How does the ethical review process work in the Czech Republic and which are the designated ethics committees?
SÚKL keeps a register of ethics committees for clinical investigations of medical devices and for clinical evaluations of medicinal products.
An ethics committee is set up by a provider qualified to carry out clinical investigations or the Ministry of Health. The committee consists of health professionals and other members and it must have at least 5 members.
An ethics committee gives a written approval to the implementation of a clinical investigation of a medical device and supervises the course of the investigation with regard to the safety and respect to the subjects’ rights.
A sponsor is obliged to give prior written notice of their intention to carry out a clinical investigation to the ethics committee and to present, along with the notice, the documentation defined in Section 11(a) of Act No. 123/2000 Coll., on Medical devices.
The ethics committee will give its approval or will communicate its disapproval of the implementation of clinical investigations within 60 days from the date of delivery of the notice. The period from when missing source materials are requested by the ethics committee to their delivery by the sponsor is not included in this time limit.
Weblinks to Czech Ethics Commitees.
