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7. Consenso informato

7.1. Foglio informativo per il paziente

7.2.5. Controllare l’avvenuta comprensione delle informazioni

Spesso i pazienti pensano di aver compreso le informazioni rilevanti e si mostrano soddisfatti delle informazioni ricevute, anche quando la loro comprensione è insufficiente.

Per questo il medico sperimentatore dovrebbe controllare che il paziente abbia effettivamente compreso le informazioni ricevute. Da una parte il paziente andrebbe incoraggiato a porre domande. Inoltre, per verificare il suo livello di comprensione il medico può fare alcune domande di verifica. Chiedere al paziente: “Ha capito?” non ha molto senso: il paziente normalmente risponderà di sì. Il medico sperimentatore dovrà piuttosto chiedere al paziente di riformulare con parole proprie gli obiettivi e le procedure del trial, e se il paziente dimostra una comprensione inaccurata spiegare il trial di nuovo.

Esempi di domande sono:

1) mi dica con le parole sue di cosa tratta questo studio; 2) mi dica cosa pensa che le capiterà in questo studio;

3) cosa si aspetta di guadagnare prendendo parte in questo studio? Quali rischi potrebbe correre partecipando questo studio? Quali sono le alternative?

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