ABSTRACT
Privacy and security of data are emerged as fundamental parts of routine clinical and laboratory practice. The adoption of electronic medical record, the connectivity of information systems and instruments to Internet have increased the risk for violation of patients privacy. The European Union General Data Protection Regulation 2016/679 (GDPR 2016/679) defines how personal information must be used by adopting measures that guarantee high level of security. Accordingly, transparency about the generation and managing of data in research became crucial. The most important ethical issue document is represented by the informed consent, which can be signed by the donor to authorize the collection, storage and use of the samples and associated data for specific research purposes. In May 2020, a screening for novel coronavirus SARS-CoV2 infection in all the patients and employees at the Santa Lucia Foundation, in Rome has been conducted, together with the voluntary opportunity for all the participants to donate biological materials for future researches for COVID-19 disease. Materials: All participants were subjected to nasooropharyngeal swab test for viral SARS-CoV2 RNA detection, and blood sampling, for Anti-SARS-CoV-2 antibodies assessment, in electrochemiluminescence immunoassay "ECLIA" (Roche). In addition, those who gave voluntary consent for donation to the Biobank, carried out an adjunctive tube for serum sample. According to the GDPR, the informed consent form is divided into two parts: The first for the donation of samples to the biobank and the second for personal data treatment authorization, including i. authorization to personal data processing, ii. genetic data processing, iii. transfer of biological samples and data to third parties in or iv. outside Europe (Research Institute, University, other biobanks), and v. consent to access to the electronic medical record. Results: A total of 742 patients and personnel participated at the screening for COVID-19: 468 gave the consent for donation of biological sample to the Biobank, while 43 denied consent. Among donors, 22 (4,7%) refused consent to the transfer/communication of biological samples/associated data to third parties in Europe while 35 (7,5%) denied the transfer/communication outside Europe. Regarding the consent for the genetic data processing, only 5 participants (1,1%) refused authorization. Conclusions: The fear of an uncontrolled dissemination of personal data, especially on internet or media, is one of the main reasons that preclude participation in research studies. Donation of biological materials and data for biobanking expose patients and donors to risk of threatening of their privacy, but represent a great need for future of translational medicine. Informed consent defines the authorizations for the processing of patient data and the possibility to withdraw at any time. Finally, transparency and security are the pillars for the patients healthcare.