Juridisch kader inzake toegang tot biobanken

The European Strategy Forum on Research Infrast ructures (ESFRI) identified biobanks as one of the main priority research infrastructures for t he European Research Area (ERA) for the next 10 to ¨20 years. Millions of human biological material ( HBM) and associated data are collected each y ear for a variety of purposes. These purposes ¨may include basic research studies, clinical tria ls and epidemiological studies. The legal fr amework that determines access to biobanks remains ¨unclear. The absence of a defined set of applicab le rules creates legal uncertainty for biobanks an d applicants. The PhD project studied the legal fr amework that determines the relationship between a ¨biobank and a researcher that applies for ac cess to HBM and data stored in a biobank. In¨ an interdisciplinary context, the PhD project aims ¨to contribute to the creation of a clear and smoo th legal framework - i.e. legislation, non-b inding normative instruments and access arrangemen ts - applicable to biobanks. The¨ general introduction provides a deeper insigh t into the use of HBM and associated data for rese arch purposes. First, it highlighted the importanc e of biobanks for biomedical research. Second, it¨ looked at different types of HBM and data collecte d for research purposes. Third, it described¨ the different research purposes to collect and use ¨HBM and data. Finally, it dug deeper into the def inition of the terms 'biobanks' and &l squo;biobank networks'. The first ¨chapter of the PhD reports on a comparative analysis of access arrangements of organizations, biobank networks and biobanks. The comparativ e analysis revealed a lack of harmonization on how ¨access conditions are defined and implemented. A¨ considerable number of access arrangements did not ¨contain clear information on how the biobank init iatives (should) implement several of the studied¨ access conditions. The lack of clear information o n access conditions could hinder access to biobank s and biobank networks. The analysis did reve al a trend to grant custodianship to biobanks¨or biobank networks and no longer to individual c ollectors or principal investigators. This can be¨ explained by the fact that biomedical research req uires access to large amounts of HBM and data ¨of high quality. Finally the comparative analysis ¨confirmed that the majority of the biobank i nitiatives establishes an access committee to ¨evaluate requests for access to HBM and data . The mandate of such access committees