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.
Open and practical exchange, dissemination, and reuse of specimens and data have become a fundamental requirement for life sciences research. The quality of the data obtained and thus the findings and knowledge derived is thus significantly influenced by the quality of the samples, the experimental methods, and the data analysis. Therefore, a comprehensive and precise documentation of the pre‐analytical conditions, the analytical procedures, and the data processing are essential to be able to assess the validity of the research results. With the increasing importance of the exchange, reuse, and sharing of data and samples, procedures are required that enable cross‐organizational documentation, traceability, and non‐repudiation. At present, this information on the provenance of samples and data is mostly either sparse, incomplete, or incoherent. Since there is no uniform framework, this information is usually only provided within the organization and not interoperably. At the same time, the collection and sharing of biological and environmental specimens increasingly require definition and documentation of benefit sharing and compliance to regulatory requirements rather than consideration of pure scientific needs. In this publication, we present an ongoing standardization effort to provide trustworthy machine‐actionable documentation of the data lineage and specimens. We would like to invite experts from the biotechnology and biomedical fields to further contribute to the standard.
Inter-organizational business processes can be designed top-down: starting from a global process model, where each activity and gateway is assigned to one of the participating organizations, local processes (or views/stubs for refinement) are generated for each organization. The resulting inter-organizational process is executed by the local processes in a fully distributed manner. Implementing the data-flow in such a scenario is highly complex, both because of the combinatorial explosion of possible solutions and because of conflicting goals for implementing the data-flow. We present a flexible, heuristic algorithm for implementing the data-flow for inter-organizational processes according to various user preferences, which significantly improves over the base-line approaches proposed so far. The approach is fully implemented and a comprehensive, multi-dimensional evaluation is provided.