Information on the VFN Ethics Committee
The General Teaching Ethics Committee operates 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). Decision of the Ministry of Health of the Czech Republic with ref. MZDR 58665 / 2017-3 / FAR extended its designation to issue opinions on multicentric clinical trials until December 31, 2022.
The General University Hospital in Prague and the independent Ethics Committee established by it are included in an international database maintained by the Office for Human Research Protections of the US Department of Health and Human Services between organizations and ethics committees that meet the requirements for human research protection (IORG0002175 - General University Hospital in Prague, IRB00002705 and Federalwide Assurance with FWA code 00003027. For more information, visit: https://ohrp.cit.nih.gov/search/search.aspx.
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
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:
- December 12, 2019
- January 16, 2020
- February 20, 2020
- March 19, 2020
- April 23, 2020
- May 21, 2020
- June 18, 2020
- July 16, 2020
- August 20, 2020
- September 17, 2020
- 15 October 2020
- November 19, 2020
- December 17, 2020
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 Czech language (in the case of KH, please specify whether it is required: local assessment of a study in a single center / local assessment of a multi-center study with their identification and multicentric ethics commission / multicentric review with a list of all centers and their local ethics committees with addresses, in the case of a corporate study, billing information, a request for an opinion of the ethics committee with the implementation of KH in electronic form (according to KLH-EK-01, issued by SÚKL on 1 July 2009);
- completed questionnaire - multi-purpose form, signed by examiner (Annex 1 to 19 CAP 03);
- study protocol with all current additions;
- information text for subjects in the KH project (Annex 2 to 19 CAP 03), respectively. KZ (Annex 3 to 19 CAP 03); 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 (Annex 4 to 19 CAP 03) for KH, resp. KZ (Annex 5 to 19 CAP 03); the requirements for the content and formulation of information material for evaluation bodies are, for example, in recommendation of SUKL labeled 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 19 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 19 CAP 03);
- organizing recruitment of evaluation subjects;
- Investigator Information Set or SPC;
- specific information on compensation of expenses and remuneration for evaluation subjects;
- certificate of insurance and copies of the whole insurance contract in Czech language (including terms and conditions) on liability insurance for the investigator and sponsor, which also provides compensation in case of death of subjects or in case of injury to subjects due to KH / 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 a request for an opinion and supervision of the General Teaching Hospital over KH / KZ in a center that does not have its local ethics committee, we require a draft written agreement concluded between the General Teaching Hospital Prague and the relevant medical facility and following Act No. 378/2007 Coll., on pharmaceuticals, or Act No. 268/2014 Coll., on medical devices), valid once for a specific KH / KZ and for its duration: (Annex 12 to 19 CAP 03) for KH drugs, respectively. (Annex 11 to 19 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 19 CAP 03), cover letter and relevant documents (description of the project, including the procedure for recruiting evaluation subjects, text of information for evaluation subjects and informed consent, CV of the examiner, approval of the head of the health center). In the case of KH / KZ, information on submitting an application for authorization / notification of KH / KZ to the State Institute for Drug Control. Also attached is the Consent to the collection and processing of personal data when conducting the study at the General University Hospital in Prague (Annex 13 to 19 CAP 03).
Documents required to assess individual research projects or observational studies:
The application for the ECFF opinion on the proposals of individual research projects is again submitted with the Universal Questionnaire - a multi-purpose form (filled in in the parts relating to the project) (Annex 1 to 19 CAP 03), cover letter and relevant documents (description of the project, including the procedure for recruiting evaluation subjects, text of information for evaluation subjects and informed consent, CV of the examiner, approval of the head of the medical facility, eventually proof of liability insurance for the investigator in the research project) additionally requested by the Ethics Committee). In case of non-sponsored research at VFN, attach a signed Affidavit (Annex 9 to 19 CAP 03). In the case of corporate support, the contact address of the representative and their billing information. In the case of KH / KZ, information on submitting an application for authorization / notification of KH / KZ to the State Institute for Drug Control.
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 19 CAP 03.
Documents required to assess non-interventional or questionnaire studies (eg bachelor theses, interviews, etc.):
- The request for the ECFF opinion on the proposals of non-interventional studies (eg questionnaires, data collection, etc.) in patients is submitted with a brief cover letter describing the project, including the procedure for recruiting evaluation subjects;
- abbreviated form EK VFN for non-interventional questionnaire study (Annex 1A to 19 of the CAP 03);
- a list of the questions submitted to the patient, indicating the form of the written answers. In the introduction of this questionnaire we ask the patient brief information about the purpose of the project, voluntary participation in the project, anonymization of 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 19 CAP 03);
- the examiner's CV;
- the consent of the head of the health care facility where the investigation will take place;
- approval of the General Teaching Hospital management (eg Mgr. Svobodová, Ph.D., MHA, Deputy for Non-Medical Health Professions) to carry out the project at the General Teaching Hospital. In case of non-sponsored research at VFN, attach a signed Affidavit (Annex 9 to 19 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 the commencement of KH. The EC will issue an opinion on the amendment or on the new IS version only if it has already expressed its opinion on the research project. Documents necessary for discussion of amendments by 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 19 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 to add data or comment on it once, while the deadline for issuing the opinion is suspended until the supplementary data or justification of the failure to incorporate the comments of the EC VFN for a maximum period of 12 months.
Please note that the lead investigator or investigator of the grant / research plan / individual research is obliged to inform the ethics committee that issued its opinion on the project about the commencement of the clinical trial, its progress (at least once a year - form see Annex 8 to 19 CAP 03) and its termination. For a company clinical trial, this is usually done by the sponsor.
Reimbursement for the consideration of KH / KZ by the General Ethics Committee of the General Teaching Hospital, the issuing of its opinion and supervision of its course are invoiced by the Department of Clinical Evaluation and Research of the General Teaching Hospital in accordance with the Director's Notice 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.