Biobanks are defined as “collections of samples of human bodily substances (e.g., cells, tissue, blood, or DNA as the physical medium of genetic information) that are or can be associated with personal data and information on their donors. Biobanks have a twofold character, as collections of both samples and data [1]”. In this context, the terms “data” and “information” mean the (genetic) information of individuals obtained from these samples as well as health-related and life style-related information about these individuals. This linkage of material samples with personal data and information, the two-fold function of biobanks, is what makes these collections of samples so important. The subject of this article is biobanks that have been set up or that are used for research purposes. Biobanks that are operated for the purpose of transplantation medicine are not my subject here. Being a member of the German National Ethics Council that has written an opinion on biobanks for research, I will draw upon my work for and within the Council as well as on our opinion Biobanks for research. Procuring, storing, handling and utilizing human biological material and the associated personal data that were gathered with the samples constitute a long-standing practice. This practice, however, is currently undergoing considerable technological change due to the increasingly improved means available to molecular genetics. There is hope that it will be possible to establish correlations between genetic make-up and physical condition through the large-scale collection and comparison of human biological material and the personal data and information associated with it—correlations that could lead in the long term to valuable diagnostic and therapeutic knowledge and that could be also useful for pharmacogenomics and for nutrigenomics. It could also lead to insights into characteristics that are particular to specific groups, communities or populations. Thus, establishing (large) biobanks could be of decisive importance to the development of the life sciences, medicine and health care. Biobanks should serve both the well-being of individuals and the public interest. In addition to the developments seen in the molecular genetics field, another important aspect here is the continually improving means available for the computer-aided processing and electronic transmission of personal data and information. As a result of this technology, personal data and information have the status of existing independently in time and space, so to speak. Although this type of data is acquired from actual biological material, it can be disseminated and utilized rapidly and globally with the help of electronic media. In view of the information content of biobanks, we could also speak of biolibraries (“biotheques”), a term that is sometimes used in France, for instance by the French National Ethics Committee CCNE [2]. Biobanks are not just a source of hope for the future; they also trigger fear and distrust in people. The question arises, whether, to what extent and in what ways can biobanks affect fundamental rights of individuals or of communities and populations. I am defending the claim that biobanks require special regulation. What are the particular reasons for this need and what specific ethical and legal problems exist in this connection?
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