Regulation of Biobanks in Italy
- PMID: 32984196
- PMCID: PMC7492532
- DOI: 10.3389/fped.2020.00415
Regulation of Biobanks in Italy
Abstract
In Italy, a biobank is "a non-profit organization that must be officially recognized by the appropriate healthcare authority in the member states and must guarantee the treatment, distribution and conservation of biological material according to standards of quality and professionalism," but must not conserve material already regulated by specific laws, as is the case for organs for transplants, blood for transfusions, as well as embryos and gametes for medically assisted reproduction. The concept of biobank includes not only biological samples, but also the related database of clinical and personal information, from which the subject's lifestyle can be deduced. Unfortunately, at the moment, Italian law does not offer specific itineraries for achieving this legal status.
Keywords: COVID-19; Italy; biobanks; genetics research; regulation.
Copyright © 2020 Cannovo, Cingolani, Guarino and Fedeli.
References
-
- Fedeli P, Cannovo N, Guarino R, Graziano V. Informed Consent for Genetics Research in Italy. Open Med J. (2019) 6:6–12. 10.2174/1874220301906010006 - DOI
-
- Conti A, Delbon P, Paternoster P, Ricci G. I Test Genetici. Etica, Deontologia, Responsabilità. Milano: Giuffrè; (2019).
-
- Working Group for the Protection of Personal Data Working Document on Genetic Data 2004. (2004) Available online at: https://www.privacy.it/grupridoc200403173.html (accessed March 15, 2020).
-
- Stelma FF. Regulations European Biobank Maastricht, Dept of Epidemiology. Maastricht: Maastricht University; (2003).
LinkOut - more resources
Full Text Sources
