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What do we do?

The Bellvitge University Hospital Clinical Research Ethics Committee (CEIC) carries out the functions assigned to it under current law (Decree 406/2006 of the Catalan Ministry of Health, Spanish Royal Decree 1090/2015 and other applicable regulations), as well as those tasks falling within its purview that are delegated to it by the hospital’s management or the management of the Southern Metropolitan Administrative Area of the Catalan Health Institute (ICS).

These functions include:

  • Evaluation of the methodological, ethical and legal aspects of clinical trials with medicinal products and/or medical devices, as an Ethics Committee for Research with medicinal products (CEIm).
  • Evaluation of the methodological, ethical and legal aspects of research projects involving the use of invasive procedures.
  • Evaluation of the methodological, ethical and legal aspects of observational post-authorization studies with medicinal products, other observational studies, and research projects involving the use of biological samples of human origin.
  • Regular monitoring – at least once a year – of the status of the approved research projects, in terms of both proposed substantial amendments and any new safety information that may emerge (ad hoc reports, annual safety reports, etc.).
  • Provision of ethical and legal advice to researchers and other agents involved in biomedical research falling within its scope of action.
  • Acting as an external advisory ethical committee for the HUB-ICO-IDIBELL Biobank.
  • Formal certification of the participation of researchers in biomedical research projects evaluated by the Committee.
  • Provision of advice to the management of the administrative area, hospital management and other agents from institutions falling within its scope of action on issues of general interest related to their activity.
  • Collaboration in the maintenance of the clinical trial module of the SAP for Healthcare program.
  • Participation in teaching activities at institutions falling within or outside its scope of action.