1. Ethical standards in biomedical research: the acquis and projects of the Council of Europe Laurence Lwoff Bioethics Division Council of Europe http://www.coe.int/bioethics 8th Global Forum on Bioethics in Research, 27 – 29 June 2007, Vilnius

2. Council of Europe Intergovernmental organisation founded in 1949, to achieve greater unity between its members with a view to defend : Intergovernmental organisation founded in 1949, to achieve greater unity between its members with a view to defend : Human rights Human rights Parliamentary democracy Parliamentary democracy Rule of law Rule of law 47 countries (all EU member states also CoE members) 47 countries (all EU member states also CoE members) Observer status: Canada, Holy See, Japan, Mexico, United States Observer status: Canada, Holy See, Japan, Mexico, United States

3. Activities of the Council of Europe in the field of bioethics To find the necessary balance between scientific /medical progress and protection of the human being Normative activities: defining fundamental principles ensuring this balance Cooperation activities: helping country implementing those principles (e.g. meetings, publication, expertises)

4. Activities of the Council of Europe in the field of bioethics: biomedical research Acquis Legal instruments Cooperation activities Projects

5. Biomedical research:relevant CoE legal instruments Convention on Human Rights and Biomedicine (Oviedo, 04.04.1997) Additional Protocol on Biomedical Research (25.01.2005) Recommendation on Research on Biological Materials of Human Origin, Rec (2006) 4 (15.03.2006)

6. European instruments but… Normative corpus reflecting European consensus, but… Normative corpus reflecting European consensus, but… International dimension of research taken into account International dimension of research taken into account Values and derived principles have vocation to contribute to general consideration at international level Values and derived principles have vocation to contribute to general consideration at international level

7. Biomedical research:Convention on Human Rights and Biomedicine Fundamental principles Free, informed, express, specific and documented consent Free, informed, express, specific and documented consent Research shall be carried out freely, subject to provisions ensuring protection of the human being. Research shall be carried out freely, subject to provisions ensuring protection of the human being. Some specific conditions Approval by the competent body after independant examination of scientific merit, including independent multidisciplinary review of ethical acceptability

8. Biomedical research: Additional Protocol on biomedical research Covers full range of research activities involving interventions on human being (including recruitment of research participants) Builds on the principles of the Convention and complements its provisions In particular Informed consent: type of information to be communicated to the person Confidentiality Research in specific situations: emergency situation, pregnant women, persons deprived of liberty Transparency: publication of all results

9. Biomedical research: Additional Protocol on biomedical research Ethical review – Ethics committee (Articles 9 to 12): Any research project submitted for independent ethical review by an ethics committee, in each state in which any research activity is to take place Ethics committee: independance, no undue external influences, declaration of conflict of interests, appropriate range of expertise, professional and lay views information to be provided for evaluation of a research project (Appendix) Recommendation on research on biological materials

10. Biomedical research: Additional Protocol on biomedical research Equivalent protection of all participants in research including in countries not bound by the Protocol (Article 29) Sponsors or researchers within jurisdiction of a Party to ensure that research project planned in a State not Party complies with the principles of the Protocol.

11. Cooperation activities DEBRA (Demo-Droit Ethical Review of Biomedical Research Activity) Objectives: Objectives: To promote ethical principles in biomedical research To promote ethical principles in biomedical research To foster the development of independent and multidisciplinary ethics committees for review of biomedical research projects. To foster the development of independent and multidisciplinary ethics committees for review of biomedical research projects. Multilateral, regional, bilateral meetings on biomedical research ethics, in particular ethical review of research projects and functioning of ethics committees Multilateral, regional, bilateral meetings on biomedical research ethics, in particular ethical review of research projects and functioning of ethics committees Publication/Code of good practices: e.g.« Ethical Review of Biomedical Research in Europe: Suggestions for best national practices », by Prof. Povl Riis Publication/Code of good practices: e.g.« Ethical Review of Biomedical Research in Europe: Suggestions for best national practices », by Prof. Povl Riis Legal expertise Legal expertise

12. PROJECTS Objective: Objective: raising awareness on ethical principles and facilitating their effective implementation Cooperation activities: Cooperation activities: Regional/bilateral meetings Regional/bilateral meetings Comprehensive programme focusing on one country Comprehensive programme focusing on one country Developments of guide(s) intended for research ethics committee members, scientists, health professionals Developments of guide(s) intended for research ethics committee members, scientists, health professionals Pedagogical tool on ethics of biomedical research Pedagogical tool on ethics of biomedical research

13. Conclusions Development of a whole set of legal instruments addressing ethical issues raised by biomedical research which are the only legally binding instruments at international level Definition of a framework for the protection of human rights and fundamental freedoms in the field of biomedical research Normative activity accompanied by cooperation activities in Central and Eastern European countries to promote ethical principles in biomedical research Current projects include: Further development of these cooperation activities Elaboration of texts intended for health professionals, researchers and research ethics committee members. Pedagogical tool Council of Europe ready to share its experience in this field and to collaborate with other organisations and bodies