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ETHICS COMMITTEE

Address
Etická komise FN Ostrava
17. listopadu 1790
708 52 Ostrava-Poruba


Ethics Committee Chairman
MUDr. Luděk Rožnovský, CSc.
Phone Nr.: +420 597 374 278
E-mail: This e-mail address is being protected from spambots. You need JavaScript enabled to view it


Ethics Committee Secretary
Bc. Jiří Hynčica
Phone Nr.: +420 597 372 510
Fax: +420 597 374 801
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Sekretariat of the Ethics Committee
Zuzana Hrubá
Phone Nr.: +420 597 372 542
Fax: + 420 597 374 801
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Establishment, staffing and cancellation of the Ethic Committee of the University Hospital Ostrava

Establishment of EC

In accordance with Sec. 35(1) of the Act No. 129/2003 Coll., the director of the University Hospital Ostrava establishes the EC in a form of Decision of directors of UH Ostrava as a consulting body of the director of UH Ostrava in questions of observing the ethics in meeting scientific and research tasks of the UH Ostrava and provision of therapeutic and nursing care.

 

Appointing the EC members and changes thereof

Based on proposal of NLP, the director of UH Ostrava appoints and recalls in writing the chairman and members of the EC in a form of Decision of the director of UH Ostrava. EC members are appointed for the 4-year term of office, but for three terms of office at maximum.

 

Personal structure of EC

EC has at least 5 members and its members are persons with qualification and experience adequate for assessing and evaluating the clinic evaluations from the scientific, medical as well as ethic point of view. At least one member of the Ethic Commission is a person with no medical education and with no specialized scientific qualification and at least one of the members is not an employee, has no similar industrial relationship or has no position of dependence in respect of UH Ostrava.

Only an integral person may be a member of the Ethic Commission, who has provided his/her written consent:

  • to their membership in the Ethic Commission and the related absence in assessment of clinic evaluation and subsequent expert supervision over the evaluation in case of any personal interest in the subject evaluation;
  • to the obligation to notify the chairman of the Ethic Commission of his/her personal involvement in the clinical evaluation being discussed;
  • to the publishing of his/her membership in the Ethic Commission and any other facts following from the activities and membership in the Ethic Commission;
  • that he/she shall keep confidential any information and facts they learn in connection with their membership in the Ethic Commission. The confidentiality obligation covers also protection of the personality and privacy of any research participants, investigators and members of the Ethic Commission among each other.

In order to obtain an opinion, the EC may invite other persons who are also subject to the provision of this Confidentiality Act in respect of information and facts they learn in connection with their activity for EC.

 

Cancellation of EC

In the event of termination of EC, the director of UH Ostrava shall immediately inform SUKL and the Ministry of Health of this fact and shall provide for submission of complete documentation of EC to the Ministry of Health, which shall than exercise the powers of the terminated EC.

 

Rules of procedure of the Ethic Committee

The main tasks of EC

  • to assess projects of clinic importance in objective and impartial manner;
  • clinical evaluation of humane drugs;
  • clinical evaluation of medical means with clinical test;
  • grant projects and other clinical research;
  • protect the rights, safety and health of human participants in clinical research;
  • to grant or withdraw consent to implementation of clinical research in accordance with ethic, medical and scientific standards and procedures;
  • to supervise the progress of clinical studies from the point of safety and preservation of rights of clinical evaluation subjects;
  • to evaluate professional competence of clinical study investigators independently of the ordering party;
  • to evaluate the propriety of the equipment, selected procedures and groups of evaluation subjects used in terms of solution of clinical study, independently of the ordering party, examiner and regulatory or other authorities;
  • to discuss and assess any reports on adverse effects in connection with clinical and other medical research;
  • to assess the observation of ethic and medical standards in implementation of new therapeutic and diagnostic procedures;
  • to supervise the prevention of abuse in research and to assess the social effect of its consequences.

EC does not assess the quality and safety of the medicine or medical device to be tested. Qualified evaluation of a medicine is the responsibility of the relevant public medical administration (SUKL). Qualified evaluation of a medical device is the responsibility of an expert who made the expert's report.

EC fulfils its tasks in close cooperation with the Central Ethic Commission attached to the Ministry of Health and in connection with valid Czech legislation, international treaties on biomedicine and internal controlling acts of the UH Ostrava.

 

Summoning of EC

As a rule, EC meets at its regular session once in a month, but at least 10 times a year. The chairman (or the vice-chairman in case of the chairman's absence) summons an extraordinary meeting of EC, if necessary. Extraordinary meeting of EC may be initiated by any member of the EC. Dates of regular EC meetings are published on the EC intranet.

All meetings of EC are non-public and, depending on the contents of issue discussed, the EC may invite other persons to attend such meeting, who are also subject to the provisions of this Confidentiality Act in respect of information and facts they learn in connection with their activity for EC.

 

Agenda of EC meeting

Based on requests registered no later than 10 days prior to the EC meeting, the EC secretary draws up the agenda of EC meeting including the general time schedule to be approved by the EC chairman. According to the approved agenda, the EC clerk shall invite the EC member and external experts and chief examiners, if appropriate (according to time schedule).

Any requests delivered later than 10 days prior to EC meeting are included into the agenda of the next EC meeting.

 

Course of EC meeting

EC shall discuss and assess the submitted study. In terms of discussion, the readiness and experience of the examiner, who may be invited to participate in a part of the meeting, may be assessed as well. The examiner, ordering party or EC members having any personal interest in implementation of the given clinic research project do not participate in the voting on approval of implementation of the project.

 

Voting of the EC

EC meetings are non-public; nor the ordering party or the examiner take part in the opinion-making. EC members having a personal interest in the result of the voting are excluded from the voting as well.

In the vote, each member has one vote. Simple majority of members constituting a quorum is necessary for an EC opinion to be adopted; in the event of equality, the chairman's vote decides.

 

Records of EC meeting

From each EC meeting, a written record containing the following is made: date, hour and place of meeting, main points to be discussed, record of the opinion including the manner in which the statement was adopted (voting). The presence sheet serves for registration of EC members and potential external experts present at the EC meeting. Both the records and the presence list are kept in accordance with ensuring documentation.

The EC clerk sends one original of the elaborated EC opinion to the applicant, the other original is kept in the file room in accordance with ensuing documentation.

The EC chairman notifies the State Institute of Drug Control of any negative opinion of the Commission.

 

Structure of Ethic Committee of UH Ostrava

Name and Surname Speciality Role in EC

MUDr. Luděk Rožnovský, CSc.

physician

Chairman

MUDr. Ivan Štefánek

physician

Vice-Chairman

Bc. Jiří Hynčica

layman

secretary

Doc. MUDr. Leopold Pleva, CSc.

physician

member

MUDr. Jitka Svobodová, Ph.D.

physician

member

MUDr. Evžen Machytka

physician

member

JUDr. Sylva Macurová

lawyer

member

Bc. Marta Vajdová

general nurse

member

Ph.Mr. Marta Kollárová

pharmacist

member

MUDr. Tomáš Posolda

physician

member

MUDr. Marie Kunčíková

physician

member

MUDr. Patrice Popelková

physician

member

MUDr. Olga Zapletalová

physician

member

MUDr. Ivana Kacířová, Ph.D.

physician

member

Zuzana Hrubá

layman

member

Martina Robenková

general nurse

member

Leo Žídek

layman

independent member

Mgr. Vladimír Janků

layman

independent member

PhDr. Blanka Svobodníková

layman

independent member

MUDr. Marta Lešková

physician

independent member

Meeting Dates of the Ethics Committee

26.4. 2012
31.5. 2012
28.6. 2012
30.8. 2012
27.9. 2012
25.10.2012
29.11. 2012
20.12. 2012

Payments

Expert assessment of a clinical trial
Local clinical trial
20 000 CZK
without VAT
Multicentre clinical trial
40 000 CZK
without DPH
Amendment to clinical trial
5 000 CZK
without DPH

The final payment will include VAT according to valid legislation.

Where you can find us?

Address

Fakultní nemocnice Ostrava
17. listopadu 1790, 708 52 Ostrava-Poruba
GPS: 49° 49' 36" N / 18° 09' 40" E
Phone: +420 597 371 111, E-mail: fno@fno.cz

Visiting hours

Each day from 3.00 p.m. to 6.00  p.m.

Map of the Premises