How does the ethical review process work in Slovakia and which are the designated ethics committees?

Types of Ethics Committees
Central Ethics Committee (CEC) of the Ministry of Health
The CEC has been established by the Minister of health as an advisory body on questions of bioethics, including those connected with ethics of biomedical research and clinical trials. This committee only exceptionally performs the ethical review of projects or protocols for a specific research project. The establishment and activities of CEC are governed by the statutes and working procedures issued by the Minister of health.

Local Ethics Committees (LECs)
LECs are established by directors of health care facilities or biomedical research institutions to review protocols of clinical trials or biomedical research projects planned to be performed in that facility/institution, and to provide a follow up of the research protocol approved.

Regional Ethics Committees (RECs)
The RECs are foreseen according to the Directive 2001/20/EC6. Their task is to review and follow up multicentre clinical trials and multicentre biomedical research projects.

What kind of projects or procedures should go to ethics committees for approval?
All biomedical research projects, as defined in the Law No. 277/1994 Coll. on health care in §40 subparagraph (1), i.e. “investigation aimed at confirmation of a previously formulated hypothesis, which is necessary for obtaining new medical knowledge, elaboration of new methods or hypotheses, or for clinical investigation (trial) of drugs or medicinal devices or health equipment in the interest of preservation or improvement of people’s health”, should be “reviewed, commented upon and approved by the health care facility” (§40 sub-paragraph (4), while ethics committees should be used to review ethical questions relating to research.

Moreover, an “opinion on the clinical trial given by the ethics committee of the facility, where the clinical trial is to be performed,” is required by §16 sub-paragraph (2), sub-paragraph j) of the Law No. 140/1998 Coll. on drugs and health equipment as a necessary document to be submitted by the sponsor to the National Institute for Drug Control (NIDC) together with the application for the clinical trial authorisation. In practice, both applications for a clinical trial authorisation, and for the notifications required for phase IV clinical trials, should contain a favourable opinion of the ethics committee. Thus, the sponsor should seek the favourable opinion of the ethics committee before submitting the application to the NIDC.