{"id":1260,"date":"2020-04-01T09:11:48","date_gmt":"2020-04-01T07:11:48","guid":{"rendered":"https:\/\/www.bbmri.it\/?page_id=1260"},"modified":"2020-11-17T14:44:49","modified_gmt":"2020-11-17T13:44:49","slug":"il-processo-informativo","status":"publish","type":"page","link":"https:\/\/www.bbmri.it\/en\/nodo-nazionale\/elsi-covid\/il-processo-informativo\/","title":{"rendered":"Il processo informativo per il biobancaggio di ricerca COVID, un processo modulato dalle circostanze"},"content":{"rendered":"
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WHERE<\/strong><\/td>\nWHEN<\/strong><\/td>\nWHO<\/strong><\/td>\nHEALTHCARE PERSONNEL INVOLVED<\/strong><\/td>\nINFORMATION TOOLS<\/strong><\/td>\nREGULATORY-ETHICAL FRAMEWORK<\/strong><\/td>\n<\/tr>\n
HEALTHCARE STRUCTURE<\/strong><\/td>\nIn Emergency<\/strong>\n\n\u00a0<\/strong><\/td>\nAffected patient, unable to express consent or in an uncomfortable condition (i.e. in ICU)<\/strong><\/td>\nHealth personnel not able to collect consensus in the emergency situation in which they operate<\/strong>\n\n\u00a0<\/strong>\n\n\u00a0<\/strong>\n\n\u00a0<\/strong><\/td>\nOral communication to the patient of a short-term sample collection, simplified consent is postponed to stabilization and\/or discharge.<\/em><\/strong>\n\nThe collection of biological materials with\u00a0 the postponement of the\u00a0 consent is reported in the patient record, creating an alert. <\/em><\/strong>\n\nHowever, available<\/em><\/strong>\n\n\u00a0<\/em><\/strong>\n\n-simplified informed consent;<\/em><\/strong>\n\n\u00a0<\/em><\/strong>\n\n-glossary;<\/em><\/strong>\n\n\u00a0<\/em><\/strong>\n\n-in-depth information sheets.<\/em><\/strong><\/td>\nNational level - for Italy:<\/strong>\n\nDecreto Legge n. 14 del 9 marzo 2020, Disposizioni per il potenziamento del Servizio sanitario nazionale in relazione all\u2019emergenza COVID-19<\/strong>\n\nLINK<\/a><\/span>\n\n\u00a0<\/strong>\n\n\u00a0<\/strong>(EDPB) - Statement on the processing of personal data in the<\/strong> context of the COVID-19 outbreak. Adopted on 19 March 2020<\/strong>\n\nLINK<\/a><\/td>\n<\/tr>\n
HEALTHCARE STRUCTURE<\/strong><\/td>\n\u00a0In ward<\/strong>\n\n\u00a0<\/strong><\/td>\nAffected, stabilized patient<\/strong><\/td>\nNurses and doctors<\/strong><\/td>\n-simplified informed consent;<\/em><\/strong>\n\n\u00a0<\/em><\/strong>\n\n-glossary;<\/em><\/strong>\n\n\u00a0<\/em><\/strong>\n\n-in-depth information sheets.<\/em><\/strong><\/td>\nGDPR, in particular ART. 5-7,13<\/strong>\n\nLINK<\/a><\/u><\/strong>\n\n\u00a0<\/strong>\n\nNational level - for Italy: <\/strong>\n\nProvvedimento recante le prescrizioni relative al trattamento di categorie particolari di dati, ai sensi dell\u2019art. 21, comma 1 del d.lgs. 10 agosto 2018, n. 101<\/strong>\n\nLINK<\/strong><\/a><\/span>\n\n \n\nREGULATION (EU) No 536\/2014 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 16 April 2014 on clinical trials, in particular CHAP. V<\/strong>\n\nLINK<\/strong><\/a><\/span>\n\nRecommendation<\/strong> CM\/Rec(2016)6<\/strong><\/a><\/span> of the Committee of Ministers to member States on research on biological materials of human origin<\/strong>\n\nLINK<\/strong><\/a><\/span>\n\nWMA Declaration of Taipei on Ethical Considerations regarding Health Databases and Biobanks 2016<\/strong>\n\nLINK<\/strong><\/a><\/span><\/td>\n<\/tr>\n
HEALTHCARE STRUCTURE<\/strong><\/td>\nAt hospital discharge<\/strong>\n\n\u00a0<\/strong><\/td>\nRecovered, SARS-Cov-2-negative patient, able to express his own will<\/strong><\/td>\nNurses and hospital doctors <\/strong>\n\n\u00a0<\/strong><\/td>\n<\/tr>\n
HEALTHCARE STRUCTURE<\/strong><\/td>\nAt the communication of diagnosis -\u00a0 results of swab analysis<\/strong>\n\n\u00a0<\/strong><\/td>\nPatient with mild symptoms, sent back to territory<\/strong>\n\n\u00a0<\/strong><\/td>\nHospital health personnel<\/strong><\/td>\n<\/tr>\n
In the territory or at home<\/strong><\/td>\nUpon notification of the quarantine obligation<\/strong>\n\n\u00a0<\/strong><\/td>\nSubject in quarantine due to familiarity or direct interaction with affected patient <\/strong>\n\n\u00a0<\/strong><\/td>\nProfessionals identified by the regional\/territorial health organization<\/strong><\/td>\n<\/tr>\n
In the territory or at home<\/strong><\/td>\nAt the take charge in the territory or at home<\/strong><\/td>\nPatient with mild symptoms<\/strong>\n\n\u00a0<\/strong><\/td>\nProfessionals identified by the regional\/territorial health organization<\/strong><\/td>\n<\/tr>\n
In the territory or at home<\/strong><\/td>\nFollow up<\/strong><\/td>\nCured citizen<\/strong><\/td>\nProfessionals identified by the regional\/territorial health organization<\/strong><\/td>\n<\/tr>\n
In the territory or at home<\/strong><\/td>\nOn the basis of the provisions in place<\/strong><\/td>\nAsymptomatic citizen<\/strong><\/td>\nProfessionals identified by the regional\/territorial health organization<\/strong><\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n\n\n<\/div><\/div>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<\/div>","protected":false},"excerpt":{"rendered":"

CONTESTO (DOVE) TEMPI (QUANDO) DESTINATARIO (CHI) PERSONALE SANITARIO IN GIOCO STRUMENTI INFORMATIVI ASSETTO ETICO –\u00a0 NORMATIVO Struttura sanitaria In emergenza \u00a0 Paziente contagiato, non in grado di esprimere il proprio consenso o in condizioni non agevoli (intubato) Personale sanitario non in grado di raccogliere il consenso stante la situazione emergenziale […]<\/p>\n","protected":false},"author":1,"featured_media":0,"parent":1258,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"page-templates\/template-fullwidth.php","meta":{"footnotes":""},"class_list":["post-1260","page","type-page","status-publish","hentry"],"publishpress_future_action":{"enabled":false,"date":"2026-05-15 03:35:55","action":"change-status","newStatus":"draft","terms":[],"taxonomy":"","extraData":[]},"publishpress_future_workflow_manual_trigger":{"enabledWorkflows":[]},"_links":{"self":[{"href":"https:\/\/www.bbmri.it\/en\/wp-json\/wp\/v2\/pages\/1260","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.bbmri.it\/en\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/www.bbmri.it\/en\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/www.bbmri.it\/en\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/www.bbmri.it\/en\/wp-json\/wp\/v2\/comments?post=1260"}],"version-history":[{"count":4,"href":"https:\/\/www.bbmri.it\/en\/wp-json\/wp\/v2\/pages\/1260\/revisions"}],"predecessor-version":[{"id":1917,"href":"https:\/\/www.bbmri.it\/en\/wp-json\/wp\/v2\/pages\/1260\/revisions\/1917"}],"up":[{"embeddable":true,"href":"https:\/\/www.bbmri.it\/en\/wp-json\/wp\/v2\/pages\/1258"}],"wp:attachment":[{"href":"https:\/\/www.bbmri.it\/en\/wp-json\/wp\/v2\/media?parent=1260"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}