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Termini di consenso presentati a un Comitato etico
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ISBN10: 6203899240
ISBN13: 9786203899245
Publisher: Edizioni Sapienza
Published: Apr 22 2025
Pages: 52
Weight: 0.18
Height: 0.12 Width: 6.00 Depth: 9.00
Language: Italian
ISBN13: 9786203899245
Publisher: Edizioni Sapienza
Published: Apr 22 2025
Pages: 52
Weight: 0.18
Height: 0.12 Width: 6.00 Depth: 9.00
Language: Italian
Lo scopo di questo studio è stato quello di analizzare i Termini di Consenso Libero e Informato (TCLE) dei progetti di ricerca presentati al Comitato Etico di Ricerca della Facoltà di Salute (CEP/FS) dell'Università di BrasÃlia tra gennaio e ottobre 2013, al fine di verificare il rispetto dei requisiti delle Risoluzioni CNS 196/96 (fino a luglio/13) e 466/12 (da luglio a ottobre/13). Questo studio è giustificato dalla necessità per la comunità scientifica di redigere moduli di consenso in un linguaggio chiaro e accessibile ai potenziali partecipanti alla ricerca, in modo che possano esercitare la loro autonomia in modo veramente libero e informato. Affinché l'autonomia sia pienamente raggiunta, ciò deve riflettersi nella stesura dell'ICF. In quest'ottica, 190 ICF presentati al CEP/FS sono stati analizzati in base a quattro categorie di parametri: 1) struttura; 2) dettagli della ricerca; 3) analisi della formulazione e 4) informazioni sul ricercatore. Il risultato comparativo mostra che non ci sono state differenze significative nella preparazione degli ICF presentati alla CEP/FS con il cambiamento della Risoluzione. L'analisi ha dimostrato che gli ICF analizzati sono parzialmente conformi alle norme.
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