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 policy - scientists - citizens - politicians Science & Society Action Plan towards synergy between

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

“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.” Rules for participation: "All the research activities carried out under the Framework Programme 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 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 ProposalInfo on ethics Scientific evaluation Ethical Review National Approval CONTRACT Annual Report Ethics in the techn. annex Ethical issues Annual ReportEthical 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 society/ethics/ethics_en.html