Regulation of Biobanks in Italy

Nunzia Cannovo; Mariano Cingolani; Rosa Guarino; Piergiorgio Fedeli

doi:10.3389/fped.2020.00415

Regulation of Biobanks in Italy

Front Pediatr. 2020 Sep 2:8:415. doi: 10.3389/fped.2020.00415. eCollection 2020.

Authors

Nunzia Cannovo¹, Mariano Cingolani², Rosa Guarino³, Piergiorgio Fedeli⁴

Affiliations

¹ Federico II University Ethics Committee, Naples, Italy.
² Department of Law, Institute of Legal Medicine, University of Macerata, Macerata, Italy.
³ University of Federico II, Naples, Italy.
⁴ Legal Medicine Section, School of Law, University of Camerino, Camerino, 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.