VFN Ethics Committee Statute

The Ethics Committee is an advisory body to the Director of the General University Hospital in Prague (hereinafter referred to as the General University Hospital).

The VFN Ethics Committee supervises the observance of ethical principles in the provision of healthcare and research within the hospital, cooperates in unifying national and regional approaches with international ethical standards containing ethical principles, and applies these standards in its practical activities.

Ethical standards include in particular:

• Universal Declaration of Human Rights adopted on 10 December 1948 by the UN General Assembly,
• Declaration of Helsinki adopted by the 18th World Medical Association (WMA) in 1964, as amended (29th WMA in Tokyo 1975, 35th WMA in Venice 1983, 41st WMA in Hong Kong 1989, 48th WMA in Somerset West 1996, 52nd WMA in Edinburgh 2000, refined at the 53rd WMA in Washington in 2002 and the 55th WMA in Tokyo 2004, 59th WMA in Seoul 2008, and 64th WMA in Fortaleza 2013),
• The Lisbon Declaration on the Rights of the Patient, adopted by the World Medical Association in 1981, as amended,
• Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine (Oviedo 1997), published in the Collection of International Treaties under No. 96/2001,
• Regulation (EC) No 1901/2006 of the European Parliament and of the Council of 12 December 2006 on medicinal products for paediatric 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),
• Regulation (EU) No 536/2014 of the European Parliament and of the Council (32014R0536) on clinical trials on medicinal products for human use and repealing Directive 2001/20/EC (the regulation is not yet in force),
• Commission Implementing Regulation (EU) 2017/556 of 24 March 2017 laying down detailed rules for the implementation of inspection procedures for good clinical practice pursuant to Regulation (EU) No 536/2014 of the European Parliament and of the Council (the Regulation is not yet in force),
• Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use, as amended by Regulation (EC) No 1901/2006 of the European Parliament and of the Council (Luxembourg, 4 April 2001),
• Commission Directive 2005/28/EC of 9 April 2005 laying down the principles and detailed guidelines of good clinical practice concerning investigational medicinal products for human use and the requirements for the authorisation of the manufacture or import of such products (Brussels, 8 April 2005),
• Guidelines for Good Clinical Practice published in 1996 by the International Harmonization Conference (ICH)
• Operational Guidelines for Ethics Committees That Review Biomedical Research (TDR/PRD/ETHICS/2000.1), WHO, Geneva 2000,
• International Ethical Guidelines for Biomedical Research Involving Human Participants (CIOMS/WHO) 2002.

Article I.

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 their membership in the EC of the General Hospital, provided that they refrain from commenting on requests for consent to conduct a clinical trial/trial in which they have a personal interest, as well as from exercising professional supervision over such a clinical trial/trial, and that they immediately notify this committee of the emergence of a personal interest in the assessed clinical trial/trial,
• with the publication of its membership in the EC of the General Hospital and other facts resulting from the activities and membership in this commission in accordance with applicable legal regulations,
• provided that they will maintain confidentiality regarding information and facts that they learn in connection with their membership in the EC of the General Hospital.

1.3 A natural person of good repute is considered to be a person who has not been finally convicted of an intentional crime committed in connection with a clinical evaluation/trial or in connection with the provision of healthcare; such person's good repute is proven by an extract from the Criminal Record.

1.4 In its activities, the EC of the General University Hospital is primarily guided by the applicable legal regulations of the Czech Republic and the EU, of which the following entered into force on the date of issue of this Statute:

• Regulation (EU) No 2016/679 of the European Parliament and of the Council, on the protection of natural persons 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); or GDPR (General Data Protection Regulation).
• Act No. 110/2019 Coll., on the processing of personal data.
• Act No. 268/2014 Coll., on medical devices.
• Act No. 378/2007 Coll., on pharmaceuticals and amendments to certain related acts (Act on Pharmaceuticals), as amended.
• Act No. 372/2011 Coll., on health services and conditions for their provision (Act on Health Services).
• Act No. 373/2011 Coll., on specific health services.
• Act No. 89/2012 Coll., Civil Code.
• Decree No. 226/2008 Coll., which establishes good clinical practice and detailed conditions for clinical evaluation of medicinal products.
• Government Regulation No. 54/2015 Coll., on technical requirements for medical devices.
• Government Regulation No. 55/2015 Coll., on technical requirements for active implantable medical devices.
• Government Regulation No. 56/2015 Coll., on technical requirements for in vitro diagnostic devices.
• Decree No. 62/2015 Coll., on the implementation of certain provisions of the Act on Medical Devices.

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).

Article II.

In the medical operation of the EC, the General Teaching Hospital assesses in particular:

• Ethics of providing health care and services.
• Ethical criteria when assessing workplace equipment, patient comfort, the content of operating rules, setting priorities in deficient services, when assessing the adequacy and effectiveness of new examination and treatment methods and their possible risks.
• Ethical criteria for the adequacy and forms of informing patients and their family members, or legal representatives, about the patient's health condition, examination and treatment.
• Ethics of contact with oncological and terminally ill patients.
• Ethics of the issues of the physically disabled and chronically ill.
• Ethics in pediatrics.
• Ethics in gerontology and interpersonal relationships.
• Ethics of psychiatric treatment.
• Ethics of reproductive medicine.
• Ethics of clinical genetics.
• Piety in dealing with the dead.
• Ethics of ecological problems.

Article III.

3.1 In the field of clinical research, clinical evaluation of medicines, clinical testing of medical devices and other scientific research programs, during the implementation of which the researcher may interfere with the integrity of the patient, the EC of the VFN assesses and supervises their progress from the point of view of safety and preservation of the rights of the subjects of clinical evaluations/trials. For this purpose, it mainly assesses the professional competence of the investigators, the suitability of the equipment used, the selected procedures and groups of subjects of the evaluation. When conducting research, it is possible to interfere with the integrity of the patient except in cases of personal contact between the doctor/researcher and the patient. An example may be the processing of personal data from the medical documentation kept about the 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 (Act on Health Services).

3.2 The proceedings of the Ethics Committee are oral without public participation; neither the sponsor's representative nor the investigator participates in the adoption of the Ethics Committee's decisions. The voting of the Ethics Committee is public, each member has one vote. The proposed opinion is adopted if no member of the EC of the General University Hospital voted against the proposal and an absolute majority of the members of the EC of the General University Hospital voted in favor 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 The EC of the General Hospital shall keep significant records of its activities, in particular written working procedures, a list of members with their qualifications, administrative documentation and minutes of meetings for a period of 3 years. Submitted applications for consent to commence clinical trials/trials, opinions of the EC of the General Hospital, clinical trial reports and correspondence relating to clinical trials/trials shall be kept for at least 15 years after the completion of the clinical trials/trials.

Article IV.

4.1 When assessing applications from sponsors of clinical trials/trials, the EC of the General Hospital is guided by the relevant provisions of Act No. 378/2007 Coll., on medicinal products and amendments to certain related acts, Act No. 268/2014 Coll., on medical devices, and its own written working procedures.

4.2 The EC of the General Hospital grants written consent to conduct clinical trials of medicines 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 EC of the General Hospital. The investigator or sponsor submits:

• 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,
• for a clinical trial of a medicinal product, an insurance contract on liability insurance for damage for the investigator and the sponsor, through which compensation is also ensured for the evaluation subject in the event of damage to his or her health as a result of conducting the clinical trial (pursuant to the provisions of Section 53(7)(i) of Act No. 378/2007 Coll., on medicinal products and amendments to certain related acts (Act on medicinal products); for a clinical trial 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 compensation to assessment/examination 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 The EC of the General Hospital shall withdraw its consent in writing to conduct a clinical trial of a drug and trials of medical devices if:

• new facts arise that negatively affect the safety of the evaluation/test subjects if these facts cannot be eliminated immediately,
• the sponsor or examiner, including the principal investigator, will seriously violate his / her obligations under the law.

Article V.

Final provisions:

• 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.