title: Biobanking and international interoperability: samples.
abstract: In terms of sample exchange, international collaborations between biobanks, or between biobanks and their research partners, have two important aspects. First, the donors' consent usually implies that the scope and purpose of any sample transfer to third parties is subject to major constraints. Since the legal, ethical and political framework of biobanking may differ substantially, even between countries of comparable jurisdictional systems, general rules for the international sharing of biomaterial are difficult, if not impossible, to define. Issues of uncertainty include the right to transfer the material, the scope of research allowed, and intellectual property rights. Since suitable means of international law enforcement may not be available in the context of biobanking, collaborators are advised to clarify any residual uncertainty by means of bilateral contracts, for example, in the form of material transfer agreements. Second, biobank partners may rightly expect that the biomaterial they receive for further analysis attains a certain level of quality. This implies that a biobank has to implement stringent quality control measures covering, in addition to the material transfer itself, the whole process of material acquisition, transport, pre-analytical handling and storage. Again, it may be advisable for biobank partners to claim contractual warranties for the type and quality of the biomaterial they wish to acquire.
authors.affiliation: Institute of Clinical Chemistry and Laboratory Diagnostics, Jena University Hospital, 07740 Jena, Germany. michael.kiehntopf@med.uni-jena.de
authors.forename: Michael
authors.initials: M
authors.lastname: Kiehntopf
authors.forename: Michael
authors.initials: M
authors.lastname: Krawczak
mesh_terms: D018070:Biological Specimen Banks / Q000941:ethics / Q000331:legislation & jurisprudence / Q000706:statistics & numerical data; D001330:Electronic Data Processing; D007258:Informed Consent; D018973:Intellectual Property; D007391:International Cooperation; D011786:Quality Control; D013048:Specimen Handling