title: REXIC Project: Retrospective Cross-Sectional Study of Documentation of Informed Consent for Research Biobanking in A Public Research and Teaching Hospital.
abstract: BACKGROUND
  The Center for Transfusion Medicine, Cell Therapy and Cryobiology, Milan, Northern Italy, is the headquarter of the POLI-MI biobank. It co-ordinates the biobank activities of the Fondazione Ca' Granda Ospedale Maggiore Policlinico of Milan. Such activities require specific safeguarding of donors' rights and protection of sensitive and genetic data. The Fondazione Ca' Granda Ospedale Maggiore Policlinico has set up a project on informed consent with the aim of developing awareness and understanding of this issue. Within this project, it has been decided to evaluate how consent for biobanking material is expressed.
  
  
  METHODS
  The aim of the study was to evaluate the quality and completeness of consent to biobanking in the POLI-MI biobank. This was a retrospective study carried out in 2012 on samples of consent declarations collected by biobank units in 2011. Some units used a single, standard consent model available from a previous POLI-MI biobank workgroup. Other units used models which had been previouly formulated. Evaluation was made using a form that indicated the essential elements of consent.
  
  
  RESULTS
  A total of 48 consent declarations were collected using the single, standard model and 84 were collected using other models. The consent declarations that used the single, standard model were found to be the most complete and were filled in better than other models.
  
  
  CONCLUSIONS
  Progressive adoption of a simple, standard consent model is expected to improve the quality of consent acquisition. Regular audit of the compliance of consent practices with ethical and legal requirements is mandatory to improve the quality of research biobanking.
authors.affiliation: Post-graduate School of Hygiene and Preventive Medicine, University of Milan ;
authors.forename: Marta
authors.initials: M
authors.lastname: Nobile
authors.affiliation: Post-graduate School of Hygiene and Preventive Medicine, University of Milan ;
authors.forename: Elena
authors.initials: E
authors.lastname: Garavelli
authors.affiliation: Center of Transfusion Medicine, Cell Therapy and Cryobiology, IRCCS Foundation Ca' Cranda Hospital , Milan ;
authors.forename: Barbara
authors.initials: B
authors.lastname: Gagliardi
authors.affiliation: Center of Transfusion Medicine, Cell Therapy and Cryobiology, IRCCS Foundation Ca' Cranda Hospital , Milan ;
authors.forename: Silvia
authors.initials: S
authors.lastname: Giovanelli
authors.affiliation: Center of Transfusion Medicine, Cell Therapy and Cryobiology, IRCCS Foundation Ca' Cranda Hospital , Milan ;
authors.forename: Paolo
authors.initials: P
authors.lastname: Rebulla
authors.affiliation: Post-graduate School of Hygiene and Preventive Medicine, University of Milan ;
authors.forename: Concetta
authors.initials: C
authors.lastname: Caccami
authors.affiliation: Post-graduate School of Hygiene and Preventive Medicine, University of Milan ;
authors.forename: Diego
authors.initials: D
authors.lastname: Iemmi
authors.affiliation: Post-graduate School of Hygiene and Preventive Medicine, University of Milan ;
authors.forename: Federico
authors.initials: F
authors.lastname: Saibene
authors.forename: Silvana
authors.initials: S
authors.lastname: Castaldi
keywords: biobanks; ethics; informed consent; public health; research