Ethics Committee

The VFN Ethics Committee works according to the principles of Good Clinical Practice. On 8 December 2004, it was designated by the Ministry of Health of the Czech Republic as an ethics committee issuing opinions on multicentric clinical trials (Ref. 236/2378). By decision of the Ministry of Health of the Czech Republic File no. MZDR 58665 / 2017-3 / FAR extended its designation to issue opinions on multicentric clinical trials by December 31, 2022.

The General Teaching Hospital in Prague and its independent Ethics Committee announce that their inclusion in the database of organizations and ethics committees has been extended to meet the requirements of protecting human subjects in research. The Federal Guarantee Code "FWA 00003027 - General University Hospital in Prague" was published by the Office for Human Research Protections at the US Department of Health and Human Services. The VFN Ethics Committee is registered under No. IRB 00002705 (valid until 20 April 2019) and VFN under No. IORG 0002175. more information.

Contact

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

Secretariat: Ing. Petra Nicková
Phone: +420 224 964 131
e-mail: eticka.komise@vfn.cz

Ethics Committee Meeting:

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

  • 17. 01. 2019
  • 21. 02. 2019
  • 21. 03. 2019
  • 25. 04. 2019
  • 23. 05. 2019
  • 20. 06. 2019
  • 18. 07. 2019
  • 22. 08. 2019
  • 19. 09. 2019
  • 17. 10. 2019
  • 14. 11. 2019
  • 12. 12. 2019

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. Incomplete documentation will not be accepted for discussion and the submitter will be notified of this defect by e-mail without delay.

Documents required for clinical trial (KH) or clinical trial (KZ) clinical trials:

  • cover letter in the Czech language (if it is a KH, please specify whether it is required: local assessment of a single center study / local assessment of a multi-center study with their identification and a multicentric ethics committee / multicentric assessment with a list of all centers) and their local ethics committees with addresses, in the case of a corporate study, billing information, an application for an opinion of the ethics committee with the implementation of CH in electronic form (according to KLH-EK-01, issued by SUKL on 1 July 2009);
  • completed questionnaire - multi-purpose form, signed by examiner (Annex 1 to 18 CAP 03);
  • study protocol with all current additions;
  • information text for subjects in the KH project (Annex 2 to 18 CAP 03), respectively. KZ (Annex 3 to 18 CAP 03); it is recommended to mark at least the date of creation of the document to distinguish different versions;
  • the text of informed consent, including information on the right to claim compensation under applicable law (Annex 4 to 18 CAP 03) for KH, resp. KZ (Annex 5 to 18 CAP 03); content requirements and the formulation of information materials for evaluation subjects are, for example, in the recommendation SUKL marked KLH-22,
  • the text of the consent or information on the collection of personal data in accordance with the European Parliament and Council Regulation 2016/679 on the protection of individuals with regard to the processing of personal data and on the free movement of such data and repealing Directive 95/46 / EC (General Data Protection Regulation) ;
  • in the case of genetic testing, the Consent / Disapproval form for genetic laboratory examination (Annex 10 to 18 CAP 03);
  • organizing recruitment of evaluation subjects;
  • investigator's information set or SPC;
  • specific information on compensation of expenses and remuneration for assessment bodies;
  • insurance certificate and a copy of the entire insurance policy in Czech (including insurance conditions) for liability insurance for the investigator and the sponsor, through which compensation is also provided in case of death of the evaluation subjects or in case of injury to the subjects of the evaluation due to the execution of the HC / KZ;
  • agreement on the amount of remuneration or compensation by the investigator within the meaning of § 53 para. j) of Act No. 378/2007 Coll .;
  • Curriculum vitae of the examiner responsible for conducting KH in the center (s) including proof of professional competence;
  • the consent of the head of the health care facility with the implementation of KH;
  • in the case of an application for an opinion and supervision of the EC General Teaching Hospital over KH / KZ in a center that does not have its local ethics committee, we require a proposal of a written agreement concluded between the General Teaching Hospital of Prague and the relevant medical facility to ensure the activities of the EC VFN as well as the local ethics committee for ZZ and Act No. 378/2007 Coll., on Pharmaceuticals, respectively Act No. 268/2014 Coll., on Medical Devices), valid for a single KH / KZ and for its duration: (Annex 12 to 18 CAP 03) for KH drugs, respectively. (Annex 11 to 18 CAP 03) for clinical trials. resources; a declaration by the contracting authority on the capability of the OC to carry out the KH / KZ; copy of the NZZ marketing authorization; the examiner's curriculum vitae with copies of documents proving the competence of the principal investigator in the center; a list of currently running KH / KZ studies in the center;
  • the opinions of ethics committees that have already assessed the study;
  • possibly additional documents requested by the Ethics Committee.

Documents required to assess research grant projects:

Request for Opinion of the EC The General Teaching Hospital for proposals of research projects (grants) is submitted with a universal questionnaire - a multipurpose form (completed in the parts related to the grant project) (Annex 1 to 18 CAP 03), cover letter and relevant documents (description of the project, including the procedure for recruiting subjects, the text of the information for the subjects of assessment and informed consent, the examiner's CV, the consent of the head of the medical department). In case of KH / KZ, information on filing an application for authorization / notification of KH / KZ to the State Institute for Drug Control. Furthermore, the Consent to the Collection and Processing of Personal Data in the Study of the General Teaching Hospital in Prague is attached.Annex 13 to 18 CAP 03).

Documents required to assess individual research projects or observational studies:

Request for the opinion of the EC of the General Teaching Hospital on proposals for individual research projects is submitted again with the Universal Questionnaire - a multipurpose form (completed in the sections related to the project) (Annex 1 to 18 CAP 03), a cover letter and relevant documents (description of the project, including the procedure for recruitment of subjects of evaluation, text of information for subjects of assessment and informed consent, examiner's CV, consent of the head of the health care facility, or proof of liability insurance for the investigator in the research project and possibly documents additionally requested ethics committee). In case of non-sponsored research in the IFF, attach a signed affidavit (Annex 9 to 18 CAP 03). In case of corporate support, the contact address of the representative and their billing information. In case of KH / KZ, information on filing an application for authorization / notification of KH / KZ to the State Institute for Drug Control.

If individual research is based on the creation of a register of treatment data, the patient whose data will be collected must be provided with information and informed consent meeting the requirements of Act No. 101/2000 Coll., On the Protection of Personal Data and on Amendments to Certain Acts, as amended. and also European Parliament and Council Regulation 2016/679 on the protection of individuals with regard to the processing of personal data and on the free movement of such data and repealing Directive 95/46 / EC (General Data Protection Regulation). If the information for the collection and processing of personal data is not submitted by the project promoter during the study, the text of the Consent to the Collection and Processing of Personal Data may be modified in a study at the General Teaching Hospital in Prague. Annexes 13 to 18 to the CAP 03.

Documents required to assess non-interventional or questionnaire studies (eg bachelor's theses, interviews, etc.):

  • Request for a statement from the EC of the General Teaching Hospital on proposals for non-interventional studies (eg questionnaire actions, data collection, etc.) for patients is submitted with a concise letter describing the project, including the procedure for recruiting subjects;
  • shortened EC VFN form for non-interventional questionnaire study (Annex 1A to 18 CAP 03);
  • a list of questions submitted to the patient, indicating the form of the answers to be written. In the introduction to the questionnaire, we require addressing the patient, brief information about the purpose of the project, voluntary participation in the project, anonymization of the data and their event. publication;
  • if the patient's personal data are processed, consent to the collection of personal data when conducting the study at the General Faculty Hospital in Prague (Annex 13 to 18 CAP 03);
  • the examiner's CV;
  • the consent of the head of the health care facility where the investigation will take place;
  • VFN leadership approval (eg. Mgr. Svobodová, Ph.D., MHA, Deputy for Non-medical Health Profession) with implementation of the project in the VFN. In case of non-sponsored research in the IFF, attach a signed affidavit (Annex 9 to 18 CAP 03).

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

The contracting authority is entitled to amend the protocol by means of amendments after initiating KH. An opinion on an amendment or a new version of the IS will only be issued to the EC if it has already given its opinion on the research project. Documents required to discuss amendments by the Ethics Committee:

  • a written request in the Czech language to discuss the amendment with a justification and a draft of the revised relevant part of the documentation and with reference to the basic study assigned by the General Committee of the General Teaching Hospital;
  • own amendment - amendment / version of IS (with indication of changes made);
  • if the personal data of patients are processed and a separate consent to the collection of personal data has not yet been submitted in accordance with Regulation (EC) No 2016/679 of the European Parliament and of the Council on the protection of individuals with regard to the processing of personal data and the free movement of such data and repealing Directive 95/46 / EC (General Data Protection Regulation), consent to the collection of personal data when conducting a study at the General University Hospital in Prague (Annex 13 to 18 CAP 03), which will be tailored to the specificities of the particular clinical trial.

Once the document has been discussed, the Ethics Committee may once ask for the data to be added or commented on, while the time limit for issuing the opinion is suspended until the supplementary data is delivered or the justification for the non-observation of the EC VFN's comments is reached.

Important warning

Please note that the principal investigator or investigator of the grant / research plan / individual research is obliged to inform the Ethics Committee that issued its opinion about the commencement of the clinical trial, its course (at least once a year - see Annex 8 to 18 CAP 03 and its termination. Usually, this is done by the sponsor for a company clinical trial.

Reimbursement fees

Payments for discussions of KH / KZ by the VFN Ethics Committee, issuing its opinion and supervising its conduct are invoiced by the Clinical Evaluation and Research Department of the General Teaching Hospital in accordance with the Director's Communication No. SR-VFN 01/2017, valid from March 1, 2017. Grant studies and individual surveys are exempt from reimbursement and the implementation team does not cooperate with the commercial sector. The full text of the order can be provided on request.

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