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7 Stud. Ethics L. & Tech. 1 (2013)

handle is hein.journals/selt7 and id is 1 raw text is: Tass6: A Legal Perspective on Harmonization, Standardization and Unification Despite (..) enthusiastic predictions about the research benefits to be achieved through the exploitation of biobanked specimens and related information, there is continuing concern that this potential may not be realized soon. The problem is the lack of international consensus on appropriate regulatory standards and governance structures for biobanks. (Pullman et al., 2011) Introduction Biobanking activities are increasingly at the heart of research practices. Access to such resources is of major importance since it avoids the limitations of research conducted among smaller numbers of subjects. Moreover, the ability to combine data from numerous biobanks is increasingly important as it allows for the creation of very large datasets - as needed to study complex disease aetiology - and optimizes the use of already collected research material. The last decade has witnessed the creation of major international research consortia such as the European Network for Genetic and Genomic Epidemiology (ENGAGE)1 and the Biobank Standardisation and Harmonisation for Research Excellence in the European Union (BioSHaRE.EU),2, but promoting biobanks networking and thus maximizing public health benefits requires at least some degree of harmonization (European Commission, 2010). In international research initiatives, any discrepancies between national/regional legal frameworks create hurdles for the development and implementation of cross-border activities. Internationalization of genetic and genomic research, including the creation of international research consortia, is limited by the diversity of national perspectives on how to deal with legal and ethical issues (Pullman et al., 2011). Unification, standardization and harmonization of national/regional legal frameworks are used to minimize legal discrepancies. Although quite different, these concepts aim, to different extents, to facilitate international activities. The terms harmonization, standardization and unification are often used rather loosely (Tay and Parker, 2009), or in association with other concepts such as interoperability (Kiehntopf and Krawczak, 2011), mutual recognition (Schmidt, 2007), or globalization (Cati Backer 2007; Crettez et al., 2009; Tay and Parker, 2009). However, these concepts have precise legal meanings, and the use of either one or another leads to specific and different consequences. 1 European Network for Genetic and Genomic Epidemiology (ENGAGE), available at: http://www.euengage.org/ 2 Biobank Standardisation and Hannonisation for Research Excellence in the European Union (BioSHaRE.EU), available at: http://www.bioshare.eu Published by De Gruyter, 2013

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