WP4 - Research
Workpackage Leader: Judit Sandor (Central European University) and Herman Nys (K.U.Leuven)
This workpackage aims to investigate the existing regulatory framework of biobanks across the EU and will focus on the following objectives (1) Collecting and analyzing legislation and regulations regarding the establishment, management and functioning of classical, population and forensic biobanks across Europe; (2) Describing the similarities and differences in such legislation and regulations; (3) Looking for the “best rules” by comparing these similarities and differences; (4) Making proposals in order to reach where appropriate a harmonized regulatory framework across the EU.
In previous European research projects (Eurogentest; EurocareCF) we have established a network of local legal contact persons in academic and administrative settings ( universities; ministries). We envisage to send three distinct questionnaires to the local contact persons: one related to classical databanks , another related to population databanks and a third related to forensic databanks. These questionnaires will contain detailed questions regarding the regulatory framework of these databanks in their country. We will also ask them to make available any information in English, French or German regarding this framework such as legislations, regulations, jurisprudence, legal commentaries etc. This information will enable us in first instance to describe and understand the regulatory framework regarding the establishment, management and functioning of biobanks across the EU. Using the comparative research method we will in a second move trace the similarities and differences in the regulatory framework of biobanks across the EU. This method will enable us to discover what are probably the “best rules” to govern the different categories of biobanks.
Finally we will elaborate where appropriate proposals for a harmonized regulatory framework across the EU. Partner 4 is responsible for the research in the 10 new Member States, plus Greece and Italy. Partner 6 is responsible for the other 13 countries.
