The use of human tissue in epidemiological research; ethical and legal considerations in two biobanks in Belgium
- 153 Downloads
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.
KeywordsBiobank research Informed consent Legislation Personal data protection
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).
- Cancer control using population-based registries and biobanks. 2007. http://www.cancerbiobank.org/.
- Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine: Convention on human rights and biomedicine (4 April 1997) and CETS No. 195-Additional Protocol on Human Rights and Biomedicine (Protocol on Biomedical Research). 2007. http://conventions.coe.int/treaty/en/treaties/html/164.htm.
- Directive 95/46/EC. 2006. http://ec.europa.eu/justice_home/fsj/privacy/law/index_en.htm.
- Godard, B., J. Schmidtke, J.J. Cassiman, and S. Aymé. 2003. Aymé data storage and DNA banking for biomedical research: Technical, social and ethical issues. European Journal of Human Genetics 11(Suppl 2): S8–S10.Google Scholar
- HuGO Ethics Committee. Statement on human genomic databases. 2007. http://www.hugo-international.org/Statement_on_Human_Genomic_Databases.htm.
- Kettis-Lindblad A., et al. 2005. Genetic research and donation of tissue samples to biobanks. What do potential sample donors in the Swedish general public think? European Journal of Public Health.Google Scholar
- Law of 19 December 2008. 2009. http://www.hsern.eu/regulation/belgium.
- Law of 8 December 1992, coordinated version (August 2003). 2006. http://www.privacycommission.be/normatieve_teksten/NL_8-12-92_levenssfeer.pdf.
- Lousbergh, D., E. Cloes, L. Op De Beeck, J.L. Rummens, J. Vanden Brande, C. Faes, L. Bruckers, G. Molenberghs, D. Dhollander, E. Kellen, K. Hensen, D. Lathouwers, E. Meekers, and F. Buntinx. 2007. Ten years of cancer in the Belgian province of Limburg: 1996–2005. Hasselt: Limburg Cancer Registry.Google Scholar
- Royal Decree of 13 February 2001. 2006. http://www.privacycommission.be/normatieve_teksten/AR%20KB%2013%20f%C3%A9v%202001.pdf.
- United nations educational scientific and cultural organisation. International declaration on human genetic data. 2007. http://unesdoc.unesco.org/images/0013/001331/133171e.pdf#page=45.