IT solutions for privacy protection in biobanking.

Biobanks containing human biological samples and associated data are key resources for the advancement of medical research. Efficient access to samples and data increases competitiveness in medical research, reduces effort and time for achieving scientific results and promotes scientific progress. In order to address upcoming health challenges, there is increasing need for transnational collaboration. This requires innovative solutions improving interoperability of biobanks in fields such as sample and data management as well as governance including ethical and legal frameworks. In this context, rights and expectations of donors to determine the usage of their biological material and data and to ensure their privacy have to be observed. We discuss the benefits of biobanks, the needs to support medical research and the societal demands and regulations, in particular, securing the rights of donors and present IT solutions that allow both to maintain the security of personal data and to increase the efficiency of access to data in biobanks. Disclosure filters are discussed as a strategy to combine European public expectations concerning informed consent with the requirements of biobank research.

The privacy-reciprocity connection in biobanking: comparing German with UK strategies.

In recent years, the adequacy of the 'gift' model of research participation has been increasingly questioned. This study used focus groups to explore how potential and actual participants of biobanks in the UK and Germany negotiate the relationship between concerns over privacy protection, reciprocity and benefit sharing. In Germany, 15 focus groups (n = 151) were conducted: 11 general public groups (n = 116) and 4 with former cohort study participants including the KORA and the Popgen cohort study (n = 35). In the UK, 9 focus groups (n = 61) were conducted: 4 general public groups (n = 33) and 5 with UK Biobank and European Huntington's Disease (Euro-HD) Registry biorepository participants (n = 28). Forms of reciprocity were found to partially mitigate potential and actual biobank participants' concerns over personal privacy risks and future unintended consequences of biobank in both Germany and the UK. Specifically, notions of individual reciprocity were at the forefront in the context of personal disadvantages to participation, while communal reciprocity was prominent when potential and actual participants were discussing the uncertainty of the long-term nature of biobanking. The research indicates that reciprocity can be viewed as a mode to deal with individuals' concerns about participating in a biobank, both by acting as a return 'favor' or 'gift,' and through establishing an ongoing relationship between participants, researchers and society. It is suggested that future biobanking projects will need to flexibly combine individual and communal forms of reciprocity if they are to recruit and maintain sufficient numbers of participants.

Biobank governance: trends and perspectives.

Biobanks are a challenge and topic for governance. Today, biobanks are identified as a biomedical scientific/infrastructural development that warrants a political/legal/ethical reaction with the goal to integrate biobanks into the preexisting fabric of regulation, medicine, law and society. Biobank governance is always a response to sociocultural challenges and requires the building of trust, acceptance, and careful political negotiation. Biobanks are regulated in networks of governance in which the state is one actor next to others, and the ordering and structuring of the interaction between biobanks, society, and politics operates through a variety of actors, on different levels and along particular rationalities. Such networks of governance reflect, to some extent, a postregulatory state in which governance has become a complicated architecture and field of action involving a multitude of forces and rationalities. Biobank governance is still a relatively new field of political-legal intervention and it will be crucial for the future of biobanks to establish governance regimes that appropriately link research with society and politics.

The Genome Austria Tissue Bank (GATiB).

In the context of the Austrian Genome Program, a tissue bank is being established (Genome Austria Tissue Bank, GATiB) which is based on a collection of diseased and corresponding normal tissues representing a great variety of diseases at their natural frequency of occurrence from a non-selected Central European population of more than 700,000 patients. Major emphasis is put on annotation of archival tissue with comprehensive clinical data, including follow-up data. A specific IT infrastructure supports sample annotation, tracking of sample usage as well as sample and data storage. Innovative data protection tools were developed which prevent sample donor re-identification, particularly if detailed medical and genetic data are combined. For quality control of old archival tissues, new techniques were established to check RNA quality and antigen stability. Since 2003, GATiB has changed from a population-based tissue bank to a disease-focused biobank comprising major cancers such as colon, breast, liver, as well as metabolic liver diseases and organs affected by the metabolic syndrome. Prospectively collected tissues are associated with blood samples and detailed data on the sample donor's disease, lifestyle and environmental exposure, following standard operating procedures. Major emphasis is also placed on ethical, legal and social issues (ELSI) related to biobanks. A specific research project and an international advisory board ensure the proper embedding of GATiB in society and facilitate international networking.

Gene therapy and the public: a matter of trust.

The relationship between genetic engineering and the public has never been a very harmonious one. Many scientists believe that public concerns about gene therapy are simply based on misunderstandings and lack of scientific information. In this 'deficit theory' of the public, most difficulties in the interaction between science and the public are derived from the assumption that there is a communication gap between scientists and the public. However, public opinion research shows clearly that the various 'publics' have a differentiated, and generally positive perception of medical biotechnology. It is not so much lack of information, as lack of trust which explains the difficult relationship between gene therapy and society. For the future, it will be crucial not only to focus on the idea of 'educating the public', but to find new communicative and institutional formats to generate trust.

German politics of genetic engineering and its deconstruction.

Policy-making, as exemplified by biotechnology policy, can be understood as an attempt to manage a field of discursivity, to construct regularity in a dispersed multitude of combinable elements. Following this perspective of politics as a textual process, the paper interprets the politicization of genetic engineering in Germany as a defence of the political as a regime of heterogeneity, as a field of 'dissensus' rather than 'consensus', and a rejection of the idea that the framing of technological transformation is an autonomous process. From its beginning in the early 1970s, genetic engineering was symbolically entrenched as a key technology of the future, and as an integral element of the German politics of modernization. Attempts by new social movements and the Green Party to displace the egalitarian imaginary of democratic discourse into the politics of genetic engineering were construed by the political élites as an attack on the political order of post-World War II Germany. The 1990 Genetic Engineering Law attempted a closure of this controversy. But it is precisely the homogenizing idiom of this 'settlement' which continues to nourish the social movements and their radical challenge to the definitions and codings of the politics of genetic engineering.