Masaryk university
Research Ethics
Veronika Smítková
MU Legal Office
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Ethical assessment of a project at MUNI
WHICH project needs an ethical assessment?
WHY is an ethical assessment required?
WHOM to submit my project for ethics assessment?
WHEN to submit my project to an REC?
WHO is supposed to submit my project?
WHAT part of my project is evaluated?
HOW to get an ethical approval of MU REC?
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WHICH project needs an ethical assessment?
Any research project involving
• human participants (biomedical, social/human science research)
• human biological samples (DNA, cells, tissues, liquids,…)
• non-commercialy available (from cooperating healthcare provider)
• commercialy available
Research project includes
• grant project (H2020, AZV, GAČR,…)
• internal faculty research project, GAMU
• disertation
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WHY is an ethical assessment required?
An ethical assessment is important to ensure the protection of research
participants.
Therefore an ethical approval is required:
• by law for biomedical research
(see Oviedo Convention on Human Rights and Biomedicine)
• by grant provider, science foundation
(see tender documentation)
• by major scientific journals
(see editorial policy, always in biomedicine, often in
psychology, research with vulnerable groups – children,
patients)
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WHOM to submit project for ethics assessment?
MU Research Ethics Committee (Etická komise pro výzkum MU)
• for all faculties (except Fac. of Medicine), CEITEC
• chair: prof. Renata Veselská
• secretary: Blanka Jančeková
• submission by ISEP https://inet.muni.cz/app/proj/navrh_find
• Web site https://www.muni.cz/o-univerzite/fakulty-a-pracoviste/rady-a-komise/eticka-komise-pro-vyzkum/o-komisi
Ethics Committee Faculty of Medicine (Etická komise Lékařské fakulty MU)
• chair: Assoc. Prof. Josef Kuře
• submission by email (jkure@med.muni.cz)
X Masaryk University Ethics Board (Etická komise MU) – rector´s advisory board in
research misconduct (see Masaryk University academic and professional employee code of
ethics)
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WHEN to submit my project to REC?
The project proposal has to be submitted before the beginning of the
whole project, not only before the research data collection.
review ethical assessment – for changes in an approved project (design
changes, new questionnaire added)
submission deadlines:
• deadlines set for grant competitions (GAČR, AZV,…) – ask R&D
office
• other submissons accepted:
• MU REC: continuously (ASAP), min. 4 weeks before the expected
beginning
• Faculty of Medicine REC: 5th day of the month
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WHO is supposed to submit the project?
According to the internal MUNI directive, it is
the main researcher/proposer from MUNI
…the person that should be mentioned in the ethical approval
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WHAT part of the project is evaluated?
• project proposal (detailed project description, not only an annotation!)
including:
• methodology
• design of experiment
• participants and their recruitment
• description of the research team
• personal data protection measures
• questionnaire (in questionnaire survey)
• inform consent including:
• explanation for participants
• consent to personal data processing
• letter of commitment (participating organization, e.g. healthcare provider)
For templates see
https://www.muni.cz/o-univerzite/fakulty-a-pracoviste/rady-a-komise/eticka-komise-pro-vyzkum/dokumenty
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HOW to get an ethical approval of MU REC?
• create your project proposal in the ISEP (title, name, funding, duration, cooperation)
• apply for REC evaluation „Ethics=YES“
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HOW to get an ethical approval of MU REC?
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HOW to get an ethical approval of MU REC?
• fill in basic information
• upload project documents for ethics (project proposal, inform consent, letter of
commitment,…)
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HOW to get an ethical approval of MU REC?
• fill in the ethics questionnaire in ISEP/Ethics (to identify ethical topics in the project)
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HOW to get an ethical approval of MU REC?
• submit the application to Research Ethics Committee MU
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HOW to get an ethical approval of MU REC?
…what happens next…
1. 2 REC members and 1 lawyer review your proposal
2. in case of comments - discussion and completion of documentation
3. whole REC voting (most often per rollam)
4. REC secretary sends you (or not) an ethical approval of your project
5. Let´s start your research!
The role of RECs is
to protect participants through research,
not from research 
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Contact:
Mgr. Veronika Smítková
Legal Office
MU Rector's Office
smitkova@rect.muni.cz