Ethics and Public Policy: the Science and Society Programme

Maurizio Salvi, MD, PhDDirectorate 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 andcareers 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

policy

- scientists

- citizens - politicians

Science & SocietyAction Plan

towards synergy between

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 self-regulatory 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:

“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.”

“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.”

• Rules for participation:

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

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

• 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

Areas excluded from funding under FP6:

No-go Areas:-

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

Evaluation of full proposals

Evaluation of Outline Proposals

Receipt of full proposal

Ethical Review

Contract Negotiation

Commission decisions on proposals accepted for funding

Receipt of outline proposal

Rejection of full proposals

Negotiation Failed

Final ranking lists

Commission decisions on rejected proposals

Inform Programme Committee

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

Implementing provisions for FP6 instruments

“ 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”.

“ 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”

Research Proposal Info on ethics

Scientific evaluation

Ethical Review

National Approval

National Approval

National Approval

National Approval

CONTRACT

Annual Report

Ethics in the techn. annex

Ethical issues

Annual Report Ethical Issues

Ethical Monitoring/audit

Technical annex including the specific recommendations of the ethical review

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

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

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

SUMMARY

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