Research Ethics Committee

1) Ethics approval is required by law - in the Czech Republic, it applies only to biomedical research.

2) Project that uses biomedical methods (e.g. fMRI, imaging/monitoring methods, biological samples collection and analysis, measurement of physical parameters) for research in another scientific field (e.g. research in psychology or sports studies).

3) Ethics approval is required by the funder (e.g. grant agency) or the journal's editorial office.

According to the professional ethical standards, ethics approval is also recommended in the following cases:

4) The research subjects are children, vulnerable groups, participants with limited capacity to consent or participants in a dependent position.

5) Projects in the psychology field, especially in research involving deception (the so-called cover story is used in the study).

6) Where sesitive personal data are collected and processed - i.e., data revealing racial or ethnic origin, political opinions, religious or philosophical beliefs, trade union membership, genetic data, biometric data (where processed to uniquely identify someone), and data concerning the health or sex life or sexual orientation of a person.

Anonymous survey research in adults do not require an ethics approval.

If you are unclear about the processing of personal data, please contact the lawyers of the MU REC (Mgr. Veronika Smítková, Mgr. Jana Klimentová and Mgr. Jana Voženílková).

If your research does not fall into any of the above mentioned categories or has already been conducted and the editorial office requires the ethics approval as a condition for accepting the manuscript for review, please contact the secretary of the committee.

Legal support is available also when collecting data which are not ethically relevant  -  It is advisable to consult the Consent to Participate in a Research Project and the Consent to Process Personal Data with a research lawyer from the RMU Legal Department (Mgr. Veronika Smítková , Mgr. Jana Klimentová and Mgr. Jana Voženílková) to comply with the applicable legislation, especially regarding the processing of personal data.

When to apply

The Commission continuously receives requests for project assessments. The time required for project assessment is highly individual and depends on the quality and completeness of the documentation provided. It is advisable to submit the Research Ethics Committee application at least 4 weeks before the deadline for submission of the project proposal to the provider or the planned start of the internal project.

In case of any uncertainties, consultation can be carried out before applying for assessment during project preparation.

National projects (GAČR, TAČR, MZ-AZV, etc.) - the deadlines for submitting applications for assessment of projects for significant grant calls are usually published on the REC website under the News tab within a few days of the announcement of individual call and sent out by the RMU Research Department in general instructions to the responsible project support staff of individual faculties.

Large consortium projects (e.g. OP JAK) that cannot be submitted for standard ethics committee review as a whole due to their complexity, for which the funder does not require ethics committee approval at the time of submission of the project proposal to the call, and which are composed of multiple research projects, only some of which require ethics committee review, are submitted to the REC for preliminary review within the standard timeframe before submission to the call (download the Request for Preliminary Review of a Project form). Only those research parts of the project that will be (co-)investigated at MU within the consortium are submitted to the REC for preliminary assessment and possible subsequent assessment.
The aim of the pre-screening is the early detection of ethically problematic projects and their possible discussion. The outcome of the pre-check is not the project's approval or any other official statement by the REC. In the case of a consortium project, individual ethically relevant research projects will be assessed by the REC as sub-studies in a standard procedure based on submitting a complete REC Project Assessment Request and other related documents before their implementation.

Horizon Europe projects (ERC, MSCA) - If the MU Research Ethics Committee needs to assess the project, this should be indicated in the ISEP. All relevant documents should be inserted before the proposal is submitted, and the details of ethical aspects should be consulted with the REC Secretary before the proposal is submitted. The REC should be contacted immediately after the publication of information on the acceptance of the project for funding. A full assessment of the project will take place during the negotiation period.

How to apply

The application for project assessment should be submitted via the INET - ISEP information system - Project Proposal Editor application.

1. In the Project Proposal Editor, in the New Proposal field, click on "New proposal according to the template" (you can select a template from the drop-down list only if it is a specific scheme listed in the drop-down list)
2. Fill in the required primary data.
3. If this is a project established in ISEP only to request a review by the Research Ethics Committee, when filling in the primary data, select Investor "Masaryk University", Programme Framework/Project Type "Project proposals for the Research Ethics Committee" and indicate in the "Note" field what type of project it is (e.g. (e.g., thesis or seminar, student or internal research project without grant support, partial research study under large grant programs such as NPO Excelles or OP JAK, partial research study under a project not requiring ethics committee review)
4. Select "Yes" under "Ethics".
5. After creating a project proposal, carefully fill in the required information in the "Ethics" tab.
6. Insert the related documents needed for the assessment (Application for Ethics Review and Consent to Participate in Research) - see the "Documents needed for the project assessment" box and select "Save".
7. Select the option "Close and forward to the MU Research Ethics Committee" (only then is the REC secretary informed by the system about your request).
8. Information on the acceptance of the project proposal for assessment or the assessment result (box "Status") and the reference number (e.g. EKV-2019-001) can be found in the upper left corner of the Ethics tab.
9. The approval with electronic signature is available for download in the Documents tab of the Project Proposal Editor (not in the Implemented Projects Editor) after completing the assessment.

If you are unsure, or if your project proposal is closed for editing in INET, please get in touch with the committee secretary.

The up-to-date forms and templates can be downloaded from the Documents and Tempates tab

For review please submit the following documents:

• Application for Ethics Review - the application form is available in Czech and English
• Consent to participate in the research (or equivalent informed consent, including instructions for research participants and Consent to the processing of personal data). The use of MU REC templates, is recommended but not mandatory.
• Any other relevant documents - you will be made aware of the need for additional documents, e.g. a questionnaire or a Letter of Commitment, when completing the Application for Ethics Review.

Project review is a dynamic process. In case of an ethically problematic project, the aim of the comment procedure is to prepare the project in cooperation between the investigator and the Committee so that it complies with the applicable international ethical and professional standards and can be approved by the committee. Thus, non-approval of a project is rare.

The project review process is subject to the Rules of Procedure of the Masaryk University Research Ethics Committee.

A vote of the entire committee decides the approval of each project. The committee's vote on a project is preceded by the  review process described below.

The submitted project documents are usually assessed in detail by two selected members of the REC (the so-called reviewers) and the Commission's lawyer, who draw up independent opinions. Any comments made by the individual reviewer or the lawyer are sent to the reseacher to be addressed, as well as he or she is notified of missing data, documents, etc. The reviewers and the lawyer then review the settlement of the comments on the project and, if necessary, the researcher will be invited again to complete the documents. The reviewer and lawyer will then complete their opinions with the conclusion 'recommend/not recommend to the ‘Committee for approval'. 

Project that obtains only opinions recommending approval, may be voted on per rollam without prior discussion at a Committee meeting. Project for which at least one opinion not recommending approval has been given  may be voted per rollam only after prior discussion of such project at a Committee meeting. The project investigator or its representative shall be invited to the Committee meeting on the project under review and shall have the opportunity to comment on the Committee's objections or supplement the documents based on the discussion at the meeting. The reviewer and lawyers may supplement their opinions following the discussion at the meeting or after further supplementing the project documents by the investigator.

The final project documents and the opinions are then submitted to the Committee for a vote.

The Committee vote usually takes place per rollam (electronically) and lasts at least 48 hours. It shall be announced as necessary, given the dates of grant calls or planned project implementation, at least once a month, usually at the end of the month.

Approval, extension and changes to the project

Approval of the project

• the fastest way to find information about approval after a favourable vote of the committee is via ISEP - Project Proposal Editor - Ethics tab - Status box
• electronically signed approval for download in PDF format is generated from the data provided in ISEP into ISEP - Project Proposal Editor - Documents tab - usually within two days
• information about the project approval will be sent to the project investigator/contact person by e-mail, usually within two working days after the voting is closed.

Validity of approval

• is linked to the duration of the project (grant projects) or the duration specified in the approved REC Project Assessment Request (internal projects and theses)
• applies to the specific form of the documents that have been approved.

Extension of approval

• an extension can be requested during the project period, not after it has expired (in which case a new application for assessment must be submitted),
• Insert the completed Application for Extension of Approval (downloadable here and in the Documents and Links tab) into the ISEP - Project Proposal Editor - Ethics tab with the other documents of the approved project
• please inform the secretary of the Commission by e-mail about the insertion of the application.

Changes during the project

• e.g., change in experimental design, change in the research sample, modification of participant information, modification of consent to participate in research,
• Submit for approval, well in advance, 1) a brief document describing and justifying the changes and 2) the revised originally approved documents (application for assessment and consent to participate - either in a new final form or with changes marked - depending on the extent of the changes - so that it is clear, and the changes are identifiable),
• please inform the secretary of the Commission by e-mail about the insertion of the documents.