title: Qualitative study on custodianship of human biological material and data stored in biobanks.
abstract: BACKGROUND
  Balancing the rights and obligations of custodians and applicants in relation to access to biobanks is of utmost importance to guarantee trust and confidence. This study aimed to reveal which issues divide different stakeholders in an attempt to determine the rights and/or obligations held on human biological materials (HBM) and data.
  
  
  METHODS
  Twenty-eight informants in the Benelux and Scandinavia were interviewed in order to capture the perspectives of experts and stakeholders in relation to the rights and obligations held by custodians and applicants with respect to access to HBM and data.
  
  
  RESULTS
  There was no consensus among the informants on whether the custodian of a biobank should decide upon the scientific merits and the utility of an access request. Nearly all informants agreed that a new request or an amendment to the initial request has to be submitted when an applicant wants to use leftover HBM in a new or follow-up project. Several informants felt that it might be justified to charge higher access fees to external or industrial applicants that did not contribute (directly or indirectly) to the collection of HBM and data. Most informants agreed that a custodian of a biobank could request the sharing and return of research results. It was furthermore argued that some of the benefits of research projects should be fed back into biobanks.
  
  
  CONCLUSIONS
  The interviews revealed a rather complex web of rights and obligations allocated to the custodian and the applicant in relation to access to HBM and data stored in biobanks. Some rights and obligations are negotiated on a case-by-case basis, while others are stipulated in access arrangements. We did find a consensus on the attribution of certain general rights to the custodians and the applicant.
authors.affiliation: Clinical Pharmacology and Pharmacotherapy, KU Leuven, Leuven, Belgium. michiel.verlinden@pharm.kuleuven.be.
authors.forename: Michiel
authors.initials: M
authors.lastname: Verlinden
authors.affiliation: Interfaculty Centre for Biomedical Ethics and Law, KU Leuven, Leuven, Belgium. herman.nys@med.kuleuven.be.
authors.forename: Herman
authors.initials: H
authors.lastname: Nys
authors.affiliation: AC Biobanking, UZ Leuven, Leuven, Belgium. Nadine.ectors@uz.kuleuven.ac.be.|Translational Cell & Tissue Research, KU Leuven, Leuven, Belgium. Nadine.ectors@uz.kuleuven.ac.be.
authors.forename: Nadine
authors.initials: N
authors.lastname: Ectors
authors.affiliation: Clinical Pharmacology and Pharmacotherapy, KU Leuven, Leuven, Belgium. isabelle.huys@pharm.kuleuven.be.|Centre for Intellectual Property Rights, KU Leuven, Leuven, Belgium. isabelle.huys@pharm.kuleuven.be.
authors.forename: Isabelle
authors.initials: I
authors.lastname: Huys
mesh_terms: D022126:Access to Information / Q000941:ethics*; D018070:Biological Specimen Banks / Q000941:ethics*; D035843:Biomedical Research / Q000941:ethics*; D006801:Humans; D007258:Informed Consent; D036301:Qualitative Research; D012537:Scandinavian and Nordic Countries; D012941:Social Responsibility; D035502:Trust