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Education, training and communication in ethics review

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Ethics is a branch of philosophy. Members of ECs have no aspirations to become philosophers ... Marxist philosophy left no theory of ethics. This creates a ... – PowerPoint PPT presentation

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Title: 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
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