1. Research ethics review in The Czech Republic: How is it done and how could it be done better Jiří Šimek University of South Bohemia in Ceske Budejovice

2. Sources Research on Czech ethics committees (2006 – 2009) Sponsored by Grant Agency of Czech Republic

3. Czech Republic 1990 - 2010 Period of social transformation = “sociological laboratory”

4. Starting point 1990 Ethics as a discipline and mere term „ethics“ did not exist No academic support of ethics No political interest in ethics No public interest in ethics

5. In spite of this ethical mechanisms worked From wild (“gold digger”) economy towards stabilised modern economy rooted in general trust. Painful process of development of political culture and „revolutionary“ results of 2010 elections.

6. Ethical mechanisms in the establishment of Czech ECs In 1990 enlightened minister of health (M. Bojar) recommended establishment of ethics committees About 40 ECs were quickly established Qualification: decent and non conflicting person

7. Ethical mechanisms in the establishment of Czech ECs People started to work with enthusiasm No need for clinical ethics consultation, only research ethics remained Pharmaceutical companies saved existence of ECs Later on grant agencies and universities started to ask for opinion

8. In 2004 accession to EU and introduction of Decree 2001/20/EC New bureaucratic order was introduced First time legally recognised existence of ECs ECs started to be officially organised Czech Forum of Ethics Committees: platform for debate and education

9. Experiences from research of Czech ECs Members of ECs are Decent and non- conflicting persons The basis of their work is debate and communication They patiently discuss the matter from as much perspectives as much they have at disposal.

10. Experiences from research of Czech ECs ECs do sound decisions and they give sound opinions. But they cannot explain why they did it Members of ECs believe that their work has sense. But they cannot explain why they feel this They lack vocabulary and theoretical knowledge to be able to explain

11. Our explanation ECs were established because there is too rapid development in research and in social relations Legal provisions and codes of conduct are out of date in the moment they are accepted Individuals can explain them differently

12. Our explanation ECs do classical ethical enterprise They discuss the matter from all accessible and reasonable perspectives

13. How could it be done better? In the work of ECs there is sound ethical mechanism We should defend this part of their work.

14. There are two dangers: Bureaucratising of the work of ECs Restriction of the work of Ecs to application of legal provisions and codes of ethics. Members need sound ethical creativity

15. How could it be done better? In next future demand for accountability of ECs will be very strong Members of Ecs need the ability to explain what they are doing They need education in ethics

16. How could it be done better? We need research ethics as academic discipline What should be the content of research ethics? What should learn members of ECs?

17. How could it be done better? “Ethical expertise” does it exist? And what we mean by that term? Second order discipline? How to educate in such disciplines?

18. Thank you for your attention