Ethics and Public Policy: the Science and Society Programme

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Ethics and Public Policy the Science and Society
Programme
Maurizio Salvi, MD, PhD Directorate General
Research European Commission
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Ethics and RD Policy Current Activities
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Eurobarometer Survey 2001

• Divergent views on science and society among the
  European population.

• Main messages of the survey
• 80 of Europeans believe that science will one
  day overcome diseases such as AIDS or cancer,
  but
• 46 of Europeans are both uninformed and
  uninterested in science
• Citizens do not always trust science and
  scientists 80 believe authorities should
  oblige scientists to observe ethical rules
• Young people do not find scientific studies
  andcareers very attractive

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European Research Area

• The internal market for knowledge and research
  
• The Lisbon Summit (March 2000) conclusionEuropea
  n Union to be developed into a knowledge based,
  dynamic and competitive economy
• Measures to boost RTD spend towards 3 of GDP by
  2010 (Council decision of Barcelona March 2002)
• Renewed impulse
• Commission Communication September 2002More
  Research for Europe (3 GDP)
• Commission Communication October 2002ERA -
  Providing a new momentum

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Science Society
Action Plan
society
towards synergy between
science
- scientists - citizens -
politicians
policy
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Science and Society Areas

• 4.3.1 Scientific advice, governance and
  reference systems
• 4.3.2 Ethics
• 4.3.3 Uncertainty, risk, and implementing the
  precautionary principle
• 4.3.4 Scientific and technological culture,
  young people, science education and careers
• 4.3.5 Women and science

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The ethical dimension

• Dialogue information exchange between ethics
  groups
• horizontal councils/local committees
• international dialogue
• observatory
• Raising awareness of researchers
• information and debate
• training material
• codes of conduct
• Deepening understanding of ethical questions
• ethics and scientific research / ethics and EU
  policies
• integrity of researchers
• infrastructures and methodologies

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Science and Society Areas

• Action Plan
• Action 29 Set up information and documentation
  observatory for ethical issues
• Action 30 Establish public dialogue on ethics in
  science
• Action 31 Raise scientific researchers
  awareness of ethical issues

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Science and Society Areas

• Action Plan
• Action 32 Foster local and national networks of
  ethical committees
• Action 33 Develop international dialogue on
  ethical principles
• Action 34 Protect animals used in scientific
  research

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Science and Society Areas

• Research on Ethics
• research on ethics in relation to science,
  technology developments and their applications

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Science and Society Areas

• Comparative research, foresight and impact
  studies on ethical 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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Science and Society Areas

• Implementation in 2003 The focus will be on
  addressing emerging ethical questions in
  research, and on developing recommendations on
  how to address them in order to improve
  understanding of ethics in the European Research
  Area.

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Life sciences and biotechnology A strategy for
Europe

• Action 20 the Commission will encourage public
  debates on biotechnology between scientists,
  industry and civil society, including specific
  interest groups, such as patients groups,
  farmers, consumers, women, and young people,
  focussing on specific technological developments,
  to raise public interest in such developments and
  offer early information on potential benefits and
  risks.

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Life sciences and biotechnology A strategy for
Europe

• Action 25 While respecting cultural pluralism,
  the Commission will work with public and private
  partners to identify areas where it is possible
  to establish consensus on ethical
  guidelines/standards or best practise. Areas
  might include stem cell research, human biobanks,
  xenotransplantation, genetic testing and
  transgenic animal research. Such guidelines could
  take the form of self-regulatory initiatives in
  the scientific community and industry.

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Ethical Review under FP6

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

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General Rules

• FP Article 3

"All the research activities carried out under
the Framework Programme 2002-2006 must be carried
out in compliance with fundamental ethical
principles.

• Rules for participation

A proposal which contravenes fundamental ethical
principles.shall not be selected. Such a
proposal may be excluded from the evaluation and
selection procedures at any time.
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No-go Areas-
Areas excluded from funding under FP6

• Human cloning for reproductive purposes
• Germline gene therapy (research relating to
  cancer treatment of the gonads can be financed.)
• Creating human embryos solely for the purpose of
  research or of stem cell procurement, including
  by means of somatic cell nuclear transfer
• ? Until Dec. 2003
• No funding of research on human embryonic stem
  cells with the exception of banked or isolated
  human embryonic stem cells in culture

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Ethical review and monitoring

• As part of the evaluation process an ethical
  review will be implemented systematically at EU
  level for proposals dealing with ethically
  sensitive issues.
• In specific cases, further ethical review may
  take place during the implementation of a project

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the ethical review

• in the evaluation process

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Applicants are requested

• to confirm that the proposed research does not
  involve

• Research activity aimed at human cloning for
  reproductive purposes
• Research activity intended to modify the genetic
  heritage of human beings which could make such
  change heritable
• Research activity intended to create human
  embryos solely for the purpose of research or for
  the purpose of stem cell procurement, including
  by means of somatic cell nuclear transfer
• Research involving the use of human embryos or
  embryonic stem cells with the exception of banked
  or isolated human embryonic stem cells in culture

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The ethical review will be performed

• After a positive scientific evaluation
• By a multidisciplinary panel of experts
• With the possibility of adjusting and improving
  proposals that impinge on fundamental ethical
  principles (rules for participation)
• The report of the ethical review will be part of
  the technical annex

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What do they discuss?

• Ensure Article 3 of FP6 is fulfilled
• Ensure that the proposers properly address
  ethical issues arising from the research
• Make sure that research fulfils all ethical
  and/or legal requirements at national, EC and
  international level
• Allows for possibility of excluding research
  projects that contravene fundamental ethical
  principles (see rules for participation)

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Evaluation procedure including
the ethical review
Call for Proposals
Receipt of full proposal
Receipt of outline proposal
Evaluation of Outline Proposals
Receipt of full proposal
Evaluation of full proposals
Final ranking lists
Ethical Review
Inform Programme Committee
Commission decisions on rejected proposals
Rejection of full proposals
Contract Negotiation
Negotiation Failed
Commission decisions on proposals accepted for
funding
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Follow up

• Reporting and follow-up to outcome of ethical
  review

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Ethical management

• IP foresee specific ethical management within the
  project if required
• In this case the ethical reporting is linked to a
  management component in the project
• NoE - no specific ethical management - but if it
  felt necessary, ER panel might for example
  recommend an ethicist be included on management
  board

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Ethical Audit

• In difficult cases

• Or in cases where the reporting is not done in a
  transparent way

?An ethical audit may be implemented
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Ethical Audit
FP6 Rules of Participation - 16 December 2002
The Commission or any representative authorised
by it, shall have the right to carry out
scientific, technological and financial audits on
the participants, in order to ensure that the
indirect action is being or has been performed
under the conditions claimed and accordance with
the terms of the contract.
Implementing provisions for FP6 instruments
Ethical audits may be launched at any time
during the implementation of the project in order
to verify that the project is respecting
fundamental ethical principles and national
regulations
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SUMMARY
If the research projects is dealing with ethical
issues, the project proposal has to inform about
the ethical justification and on the foreseen
management of the ethical issues.
The scientific evaluation panel has to indicate
whether an ethical review is required
Research Proposal
Info on ethics
After positive scientific evaluation and when
indicated by the scientific panel, an Ethical
Review is conducted on the basis of European
regulations (incl. the conditions formulated in
the FP.) Contract Negotiation based on the
comments of the scientific evaluation and the
ethical review.
Scientific evaluation
Before the start of the Research project
Approval of the competent national authorities
(local ethical committees) must be given
Ethical Review
Technical annex including the specific
recommendations of the ethical review
National Approval
National Approval
National Approval
National Approval
The annual report of projects dealing with
ethical issues should include a chapter on the
management of these ethical issues.
CONTRACT
Ethics in the techn. annex
In the case of a second research phase requiring
approvala system of monitoring should be
established. National authorities approval must
be checked
Annual Report
Ethical issues
Annual Report
Ethical Issues
If concerns arise during the project an ethical
audit can be performed.
If ethical requirements are not followed, the
contract can be terminated
Ethical Monitoring/audit
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Further Information

• Further information on ethics requirements and
  rules are given at the science and ethics website
  at
• http//europa.eu.int/comm/research/science-society
  /ethics/ethics_en.html