Abstract
This paper discusses the legal implications of setting up two new biobanks in Belgium. The first is hospital-based and will archive tissue from patients with haematologic cancer, whereas the second is linked to a general practice based morbidity registry and will involve storage of blood samples. To date, Belgium has no specific legislation that regulates storage of human tissue and related databases. Several issues concerning the protection of individuals with regard to the processing of personal medical data are discussed from the existing privacy legislation. We will address the principle of consent (broad versus specific) and the type of data recorded (anonymous, encoded and identifiable) for both biobanks.
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Acknowledgments
The authors acknowledge CCPRB (Cancer Control using Population based Registries and Biobanks), a Network of Excellence, funded by the 6th Framework Programme of DG Research (European Commission, Brussels), through the University of Lund (Malmö, Sweden). MA (coauthor) was also funded by the Belgian Foundation Against Cancer (Brussels; Belgium). Intego is financially supported by the Flemish Government (project number 3H010475).
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Recommendations: All information about the intended research and patient rights has to be available to the patient. Data should be coded within the practice, without the assistance of a third trusted party.
The whole protocol has to be approved by an ethical board and each research question should be discussed and approved by an independent board within the research facility.
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Truyers, C., Kellen, E., Arbyn, M. et al. The use of human tissue in epidemiological research; ethical and legal considerations in two biobanks in Belgium. Med Health Care and Philos 13, 169–175 (2010). https://doi.org/10.1007/s11019-009-9230-y
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DOI: https://doi.org/10.1007/s11019-009-9230-y