Presentation

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The mission of the Research Ethics Committee (CRE) with medicines (CREm) at Bellvitge University Hospital is to ensure the protection of the rights, safety and well-being of human beings involved in research projects that may entail some physical or psychological risk and to provide them with public assurance, while evaluating the correctness of such projects and monitoring their development.

It also aims to be a reference point and support the Hospital’s researchers and research groups with regard to their areas of competence, especially by providing guidance on the criteria required in terms of methodological, ethical and legal aspects of the projects, as well as their monitoring at the centres included in their scope.

To carry out this task, the Committee refers to the main internationally accepted bioethical codes, the Guidelines of Good Clinical Practice (GCP) and current legal regulations, such as Organic Law 3/2018 on Personal Data Protection and the guarantee of digital rights, General Data Protection Regulation (EU) No. 2016/679, Organic Law 41/2002, as regards its general scope, and RD 1090/2015 on clinical trials with medicines and Law 14/2007 on Biomedical Research, within the specific regulations, among others.

The Committee is accredited by the Directorate General for Healthcare Planning and Regulation of the Department of Health of the Regional Government of Catalonia, in accordance with the provisions of Decree 406/2006 and Instruction 1/2017 of the Directorate General for Healthcare Planning and Regulation of the Department of Health. Moreover, the Bellvitge University Hospital Committee is registered with the Office for Human Research Protections (OHRP) of the U.S. Department of Health and the Human Services Office of the Secretary Office of Public Health and the Science Office for Human Research Protections (HHS), with code IRB00005523 and Federal-wide Assurance Number FWA00010235.

This 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 RD 1711/2016 on Biobanks.