Ethics Committee

Information on the VFN Ethics Committee

The Ethics Committee of the VFN works according to the principles of Good Clinical Practice. The Ethics Committee of the VFN assesses and authorizes clinical trials according to Regulation (CTR) No. 536/2014. According to Act No. 375/2022 Coll., it assesses clinical trials of medical devices and in vitro diagnostic medical devices.

The General University Hospital in Prague and the independent Ethics Committee established by it are included in an international database maintained by the Office of Human Research Protections at the US Department of Health and Human Services between organizations and ethics committees that meet the requirements for human protection in research (under IORG0002175 - General University Hosp in Prague, IRB00002705 and Federalwide Assurance with code FWA00029052). More information can be found at https://ohrp.cit.nih.gov/search/search.aspx.

Contact:

Ethics Committee of the General University Hospital in Prague
Na Bojišti 1, 3rd floor, 128 08 Prague 2

Secretariat of the Ethics Committee of the General Hospital:
Phone: +420 224 964 131
e-mail: eticka.komise@vfn.cz

Secretary of the VFN Ethics Committee:
Jana Travnickova, DiS.
phone: +420 224 964 131
e-mail: jana.travnickova@vfn.cz

Ethics Committee Meeting:

The VFN Ethics Committee discusses incoming applications usually every 3rd Thursday of the month. For the following period, meetings are scheduled from 15:30 in the meeting room of the Na Bojišti 1 building, Prague 2. Dates of the Ethics Committee meeting:

  • January 15, 2026 (deadline January 5, 2026)
  • February 19, 2026 (deadline 9. 2. 2026)
  • March 19, 2026 (deadline March 9, 2026)
  • April 16, 2026 (deadline 4/7/2026)
  • May 21, 2026 (deadline May 11, 2026)
  • June 18, 2026 (deadline June 8, 2026)
  • July 16, 2026 (deadline July 7, 2026)
  • August 20, 2026 (deadline 8/10/2026)
  • September 17, 2026 (deadline September 7, 2026)
  • October 15, 2026 (deadline 5. 10. 2026)
  • November 19, 2026 (deadline November 9, 2026)
  • December 17, 2026 (deadline 7. 12. 2026)

We would like to draw your attention to the fact that if you are interested in discussing your applications by the Ethics Committee at the next meeting, it is necessary to submit the complete required documents to the Commission at the latest 10 calendar days before the meeting, no later than 12:00 on the day in questionIncomplete documentation will not be accepted for consideration and the submitter will be immediately informed of this defect by e-mail or via the VFN EC Application.

Please note that in the case of a VFN employee the documentation listed below is submitted exclusively electronically via Ethics Committee application.

Documents required for the assessment of non-interventional or questionnaire studies (e.g. bachelor's theses, interviews, etc.):

Please note that the statement of the Ethics Committee of the VFN (EC VFN) does not apply anonymous questionnaire campaigns involving VFN employees and volunteers. The statements are subject only to questionnaire campaigns/research activities involving patients, family members and other persons.

A request for the opinion of the EC of the General Hospital on proposals for non-interventional studies (e.g. questionnaires, data collection, etc.) in patients is submitted with a brief cover letter describing the project, including the procedure for recruiting study subjects, and with the following required documents:

  • Completed Questionnaire on submitted documents – multipurpose form of the EC VFN duly completed in all parts (appendix 1 to SPP 03a,b);
  • Information for the patient/participant (we require appropriate addressing, an offer of participation, brief information about the purpose of the project, voluntary participation in the project, anonymization of data and their possible publication);
  • Informed consent for the patient/participant (can be used for inspiration) appendix 4 to SPP 03a);
  • In the case of a control group, separate information and informed consent for that group;
  • A list of questions presented to the patient/participant, indicating the format of the recorded responses;
  • If personal data of patients/participants is processed (which is always the case in non-anonymous research), consent to the collection of personal data when conducting the study at the General University Hospital in Prague must also be attached (Annex 13 to the CAP 03);
  • Applicant/examiner's CV;
  • Consent from the head/management of the healthcare facility where the investigation will take place (part of the multipurpose form of the EC VFN);
  • Approval of the management of the VFN (Mgr. Svobodová, Ph.D., MHA, Deputy for Non-Medical Health Professions, contact: Zdeňka Elišáková, tel. 224 969 341) with the implementation of the project at the VFN (part of the form F-VFN-075 "Request for a questionnaire campaign").
Documents required for the assessment of clinical trials of medical devices (KZZP); performance studies (SFZ) and in vitro diagnostic medical devices (IVDR):

The following is submitted in response to the request for a statement from the EC of the General Hospital:

  • a cover letter in Czech; in the case of a company study, billing information; a request for the opinion of the ethics committee on the implementation of the KZZP, SFZ or IVDR in electronic form (according to KLH-CTIS-01, issued by SÚKL on 18. 1. 2026);
  • Completed Questionnaire on submitted documents – multipurpose form of the EC VFN signed by the examiner (appendix 1 to SPP 03a,b);
  • study protocol/test plan or diagnostic protocol with all current amendments;
  • information text for participants in the KZZP, SFZ, IVDR evaluation (appendix 3 to SPP 03b); it is recommended to mark at least the date of creation of the document to distinguish different versions;
  • text of informed consent, including information on the right to claim damages in accordance with applicable law (appendix 5 to SPP 03b); requirements for the content and formulation of information materials for evaluation participants are, for example, in SÚKL recommendation marked KLH-22,
  • text of consent or information about the collection and processing of personal data in the General Teaching Hospital in Prague (Annex 13 to the CAP 03) in accordance with Act No. 110/2019 Coll., on the processing of personal data, and Regulation 2016/679 of the European Parliament and of the Council on the protection of individuals with regard to the processing of personal data;
  • in the case of a genetic examination, the Consent / Disagreement with the genetic laboratory examination form (Annex 10 to the CAP 03);
  • organization of recruitment of evaluation participants;
  • a set of information for the examiner;
  • specific information on expense compensation and rewards for participants;
  • a certificate of insurance and a copy of the entire insurance contract in Czech (including insurance conditions) for liability insurance for the investigator and the sponsor, which also ensures compensation in the event of injury to the health of the evaluation participants as a result of the implementation of KZZP, SFZ, IVDR;
  • agreement on the amount of remuneration or compensation by the investigator within the meaning of § 53 para. j) of Act No. 378/2007 Coll .;
  • CV of the examiner responsible for conducting KZZP, SFZ, IVDR in the centre(s) including proof of his/her professional competence;
  • consent of the head of the healthcare facility to the implementation of KZZP, SFZ, IVDR;
  • In the case of a request for an opinion and supervision of the EC of the General Hospital over the KZZP, SFZ in a center that does not have its own local ethics committee, we require:
    • draft written agreement concluded between the General Hospital in Prague and the relevant healthcare provider on ensuring the activities of the General Hospital EC as a local ethics committee for ZZ (Act No. 375/2022 Coll. on medical devices and in vitro diagnostic medical devices, as amended), valid once for a specific KZZP, SFZ and for its duration (appendix 11 to SPP 03b);
    • declaration of the contracting authority on the competence of the healthcare service provider to perform KZZP, SFZ;
    • copy of the Decision on registration of a healthcare provider;
    • CV of the examiner with copies of documents proving the professional competence of the principal investigator at the center.
Documents required to assess research grant projects:

The following is submitted in response to the request for a statement from the EC of the General Hospital:

  • a signed cover letter including a list of attachments;
  • Completed Questionnaire on submitted documents – multipurpose form of the EC VFN duly completed in all parts (appendix 1 to SPP 03a,b);
  • a description of the project, including the procedure for recruiting research participants;
  • text of information for research participants and informed consent;
  • the examiner's CV;
  • consent of the head of the healthcare facility (a signature on the EC VFN questionnaire in the relevant section is sufficient);
  • consent to the collection and processing of personal data when conducting a study at the General University Hospital in Prague (Annex 13 to the CAP 03).
  • If this is a grant application that has already been submitted to the EC for assessment in the past and for which a positive opinion was issued, the EC requires the submission of a Declaration of Project Conformity, which will state how the currently submitted project differs from the previous one (with the name, reference number and date of approval by the EC of the General University Hospital).
  • If it is a clinical trial and the research study or project is governed by European Union Regulation No. 536/2014 on clinical trials of medicinal products for human use, such an application is not submitted to the EC of the General Hospital, but exclusively through the European portal CTIS (Clinical Trials Information System).
Documents required for the assessment of individual research projects, registries or observational studies:

The following is submitted in response to the request for a statement from the EC of the General Hospital:

  • a signed cover letter including a list of attachments,
  • Completed Questionnaire on submitted documents – multipurpose form of the EC VFN duly completed in all parts (appendix 1 to SPP 03a,b);
  • a description of the project, including the procedure for recruiting research participants;
  • text of information for research participants and informed consent (if required by the nature of the project);
  • the examiner's CV;
  • consent of the head of the healthcare facility (a signature on the EC VFN questionnaire in the relevant section is sufficient);
  • proof of liability insurance for the investigator in the research project, if required;
  • signed Affidavit (Annex 9 to the CAP 03) in the case of a demonstrably unfunded or commercially unsponsored study or project (the implementation of the research project is not financially supported by a third party and the study team does not cooperate with the commercial sector).
  • In the case of financial support for the given research by a third party or cooperation with the commercial sector, the contact address of the representative and the relevant billing information.

If individual research consists in the creation of a treatment data register, the patient whose data will be collected must be provided with information and informed consent in accordance with Act No 110/2019 Coll., On the processing of personal data, and under the Regulation of the European Parliament and the Council 2016 / 679 on the protection of individuals with regard to the processing of personal data. For the purposes of a specific study, it is possible to modify the text of the Consent to the Collection and Processing of Personal Data in Conducting the Study at the General Teaching Hospital in Prague, a specimen of which is given in Annex 13 to the CAP 03.

Requirements for amendments to the Protocol in the form of amendments or other versions of informed consent

The sponsor is entitled to change the protocol through amendments after the start of the study. The EC will issue an opinion on the amendment or on the new version of the IS only if it has already expressed its opinion on the given research project. Documents required for the discussion of amendments by the ethics committee:

  • a written request in Czech to discuss the amendment, stating the reasons for and proposing a revised relevant part of the documentation and stating also ref. a basic study assigned by the Ethics Committee of the General Teaching Hospital;
  • own amendment - amendment / version of IS (with indication of changes made);
  • text of consent or information about the collection and processing of personal data in the General Teaching Hospital in Prague (unless it has been submitted as Annex 13 to the CAP 03) in accordance with Act No. 110/2019 Coll., on the processing of personal data, and Regulation of the European Parliament and the Council 2016/679 on the protection of individuals with regard to the processing of personal data, which will be adjusted according to a specific clinical trial.

After discussing the document, the Ethics Committee may request additional information or make comments on it once, in which case the deadline for issuing an opinion is suspended until the additional information is delivered or the justification for not incorporating the comments of the EC of the General Hospital is provided, for a maximum period of 12 months.

Important warning

We would like to point out that the principal investigator or investigator of the grant / research plan / individual research is obliged to inform the ethics committee, which issued its opinion on the project, about the start of the project, about its progress (at least once a year – see form) Annex 8 to the CAP 03) and about its termination. For a corporate study, this is usually provided by the client.

Reimbursement fees

Payments for the discussion of the KH/KZ by the VFN Ethics Committee, the issuance of its opinion and supervision of its progress are invoiced in accordance with the Order of the Director of PR-VFN 01/2026, valid from 1 January 2026. The full text of the order can be provided upon request.

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