ELSI

Ethical, legal and social issues

In BioResource-Med data and samples will only be used for ethically and scientifically approved research. A legal expert opinion from Prof. DDr. C. Kopetzki, head of the Institute for Ethics and Law in Medicine, University of Vienna, confirmed that concept of BioResource-Med is in accordance with all applicable legislation in the areas of public health care, medicine, personal rights, data protection, genetics, civil law and criminal law, and university policies.

By Austrian legislation, existing human tissue collections containing tissues from patients that have died can be used for scientific investigation without specific informed consent as long as patient confidentiality is maintained and approved by the local ethical committee. This is in accordance with the emerging opinion in most European countries (for review see Opinion of the German Ethics Council and the report from EU working group on Biobanks for Health "Optimizing the use of European Biobanks and Health Registries for Research Relevant to Public Health and Combating Disease", Oslo 2003). For newly collected samples, specific informed consent is obtained (approved by The Ethical Committee of the Medical University). The informed consent is also in line with the recommendations of the German Ethics Council and other international guidelines.

Data protection / sample donor privacy

Protection of sample donor privacy is of highest priority. A series of data protection measures prevent that information generated from samples can be related to the sample donor's identity. All samples are automatically coded when data are entered into the data base (Sample DB) and only the sample code is disclosed to researchers. Information on sample donor identity is only available in the hospital where the patient has been treated and data are stored separate from all sample-related information. Innovative IT-tools are developed to prevent re-identification of sample donors even if detailed genetic and medical data are combined (control of k-anonymity in the Data Mart).

Ethical, legal, and social guidance

BioResource-Med will encounter a number of new challenges concerning social, political, and ethical context due to its transnational ambition and strategy. For example, the circulation of specimens and genetic data between different countries and the evolving patterns of cooperation will have to deal with vastly different legal contexts. Measures to communicate with society in a number of different countries will have to deal with significant differences in cultures. On the other hand, related or similar biobank projects and networks such as in the UK, Iceland, or in Spain already have a rich local experience of interacting with society, dealing with ethical and legal issues, or with patient's needs and sensibilities. Also, there are numerous experiences with the linking of biobank data collections with financing and business interests. The previous GEN-AU ELSA project lead by H. Gottweis, which should become an integral part of BioRecource-Med, proactively contributes to the social, ethical and political embedding of BioResource-Med in the field of genomics, to learn from previous international biobank efforts, and to contribute to the understanding of the ethical, socio-economic, and political implications of biobank-networking in the transnational field.

http://www.univie.ac.at/transformation/Elsa/ELSAenter.htm

ELSI Advisory Board

• Ruth Chadwick, Lancaster UK
• Gil Siegal, Haifa/Tel Aviv Israel
• Manfred Stelzer, Vienna, Austria
• Cathrine Waldby, Sydney, Australia