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Presentation

The mission of the Clinical Research Ethics Committee (CEIC) of Bellvitge University Hospital (HUB) is to ensure the protection of the rights, safety and welfare of the human subjects participating in research projects potentially involving a physical or psychological risk and to provide public assurance of that protection, reviewing the suitability of the aforementioned projects and monitoring their progress.

At the same time, it aims to be a benchmark and to support the hospital’s researchers and research groups in matters falling within its purview, especially by offering guidance with regard to both the requisite criteria for the methodological, ethical and legal aspects of the projects and the monitoring of these projects at the centres within its scope of action.

To accomplish this task, the Committee adheres to the main internationally accepted bioethical codes, Good Clinical Practice (GCP) standards, and current law, including the Spanish Data Protection Act (LOPD 15/1999) and Spanish Royal Decree 1720/2007 enacting it, Organic Law 41/2002 on the general scope, Spanish Royal Decree 1090/2015 on clinical trials with medicinal products, and Spanish Law 14/2007 on Biomedical Research, amongst other specific regulations.

The Committee is accredited by the Directorate General for the Regulation of Healthcare and Healthcare Professionals of the Catalan Ministry of Health in accordance with the provisions of Decree 406/2006. The Bellvitge University Hospital CEIC is also registered with the Office for Human Research Protections (OHRP) of the U.S. Department of Health and Human Services (HHS), part of the Office of Public Health & Science (OPHS) overseen by the Office of the Assistant Secretary for Health (OASH), with code IRB00005523 and Federalwide Assurance Number FWA00010235.

In accordance with the terms of Spanish Royal Decree 1090/2015, the Bellvitge University Hospital CEIC also assumes the functions of an Ethics Committee for Research with medicinal products (CEIm) as provided for under the said Royal Decree. However, the Committee acts as an external advisory ethics committee for the HUB-ICO-IDIBELL Biobank, in accordance with the provisions of Law 14/2007 on Biomedical Research and Spanish Royal Decree 1711/2016 on Biobanks.