Art. 1 The Ethics Commission, its establishment, principles and scope

(1) Ethics Commission of the Ministry of Health of the Slovak Republic (hereinafter referred to as "the Slovak Health Department') "Commission') is established by the Ministry of Health of the Slovak Republic (hereinafter referred to as "the Commission') only "Ministry'), pursuant to § 5 (Law No 576/2004) Z .z. on health care, healthcare services; and amending certain laws, as amended (hereinafter referred to as: Law No 576/2004 Z. z.).

(2) The Commission is an independent expert and advisory body of the Ministry of Assessment ethical issues arising from the provision of healthcare, including biomedical research.

(3) The activities of the Commission are governed by this Statute of the Ethics Committee of the Ministry the health of the Slovak Republic (hereinafter referred to as "the Statute').

(4) In its work, the Commission respects the values and principles of human protection rights, in particular those recognised by the Slovak Republic, the European Union, the Council of Europe, and The United Nations. The Commission respects and applies the Constitution of Slovakia. Republic. and the laws of the Slovak Republic as well as other important conventions; and Declarations, in particular the Universal Declaration of Human Rights, the Convention for the Protection of Human Rights rights and fundamental freedoms, the Charter of Fundamental Rights of the European Union. The Commission shall also carry out its activities in the light of the obligations arising, in particular, from the Art. 28 tablets Convention on the Protection of Human Rights and Human Dignity in relation to Application biology and medicine, in particular the obligations arising from Articles 9-12 Additional Protocol to the Convention on Human Rights and Biomedical biomedical research.

(5) The Commission shall perform its tasks on the basis of this Statute or at the request of the Minister.

  1. prepare, adopt opinions and conclusions on ethical issues arising from the provision of health care, including biomedical research.
  2. prepare the basis for legislation on ethical aspects providing health care and biomedical research;
  3. processes conceptual materials on ethical aspects of provision health care and biomedical research;
  4. discuss the proposals of the individual members of the commission;
  5. cooperates with ethical committees and commissions at national and international level level, particularly in EU Member States;

Art. 2 Composition and membership of the Commission

(1) The Commission shall be a collective body comprising at least 5 members and up to 15 members.

(2) The Commission is made up of workers within the meaning of Article 5 (3) of Law No 576/2004 Z. z. z.

(3) Members of the commission are appointed and recalled by the Minister of Health of the Slovak Republic Republic (hereinafter referred to as "the Minister') to ensure a pluralistic assessment ethical aspects of healthcare provision, including biomedical research.

(4) The condition of membership of the Commission is

  1. written consent of the proposed person to the appointment as a member of the commission;
  2. written consent to the publication of name, surname, workplace and information on membership of the Commission,
  3. integrity
  4. a written obligation of secrecy as to all facts which, have been informed in the performance of their duties; the obligation of confidentiality shall not apply to: cases where they report those facts with the agreement of whom they relate.
  5. a written undertaking to notify the Ministry of the facts which constitute or would be may constitute a conflict of interest.

(5) The duties of a member of the commission shall be irreplaceable and honorable.

(6) The term of office of a member of the panel shall be five years. Membership of the Commission shall cease to exist

  1. the expiry of the term of office,
  2. by written resignation of the Minister,
  3. the removal of a member by the Minister,
  4. death of member
  5. the end of the Ethics Committee.

(7) The Minister shall remove a member of the Commission if he is a member of the Commission

  1. repeatedly fails to comply with the obligation under Art. 4 (1) point (a) (a) or
  2. it fails to fulfil its obligations under Article 4 (1) point (a) (b)
  3. if a member of the Commission has been convicted of an intentional offence or of a criminal offence; a prison sentence has been legally imposed.

(8) Commission meetings may be attended by the Minister, State Secretary Ministry, Director-General of the Health Section or other person in writing appointed by a minister who has the right to comment on the issues under discussion without voting rights.

Art. 3 Independence of the Commission and its members

A member of the Commission acts freely, according to his conscience, is not bound by orders and is independent of the political, economic and other influences which could lead it in the performance of his duties in an action contrary to the principles of operation Commissions.

Art. 4 Obligations of members of the Commission

(1) A member of the commission is required

  1. to attend meetings and other work of the Commission,
  2. to report facts which constitute or could constitute a conflict interests; if a member of the Ethics Committee is in a conflict of interest with the assessment specific theme, may not participate in the assessment and adoption of an opinion the Ethics Committee.

(2) The facts referred to in paragraph 1 (a). b) announces the member of the commission in writing to the Ministry and the President of the Commission without undue delay

Art. 5 President and Vice-President of the Commission

(1) The Chair and Vice-Chairperson of the Commission shall be appointed and dismissed by the Minister on the basis of a proposal by an absolute majority of all members of the Commission.

(2) The term of office of the Chairperson and Vice-Chairperson shall be five years.

(3) The President of the Commission shall direct the Commission and shall in particular carry out the following tasks:

  1. represent the Commission externally;
  2. convene and conduct meetings of the Commission;
  3. manage the commission's intersessional activities;
  4. prepare materials and agenda for the commission meeting, verify the correctness the minutes,
  5. submit, at the request of the Ministry, documents on the activities of the Commission for the preceding calendar year.

(4) The Vice-President shall represent the President of the Commission in his absence full scale.

(5) Pending the appointment of the chairman and vice-chairman of the Commission, the President shall perform his duties the Commission's oldest member.

Art. 6 Commission working groups

(1) To fulfil specific tasks, the Commission makes its members work groups presenting the conclusions and the results of their work to the Commission.

(2) The members of the working groups shall be appointed by the President of the Commission on a proposal from the members of the Commission.

(3) Membership of the working groups set up under the statute of the Commission shall cease to exist. carrying out their tasks for which they have been set up.

Art. 7 Secretary of the Commission

(1) The Secretary of the Commission shall appoint and dismiss the Minister. The Secretary of the Commission is not members of the Commission shall not have the right to vote. The appointment condition is signed a declaration of secrecy as to all facts which are learned in the performance of his duties; the obligation of confidentiality does not apply cases where such information is communicated with the demonstrable agreement of whom concern.

(2) In particular, the Secretary of the Commission shall perform the following tasks:

  1. attends the meeting of the Commission;
  2. keep records of the Commission's activities;
  3. draw up the minutes of the sittings, conclusions, opinions and recommendations,
  4. provide for organisational activities related to: the work of the Commission,
  5. transmit documents relating to the operation of the preservation committee Ministry.

Art. 8 Discussion of the Commission

(1) The Commission shall normally meet four times a year.

(2) Meetings of the Commission shall be convened and chaired by the chairman of the Commission.

(3) The chairman of the commission shall convene a meeting of the commission within 7 days at the latest. a proposal by the Minister or by thirds of the members of the Commission.

(4) With the agenda and background for the commission meeting, its members shall be not later than 7 days before the beginning of the meeting of the Commission. In Exceptional cases may be decided by the chairman of the commission to shorten that time limit.

(5) The Commission shall negotiate if a majority of all its members are present.

(6) If necessary, the chairman of the commission may authorise the participation of persons who are not members of the Commission, except the persons referred to in paragraph 8 of the Art. 2 of this Statute. The Commission may, in particular when dealing with certain serious professional issues in justified to invite experts from different scientific specialties (hereinafter referred to as "the Parties'). (sssssssssssssss) who has the right to comment on the issues discussed without voting rights. The expert submits a signed declaration to the President to maintain confidentiality of all facts which he has become aware of in the performance of his functions; the obligation of confidentiality shall not apply in cases where those facts notify with the demonstrable consent of the person concerned.

(7) The meetings of the Commission and all the material attached to the meeting shall not be public. If an expert or other interested person not a member of the Commission is invited, attend the meeting of the Commission, the President shall request and verify its agreement in advance a requirement of confidentiality.

(8) In matters which do not permit a stay, the chairman of the commission may request members Committee opinion "per role." Opinions thus obtained shall be drawn up appropriate entry and supplementary action may be taken on the proposal of any member of the commission a debate at the next meeting of the Commission.

Art. 9 Commission opinions

(1) The Commission shall adopt opinions by a two-thirds majority of all members. This the opinion is published on the website of the Ministry.

(2) A member of the Commission who disagrees with the Commission's position adopted shall be entitled to: his different opinion, together with the reasons for the opinion adopted. This opinion is published on the Ministry's website.

(3) If the Commission does not deliver an opinion pursuant to paragraph 1, each member of the Commission shall be entitled to publication of a different opinion, together with a justification, on the website Ministry.

Art. 10 Organisational and financial security of the Commission's activities.

(1) The Ministry of Organisation and Technology ensures the operation of the Commission in particular by: provides

  1. appropriate premises for regular meetings of the Commission,
  2. adequate amount of office material at committee meetings,
  3. archiving of documents relating to the activities of the Commission.

(2) Ministry provides financial support for the commission's activities

  1. reimbursement of travel (excluding taxi services and air transport, if total price ticket with fees and taxes on the fare exceeds the total price of the train ticket first class or bus) from the point of departure to the place of the commission and back to members of the Commission, and invited experts pursuant to Act 283/2002 Coll. on Travel reimbursement of travel expenses, as amended; reimbursement of travel expenses reimbursement after receipt of original documents to the Ministry,
  2. adequate refreshments during the commission meeting, refreshments costs are implemented through the Ministry's representation fund (i.e. from the limit Section or Minister Directors General),

(3) The Ministry supports the development of the cooperation of the Commission with international and supranational institutions.

Art. 11 Final and transitional provisions

(1) The Statute of the Ethics Commission of the Ministry of Health of the Slovak Republic is repealed Republics of 1 May 2005 published in the Journal of the Ministry of Health Slovak Republic dated 12 June 2005, amount 32-34, year 53, as amended Appendix 1 published in the Journal of the Slovak Ministry of Health Republic of 15 April 2011, amount 9-14, year 59.

(2) Membership in the Commission, created on the basis of existing rules, will cease the expiry of the term of office of the chairman, vice-chairman and member of the commission by existing regulations.

(3) The Statute may be amended by written additions.

Art. Efficacy

This Statute shall enter into force on the date of its publication in the Official Journal of the Ministry. Health of the Slovak Republic

William Chislak
Minister