The technical possibilities of automated data analysis of DNA samples and their bioinformatic processing have developed rapidly over the last few years and are constantly being improved. A decade after the completion of a draft human genome sequence was announced, a whole range of possibilities for medical research has unfolded, based on a combination of health and genetic data in so-called biobanks. Biobank research is an essential element of new fields such as epigenetics, metagenetics, and pharmacogenetics. Many European countries have invested considerably in this important research tool, which is expected to further the understanding of the interaction between genes and the environment and its implication for human diseases, as well as the development of efficient medical treatments. However, biobanks will be able to reach their full potential only if certain preconditions are met regarding the harmonization of databank structures and their regulation. The collection and storage of DNA, cell tissue samples as well as the collection of phenotypic, environmental and lifestyle data from medical records and patient questionnaires need to be standardized in order to guarantee sufficient quality of research and to permit collaboration. This process of technical standardization is currently underway. Even more difficult is the harmonization of ethical and legal frameworks. Over the last years, various national and international initiatives have been launched in this respect. This chapter intends to provide an overview of the scientific potential of biobanks and to show the extent to which its realization is dependent on efficient solutions for the regulatory challenges. Europe can only take advantage of the wealth of information contained in its collections of samples and data if the ethical debate about research involving biobanks is adequately resolved. The main goal of this debate is to ensure the protection of the rights of those who have provided the human material, without unduly hampering research. The chapter will outline the most influential regulatory positions, focusing on the recommendations issued by the Council of Europe and the OECD guidelines, and describe the most recent challenges.