Ethical, legal and social aspects of
biotechnology, nanotechnology and cognitive
science
Recommendation from a committee appointed
by the Research Council of Norway
Division for Strategic
Priorities
Research Council of Norway
Stensberggata 26
P.O. Box 2700 St. Hanshaugen
NO-0131 Oslo
Telephone
+47 22 03 70 00
Fax:
+47 22 03 70 01
e-mail: [email protected]
www.forskningsradet.no
2
Preface
On 5 September 2006 the Research Board of the Division for Strategic Priorities of the
Research Council of Norway appointed a planning group tasked with reporting on research
challenges facing research on ethical, legal and social aspects of biotechnology,
nanotechnology and cognitive sciences and making recommendations on how such
research should be organised in the future. The group’s terms of reference appear in
Appendix 1. Owing to delays in getting the group’s work under way, the original timetable
in the terms of reference was moved back somewhat.
The planning group was composed as follows:
Dagfinn Føllesdal, Professor, Stanford University (chair)
Peter Aleström, Professor, Norwegian School of Veterinary Science
Rigmor Austgulen, Professor, Norwegian University of Science and Technology (NTNU)
Hans Glimell, Professor, Göteborg University
Fabrice Lapique, Research Manager, SINTEF Materials and Chemistry
Anne Ingeborg Myhr, Research Fellow, Norwegian Institute of Gene Ecology, University
of Tromsø
Andreas Roepstorff, Associate Professor, University of Aarhus
Henriette Sinding Aasen, Professor, University of Bergen
Thorvald Sirnes, Research Fellow, Stein Rokkan Centre for Interdisciplinary Studies
Berge Solberg, Associate Professor, Norwegian University of Science and Technology
(NTNU)
Anne Bjørneby Vik, Chief Operating Officer, Nattopharma ASA
The secretary for the group was Research Fellow Egil Kallerud, NIFU STEP.
From the Research Council:
• Senior Adviser Elisabeth Gulbrandsen
• Adviser Helge Rynning
Executive officer Lise Johansen was responsible for printing out the report.
The planning group submitted the report on 1 June 2007. The Research Council thanks the
working group and others who have contributed to a very interesting and thorough report.
Particular thanks go to Professor Dagfinn Føllesdal for his work as group chair and to Egil
Kallerud for his excellent service as secretary.
Oslo, June 2007
Christina Abildgaard
Division Director
Research Council of Norway
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Contents:
1
Towards a new ELSA initiative - background and perspectives.............................6
1.1 Research Council of Norway support for research on ethical, legal and social
aspects of biotechnology .........................................................................................6
1.2 Generic technologies’ special challenges in ELSA research ..................................7
1.2.1 Nanoscience and nanotechnology .................................................................7
1.2.2 Cognitive science...........................................................................................9
1.2.3 Basic technologies, radical innovations, revolutionary social changes.........9
1.3 Acceptance, value choices, democracy.................................................................12
2
Research challenges ...................................................................................................16
2.1 Science, technology and society ...........................................................................16
2.1.1 Technological and cultural change ..............................................................16
2.1.2 Biotechnology and self-image .....................................................................17
2.2 Democracy, justice, power....................................................................................18
2.2.1 Democracy and technological developments ..............................................18
2.2.2 Fair distribution ...........................................................................................19
2.2.3 Needs and market ........................................................................................19
2.2.4 The relationship between industrialised and developing countries .............20
2.3 Language, dissemination, dialogue.......................................................................20
2.3.1 Dissemination ..............................................................................................20
2.3.2 Dialogue and the production of meaning ....................................................21
2.4 Governance and priorities .....................................................................................22
2.4.1 Governance, funding, incentives .................................................................22
2.4.2 Individual needs and social governance ......................................................23
2.4.3 Knowledge economy and commercialisation..............................................23
2.5 Medicine and health: Prevention, enhancement and design .................................25
2.5.1 Risk of irreversible harm .............................................................................25
2.5.2 Epidemic of risk...........................................................................................26
2.5.3 Prevention of individuals.............................................................................26
2.5.4 Selection and design ....................................................................................27
2.5.5 Enhancement ...............................................................................................28
2.5.6 Bioethics and neuroethics............................................................................28
2.6 Food, environment and nature. .............................................................................29
2.6.1 Biotechnology and gene technology............................................................29
2.6.2 Nanotechnology...........................................................................................32
2.7 Privacy, consent ....................................................................................................33
2.8 Risk, precautionary principle ................................................................................33
3
Norwegian ELSA research ........................................................................................36
3.1 The Research Council’s ELSA initiative ..............................................................36
3.2 Social science research..........................................................................................37
3.3 Ethics research ......................................................................................................38
4
3.4 Legal research....................................................................................................... 39
3.5 ELSA research in biotechnology, nanotechnology and cognitive science
disciplines............................................................................................................. 40
4
Strategy for a new initiative for ELSA research .................................................... 42
4.1 Funding and organisation ..................................................................................... 42
4.2 Objectives, tasks and funding criteria .................................................................. 44
4.2.1 Primary objective: ELSA research of a high international calibre ............. 44
4.2.2 Concentration, diversity and networks ....................................................... 44
4.2.3 Interdisciplinary quality .............................................................................. 45
4.2.4 Expertise building and project initiating..................................................... 46
4.2.5 ELSA research in the wider society............................................................ 46
4.2.6 International dimensions............................................................................. 47
Terms of reference for the planning group for ELSA research...................................... i
5
1
Towards a new ELSA initiative - background
and perspectives
1.1
Research Council of Norway support for research on
ethical, legal and social aspects of biotechnology
On 5 September 2006 the Research Board of the Division for Strategic Priorities of the
Research Council of Norway decided to appoint a planning group tasked with “[reporting]
on research challenges facing ELSA research, i.e. research on ethical, legal and social
aspects of biotechnology, nanotechnology and cognitive sciences. The aim of the process is
to obtain knowledge, perspectives and assessments that can be applied to launching a new
initiative in the area of ELSA research”. The planning group’s discussion of this issue
understands this mandate as implying that any further commitment to ELSA research
ought to address experiences and challenges that cut across these disciplines.
The basis and point of departure for a further commitment to bolstering and enhancing
Norwegian ELSA research under the auspices of the Research Council of Norway are in
the Council’s previous initiative in this area. With few exceptions this has been associated
with biotechnology. Many of the same issues and challenges underlying the previous
initiative will also apply to the new initiative. 1 Key challenges have been investigated to a
limited extent, and an important consideration in a new initiative will be to ensure that the
results and expertise already amassed are maintained and developed further.
The development of biotechnology has been characterised by tensions. On the one hand,
modern biotechnology opens up a broad spectrum of new issues, services and products in
areas ranging from medicine and agriculture to environmental protection and law. At the
same time, its development has been marked by uncertainty and has been greeted with
considerable scepticism and resistance by many members of the public. Although
uncertainty and disagreement continue to be important features of the position and
development of biotechnology, the scepticism and resistance of Norwegian opinion now
appear to be on the wane in favour of more positive attitudes.2 The interplay between
benefits, risk and ethics appears to play a major role for social acceptance. The fact that the
new products are perceived as beneficial seems to explain the existence of overwhelmingly
positive attitudes towards medical applications, whereas negative attitudes have tended to
overshadow the positive with regard to genetically-modified food products and plant
varieties. Laws and regulations designed on the basis of growing knowledge and
experience regarding the particular challenges raised by biotechnology are now in place,
1
Cf. Etikk, samfunn og bioteknologi [Ethics, society and biotechnology]. Report of the planning
committee, December 2000, and Etikk, samfunn og bioteknologi [Ethics, society and biotechnology].
Programme plan, January 2002
2
Torben Hviid Nielsen. “Flere ser mere positivt på bioteknologi” [More people have a more positive
view of biotechnology], Samfunnspeilet no. 1, 2007.
6
while the results of new research and innovations require constant adjustments in rules and
regulatory practice.
As the products, methods and terminology of biotechnology make inroads into new
markets and areas of society and experience, the basis is expanded for empirical studies of
dilemmas, options and impacts related to the development of biotechnology. One feature of
the development of biotechnology is that it often takes longer, has different impacts,
follows other paths and is more complicated and multifaceted than anticipated. This
necessitates continued vigilance, knowledge development and a wide-ranging debate on
the further development of biotechnology. And if it is correct that biotechnology is about
to lose some of its special status as a particularly complicated and controversial
technology, new knowledge about the causes and processes underlying such a change will
provide an important new insight into the relationship between technology and society in
general. Furthermore, the process may serve as a guide for dealing with other, related
technologies.
1.2
Generic technologies’ special challenges in ELSA
research
Nanotechnology and cognitive science are at an earlier stage of development than the one
biotechnology is at, which raises questions that in many areas and in many ways coincide
with or are closely related to those in biotechnology. A joint effort can lay the groundwork
for utilising experience and results from research on the ethical, legal and social challenges
of biotechnology in comparable research on nanotechnology and cognitive sciences.
1.2.1
Nanoscience and nanotechnology
It is not uncommon for nanoscience and nanotechnologies to be referred to only as
nanotechnologies. It is hard to define a sharp demarcation between the two. However, it is
generally accepted that nanoscience is the study of phenomena and techniques, whereas
nanotechnologies deal with the design, production and application of nanostructures.
Such structures represent a “magical” limit in dual sense. They are not only smaller than all
previous structures that have been created for practical use, but are also the smallest size
where structures are stable and solid. For that reason nanostructures are also at the limit at
which the properties of materials that we encounter day to day (such as hardness, melting
point, conductivity etc.) are replaced by the properties of the atomic and molecular world.
A number of definitions of nanotechnology have been proposed. What they all share is a
scale that is usually from sub-nanometre to a few hundred nanometres (1 nanometre is 10-9
metres, i.e. one one-thousandth of a micron). But almost all chemical compounds are
within this scale of length. For that reason nanotechnologies must involve more than just
size. Specifically, nanostructures must represent a particular form, or geometry or
particular properties. Likewise, nanoscience and nanotechnology must represent an ability
to manipulate or control those properties at this scale.
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Mastery over phenomena at the nanoscale requires technologies that enable us to
manipulate atoms and molecules at this scale. Nanofabrication techniques are usually
divided into two categories: “bottom-up” and “top-down”. In “bottom-up” assembly,
structures are built atom by atom or molecule by molecule. “Top-down” fabrication
processes begin with a larger block of material and etching or milling/cutting to
nanostructures by removing material from the original block. Such techniques have been
used in the electronics industry for several decades to produce circuits and microchips.
A broad spectrum of possible applications may have a sizeable impact on such areas as
medicine, food and agriculture, information and communication, materials, the military
and energy and the environment. Nanosciences and nanotechnologies constitute a wide
interdisciplinary field of research where physicists, chemists, biologists, engineers and
medical scientists collaborate in areas that range from biology to material science.
The discussion of social and ethical aspects of nanoscience and nanotechnology is already
an integral part of the process of defining and developing areas for science and technology.
There is a desire to avoid the mistakes from other areas of technology, particularly gene
technology, so that this time everything can be done correctly from the start. At the same
time, this involves an approach that creates fundamental ambiguity and tension, where on
the one hand the radical and revolutionary nature of this technology is emphasised and on
the other, assurances are given that foresight will provide an adequate basis for control and
accountability.
The problems relating to nanotechnology may be grouped into three classic categories: (1)
scientific experiments that go haywire and end up beyond human control (cf. apocalyptic
fantasies and Frankenstein’s monster); (2) abuse or usurpation of discoveries (cf. the myth
of the sorcerer’s apprentice; Dr Strangelove); and (3) violation of the natural order, human
hubris (cf. “playing God”; the Prometheus myth).
After a certain amount of media focus on “grey goo” scenarios (self-replicating
nanosystems out of control), discussions under Category 1 have concerned more pragmatic
discussions of testing of products containing nanosubstances prior to market launch and
prevention of the risk of uncontrolled dissemination into the environment or the body.
Under Category 2 the particular emphasis is on the technology’s potential for biometric
applications of a type and scope that may threaten personal integrity, as well as ethical
questions regarding possible military applications. The potential for abuse and
uncontrolled development may appear to be particularly great if developments take place
in areas not subject to public access and oversight. Related to Category 3 are ethical issues
springing from nanotechnology’s ambition for full control over living material and to use
self-organisation of such material to perform mechanical functions.
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1.2.2
Cognitive science
On the one hand, cognitive science embraces studies of the brain and nervous system and
the physiological processes that take place there. On the other hand, cognitive sciences also
include the study of cognitive processes and the interaction between them and what takes
place in the brain and nervous system. Applications of cognitive science are on the
threshold of development.
Cognitive sciences are undergoing a revolution on several fronts. There is, for example, an
ever closer connection in research methods between research in neurology and research in
cognition, and a number of new technologies are emerging that utilise knowledge about
cognition in natural and artificial systems for expanding human capabilities and/or
establishing new forms of intelligent systems and robots. Compared with biotechnology,
these possibilities have really yet to be realised, and it is at the present time unclear that
they will even be practicable. Even so, these developments may prove to be momentous,
because they may change the way in which we humans think and talk about ourselves.
The developments in cognitive sciences towards focusing on the brain means that the brain
as an explanatory model is being made increasingly relevant across a number of academic
disciplines, from aesthetics and economics to psychology and philosophy. This is reflected
in the emergence of a number of new subdisciplines, such as neuroaesthetics,
neuroeconomics, etc., which indicates that the brain as a model for what is human has been
given a new role in recent years. At a certain level, the brain is about to assume importance
as a general explanatory model. This may eventually affect how social, medical and
pedagogical practice is described, conceived and perhaps designed. As the British
sociologist Nikolas Rose has noted: just as in the twentieth century people came to
understand themselves as inhabiting a deep psychological space, they now increasingly
understand themselves in terms of a “brain space”. At the same time research-based visions
of the future are emerging involving cognitive enhancers, pharmaceuticals that can boost
cognitive abilities such as memory and attention. Another vision is the possibility of new
forms of intelligent human/machine interaction that enlarges the potential for human action
by establishing intelligent links between the brain and machines, or by creating new forms
of intelligent robots and artificial life on the basis of knowledge of naturally occurring
cognitive processes.
1.2.3
Basic technologies, radical innovations, revolutionary social changes
Nanotechnology and biotechnology are both generic or basic technologies; they both have
potential applications in very many areas and ways. They are also technologies that can
give rise to a broad array of radical innovations, novel solutions and services, products and
markets, as opposed to gradual innovations that involve minor improvements and/or cost
reductions of existing products, etc. Both technologies are also often called strategic
technologies. This means that they are technologies that companies and economies need to
master and be able to exploit effectively in order to assert themselves in an increasingly
9
knowledge-based global economy. To an even greater degree than is the case for
biotechnology currently, nanotechnology can also be characterised as an emergent
technology.
One reason for linking ELSA research on biotechnology and nanotechnology, respectively,
a linkage on which this report is based, is that the development of biotechnology has been
marked by conflicts that could have and should have been avoided through a different and
better balance between an early sharp focus on technological possibilities and economic
opportunities on the one hand, and a subsequent or more narrow focus on and attention to
ethical and social implications on the other. As nanotechnology emerges as a new
technology with much of the same generic, radical and “disruptive” potential as
information and communications technology (ICT) and biotechnology, we should try to
avoid the legitimacy and acceptance problems that biotechnology in particular has faced.
For that reason it is crucial to learn from the positive and negative experiences from the
turbulent development of biotechnology. They have clearly shown that in technologies that
can be developed and used in so many areas and ways, the importance of social acceptance
and benefits must take centre stage. At the same time, the two technologies are at different
stages of their evolution, which different conditions for ELSA research.
Cognitive science is not a basic or “enabling” technology in the same sense and to the
same extent as biotechnology and nanotechnology. It scarcely has the same comprehensive
generic potential as the others. However, novel applications on the basis of progress in
brain science and other cognitive sciences may be radical and sensitive, because they
pertain to such fundamental abilities and characteristics of what it is to be human - as a
species, social being and person. Just as modern knowledge in biotechnology has
dramatically deepened our insight into and ability to intervene technically in fundamental
biological processes, brain science and other cognitive sciences are creating similar
possibilities with regard to the brain, consciousness and mind. For example, issues relating
to selection may arise in connection with the potential for non-therapeutic enhancement of
human cognitive abilities in ways that may lead to a fundamental shift in understanding the
relationship between human and technology/machine.
These three fields of science and their technologies are often referred to jointly – and
together with information and communications technology –as converging technologies.
This is a concept on the technology policy agenda that springs from a scientific and
technological evolution where ICT, biotechnology, nanotechnology and cognitive sciences
are increasingly merging and/or complementing one another. As an area of research that
cuts across traditional discipline boundaries, nanotechnology itself is a converging
technology. The definition of nanotechnology and converging technologies (“nano-bioinfo-cogno”) does not have an unambiguous scientific and technological foundation, but
also reflects an agenda and a project to encourage the fusing and convergence of
technologies in order in this way to speed up and streamline the exploitation of the vast
potential of these technologies to create radically novel products, applications and markets,
10
and disruptive changes in social conditions and human abilities. According to many, a
convergence of nanotechnology, biotechnology, information technology and cognitive
sciences will increase our ability to control and manipulate at the nanoscale, so as to
improve human physical and cognitive performance. Converging technologies are defined
as “technologies and knowledge systems that support one another in the evolution towards
common objectives”. In this way, this evolution is not only to be determined by the
autonomous scientific and technological developments themselves, but also by purposes
and values.
A consequence of converging technologies primarily being perceived as enabling
technologies, those with a broad but unspecified potential and thus not associated with any
specific objectives or certain types of applications, is that they are discussed on the basis of
visions rather than results. There is a growing discussion of what view of development and
innovation such visions are to be based on. In the international debate, two different
paradigms or regimes of innovation have been juxtaposed.3
In the first paradigm, the point of departure and driving force are intimately connected with
the new promises that today’s techno-sciences are regarded as being able to keep at an ever
increasing pace and where the underlying assumption is that we need technological
innovation to realise human potential. This paradigm implies a belief that scientific
discoveries automatically or by law lead to technical innovations and to applications that
meet societal needs and create economic growth. The influence parties outside the circle of
scientific and technical experts may have is limited to making up their minds for or against
the techno-scientific promises.
An alternative that instead broadens the “circle of innovation” is a paradigm involving a
notion of collective experimentation. Here the society becomes a kind of laboratory for
experiments springing from objectives formulated through collective processes comprising
many kinds of actor and forms of knowledge. The assumption here is that we need social
innovation to realise technological potential. Instead of strong confidence in technoscientific promises (or even in technological fixes), technologies are mobilised as a
resource in a process that sets and carries out an agenda governed by long-term social
objectives and needs.
This second paradigm comprises both other kinds of actor and different norms for
collaboration between laypersons/users and experts than those in the “orthodox” regime of
innovation, like the one we see in the Open Source Software Movement, the increasing
role of patient organisations in medical research and in the “slow food movement”. The
spectacular launch in the US of nanotechnology and other converging technologies has
been described as an illustration of the first paradigm, while individual initiatives in the
11
same areas under the auspices of the EU have recommended approaches and new
institutional forms that correspond to the second model4.
A key aspect of the evolution of converging technologies, as considered within the first
paradigm, is that technological and social innovation takes place and ought to take place at
high speed. This is partly due to the dynamics of scientific and technological evolution
itself. However, this also happens in order to hasten and accelerate developments that can
create competitive national and regional economies or solve pressing problems of a healthrelated or environmental nature (the “tyranny of urgency”). Economic competitiveness is
commonly invoked for maximising the speed of developments. In the area of human
biotechnology we also see that patient groups, for example those with genetic ailments, are
helping to increase the pressure for maximising the speed of biotechnological
developments. Hopes, expectations and promises are directly linked to the issue of access
to resources and trigger an uncritical and unrealistic “hope and hype” dynamic, where the
time-consuming and complex nature of innovation processes and the social dissemination
of new applications are easily underestimated. There is a concurrent risk of downplaying
the need for quality assurance and proper regulation and for developments to take place in
accordance with accepted standards and vital social needs. The development of
biotechnology confirmed not only that the price of neglecting the importance of ethical and
social acceptance can be deadlocked conflicts and stagnation, but also that profitable and
useful applications emerge through other process that are slower than scientific
breakthroughs.
1.3
Acceptance, value choices, democracy
A recurrent feature in the history of research policy is a widespread concern in scientific
and academic communities about the lack of knowledge about and support for research in
society. The public and policymakers, the argument usually goes, are inadequately aware
of research for it to get the support and resources it deserves. However, despite variations
between countries and over time, surveys of general perceptions of and attitudes towards
science and technology show a relatively stable picture, characterised by overwhelmingly
favourable attitudes. One exception from this general picture has been nuclear power,
while biotechnology became a new example, not least in Norway, of the fact that
considerable scepticism and resistance to science and technology nonetheless exist.
3
See Taking European Knowledge Society Seriously. Report of the Expert Group on Science and
Governance to the Science, Economy and Society Directorate-General for Research, European
Commission, DG Research, 2007.
4
Roco, M.C. & W.S. Bainbridge (red) (2004) Converging Technologies for Improving Human
Performance – Nanotechnology, Biotechnology, Information Technology and Cognitive Science. New
York: Springer; Nordmann, A (reporter) (2004) Converging Technologies. Shaping the Future of
European Societies. A Report from the High Level Expert Group on “Foresighting the New Technology
Wave”. European Commission. EUR 21357
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As mentioned earlier, there are signs that the picture of polarisation and sharply negative
attitudes towards biotechnology may be about to change. This may be because after
decades of intense debate and changes in political processes and regulatory systems the
power imbalance characterising earlier stages of the development of biotechnology –
between the powerful forces pushing for the fastest possible scientific, technological and
economic development on the one hand, and the society’s underdeveloped capacity for
access and oversight on the other – appears to have been levelled out. With greater public
attention and vigilance, deeper understanding and knowledge of ethical and social aspects
and functioning regulatory systems, confidence is growing that society has strengthened its
capacity to regulate and steer developments.
New forms of discussion, dialogue and consultation have emerged that emphasise
encouraging a broad public debate and enable the public to voice their concerns
independently. The objections and scepticism of laypeople are taken seriously. The
experiences that crystallised during the development of biotechnology form the basis of
initiatives regarding nanotechnology, in order to prevent the same imbalances and time lag
from occurring again. Growing and potential objections, legitimate as well as groundless
fears, are to be noted and addressed as early as possible, while developments are still in an
early phase.
At the same time, the emergence of experimental and increasingly institutionalised forms
of deliberation and dialogue heavily emphasising public opinion and lay perspectives has
also gradually led to increased attention to the costs and limitations of such approaches.
Unless people have real influence on decisions, such processes will easily be perceived as
window dressing, staged to create the appearance of dialogue and shared influence, while
decisions remain unchanged and power imbalances persist. Opinion, attitudes and
expectations among the public appear largely connected with their understanding of the
institutional framework within which research and innovation is initiated, funded and
regulated, as they determine and reflect various groups’ access, power and control, and
thus how benefits and costs for affected groups are weighed against one another.
Increased knowledge is vital for creating greater awareness of these issues. We need to
improve our ability to identify and formulate the problems that arise, in order to bring such
issues and concerns into the processes and institutional systems where technological
developments are shaped, steered and regulated at as early a stage as possible. In this way
society will be able to establish an active relationship with these issues, make choices and
set priorities and put in place adequate systems for regulation and control as early as
possible. This will help to ensure that developments take place in accordance with
fundamental norms and values and are based on acceptance and trust.
The institutional system for science and technology policy is marked by a division and a
distance between, on the one hand, interests and bodies intent on promoting and
advocating research, technological development and innovation, and, on the other hand
13
institutions that are supposed to exercise oversight and on behalf of society avert risk and
limit environmental, human and social costs. The relationship among these functions and
institutional systems are characterised by a fundamental asymmetry of power and time lag.
In early, formative stages of developments (“upstream”), objectives are formulated, tasks
assigned priority and resources mobilised under the direction of players in research and
innovation. The society’s regulatory interest does not enter in until at a later stage
(“downstream”), when the technologies have largely taken shape and their applications are
more or less determined. At this stage the possibility for action may be limited, among
other reasons because the profitability of large, tied-up investments in technological
projects is at stake. This asymmetry and time lag are especially problematic when
technological developments proceed particularly quickly and may lead to rapid, farreaching and complex social changes.
For that reason it is essential that the debate on technological developments be organised
so that the time lag and power asymmetry in the relationship between promoting and
controlling poles are reduced. The initiatives that are now being taken to create awareness,
discussion and knowledge of ethical, legal and social aspects of the development of
nanotechnology should be taken early on.
ELSA research on biotechnology has largely concerned risk and impacts. It has situated
itself “downstream” in the innovation processes, with no aim to influence these processes.
In that way, ethical and social issues were decoupled from the other economic and political
issues pertaining to social goals, oversight, power and accountability. In the Netherlands,
the UK and Denmark alternative approaches are emerging in ELSA research relating to
nanotechnology, under such terms as “constructive (real-time) technology assessment” and
“upstream public engagement with science”.
These are examples of new initiatives in the ELSA tradition to reduce the distance,
asymmetry and time lag between “upstream” and “downstream” innovation processes.
They aim a critical spotlight on established structures and processes for governance and
regulation of research and innovation and raise questions about the need for institutional
innovations to make it possible to meet the high ambitions for structural changes in the
relationship between scientific and technology policy institutions. This spotlight is
increasingly shone on upstream processes in research and innovation policy, where it raises
questions about how technology assessments oriented towards laypersons and participants
can be brought to bear earlier in such processes and how ELSA research can be organised
and conducted to obtain greater influence on shaping technologies and choices of
applications.
In other areas, however, ELSA research has not just been early; it has analysed possible
impacts of technology long before they are realised and exist only as long-term objectives
or hopes within the scientific community. Key examples are human cloning, manipulation
of sex cells to achieve certain characteristics in people, determination of key genetic causes
14
of widespread disorders, halting of ageing, etc. For that reason large portions of ELSA
research can be characterised as being “futurology”. This is important for focusing on the
transformative potential of the technologies at a human, cultural and social level, but it
may also mean the risk that the impacts of the broad implementation and socialisation of
less spectacular technologies, in the health service, for example, get less attention.
Concerns and hopes relating to future technologies may also serve to give them misleading
status in political and general consciousness as already existing technologies. In this way,
ELSA research is helping to construct and create its object of research in a political and
economic sense, of which nanotechnology can be a key example.
Moreover, key parts of ELSA research have focused on the ethical and cultural
significances and impacts of biotechnological research and scientific experiments in
themselves, and not only on the consequences of any subsequent implementation in
various areas of society. This applies, for example, to research on fertilised ova and
therapeutic cloning. ELSA researchers have been concerned that individual experiments
and individual incidents in the scientific community can send ethical and normative signals
to the general public.
Such questions concerning ELSA research’s own roles, positions and functions with regard
to the social and political development of science and technology focus on key selfreflexive challenges relating to ELSA research. These can and ought to be central research
topics for ELSA research itself: What role does such research play in political processes
and public debate? What results and effects does it have, under what conditions?
15
2
Research challenges
The aim of this recommendation is to establish a framework for an ELSA research
initiative that needs to be very broadly conceived in respect of topic as well as technical
approaches. Not only is it to lay the groundwork for a continuation and refinement of
ELSA research with regard to biotechnology, an area where it is necessary to address new
issues and a quickly growing body of knowledge. This focus will also include two other
areas of science/technology that on a number of points raises issues of concern to ELSA
research that are, or apparently will be, closely related to those faced in biotechnology. At
the same time, on other points, they raise distinct issues and present ELSA research with
essentially different initial conditions. To view and plan ELSA research with regard to
three different areas of science/technology taken together may lay the foundation for
transmission and learning across these areas. However, this also creates a very extensive
and complex field of study, where science and technology (biotechnology, nanotechnology
and cognitive science), ELSA disciplines (ethics, law, society) and topics cross, contrast
with and overlap one another in innumerable ways. In the following overview of relevant
research challenges facing an interdisciplinary and “intertechnological” ELSA programme,
these fundamental topics serve as the primary dimension. This is intended to underscore
the cross-disciplinary perspective. At the same time it means that researchers are moving
into virgin territory. For that reason the overview of relevant research challenges should be
understood as a call to research communities to develop innovative ELSA research along
the lines suggested. Therefore the topics mentioned are not to be understood as proposals
for set thematic guidelines for the research that should be supported as part of the initiative.
2.1
2.1.1
Science, technology and society
Technological and cultural change
Technological change is a powerful engine of social transformation. However, few today
would see the connection between technological and social change as a one-way causeand-effect relationship, where technological development processes unilaterally and
unambiguously determine the content and direction of social changes. Technologies are
developed, shaped and transformed through complex social processes, in which social
acceptance and societal needs affect the selection, design and dissemination of
technologies. Insights into social processes and factors relating to technological change and
innovation may help society to avoid unsound investment and social conflict.
ELSA research applies a broad approach to studies of social processes with particular
focus on values, attitudes and expectations with regard to technology and particular
applications. Comparative ELSA studies of biotechnology have shown that there is wide
variation among different societies in terms of the issues perceived as problematical and
requiring special attention and elucidation. Thus, studies of ethical, legal and social
16
processes relating to technological change also are key sources of knowledge about the
social, cultural and political characteristics distinguishing various societies.
Research on ethical and values aspects of technological development is usually motivated
by the attitudes researchers find in their own society. At the same time, such research can
also help us to understand ethical and values aspects of developments that few people or no
one noticed before.
2.1.2
Biotechnology and self-image
While with regard to nanotechnology and cognitive science ELSA research primarily
addresses possibilities and expectations, visions of the future and projects, research in
biotechnology can increasingly undertake empirical studies of how the interaction of
technological, social and cultural factors affects how technological possibilities are
actually adopted or rejected, chosen and modified. Such studies of the societal aspects of
the development of biotechnology will also provide an insight into how much and in what
ways biotechnology affects individuals, normative structures and social processes - in what
sense and to what extent are we about to become “the biotech society” that many have
warned about? The range of possible research topics on such questions is extensive. Some
examples are:
Changed medical practices and understanding of disease
Expanded knowledge of the use of modern biotechnology in the health service may change
our understanding and definitions of the concepts healthy and sick. How will knowledge of
genetic susceptibility to disease or disorders affect our perception of ourselves and our
behaviour towards sick people and people with disabilities? Access to genetic information
creates an opportunity and responsibility to actively relate to the genetic aspects of one’s
existence and may have implications for the individual’s future and relations with family.
Shared genetic characteristics may form the basis of social identity and organisation. In
this way genetics becomes a new social dimension (“genetic citizenship”). It also does this
because the new diagnostic and therapeutic avenues that biotechnology opens up are
increasingly becoming an integral part of the ordinary range of health services. This
provides the basis for developing an understanding based on experience and empirical
research on the consequences this has for the individual, society and health sector. These
developments entail a need for ethical, legal and legal policy analyses and legal regulation
that addresses key ethical implications.
Religion and biotechnology
A crucial constraint on the development of biotechnology, and perhaps other technologies
too, is the global revitalisation and reinforcement of the religious dimension that has taken
place in the past decades. Many believe that they see in this development not only a
quantitative increase, but also a fundamental change in the religious dimension and its
relationship to other cultural and social dimensions. The development of biotechnology,
especially human biotechnology, is one of the key arenas where these change processes are
17
expressed as more or less powerful reactions against what is perceived as the
objectification of life, body and mind. To what extent does this confrontation between
human biotechnology and ethically, philosophically and religiously founded views of what
is uniquely human help to strengthen the importance of the religious dimension in research
and politics? Will they serve to amplify political conflicts regarding developmental trends
in modern genetics?
2.2
2.2.1
Democracy, justice, power
Democracy and technological developments
The transformative potential of biotechnology, nanotechnology and cognitive sciences
places problems connected with democracy at the centre of ELSA research. As it is no
longer possible to appeal to a universal faith in “progress” in general and scientific and
technological progress in particular, scientists and engineers no longer have a “free pass”
from society to engage in their activities. The terms for public reflection, opinion
formation and democratic decision processes on these technologies are thus taking centre
stage. This raises such issues as: What are the implications of the enormous gap in
expertise between specialist research teams and the public? And what is the effect of the
systematic “blindness” of scientific disciplines? While it is the overall effects on nature,
human beings and society that are crucial from the perspective of the public, scientific
disciplines select for themselves among issues that are relevant for the problems they
address. What are the possibilities for science and democracy that interdisciplinary
approaches open up? How can broad public discussions compensate for the narrowness of
scientific disciplines?
These are questions that are vital to a large number of venues where it is important to
establish forms of dialogue and mutual understanding between society and science, the
layperson and the professional. This kind of dialogue is essential if scientific and
technological development is to be subjected to adequate forms of democratic access,
influence and responsibility. One particular research topic worth mentioning is technology
assessment. During the past 10 to 15 years participant-oriented technology assessments
have created greater general awareness, knowledge and discussion of social and ethical
consequences of technology. Through experimenting with methods and building
institutions researchers have sought to create a framework for debate that opens up a
diversity of perspectives and value considerations. The idea was to make technological
development and technology policy more democratic with the aid of methods inspired by
theories of direct and deliberative democracy. Following the example of other countries,
Norway has institutionalised technology assessments of this kind as part of its technology
policy. What has been the experience in Norway, compared with other countries? In what
way and to what extent have participant-oriented technology assessments raised awareness
and sparked debate on the consequences, dilemmas and choices with regard to
technological developments?
18
However, ELSA research on consensus conferences and other participant-oriented
initiatives has also been critical of their democratic potential. According to critics these
initiatives can be controlled directly and indirectly by the choice of experts and the issues
accorded status as the essential ones, through a requirement for consensus, etc. Such
initiatives derive much of their legitimacy by virtue of appearing to be a representation, a
miniature version, of broad public discussions. However, tight time constraints, the
reduced diversity of possible voices and their staged character can limit the status of such
initiatives as “mini-publics”.
In a further context it is also important to investigate which forces are putting stumbling
blocks in the way of a more democratic technology policy. What power mechanisms and
conscious or unconscious tactics suppress or squelch the public debate on human
technologies? What about the use of faces and the sufferings and illnesses of individuals,
the use of examples of war and the history of eugenics, the use of hopeful or risk
narratives, etc.? Where is the boundary between moralistic tabooing and insightful
contextualisation? These and other research questions focus on the relationship between
“discursive” power – the power of language and the power to define – and the conditions
for public reflection and debate.
2.2.2
Fair distribution
In all three areas, biotechnology, nanotechnology and cognitive sciences, new insights are
being produced that open up new opportunities for action. How should society’s resources
be distributed between science and other needs? And what concerns or interests should
govern the distribution of these resources? Will science and its applications benefit those
who need them most, or will they serve to amplify the inequalities in the society?
Here, too, a close collaboration is needed between nature researchers, social scientists,
ethicists and legal scholars to find out what is possible, what societal consequences it will
have, what consequences it ought to have and how legislation and regulations can best be
used to get the desired outcome.
2.2.3
Needs and market
Developments in science and technology are largely and increasingly market-oriented and
are therefore automatically focused on markets and groups with considerable purchasing
power and/or the ability to influence the use of public resources. Needs that are not
expressed in terms of purchasing power demand or voiced by influential pressure groups
are neglected, and the technological potential for meeting these needs is not exploited.
What possible alternative systems and mechanisms can help to redress such imbalances?
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2.2.4
The relationship between industrialised and developing countries
The last issue mentioned is particularly germane to the relationship between industrialised
and developing countries. There are dramatic differences between countries and regions
with regard to the distribution of science and technology resources. Even if new
technologies have a vast potential to solve enormous development, nutritional and health
problems in less developed parts of the world, this skewed distribution means that this
potential is being underutilised. Conversely, the high concentration of these resources in
the rich part of the world means that developments are focused on less important tasks and
luxury needs. Both biotechnology and nanotechnology can open up new technological
opportunities for creating wealth and meeting needs in the poor world – in agriculture, for
developing new medicines and for exploiting genetic resources. However, these countries
have few science and technology resources that they can mobilise themselves to solve
these problems. What mechanisms create and maintain the imbalance in research resources
and in the fruits of technological developments? What can and ought to be done to redress
these imbalances, and how can we ensure that poor parts of the world can enjoy the
benefits of developments in science and technology to a materially greater degree? What
forms of legal regulation of a national and international nature are necessary to ensure a
fair distribution and fundamental human rights? It is important to be able to shed light on
how industrialised countries can help to support developing countries’ development of
their own bioresources and to honour international obligations regarding modern
biotechnology, including the Convention on Biological Diversity and the Cartagena
Protocol. In this connection, the distribution of benefits and costs connected with new
technology is also relevant: will new technology developed in the West also lead to
benefits in developing countries or will they bear the burdens?
2.3
2.3.1
Language, dissemination, dialogue
Dissemination
Communication and dissemination in actually and potentially controversial technologies
like biotechnology, nanotechnology and cognitive science raise particular demands and
obligations. Those engaged in them face the same dissemination challenges as in science in
general. The language of research is technical and complicated, and needs to be simplified
to be understood outside the experts’ own sphere. This leads to losses of nuance and
qualifications, with numerous opportunities for misrepresentation and exaggeration. The
dissemination of research results appears as an asymmetric form of communication, which
gives laypeople scant opportunities independently to check whether information is
balanced and matter-of-fact or whether, for example, it may be slanted out of a desire to
link particular value associations, positive or negative, to the message. This makes an
ethical demand on disseminators to communicate sober, balanced, complete and reliable
information. This also includes an obligation to communicate and warn about possible
ethical and societal consequences, positive as well as negative.
20
The general media play a key role in disseminating research results, but are subject to
separate mechanisms that can serve to amplify imbalances, by removing disclaimers and
objections and by accentuating aspects that attract attention, whether they are positive
promises and the prospects of useful results or negative scare scenarios of risks and ethical
violations. Professionalism and quality assurance in disseminating research results are
especially crucial in areas like these, where the public debate is often characterised by a
polarisation between utopian images of the future and dystopian worst-case scenarios.
2.3.2
Dialogue and the production of meaning
Placing the phenomena, concepts and applications of science in new semantic contexts
other than those within which they were created results in their being given new meanings
and semantic dimensions. This translation process determines how science and technology
are defined, transformed and integrated not only as science and technology per se but as
integrated into the economic, cultural and political processes in the society. These
processes involve confrontations between different languages and perspectives and may
lead to meaning being created and not just communicated.
This raises fundamental issues regarding the key role language and meaning, discourse and
interpretative frameworks play in the debate on these technologies. These come into play
in the research and innovation policy language and conceptual frameworks these
technologies are placed in when they are defined as generic and future-oriented, with an
enormous potential for economic growth and radical new products and solutions with
regard to health, poverty, the environment and energy. These overwhelmingly economic
and utilitarian conceptions are challenged by other perspectives that stress ethical and
redistributional concerns for a right to be a part of the agendas that set the framework for
the development of the technologies.
The fundamental issue of meaning and translation in the relationship between science and
everyday life takes on acute importance in these areas. The specialised language of science
almost never captures the dimensions that the societal transformations pertain to or within
which they take place. For example, biotechnology does not have a conception of the
human as a privileged normative phenomenon or of the social or cultural. This is pushed to
extremes in debates about human embryos, genetic manipulation, cognitive enhancement,
etc. Translating the phenomena and technologies defined by science into the language of
daily life or the lifeworld is therefore a sine qua non for overarching reflections. Is it
possible to study the conditions for such translations and how they happen in practice?
In cognitive science, mind and brain are more or less synonyms. This understanding
appears to be more generally widespread, with the cultural implications it has such as:
“You are (observed distinctive attributes of) your brain”. This may lead to a reductionist
understanding of mind and personal identity, which is tied to the molecules and processes
that brain science can observe.
21
And what does the modern, late-modern or even post-modern norm pluralism mean for the
formation of public opinion on the human technologies? Do the technologies function as
catalysts for competing or even hostile world views, for example secular and religious?
Are the human technologies becoming a venue of cultural and normative conflicts, where
strategic initiatives dominate, or can we detect tendencies towards discussions that go
beyond such conflicts? In that case, what are the political, social and cultural conditions for
communicative measures where the various players are willing to participate in genuine
processes of learning and understanding?
2.4
Governance and priorities
Studies of social aspects of technology also include studies of factors that make it possible
to influence what forms of knowledge, what technologies and what applications are
supported and given priority. These may be incentives and other instruments intended to
prioritise among areas of knowledge and applications. They also include institutional
structures and social processes that assign various players and interests key or marginal
roles, respectively, in processes where agendas are set, tasks given priority and resources
distributed. It is important to study technology and innovation processes that can yield a
better understanding of how various constraints affect these processes, in order thus to
have a more solid knowledge base on which to develop incentives and instruments to
encourage the technological development and innovation in the direction of areas, tasks
and applications that are not just economically profitable but also especially important in
terms of public value.
2.4.1
Governance, funding, incentives
As we have pointed out earlier, it may be important for ELSA research to shift its focus
somewhat in the direction of more “upstream” perspectives on research and innovation.
Ethical considerations should not play a part only in the final commercialisation and
regulatory phases of research and technology development, but also come in in ways that
give them a stronger influence on the choices made early, “upstream”, in the research and
innovation processes, where the main objectives and direction are set for long-term
research and development processes in respect of the technologies, applications and needs
that govern the processes. It is vital for ethical considerations not merely to become a
question of setting boundaries and formulating prohibitions, but also to help to influence
choices and priorities that ensure that developments proceed in a direction that yields
optimal benefits for society as a whole (“public value”).
In order for ELSA research to shift its focus more “upstream”, it will be important to
understand how early strategic choices for the objectives and direction of research and
innovation processes affect incentives in indirect and complex ways. These include
everything from financial constraints to factors affecting the organisation of processes in a
direction where certain values, interests and concerns have great influence whereas other
are marginalised and powerless. Relevant research topics include: participation in
22
processes where scientific challenges and the potential for applications are identified and
chosen, and in processes where research programmes are formulated; organisation of
processes in which decisions are taken on distributing resources; as well as under the
choice and design of policy or funding instruments.
2.4.2
Individual needs and social governance
The increasing amount of information and number of treatment options are subjecting
society’s resources to growing cost pressure. It is becoming increasingly possible to offer
new kinds of information and treatment of great importance to the individual, but which at
the same time lays claim to extensive resources on society’s part, at the expense of
resources for offerings that are less advanced but that may have greater overall benefits to
society.
Criteria for benefits to society and sustainable development
Among the features that distinguish the Norwegian system for approval of products of
gene technology is that not only health and environmental risks are to be taken into
account, but also ethical considerations, benefits to society and sustainable development.
What distinguishes the Norwegian regulation of gene technology are the criteria
“sustainable development” and “benefits to society”. These terms are controversial and
unclear in part, and there is a need for further analyses of how they are to be understood
and applied.
2.4.3
Knowledge economy and commercialisation
Intellectual property rights
There have been strong ethical objections to a development that in the biotech area has
resulted in constantly expanding rights to “patent” life. Changes in legislation and case law
in the US in particular have driven the development towards liberal legal treatment of
claims of novelty and industrial applications, which in many people’s opinion result in too
many and excessively broad patents being granted. The international trend in intellectual
property rights has also led to changes in Norwegian statute and case law (Patent Act, Act
relating to the plant breeder’s right). The International Union for the Protection of New
Varieties of Plants (UPOV Convention) of 1961 has advantages over patent legislation
with regard to protecting traditional culture and enabling small farmers in developing
countries to continue to engage in agriculture.
Especially with the so-called TRIPS Agreement5 under the WTO, the protection of
intellectual property rights (IPR) became a key part of the global trade regime. Through
multilateral and bilateral trade agreements there is a trend towards greater harmonisation in
the IPR area at a global level. How this will play out is unclear, and the development has
triggered the opposing interests of industrialised and developing countries that are
5
The Agreement on Trade Related Aspects of Intellectual Property Rights
23
expressed by such issues as bioprospecting and “biotheft”, sharing benefits, protection of
traditional knowledge, the right of developing countries to choose IPR protection adapted
to their needs and level of development, the right to vital medicines at an affordable price,
etc.
There is growing uncertainty and doubt that the strong protection of intellectual property
rights actually encourages innovation. Too many and excessively broad patents also create
obstacles to innovation in the form of “patent jungles”, reduced or more expensive access
to methods and techniques, etc. Excessive commercialisation of university research may
serve to undermine the key role for innovation played by open access to general scientific
and technological knowledge. There is a growing interest in alternative approaches to the
question of protecting IPR, some of which are inspired by Open Source Movement, where
licensing schemes have been developed to manage collective, non-commercial property
rights, such as a General Public Licence (GPL, or “copyleft”), which confers the right to
use free of charge, to make changes and to distribute modified products.
How the area of IPR is developing remains unsettled, and it is important to follow and
contribute to the ongoing debate, especially at the European and global level, on how IPR
regimes can be designed that balance the interests of openness and exclusive private rights,
of innovation and development and of growth and fair distribution.
Basic research under pressure: commercialisation and a “new social contract”
As a result of incentives to encourage the commercialisation of scientific results in the
form of patents, licences and the founding of spin-off companies and through a desire to
create a closer working relationship between industry and academia, research in generic
sciences/technologies appears to be subjected to particularly severe normative crosspressure. This has led to extra-scientific interests and motives, primarily commercial and
resource-economic, becoming an integral part of this research’s organisation and
normative and incentive system. This trend is most pronounced in generic technologies
like biotech and IT. Some see this as a worrying development that can undermine the
independence and autonomy of science, based on truth as an objective in itself and the
intrinsic value of knowledge as paramount values. Many wonder whether there is a
connection between growing cross-pressure and several spectacular examples in recent
years of scientific fraud. Such instances have largely been in biotechnology and
nanotechnology research, where the individual and national benefits, scientific and
financial, of being first are immense. Is it the case that in these new areas researchers are
subject to particularly severe pressure to achieve quick and sensational results with an
added risk of undermining the ethical standards of research and providing a breeding
ground for cheating and dishonesty?
Changes appear to have taken place in the operating constraints of science that raise issues
related to well-established normative divisions and institutional differences between basic
and applied research. Yet is it actually the case, as it is often claimed, usually with
24
reference to research in generic technologies in particular, that these differences have been
erased? In what sense and to what extent do commercial motives actually influence the
type of research that takes place under conditions traditionally dominated by the
institutional and financial conditions of basic research? Is it the case that traditional goals
and norms of basic research are under particular pressure in biotech and nanotech
research? Or is it the case that these norms not only continue to apply in these areas, but
that it is also regarded as being important to maintain and strengthen them, as a condition
for being able to realise its technological and commercial potential in the long run? Do
social, ethical and economic changes provide basic research with new venues and ground
rules?
However, the institutional and normative tensions within these areas are not only tied to
the relationship between scientific and commercial aims. Research in these areas is also
faced with a number of intersecting claims, objectives and considerations. With such
concepts as “Mode 2”, “post-normal science” and the “new social contract”, it is claimed
that research takes place – and ought to take place – in ways that demand more in terms of
the ability of research and research institutions to anticipate an ever broader spectrum of
social implications and social consequences. It may, and ought to, be of significance in all
stages of the research process for the way research problems are formulated, collaborative
and network relationships established and results reported. To what extent and in what
ways does this take place in various kinds of research? For example, is it the case that
research and innovation taking place under the auspices of companies are guided by purely
commercial considerations, or do agendas and practices in private R&D also reflect the
many intersecting aims and interests that make themselves felt in research in areas of
science that are in part controversial? How do changes in the law serve to encourage or
inhibit basic research in companies, nationally and globally?
2.5
Medicine and health: Prevention, enhancement and
design
Prevention and treatment of disease and disability are the primary justification of medicine.
The use of biotechnology in combination with nanotechnologies makes design and
development of systems at the molecular level possible, for example delivering medicines
to particular cells. This falls under the objective of treating/preventing disease and is not, in
principle, ethically problematical. “Personalised medicine” may reduce side effects and
improve patient response, increasing the benefits of medicinal treatment.
2.5.1
Risk of irreversible harm
Nevertheless, technological developments in the health sector in modern times have put at
number of key ELSA issues on the agenda, even in the areas of traditional prevention and
treatment. Risk is a recurring theme. The use of biotechnology to treat and prevent has
brought with it new risks. Gene therapy is one example. Xenotransplantation is another.
The path from research to treatment has proved to be considerably longer than anticipated.
25
And in a number of cases it may appear that it involves forms of risk that are of a
qualitatively new nature. For example, to prevent organs from animals from being rejected
when transplanted into humans, the animal organs’ genetic composition can be altered by
inserting human genes. This entails a risk of transmitting infectious diseases (zoonoses)
from animals to humans. A patient undergoing xenotransplantation may have to consent to
spending the rest of his or her life in the isolation ward if an infectious disease is
transmitted from an animal in connection with the organ transplant. As Hans Jones has
commented, we can junk a car that is full of faults, but if we perform an operation on
people that can infect or spread to others, we can’t just recall the vehicle. Risk and
uncertainty in medical science and their relationship to the requirement for informed
consent and safeguarding of society’s interests are key topics for ELSA research in
medicine and health.
2.5.2
Epidemic of risk
However, risk also has several aspects of interest to ELSA research. Modern medical
technology is genuinely focused on risk. Much of the idea behind improved diagnostic
tools is to discover disease at an earlier stage than before. This changes the focus of
diagnostics from establishing the presence of disease to establishing the risk of disease.
This had led some theoreticians to speak of an “epidemic of risk” in the health sector, and
the perception of risk is an important ELSA area. The positive aspect whereby any future
disease can be discovered and prevented must be weighed against the risk of
“medicalisation” and “pathologising”. People need to critically consider the consequences
of a possible future disease affecting years of a healthy life. How do they live with the
knowledge early in life that they have an elevated risk of Alzheimer’s? In the Norwegian
health service, predictive and presymptomatic genetic tests have been treated “differently”
(compared with “diagnostic tests”) to this day. This is also expressed by the fact that
genetic counselling has been a special requirement, prior to and following such tests.
However, we see that this special treatment is being subjected to pressure, not least also
because better preventive treatment for a number of hereditary diseases is being developed.
This is likely eventually to add to the pressure to introduce new mass screening, combined
with laxer requirements for genetic counselling. Furthermore, the array of home tests
marketed over the Internet will expand considerably. ELSA research is needed that can
follow this trend and draw conclusions about its impact on people’s health, on society and
on the law.
2.5.3
Prevention of individuals
The most dramatic way to prevent disease and disability in an individual is to “prevent” the
individual. This is done today through prenatal diagnosis and abortion and through
preimplantation genetic diagnosis (PGD). From a social perspective these practices are not
primarily about preventive medicine. In most western countries people have now distanced
themselves from the eugenics of earlier times the precise aim of which was to prevent
individuals with undesirable genetic material from reproducing or being born. Prenatal
26
diagnosis and PGD are offered primarily in view of the woman’s right to selfdetermination over her own body and reproduction. This transition in itself is a research
topic, and it is uncertain how fundamental the “paradigm shift” is, how strong the
perception of “self-determination” is in reality. For example, it was recently proposed to
ban cousin marriage in view of the risk of physical disabilities in children of such
marriages.
However, from the perspective of the individual – the individual woman or man – the
concern is to avoid having a child with a particular disability or disease. And such
individuals are keen on preventing heavy strains on and harm to family life. Prevention has
become privatised. Yet at the same time the groundwork is being laid for decisions on
prenatal diagnosis and abortion in society’s understanding of how it is to live with certain
sicknesses and disabilities. The interplay between individual and society in confronting
“trait selection technologies” is an important area for ELSA research. More knowledge is
needed about how these technologies affect and interact with various societies’
understanding of disability, their view of the disabled, of the content of the idea of human
dignity and of “a society where there is room for everyone”, as it is formulated in the
Norwegian Biotechnology Act. More research is also needed on how the aforementioned
technologies, like incipient research on surplus fertilised ova, affect and interact with our
understanding of the dignity and value of unborn life.
2.5.4
Selection and design
PGD, gene therapy, cloning technologies, etc., also pave the way for research on the limits
of prevention and treatment on the one hand, and “design” on the other. Many have
claimed that so-called “designer babies” will never be a reality because from a
technological standpoint they will be impossible to create. However, what we are already
living with are technologies that are used not only to eliminate future people with
undesired traits, but also to select for future people with desired traits. The growing
commoditisation of sperm and ova in western countries has long contributed to this
development through assisted reproductive technologies. We now see technologies that
more precisely offer the ability to select traits. With PGD the selection of the baby’s sex is
the typical example. People are not necessarily choosing against something undesirable but
rather are choosing for something especially highly desired. To choose for disabilities such
as deafness and dwarfism is another example. Even though this is a marginal phenomenon,
it is increasingly the case that disabled parents want children “in their image”. Tissue
typing to create a sibling to save a sick child is a third example. Here traits are selected to
ensure that the future child can cure his or her brother or sister of a serious disease. All
these examples show choices where the future child is selected with certain desired,
biological traits that to one degree or another are intended to realise definite social goals.
There are numerous empirical and philosophical aspects to these practices and
technologies that ought to be of interest to ELSA research. The risk of inflicting harm on
future people, relational challenges, conceptions of nature and gender and sex and aspects
27
of instrumentalisation are some of them. In particular the challenges to one’s identity are
crucial the more a feeling of “having been manufactured” breaks into one’s self-image.
This element may be present in connection with the aforementioned selection situations.
However, it may also be found, for example, in connection with transplantation of animal
organs.
2.5.5
Enhancement
It is precisely design and enhancement that are among the areas where biotechnology,
nanotechnology and cognitive science most overlap with regard to ELSA challenges.
Enhanced memory, immunity, intelligence and hearing or deferral of ageing, etc., affect
questions about the boundaries between treatment and enhancement, they challenge our
view of nature and normality and raise legal and empirical questions and questions of
principle regarding the understanding of identity and the instrumentalisation of humans. At
the same time, crucial issues are also raised here with regard to risk, future harm and fair
distribution. The question for ELSA research are numerous, but there are also fundamental
ELSA questions relating to the plausibility of the scenarios outlined here. It has been
claimed that the focus of bioethics on enhancement functions as an advertisement for
nanotechnology and nanoscience, among others. By emphasising their transformative
potential it contributes to hype rather than to sober analyses. For that reason, ELSA
research ought to include technology studies that ground ELSA questions in empirical
evidence and not merely speculation.
Brain science is related to technologies aimed at treating neurological disorders. However,
these methods can also be used to improve cognitive functioning or elevate moods in
people who are not ill. A trend towards an extensive use of methods of cognitive
enhancement may have considerable social ripple effects. If the “average” cognitive
performance of the population increases, but only portions of the population have the
resources to reach this level, this may create new kinds of social pressure and new social
norms. It may also have significance for the extent to which personality traits and
behavioural patterns of this kind that can be read from images of the brain and be affected
by such methods are socially acceptable. If such enhancement methods become generally
available, this may create social pressure on the individual and make it difficult to choose
not to employ these enhancement methods.
2.5.6
Bioethics and neuroethics
The cognitive sciences are increasingly offering an explanatory framework for basic
human conditions such as free will, decision-making, acting and emotions. The linkage
between brain activity and behaviour, combined with a number of powerful new
techniques for investigating the structure and function of the brain, has a potential to
redefine our understanding of key legal concepts such as responsibility, identity and
privacy. Depending on the status these new techniques will have, legally and in the view of
the public, they may have considerable legal ramifications. There are discussions on
28
whether “brain fingerprinting”, a technique claimed to be able to tie offenders to crime
scenes and acquit the innocent, should be used as evidence in court cases. At the same time
there are discussions on whether brain scanning techniques should be used as advanced
forms of lie detectors, which directly “read” the individual’s thoughts and motives.
Questions are being raised as to whether a particular neural configuration or imbalance in
the brain can excuse the individual from responsibility for his own actions. The content of
these debates is not new, but there is a lot to suggest that in the near future they will be
undertaken within a cognitive/neuroscience explanatory framework. This prompts a
number of questions not least of a legal nature.
On the basis of developments in brain science, there is in certain scientific circles a
movement towards naturalising ethics by basing it on biology. This occurs especially in
versions of “neuroethics”, which seeks to substantiate that basal elements of ethical
behaviour are “hard-wired” in the brain and thus a human condition, biologically given and
neurally implanted. Other versions of neuroethics study whether this new neuroscience
explanatory model gives birth to new ethical issues, whether it affects perceptions of “free
will”, “justice”, etc.
One problem may be that developments in this area can amplify the trend towards
medicalising consciousness and behaviour. In brain science the boundaries between real
pathology and medicalised social problems are blurry. Conditions that are not necessarily
pathological, such as moods and behaviour problems, receive medical labels. This may
result in other, more socially-oriented explanations – and corresponding therapies – being
supplanted.
2.6
Food, environment and nature.
The use of biotechnology and nanotechnology may help to solve environmental problems,
improve animal health and raise the efficiency of agriculture, forestry and aquaculture.
Examples of this will be elucidated in what follows. Today there are a number of different
applications of biotechnology, and there is knowledge and experience that have yet to be
generated from nanotechnology. The focus in this section is therefore primarily on
biotechnology, with some analogies drawn to nanotechnology. There are also potential
synergies between bio and nano. Although it is possible that we will see examples of
combined bio-nano products, these are not included in what follows below.
2.6.1
Biotechnology and gene technology
Today, modern biotechnology uses gene technology to transfer genes to organisms that do
not naturally carry them in the form that is established. These are called transgenic or
genetically modified organisms (GMOs).
The manufacturers of GMOs usually promise better medicines and vaccines for fighting
disease, more efficient agriculture, forestry and aquaculture, fast-growing and attackresistant tree species for more efficient forestry and cheaper and better food. Gene
29
technology is being used to create DNA vaccines to fight diseases for which good
traditional vaccines do not exist. Recently, cloning and gene therapy have emerged as a
new strategy for increasing the growth and improving the quality of livestock.
Uncertainty and the precautionary principle. Especially in the area of food production,
biotechnology has raised numerous questions and has led to a polarised debate. This debate
is due in part to information lacking nuance and incomplete risk studies. This shows that
there is still a great need for research on and dissemination of whether the expected
beneficial effects of GMOs become reality. It is difficult yet vital to deal rationally with
risk factors and the possibilities of unexpected effects. How do we apply the precautionary
principle? How do we deal with scientific uncertainty? Yes or no to new technology and
new products is a momentous decision that can cut both ways. When the assumption is that
a yes will lead to unacceptable adverse effects, who will then bear the costs (the producers,
the general population, the environment)? Conversely, when a no means a lost
environmental gain or forgone economic growth, who will be responsible for that?
Animal welfare. Genetic modification of animals and in some cases vaccination of animals
raises questions related to animal welfare. A crucial issue for the use of transgenic animals
is whether they suffer and whether any reduction in welfare can be justified by the purpose
of the application. Animal protection is a central topic in this regard.
New methods for gene modification. The knowledge continues to accumulate of how
genomes are organised and how the regulation of which genes in the genome are supposed
to be active in the various types of cells and at different times or after having received
various stimuli. This leads to new knowledge that can be implemented in biotechnology. In
addition to coding elements in the DNA molecule, scientists found that a number of small
RNA molecules, along with the pattern of chemical markers on the histone proteins bound
to the DNA (epigenetics), play a key role in regulating the activity and function of genes.
The application of synthetic biology (“technological biology” – e.g. combined bio-nano)
opens up new possibilities for achieving the modification of gene activity. This raises
crucial questions: Will these new methods of gene modification reduce risk or carry with
them new risk factors? Will the use of these new methods positively or negatively affect
the general public’s acceptance of genetically modified food and organisms? Do these new
methods represent a challenge to the definitions used in the Norwegian Gene Technology
Act?
Ethical and existential challenges. Nanotechnology and biotechnology both raise ethical
and existential challenges, for example related to the boundary between the organic and the
mechanical, the natural and the unnatural, which can be justified from a religious and an
evolutionary standpoint. Gradual modification of animals, plants and microorganisms can
foster technological developments that can lead to societal changes that may or may not be
desired. There will be a need for ethical research in the area of these existential challenges,
30
as well as elucidation from the social sciences of the impacts that nanotechnology and
biotechnology are having and can have on the society.
Below are some examples of GMOs:
•
Genetically modified (GM) plants. Insect-resistant and herbicide- and pesticidetolerant plants or plants with a combination of these traits are the most common
GM plants in use today. The next generation of GM plants will soon be on the
market and involve GM plants that produce ethanol, medicines and vaccines
(molecular pharming), edible vaccines, industry-related products (such as reducedstarch potatoes) and GM plants with combinations of various introduced
transgenes. Will GM plants aimed at applications in medicine and bioenergy be
more favourably received than maize and soya for food and animal feed?
•
Transgenic animals. In a Norwegian context, it is transgenic fish that are most
relevant. Researchers in Canada have achieved the greatest effect by inserting an
extra copy of a salmon’s growth hormone gene, which leads to up a tenfold
increase in the speed of growth. For years there have been attempts to get
“AquAdvantage Bred Salmon” approved for fish farming in Canada and the US, so
far without success. Research to ascertain whether growth-hormone salmon may
affect health and the environment has not been able to show any impacts harmful to
human health, but has not provided answers as to the ecological effects escaped fish
may have. Another trait important to productivity, health and the environment that
can conceivably be achieved with gene modification is e.g. disease resistance.
Besides use in animal breeding, transgenic animals are used for the production of
medicines (bioreactors). Best known are GM sheep that produce Factor IX, a vitally
essential medicine for haemophiliacs, in their milk. Most GM animals are used in
basic research to determine genes’ function and correlation with disease. A special
area is genetically modified pigs with the aim of “humanising” organs for
transplant surgery (xenotransplantation). A number of issues relevant to ELSA can
be formulated around the production and use of GM animals.
•
GM microorganisms. A primary area of application is manufacturing
pharmaceuticals, enzymes for detergents, vaccines and products containing a
particular natural substance, often a protein. This application takes place in closed
fermentors and is rather uncontroversial today. In the food industry,
microorganisms play many key roles in fermentation and flavouring. An example is
a GM yeast for use in beer brewing. More problematical is the release of
genetically modified microbes into the natural environment with the task of
cleaning up environmental toxins etc. The use of GMOs in the food processing
industry or in field applications will contain issues relevant to ELSA research.
•
GM vaccines. Vaccines manufactured with the aid of gene technology can be
divided into three main categories: recombinant subunit vaccines, DNA vaccines
and live virus vectors. Subunit vaccines are produced in closed fermentors. DNA
31
vaccines consist of DNA molecules with an artificial gene that is produced in a
laboratory and after injection expresses an antigen to a particular pathogen, which
can induce immunity. DNA vaccines are not infectious (as classic vaccines can be)
but are controversial because the recipient can be defined as a GMO. Relevant
issues are uncertainty about the definition of GMO and assessing the risk of DNA
vaccines relative to benefits. For example, will DNA vaccination of salmon affect
exports to the EU if the salmon is labelled a GMO? Is it conceivable that a change
in legislation that allows for greater acceptance of the use of DNA vaccines will
affect the spread of other DNA treatments, such as e.g. gene therapy?
The category GM virus as a live vaccine is based on a nonpathogenic vaccinia virus
that imitates an ordinary viral infection but without the development of disease.
Vaccines of this type are relevant for vaccination in developing countries and of
wild animals, since they are thermostable. Both applications have relevance to
ELSA research.
2.6.2
Nanotechnology
Sensors and nanocomposites
In the area of food production sensors based on nanotechnology can be used to trace the
content of food products back to the original animal or field. This will enable consumers to
find out where the food product was produced and help to identify and isolate food
containing contaminants or contagion. Another future application involves designing food
products through modification at the atomic level. Nanocomposites, such as silver ions, are
already being used in food packaging to kill microorganisms during packing and transport.
The use of nanocomposites in food packaging may possibly pose a risk, and it should be
studies what their impacts are a) when ingested by mouth (microorganisms naturally found
in the stomach and gut and in the gut epithelium), and b) when packaging is destroyed
(spread and effect on the environment). There will be a need for methods to measure the
level and composition of nanoparticles and suitable biological modelling systems to study
biological effects of exposure. Other questions are related to control and labelling: how to
regulate food products that contain nanoparticles – should they be labelled? Consumer
protection and product liability are key legal issues in this connection.
Energy and environmental pollution
Nanotechnologies represent possibilities for future energy production, by reducing energy
production and helping to make the transition to greener energy systems. With regard to
environmental pollution, nanotechnologies have already been introduced in various
industrial processes to reduce the use of solvents and other harmful chemicals.
Furthermore, it is expected that nanotechnologies can help to remove environmental
contamination from soil and water. On the other hand, nanotechnologies in energy
production and environmental remediation may lead to nanoparticles being released into
the environment, thus raising questions related to the risk of undesired effects on animal
32
health and the environment. This development raises a number of questions in the area of
environmental law, including working environment.
2.7
Privacy, consent
Biotechnology and cognitive sciences open up the possibility of increasing amounts of
sensitive information connected to individuals being generated. In addition,
nanotechnology offers new possibilities for obtaining and disseminating information that
we can barely foresee. Because nanoparticles are extremely tiny and invisible, they present
particular challenges with regard to privacy and surveillance. Traditional questions
regarding access to and use of personal data will thus be especially acute in areas where
these technologies are adopted.
The insurance industry will be interested in all kinds of information relating to an
individual’s health, and questions arise as to how access to such information can be
regulated and how abuse can be prevented. Questions also arise as to the extent the
individual is the “owner” of all information that can be traced back to himself or herself,
and the considerations and interests that are to govern use in a social perspective.
The requirement of informed consent, which is fundamental with regard to medical and
other interventions in an individual’s body and private life, is a vital guarantee for the legal
protection of the individual. Questions arise regarding the extent to which the requirement
for informed consent will be suitable for protecting the individual’s interests with regard to
new technology with partly unknown impacts on the individual and society. What types of
information must be disclosed about a particular technological application for consent to be
said to have been “informed”? Is it conceivable that in some cases the requirement for
informed consent ought not to apply? In the event, should other legal protection
mechanisms be established?
Questions regarding consent, the administration of personal data in compliance with
privacy law principles and averting appear in force with regard to the regulation of
biobanks, medical on-line databases, diagnostic tests, storage of medical data, for example,
in connection with brain science and genetic research, etc.
Greater access to information also raises new questions with regard to surveillance, crime
fighting, solving crimes, military purposes, etc., where the issues will be the extent to
which and for what purposes society is to avail itself of the greater opportunities to control
the individual. In this area it is important for a broad spectrum of considerations and
analyses be adopted, so as to ensure as nuanced and informed a foundation as possible for
political decisions.
2.8
Risk, precautionary principle
33
Many kinds of research and innovation entail risk. This especially applies in new sciences,
where it is often difficult to foresee what will happen. What demands should be made of
someone who sets such processes in motion? Numerous laws and regulations stipulate
certain limits that exclusively depend on the probability of something going wrong. But
does not also the distribution of costs and benefits also play a certain role? Often those
subjected to hazards will not be those who enjoy the benefits of these measures. This raises
questions about the distribution of costs and benefits as well as information, consent and
other ethical considerations.
Risk research is rather well developed in connection with applications of technology,
particularly new technology. However, biotechnology, nanotechnology and the cognitive
sciences present new possibilities and new considerations and interests that are important
to clarify and address. In particular, risk analyses related to nanotechnology have shown
their limitations. The risk analysis consists primarily of a determination of the probability
that a hazard will occur and of the consequence(s) of its occurring.
The precautionary principle, which has been discussed in connection with numerous other
technologies, is particularly important with regard to these new technologies, where the
likelihood of various unfavourable impacts is difficult to estimate and is partly unknown.
The work already done to clarify the precautionary principle will be of great use also in the
applications of these new technologies. The principle is recognised as the basis for
addressing the health and environmental risks of new technology. Yet it remains unclear
and controversial how this principle is to be rendered concrete and be applied and
implemented in different contexts.
Ethics research in connection with the new technologies needs to focus on clarifying these
issues, as well as many others that will appear as the technologies evolve. This work must
take place in close collaboration with insights from science and technology, social sciences
and law and will require broad expertise of the individual researcher and in the research
groups that are established.
In particular, regulation of risk and the application of the precautionary principle to new
technologies present legislators with great and complex challenges. Risk and the liability
for harm connected with research and innovations relating to the new technologies must be
governed by legal provisions and practice. The fundamental question that legal regulation
of new, generic technologies like biotechnology and nanotechnology faces is whether and
to what extent regulation can take place adequately within the framework of existing legal
and regulatory practice and to what extent and in what way this practice should be
clarified, adjusted and expanded, or whether new special provisions and systems are
necessary that are adapted to these technologies in particular.
Like in many other countries, this regulation in Norway is based on dedicated legislation
and a special supervisory and regulatory system for genetic and biotechnology research
34
and (Biotechnology Act, Gene Technology Act). Even if there appears to be agreement
that this regulatory regime has more or less assumed its shape, it needs to be adjusted and
refined in step with experiences gained, scientific and technological developments, followup of international agreements and shifting political constellations. Research-based
knowledge of how the Norwegian regulatory system under both the Biotechnology and
Gene Technology Acts has evolved and works in practice is desired.
With regard to nanotechnology it is still too early to have a clear picture of the extent to
which adequate regulation can and must take place through adapting and modifying
existing rules and systems or whether special schemes will be necessary, like those for
biotechnology. It will be important to draw on experience for the legal and regulatory
policy development of biotechnology, and it may be relevant – as many have suggested –
to expand and adapt regulatory provisions and practice for biotechnology also to include
nanotechnology.
This applies inter alia to questions pertaining to working environment law regulation of
environmental and health risks connected with research and production. It also includes
regulating risk and liability for harm connected with releases/discharges into the natural
environment and with the use of nanoparticles in commercial products, including
cosmetics and pharmaceuticals. Despite the fact that little is yet known about how
nanoparticles behave and the effects they can have, nanoparticles are found in products on
the market today. Nanoparticles raise particular issues relating to product liability and
consumer’s rights (including labelling).
35
3
3.1
Norwegian ELSA research
The Research Council’s ELSA initiative
Seen in relation to the three technologies this programme addresses, Norwegian ELSA
research is, as expected, focused on issues relating to biotechnology. ELSA research
connected with nanotechnologies are in the initial stages. A large portion of ELSA research
has been initiated and funded through programmes under the Research Council of Norway.
They primarily include the programmes Ethics, Society and Biotechnology6, FUGE
(Functional Genomics) as well as NANOMAT (Nanotechnology and New Materials). The
Research Council does not have an initiative to fund ELSA research related to cognitive
sciences/technologies.
Ethics, Society and Biotechnology started in 2002 as a collaboration among the divisions
of the Research Council with a budget of around NOK 5 million per year. The aim of the
programme is to help to amass expertise on ethical, legal and social aspects of
biotechnology, to develop research-based knowledge in the field and to bolster
communication between experts and the general population regarding modern
biotechnology. The FUGE programme spends around 5% of its funds on research on
ethical, social and environmental aspects of functional genomics. In the period 2002-2006
this amounts to about NOK 32 million. The FUGE steering committee collaborates with
the Programme Committee for Ethics, Society and Biotechnology on ELSA research. The
two programmes have supported 23 projects in all. 7
Among the topics of the funded projects relating to biotechnology we find genetically
modified food, aquaculture and salmon, biometrics, heritable diseases, screening and
gender/reproduction. Several projects with a particular focus on bioethics issues have been
funded, e.g. related to stem cells and the status of embryos. The support includes a major
initiative for research regarding the establishment of biobanks, based on a special call for
applications, and the coordination of three major applications from the universities of Oslo,
Bergen and Trondheim, respectively. Additionally, there has been research into the
application of the precautionary principle and the regulation of access to genetic resources.
In this project portfolio there is a certain preponderance of projects on ethical issues and
approaches, around half of the projects funded. Projects primarily taking legal and general
social science approaches each represent about half of the remainder of the project
portfolio.
6
http://www.forskningsradet.no/elsa/
7
http://www.forskningsradet.no/servlet/Satellite?cid=1088708193828&pagename=elsa%2FPage%2FHovedS
ide&site=elsa
36
The NANOMAT programme started two ELSA projects in 2006 and has approved funding
for an additional two projects to start up in 2007. The total grants to the four projects are
NOK 9.9 million for 2006-2009. For 2007 and 2008 the grants to the ELSA projects come
to NOK 3.0 million and NOK 3.5 million, respectively. For 2007 this yields a share of
4.5% of NANOMAT’s revenue budget. The share for 2008 depends on the outcome of the
Research Council’s proposed budget, but will come to 5% in the zero growth alternative
for NANOMAT.
The projects cover nanoethics and post-normal science, consumer perceptions of
nanotechnology and other stakeholders, as well as what is required to create confidence in
the use of nanotechnology as a delivery system for fish vaccines.
The Ethics Programme (1991-2001) under the direction of the Research Council of
Norway made a substantial contribution to the development of expertise in the area of
ethics in Norway. After the programme concluded, the Research Council continued to fund
the National Ethics Network, which has its secretariat at the University of Oslo. The
network’s primary instruments are coordinating national researcher training courses and a
website for researcher training and research in ethics, www.etikk.no
3.2
Social science research
Universities
At the University of Oslo’s Centre for Technology, Innovation and Culture (TIK)8 ELSA
research particularly focused on biotechnology is included in the centre’s general research
on culture and technology. Key questions have been the evolution of biotechnology in a
social and policy perspective, attitudes among the public towards biotechnology, and stem
cells. The research at TIK also covers research on technology in general and biotechnology
in particular in the perspective of innovation theory and policy and economics.
At the Centre for Development and the Environment, University of Oslo, 9 ELSA research
is taking place on bioprospecting, with an emphasis on access to and management and
preservation of plant resources.
At the University of Bergen in the area Culture, Technology and Work at the Stein Rokkan
Centre for Interdisciplinary Studies (the Rokkan Centre),10 there is research on
ethical/social issues relating to stem cells, biobanks and abortion. Research aimed
particularly at biotechnology is part of a wider spectrum of research and research-based
activities on cultural aspects of technology.
8
http://www.tik.uio.no/forskning.html
9
http://www.sum.uio.no/research/index.html
37
The Centre for the Study of the Sciences and the Humanities (SVT)11 at the same university
is an interdisciplinary and inter-faculty institution with responsibility for research,
education and dissemination of results in the theory of science. Of particular relevance to
ELSA is an exploratory project for developing perspectives for ethics and theory of science
studies of nanotechnology. The centre will host a conference on nanotechnology, ethics
and sustainable development in 2007.
At the Norwegian University of Science and Technology (NTNU) there are studies being
done of technology, science and society in the Department for Interdisciplinary Studies of
Culture.12 These studies focus in particular on ICT, but also cover research on issues in
gene technology (for example, Post-human Dialogues: Production of Visions,
Communication and Culture in Relation to Genetic Research).
Research institutes
At social science institutes there is ELSA research to varying extents, at, for example, the
Norwegian Centre for Rural Research, the Institute for Research in Economics and
Business Administration (SNF) and NIFU STEP Studies in Innovation, Research and
Education. This research is funded on the whole by the Research Council of Norway.
There is not much expertise and activity in Norwegian ELSA research on nanotechnology.
One exception is a project at the National Institute for Consumer Research (SIFO) funded
by the Research Council of Norway on consumer perspectives on the use of the
precautionary principle in relation to nanotechnology 13
3.3
Ethics research
The project portfolio in the programmes the Research Council supports in ELSA has a
considerable number of ethics research programmes relating to biotechnology in general
and to bioethics and biomedical issues in particular. This means that such research is
relatively prominent in Norwegian research communities.
Universities
At the University of Oslo the Section for Medical Ethics, Faculty of Medicine14 has
research activities on topics like stem cells, biobanks, genetic counselling, genetic testing
and population genetics. Research aimed particularly at biotechnology is part of a wider
spectrum of research on bioethics, medical ethics and research ethics.
10
http://www.rokkansenteret.uib.no/area/
11
http://svt.uib.no/?mode=show_page&link_id=145518&sublink_id=146440&toplink_id
12
http://www.ntnu.no/kult/tekno
13
http://www.sifo.no/page/Forskning//10060/61995.html
14
http://www.med.uio.no/iasam/sme/,
38
At the Norwegian University of Science and Technology (NTNU) portions of the activities
of the Programme for Applied Ethics and the Bioethics Research Group are related to
nanotech, biotech and gene technology issues. The Bioethics Research Group is composed
of researchers from a number of departments, such as the Department of Community
Medicine, Department of Philosophy, Department of Sociology and Political Science,
Department of Psychology and the Department for Interdisciplinary Studies of Culture.
Research focusing on biotechnology in particular is a key subcategory of research and
research-based activities on bioethics issues in a wider sense.
The aforementioned two research groups collaborate with the Rokkan Centre, cf. above, on
research funded by the Research Council of Norway on ethical and social aspects of
biobanks.
At the University of Tromsø’s Norwegian Institute of Gene Ecology (GenØk)15 there is
research on ethical, environmental and health consequences of the use of nanotechnology,
gene technology and genetic modification, among other topics.
Other institutions
In connection with the National Committees for Research Ethics in Norway, particularly
the committees for medical research ethics and ethics in science and technology, there is
research and research-based activities related to ethical aspects of biotechnology. Among
the topics are ethics relating to biotechnology16, and new human technologies17,
operationalising the precautionary principle with regard to fish vaccine and transgenic
plants18, and technology assessment tools with regard to agriculture and food production.
The MF Norwegian School of Theology19 engages in research in bioethics in general, and
on ethical issues connected with stem cell research in particular.
3.4
Legal research
Universities
In the Faculty of Law, University of Oslo, there is research on legal dimensions of
biotechnology and nanotechnology in various departments and interdisciplinary research
groups. The Center for Research on Markets, Innovation and Technology (CeRMIT)20
engages in research activities Intellectual Property Rights (IPR) and patenting, among
15
http://www.genok.org/norsk/view_genok.asp
16
http://www.etikkom.no/HvaGjorVi/Prosjekter/BioTEthed
17
http://www.etikkom.no/HvaGjorVi/Prosjekter/clemit,
18
http://www.etikkom.no/HvaGjorVi/Prosjekter/arkiv/pp04
19
http://www.mf.no/
20
http://www.jus.uio.no/forskning/grupper/mit/
39
other topics. The principle topic of the Natural Resources Group21 is research on the
management of natural resources, energy, the environment and real property. At the
Norwegian Research Center for Computers and Law there is research into the legal
regulation of biometric identification and authentication, among other topics.
The Research Group for Health and Social Welfare Law in the Faculty of Law of the
University of Bergen22 works on various issues relating to health and social welfare law.
The human rights dimension has become more evident in this research, for example with
regard to the privacy and personal integrity of patients and clients in connection with
treatment and social service provision. Other topics are issues relating to self-determination
and the protection of personal integrity in connection with medical and health sciences
research.
The Research Group for Resource Management, Environmental and Development Law in
the Faculty of Law at the University of Bergen23 works on various environmental law
issues, including environmental impact studies in a legal perspective and uncertainty
considerations connected with the regulation the development, production and distribution
of transgenic fish. Development law issues relating to property and land rights in
developing countries are being studied.
Research institutes
At the Fridtjof Nansen Institute (FNI) there is research on international legislation and
agreements on genetic resources and biodiversity24, such as access to genetic resources in
the oceans and to plant genetic resources in developing countries, including patenting and
“farmers’ rights”, bioprospecting and GMOs and safety.
3.5
ELSA research in biotechnology, nanotechnology and
cognitive science disciplines
In some cases ELSA research will be closely tied to the disciplines whose core activity is
biotechnology, nanotechnology and cognitive science. In these instances the researcher can
be a “core player” with a great interest in and knowledge of ELSA issues. Although such a
constellation guarantees that the issues addressed will be relevant, in such cases the
researcher should link up with networks of other ELSA researchers to ensure that the
research has the necessary quality. An alternative is for the researcher to have a
background in a typical ELSA research environment and spends a period in residence in an
institute or organisation where core research is conducted to study a given problem as an
observer and perhaps participating partner. Both of these ways of organising ELSA
21
http://www.jus.uio.no/forskning/grupper/naturressurs/
22
http://www.jur.uib.no/forskning/forskergrupper/HS_rett/Aktiviteter.html
23
http://www.jus.uio.no/forskning/grupper/naturressurs/
40
research have been used for example at the National Centre for Foetal Medicine in
Trondheim, where the issue was related to prenatal diagnostics and choosing whether to
abort on the basis of the findings of ultrasound examinations.
24
http://www.fni.no/themes/biodiversity.html#publ
41
4
4.1
Strategy for a new initiative for ELSA research
Funding and organisation
The Research Council’s commitment to ELSA research in connection with biotechnology
has rested on two pillars. There has been a dedicated programme for “Ethics, Society and
Biotechnology”, with its own budget and programme committee authorised to make
decisions on allocating funds for research support within the framework of the programme.
In addition, grants have been made to ELSA research under two of the Council’s other
programmes, FUGE and NANOMAT. The programme committee for FUGE (Functional
Genomics) has granted funding, after applications were submitted to the programme
committee for “Ethics, Society and Biotechnology” for comment and prioritising. The
NANOMAT (Nanotechnology and New Materials) programme has also granted funding
for ELSA research. In this case, the ELSA applications were evaluated by external panels
of experts and decided on by the programme committee.
There are numerous arguments in favour of the continued initiative to largely be based on
such a bifurcated funding and organisation model. Grants through a separate ELSA
programme make it easier to address fundamental issues and projects that cut across
biotechnology, nanotechnology and cognitive science. Grants from the other programmes
ensure proximity, contact and coordination between scientific and technological
developments and ELSA research and also help to provide interdisciplinary quality
assurance of ELSA research.
In view of the arguments made in the first part of this recommendation, a new ELSA
initiative should be organised so as to promote learning and transfers of experience among
biotechnology, nanotechnology and cognitive science. This should be a key consideration
in designing and organising individual research projects and researcher training,
dissemination of research results and other interdisciplinary measures. ELSA research
needs to be viewed as a broad, interdisciplinary professional field that extends over a wide
range of social science and humanities disciplines. It will be difficult to assure quality with
regard to this interdisciplinary breadth within the framework of programmes where such
disciplines will have to have limited representation.
For that reason the Committee believes that there should continue to be a combined model.
As today a separate ELSA committee should be established tied to the overall commitment
to ELSA research. This committee should have the task of making recommendations on all
ELSA applications to the individual technology programmes. In such a model it is crucial
that calls for proposals and the processing of ELSA applications be closely coordinated.
Such a committee should also have its own means and authority to fund projects and
initiate measures where it is particularly important to address perspectives and problems
42
that cut across the technologies and primary programmes. This applies to researcher
training in ELSA disciplines, for example.
We believe the best way to ensure this is also by allocating the interdisciplinary ELSA
committee its own budget as part of a combined model. This budget should not be too
small and in our view should total at least NOK 10 million per year. This corresponds to
the average amount for the previous Research Council programme for ethics research
(1991-2001). It will make it possible to fund special projects difficult to give priority to
within and/or across the primary programmes. It will also help to create a balance in the
relationship ELSA research ought to have to scientific and technological research, where it
is crucial to attach importance to integration and proximity on the one hand as
counterweights to isolation, but also to independence as a counterweight to being co-opted
on the other. The funds set aside for ELSA research under the Council’s other programmes
(NANOMAT, FUGE) should be in the order of 3 – 5 per cent of total programme grants.
FUGE’s grants for ELSA research should be at least at the level they have been at until
now, nearly 5 per cent. In the areas of nanoscience and nanotechnology the commitment
should initially be at the same level, especially given the desire for ELSA research to have
a stronger presence at an earlier stage of scientific and technological developments than
was the case for biotechnology. Total grants under both pillars of the ELSA initiative,
specific ELSA funds controlled by the ELSA committee and ELSA research in the
technology programmes, respectively, should be at least NOK 20 million. Funding at this
level will make it possible to carry out major research projects in areas that the programme
committees for these other programmes deem especially important.
Freestanding ELSA projects may be funded by mechanisms other than the ELSA
Programme, FUGE and NANOMAT. Research on risks to the environment and health that
does not have ethical, legal or social aspects should primarily take place in initiatives other
than the ELSA programme. The programmes Environment, Genes and Health (2006-2010)
and Environment 2015 (2007-2016) may be particularly appropriate for risk research that
does not have ELSA relevance.
In the interest of coordination there should be overlapping representation between the
central ELSA committee and the programme committees for the primary programmes. To
avoid problems of conflict of interest and dual roles there should be a preponderance of
Nordic/international representation on the ELSA committee.
A new ELSA programme should have a time horizon of at least seven years. The first
argument for such a long time horizon is that framework conditions should be created to
achieve a long-term accumulation of knowledge and expertise in Norwegian ELSA
research. Another argument is that ELSA research relating to nanotechnology and
cognitive science is in a formative phase, and it will take time before expertise is
developed in this area at a level high enough to carry out research projects of a high
international calibre, which is to be the primary objective of a new ELSA initiative.
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4.2
4.2.1
Objectives, tasks and funding criteria
Primary objective: ELSA research of a high international calibre
The overarching objective of a new ELSA initiative should be to lay the groundwork for
developing Norwegian ELSA research that maintains high international standards of
quality. This research should have high visibility in and make active contributions to
international ELSA research. One implication of this objective is that calls for proposals
must not narrowly prescribe topics but must largely leave it to the research centres
themselves to select topics and formulate issues for investigation.
Funding research projects that are premature due to inadequate qualifications, inadequately
conceived issues for investigation and/or insufficient data should be avoided. For that
reason there should be a heavy emphasis on researcher training and expertise building in
ELSA disciplines, and the programme should be open to funding surveys identifying
research needs and project development (see below, subsection 4.2.4, on expertise
building). This may be especially relevant to ELSA research in nanotechnology and
cognitive science.
Given this approach, the survey in Chapter 2 of the challenges of ELSA research is to be
understood as an indicative overview and delimitation of key issues under the initiative and
not an attempt to give some challenges priority over others. However, even if we regard it
as inappropriate to recommend a strict prioritising of the various challenges in relation to
one another, it is nonetheless a key consideration for the initiative to provide a basis for
pursuing these challenges in considerable breadth. The essential and unconditional interest
of quality must therefore be addressed in ways that reflect the fact that research with regard
to the various challenges have different points of departure and conditions, so that areas
with well-developed issues and research traditions do not outcompete new areas that are
emerging and that lack established expertise. Within these less-established areas, quality
should be addressed by supporting researcher training and other expertise building, surveys
to identify research needs and project development, rather than compromising quality
standards and funding research projects where there is a lack of researchers with high
international qualifications.
4.2.2
Concentration, diversity and networks
A principal focus of the initiative should be to bolster or build up research communities
with high and complex expertise in ELSA issues. It is important to avoid spreading
resources so widely that the research effort becomes fragmented and vulnerable.
44
Even so, the prerequisites do not appear to be in place to apply a “centre of excellence”
model. ELSA research spans a very wide range of topics, and it is important to be able to
draw on a number of social science, humanities and interdisciplinary approaches. Too
strong a concentration of support may undermine the basis for topical breadth and diversity
in disciplines. In a field like this it is vital and even desirable to accommodate some degree
of tension and competition among various approaches and traditions.
Important elements in the strategy to be pursued is initially to provide funding to broad
research groups and communities. Individual projects and stipends should be tied to such
communities and be part of broader ELSA research projects/programmes. It is desirable for
groups that are funded to have a multi- and interdisciplinary composition. It is essential for
projects and groups receiving funding to have contact with research in the technology or
technologies that ELSA research is focused on. This contact may be with research at
universities, institutes or companies.
There should be great flexibility in the choices of instruments and forms of support that
can be used under the ELSA initiative. Research support should be able to be given in
various forms, including fellowships, post-docs and buying release time for experienced
researchers, depending on what is deemed appropriate with regard to the need for
recruitment or expertise and project development, etc.
It is desirable for projects to be initiated that address issues that cut across the technologies.
At the same time it should be set up so that larger projects and groups receiving funding
can collaborate and together comprise a national network. For example, they should
collaborate on and apportion/rotate responsibility for national measures and tasks, such as
researcher training courses. On the model of similar gatherings in the previous Research
Council programme for ethics research, annual gatherings for all researchers, research
fellows and supervisors should be a key element in developing and maintaining such a
national network. To bolster the contact among the various research communities and have
their projects comprehensively elucidated, ELSA researchers from different parts of the
country should come together at these meetings to present and discuss their projects.
4.2.3
Interdisciplinary quality
ELSA research without the necessary knowledge about the content of and agenda for
scientific and technological developments is poor ELSA research. The Achilles’ heel of
ELSA research is the special and high standards for interdisciplinary quality expected of it.
A heavy emphasis should be placed on research to be funded being able to point to
adequate solutions for this interdisciplinary quality assurance of its activity. What is
adequate may vary somewhat from project to project, and there should be flexibility for
individual projects to find solutions that are suitable in each case. These may vary from the
use of reference groups to project collaboration among researchers with scientific,
technological, ethical, legal and social science backgrounds to individual dual
45
qualifications. Although it is not appropriate to impose on all projects obligatory standard
solutions, this issue should have considerable emphasis so that it becomes a key criterion
for “fundingworthiness” that the proposed solutions for interdisciplinarity are carefully
evaluated and found effective and satisfactory.
4.2.4
Expertise building and project initiating
The choice of forms of support must reflect the very different points of departure that the
research and development of knowledge have in the various areas the programme covers.
Biotech-related research can be based on extensive previous research and expertise, and
this activity will normally take place within the framework of ordinary research projects.
The two other areas, however, should be much more open to providing researcher training
and other expertise building, including also buying release time for established researchers
wanting to take up ELSA research and in need of release time from a longer period to read
up on the fields they wish to take up.
Wherever there are promising researchers, funding should also be given to projects and
activities of an orientational and exploratory nature, also including project development
and design. Such support should be able to be given in the form of funding for project
development, pilot projects and extended stipend periods.
There should be a heavy emphasis on projects and research communities being funded
being able to show, or having specific plans for, adequate ties to leading international
research communities. Research stays in such communities and invitations for guest
researchers to Norway for periods of varying length should be key elements of the
strategies of funded research communities.
It ought to be possible to provide portions of the support in the form of relatively
unspecified, long-term funding to such research groups and communities, and not only to
already fully-developed projects. This will make possible project initiation and
development along the way. This may be particularly relevant in the areas of
nanotechnology and cognitive science, where the agenda and issues are open and are
evolving at breakneck speed.
4.2.5
ELSA research in the wider society
ELSA researchers’ social task may be said to be of a political nature. In part it involves an
obligation to communicate their research results to the general public, as all researchers
should do. However, “communication” provides a simplified picture of the social activity
the ELSA researcher ought to engage in. The ELSA researcher’s input of an ethical, social
and legal nature may often influence and alter the very thing that has been the ELSA
researcher’s object of study. Thus, the ELSA researcher may become enmeshed in social
policy debates and help to create the social reality that he or she is studying. We wish for
ELSA researchers to be conscious of this social task and social responsibility. We do not
46
want ELSA research that hides away and does not involve itself actively in society but
rather research that becomes a visible part of the ethical policy debate on modern science
and technology.
The programme ought to be able to fund a wide spectrum of activities and not just pure
research projects. For example, Ph.D. courses are an important means of developing and
disseminating ELSA research. However, ELSA research should be communicated to a
wide public. A good model for including the entire public as a framework for ELSA
research is exemplified by the project “Tre ringer i vannet” (Three Ripples in the Water).
In it, Ph.D. courses were coupled with open meetings and topic presentations for
journalists, teachers and instructional staff as well as pupils and parents or guardians. The
project was funded by the Research Council of Norway, the Norwegian Biotechnology
Advisory Board and the National Ethics Network.
Being engaged with the greater society ought to be an essential and integral dimension of
all ELSA research. As ELSA research has arisen as a consequence of public concern
regarding where modern science and technology are taking us, it is reasonable for ELSA
research to be visible to that same public.
It ought to be a key criterion in the assessment of whether research projects and
communities merit funding that they can present a thoroughly thought-through plan for
how their ELSA research is to be made available to the wider society and have an impact
on ethical and political processes.
4.2.6
International dimensions
The international dimension should play a key role in research funded under the initiative.
The first reason for this is the interest of quality: researchers should seek out active
collaboration with international research communities considered to be particularly
outstanding or leading in the field. Research stays will often be an effective way to link up
with such research communities, in the form of stays abroad for experienced researchers
and by research fellows applying for admission to institutions that offer particularly good
researcher training in the ELSA disciplines.
There is also a thematic rationale: the issues that scientific and technological developments
raise are themselves of an international and global nature. The evolution of the
international agenda for the development of research and technology, the public debate and
ELSA research are propelled by players that set the tone at a global and regional level - the
US, the EU, China, India, Japan, Brazil, etc. The monitoring, “importation” and
articulation of these agendas in a Norwegian context is a central task of Norwegian ELSA
research. Furthermore, comparative research has proved to be a particularly fruitful
approach in ELSA research.
47
In addition, in this area as well Norway has both an obligation to and a self-interest in
collaborating with research communities in countries that at the outset are not as far
advanced in this area and have a need to collaborate with a view to bolstering their own
research in this area in terms of expertise, capacity and quality.
48
Appendix 1.
Terms of reference for the planning group for
ELSA research
1
Responsibility and authority
The planning group is acting on behalf of the Research Council. It is to follow the
overarching principles and guidelines set forth by the Research Council for programme
development. The group is responsible for maintaining adequate contact with relevant
parties throughout the planning process. The planning group’s report is to be completed
by 15 March 2007
2
•
•
•
•
•
•
•
•
•
3
Tasks
The planning group is to report on research challenges facing ELSA research
relating to biotechnology, nanotechnology and cognitive sciences. The aim of the
process is to obtain knowledge, perspectives and assessments that can be applied to
launch a new initiative in the area of ELSA research.
The planning group is to assess the relationship between a core commitment to
ELSA research and the FUGE and NANOMAT programmes
The planning group is to assess where the boundaries are with regard to risk to the
environment and health connected with biotechnology and nanotechnology
The group is to make recommendations for a future initiative in the area of ELSA
research relating to biotechnology, nanotechnology and cognitive sciences. These
recommendations are to indicate the main perspectives and important areas for
research moving forward in a six-to-seven-year period
Recommendations are also to be made as to how this research should be organised
in the future and what the interfaces ought to be in relation to existing, adjacent
research programmes.
The group is to ensure adequate contact with, and input from, relevant users with
regard to the research topics dealt with. This includes affected programme
committees, the administration, business and industry and organisations. The
planning committee is called upon to ask for input from researchers and users with
relevant expertise. The planning group can also link up with one or more reference
groups.
R&D communities and users are to be invited via Internet invitation to provide
brief input early in the process.
The planning group is to draft a memorandum with recommendations for
structuring and professional and strategic priorities for ELSA research related to
biotechnology, nanotechnology and cognitive sciences.
The group is to estimate the funding needs for the ELSA research encompassed by
the group’s work.
Administration
i
Appendix 1.
The Research Council will assist the working group by providing secretariat functions. The
secretariat will assist the group in holding meetings and maintaining contact with various
parties, keeping the Research Council briefed on the work and attending the group’s
meetings with the right to speak and make motions. The secretariat is to ensure that all
input the Research Council receives or has received regarding the continuation of ELSA
research is presented to the group and is added to the documentation on which the group
makes its recommendation.
The members of the planning group will receive remuneration for attending meetings and
have their travel and lodging expenses met in accordance with the rules applying at the
Research Council at the time in question.
ii