Všeobecná fakultní nemocnice v PrazeU Nemocnice 499/2128 08 Praha 2__________________Váš dopis značky / ze dneNaše značkaVyřizuje / linkaV Praze, dne 26.7.2017VFN/ Mgr. Korbová 21.8.2017Poskytnutí informací podle zákona č. 106/1999 Sb., o svobodném přístupu k informacím Vážený pane doktore,Všeobecná fakultní nemocnice v Praze, IČO: 00064165, se sídlem U Nemocnice 499/2, 128 08 Praha 2 (dále jen „VFN“), obdržela dne 1.8.2017 Vaši žádost o poskytnutí informací podle zákona č. 106/1999 Sb., o svobodném přístupu k informacím, ve znění pozdějších předpisů (dále jen „žádost“), ve které VFN žádáte o poskytnutí informace týkající se klinického hodnocení s č. protokolu: DE038: A Multicenter, Randomized, Double-Blind, Placebo Controlled Study of the Safety, Efficacy and Pharmacokinetics of the Human Anti-TNF Monoclonal Antibody Adalimumab in Childern With Polyarticular Juvenile Rheumatiod Arthriritis. Ve Vaší žádosti jste požadoval předložit:„Poučení subjektu hodnocení“ nebo „informace pro pacienta“, resp. písemnou informaci, která byla poskytnuta pacientům, resp. jejich zákonným zástupcům, aby mohli poskytnout informovaný souhlas před tím, než byli zařazeni do klinického hodnocení uvedeného výše; a„informovaný souhlas“ udělený pacientem nebo zákonnými zástupci pacientů, kteří byli zařazeni do klinického hodnocení.Vzhledem k tomu, že Vaše žádost se vztahovala k dokumentům z roku 2003, v němž VFN uzavřela smlouvu o provedení výše specifikovaného hodnocení, byla lhůta k poskytnutí informací prodloužena ve smyslu ustanovení § 14 odst. 7 zákona prodloužena o deset dnů. K Vaší žádosti uvádíme, že VFN Vám vyžádané informace neposkytne s ohledem na ustanovení § 11 odst. 2, písm. a) zákona, které stanoví: „Povinný subjekt informace neposkytne, pokud jde o informaci vzniklou bez použití veřejných prostředků, která byla předána osobou, jíž takovouto povinnost zákon neukládá, pokud nesdělila, že s poskytnutím informace souhlasí.“ Formulář informovaného souhlasu pacienta i formulář poučení pacienta byly vytvořeny zadavatelem klinického hodnocení, který VFN sdělil, že nesouhlasí, aby byly vyžádané dokumenty zpřístupněny třetím osobám. 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