Education, training and communication in ethics review

1
Education, training and communication in ethics
review
University of South Bohemia in Ceske
Budejovice Faculty for Health and Social Studies
Jiri Simek
2
Ethical regulation of research

• Started after Second World War
• Nuremberg code was the first
• Good will and informed consent is not sufficient
• Research is done in many ways
• There are many forms of risk

3
Observational studies

• Issues of data protection
• Possible invasiveness
• unwanted memories
• Unwanted presence of observers

4
Human intervention studies

• Connected with more or less serious multiform
  risk.
• Side effects and unexpected effects of drugs
• Invasive studies
• blood and tissue samples, surgery
• magnetic resonance imaging

5
Human intervention studies

• Issues of human dignity
• Informed consent
• Research on subjects not able to give valid
  consent
• Assurance of research institution

6
Research with the use of animals

• Movement of animal protectors in the last quarter
  of twentieth century
• Animal protection became a new issue in research
  ethics
• Many regulations came in force

7
Research with the use of animals

• Strategy of 3R
• Replacement
• Reduction
• Refinement
• Minimum standards for housing and care
• Animal care committees

8
Difficulties in safeguard of research subjects

• Many issues at stake
• Language of ethics is different from the language
  of biological science
• Research teams have difficulties in ethical part
  of project submission
• Way out collective guidance
• Ethics committees
• Ethical review panel

9
Is there the need for education and training?

• Is ethical expertise a special profession?
• Complexity of ethical review
• Education and training is the matter of
  discussions
• Ethics is a branch of philosophy
• Members of ECs have no aspirations to become
  philosophers

10
Is there the need for education and training?

• In omission of philosophy rules and legislation
  are too important
• Ethics is broader issue than legislation
• Ethical reviewers should be able to argue
• It is necessary for
• transparency
• accountability

11
Content of education and training

• Essentials in general ethics
• Specific issues in research ethics
• Essentials in scientific thinking
• Existing rules and legislation
• Essentials of bureaucratic work
• Training in ethical argumentation
• Training in ethical debate

12
Who should be educated and trained?

• Some (not all) members of reviewing body
• External incentives for members of ECs to meet
  and discuss
• Investigators !

13
Subcultures in Europe

• North south
• differences in emphasis on individual human
  rights
• West east
• tradition in democracy

14
Post-communist countries

• Restoration of democratic institutions was simple
  
• Everyday democratic negotiation is more difficult
  to learn

15
Post-communist countries

• Skills in negotiation are weak
• Marxist philosophy left no theory of ethics
• This creates a special situation
• Adherence to legislation is stronger
• Ability to openly defend own position is weaker

16
Post-communist countries

• Post-communist countries deserve special
  attention
• Importance of ethics is underscored
• There are no teachers

17
Should EU help?

• Sponsoring
• international contacts of ordinary members of ECs
  
• Education for some of them at western
  universities

18
Should EU help?

• Dangers
• For many years ethical review will be formal and
  non transparent
• Rules and directives will be understood in a
  specific way
• Harmonization of ethical reviews will be in fact
  blocked.

19
Thank you for your attention