (Renn, 2003). This research project aimed to provide insight in ways to optimize the implementation process of nutrigenomics. Therefore we first analysed relevant stakeholder groups and then we studied experts’ visions on public acceptance of successful implementation of nutrigenomics applications. An overview of stakeholders’ mutual relationships provides a better understanding of their role, commitment and expertise with regard to the nutrigenomics developments. And, to take account of experts’ awareness of the public’s likely perception of nutrigenomics, including related contextual factors, it must be found out what experts think about the context of public perception and acceptance. Thus, understanding experts’ visions on public risk perception provides valuable information about how they might frame a future implementation process of nutrigenomics. From literature, we discerned three essential elements that contribute to this framing of acceptation of innovations: risk perception, communication, and public participation (Shepherd, 2008).
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Method From a stakeholder analysis with 19 semi-structured interviews, different types of stakeholder groups were identified, of which five groups were identified as being most involved in nutrigenomics. Three of these groups – scientists, food industries, and government – already have a say in nutrigenomics developments; two other groups of stakeholders – patient/consumer organizations and the public – should be more involved in the future implementation process. Three focus group discussions with the four most-involved stakeholder groups were then conducted, to reveal experts’ visions on issues regarding public perception, communication and public participation in the context of nutrigenomics applications. Results First of all, results indicate that feeling involved seems to be an important condition for public acceptance of a technology like nutrigenomics. To make people feel involved, it can be useful to involve representative opinion leaders or other relevant parties first, on the condition that these representatives represent the public very well. Second, communication seems to play a central role, since it creates awareness and a sense of commitment. Additionally, information should be complete, well-founded, transparent and easy to understand. Third, experts acknowledge the importance of public participation, but prefer consultation activities as a first step. According to the experts, public knowledge, interest and motivation are not (yet) sufficient enough to let people make decisions with regard to nutrigenomics research. Author(s) Institution(s) Title
K Dortmans Faculty of Science, Radboud University Nijmegen / CSG, NL Talking genomics: scientists and publics in DNA-dialogues
Introduction Genomics and other developments in the life sciences have been the focus of much public debate. Public engagement activities have been referred to as ‘dialogue’, suggesting a process where not only policy-makers and politicians but also (genomics) scientists “should seek to understand the impact of their work and its possible applications on society” (House of Lords, 2000) for a socially robust science and technology development. In the project Talking genomics the focus shifts from public engagement with science to scientific engagement of (genomics) scientists with publics: in a Dutch debating centre (LUX) we have organized dialogue events, not immediately linked to policy processes, that aim to contribute to the articulation of public issues at stake in relation to genomics research and governance. Dialogue then refers to a collective investigation into the nature of an issue, by genomics scientists (and others who are involved in its development and application) as well as by those who are affected by the unintended consequences of genomics (publics). 65
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Main question How can public debate on genomics issues, organized and designed as dialogue, contribute to Scientific Engagement with Publics? Conceptual framework Pragmatist view on democracy and ethics • Dewey, J. (1927). The public and its problems. New York, Holt. • Dijstelbloem, H. (2007). De democratie anders. Politieke vernieuwing bij Dewey en Latour. Amsterdam, University of Amsterdam. • Keulartz, J., M. Schermer, et al. (2004). “Ethics in Technological Culture: A Programmatic Proposal for a Pragmatist Approach.” Science Technology Human Values 29(1): 3-29. • Marres, N. (2007). “The Issues Deserve More Credit: Pragmatist Contributions to the Study of Public Involvement in Controversy.” Social Studies of Science 37(5): 759-780. NEST-ethics • Swierstra, T., Rip, A. (2007). Nano-ethics as NEST-ethics: patterns of moral argumentation about new and emerging science and technology. Nano-ethics 1 (1): 3-20 Public engagement with science and (critical) public understanding of science, public dialogue • Irwin, A. (2006). “The Politics of Talk: Coming to Terms with the ‘New’ Scientific Governance.” Social Studies of Science 36(2): 299-320. • Jasanoff, S. (2003a). “Technologies of Humility: Citizen Participation in Governing Science.” Minerva 41(3): 223-244. • Wynne, B. (2006). “Public engagement as a means of restoring public trust in science - hitting the notes, but missing the music?” Community Genetics 9(3): 211-220. Method Interventionist ethnography methods of participant observation and (semi- or unstructured) interviews, combined with methods and tools developed in public engagement, participative policy-making, interactive technology assessment and social sciences. Results First, the perception of both invited (genomics) scientists and visitors of what a public debate is supposed to be, seems to direct their behavior and action; public debates on complex techno-scientific issues, like genomics, tend to confirm the distinctive roles of experts and lay persons and the role of these centers as venues for transmission. Second, the public is coincidental, large, diverse and unprepared, whereby the conditions of dialogue as a thorough, open and two-way investigative conversation are hard to fulfill. Third, a cultural shift among organizers at debating centers is required; this affects the professionalism of programme makers. 66
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L Gao Tsinghua University, China Title ELSA Agenda and beyond: a case study of EGN, its context and development
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Introduction Research into the ethical, legal and social aspects (ELSA) or implications (ELSI) of genetics, and later genomics, was originally developed in the context of the Human Genome Project (HGP).This article will begin with the shaping of ELSA agenda and how genomics-related social science research was influenced by the HGP at the very beginning. The boundary of the ELSA agenda was controlled by the leader scientists by determining the boundaries of the funded research. This ELSA research became problematic because it operated in such a way that it locked into a frame which assumed the technology as a given. While in Europe, the social scientists’ approaches to the genomic issues are different from the ELSA agenda. What are the new characteristics embedded in the European social science practice, especially in UK? Conceptual framework STS greatly contributed to the shaping of the UK’s social science agenda for genomics, which raises the question of why in the UK the STS-er could tell a better story than the others? A‘serviceable STS’(Webster, 2007) can engage with science policy but also draw on SSK analysis. Some believe STS can play a better role between science and society, to be an intermediary (Calvert, 2009) or to be a convergence worker’ (Stegmaier, 2009). This paper tries to use the ‘social science arena’to explain how different social science agendas were shaped, and shaped the transformative power of genomics. (Hedgecoe and Martin, 2005) Method The author interviewed nearly 30 people in the ESRC Genomics Network and in ESRC to investigate how the network started as a compromise between the ESRC and the social scientists and how EGN fulfils its roles in the new genomic technology governance. Also the author analyzed the documents of the EGN to better understand their administrative approach and their research impacts. Results The social scientists’ role in the UK and their research has gone beyond the ELSA agenda, and new value has been added into the social science research in the postgenomic era. STS helps to draw the boundary of the social science arena in the UK, which in turn tries to break down the boundaries. The new agenda in the UK could help the social scientists to engage themselves in the process of “science in the making”.
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References • A ndrew Webster(2007). Crossing Boundaries-Social science in the policy room, Science Technology and Human Values,32(4):458-478 • Calvert, J. and P. Martin (2009). The role of social scientists in synthetic biology. EMBO Report 10 (3): 201-204. • Stegmaier, P. (2009). “The rock and roll of knowledge co-production.” EMBO Report 10 (2): 1-6. • Adam M. Hedgecoe and Paul A. Martin(2005) Genomics, STS and the making of sociotechnical futures in Edward J. Hackett , Olga Amsterdamska, Michael Lynch and Judy Wajcman (eds), The Handbook of Science and Technology Studies (London The MIT Press): 817-838 Author(s)
J Gupta University for Humanistics, NL Title Investigating hope and accountability in umbilical cord blood banking in India Institution(s)
Conceptual framework Concepts such as ‘manufactured risk’ (Anthony Giddens) and ‘risk society’ (Ulrich Beck), ‘governmentality’ (Foucault) and ‘agency’ are found to be useful. Method Scrutinise the promotional literature used by two of the leading private UCB banks and conduct interviews with some key stakeholders as part of an exploratory study. Results Cord blood banking is a growing business, selling the idea of biological insurance to deal with possible future health risks, targeting the higher income, educated middleclass in India. Preliminary research shows that there is much in the promotional literature which is selling hope regarding therapies derived from umbilical cord blood cells in case they are needed by the child or its family in the distant future, although these promises are built on yet unproven therapies. Author(s) L
Introduction During the 1990s, most developed nations organised public systems for the collection of umbilical cord blood (UCB). UCB, it is claimed, is a rich, safer, and less controversial source of stem cells (compared to embryonic and adult stem cells), which could be used for therapeutic applications for a host of diseases. There has been also a parallel development of the private, commercial sector. UCB banks offer collection, processing and storage of UCB for the donor/ the donor’s relatives or unrelated donors and advertise it as a kind of personal biological life insurance. The first private UCB bank in India was opened by LifeCell in 2004 and in July 2008, its 33rd centre was established, making it Asia’s largest UCB bank. Since then, several other UCB banks have been established in India, many with international collaboration. With 43 million births a year, and an increase in medical tourism to India, the country could be the largest potential supplier of UCB in the world. In contrast to some countries’ well-regulated law and practice regarding the collection of stem cells derived from UCB, India does not have an official policy in place yet, only some guidelines. There is a lack of transparency regarding the supply of UCB required for research and the conduct of research and clinical experimentation with stem cells. I will examine: What is the information being given to pregnant women and their husbands/ families regarding umbilical cord blood banking? Is the information balanced (educating) and not biased (persuading) in favour of aggressive marketing and profit motivations of private enterprise or the ambitions of researchers? What regulatory structures are there to ensure this?
Henneman1,2,3,D Timmermans1,2, C Bouwman2, M Cornel2,3, H MeijersHeijboer3 1 Institution(s) Department of Public and Occupational Health, VU University Medical Center, Amsterdam, NL 2 EMGO Institute for Health and Care Research, VU University Medical Center, Amsterdam, NL 3 Department of Clinical Genetics, VU University Medical Center, Amsterdam, NL Title Women’s attitudes towards genetic testing for breast cancer susceptibility in order to target disease prevention Background Population screening programmes for breast cancer by mammography are offered to women in the Netherlands based on age, usually beginning at age 50. It has been suggested that a screening program based on genetic risk profiling could be more effective by targeting interventions at those women with higher genetic risk. This study explores women’s attitudes towards genetic testing for breast cancer susceptibility in order to target breast cancer prevention. Methods A qualitative study was conducted using 4 focus groups with 26 women aged 42-73 years. Women were selected irrespective of personal or family history of breast cancer. Discussions were audio taped and content analyzed. Results The results show that in general, women are positive towards a breast cancer screening
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program based on genetic risk profiling, provided that women in the low-risk group are still offered mammography screening, albeit less frequently (i.e. right to screening (I)). Other themes that women addressed were: (II) value of the genetic risk information (e.g. possibilities for cancer prevention at younger ages, less screening burden for lowrisk women), (III) personal autonomy (e.g. free choice to undergo testing), (IV) dealing with test results (e.g. burden of risk, motivation to reduce the risk), (V) discrimination, and (VI) financial aspects and priority (e.g. with respect to other health care programs). Conclusion These results suggest that women currently offered breast cancer screening based on age have a positive attitude towards population susceptibility screening for breast cancer, but also identified issues that need to be discussed and studied further, especially if women in the low-risk group were no longer to be offered mammography screening. Author(s) D Horstkötter, R Berghmans, G de Wert Institution(s) Maastricht University / CSG, NL Title Ethical Implications of a genomics and (neuro)biology account of antisocial behaviour (ASB) Introduction Anti-social behaviour (ASB), especially in youth, is seen as an urgent but persistent social problem. During the past decades, the genetic and (neuro)biological codeterminants of ASB have been increasingly emphasized and investigated. The background of this development is twofold. First, the effects of traditional social and psychological interventions on the reduction of ASB are often limited; and second, relevant genetic and (neuro)biological research raises expectations about the development of more effective prevention and intervention strategies. Despite the new hopes and expectations, proactive ethical scrutiny of the moral and societal questions and concerns with regard to the genomics and (neuro)biology of ASB is of utmost importance. This poster presents the main elements of this ethical research agenda and it identifies the morally relevant differences and similarities of genomic and (neuro)biological approaches regarding ASB as compared to more traditional social and psychological intervention and prevention strategies.
identification and discussion of relevant ethical implications is crucial (Andrews, 1999; Parens, Chapman, & Press, 2006). Questions that should be asked include: What about possible deterministic assumptions, stigmatization, parental responsibilities, the position of incompetent minors, informed consent of various parties involved, the ethics of compulsory oversight and other preventive measures? Method The project’s research design includes a literature study of philosophical as well as scientific and professional texts. Further, interactive qualitative empirical research will be conducted that involves focus-group meetings and in-depth interviews with various stakeholders. Together, these activities will be conducive to the ethical analysis of the question to what extent a genomics and (neuro)biology account of ASB is normatively acceptable. Results The ethical analysis will contribute to and enrich the public and political discussion of normative issues concerning the genomics and (neuro)biology of ASB and it will trace the outline of desirable means of prevention and intervention. Thereby, it will contribute to the agenda-setting of youth welfare work and facilitate responsible and effective policy-making. Literature • A ndrews, L. B. (1999). Predicting and punishing antisocial acts: How the criminal justice system might use behavioral genetics. In R. A. Carson & M. A. Rothstein (Eds.), Behavioral Genetics (pp. 166-155). Baltimore, MD: John Hopkins University Press. • Hodgins, S., Viding, E., & Plodowski, A. (2009). The neurobiological basis of violence. Oxford, UK: Oxford University Press. • Ishikawa, S. S., & Raine, A. (2002). Behavioral genetics and crime. In J. Glicksohn (Ed.), The Neurobiology of Criminal Behavior (pp. 81-110). Norwell: Kluwer Academic Publishers. • Parens, E., Chapman, A. R., & Press, N. (Eds.). (2006). Wrestling with behavioural genetics, Science, ethics and public conversation. Baltimore, MD: John Hopkins University. Author(s)
Conceptual Framework The poster provides a brief overview of the current insights of the genomic and (neuro) biological sciences with regard to ASB. It presents insights regarding the genetic influences (Ishikawa & Raine, 2002) and the neurological basis of violence (Hodgins, Viding, & Plodowski, 2009). A great challenge that the development of these insights faces is the question how they can be translated into ethically acceptable and desirable means of prevention and intervention of ASB. In order to meet this challenge, the 70
T Idema Faculty of Science, Radboud University Nijmegen / CSG, NL Title Genomic horizons: Mapping issues of race and health with Octavia Butler’s Xenogenesis trilogy
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Introduction When studying the societal ramifications of genomics for notions of humanity, race and health, scholars look at developments in different spaces and at different times. 71
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Scholars have pointed out that while genomics is a globalized phenomenon linking disparate places and multiple timescales, it is risky and potentially wrongheaded to treat local genomics infrastructures as unified in a global historical event, or to lump various developmental phases, including genetics and eugenics, in a single culturally homogeneous (cosmopolitan) narrative (M’Charek 2005; Fujimura 2008; FaustoSterling 2008). This calls for a conceptual framework that captures time and space in a single gesture (without subordinating one to the other), revealing the spatio-temporal hybridity and openness of genomics by linking developments, practices and spaces in a non-linear fashion. Whereas notions such as archaeology (Foucault) and cognitive mapping (Jameson) go a long way to meet this requirement, they largely fail to address the future, which is unfortunate considering the immense potential of genomics. Conceptual framework To study the future implications of genomics, I argue, the concept of horizon, understood as a virtual (non-local) spatio-temporal border, may be of use. Significantly, a horizon is never simply ‘here’ or ‘elsewhere,’ ‘now’ or ‘then’: its potential animates the past and present in an emergent, cyclic and continuous movement. I will elucidate the concept of horizon by showing its affinity with the notion of “becoming” developed by philosopher Gilles Deleuze. Conceptualizing the horizons of genomics as a series of becomings may contribute to the task of detecting and creating productive connections across spatio-temporal, cultural, and other dimensions. This conceptual endeavor may serve as an antidote to the pitfalls of presentism (“let’s stick to the here and now and be realistic”) and an all-too-radical speculation that lacks empirical grounding. Method One useful site to reflect on the horizons of genomics is science-fiction writing. Scifi novelists who actually engage with the science of genomics (through academic training and/or substantial studies) create a virtual world that —while existing on the borders of reality and fantasy, science and fiction—engages real scientific, social and ethical problems. The strength of these particular science fiction novels, I propose, is their experimental nature: apart from reinvigorating problems that have already crystallized to a certain extent (such as genetic engineering and its social ramifications), these novels also elaborate problems that are on the horizon, problems that may have many practical repercussions in the future (e.g. the changing meanings of race and health). Results In Octavia Butler’s sci-fi trilogy Xenogenesis, an alien species called Oankali has evacuated a deteriorated, culturally diverse human population after an apocalyptic world war, and allows them a new future in exchange for access to human genetic material, which involves a certain kind of sexual intercourse. Through this example, I want to show how science fiction novels can help us to map the horizons of genomics 72
in relation to issues of human identity, race, and health, and more specifically to genetic engineering and transgenic species. Author(s)
S Jans, C van El, E Houwaart, M Cornel, A Lagro-Janssen, A Plass VU University Medical Center, Amsterdam, NL Title Haemoglobinopathy screening in the Netherlands: witnessing the past, lessons for the future
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Introduction In the Netherlands there are no formal recommendations for screening for haemoglobinopathies (e.g. sickle cell disease and thalassaemia). Despite the recommendations of the Dutch Health Council, there is only limited screening: in 2007 neonatal screening was expanded to include a test for sickle cell disease(1). As an unintended finding, carriers of this disease are also identified. The aim of this study was to explore the decision-making process of the past two decennia, why it was decided that screening was not ‘opportune’, and to investigate whether ethnicity played a role, given the social unrest in the US regarding haemoglobinopathy screening(2). Methods A literature search of both scientific and grey literature was performed identifying key-figures involved in the decision-making process at the time. Key-figures were telephone-interviewed. The resulting material was used to identify themes in the discussion and to construct a discussion route. These key-figures were invited to attend a “witness seminar”. This method was originally developed by the Institute of Contemporary British History and further implemented as a special method of oral history in which experts are invited to meet in order to discuss a particular period or subject. This method enables researchers to elaborate on traditional sources of historical research and add new perspectives on past events. The transcript was content-analyzed. Results The issue of haemoglobinopathy-screening was first identified in the seventies. Overall, during the 1980s and 1990s official screening policy was restrained regarding reproductive issues. Political parties expressed their concerns about eugenics(3). However, locally screening practices did occur. Rather than haemoglobinopathy-related social unrest in the US, the heritage of WWII seemed to have influenced the decisionmaking process: registration of ethnicity surfaces as an important impeding factor. In the nineties a research report requested by the government played a central role(4): Screening was considered not opportune due to low prevalence, and lack of knowledge amongst professionals and high-risk groups.
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Future issues for debate The negative attitude to registration of ethnicity seems to have been relevant, but is changing in the new millennium as a result of increasing multi-ethnicity. The prevalence of haemoglobinopathies has increased. For future decision-making on extended haemoglobinopathy screening programmes, it is important to include representatives of high-risk groups in the discussion and implementation. These challenges need to be addressed in policymaking if a screening programme is to be introduced in the Netherlands. Reference List 1. The Health Council of the Netherlands. Neonatal Screening. The Hague: The Health Council of the Netherlands; 2005 Aug 25. Report No.: 2005/11. 2. Tapper M. In the blood. Univ. of Pennsylvania Press; 1999. 3. Commission of the Scientific Institute of the Christian Demoratic Party (chaired by Prof.E.Bleumink). Genen en grenzen (Genes and limitations). The Hague: CDA; 1992. 4. Rengelink-van der Lee JH, van der Most van Spijk MW, Schulpen TW. National investigation into sicklecellanaemia and thalassaemia: Final Report. Utrecht; The Netherlands: Stichting Gezondheid Derde Wereld Kind; 1994. Author(s)
M Kato Institution(s) International Institute for Asian Studies, Leiden, NL Title Meanings of the Embryo in Japan: Narratives of IVF experience and embryo ownership and the gap with state regulations on embryonic research This presentation explores the socio-cultural meanings of the embryo implied in the narratives of fifty-eight women who have undergone in vitro fertilization (IVF) in Japan over a period beginning in 2006 to 2008. This study argues that a lack of sufficient analysis of the socio-cultural meanings of the embryo has resulted in state regulations where the use of reproductive technologies advance in Japan without reflecting upon the voices of women/couples that use them. Additionally, we argue that the oft-heard view, that pre-implantation genetic diagnosis causes less pain to women/couples compared to selective abortion in which foetuses are discarded, should be reviewed in the light of the new empirical evidence offered in this article. Furthermore, this presentation disproves the claim, often expounded by Japanese scientists, that in Japan the cultural meanings attached to the embryo are insignificant. Consequently, the argument that Japan has no need for active national debates on the status of embryos should be questioned. Though agreeing with some feminist views of the embryo debate, this article is also critical of feminist views that discuss embryo donation in terms of the loss of ownership of the embryo and the alienation of the embryo due to commodification. 74
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A Plass1,2, M Westerman, M Cornel1,2 Institution(s) VU University Medical Center, Amsterdam, NL 2 Centre for Society and Genomics, NL Title Parental feelings towards the identification of their infant as carrier of sickle cell anaemia by newborn screening 1
Abstract In 2007, the neonatal screening programme in the Netherlands was expanded to include a test for sickle cell anaemia. Besides identifying patients, this also leads to unsought identification of sickle cell carriers. The latter is not directly in the child’s best interest, therefore parents may ‘opt-out’ from receiving this information. The most important reason to disclose information about the child’s carrier status to the parents is to enable parents to base their future reproductive choices on this. The aim of this study was to explore how (future) parents are being informed about this new possible neonatal screening test result, how they perceive their child’s carrier status being disclosed to them, and to see whether they take this information into account regarding their future reproductive choices. Method From March to September 2007, parents of newborns identified as sickle cell carriers, were invited to take part in a qualitative semi-structured face-to-face interview. Results 48 parent-couples were invited, 19 couples accepted the invitation; eventually 13 interviews could be held. Parents were unaware of the possibility they had to ‘optout’ from receiving information about their child’s carrier status. Initially, parents were shocked after hearing the diagnosis, mainly because they were unaware that their child would not suffer from sickle cell anaemia at any point in life. Most parents became less worried after looking up information on the Internet. Still, most parents did not understand the proper meaning of “carrier status”. None of the parents linked their child’s carrier status to their own future reproductive choices. Conclusion The way in which information is being disclosed on carrier status of sickle cell anaemia needs to be improved. The most important reason for disclosing this information - to enable the parents to make future reproductive choices - is not yet being achieved. Author(s)
R Verhoeff Faculty of Science, Radboud University Nijmegen, NL Title Collaborative learning of stakeholders in cancer genomics: a speed date approach
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Introduction Genomics marks a fast-developing field of research that has increasing impact on individuals and society. In health care, new innovations related to prevention, diagnosis and treatment of disease are changing daily routines in different social practices, i.e. academic research, medical practice, and everyday life. Introducing the benefits of cancer genomics research in clinical practice and dealing with its complexity requires ongoing interaction between scientists, physicians and patients (Guttmacher et al, 2007). Our research aims to improve the societal embedding of genomics and further dialogue between these stakeholders by designing and optimizing collaborative learning processes. Simultaneously, our research aims to enable patients to reflect on their experiential knowledge and translate this to issues that could be addressed by cancer genomics experts. Conceptual framework Our research frames dialogue as collaborative learning processes of stakeholders from different communities of practice; i.e. academic, clinical and life-world practices. Yet, although communities overlap and interact, collaborative learning may be problematic due to differences in value systems and knowledge modes, i.e. academic, professional and experiential (Kunneman, 2005). Designing collaborative learning implies finding common ground that forms a basis for understanding between different actors and a starting point for the articulation and exchange of knowledge, views, perspectives and experienced problems, and aims at mutual understanding (Woolfolk, 2004). Method As part of the societal programme of the Dutch Cancer Genomics Centre (CGC) and the Dutch Federation of Cancer Patients Organisations (NFK), we have designed and analyzed a series of interactive meetings, including a workshop focused on patient empowerment, speed date sessions with an emphasis on personal storytelling (see also Lank et al, 2008), and a public discussion within the context of a large public event on cancer genomics. Data were collected by interviews with participants before, during and after the sessions, and via observation and audio recordings of all meetings.
the implications of genomics research for clinical and everyday life practices, the empowerment of scientists in their societal responsibility proved to need more effort and time for reflection. Author(s) Institution(s) Title
S Blad Institute for Interdisciplinary Studies, University of Amsterdam, NL A comparative search for human-specific genomic distinction
Author(s)
DJ Boerwinkel Institute for Science and Mathematics Education, Utrecht University, NL In search for new metaphors
Institution(s) Freudenthal
Title
Author(s) Institution(s) Title
C Staunton Faculty of Law, National University of Ireland, Galway, Ireland The future implications of Preimplantation Genetic Diagnosis
 Author(s) T van der Valk Institution(s) Dutch Genetic Alliance (VSOP), NL Title Biobanking: Patient organisations in the lead?
Results This paper describes how our interactive approach enabled collaborative learning of the participants. A first meeting focused on articulating experiential knowledge and encouraged patients to articulate issues that transcend their individual disease management. Subsequently, in four speed date sessions between patients (n=12) and cancer genomics experts (n=12), a shared list of cancer-related issues was developed to be addressed in future research and clinical care. These issues included: improving multidisciplinary expertise in early diagnostics, improving alertness for late side effects of treatments, improving the quality of doctor-patient communication and reducing short-term effects (neuropathy and vitamin B sufficiency). Although our speed date approach contributed to the articulation of a shared list of priorities concerning 76
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• industrial biotechnology • safety and sustainability • innovations
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Industrial zone – Parallel session i
Thursday, 27 May, 10.45 – 12.15
Safety and sustainability: identifying issues in industrial genomics Author(s)
L Asveld1, D Koppejan1, D Stemerding1,2 Institution(s) Rathenau Institute, NL 2 Department of Science, Technology and Policy Studies (STePS), University of Twente / CSG, NL Title Bio-based economy 1
Introduction The concept of a bio-based economy has become a central element in the global search for a sustainable future. Climate change, peak oil and geopolitical tensions are the main drivers for the development of an economy in which fossil fuels are replaced by vegetable, renewable materials. Biofuels are the most prominent application of a biobased economy, but other applications, such as bio-materials, are gaining ground as well. Whether the bio-based economy can indeed live up to the expectations is a matter of intense debate. This debate is characterized by widely diverging perspectives, partly due to uncertainty about the economic feasibility of relevant technological developments such as oil derived from algae. The Dutch government sees possibilities for a leading part for the Netherlands since it has well-developed logistical, chemical and agricultural industries. In order to contribute to the Dutch political debate about the conditions under which, if at aall, a bio-based economy can be considered desirable, we have identified key issues that need to be discussed publicly and politically and which are currently not featured prominently enough on the public and political agenda. Conceptual framework We have used the concepts of bio-based economy as put forward in policy documents issued by the Dutch government such as “De keten sluiten”. Central concepts are biomass cascading, co-production and chain-integration. Biomass cascading implies that biomass is used first in ways that are economically most feasible and ecologically most efficient. Co-production implies that plants are preferably used for multiple aims. Chain-integration implies that existing production and processing facilities are integrated.
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Method The formulation of policy issues is the result of literature study, a historical study into the pre-industrial bio-based economy of the Netherlands, interviews with experts and an expert meeting. Results In the transition to a bio-based economy each step forward might at the same time imply one step backward. For instance, the concept of a bio-based economy may be considered a competing concept with regard to biofuels. From the perspective of biomass cascading, biofuels are only marginally interesting: after all other possible applications have been realized, such as pharmaceuticals, food and chemicals, the remaining organic material may be used to produce biofuels. Even then, it may be wiser to simply burn this material. However, biofuels are interesting for other reasons. Liquid fuel is indispensable for air travel and is very convenient for other means of transport such as cars. Also, technology to produce biofuels from biomass is readily available and operating. But once biofuels become economically competitive they will probably use up a lot of the biomass potential, thereby undermining the development of a more wide-ranging bio-based economy. Other issues relevant to the development of a bio-based economy which should be on the policy agenda are: • t he gap between the current policy of ‘learning by doing’ and the ‘precautionary principle’, which possibly inhibits a fundamental transition to a sustainable economy. • the dilemma of sustainability versus a level playing field • representation at the beginning and the end of the bio-based chain Author(s)
M Pijnappel Faculty of Science, Radboud University Nijmegen/ CSG, NL Title Looking back: The role of societal valued promises in the development of toxicogenomics Institutions(s)
Introduction Since the release of the working draft of the human genome in 2000, the life sciences have increasingly relied on genomic insights. This stimulated the development of several high throughput molecular profiling technologies such as transcriptomics (gene expression), proteomics (large scale study on proteins) and metabolomics (metabolic products). Toxicogenomics uses these technologies to assess the toxic character of all kinds of chemicals (i.e. Olden and Guthrie 2001; Pennie, Woodyatt et al. 2001; Aardema and MacGregor 2002; Hamadeh, Amin et al. 2002). It promises to deliver more reliable and accurate data (and hence safer products), whilst simultaneously reducing the number of animals used in the assessment thereof (i.e. (Baken, Vandebriel et al. 2007) 81
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NGI, 2010). Safe products with a reduced use of laboratory animals are of significant societal, industrial and political value. The question remains whether toxicogenomics will live up to this expectation. Conceptual framework This paper will draw on several concepts from within the sociology of technology, especially the sociology of expectations and the framing process. Future expectations and promises are crucial in giving many ventures in science and technology their appeal and dynamism. This is especially the case with applications where practical utility has yet to be demonstrated, where investments still have to be mobilized and societal approval is needed (Van Lente 1993; Brown and Michael 2003; Hedgecoe and Martin 2003; Borup, Brown et al. 2006). Scientists are well aware that promising to provide these utilities appeals to the interest of the policy-makers who fund them. Policy-makers, on the other hand, request promissory results within a relatively limited time frame. In some cases however, the failure of expectations has severely damaged the reputation and credibility of scientists, institutions and industry (Brown and Michael 2003). Frame analysis provides insights into the way people or institutions view the world around them. Frames are made of beliefs, meanings and interpretations that inspire and legitimate the activities of those institutions (Benford and Snow 2000). Methods The Dutch Assuring Safety without Animal Testing (ASAT) initiative is taken as case study for this paper, as one of the projects is on toxicogenomics specifically. In this initiative, the interests and promises of scientists, policy-makers and funding authorities coexist. By performing frame analysis on the institutions that are involved in this initiative, this paper provides insight in the way various actors at the sciencepolicy interface frame the ‘reduction-promise’ to gain approval and justification for the continuing of toxicogenomics investments. Results This paper provides empirical data to the sociology of expectations and framing analysis, drawing on recent writings within Science and Technology Studies (STS). Moreover, this paper shows that ‘alternatives to animal testing’ is a rather contested term with various meanings for different players within Dutch society. Author(s)
S Sleenhoff 1, 2,, P Osseweijer 1, 2 1 Institution(s) Delft University of Technology, Department of Biotechnology, Section Biotechnology & Society, Delft / CSG, NL 2 Kluyver Centre for Genomics of Industrial Fermentation, Delft / CSG, NL Title Interaction for Sustainability
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Introduction The transition towards the use of biorenewable feed-stocks and biological processes in stead of chemical ones is known as the bio-based economy. This transition will not only challenge industries, but also society (will be challenged) with major changes of which most people are still unaware. People will be forced to make important choices and perhaps personal sacrifices in their daily life due to this transition and might be asked to take some responsibility. By involving society in the agenda setting process for research society can be prepared to make these changes with the right information, emotions and attitudes at hand. This also includes involving scientists. The pressing question however is: how can we effectively involve society and scientists with advances in industrial biotechnology? Conceptual Framework Novel approaches in science communication aim at high levels of engagement. However, in order for society or scientists to get successfully engaged in any agenda setting process it is important to have an idea about their level of involvement with the subject. A person’s state of involvement is not absolute and can change over time. The three-E model suggest that by using entertainment and emotion people become interested and connected with the subject which changes their level of involvement (Osseweijer, 2006ab). This involvement can be defined by three comprising elements: cognitive, affective and behavioural (Lorenzoni, 2007). Measuring involvement is not easy and hardly covered in literature about evaluating the effect of engagement (Rowe & Frewer, 2005). We are developing a methodology to measure this important element of involvement so as to enable adequate assessment of these new forms of science engagement. Method To asses people’s levels of involvement a simple questionnaire is designed. This questionnaire measures people’s levels of involvement on the three elements as defined by Lorenzoni. The results of a zero-time (before intervention) questionnaire are used as a standard. Small groups of people have been invited for focus group interventions testing the 3E model. During these interventions people were asked to participate in activities that were designed to address different aspects of involvement combined with different forms of entertainment. After the interventions the participants completed the same questionnaire. Results Preliminary results show that the designed questionnaire can be used as a tool to measure people’s level of involvement with industrial biotechnology. It shows that scientists and the public differ in their level of involvement on the cognitive and affective levels. The tool can give an indication of different elements that form ‘involvement’ and in combination with specifically designed interventions the tool can assist in defining the type of entertainment and emotion that will create the 83
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highest involvement of different types of public. Although involvement is a necessary component of engagement in an agenda-setting process we do argue that a changed level of involvement may still not be sufficient for people to engage in an agenda setting process on industrial biotechnology.
Industrial zone - Industrial biotechnology: inside views on innovation
II Session
Industrial zone – Parallel session ii
Thursday, 27 May, 14.00 – 15.30
Industrial biotechnology: inside views on innovation Author(s)
D Castle1, P Phillips2 Institution(s) Canada Research Chair in Science and Society, Faculty of Arts and Faculty of Law, University of Ottawa, Canada 2 Johnson-Shoyama Graduate School of Public Policy, University of Saskatchewan, Canada Title Industrial biotechnology and the Place of ELSA Research 1
Introduction For more than a decade, ELSA research has been stimulated by the issues and resources arising from the human genome project, creating a general bias in ELSA research toward the human health sciences. To a lesser extent, ELSA research has addressed topics arising in agri-food genomics and biotechnology. All but forgotten by ‘mainstream’ ELSA research is the use of genomics and biotechnology in the industrial context. There is, however, growing interest among ELSA researchers in the role of genomics in the energy sector (biofuels), consumer applications (organic LEDs), convergent technologies (plant-derived vaccines), molecular nutrition (bioactives and nutrigenomics), and structural genomics and synthetic biology industrial applications. Methodological approach ELSA research as a whole has followed a common pattern of tracking and responding to developments in science and technology. As the scientific issues change, ELSA researchers change their focus by adapting familiar and established methodologies to new topics. Returning to a common tool kit of methods has its advantages – it can provide longitudinal comparisons of social aspects of science and technology development, rapid ELSA response to arising issues, and continuity of methods underlying regulatory and policy recommendations. The downside is, in the worst case, a form of “bioethics ambulance chasing” where application of method eclipses the nuances in the development of science and technology. The potential for ELSA research to become unresponsive or ill-adapted to new problems raised by sector-specific applications of genomics raises the more general methodological issue about whether ELSA research has evolving capacity and competencies. With this hypothesis in mind new approaches for ELSA research are being sought.
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Industrial zone - Industrial biotechnology: inside views on innovation
Results Four avenues for growth in ELSA research have been identified: 1) new approaches to ‘integrating’ ELSA research in science, technology and industry; 2) new models for analysis; 3) new methods adapted from other fields to ELSA research; 4) new metrics for evaluating impact of new science and technology and appraising ELSA research. Author(s)
S Flipse 1,2, P Osseweijer 1,2 Institution(s) TU Delft, Department of Biotechnology, Section Biotechnology & Society, Delft / CSG, NL 2 Kluyver Centre for Genomics of Industrial Fermentation, Delft / CSG, NL Title The Dilemmas of Life Cycle Assessments in Industrial Biotechnology 1
Introduction Industrial biotechnology is proclaimed to become the sustainable alternative for fossil fuel based production of chemicals and materials. Large effort is put in the development of biobased bulk chemicals, such as biofuels and bioplastics, for which genomics often provides useful new insights and applications. From the point of view of credibility, these new products need to perform well technologically, but product perception is also considered very important. Industrial or white biotechnology wishes to uphold a green character. Sustainability is the key concept, often translated in claims of lower environmental impact and lower CO2 emissions. Conceptual framework To prove and quantify this sustainability, trustworthy life cycle assessments (LCAs) of the biotechnology based counterparts of chemicals produced from oil would be very welcome. Unfortunately, it proves very difficult to make these LCAs. Also, available assessments regularly show that large scale production of biobased chemicals is not always directly more sustainable than production through fully developed and specialized petrochemical processes.This poses major dilemmas for industrial biotech companies, both concerning incentives for further development and communicating their assets. Method We recently finished a first unique study with an adapted approach of Midstream Modulation (), on the innovation practice within a large biotechnology company to identify and assess these issues relating to LCAs. Over a period of four months, the problems and societal relevant questions related to LCAs were identified and discussed with industry representatives during weekly interviews, frequent laboratory visits and in project team meetings Results Questions which were discussed were, for example, ‘Does responsibility of a product’s 86
life cycle end when the product leaves the factory gate?’ and ‘What if a competitor claims a high sustainability level for a process that you know to be much worse from your own LCA calculations?’. Further questions addressed other more global ELS issues, including ‘What if this new product needs a renewable sugar source that might directly or indirectly come at the expense of Brazilian rain forest?’ We present these dilemma discussions together with other results of our in-company study into current dilemmas that industrial biotechnology faces in relation to novel applications of genomics, and argue that while LCAs are meant to quantify and elucidate sustainability, they may actually make sustainability more difficult as a concept from a corporate perspective. References • Fisher, E., Mahajan, R.L., Mitcham, C. (2006). “Midstream Modulation of Technology: Governance from Within.” Bulletin of Science, Technology & Society 26(6): 485-496. Author(s)
Bart Penders1,2 Institutions(s) Faculty of Science, Radboud University Nijmegen, Nijmegen/ CSG, NL 2 Department of Health, Ethics & Society (HES), School of Primary Care and Public Health (CAPHRI), Maastricht University, Maastricht, NL Title Safe ice cream innovation: The many safeties of ice structuring protein 1
Introduction & Framework The notion of risk has been at the centre of attention in ELSA research for quite a while now. This paper, although closely related to discussions on risk, will take a different approach; not as a study of risk, but as a study of safety. While safety is much discussed in literature in general, the subset of ELSA literature has left it largely untouched until recently. What safety is, what it does, how it is made, unmade and managed, in complex or even contested (genetic) technological practices deserves (additional) attention from scholars, beyond the sole perspective of the study of risk. Method Since early 2008, I have been qualitatively studying R&D developments at Unilever. I have conducted interviews with scientists and research managers, as well as studied Unilever documents and scientific literature. Based upon these, this paper will describe how a particular innovation, namely ice-structuring protein (ISP), was made safe. Results I will show that for the protein to become safe, it had to traverse multiple processes of safety construction, populated by various notions of safety. Strikingly, the GM component of the ISP production process has barely influenced the construction of toxicological safety, while it has had great ramifications for constructing economic and societal safety.
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The existence of parallel, or even conflicting, views on what safety is and how to reach it represents a large variety – a rich resource for learning on individual and institution levels. This paper will stretch this argument to include a variety of epistemological perspectives towards safety. It will show that safety in fact consists of many safeties, complex characteristics co-constructed through the intricate interconnectedness of contemporary innovation pathways. Each safety has its own origins, its own epistemological and political ingredients and, as a result, its own history. Like the histories of countries on a single continent, those histories are interwoven, interconnected and highly dependant, yet simultaneously they are conflicting and struggling for priority.
III Session
Industrial zone – Parallel session iiI
Friday, 28 May, 9.30 – 11.00
Genomic sources: routes and strategies Author(s)
R Nahuis, D Stemerding of Twente, Management and Governance, Science, Technology and Policy Studies, NL Mapping emerging stabilization in the genomics landscape
Institution(s) University Title
Introduction With the rise of genomics we see significant changes in the landscape of medical genetics research, including the creation of large scale consortia, the use of high throughput technologies, strategic public investments, public-private relationships, large genetic databases serving as links between academic and commercial interests, and a strong public policy emphasis on knowledge valorisation. Our research aims at understanding these developments as part of a transformation of ‘innovation regime’. This paper reports methodological achievements.
Conceptual framework An innovation regime we define as a stable complex of coordination rules on how to act and interact in networks of innovation. These rules are embedded in knowledge institutions, such as shared visions, collective agendas or collaboration agreements. They govern the relations between various actors - research institutes, universities, hospital clinics, firms, regulatory bodies and patients - which participate collectively in knowledge production, appropriation, translation, and valorisation. In our research project we investigate whether changes in the genomics landscape are part of what Hopkins has described as a transformation from an internal (self-regulating) innovation regime, governing a network of hospital-based laboratories and clinics, to a more expanded and politicised external innovation regime, linking academic and commercial interests in the field of human genetics.
Method We assessed existing approaches to trace regime changes. Based on this assessment a methodological framework is developed that will be applied to different case studies. Criteria for case selection are also established.
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Industrial zone - Genomic sources: routes and strategies
Results Regime changes in the landscape of medical genetics can be mapped with a specific tool designed to trace emerging stabilization. This tool originates in the sociology of expectations and positioning theory, where it serves to characterise emerging technological fields. After adaptation, this tool distinguishes four modes of institutionalisation: shared visions, shared expectations, collective agendas and collaborations. This distinction reflects a scale of increasing stability. An analysis of texts produced by various kinds of actors will show how - over time - interests in particular research topics or technological opportunities are governed by these modes of institutionalisation. It also shows how actor relations are subject to these modes of institutionalisation. In statements about possible, plausible or desirable futures, actors position both themselves and others. Time-scale analyses can be done to map the institutionalisation of actor relations. In this way, changes in the genomics landscape can be characterised as a transformation of innovation regime in terms of emerging and established research topics and technologies in the field, the kind of actors occupying innovation networks around these topics and technologies, and the institutionalisation of relations between actors in these networks. We aim to apply this approach in two case studies. The first focuses on a monogenetic disease and investigates in which respect the external regime has evolved out of the existing internal regime. The second focuses on a multifactorial disease and investigates in which respect the external regime is a new regime, originating outside of the internal regime. Author(s) Institution(s) Title
E Marden University of British Columbia, Canada Open Source and Drug Development: A Feasible Route to Access?
approach is indeed likely to lower costs and increase access to drugs.
Conceptual Framework Drug development refers to the processes involved in taking a candidate drug through the stages necessary to obtain marketing approval. The process of drug development is heavily regulated, requires substantial resources and often involves complex intellectual property inputs. Conventional intellectual property regimes generally allow a drug developer a limited monopoly, resulting in high prices for end users. Conventional intellectual property can also have limiting effects on drugs developed because of limited access to necessary innovations. Open source is an alternate approach to intellectual property, which in its most basic expression makes innovations, covered by copyright or patent, available non-exclusively to all comers. Proponents of open source (Janet Hope, Katherine Nolan-Stevaux, Richard Gold, Arti Rai) maintain that such an approach in drug development can reduce proprietary interests and hence result in better access to and availability of drugs.
Method The paper is a legal analysis primarily of the United States laws and regulations relating to intellectual property and regulation. Results The paper concludes that open source is not a simple option for drug development, as it is not clear that full-scale open source drug development can yield less costly and more accessible drugs. Patent rights differ markedly from copyrights and the efforts that must be undertaken to make open source workable for drug compounds are difficult and expensive. Even if interacting patent rights could be resolved, the legal and regulatory requirements of drug development make that process expensive, highly structured and resourceheavy, whether or not open source plays a part in the process. Given all this, it cannot be maintained that open source drug development offers a better alternative.
Introduction It has become increasingly common to identify conventional intellectual property regimes as a barrier to drug (medicinal product) access and to point to open source drug development, modeled on practices in software, as a potential solution to problems relating to availability and cost. In support of this proposition, proponents point to the fact that open source operates elegantly in the information technology context and has produced a number of widely used products, even while sharing access to the underlying source code. Proponents also point to successful endeavors to use open source in early drug discovery where such an approach can assist in keeping certain underlying intellectual property open and available for further innovation. The aim of this paper is to critically examine claims made for open source in the drug development context and to evaluate whether this alternative intellectual property
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Author(s) Institution(s) Title
A Delfanti University of Milan and SISSA, Italy Hacking genomes – A study of open source biotech ethos
Crack the code, share your data, have fun, save the world, be independent, become famous and make a lot of money. In this work I link the public image of a particular type of contemporary biotechnologist devoted to open source genomics to the ethics and myths of the hero of informational capitalism – the hacker. Analyzing both discursive strategies and material practices of some of these scientists and drawing from post-Weberian theoretical tradition, I try to investigate their role in the changing relationship between science and society. Several components of hacker ethics have a deep historical dimension, having been continuously present in the 20th century’s narratives and normative accounts of science:
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Industrial zone - Genomic sources: routes and strategies
in the tension between science as public or private knowledge, between industrial and academic scientist’s ethos, between hedonism and generosity, heresy and independence. From this perspective, as several historians and sociologists have pointed out, the scientist’s ethos and norms are means of positioning into the changing social contract between science and society, capital, industry. Science ethos is a justificatory apparatus used to sail the complex seas of science-industry-society relations. My argument is supported by an empirical research based on case studies located in the post-genomic age and distributed across the United States and Italy. They are research projects by highly mediatized biologists in which the problem of access to and sharing of the data emerged as a crucial issue. These include the Sorcerer II, the Craig Venter Institute’s ship that circumnavigated the planet to collect and classify marine microbial genomes; the open access avian flu database GISAID, founded by the Italian veterinarian virologist Ilaria Capua; Harvard’s George Church, nicknamed “open source junkie” and his Polonator, the open source genome sequencer. To examine these case studies, I have collected communicative materials from international media, scientific journals and press offices: data from multiple sources were analyzed ( journalistic articles, interviews, scientific papers, press releases, websites). Then, by means of qualitative discourse analysis, I have focused on the images of scientist and his norms, virtues or ethics. Finally, I have crossed the results with an analysis of the material practices and socio-economic ecologies of these same cases. The results support the idea that public dimensions of this new wave of “public scientists” who use open source tools are tied to the particular relationship they express between science and society, enterprises, universities and other actors who participate in the making and marketing of contemporary biology. I therefore argue that open source (but also rebel, heretic, diy) biotechnology is a way for biology to become “moral” again, after the infamous clashes and disputes related to patents, GMOs, knowledge enclosures, and evil corporations entering and changing science dynamics. Indeed, these scientists and their public virtues can be a rich model for the transformations undergoing in both 21st century’s science and informational capitalism.
Industrial zone
Posters
Industrial zone
Thursday, 27 May & Friday, 28 May
Posters
Author(s) Institution(s) Title
D Engelbrecht Dept. of Philosophy, VU Amsterdam, NL IPR and Genetic Information
Introduction Increasingly, intellectual property rights (IPR), particularly patents, are shaping the way in which genomics information is made available to society. Therefore, any study of the societal impact of genomic information would be incomplete without consideration for IPR. In this paper, the relevance of the supposed informational nature of DNA molecules for their patentability is addressed from the perspective of philosophy of biology. Conceptual framework In the patent law literature, the view that DNA sequences somehow contain information is omnipresent. The European Directive on the Legal Protection of Biotechnological Inventions, for example, defines ‘biological material’ as material containing genetic information and capable of reproducing itself or being reproduced in a biological system. Critics of gene patenting claim that due to their informational nature, DNA molecules cannot meet the criterion of inventive step if the corresponding proteins are in the prior art (i.e. are known). Method The analysis presented in this paper draws on both the patent law and philosophy of biology literature. The paper starts with a summary of the patent law literature in which DNA molecules are described as having a dual nature, i.e. as being both chemical and informational, and the problem this is said to pose for their patentability. Specifically, it examines how the supposed informational content of DNA molecules is said to conflict with the criterion of inventive step. Next, the paper asks the question whether the attribution of informational content to DNA molecules is warranted in light of the philosophical discussion on this issue, and highlights some of the major philosophical positions in that debate. The paper closes with a comparison of the way in which the criterion of inventive step is applied in practice in the United States and in Europe.
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Results The primary conclusion of the paper is that the critique that the informational nature of DNA molecules should preclude their patenting if the corresponding proteins are in the prior art misses the target in two important respects. Firstly, the philosophical literature shows that the claim that DNA either constitutes or carries information is controversial and not generally accepted. Secondly, in both the United States and the European Union, the alleged informational nature of DNA is side-stepped in the patent examination process, albeit in different ways. In the United States the Courts have ruled that any potential information transfer from proteins to genes is effectively blocked by the phenomenon of genetic redundancy. Conversely, in Europe there is no need for the introduction of the information concept because there the criterion of inventive step is evaluated on the basis of the inventiveness of the methods of isolation of the molecule rather than the molecule itself.
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environmental zone • ecological genomics • promises and expectations
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Session
II
Environmental zone - Engaging with ecological genomics
Environmental zone– Parallel session ii
Thursday, 27 May, 14.00 – 15.30
Engaging with ecological genomics
S van der Hout Faculty of Science, Radboud University Nijmegen/ CSG, NL Title Mapping and assessing the emerging landscape of ecogenomics: a voyage of discovery
or on developing concrete applications for valorization notably in industrial contexts. Literature • D upré, J. (2004) Understanding contemporary genomics, Perspectives on Science, 12(3), pp. 320–38. • Keulartz J., M. Drenthen, J. Proctor (eds.) New visions of nature: complexity and authenticity. Series: The International Library of Environmental, Agricultural and Food Ethics. Vol. 15. Dordrecht / New York: Springer • Straalen N. van, Roelofs D. (2006) An introduction to ecological genomics. Oxford University Press.
Author(s)
Institution(s)
Introduction and conceptual framework The term ecogenomics was coined and introduced in order to convey important promises. First of all, ecogenomics intended to overcome the time-old tension within biology as a field between ecological (systems-oriented or holistic) approaches and bio-molecular (reductionist) approaches (Dupré 2004, Van Straalen & Roelofs 2006, Keulartz et al 2009). Moreover, ecogenomics was dedicated to exploring and bringing to the fore the diversity and richness of nature, to reveal the microbial dimensions of life, and to understand the ecological functions of microbial networks. Finally, building on these claims, ecogenomics was expected to support a more nature-friendly interaction with our natural environment, unlocking and using the dynamics of natural systems in more intelligent and adapted ways. Although these promises are clearly articulated in a number of programmatic texts, the extent to which these claims and ideals can and will be realized in actual research practices carried out under the heading of economics is still an open question. Methodology In my paper I will analyze and assess a number of obstacles I encountered through discourse analysis (text books, journal articles, research program, interviews, key note lectures) and interviews with key experts in the ecogenomics field. Results In my paper I will present and assess the results of my “voyage of discovery” in the emerging and evolving landscape of ecogenomics. First of all, the term ecogenomics is beset with conceptual difficulties and in fact proves to be a highly controversial concept that is interpreted differently by various ecogenomics researchers in various settings. Secondly, some skepticism seems justified concerning the extent to which ecogenomics research is really able to develop a more holistic, non-reductionist view on life, as many research projects still focus on sequencing genomes of model organisms 96
Author(s) Institution(s)
Title
A Roelofsen1, W Boon1, R Kloet1, J Broerse1, 2 Athena Institute for Research on Innovation and Communication in Health and Life Sciences, Vrije Universiteit Amsterdam, NL 2 Centre for Society and Genomics, NL Ecological genomics & society in interaction: the challenge of learning 1
Introduction Within the context of public-private R&D collaborations on genomics, one of the key questions is how to involve societal actors in a meaningful way in order to adequately address societal questions and improve societal valorisation. In the case of ecological genomics (ecogenomics) we took up this challenge and organised a four year interactive learning and action process (based on Constructive Technology Assessment, CTA) to broaden agenda-setting within the Dutch Ecogenomics Consortium. At the start of this process, interviews and focus groups were held with technology developers to investigate the current guiding visions in ecogenomics (Roelofsen 2010, 2008). Subsequently, groups of potential future users (e.g. farmers, soil companies, hobbyist gardeners) reflected on ecogenomics from their own perspectives in focus groups (Roelofsen, 2010). As a last step we designed two dialogue meetings that aimed to facilitate a deliberative process between ecogenomics researchers, potential future users and actors related to policymaking. Although reflexive learning between technology developers and societal actors is generally considered crucial to generate a sustainable impact on science and technology developments, little structural insight is available on how to facilitate and analyse this learning. In this paper we present our dialogue methodology, and develop and apply an analytical framework to analyse the learning processes that took place. Conceptual framework With the dialogue meetings we aimed to facilitate learning between participants on both first-order (or single loop) level and second-order (or double loop) level. Firstorder learning refers to learning on the substantive level of (proposed) actions and outcomes, ideas and problem definitions, and results in incremental changes in problem-solving strategies. In second-order learning a critical reflection of one’s own 97
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Environmental zone - Engaging with ecological genomics
and others’ fundamental values and world view takes place, resulting in a deeper insight into problem structures and effective solutions (Boon 2008; Kerkhof, 2005; Hoogma, 2000; Grin, 1996; Sabatier, 1987; Fischer, 1980; Argyris, 1978). In order to assess whether participants learned in a reflexive way, both levels need to be taken into account. Method In order to expose the learning processes that took place as a result of the dialogue meetings, our data was analysed by taking the following three steps: Step 1 (ex ante): Assess the extent to which different actors agree or disagree with each other on first- and second-order level before the dialogue meetings. Step 2 (ex durante): Assess the extent to which the ideas and perspectives of the different participants change on both first- and second-order level. Step 3 (ex post): Assess the extent to which participants were satisfied with the results of the dialogue meetings, and reflect on whether follow-up activities were initiated. Results The analysis shows the divergence and convergence between participants on ideas, problems, and underlying assumptions. For example, ecogenomics researchers and future users became aware of each others’ positions and searched for connections between research and practice. Interestingly, in the discussion there seems to be little room for manoeuvre in the positions of the policy-related actors. They did not seem highly susceptible to the ideas raised by other participants. Longer-term effects of the dialogue meetings have been observed on a cross-institutional level (expanding network and new initiatives), program level (actions of the ecogenomics consortium), and individual level (ecogenomics researchers rethinking their research approach, aims and objectives). At the same time, our results show the vulnerability of these effects, and the need to create conditions that ensure continuation of this learning process in the future. Author(s)
K O’Doherty, D Badulescu for Applied Ethics, College for Interdisciplinary Studies, University of British Columbia, Canada Title Military pollution, microbes, and genomics: engaging the public on messy issues Institution(s) Centre
Introduction RDX is an explosive used extensively by the military, as well as in some non-military applications such as mining and avalanche control. RDX is also a neurotoxin and RDX pollution is becoming an increasing concern. One of the technologies being investigated as a potential solution to RDX pollution involves genomic studies of naturally occurring soil microbes known to biodegrade RDX. Given the nature of these issues and the questions they raise, we argue that public engagement is not only appropriate, but necessary in guiding application and governance of such technology. 98
In this paper we report on a public engagement on these issues conducted using principles of deliberative democracy in British Columbia, Canada. Conceptual framework The potential development of microbial bioremediation technology is associated with many issues of a social nature. In particular, (i) As RDX pollution is caused primarily by military training activities, a tension can be observed in the mandate of the military between maximising combat readiness and taking into account adverse impacts on the environment. (ii) Existing remediation options for RDX themselves have significant adverse effects on the environment. On the other hand, new bioremediation options are largely untested and may be associated with many unknown risks. Particularly as these new bioremediation options involve genomic technologies, public values may be an important factor to consider next to professional risk assessment. (iii) Bioremediation options that specifically involve the enhancement of certain naturally existing microbes, or even the release of genetically engineered microbes into the environment, are relatively novel and therefore largely unknown to the general public. Public acceptance of such technologies may be difficult to predict, even if experts advocate their effectiveness. Method Deliberative democracy events are designed to create a forum for learning, debate and discussion in which public opinion on certain topics may be gauged, and publics can be involved in policy formation processes more directly. The specific format followed for the design and implementation follows previous work on other areas of biotechnology (Burgess, O’Doherty, & Secko, 2008; O’Doherty & Hawkins, 2010; O’Doherty & Burgess, 2009). In particular, participants were recruited randomly to fill demographic stratification for diversity. They met in person over four days of deliberation in Vancouver, Canada. Information materials were prepared specifically for this event to enable debate on the issue informed by multiple different perspectives and stakeholder interests. Significantly, while some deliberation exercises focus exclusively on achieving consensus, facilitators for this particular forum were instructed to move towards consensus where possible, but to also focus on identifying and clearly articulating persistent disagreements where fundamental differences in values became evident. Results At the time of writing this abstract, results are not yet available (though results will be presented at the conference).
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Session
IV
Environmental zone - Promises and expectations of ecogenomics research
Environmental zone– Parallel session iV
Friday, 28 May, 13.30 – 15.00
Promises and expectations of ecogenomics research
normative implications. Whereas the reductionist assumption that eventually nature can be totally understood implies that the ecologist can overlook and stand above nature, the ecologist’s attempts to understand the complexities of nature ultimately merely confirm his initial response of awe and wonder towards nature. This holistic ecological ethos seems pivotal for ecogenomics as well. The question remains whether most ecogenomicists are fully aware of the implicit ecological ethic of their field. Author(s)
R Kloet, T de Cock Buning Athena Institute, VU University Amsterdam, NL Title Why change a winning horse… or bug? Reflecting on structural aspects of six years of Ecogenomics Consortium Institution(s)
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M Drenthen Faculty of Science, Radboud University Nijmegen/ CSG, NL Title Zooming in on the web of life. Ecogenomics contribution to an ecological ethics Institution(s)
Contrary to what is often suggested, it is questionable that ecogenomics will inevitably produce green technologies in the foreseeable future. On a more conceptual level, however, ecogenomics (understood as environmental metagenomics) can have a positive contribution to greening our world view. In practice, many molecular biologists often restrict themselves to a mere instrumentalist and reductionist attitude toward nature. Yet, I argue, ecogenomics implies a more integral, more holistic view of nature with normative implications. Ecological metagenomics starts with the holistic concept of ecosystems as wholes that are bigger than their constituent parts and extends this concept to include the micro-world. The concept of a metagonome used in genomic analysis of for instance soil samples, cannot be understood in terms of the reductionist ideal of a complete understanding of the workings of the machinery of nature. Rather, it should be understood more pragmatically: the concept does not refer to the thing itself, but is merely an approximation of nature’s irreducible complexity. Thus, ecogenomics embodies a more humble epistemological attitude toward nature. Moreover, in the metagenomics view humans are not merely part of ecosystems, but are, at least in a sense, ecosystems themselves. Thus, the ecogenomics worldview consists of an intricate network of interrelated elements that in turn can be understood as networks themselves. This leads to an irreducibly complex understanding of nature. What distinguishes the ethos of holistic ecology from that of a more conventional reductionism is the recognition that ecosystems are complex entities that include humans and that ultimately lie beyond comprehension. In a holistic perspective, ecosystem models are merely approximations of nature’s complexity. This has 100
Introduction In January 2004 the Dutch Ecogenomics Consortium (EC) – a collaborative entity of 16 Dutch universities, research institutes and companies – started. Promises and expectations were high, for the EC not only aimed to deliver challenging new scientific information on (soil) ecogenomics, but also to ‘apply this knowledge in the interests of sustainable land use for various social purposes’ (NGI Annual Report 2003). However, to balance academic excellence and societal relevance turned out to be a challenge: especially since EC partners had different ideas on what the optimal balance would be. During the course of the EC this resulted in various dynamics, e.g. internally between EC groups, and with the external societal partners. The structure of these R&D dynamics in innovative research consortia are the focus of our research. Conceptual Framework We analysed and described the R&D process for ecogenomics in the theoretical frames of system innovation and transition management. We adapted Geels’ (2002) multi-level perspective on technological transitions (MLP) and developed a generalised conceptual framework for R&D in national research systems, building on the conceptual distinction between ‘landscape-, regime-, and niche level (Kloet et al., forthcoming). In this context the research programme level appears as the smallest unit of analysis and the EC was framed as an innovative niche initiative. The developed framework might serve as a generalised model to manage multiple scientific perspectives on knowledge production, but can also be used as an instrument for research policy makers to design - and for governmental evaluators to assess - R&D programs for emerging science and technology. Method We followed the EC longitudinally for six years, acting as participant-observers for the programme’s length. To obtain insight in the EC’s formal and informal communication and decision-making, we studied the communication documents and were present in many meetings of the EC and EC subgroups. Furthermore, we held interviews with 101
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Environmental zone - Promises and expectations of ecogenomics research
most of the EC partners and external stakeholders (over 70) and organised focus groups with EC-partners (2), potential future users of ecogenomics (9) and lay public (3). In addition we organised two dialogue meetings to obtain a deepened understanding of potentials and limits of transdisciplinary agenda setting in R&D, and the effects of confrontations between different research ‘cultures’. Results On the basis of our model we can explain how internal processes (for instance academic competition) and external pressures (a combined push for excellence and relevance, confrontations with societal actors) moulded the EC praxis, and influenced the current embedding of ecogenomics in society. Several approaches to promote research relevance and application – i.e. budget matching and evaluation practices – are only partly successful. Today, the EC despite efforts to realise upstream engagement and stakeholder involvement (Roelofsen et al., 2008), seems to be trapped in a classical knowledge paradox*. Our analysis points at structural flaws in genomics- and life science research governance in the Netherlands and options to avoid are proposed, although FES funding schemes seem to reproduce the same system flaws. * The knowledge paradox is commonly used by research decision makers to describe situations where academic output is outstanding, but the industrial and societal use of knowledge low. Author(s)
H Zwart Faculty of Science, Radboud University Nijmegen / CSG, NL Title Rules for the animal park: genome management as a life-line for endangered species in an era of mass extinction Institution(s)
Introduction and conceptual framework The Bible Book Genesis contains a fascinating legend: the story of the Ark. Against the backdrop of an ecological disaster, - a sudden dramatic climate change unleashed by chronic and massive human (mis-)behaviour -, a protective contrivance is built, a kind of life-boat in order to support and ensure the survival of a limited number of favoured and carefully selected human beings and animals. After the Flood, they are allowed to repopulate the land. In various ways, the story of the Ark can be seen as a model narrative for framing important events, such as periods of climate change and mass extinction in the recent or distant past (as studied and uncovered by geology and palaeontology), but also as a narrative scheme that allows us the frame and assess what is happening in the present (the genomics era) in terms of conservation policies to ensure survival of favoured yet endangered species for the landscapes and environments of the future. Thus, the Ark provides an archetype for framing the narrative of the interaction between humans, animals and other organisms (Ponting 1991, Diamond 1997, Zwart 2009), an ecocentric view on human history. 102
Methodology Building on this archetype or metaphor, an assessment will be presented of the contemporary significance of genomics for the societal landscape in the environmental zone. This assessment is informed by a systematic reading of multiple sources, ranging from top scientific journals such as Nature and Science up to policy debate and philosophical deliberations. The thesis to be presented is that we are once again facing a period of mass extinction at a tremendous pace in which human impact is clearly noticeable as a major factor. At the same time, this development, closely connected with worldwide human decision-making, life-style and demography, is counteracted by a series of research-based conservation policies. Notably, by singling out a number of species that are formally acknowledged as endangered, so that they become target species of conservation policies with the objective of safeguarding their survival. Results Whereas the original story of the Ark may be regarded as a legend, it is a story that in the course of history became increasingly real in the sense that more and more species became dependent on human policies, decisions and practices for their survival. They have entered our Ark. This was already the case when, during the Neolithic revolution, human villages provided a life-line for domesticated animals whose wild relatives became extinct or endangered. Genomics constitutes the most recent chapter in this narrative in various ways. First of all by revealing (through genome sequencing, using genomes of various extinct or endangered species as historical archives) the history of the emerging Ark, as well as outlining its possible futures. But also more directly in the sense that genomics, through genome sequencing of endangered species, becomes a tool in conservation policy and the management of endangered animals in wildlife parks, safeguarding or even restoring their genomic authenticity and biodiversity (Marris 2009). The focus has shifted from the conservation of endangered species as living, visible organisms to the conservation and restoration of sequenced genomes. A subsequent shift from endangered to (recently) extinguished species (“Pleistocene Parks”) seems a logical if not inevitable next step (Zimov 2005). My paper will analyse and assess the role and dilemmas of “genome management” in ecosystem preservation and restoration in wild-life settings. Literature • Marris E. (2009) The genome of the American West. Nature 457:950-952. • Zwart H. (2009) Biotechnology and naturalness in the genomics era: plotting a timetable for the biotechnology debate. Journal of Agricultural and Environmental Ethics, 22, 505–529. • Diamond J. (1997) Guns, Germs, and Steel: The Fates of Human Societies. New York: Norton. • Ponting, C. (1991) A green history of the world. New York: Penguin Books • Zimov, S.A. (2005). Pleistocene Park: Return of the Mammoths Ecosystem. Science 308(5723): 796-8. 103
Posters Environmental zone
Environmental zone
Thursday, 27 May & Friday, 28 May
Posters
Author(s) Institutions(s) Title
E Dücker Faculty of Science, Radboud University Nijmegen / CSG, NL Bioprospecting in the Genomics Era: Assessing the Normative Issues
Introduction Bioprospecting is the first step in charting the natural world around us in order for us to derive commercial products from nature. Mother Nature invents at a grand scale and a geological timescale, proving herself the superior inventor. We are starting to acknowledge this and are keen to exploit it for our own benefit. Life in the extreme environment of the deep sea might be the oldest of the natural experiments, requiring the evolution of unique adaptations, which in turn can provide us with new ways to further our own societal evolution. These remote areas of the planet constitute the largest ecosystems found on earth and provide an essential function in maintaining global ecosystem homeostasis. Knowledge about deep-sea ecosystems started to develop at the end of the nineteenth century but only recently has the technology been developed to exploit the genomic resources (such as particular gene sequences) found in these areas. While our knowledge and understanding of these ecosystems is still in its infancy, the promise of striking ‘blue gold’ drives our knowledge economy mindsets to pursue the exploitation of these areas. Initiatives by governments such as Norway to include bioprospecting as a pillar of their knowledge-driven economy present us with the question if and how such undertakings can be sustainable in the long term. The science involved provides both the knowledge for progress and the understanding for conservation. Can deep-sea bioprospecting provide a platform for conservation while sustainably utilizing the genomic resources found in the deep? Conceptual framework In 1949 Aldo Leopold published the book A Sand County Almanac (Leopold 1949) in which he addressed the imbalance between human progress and the health of the natural world around us. His work, though sixty years old, is still as relevant today as it was back then. Garrett Hardin named it The Tragedy of the Commons in his 1968 104
academic paper (Hardin 1968). Today anthropogenic influences are reaching the deep sea through waste disposal, fisheries, oil and gas drilling, mining and climate changes (Glover and Smith 2003). Bioprospecting is the latest endeavour to reach the depths of the sea and its consequences are difficult to predict, as a recent UNU-IAS report has shown (Arico and Salpin 2005). Methods A historical study provides an understanding of how the current situation came about and how it might develop in the future. Interaction with the different actors (scientists, corporations, non-government organizations and the general public) will provide insights into the interests and concerns of the different actors and how these might relate to each other. These methods are combined with desk research of available literature and publications. (Proposed) Results The normative assessment of issues surrounding deep-sea bioprospecting will use lessons from the past and a comprehensive analysis of the current situation to work towards an ethics of the deep sea reminiscent of Aldo Leopold’s The Land Ethic. References • A rico S & Salpin C 2005 Bioprospecting of Genetic Resources in the Deep Seabed: Scientific, Legal and Policy Aspects. UNU-IAS. • Glover AG & Smith CR 2003 The deep-sea floor ecosystem: current status and prospects of anthropogenic change by the year 2025. Environmental Conservation 30 219-241. • Hardin G 1968 Tragedy of Commons. Science 162 1243-&. • Leopold A 1949 A Sand County Almanac: Ballantine Books, New York. Author(s) Institutions(s) Title
C Timmermann, H van den Belt, M Korthals Wageningen University / CSG, NL Bioremediation, Technology Transfer and Global Justice
Introduction Genomics widens the window of opportunities for bioremediation as well as the risks of introducing new organisms to an ecosystem. The fierce progress made by some developing countries over the last years has come with a huge cost for the environment. Yet many developing countries lack the biotechnological resources to develop bioremediation. The richest wildlife reserves are harbored in the developing world, so it is also in the interest of the developed world to assist the countries in need in order to maintain and rescue as much of the global biodiversity as possible. Technology transfer is only successful if, rather than simply transferring a ready-made
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technology, a serious effort is made to adapt the technology to local conditions. In principle this also makes it possible to involve local partners in joint R&D and to create less unequal opportunities for building IP portfolios (e.g. shared patent pools). This contribution concentrates on how and why the developed world should help those countries with bioremediation techniques.
Conceptual Framework Basic Concepts: Bioremediation, Intellectual Property, Technology Transfer, Biosafety, Pollution, Development Aid, Biodiversity, Public-Private-Partnerships, Global Justice.
References Literature, from experts in the field and reports by international and non-governmental organizations, has been analyzed. Issues concerning traditional knowledge have also been discussed with colleagues in Wageningen.
Method We will discuss several dilemmas. On the one hand, technology transfer can only succeed when focused on local contexts and needs; on the other hand, a strictly local orientation runs the risk that global environmental impacts are neglected. Secondly, a joint effort between profit-oriented companies and local authorities is necessary, but those authorities are often too weak to create win-win strategies. Thirdly, the current IPR system allows the creation of common patent pools to stimulate innovations, but these pools can exclude weaker parties. Fourthly, when these dilemmas are overcome, environmental progress can be made. However, it still remains to be seen to what extent the needs of the most vulnerable are met. This is of special concern for countries with less biodiversity. Companies might want to prefer working in fields that give access to more profitable genetic resources and work on types of contamination that also occur in the developed world. But such a focus is not necessarily aligned with the environmental problems of the poorest countries.
rural zone • animals, plants and seeds: genomics technologies in the rural zone • international developments • governance of agricultural genomics
Results Areas of impressive biodiversity are considered a common heritage to mankind, but this notion does not act as an incentive for easing the rigid market-demand orientation of biotechnology firms. There is a need for policy change in order to foster equitable research cooperation and a rapid transfer of technologies once they have been developed, in order to save the threatened areas from pollution. The responsibility for damage due to the migration of heavy industry to countries with loose environmental safety standards is hardly recognized by developed countries.
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rural zone– Parallel session i
Thursday, 27 May, 10.45 – 12.15
International developments in plant genomics Author(s)
E Nuijten
Institution(s) Technology
and Agrarian Development group, Wageningen University,
NL Title Varietal,
agro-ecological and social aspects of drought tolerance in rice farming in West Africa
Introduction Crop genomics holds the promise of a new gene revolution. The crop trait that receives most attention in functional genomics research is drought tolerance, amongst others in a worldwide Generation Challenge Program. Given the increasing scarcity of water in the near future this seems to be a logical choice, in particular for a crop like rice. But just like traditional agricultural research during the Green Revolution, functional genomics ignores agricultural development at the farmer level and how scientific innovations can be linked with local knowledge. This study looked at farmer management of rice diversity in relation to drought tolerance in three countries in West Africa (The Gambia, Senegal and Guinea Bissau). In particular in Senegal and Gambia the rainy season is very short and rainfall very erratic and farmers often experience bad harvests. This study aims to show a) how farmers understand genetics and GxE interactions in rice, b) how their rice farming practices with regard to coping with drought are shaped by agro-ecological and socio-economic factors, and c) how functional genomics may be better linked with farmer knowledge. Conceptual framework The coordinative frame used in this study is that of Genotype x Environment interactions (GxE interactions). The basic principle is that genetic expression in the rice plant engages socio-biological frameworks of coordination that vary in different settings, i.e. between genomics research and farmer management of crop diversity. From this follows a crucial question what the differences and similarities in understanding of drought tolerance are between genomics researchers and WestAfrican rice farmers. Methods The research was conducted in several areas in Gambia, Casamance (South Senegal) 108
and northern Guinea Bissau during the rainy seasons of 2007 and 2008. The research sites in The Gambia were chosen based on earlier research conducted in The Gambia from 2000 to 2003. The research sites in Casamance and northern Guinea Bissau were selected when tracing the origin of certain traditional varieties. In addition to informal interviews and on-farm experiments, 63 questionnaires were conducted in Mandinka villages in The Gambia (three villages), Casamance (two villages), and northern Guinea Bissau (two villages). In all research areas Mandinka are the dominant ethnic group. In the Gambian case study villages considerable numbers of Jola live, who fled the war in Casamance. Results The results suggest drought is only one of many adversities farmers deal with. Instead of specifically focusing on drought, farmers use various strategies to deal with adversities in general. In addition, the results suggest that certain social aspects, such as access to land and labour organisation influence drought tolerance in rice. Hence, to improve drought tolerance in crops a broader focus is needed than only focusing on the genetics regulating drought tolerance. It is also important to understand the wide variety of forms in which drought occurs, and in which ways genes regulating crop drought tolerance interact with the agro-ecological environment and the societal context (so-called GxExS interaction). Understanding such interactions better may help building an institutional framework that enables developments at genomics and farmer level to complement each other. Author(s)
C Rhodes for Science, Ethics and Innovation, School of Law, University of Manchester, UK Title The Changing Landscape of International Genetic Resources Governance
Institution(s) Institute
Introduction International cooperative activities in the genetic resources area provide an interesting example of how an area of governance has changed – both in terms of regulatory adaptation and increased cooperation between international organisations – as the scope of international concern has expanded, partly in response to scientific developments. The first part of the paper outlines how developments in genetics and genomics have brought the issue of genetic resources governance into different regulatory realms, identifying the range of international rules and organisations that are now involved. The second part of the paper will explore the difficulties and opportunities that arise in trying to govern an area that involves multiple interacting regulations and institutions, which can have different motivations and aims. 109
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Conceptual Framework Genetic resources are of international interest because states depend on an/the exchange of genetic resources to form the basis of agricultural production and significant avenues of scientific and medical research. To examine governance of genetic resources international regulations and organisations have been studied. International regulations include standards, guidelines, codes, and treaties used to govern state behaviour. This paper focuses on those regulations with potentially universal adherence/membership. International organisations are public international institutions formed by the agreement of states, which make up their membership. Again the focus is on those with a potentially universal membership. Cooperative activities are those involving two or more organisations addressing an issue of common concern. They can range from the exchange of information ( or information exchange) to the formation of joint institutions. Method The first part of the paper uses documentary study of the history of genetic resources governance and maps its spread across regulatory realms and into the jurisdictions of several international organisations. The second part involves research into the opportunities and constraints faced by international organisations cooperating on issues of common concern. This includes: identification of cooperative mechanisms provided by constitutions and agreements of the relevant organisations, and how their mandates overlap; theoretical research on international organisations; and reflection on the applicability of theory and the use of cooperative activities including discussions with staff of some of the organisations. Results International governance of genetic resources has expanded in several ways: from a focus solely on plant genetic resources to incorporate human, animal and microbial genetic resources; and from a focus on facilitation of collection and exchange to incorporation of concerns about conservation, access, benefit-sharing, equity and property rights. Genetic resources are now governed by a range of international rules and, as the scope of concern has expanded into the remit of several international organisations, cooperative initiatives have been developed in an attempt to promote more balanced and coherent policy making. The long time periods necessary for negotiation to amend existing or develop new regulations means that these activities are an increasingly significant form of governance. The main constraint on cooperation between international organisations is the attitude of member states, which need to become more supportive if key international issues are to be effectively addressed.
Author(s)
C Ryan, S Smyth of Saskatchewan, Canada Title Detrimental Social and Trade Impacts due to Adventitious Presence (AP): case study of GM Flax Institution(s) University
Introduction This paper examines the social, economic and governance aspects of adventitious presence (AP) of Triffid flax in seed, food and feed markets; outlines the historical timeline of Triffid from its development to its current detection in Canadian and global markets; maps the Canadian and EU flax supply chain to ascertain potential gaps wherein leaks occurred; and conducts a systematic analysis to estimate costs associated with AP. Conceptual Framework The Liability Analysis Framework (LAF) provides an effective framework for stakeholders to evaluate and mitigate liabilities both quantitatively and qualitatively. The LAF is based upon three interconnected/overlapping spheres: contractual legal issues, legislative/regulatory issues and common law/statutory attributes. The Framework, with is broad scope, is grounded in governance and legal principals and is useful for dealing with containment in the face of a market failure such as AP. Method The detection of Triffid in flax supply chains has obviously had market impacts in not only Canada, but also in Europe, especially Belgium. Not only are there costs associated with loss of trade, the opportunity costs associated with securing substitute export markets and the high testing costs for the Canadian industry but there are also high social and economic costs associated with loss of a key natural Omega-3 source for both human and livestock health for the EU. The methodology of this research will involve gathering data on the economic costs regarding the detection of Triffid flax in Europe as well as the data on testing costs all along the value chain in the Canadian market. Transaction cost analysis (TCA) measures the cost of participating in a market, or more simply, the cost of a specific transaction. Utilizing TCA will allow us to divide the flax supply chain into specific compartments and then compare the cost of testing and exporting flax presently against historical flax export data, identifying the cost differences. The comparison against historical transaction data will provide a concise assessment of the total increase in cost due to the AP of GM flax in non-GM flax exports. This research represents a case study of the entire supply chain for flax, from the fields of Canada through to the final products available internationally in the EU and its export markets. Stakeholders include, but are not limited to: trade commissioners;
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transportation and port authorities; commodity brokers; industrial associations and affiliated actors; processors; certified seed growers; and producers.
rural zone– Parallel session iii
Results More than 15 countries have filed a total of one hundred notifications in the EU’s Rapid Alert System for Food and Feed since early September when Triffid was first identified in the EU food supply chain. Products, in the form of nuts and seeds, feed materials, and cereal and bakery products, were distributed to 45 countries. Most (as of February 2010) identify Canada (68%), Belgium (49%) and Germany (28%) as originating countries of unauthorized FP967-contaminated material.
Animals, plants and seeds: genomics technologies in the rural zone
Based upon preliminary analyses, costs are estimated conservatively at CDN$10 Million. These costs include demurrage, quarantine costs and testing costs incurred along the Canadian supply chain. However, actual costs are expected to be in the tens of millions across the broader supply chain (including EU and Canadian markets).
Friday, 28 May, 9.30 – 11.00
Author(s) Institution(s) Title
A Bruce ESRC Innogen Centre, University of Edinburgh, UK The landscape of animal diseases
Introduction Genomic technologies have combined with other technologies to produce new, potentially disruptive, features in the landscape. One of these is the promise of rapid/ point of care (or bed-side) diagnostic devices, which will alleviate the need to send samples for laboratory analysis. These devices can also be applied in the context of animal disease (pen-side or cow-side tests). This paper will describe some of the contours of this landscape based on empirical data on attitudes of vets (government and working directly with farmers) and farmers to these developments. Method Rapid/POC devices have not yet been widely adopted for use in food animals therefore the subject under study is a prospective study with some respondents having experience with such devices on an experimental basis and others having no experience. A total of 41 semi-structured interviews were conducted with a range of stakeholders during Sept-Dec 2009. Respondents included government vets, vets in practice, farming industry vets, representatives of veterinary bodies and farming and food chain professionals and covered a range of different species including cattle, sheep, pigs, poultry, horses and aquaculture species. Interviews focussed around key issues in the control of infectious animal diseases, reactions to the potential deployment of rapid/POC devices, barriers and enablers of uptake of these devices and data collection issues. Conceptual framework The conceptual framework includes the role of expectations in innovation (Nik Brown) and the credibility of scientific expertise among farmers (Brian Wynne). Results Three main geographic tensions will be described. The first is the tension between what technology is perceived to promise and what is needed by vets, particularly in
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the context of diseases such as Foot and Mouth Disease with implications not just for farmers but also for wider society. The second explores the potential for shifts in power and a re-shaping of the landscape of animal disease control as an increasing range of stakeholders could have access to diagnostic devices with authority consequently becoming more distributed. Thirdly, the landscape of different knowledges will be explored. Rapid/point of care devices codify the expert knowledge of laboratory diagnostic tests and make it available to a wide-range of animal keepers to add to their situated knowledge of their animals. However, one potential consequence is the devaluing of the clinical, professional and practical knowledge of vets with resulting impact on the role of vets and their relationship with animal keepers. Author(s)
H de Vriend1 and E Lammerts van Bueren2 Institution(s) LIS Consult, NL 2 Louis Bolk Institute / Wageningen UR Plantbreeding, Wageningen University, NL Title Perspectives for the use of molecular markers in plant breeding for organic agriculture 1
The development of knowledge in plant genomics is resulting in an increasing amount of molecular markers that can be used as an additional tool in plant breeding programs. Although molecular markers are not explicitly excluded by organic standards, their use in organic breeding programs is discussed by the organic sector for several reasons. Organic agriculture (OA) has to cope with more variable environmental conditions than conventional agriculture, and therefore requires varieties that are sufficiently robust and flexible. One of the discussion issues is whether the use of molecular markers may hamper the development of such varieties. The discussion on the use of molecular markers is also related to the fact that OA refrains from the use of genetically modified organisms (GMOs) and can therefore not be used in the development and application of molecular markers. This rejection is based on the basic values of organic agriculture, formulated as four principles of health, ecology, care and fairness. As a result, two aspects often raised in debates to argue why GMOs are not compatible with organic agriculture also play a role in the question whether molecular markers are an appropriate tool in breeding programme for organic agriculture: a) the socio-economic threats of the dominance of multinationals controlling the agro-food industry and b) the fact that GMOs are considered to be a product from a reductionist approach of life. On the other hand, molecular markers are a diagnostic tool for selection and therefore not directly interfering or altering the genome at a DNA level. In addition, molecular markers may also contribute positively to the development of plant varieties with traits that meet the needs of organic production. In a European plant breeding workshop in February 2009, several of those opportunities for the use of molecular markers in breeding for organic cultivation 114
of potato, wheat and tomato were highlighted. The participants, which included plant breeders, scientists in the field of organic and conventional agriculture, and a few agricultural policy makers, discussed several aspects of molecular markers, such as costs and competition, their role in the breeding process, better use of genetic diversity, and education and communication. They made a SWOT analysis (strengths, weaknesses, opportunities, and threats) of the use of molecular markers. The authors formalised their inputs into breeder’s perspectives and perspectives seen from the organic sector’s standpoint. Strengths identified included better knowledge about gene pool of breeding material, more efficient introgression of new resistance genes from wild relatives, and testing pyramided genes. Molecular marker development and application becoming cheaper and ‘cleaner’ (including less harmful chemicals) was considered an opportunity. There were also common concerns among breeders aiming at breeding for organic and/or conventional agriculture, such as the increasing competition and cost investments to get access to marker technology, and the need for bridging the gap between phenotyping and genotyping especially with complex and quantitative inherited traits such as nutrient-efficiency. A major conclusion of the authors is that more interaction and mutual understanding between organic and molecular oriented breeders is necessary and can benefit both research communities. This abstract is based on: Lammerts van Bueren E.T., Backes G., de Vriend H., Østergård H., The role of molecular markers and marker assisted selection in breeding for organic and low-input agriculture, Euphytica, not yet published. Author(s)
M Hodges Centre for Genomics in Society (EGENIS), University of Exeter, UK Title Becoming Public-Private: Emergent Technologies, the Private Sector, and the Sideshadows of Apomixis Technoscience Institution(s) ESRC
Introduction Apomixis is the capability of certain plants to reproduce asexually – ‘self-clone’ – via producing seed which replicates the maternal genome. In 2000, stakeholders were optimistic that an ‘apomixis technology’ would be commercialised by 2010, enabled by genomics, which quickly established a hegemony over the field. Advocates of this revolutionary agricultural biotechnology claim benefits – and drawbacks – for a wide spectrum of end users. For example, an apomixis tool would greatly reduce the cost to industry of producing hybrid seed, a chief source of profit. Yet it might enable farmers to recycle this seed. The vision has not come to pass. Scientific challenges remain significant. But political economic struggle over the form a technology should take is consequential. This paper 115
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dissects a key project. The CIMMYT Apomixis Project was founded in 1989 to create open source apomictic maize for the resource-poor. In 2000 it was refinanced as a PPP integrating three leading seed corporations. By 2004, the project was focused on the goal of a patentable, GM tool. The paper presents a critical ethnographic analysis of this rupture, which has wider parallels in the field.
Ignorance. Stanford UP. • R ichards, P. 2004. Private Versus Public? Agenda Setting in International AgroTechnologies, in Jansen, K. & Vellema, S. (eds), Agribusiness and Society. Zed Books.
Conceptual Framework Building on theories of technology and emergence (e.g. Pickering 1995, Proctor & Schiebinger 2008, Richards 2004), alternative trajectories towards an apomixis technology – the field’s temporally emergent ‘sideshadows’ – are framed as suppressed via the social embedding of plant genomics. Scientific debate emerges as political struggle over which biotechnologies remain undeveloped. Through this negative dialectics, the construction of scientific ‘ignorance’ becomes visible as a cultural practice. This is linked to recurring epochal moments in project development, termed ‘protophases’. A protophase is the liminal zone, for example, between basic research and technological development. Within PPPs, it can involve decisive moments of agenda-setting, precipitating conflict over research trajectories impelled by funding constraints, governance structures, and commercial imperatives. Norms established can exert significant influence compared with decisions taken at other phases of R&D. Method The paper is grounded in historical anthropological analysis of archival and documentary materials, oral history, and contemporary interviews. It is the first social scientific mapping of the field. Results 1) S ocial studies of technology tend to focus on developed or emerging technologies. Analysts should also attend to the protophase, this locale of disarticulation and reterritorialisation, and the social rationale for exclusion and implications of technological ‘sideshadows’ which go undeveloped. 2) Greater flexibility within PPP agreements would enable the public sector to explore and capitalise on emergent opportunities at these and other junctures which may not deliver immediate commercial benefits, but in the long-term, could deliver significant ‘public goods’. 3) Longer-term funding cycles for frontier research could facilitate flexibility, and encourage diversification of agro-technological research, nourishing technological ‘heterocultures’ alongside dominant PPP models for ag-biotech. References • Pickering, A. 1995, The Mangle of Practice: Time, Agency and Science. Chicago UP. • Proctor, R.N. & Schiebinger, L. (eds) 2008, Agnotology: The Making and Unmaking of 116
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rural zone - Trends in the governance of agricultural genomics
rural zone– Parallel session iV
Friday, 28 May, 13.30 – 15.00
Trends in the governance of agricultural genomics Author(s)
J Rayner1, E Einsiedel2 Institution(s) University of Regina, Canada 2 University of Calgary, Canada Title Designing engagement for policy development in agricultural genomics: a policy cycle approach
proposed by the conceptual framework were effective in practice, drawing from Canadian and European agricultural biotechnology examples. Comparative case studies are used in an attempt to control for other factors limiting or promoting the effectiveness of participatory processes. Results The results generally support the hypothesis that participatory designs are likely to be more effective if they take into account the relevant stage in the policy process. However, effectiveness is also heavily dependent on attention to the structure of policy networks and the ways in which particular jurisdictions address issues of multi-level governance, suggesting revisions to the original design principles.
1
Introduction Over the relatively short space of the last decade, the application of genomics to agriculture has raised a host of governance issues. In few other areas has the promise of innovation through genomics been so great and the delivery so small. In part, this disappointing performance can be attributed to the treatment of agriculture as an industrial system when its products are part of the complex of “life politics” issues that have emerged over the last decade. In such cases, it is generally recognized that older governance patterns featuring closed consultations between organized interests and a reliance on traditional scientific expert knowledge fail to address broader public concerns. How to design these processes, however, remains elusive. Conceptual Framework New modes of engagement will be a key feature of governance in policy areas that raise issues of life politics (Gottweis 2008). Design of engagement has been hampered by an older and overly theoretical approach that has linked engagement directly with democratic theory and operated on a simple design principle that “more is better” (Arnstein 1969). While recent developments have shown a welcome interest in distinguishing the different modalities of engagement according to different government functions (Warren 2009), there is a large body of work on the policy cycle that explicitly addresses the role of different kinds of participants and the limitations of relatively open versus relatively closed approaches to policy making at each stage (Howlett et al. 2009; Howlett and Rayner 2007; Howlett and Ramesh 1998). The paper will adapt the “stages heuristic” to propose some general design principles for appropriate and effective participation. Methods The paper will use a case study approach to test whether the design principles 118
References • A rnstein, Sherry. 1969. “A Ladder of Citizen Participation”. Journal of the American Institute of Planners 35(4): 216-224. • Gottweis, Herbert. 2008. Participation and the New Governance of Life. BioSocieties 3: 268-285 • Howlett, Michael, M. Ramesh and Anthony Perl. 2009. Studying Public Policy. 3rd edition. Toronto: Oxford University Press. • Howlett, Michael and M. Ramesh. 1998. “Policy Subsystem Configurations and Policy Change: Operationalizing the Postpositivist Analysis of the Politics of the Policy Process”. Policy Studies Journal 26(3): 466-482. • Howlett, Michael and Jeremy Rayner. “Design Principles for Policy Mixes: Cohesion and Coherence in ‘New Governance Arrangements’. Policy and Society 26(4): 1-18. • Warren, Mark. 2009. “Governance-driven Democratization”. Critical PolicyStudies. 3(1): 3–13. Author(s) Institution(s) Title
M Saner Regulatory Governance Initiative, Carleton University, Canada The Societal Landscape of Future Genomics
The early history of biotechnology regulation was characterized by the “product vs. process debate.” Biotechnology (including the products that arise from genomics) describes a process of invention and production. Biotechnology risk, however, depends mostly on the features of a released or marketed product, rather than its mode of production. As a result, regulators particularly in the US and in Canada have deemphasized the process of production (e.g., biotechnology versus traditional methods) and favoured a focus on product features. In this paper, I argue that we need to prepare ourselves for a return to the process focus both in the public debate and in technology regulation. The outlook into the future is, thus, also a return to the roots of the public controversy and regulatory systems design.
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I provide two examples to illustrate the need for a renewed attention on process. First, genomics and biotechnology production is becoming diffuse. Synthetic biology from garage labs is already emerging, and the term “biohacking” has been coined to label this phenomenon. Critics call synthetic biology “extreme genetic engineering.” The safety of garage labs is very difficult to regulate, which is a game-changer from a regulatory perspective and requires a focus on process. Secondly, genomics and biotechnology are becoming more potent. Advances in genetic therapy and genetic doping, in concert with advances in neurobiology, nanotechnology, and prosthetics will make it increasingly hard to culturally agree on what we consider normal and how we conceive of a healthy person. We are on the verge of a period of human development where all newborns will be viewed as candidates for enhancement – enhancement to a level of cosmetic, physical, and intellectual performance that is currently exceptional rather than average. Again, this issue will refocus the societal landscape of genomics on the development of the technologies themselves (the process). Author(s)
H Walmsley, D Secko Genozymes-GE3LS Project, Department of Journalism, Concordia University, Canada Title Reporting Genozymes: Mapping a Deliberative Model of Science Journalism Institution(s) The
from theories of deliberative democracy [3, 4], and from work defining theoretical frameworks against which science journalism can be judged [5], we map the potential of a new ‘deliberative’ model. Finally, we use biofuels as an illustrative case to consider how this model can be used to offer practical guidance to working journalists. Results This paper argues that a new ‘deliberative’ model of science journalism is needed to deal with the complex, contested and ‘hybrid’ [6] socio-technical terrain of genomics. Existing ‘deficit’, ‘contextual’, ‘public participation’ and ‘interactive’ models fail to meet the challenge. Novel story development criteria are needed, which are sensitive to the ‘co-construction’ of science and society, the ‘promissory’ nature of the bio-economy and the pressures of the newsroom. 1. Racine, et al. 2006. Social Science & Medicine 62: 1278–1290. 2. Bubela, T. 2006. Clinical Genetics 70: 445-450. 3. Guttmann, A., and D. Thompson. 2004. Why Deliberative Democracy? Princeton University Press. 4. Dryzek, J. S. 2000. Deliberative Democracy and Beyond: Liberals, Critics and Contestations. Oxford University Press. 5. Secko, D. M. 2007. Health Law Review 15(3):32-35. 6. Latour, B. 2004. Politics of Nature: How to bring the sciences into democracy. Harvard University Press.
Introduction As the terrain of genomics grows in scientific, societal and ethical complexity, ‘public engagement’ initiatives proliferate at rapid rate. Research into the potential role of science journalism in facilitating public deliberation about genomics lags behind. Conceptual framework In Canada, critiques of science journalism abound. They profile uncritical reporting and inadequate attention to ethical issues within press coverage of genomics [1] and expose inaccuracy, sensationalism and failure to meaningfully connect citizens with science governance [2]. But where have these criticisms taken us? To date, they have generated no clear consensus on what ‘better’ science journalism might entail. Method This is a conceptual paper, emerging from the science journalism portion of the large scale genomics project (‘Genozymes’) at Concordia University (Montréal, Canada), which is sequencing important fungi to identify improved enzymes for the sustainable production of biofuels and biochemicals. First, we review existing ‘deficit’, ‘contextual’, ‘public participation’ and ‘interactive’ models of science journalism, evaluating their potential for communicating advances in genomics to the public. Second, drawing 120
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Posters
rural zone
rural zone
Thursday, 27 May & Friday, 28 May
Posters
Author(s)
M Weir, K Morin, D Castle of Ottawa, Canada Title Perceptions of the Canadian Public and Health-care Professionals Towards Nutritional Genomics Institution(s) University
Introduction Nutrigenomics represents a leading application of genomic knowledge and a movement towards personalized health where the links between nutrition and genetic-based disease are being understood. Public access to tests sold directly to consumers (DTC) without the involvement of a health-care professional (HCP) has received considerable attention from academic and policy observers. Currently, a wave of scientific and commercial momentum suggests that tests will penetrate the healthcare market within the next decade.
value. On the other hand, HCPs indicated scepticism towards genetics being used to predict disease. They also indicate concern over DTC testing reaching the public without a health-care intermediary. Rather, they believe HCPs should occupy a role in delivering services, but contradictorily recognize they lack the competency to provide such services. Clearly, disconnect exists between the perceptions of the public and HCPs towards nutrigenomics. Some HCPs cite the importance of more stringent oversight to regulate DTC genetic testing. Whether such an approach is necessary to address the various ethical and social issues raised by nutrigenetic testing remains an open debate. Regardless, governments and HCPs need to take steps to prepare for the arrival of nutrigenomics, including educating HCPs as well as the public. References • L ehoux P, Blume S. Technology assessment and the sociopolitics of health technologies. J Health Polit Policy Law 2000; 25:1083-1120. • Potter BK, Avard D, Entwistle V, et al. Ethical, legal, and social issues in health technology assessment for prenatal/preconceptional and newborn screening: a workshop report. Public Health Genomics (2008). Author(s) Institution(s) Title
B Gremmen Wageningen University, NL A Scientific Evaluation of the Societal Interface Group of CBSG
Conceptual framework Engaging the public at an early stage recognizes the social and political implications embedded with any health technology (Lehouz & Blume, 2002). This process also informs health technology assessment, providing useful input into whether this technology may eventually be implemented into clinical practice (Potter, Avard, Entwistle et al., 2008). So far, little input regarding the direction of these tests has been given by the public or HCPs. Method For these reasons, we sought to better understand the knowledge and attitudes regarding nutrigenomics of Canadians and HCPs through telephone surveys and qualitative focus groups. Data analysis involved identifying key themes which depicted participant attitudes, as well as identifying which professions are more comfortable or suited to provide clients with knowledge, expertise, and clinical advice. Results The public demonstrated limited knowledge and awareness of nutrigenomics. Interest levels for testing were low; however, favourable perceptions of and belief in lifestyle modification to mitigate disease/illness indicate they perceive it as a technology of 122
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Author index
Plenary speakers
Gaskell, G Jetten, M Knoppers, B Taussig, K-S Zwart, H
17 19 14 15 14
Oral presentations
Aarden, E Asveld, L Boeckhout, M Bonham, V Boon, W Broerse, J Bruce, A Bunnik, E Castle, D Cornel, M Darmonkow, V De Vriend, H Delfanti, A Drenthen, M Flipse, S Fortier, I Geesink, I Hardy, B-J Hens, K Hodges, M Isasi, R Kahn, J Kloet, R Marden, E Martin, P Meijer, I Nahuis, R Nuijten, E O’Doherty, K Penders, B Pijnappel, M Rachul, C Rayner, J Rhodes, C 124
Urban zone Industrial zone Urban zone Urban zone Urban zone Urban zone Rural zone Urban zone Industrial zone Urban zone Urban zone Rural zone Industrial zone Environmental zone Industrial zone Urban zone Urban zone Urban zone Urban zone Rural zone Urban zone Urban zone Environmental zone Industrial zone Urban zone Urban zone Industrial zone Rural zone Environmental zone Industrial zone Industrial zone Urban zone Rural zone Rural zone
27 80 24 52 57 29 113 56 85 46 49 114 91 100 86 31 40 32 33 115 42 53 101 90 55 23 89 108 98 87 81 51 118 109
Rial-Sebbag, E Roelofsen, A Ryan, C Saner, M Sleeboom-Faulkner, M Sleenhoff, S Stoklosa, A Tutton, R Van der Hout, S Van El, C Vermeulen, E Walmsley, D Wieser, B Wijdenes-Pijl, M Zwart, H
Urban zone Environmental zone Rural zone Rural zone Urban zone Industrial zone Urban zone Urban zone Environmental zone Urban zone Urban zone Rural zone Urban zone Urban zone Environmental zone
37 97 111 119 38 82 28 22 96 45 41 120 36 47 102
Poster presentations
Bitsch, L Blad, S Boerwinkel, DJ Bredenoord, A De Jong, A Dijkstra, A Dortmans, K Dücker, E Engelbrecht, D Gao, L Gremmen, B Gupta, J Henneman, L Horstkötter, D Idema, T Jans, S Kato, M Plass, A Staunton Timmermann, C Van Baren, J Van der Valk, T Verhoeff, R Weir, M
Urban zone Urban zone Urban zone Urban zone Urban zone Urban zone Urban zone Environmental zone Industrial zone Urban zone Rural zone Urban zone Urban zone Urban zone Urban zone Urban zone Urban zone Urban zone Urban zone Environmental zone Urban zone Urban zone Urban zone Rural zone
59 77 77 61 62 64 65 104 93 67 123 68 69 70 71 73 74 75 77 105 59 77 76 122
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si es
ons abou t
urban zone
• biobanks • health care • genes, race and ethnicity • genetic screening and testing • personalised health
industrial zone
• industrial biotechnology • safety and sustainability • innovations
environmental zone • ecological genomics • promises and expectations
rural zone • animals, plants and seeds: genomics technologies in the rural zone • international developments • governance of agricultural genomics
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