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Ethical, legal and social issues

Samples and data provided by Biobank Graz will only be delivered to ethically and scientifically approved research projects. The ethical concept of Biobank Graz is in accordance with all applicable laws and the respective legislation in the areas of public health care, medicine, personal rights, data protection, genetics, civil and criminal law and university policies in Austria. Biobank Graz has been approved by the local ethics committee and by the official Austrian data regulatory board (DVR). A comprehensive data protection policy has been developed and implemented to protect sample donor privacy. A respective data protection officer is in place. A broad Informed Consent has been established by an iterative process involving all interested parties and the local ethics committee. Biobank Graz is regularly reviewed by a Scientific and Ethical Advisory Board (SEAB).


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Informed consent of Biobank Graz

Biobank Graz has developed an Informed consent procedure that covers all issues of modern biomedical research. All interested parties and the local ethics committee were involved in the development process. The informed consent is in line with the recommendations of existing international guidelines (e.g. "OECD Guidelines for BRC") and is approved by the Ethics Committee of Medical University of Graz. This informed consent needs to be signed prior to sample collection.



Long established sample collections often face the problem that an informed consent is not available for older samples. The general understanding according to ethical preconditions of biomedical research and the imperative to obtain consent from patients to use residual samples and data for research purposes has changed considerably during the last decade. In a report on biobanking, the Austrian Bio-Ethics Committee recommended that existing human tissue collections containing tissues collected during the years before the recommendation can be used for scientific investigation without re-contact and/or specific informed consent, provided that sample donor confidentiality is maintained and that the specific research project is approved by the local ethics committee.

This position complies with the emerging opinion in most European countries (further reading: Husebekk, Anne; Lærum, Ole Didrik; Iversen, Ole Jan; Ottersen, Ole Petter; Langmark, Frøydis. (2003) Biobanks for Health. Optimising the Use of European Biobanks and Health Registries for Research Relevant to Public Health and Combating Disease). This procedure was accepted by the local ethics committee and was adopted by Biobank Graz.

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