ABSTRACT

Ethics committees are established and managed by the single healthcare facility in which the research is to be processed, by a regional office, or by the Ministry of Health (MoH). The Ethics Committee of the MoH also works as an advisory body to the Minister of Health. These ethics committees can also give their opinion on other fields of biomedical research, not only for pharmaceuticals, unless legal regulations state otherwise. Particular ethics committees can be named on the basis of the researcher's application, and after the approval of the State Office for the Control of Pharmaceuticals, may be nominated by the Ministry of Health as the ethics committee for the multi-centric clinical research. The main problem is that the law changes very frequently in the Czech Republic and therefore ethics committees, as with other institutions and bodies, sometimes struggle with knowing and thus following, valid legal regulation.