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Ethics Committee

The Ethics Committee (EC) of the Institute of Hematology and Blood Transfusion (IHBT) is an independent committee established by the Director to ensure and protect the rights and preserve the dignity, safety and welfare of people who receive treatment, participate in medical research or undergraduate or postgraduate teaching at the Institute. The Ethics Committee has been established and operates according to rules of procedure in accordance with Good Clinical Practice (GCP) and applicable legislation.

The members of the EC are both medical and non-medical professionals. At least one member shall not be in an employment or dependent status with the IHBT. The term of office of a member shall be 5 years with the possibility of renewal. More detailed terms and conditions of the EC shall be set out in written standard operating procedures. They can be provided to the sponsor of the clinical trial upon request.

The Committee assesses ethical issues of proposed studies and academic research, and issues an opinion on the conduct of all clinical trials (CT) at the IHBT. The EC supervises the conduct of clinical trials, in particular with regard to safety and the preservation of subjects' rights.

The EC meets at least once every two months, more frequently if necessary. At the next EC meeting, all applications received at least 10 days before the meeting date are discussed. The EC meeting may be attended by invited guests and is closed to the public. Written minutes of each EC meeting shall be taken, including a record of the EC decision. The Commission shall issue its written opinion within 10 days to the applicant, the State Institute for Drug Control (SÚKL) and the multicentre EC in the case of a clinical trial, and within 7 days in the case of the consideration of amendments to the CT.

 

Meeting dates of the Ethics Committee of the IHBT:

28.8.2024

4.10.2024

15.11.2024

13.12.2024

24.1.2025