Ethics and Governance in the 7th Framework Programme

1
Ethics and Governance in the 7th Framework
Programme
Peteris Zilgalvis, J.D. Head of Unit Governance
and Ethics DG RTD
2
Ethics and EU Law

• Under existing EU Treaties, there is no specific
  EU competence on ethics in research
• However, ethical issues in research are
  addressed
• -in several sectoral EU Regulations and
  Directives
• (i.e. patents, clinical trials, data protection,
  animal welfare, biosafety)
• -in the various Decisions on framework research
  programmes (i.e. FP6 and FP7 Framework
  Programmes)
• -in a variety of International Treaties and
  Protocols that have been incorporated into the
  Community legal order

3
European Charter of
Fundamental Rights

• It is the cornerstone of EUs competence on
  research ethics
• Article 3
• Everyone has the right to respect for his or her
  physical and mental integrity
• In the field of medicine and biology
• the free informed consent of the person
  concerned
• the prohibition of eugenic Practices
• the prohibition on making the human body and its
  part as such a source of financial gain
• the prohibition of the reproductive cloning of
  human beings

4
EU secondary legislation on research
ethics (examples)

• Directive 95/46 on the protection of personal
  data
• Directive 2001/20/EC on good clinical practice
• Directive 2001/83/EC on medicinal products for
  human use
• Directive 86/609/EEC on the protection of animals
  used for experimental and other scientific
  purposes
• Directive 98/44/EC on the legal protection of
  biotechnological inventions
• Directive 2000/54 on the protection of workers
  from risks related to the exposure to biological
  agents at work

5
International legislation on ethics
in research (examples)

• The Helsinki Declaration - Ethical Principles for
  Medical Research Involving Human Subjects (World
  Medical Association, 1964)
• European Convention for the Protection of
  Vertebrate Animals used for Experimental and
  Other Scientific Purposes (Council of Europe,
  1986)
• Convention for the protection of Human Rights and
  dignity of the human being with regard to the
  application of biology and medicine Convention
  on Human Rights and Biomedicine (Council of
  Europe, 1997)
• The Universal Declaration on the Human Genome and
  human Rights (UNESCO,1997)
• International Treaty on Plant Genetic Resources
  for Food and Agriculture (FAO, 2001)
• The Universal Declaration on Bioethics and Human
  Rights (UNESCO, 2005)

6
Ethics in the context of the EUs
research policies

• In 2000, a system of scientific research
  programmes integrating EUs scientific resources
  was created
• the European Research Area (ERA)
• ERA is the central pillar of the EU 'Lisbon
  Strategy' for growth and jobs, together with the
  completion of the Single Market, the European
  'broad-based innovation strategy' and the
  creation of a European Higher Education Area
• According to the 2020 vision for the European
  Research Area document
• Research carried out in the ERA should respect
  the ethical principles of the EU and supports its
  democratic values as well as the cultures and
  identities of Member States

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Towards a European Research Area

• Promotion of common social and ethical values in
  scientific and technological matters was defined
  as a core implementing measure
• Main objectives
• To strengthen the links between the ethics
  committees established at national and European
  levels.
• To encourage the opening up of the various
  national committees to experts from other
  European countries in view of helping to make for
  mutual understanding of points of view and the
  development of harmonious approaches.
• To compare the rules in force and the criteria on
  ethics used in national and European research
  programmes with a view to alignment around shared
  principles and respect for differences in
  sensitivities and opinions. (Communication
  'Towards a European Research Area,' 2000)

8
The European Research Area

• European Research should experiment with new ways
  of promoting responsible scientific and
  technological progress, within a framework of
  common basic ethical principles and on the basis
  of agreed practices that can inspire the rest of
  the world.
• (Green Paper 'The European Research Area New
  Perspectives')

9
European Commission Research Action Plan

• 2001 Action Plan Science and Society
• 6 actions (out of 38 suggested actions) aim at
  the improvement of the understanding and
  awareness of ethics in research as well as at the
  promotion of networking of existing institutions
  that deal with research ethics

10
EU financial instruments for research

• Decision 1982/2006/EC of the European Parliament
  and of the Council (Recital 30 and Article 6)
• All the research activities carried out under
  the 7th Framework Programme shall be carried out
  in compliance with fundamental ethical principles

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Areas excluded from funding under FP7,
Art. 6 (2)

• i) Research activities aiming at human cloning
  for reproductive purposes
• ii) Research activities intended to modify the
  genetic heritage of human beings
• iii) Research activities intended to create human
  embryos solely for the purpose of research or
  stem cell procurement

12
EU-wide initiatives on ethics in
research

• Establishment of the European Group on Ethics in
  Science and New Technologies (EGE, 1998) (before
  Group of advisers to the European Commission on
  the ethical implications of biotechnology (GAEIB,
  1991))
• Adoption of Action Plans and other policy
  initiatives for the promotion of responsible
  research and for linking scientific research
  closer to societal and ethical concerns
• Funding of research projects that examine the
  role of ethical standards in science and research
• Creation of an Ethical review institutional
  platform for all Community Framework research
  proposals

13
The role of the Governance and
Ethics Unit

• Generally, the Governance and Ethics Unit deals
  with European and international governance
  aspects linked to risks and ethics in research.
• -Safeguards the compliance of the EU-supported
  research
• community with EU and International norms on
  ethics in science
• -Selects and manages FP7 research projects in the
  area of science and society with a particular
  focus on ethical issues (including
  capacity-building projects)
• -Ensures the coordination of national and
  regional ethical committees on particular
  thematic areas and creates synergies between the
  scientific community and ethical boards as well
  between national and supranational fora on
  ethical issues

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Compliance of researchers with ethical
standards

• This is achieved through a case-to-case review of
  all research proposals submitted in the frame of
  the PF7 that have successfully passed the
  scientific evaluation step and have been found to
  involve sensitive ethical issues that have not
  been adequately addressed
• The Unit is in charge of organising the necessary
  ethical expert review meetings and of ensuring
  the compliance of the produced reports with the
  relevant EU and International legal standards
• The organisation of the Ethics Review involves
  the appointment of the members of the Ethics
  Review panels and the procedural coordination of
  the entire evaluation process.
• Apart from an ex-ante review, the Unit is also
  designing and setting up an ex-post evaluation
  (ethical follow-up/audit)

15
Ethical standards in research

• Research ethics rests on the following 3
  fundamental principles
• Autonomy - obligation on the part of the
  investigator to respect each participant as a
  person capable of making an informed decision
  regarding participation in the research study
• Beneficence - obligation on the part of the
  investigator to attempt to maximise benefits for
  the individual participant and/or society, while
  minimizing risk of harm to the individual
• Justice - demands equitable selection of
  participants, i.e., avoiding participant
  populations that may be unfairly coerced into
  participating, such as prisoners and
  institutionalised children. It also requires
  equality in distribution of benefits and burdens
  among the population group(s) likely to benefit
  from the research.

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Promoting research in research
ethics (I)

• Ethics research - 10m for 2008 for projects that
  deal with
• ETHICAL - Promoting International Debate on
  Ethical Implications of Data collection, use and
  retention for Biometric and Medical Applications
• RISE - Rising pan-European and International
  Awareness of Biometrics and Security Ethics
• EFORTT- Designing ethical standards for Telecare
  Technologies for older people at home
• GEESE Guiding the Early identification of
  Ethical issues likely to emerge in the context of
  the Societal Embedding of new technologies
• SYNTH-ETHICS - Addressing the ethical, legal and
  social implications of the emerging field of
  synthetic biology

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Examples of Ethics-related actions
funded by DG Research (I)

• Research on ethical frameworks of new
  technologies
• Research on appropriate ethical frameworks of new
  technologies research on foresight of ethical
  issues likely to emerge in the context of the
  societal embedding of new technologies.
• Research underpinning policy at European and
  International levels, related to ethics,
  precaution and sustainable development.
• Research on benefit sharing aspects of natural
  and genetic resources IPR and bioethics.
• Research on privacy and emerging fields of
  science and technology ethical, social and legal
  aspects.
• Research on information technology, security
  technology, biometrics, biomedical technology and
  the prospective applications of particular
  nanotechnologies.

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Examples of Ethics-related actions
funded by DG Research (II)

• Research on networking and capacity building
  activities to support ethics committees
• Enhancement the knowledge base and best practice
  - across local, national and international levels
  - of ethics committees respective working
  practises, reviews and opinions.
• Research on Governance and Ethics of the
  responsible development of Nanosciences and
  Nanotechnologies
• articulating and implementing the European Code
  of Conduct on the responsible development of
  nanosciences and nanotechnologies
• Research is sought on ethical issues for which no
  European or international guidelines exist and
  which would be relevant for European science and
  technology policy.

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Examples of Ethics-related
actions funded by DG Research (III)

• Research on ethics either during the Research and
  Technology Development phase or during the
  application phase of new technologies
• Establishment of privileged and mutually
  beneficial partnerships for jointly addressing
  crucial research-related societal issues such as
  the recognition of ethical issues entailed in
  clinical trials
• Sharing good practices on the ethical, legal and
  social arrangements that help reconcile
  fast-growing scientific knowledge with local and
  regional cultures

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Priorities for ethics-related
actions

• European Ethics Documentation Centre
• Create an inter-connected European information
  and documentation system to promote critical
  debate on issues of major significance in ethics
  and science
• Forum of National Ethics Councils
• Support for the networking of National ethics
  councils
• Ethics and security research
• Promote a pan-European discussion on ethical
  aspects of dual use (e.g. potential use for
  military purposes and/or potential use by
  terrorists) and security-related research,
  focusing in particular on biometric technologies
• International dialogue capacity building in
  developing countries
• Helping developing countries to build up their
  own best practices in the field of ethics and
  science, and ensuring that European research
  conducted in developing countries (international
  cooperation partner countries) will comply with
  fundamental ethical principles

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EU-wide and international
coordination and synergies

• The Unit is responsible for the Forum of National
  Ethics Councils (NEC Forum) and of the European
  Network of Research Ethics Committees (EUREC)
• NEC is an informal, independent platform for
  exchange of information, experience and best
  practices on issues of common interest in the
  field of ethics and science
• The Unit participates to the relevant
  intra-Commission discussions on ethics (such as
  in the Inter Service Group on Ethics and EU
  Policies) and to activities organised by
  international organisations and professional
  associations in the field of medical care, animal
  welfare, biobanking, etc.

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Challenges when dealing with
research ethics at the EU level (I)

• Designing ethical review instruments that will
  respond in a timely manner to modern
  technological challenges (such as synthetic
  biology) is a challenging task
• Various research communities still view ethics in
  science as a necessary evil (but less and less)
• The methodological structures and legal tools for
  dealing with several dimensions of research
  ethics at the EU level are still under
  elaboration

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Challenges when dealing with
research ethics at the EU level (II)

• -Highlighting the need for adding an ethical
  layer to traditional scientific disciplines
  requires the consensus between a wide variety of
  actors
• -Balancing between national/local specificities
  and supranational norms
• -Formulating an EU language on ethics becomes, at
  times, a political task that clashes with
  established local and national cultural habits,
  customs and traditions

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Ethics Review and the FP7 Ethics
Framework

• Any questions?
• Contact
• Peteris Zilgalvis, J.D.
• Head of Unit, Governance and Ethics
• Directorate L Science, Economy and Society
• European Commission, Research Directorate-General
  
• peteris.zilgalvis_at_ec.europa.eu