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Education, training and
communication in ethics review
University of South Bohemia in Ceske Budejovice
Faculty for Health and Social Studies
Jiri Simek
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Ethical regulation of research
Started after Second World War
Nuremberg code was the firstGood will and informed
consent is not sufficient Research is done in many waysThere are many forms of risk
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Observational studies
Issues of data protection Possible invasiveness
unwanted memories Unwanted presence of
observers
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Human intervention studies
Connected with more or less serious multiform risk.
Side effects and unexpected effects of drugs
Invasive studiesblood and tissue samples,
surgerymagnetic resonance imaging
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Human intervention studies
Issues of human dignityInformed consentResearch on subjects not able
to give valid consent Assurance of research
institution
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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
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Research with the use of animals
Strategy of 3R:ReplacementReductionRefinement
Minimum standards for housing and care
Animal care committees
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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
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Is there the need for education and training?
Is ethical expertise a special profession?
Complexity of ethical reviewEducation and training is the
matter of discussionsEthics is a branch of philosophyMembers of ECs have no
aspirations to become philosophers
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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
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Content of education and training
Essentials in general ethicsSpecific issues in research
ethicsEssentials in scientific thinking Existing rules and legislationEssentials of bureaucratic workTraining in ethical
argumentation Training in ethical debate
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Who should be educated and trained?
Some (not all) members of reviewing body
External incentives for members of ECs to meet and discuss
Investigators !
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Subcultures in Europe
North – south: differences in emphasis on
individual human rights West – east:
tradition in democracy
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Post-communist countries
Restoration of democratic institutions was simple
Everyday democratic negotiation is more difficult to learn
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Post-communist countries
Skills in negotiation are weakMarxist philosophy left no theory
of ethics This creates a special situation:
Adherence to legislation is stronger
Ability to openly defend own position is weaker
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Post-communist countries
Post-communist countries deserve special attention
Importance of ethics is underscored
There are no teachers
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Should EU help?
Sponsoring international contacts of
ordinary members of ECs Education for some of them at
western universities
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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.
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Thank you for your attention
10/04/23
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