1. 1 17/02/2014 Education, training and communication in ethics review University of South Bohemia in Ceske Budejovice Faculty for Health and Social Studies Jiri Simek

2. 2 17/02/2014 Ethical regulation of research lStarted after Second World War lNuremberg code was the first lGood will and informed consent is not sufficient lResearch is done in many ways lThere are many forms of risk

3. 3 17/02/2014 Observational studies lIssues of data protection l Possible invasiveness lunwanted memories lUnwanted presence of observers

4. 4 17/02/2014 Human intervention studies lConnected with more or less serious multiform risk. lSide effects and unexpected effects of drugs lInvasive studies lblood and tissue samples, surgery lmagnetic resonance imaging

5. 5 17/02/2014 Human intervention studies lIssues of human dignity lInformed consent lResearch on subjects not able to give valid consent lAssurance of research institution

6. 6 17/02/2014 Research with the use of animals lMovement of animal protectors in the last quarter of twentieth century lAnimal protection became a new issue in research ethics lMany regulations came in force

7. 7 17/02/2014 Research with the use of animals lStrategy of 3R: lReplacement lReduction lRefinement lMinimum standards for housing and care lAnimal care committees

8. 8 17/02/2014 Difficulties in safeguard of research subjects lMany issues at stake lLanguage of ethics is different from the language of biological science lResearch teams have difficulties in ethical part of project submission lWay out – collective guidance lEthics committees lEthical review panel

9. 9 17/02/2014 Is there the need for education and training? lIs ethical expertise a special profession? lComplexity of ethical review lEducation and training is the matter of discussions lEthics is a branch of philosophy lMembers of ECs have no aspirations to become philosophers

10. 10 17/02/2014 Is there the need for education and training? lIn omission of philosophy rules and legislation are too important lEthics is broader issue than legislation lEthical reviewers should be able to argue lIt is necessary for ltransparency laccountability

11. 11 17/02/2014 Content of education and training lEssentials in general ethics lSpecific issues in research ethics lEssentials in scientific thinking lExisting rules and legislation lEssentials of bureaucratic work lTraining in ethical argumentation lTraining in ethical debate

12. 12 17/02/2014 Who should be educated and trained? lSome (not all) members of reviewing body lExternal incentives for members of ECs to meet and discuss lInvestigators !

13. 13 17/02/2014 Subcultures in Europe lNorth – south: ldifferences in emphasis on individual human rights lWest – east: ltradition in democracy

14. 14 17/02/2014 Post-communist countries lRestoration of democratic institutions was simple lEveryday democratic negotiation is more difficult to learn

15. 15 17/02/2014 Post-communist countries lSkills in negotiation are weak lMarxist philosophy left no theory of ethics lThis creates a special situation: lAdherence to legislation is stronger lAbility to openly defend own position is weaker

16. 16 17/02/2014 Post-communist countries lPost-communist countries deserve special attention lImportance of ethics is underscored lThere are no teachers

17. 17 17/02/2014 Should EU help? lSponsoring linternational contacts of ordinary members of ECs lEducation for some of them at western universities

18. 18 17/02/2014 Should EU help? lDangers: lFor many years ethical review will be formal and non transparent lRules and directives will be understood in a specific way lHarmonization of ethical reviews will be in fact blocked.

19. 19 Thank you for your attention 17/02/2014