title: Drafting biological material transfer agreement: a ready-to-sign model for biobanks and biorepositories.
abstract: OBJECTIVE
  Due to the scarcity of publications, guidelines, and harmonization among national regulations, biobanks and institutions face practical and theoretical issues when drafting a material transfer agreement (MTA), the fundamental tool to regulate the successful exchange of biosamples and information. Frequently researchers do not execute MTAs because of a general lack of knowledge about this topic. It is thus critical to develop new models to prevent loss of traceability and opportunities both for researchers and biobanks, their exposure to various risks, and delays in transferring biomaterials.
  
  
  METHODS
  Through the involvement of institutional groups and professionals with multidisciplinary expertise, we have drawn up a ready-to-sign MTA for the CRO-Biobank (the biobank of the National Cancer Institute, CRO, Aviano), a standardized template that can be employed as a ready-to-use model agreement.
  
  
  RESULTS
  The team identified the essential components to be included in the MTA, which comprise i) permissions, liability and representations; ii) custodianship and distribution limitations; iii) appropriate use of materials, including biosafety concerns; iv) confidentiality, non-disclosure, and publications; v) intellectual property protection for both the provider and recipient.
  
  
  CONCLUSIONS
  This paper aims to be an unabridged report (among the few works in the existing literature) providing a description of the whole process related to the formation of an MTA. Biobanks and institutions may consider adopting our ready-to-sign form as a standard model. The article discusses the most important issues tackled during the drafting of the document, thus proposing an operative approach for other institutions that face the same problems.
authors: CRO Biobank, CRO Aviano National Cancer Institute, Aviano (Pordenone) - Italy.|Clinical Cancer Pathology, CRO Aviano National Cancer Institute, Aviano (Pordenone) - Italy.
authors: Silvia
authors: S
authors: Cervo
authors: Scientific Directorate, CRO Aviano National Cancer Institute, Aviano (Pordenone) - Italy.
authors: Paolo
authors: P
authors: De Paoli
authors: Technology Transfer Office - Scientific Directorate, CRO Aviano National Cancer Institute, Aviano (Pordenone) - Italy.
authors: Ermes
authors: E
authors: Mestroni
authors: CRO Biobank, CRO Aviano National Cancer Institute, Aviano (Pordenone) - Italy.|Pathology Division, CRO Aviano National Cancer Institute, Aviano (Pordenone) - Italy.
authors: Tiziana
authors: T
authors: Perin
authors: Innoventually S.r.l.s., Trieste - Italy.
authors: Luca
authors: L
authors: Escoffier
authors: CRO Biobank, CRO Aviano National Cancer Institute, Aviano (Pordenone) - Italy.|Pathology Division, CRO Aviano National Cancer Institute, Aviano (Pordenone) - Italy.
authors: Vincenzo
authors: V
authors: Canzonieri
authors: CRO Biobank, CRO Aviano National Cancer Institute, Aviano (Pordenone) - Italy.|Clinical Cancer Pathology, CRO Aviano National Cancer Institute, Aviano (Pordenone) - Italy.
authors: Agostino
authors: A
authors: Steffan
mesh_terms: D018070:Biological Specimen Banks / Q000592:standards*; D006801:Humans; D010865:Pilot Projects; D014164:Transfer Agreement