|Composition of the VFN Ethics Committee
|MUDr. Josef Sedivy, CSc.||clinical pharmacologist||EK VFN|
|MUDr. Magda Šišková, PhD.||hematolog||1st Internal Clinic of General Faculty Hospital and First Faculty of Medicine|
|Jana Farkačová||laborant||ÚLBLD VFN a 1. LF UK|
|MUDr. Anna Jedličková||clinical microbiologist||former ÚLBLD VFN and 1. LF UK|
|MUDr. Hana Honová||onkolog||Department of Oncology, General Faculty Hospital and First Faculty of Medicine|
|prof. MUDr. František Perlík, DrSc.||pharmacologist||Institute of Pharmacology, First Faculty of Medicine|
|Mgr. Libuše Roytová||theologian||Diakonie ČCE|
|prof. MUDr. Jiri Zeman, DrSc.||pediatrician||Pediatric and Adolescent Clinic. Medicine, General Faculty Hospital and First Faculty of Medicine|
|doc. MUDr. Pavel Freitag, CSc.||gynecologist||Department of Obstetrics and Gynecology, General Faculty Hospital and First Faculty of Medicine|
|prof. MUDr. Eva Havrdova, CSc.||neurologist||Department of Neurology, General Faculty Hospital and First Faculty of Medicine|
|JUDr. Šárka Špeciánová||lawyer||
Institute of Public Health and Medical Law of the First Faculty of Medicine
|MUDr. Ladislav Korábek, CSc., MBA||dentist||Department of Stomatology, General Faculty Hospital and First Faculty of Medicine|
|doc. MUDr. Jan Roth, CSc.||neurologist||Department of Neurology, General Faculty Hospital and First Faculty of Medicine|
|MUDr. Marcela Trojánková||nefrolog||Internal and nephrology clinic Prague 1|
|JUDr. Milada Džupinková, MBA||lawyer||VFN Legislative Legal Department|
|MUDr. MgA. Kateřina Rusinová, Ph.D.||intenzivista||KARIM VFN and 1. LF UK|
|Ing. Antonín Grošpic, CSc.||elektroinženýr||formerly Head of OZT IKEM, Prague 4|
VFN Ethics Committee Statute
The Ethics Committee of the General University Hospital in Prague oversees the observance of ethical principles in medical care and research within the hospital, cooperates in unifying national and regional approaches with international ethical standards containing ethical principles, and applies these standards to its practical activities. Ethical standards include in particular:
- The Universal Declaration of Human Rights, adopted by the UN General Assembly on 10 December 1948,
- Helsinki Declaration adopted by the 18th World Health Assembly in 1964, as amended (World Medical Assembly, Tokyo 1975, Venice 1983, Hong Kong 1998, South African Somerset West 1996, Scotland, 2000, including explanatory notes) 29 and 30 of 2002, in Seoul 2008, and finally in Fortaleza 2013),
- The Lisbon Declaration on Patients' Rights, adopted by the World Medical Association in 1981, as amended,
- 2002 International Ethics Guidelines for Biomedical Research with Human Participants (CIOMS / WHO)
- Guidelines for Good Clinical Practice published in 1996 by the International Harmonization Conference (ICH)
- Convention for the Protection of Human Rights and Dignity of the Human Being in the Application of Biology and Medicine (Oviedo 1997)
- Directive 2001/20 / EC of the European Parliament and of the Council of the European Union on the approximation of the laws, regulations and administrative conditions of the Member States relating to the implementation of Good Clinical Practice in conducting clinical trials on medicinal products for human use (Luxembourg, 4 April 2001)
- Commission Directive 2005/28 / EC laying down the principles and detailed guidelines of good clinical practice concerning investigational medicinal products for human use as well as the requirements for the authorization of the manufacture or import of such products (Brussels, 8 April 2005),
- Regulation No 1901/2006 of the European Parliament and of the Council on medicinal products for pediatric use and amending Regulation (EEC) No 1768/92, Directive 2001/20 / EC, Directive 2001/83 / EC and Regulation (EC) No 726/2004 (Strasbourg, 12 December 2006)
- Operational Guidelines for Ethics Committees That Review Biomedical Research (TDR / PRD / ETHICS / 2000.1), WHO, Geneva 2000.
1.1 The Ethics Committee of the General Teaching Hospital in Prague (hereinafter referred to as the EC General Teaching Hospital) is established by the Director of the General Teaching Hospital by appointing its members.
1.2 Members of the EC VFN may be only natural persons with no personal interest or involvement in conducting a clinical trial / trial, which will provide written consent
- with his / her membership in the EC VFN, refraining from making comments on applications for consent to conducting a clinical trial / trial for which they have a personal interest as well as performing professional oversight of such clinical trial / trial and notifying the occurrence of personal interest without delay at the clinical trial / trial under consideration,
- with the publication of its membership in the EC VFN and other facts arising from the activities and membership of this Commission under applicable legislation,
- with the fact that they will keep confidential information and facts they will learn in connection with their membership in the EC VFN.
1.3 A natural person of integrity shall be deemed to be a person who has not been the subject of a judgment which has the force of res judicata for an intentional offense committed in the context of a clinical trial / trial or in connection with the provision of healthcare; Integrity is proven by an extract from the Criminal Register.
1.4 In its activities, the ECF is governed primarily by the valid legal regulations of the Czech Republic, from which the following came into effect on the date of this Statute:
- Act No. 101/2000 Coll., on Personal Data Protection, as amended,
- Act No. 268/2014 Coll., on medical devices,
- Act No. 378/2007 Coll., on Pharmaceuticals and on Amendments to Certain Related Acts (Act on Pharmaceuticals), as amended,
- Act No. 372/2011 Coll., on health services and conditions for their provision,
- Act No. 373/2011 Coll., on Specific Health Services,
- Act No. 89/2012 Coll., Civil Code,
- Decree of the Ministry of Health No. 316/2000 Coll., laying down the essentials of the final report on clinical evaluation of a medical device, as amended,
- Decree of the Ministry of Health and the Ministry of Agriculture No. 226/2008 Coll., establishing Good Clinical Practice and Detailed Conditions of Clinical Evaluation of Drugs
- of the Government of the Czech Republic No. 54/2015 Coll., on Technical Requirements for Medical Devices.
- Government Order No. 55/2015 Coll., on Technical Requirements for Active Implantable Medical Devices
- Czech Republic Government Order No. 56/2015 Coll., on Technical Requirements for In Vitro Diagnostic Devices,
- Decree No. 62/2015 Coll., on Implementation of Certain Provisions of the Medical Devices Act.
1.5 The EC of the RFC governed by this Statute is different from the ethics committee expressing its consent to the withdrawal of the body pursuant to Section 5 of Act no. No. 285/2002 Coll., on donation, collection and transplantation of tissues and organs and on changes in some organs (Transplantation Act).
In the medical operation of the EC, the General Teaching Hospital assesses in particular:
- ethics of providing medical care
- ethical criteria in assessing workplace equipment, patient comfort, operating rules, prioritization of scarce services, assessing the adequacy and effectiveness of new investigative and treatment methods and their potential risks
- ethical criteria of adequacy and the forms of informing patients and their family members, where appropriate legal guardians, of the patient's health, investigation and treatment,
- ethics of contact with oncological and terminally ill
- ethics of problems of physically handicapped and chronically ill
- Ethics in Pediatrics
- ethics in gerontology and interpersonal relationships
- ethics of psychiatric treatment
- ethics of reproductive medicine
- ethics of clinical genetics
- in dealing with the deceased,
- ethics of ecology problems.
3.1 In the area of clinical research, clinical evaluation of drugs, clinical testing of medical devices and other scientific research programs, where the researcher can intervene in patient integrity, the EC VFN assesses and supervises their course in terms of safety and the preservation of the rights of clinical trial subjects. To this end, it shall, in particular, assess the competence of the examiners, the suitability of the equipment used, the procedures chosen and the groups of subjects of assessment. When conducting research, it is possible to interfere with patient integrity beyond cases of personal contact between physician / researcher and patient. An example could be the processing of personal data from a medical record kept by a VFN patient, the collection of data in registers that are not defined by Act No. 372/2011 Coll., On health services and the conditions for their provision.
3.2 The ethics committee meetings are oral without public participation, the representative of the sponsor or the examiner will not participate in the decision of the ethics committee. The Ethics Committee voting is public, each member has one vote. The proposed opinion is adopted if no member of the EC VFN has voted against the proposal and an absolute majority of the present members of the ECF voted for the adoption of the proposal.
3.3 When assessing the EC, the FMC is independent of the contracting authority, examiners and administrative or other authorities. By giving its opinion on the proposed procedure, either by giving written consent or by requesting the completion of supporting documents, or by rejecting the proposed procedure in writing.
3.4 EC VFN keeps important records of its activities, in particular written working procedures, a list of members with their qualifications, administrative documentation and minutes of meetings for 3 years. Submitted applications for clinical trial / trial initiation, EC VFN opinions, clinical trial reports and clinical trial / test correspondence shall be kept for at least 15 years after the end of clinical trials / trials.
4.1 When assessing applications of clinical trials / examiners, the ECF is governed by the relevant provisions of Act No. 378/2007 Coll., On Pharmaceuticals and on Amendments to Certain Related Acts, Act No. 268/2014 Coll., On Medical Devices, and by its own written working procedures. .
4.2 EK VFN grants written consent for conducting clinical trials or testing of medical devices only on the basis of a written application and after assessing all submitted documentation. All documents are submitted in a language that is understandable to the members of the European General Teaching Hospital. The examiner or sponsor shall submit:
- in the case of clinical trials, the protocol of the study, its possible additions and the consent of SÚKL, in the clinical trial of the medical device, the test plan containing the necessary data on the subjects of the test and the tested device,
- the text of informed consent and other written information provided to the evaluation / testing bodies
- procedures for the recruitment of subjects / subjects, in particular advertising,
- investigator's file containing available data on the safety of the investigational drug or medical device under investigation,
- in the case of a clinical trial, an insurance contract for liability insurance for the investigator and the sponsor, through which the assessment subject is also compensated in the event of damage to his / her health as a result of conducting a clinical trial (pursuant to Section 53 (7) (i) of Act no. 378/2007 Coll., On Pharmaceuticals); in the case of a clinical examination of a medical device, an analogous insurance contract (pursuant to Section 19 (2) (d) of Act No. 268/2014 Coll., on Medical Devices),
- Information on payments and compensations to evaluation / test subjects
- the examiner's curriculum vitae or documents confirming his / her qualifications
- other documents requested by the EC VFN.
4.3 If it is necessary to change the conditions of clinical evaluation of medicines and tests of medical devices approved by the European General Teaching Hospital, the examiner or sponsor shall ask the Commission for written approval of changes to the conditions and submit proposals for changes in the documentation.
4.4 EK VFN will withdraw its consent in writing to conduct a clinical trial of the drug and to test medical devices if
- there are new facts adversely affecting the safety of the trial / test subjects if these cannot be removed immediately, or
- the sponsor or examiner, including the principal investigator, will seriously violate his / her obligations under the law.
- Amendments and supplements to this Statute are issued by the General Manager.
- This Statute becomes effective on the day of its signing by the Director of the General Teaching Hospital.