1. Vilnius, 29 June 2007 CIOMS Recommendations on Ethics in Medical Research The Eighth Global Forum on Bioethics in Research Gottfried Kreutz Dr. med., Dipl.-Chem.; Director and Professor Secretary-General Council for International Organizations of Medical Sciences

2. Outline - 1 Council for International Organizations of Medical Sciences (CIOMS) -Founding -Status -Purpose and Objectives -Domains of Activities

3. Outline - 2 CIOMS MedDRA Working Group -Organization -Task -Composition of WG -Work process -Development steps

4. Founding and Founding Organizations Year:1948 Consultation (UNESCO > WHO) 1949 Conference and Agreement (Bruxelles) By United Nations (UN) World Health Organization (WHO) United Nations Education and Science Organization (UNESCO)

5. Status of CIOMS Non-Governmental Organization with financial assistance from the two parent organizations (WHO, UNESCO)

6. Purpose of CIOMS " … facilitate the exchange of views and scientific information in the medical sciences by securing continuity and coordination between international organizations of medical sciences, by making their work known, and by furnishing them with material aid where necessary. " (Introduction to current Statutes)

7. Objectives of CIOMS (Article 3 of Statutes) To act as a co-ordination centre between the international associations and the national institutions adhering to the Council To facilitate and co-ordinate the activities of the international members of the Council To maintain collaborative relations with the United Nations and its specialized agencies, in particular with UNESCO and WHO

8. Objectives of CIOMS (Article 3 of Statutes) To promote international activities in the field of medical sciences whenever the participation of several international associations and national institutions adhering to the Council is deemed necessary To serve the scientific interests of the international bio-medical community in general

9. Domains of Activities of CIOMS Planning and timing of international medical congresses (until 1966) Medical nomenclature Medical research ethics Pharmacovigilance New therapeutic or diagnostic approaches

10. International Ethical Guidelines for Biomedical Research Involving Human Subjects Geneva 2002

11. International Ethical Guidelines for Biomedical Research Involving Human Subjects The Guidelines relate mainly to ethical justification and scientific validity of research; ethical review; informed consent; vulnerability ­ of individuals, groups, communities and populations; women as research subjects; equity regarding burdens and benefits; choice of control in clinical trials; confidentiality; compensation for injury; strengthening of national or local capacity for ethical review; and obligations of sponsors to provide health-care services. (Versions 1982, 1993, 2002)

12. CIOMS International Guidelines for Ethical Review of Epidemiological Studies Published:Geneva 1991 Current working title, first revision: International Ethical Guidelines for Epidemiological Studies

13. Process for revision of the 1991GL on epidemiological research The Core Group has met seven times since 2003 - latest Group meeting March 2007 Draft document (currently on the CIOMS website for second external comment) First external consultation from summer 2006 to January 2007 More than 500 comments from some 30 institutions From 4 - 6 June 2007, as a pre-final step, Consultative Meeting for invited experts together with the Core Group Core Group to re-consider all comments received and to prepare the pre-final document The pre-final draft is planned to be presented again on the CIOMS website (expected by fall 2007) before final approval

14. Drug Development Research in Resource-Limited Countries Date of draft report:December 2005 Deadline for external comments: on-going (the original deadline, April 2006, has been extended Composition of Joint CIOMS / WHO Working Group: Regulatory Authorities from developing countries, senior scientists from pharmaceutical companies, WHO & CIOMS officers

15. Summary (CIOMS) CIOMS is the only institution worldwide who provides organizational structure and a forum for all organizations of medical sciences, for professional experts from all sectors (academic, private, regulatory), and for all domains CIOMS provides expertise in the organization and efficient communication of globally harmonized expert opinions CIOMS works as a Think-Tank

16. Summary (Guidance in Research Ethics) CIOMS has published for almost three decades globally harmonized recommendations for research ethics CIOMS guidance document are reviewed and updated periodically Contributions to documents, draft or final, are welcomed and encouraged at any stage in the process

17. Thank you for your attention ! For further questions, please … Ask now, Consult the CIOMS website: www.cioms.ch,www.cioms.ch Write to: kreutzg@who.int