ÚHKT - Ústav hematologie a krevní transfuze
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Ethics Commission

 

The Ethics Committee (EC) of the Institute of Hematology and Blood Transfusion (IHBT) is an independent committee established by the director, which ensures and protects the rights and preserves the dignity, safety and well-being 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 to IHBT. The term of office of a member is 5 years with the possibility of extension. More detailed conditions for the functioning of the EC are set out in written standard operating procedures. Upon request, these can be provided to the sponsor of the clinical trial.

The Committee assesses 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 progress of clinical trials, particularly from the perspective of safety and preservation of the rights of trial subjects.

The EC meets at least once every two months, more frequently if necessary. All requests received at least 10 days before the date of the meeting are discussed at the nearest EC meeting. EC meetings may also be attended by invited guests; the meeting is not open to the public. A written record of each EC meeting is made, which also includes 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 (SIDC) and the multi-centre EC, in the case of reviewing amendments to the CT within 7 days.

Statute of the Ethics Committee IHBT (PDF)

Requirements for submitted documentation (PDF)

​Meeting dates of the Ethics Committee IHBT:

 

 

 

List of members

Fees