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

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10/04/23

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