Objectives
The last few years have witnessed an important expansion of collection and processing of human biological samples and of the related information data. This activity has strategic importance for genetic research, clinical care and future treatments. Biobanks are huge repositories of human biological specimens. Biobanks are often key links between abstract genomic data and concrete patient medical records, between genotype and phenotype. We distinguish specifically between three types of biobanks: small scale databases in clinical and academic research, large-scale population banking and forensic DNA databases.
List of objectives
Objective 1: To study the issue of confidentially and privacy in relation to the different kind of biobanks
The major ethical and legal problem that relates to all types of biobanks is the question about privacy and confidentiality of the sample and the (genetic) information. In the context of modern biobanking a duty of confidentiality and a right to privacy have mainly been seen as basic features of ethical biobanking and the required confidentiality has rarely been problematised. There is, however, reason to believe that an unquestioned transfer of the traditional concept of confidentiality to the three types of biobanking we described may be problematic, and that the concept needs to be re-analysed in these new contexts.
Objective 2: To systematically investigate the existing regulatory framework across the European Union, with special attention to confidentiality
We aim to investigate the existing regulatory framework of biobanks across the EU and will focus on the collection and analysis of legislation and regulation regarding the establishment, management and functioning of classical, population and forensic biobanks across Europe. An important objective is to look at the similarities and differences in such legislation and regulations, in order to formulate recommendations towards a harmonization of European practices and regulations.
Objective 3: To systematically investigate the ethical issues about the creation and organisation of forensic DNA biobanking
We aim to investigate the ethical and policy issues about the creation and organisation of the forensic DNA analysis, the methods of obtaining and using samples, issues related to informed consent, privacy and confidentiality, the right of self-defence of a community. Based on the careful examination of already existing national forensic DNA databases, the analysis of individual rights related to privacy, confidentiality, dignity, physical and moral integrity, we want to proactively contribute to the ethical discussion of the collection and processing of human biological samples and their related information data in the context of forensic DNA databases.
Objective 4: To systematically investigate governance aspects of biobanking
We aim to investigate governance aspects of biobanks. Any biobank project operates in a highly complicated socio-economic, political, cultural, ethical, and legal context. New medical-scientific strategies to deal with disease require a careful embedding into complex context constellations that vary from country to country, and that display special features on the transnational level. Hence, the objective is to study the social, ethical, scientific-technological, and political-regulatory embedding of biobanks, to help the understanding of the ethical, socio-economic, scientific-technological and political implications of biobank development on the local and the national level, and in the transnational field and thereby to contribute to a better understanding of biobank governance. “Good biobank governance” will proactively integrate insights as developed in this project to avoid difficulties or failures and in order to guarantee smooth interaction and exchange with society, politics, the health care and the economic system.
Objective 5: To develop policy oriented recommendations
The results obtained by the different objectives described above will be of great use for the development of policy oriented recommendations concerning the organisation and management of small scale biobanks, population databanks and forensic DNA databases. The analysis of ethical and legal literature, mission statements, and existing legislation will also provide suggestions for “best rules” with regard to the issue of confidentiality in genetic biobanking and databases. We aim also to make proposals in order to reach where appropriate a harmonized regulatory framework across the European Union. This will be done in broad consultation with experts not involved in the project.
