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.
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 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.
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:
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.):
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:
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.
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.
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.