1. Teaching of Medical Ethics in Postgraduate Medical Education Jozef Glasa Slovak Health University - Dpt. of Clinical Pharmacology; Institute of Medical Ethics and Bioethics n.f.; Central Ethics Committee, Ministry of Health Bratislava, Slovak Republic FEAMC, Bratislava, Slovak Republic, 1. - 4. 7. 2004

2. Europe

3. In CEE - NEUMS: Legislation changes towards the full comptibility with EU Acquis communitaire e.g. Directive 2001/20/EC on GCP

5. Ethics Committees in NEUMS - Types & Tasks National (Central) (Bio)Ethics Committee – legislation, national policies & standards, conceptual and consulting work, education, public debate, etc. Regional (Research) (Bio)Ethics Committee – mulicentric clinical trials, multicentric biomedical research, regional policies, consulting work, education, public debate, etc. Local (Institutional) (Research) Ethics Committee – institutional clinical trials & biomedical research, local aspects of multicentric trials, institutional policies, consulting work, education, public debate, etc.

6. RECs in CEE NEUMS - Status Quo Question: What is the Situation in CEE - NEUMS? –Answers are scarce. Some resources: –NECs - Council’s of Europe Comparative Study (1998) http://www.coe.int; Sabatier, S., 2000 –ECs in Central and Eastern Europen Countries Glasa, J. (Ed.), CE & IMEB Fdn., 2000 –Legislation in biomedical research in NAS (NEUMS), survey, European Commission, Directorate C - ERA: Science and Society, Rhode, B., Bitušíková, A. (Eds.), 2004, in press –RECs in EU and some NAS PRIVIREAL Project - 5FP EC, survey, 2004, in press –other surveys, occasional reports, etc.

7. ECs in CEE: ‚Internal‘ Problems & Future Challenges recognition, authority, influence of RECs independence, conflicts of interest professional & ethical competence of members moral/ethical pluralism/relativism & REC‘s decisions (consensus - compromise, deadlocks ?) workload (quality of review) ethics review - or just „procedural“ ethics ? mere bureaucracy ? mere paperwork ? manpower problem (rewards, payments, motivation) participation of the „lay persons“, public

8. ECs: Possible Ethical Dilemas in CEE interests of science/scientists vs. interests of individual or society (benefits/risks) local policies & local „politics“ (hidden agendas) „conservative“ vs. „liberal“ views & attitudes ethnic, national, religious & „political“ aspects appropriatness of rewards/payments (reimbursements, salaries, fees, etc.) informed consent (information, autonomy, protection,...) insurance policies benefits of the research for the subjects/participants, community(ies) and population of the country

9. Developments in the Slovak Republic 1990 - Central Ethics Committee (CEC; MH SR) 1991/2 - (Research) Ethics Committees in research institutions and major teaching/university hospitals 1992 - Guidelines on establishment and work of ethics committees ( prepared by CEC; MH SR ) 1994 - new Health law ( No. 277/1994 Coll.) - provision on RECs 1998 - Law on drugs ( No. 140/1998 Coll. ) - provision on RECs 2002 - program of revitalisation of the system of ethics committees in the Slovak Republic ( by CEC ) 2002 - Draft Regulation on ethics committees ( by CEC ) 2002 - 1 st national meeting of (R)ECs ( sponsored by CEC ) 2003 - 2 nd national meeting of (R)ECs ( sponsored by CEC ) 2004 - amendments of the Health law ( No. 277/1994 Coll.) and Law on Drugs ( No. 140/1998 Coll. )

10. RECs system in the Slovak Republic Central Ethics Committee of the Ministry of Health – national bioethics advisory body (since 1990) – reviews protocols exceptionally, when no other (L)REC exists (Local Research) Ethics Committees – established at the health care facilities/research institutes – favourable opinion/statement necessary [prior/in paralel to permission of the State Institute for Drug Control - for CTs; Law No. 140/1998 on drugs and health equipment; prior to permission of biomedical research of the director of the health facility; Law No. 277/1994 on health care] – to assess ‚local aspects‘ in multicentric biomedical research/CTs Regional Ethics Committees – to be established (legislation/regulations pending) – to review multicentric biomedical research/CTs‘ protocols in compliance with the Directive 2001/20/EC

11. Medical Ethics (Bioethics) Teaching Institutions in the Slovak Republic Institute of Medical Ethics and Bioethics (n.f.) Bratislava Institute of Social Medicine and Medical Ethics, Faculty of Medicine, Bratislava Department of Medical Ethics, Slovak Medical University, Bratislava programs in medical ethics: – Faculty of Medicine, PJSU, Košice – Faculty of Medicine, CU, Martin programs in nursing ethics – Institute of Nursing, FoM CU, Martin – University of Trnava (FoNSW), Trnava programs in nursing ethics at schools of nursing (ETC.)

12. Thanks for your attention!