Rompre avec le pass

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 La perception de la Commission sur la
construction dun éspace européen déthique des
sciences  action en cours et a venir  Science
and Society 

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overview

• Introduction How can ethical principle operate
  within the European research area?
• The 6 action on ethics in the action plan
  science and society
• What has been done until now
• Workprogramme 2003
• Workprogramme 2004

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1.

• How can
• ethical principles operate
• within the European research area?

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The architecture of supranational organisations
in Europe

• After the disaster of the WW2
• Any many other wars in Europe before
• Two approaches emerged
• on how to overcome hostility amongst the nations
  in Europe
• A British proposal
• and a French proposal

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The British suggestionthe Council of Europe

• created to implement the European
  Declaration of Human Rights
• Through instruments of international law
• Conventions and protocols developed by the
  members of the Council
• Agreeing on shared values
• Conventions enter into force
• By ratified of their members

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the conventions of the Council of Europe

• Are most important for ethical considerations
• The convention on Human Rights and biomedicine
  and the protocols
• Data protection
• Animals welfare
• Environmental penal law
• etc

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The French proposalfrom the union of steel and
coal to the EEC

• Direct economic co-operation
• To create a situation of economic benefit through
  co-operation
• When agreed directly transferred into national
  law
• Cultural values stay in the national
  responsibility
• Application of the principle of subsidiarity

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Directives to regulate the market

• Direct powerful instruments
• But no mandate to regulate ethics
• Ethics occurs as side effects of market
  regulations
• Such as the good clinical practice
• Invention of biotechnology
• Data protection

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The ethical dimension in the Union lt ethics is
not absent in the EUgt

• since the Maastricht treaty 1992 Political
  dimension of the E Union Human Rights
• 1991 Delors nominated an Ethics Committee to
  advise the President
• - follwing the French model the EGE
• 2000 Treaty of Nice
  Charter of fundamental Rights
• The Charter will become part of
  the constitution

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Ethics in the European Research Area

• In the pride and full respect of the cultural
  diversity
• Ethical consideration is fully in the
  responsibility of the nation state
• We therefore defined three tasks for our work
• Dialogue and information exchange between groups
  concerned with ethical issues
• Raising awareness of researchers on ethical
  issues
• Deepening the understanding of ethical issues

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2.

• The 6 action on
• ethics in the action plan science and
  society

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Science and Society action plan to improve the
mutual understanding of the different national
contexts

• actions proposed in ethics
• Information and documentation system
• Public debate
• Awareness and education of researchers
• Networking across national and local ethical
  committees
• Intercultural dialogue and capacity building for
  developing countries
• Improvement on animal protection

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Action 29Making information more accessible

• An information and documentation observatory will
  be developed to help track and analyze the
  development of ethical issues in science at
  national and international level.

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Implementation

• Building on EURETHNET
• through the workprogramme 2003
• a Feasibility study
• To later propose to the infrastructure programme
• A network of documentation centres and a search
  machine for networks

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Action 30A European public dialogue
on ethics in science

• An open dialogue will be established between
  NGOs, industry, the scientific community,
  religions, cultural groups, philosophical schools
  and other interested groups, stimulating an
  exchange of views and ideas on a range of
  critical issues, such as the ethical impact of
  new technologies on future generations, human
  dignity and integrity, infoethics and
  sustainability.
• A variety of mechanisms will be used (focus
  groups, polling exercises, e-debates, workshops
  or institutionalised forums etc).

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Public debatedifficult to create on the
European level

• Therefore two high level groups are running this
  year
• to negotiate a report between industry, NGO and
  academia on genetic testing
• High level group to prepare new EUROBAROMETER

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Action 31Promoting awareness and integrity of
researchers

• Model courses and training modules will be
  developed in order to raise the awareness of
  researchers in the field of ethics

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Awareness and education of researchersstate of
the art

• 3 studies launched last year
• Results by November 2003
• Identifying university courses
  in ethics in Europe
• Select excellent teaching material
• Collect existing codes of conduct

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Awareness in Candidate countries

• Collect the national legislation
• On ethical issues in science
• Publish in two languages
• English and native language
• Ready before the end of this year
• 2002 Bratislava conference
• 2003 Enwise conference in Budapest

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Observation

• risky experiments are moved to countries with
  weaker legislation
• Clinical trials in Europe have moved east
• Lower saleries and weaker legislation
• Big chance for the scientists
• Necessity to comply with international rules
• Also the US is training in central and eastern
  Europe for the FDA approval

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Action 32 Facilitating exchange between
ethics committees

• Networks of ethical committees will be fostered
  at both
• national and
• local levels.
• The aim will be closer co-operation and a more
  effective exchange of experience and best
  practice.

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Networking across national and local
ethical committeesstate of the art

• Meeting of the Presidents of the national ethics
  councils
• Preparatory meeting in Brussels
• 1st meeting in Athens
• Next meeting the 19 December in Rome under
  Italian presidency

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Local ethics committees

• Study to establish a directory of all local
  research committees in the 33 countries
  collaborating in the FP
• To be published on the net beginning next year
• Plan to organise next year a first conference
  (march 2004)

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Action 33A dialogue on ethics with other
regions of the world

• An international dialogue on ethical principles
  will be developed through a series of conferences
  and workshops.
• An important aim will be to build up a capacity
  for ethical review in developing countries.

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Intercultural dialogue and capacity building for
developing countriesstate of the art

• Co-operation with the NIH
• In capacity building of ethical review in
  developing countries for EDCTP
• In June 2002 in South Korea/Seoul
• In January 2003 in Bamako/Mali
• In April 2003 in Kampala/Uganda
• In March 2004 in Egypt

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Action 34 Protecting animals in research

• Networks of animal welfare committees will be
  fostered
• and training of young scientists on animal
  welfare issues will be promoted
• to support the implementation of European
  legislation on the protection of animals in
  research.

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Improvement on animal protectionstate of the art

• Study to collect an overview
• Result in December
• On all existing animals committees in the 33
  countries of the FP
• Possibly organise a conference with the Council
  of Europe in 2005 and together with DG
  Environment on the new directive on animals in
  research

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3.

• Workprogramme 2003
• Open call
• Last cut off date
• 9 December 2003

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Workprogramme for 2003 1. Instrument
co-ordination action and specific support action
for training events, workshops, conferences or
networks

• objective Fostering networking and dialogue
  between ethics bodies in and beyond Europe
• Implementation in 2003 The focus will be on
• i) Helping European ethics councils or committees
  responsible for policy advice on ethics in
  research at the national level (including the
  European Group on Ethics) to improve information
  exchange and promote better understanding of
  topics and methodologies

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continued Fostering networking and dialogue
between ethics bodies in and beyond Europe
Implementation in 2003 The focus will be on
ii) Encouraging co-operation between local
ethics committees. Activities should lead to the
identification of good practices for research
evaluation and related methodological aspects.
Topics to be addressed should focus on newly
emerging questions in the ethical assessment
process with particular emphasis on the
requirements of the European regulatory
framework, and the differences or similarities
between national legislation in Europe
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continued Fostering networking and dialogue
between ethics bodies in and beyond Europe
Implementation in 2003 The focus will be on
iii) Promoting an international dialogue with
other regions of the world on ethical issues
arising from new scientific developments. For
developing countries, activities should help
improve training and the development of local
ethical review capacity, concentrating on topics
of the Europe/ Developing Country Clinical Trials
Platform research co-operation (cross reference
priority 1)
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Instrument specific support action for studies
on techniques and methodologies that can improve
the structure and the management of content, the
development of electronic networks, information
and communication tools
Creating a systematic information tool on ethical
issues in science Implementation
in 2003 The focus will be on preparatory work
to develop an information tool on ethical issues
that goes beyond EURETHNET, to other fields of
ethics, and connected to other relevant
information centres in the world. Work must build
on other research networks on ethics, such as
those on food and agro research, environment,
legal issues, data protection etc. In contract
negotiation Merging two proposals
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Instrument co-ordination action and specific
support action for studies, surveys,
dissemination, information and communication tools
Raising the awareness of researchers on ethical
issues Development of cross-cultural training
material and training programmes for researchers
on ethics in science and technology
identification and development of Codes of
Conduct for research in evolving technologies,
promotion of research integrity and transparency
of research results. Implementation in 2003 The
focus will be on analysing current provisions and
on identifying solutions to improve codes of
conduct on research ethics and cross-cultural
teaching and training material suitable also for
developing countries.
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Instruments specific targeted research projects
and co-ordination actions
The research call closed in June,
7 projects with
a total budget of 4,8 mEuro in negotiation Deepeni
ng the understanding of ethical
issues Comparative research, foresight and impact
studies on ethical, legal, socio-economic, and
cultural issues in relation to science, and
technology developments and their applications.
The emphasis is on cross-cutting questions
relevant to a number of research areas (e.g.
information society, nanotechnologies, human
genetics and biomedical research in food
technologies), that cannot be addressed within
the integrated projects of the relevant thematic
priorities.
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Deepening the understanding of ethical issues-
continued
Implementation in 2003 The focus will be on
emerging ethical questions in research and on
developing recommendations on how to address them
in order to improve the understanding of ethics
in the European Research Area. Outlook in 2004
A new call is planned in 2004, concentrating on
research into ethical issues that have not been
addressed in the 2003 call
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3.

• Workprogramme 2004
• Not yet official

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Orientation 2004 consolidation and follow-up 

• No open call anymore, but tenders and conference
  support
• Research call encourage opening to new fields
• SSA call support for conferences and
  workshops
• Call for tender targeted studies
• 3 conferences exploiting previous activities

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Research call

• Research call (March to October 2004)
• a) to improve understanding of the ethical
  issues and develop guidance on topics such as
• Nano and converging technologies
• Data protection in genetic data and bio banking
• Pharmaco genetics
• Question relating to dual use research
• Fusion of human and non-human material
• Neurosciences and enhancing human capacities
• b) Ethics in international research co-operation

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SSA

• Support for conferences
• For National Ethics Councils
• Training workshops for developing countries
• Global questions of research ethics

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Call for tender three conferences

• 4 calls for tender (studies)
• Comparative analysis of opinions produced by
  national ethics councils
• Cross border transfer of human tissues
• Impact study on ethical review in research
  projects
• Compilation on resource material for training
• 2 conferences
• Genetic testing (stakeholder conference and
  social security)
• Networking of local ethics committees
• Eurobarometer survey on underlying values

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On the Europa website

• http//europa.eu.int/comm/research/sciene-society/
  ethics/rules_en.html