Statute of Bioethical Commission
Article 1
Preamble
1. The Bioethics Committee is established by the Research, Development and Innovation Council (hereinafter referred to as the “Council”) as an expert and advisory body thereof further to Section 35(7)(c) of Act No 130/2002 on the promotion of research, experimental development and innovation from public resources and amending certain related laws (the Act on the Promotion of Research, Experimental Development and Innovation), as amended by Act No 110/2009, and further to Section 24 of Act No 227/2006 on human embryonic stem cell research and related activities and amending certain related laws (hereinafter referred to as the “HESCR Act”).
2. In its activities, the Bioethics Committee shall be governed by the Statutes and Rules of Procedure of the Bioethics Committee. The Statutes and Rules of Procedure of the Bioethics Committee or any amendment thereto shall be subject to approval by the Council chairman on a proposal from the Council.
Article 2
Competence
1. The Bioethics Committee shall perform activities under the Act on the Promotion of Research, Experimental Development and Innovation and the HESCR Act, and tasks assigned by the Council. In particular, the Bioethics Committee shall
a) draw up
1. draft expert opinions of the Council on applications for permission to carry out research on human embryonic stem cells or on applications for a change to such permission, or on applications for permission to import human embryonic stem cells,
2. further supporting documentation to address the Council’s tasks associated with the bioethical aspects of research, experimental development and innovation in the field of modern biology and medicine,
b) make observations, within the scope of its competence, on documents being prepared by the Council,
c) monitor the situation in bioethical issues in the EU and, where necessary, collaborate with similar committees of EU Member States.
2. The Bioethics Committee shall draw up a framework annual programme (plan) of its activities and submit it to the Council for approval by 30 November of the previous calendar year.
3. The Bioethics Committee shall report annually to the Council on its activities by 30 September of the year for which the report is written.
Article 3
Management of the Bioethics Committee
1. The Bioethics Committee shall operate independently and autonomously.
2. The Bioethics Committee’s activities shall be managed by its chairman, who shall be appointed and removed by the Council chairman on a proposal from the Council. The Bioethics Committee chairman shall be elected by Council members by secret ballot from among the Council members.
3. The chairman of the Bioethics Committee shall be accountable to the Council for the Committee’s activities, shall act on behalf of the Committee, shall chair the meetings thereof, and shall approve the minutes of meetings.
4. The Bioethics Committee chairman shall be represented by a vice-chairman elected by the Bioethics Committee from among its members. The vice-chairman may be removed on a proposal from Bioethics Committee members. The election or removal of the vice-chairman shall be decided by Bioethics Committee members in a secret ballot by an absolute majority of all Committee members.
5. The Bioethics Committee’s tasks shall be assigned by the Council through the Bioethics Committee chairman. The Bioethics Committee chairman may attend Council Board meetings when invited to do so by the Council chairman or the Council’s first vice-chairman. For such meetings, underlying documentation on the items of the agenda at which the Bioethics Committee chairman is to be present shall be made available to him.
6. The Bioethics Committee chairman may, in case of his pre-excused absence from a Council meeting, be represented by the Bioethics Committee vice-chairman if delegated by the Bioethics Committee chairman to represent him at a Council meeting in such a situation.
Article 4
Bioethics Committee Members
1. The Bioethics Committee shall have 9 to 15 members, including the chairman. Membership of the Bioethics Committee shall be a public office and shall not constitute an employment relationship with the Czech Republic.
2. Members of the Bioethics Committee shall be elected by the Council by secret ballot from among experts, particularly in the fields of medicine, molecular biology and genetics, law, sociology, philosophy and theology.
3. Bioethics Committee members shall be appointed and removed by the Council chairman on a proposal from the Council.
4. The term of office of Bioethics Committee members shall be four years. A member of the Bioethics Committee may be appointed for a maximum of two consecutive terms.
5. Bioethics Committee membership shall be incompatible with the concurrent membership of
a) the board of the Czech Science Foundation,
b) the board of the Technology Agency of the Czech Republic, or
c) the board of the Academy Council of the Academy of Sciences of the Czech Republic.
6. Bioethics Committee membership shall not be substitutable. Bioethics Committee members shall attend Committee meetings and actively participate in the Committee’s work.
7. Should any member of the Bioethics Committee fail to officiate for a period of at least three months, subject to the approval of the majority of Bioethics
Committee members, the Bioethics Committee chairman may make a proposal to the Council for the removal of that member of the Bioethics Committee and the appointment of a new member of the Bioethics Committee.
8. Bioethics Committee members shall respect the confidentiality of materials discussed until such time as they are approved and published, shall not disseminate information identified as confidential, personal data obtained in connection with Bioethics Committee membership or information about pending administrative proceedings, even after termination of Bioethics Committee membership. This shall not preclude expert consultation on an issue under discussion.
Article 5
Bioethics Committee Meetings
1. Bioethics Committee meetings shall be governed by the Rules of Procedure of the Bioethics Committee.
2. Bioethics Committee meetings shall be held twice a year or as necessitated by the requirements of the HESCR Act. The dates and places of meetings shall be specified in the Bioethics Committee framework annual programme (plan) of activities approved by the Council.
3. An extraordinary meeting of the Bioethics Committee shall be held at the request of the Council or at the request of one third of Bioethics Committee members within 14 calendar days of delivery of the request to the Bioethics Committee chairman. Meetings of the Committee shall be convened by its chairman.
Article 6
Conflict of Interests
1. A person who is in a conflict of interests shall not participate in the preparation of an expert opinion on an application for permission to carry out research on human embryonic stem cells, on an application for a change to such permission, or on an application for permission to import human embryonic stem cells, or in the discussions on such a draft. “Conflict of interest” shall mean a situation where a person has any relationship to an applicant for permission or to a workplace at which the research is conducted, or is in any way involved in the research to which the application refers.
2. A statement of the non-existence of a conflict of interests referred to in paragraph (1) shall be included in the minutes of Bioethics Committee meetings where a draft expert opinion is discussed and in the minutes of Council meetings at which at a draft opinion of the Bioethics Committee is discussed.
Article 7
Cost of Activities and Remuneration of Bioethics Committee Members
1. The costs of the Bioethics Committee’s activities, including the remuneration of the members thereof, shall be covered by expenditure on research, experimental development and innovation under the budget heading of the Office of the Government of the Czech Republic.
2. In the preparation of documents commissioned in advance which are covered by expenditure intended for Council activities, the procedure under special legislation shall be followed.
3. Bioethics Committee members shall be entitled to remuneration for holding such public office, the amount of which shall be set by the Council chairman, and travel expenses, which shall be provided in the amount and under conditions prescribed by the Labour Code. To this end, the Council secretariat shall keep attendance lists of Bioethics Committee meetings on file.
Article 8
Final Provisions
These Statutes shall enter into effect on the date of signature hereof by the Council chairman.
Prague, 3 March 2011
Petr Nečas, m.p.
Prime Minister
and Chairman of the Research, Development and Innovation Council
