Committee on Ethics of Research
The Committee on Ethics of Research (CEI) of Córdoba, and the Committee on Ethics of Research with medicines (CEIm) of Córdoba Province, are accredited bodies belonging to the Andalusian Health Service (SAS). Their headquarter is located in the Reina Sofia University Hospital and their area of influence covers the entire province of Córdoba. Their functions include the evaluation of both clinical studies with medicines for human use and medical devices (Regulation (EU) No. 536/2014 of the European Parliament and of the Council, of April 16, 2014, on clinical trials of medicines for use Human and Royal Decree 1090/2015, of December 4, which regulates clinical trials with medicines, the Clinical Research Ethics Committees with medicines and the Spanish Registry of Clinical Studies) as well as research projects (Law 14/2007, of July 3, on Biomedical Research), guaranteeing at all times the adequacy of the methodological, ethical and legal aspects of research involving interventions in humans or use of biological samples of human origin.
For the applications of clinical trial evaluation and authorisation of EPA-SP in Andalusia, as well as for the substantial amendments and inclusion of additional sites in the studies, the corresponding fees have been set. Studies promoted by sites and foundations integrated into the Public Health System of Andalusia (SSPA) and in trials that meet the non-commercial clinical trial definition contained in the RD 1090/2015 may ask for the exemption of the fees. This information is included in the documents “Información sobre tasas dirigida a los promotores de investigación clínica con medicamentos y a las organizaciones de investigación por contrato (CRO)” and “Modelo de solicitud de exención de tasas” only available in Spanish.