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T eaching of M edical E thics in P ostgraduate M edical Education

FEAMC, Bratislava, Slovak Republic, 1. - 4. 7. 2004. T eaching of M edical E thics in P ostgraduate M edical Education. Jozef Glasa Slovak Health University - Dpt. of Clinical Pharmacology ; Institute of Medical Ethics and Bioethics n.f.; Central Ethics Committee, Ministry of Health

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T eaching of M edical E thics in P ostgraduate M edical Education

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  1. FEAMC, Bratislava, Slovak Republic, 1. - 4. 7. 2004 Teaching of Medical Ethicsin 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

  2. Europe

  3. In CEE - NEUMS: Legislation changes towards the full comptibility with EUAcquis communitairee.g. Directive 2001/20/EC on GCP

  4. 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.

  5. 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 CountriesGlasa, 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.

  6. ECs in CEE: ‚Internal‘ Problems&Future Challenges • recognition, authority, influence of RECs • independence, conflicts of interest • professional & ethical competenceof 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

  7. ECs: Possible Ethical Dilemas in CEE • interests of science/scientistsvs. 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

  8. 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 - 1st national meeting of (R)ECs (sponsored by CEC) • 2003 - 2nd 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.)

  9. RECs system in the Slovak Republic • Central Ethics Committeeof 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

  10. Medical Ethics (Bioethics) Teaching Institutionsin 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.)

  11. Thanks for your attention!

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