Ethics Commission
The Ethics Committee (EC) of the Institute of Hematology and Blood Transfusion (IHBT) is an independent committee established by the director that ensures and protects the rights and preserves the dignity, safety and welfare of people who are treated at this institute, participate in medical research or undergraduate or postgraduate education. The Ethics Committee was established and operates according to its rules of procedure in accordance with good clinical practice (GCP) and applicable legal regulations.
EC members include healthcare professionals and persons without healthcare education. At least one member is not in an employment relationship or dependent position with IHBT. A member's term of office is 5 years with the possibility of extension. More detailed conditions of the EC's function are set out in written standard operating procedures. Upon request, these can be provided to the sponsor of the clinical trial.
The Committee reviews ethical issues of proposed studies and academic research, issues an opinion on the conduct of all clinical trials (CT) at IHBT. The EC supervises the course of the clinical trial, particularly from the perspective of safety and protection of the rights of trial subjects.
The EC meets at least once every two months, more frequently if needed. All requests received at least 10 days before the meeting date are discussed at the next EC meeting. EC meetings may be attended by invited guests, the proceedings are non-public. A written record is made of each EC meeting, which also contains a record of the EC's decision. The Committee issues its written opinion in the case of a clinical trial within 10 days to the applicant, the State Institute for Drug Control (SÚKL) and the multicentre EC, in the case of discussion of amendments to CT within 7 days.
Statute of the Ethics Committee IHBT (PDF)
Documentation requirements (PDF)
Meeting dates of the Ethics Committee IHBT