Transcript Document 7149233

Ethics and
Public Policy:
the Science and
Society
Programme
Maurizio Salvi, MD, PhD
Directorate General Research
European Commission
Ethics and R&D Policy
Current Activities
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 and
careers very attractive
European Research Area
– The ‘internal market’ for knowledge and research
– The Lisbon Summit (March 2000) conclusion:
European 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 2002
“More Research for Europe” (3 % GDP)
• Commission Communication October 2002
“ERA - Providing a new momentum”
Science & Society
Action Plan
society
towards
synergy
between
- scientists
- citizens
- politicians
science
policy
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
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
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
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
Science and Society Areas
Research on Ethics
• research on ethics in relation
to science, technology
developments and their
applications
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.
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.
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.
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 selfregulatory initiatives in the scientific community and
industry.
Ethical Review under FP6
http://europa.eu.int/comm/research/science-society/ethics/rules_en.html
“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.”
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
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
the ethical review
…in the evaluation process
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*
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
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)
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
Inform Programme Committee
Ethical
Review
Commission decisions on rejected proposals
Rejection of full proposals
Contract Negotiation
Negotiation Failed
Commission decisions on proposals accepted for funding
Follow up
Reporting and follow-up to
outcome of ethical review
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
Ethical Audit
• In difficult cases
• Or in cases where the reporting
is not done in a transparent way
An ethical audit may be implemented
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”
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.
Research Proposal
Info on
ethics
Scientific evaluation
Ethical Review
National
Approval
National
Approval
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.
Before the start of the Research project: Approval of the
competent national authorities (local ethical committees)
must be given
Technical annex including the specific
National National
recommendations of the ethical review
Approval Approval
CONTRACT
Ethics in the
techn. annex
Annual Report
Ethical
issues
Annual Report
Ethical
Issues
Ethical Monitoring/audit
The scientific evaluation panel has to indicate
whether an ethical review is required
The annual report of projects dealing with ethical
issues should include a chapter on the management of
these ethical issues.
In the case of a second research phase requiring
approval…a system of monitoring should be
established.
National authorities approval must be checked
If concerns arise during the project an ethical audit can
be performed.
If ethical requirements are not followed, the
contract can be terminated
Further Information
• Further information on ethics requirements and rules
are given at the science and ethics website at
• http://europa.eu.int/comm/research/sciencesociety/ethics/ethics_en.html