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"preizkušanec":
"subject":
Última atualização: 2014-11-21
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se lahko preizkušanec brez kakršne koli škode iz kliničnega preskušanja kadar koli umakne, tako da prekliče svoje prostovoljno soglasje;
the subject may without any resulting detriment withdraw from the clinical trial at any time by revoking his informed consent;
če preizkušanec ne more pisati, lahko v izjemnih primerih v prisotnosti najmanj ene priče da ustno soglasje, kot to določa nacionalna zakonodaja;
if the individual is unable to write, oral consent in the presence of at least one witness may be given in exceptional cases, as provided for in national legislation;
je imel preizkušanec ali, če oseba ne more dati prostovoljnega soglasja, njen zakonit zastopnik priložnost, da se je v predhodnem razgovoru z raziskovalcem ali članom raziskovalne skupine seznanil s cilji, tveganji in neprijetnostmi preskušanja in s pogoji, v katerih se bo preskušanje izvajalo, in če so ga obvestili tudi o njegovi pravici, da se iz preskušanja kadar koli umakne;
the trial subject or, when the person is not able to give informed consent, his legal representative has had the opportunity, in a prior interview with the investigator or a member of the investigating team, to understand the objectives, risks and inconveniences of the trial, and the conditions under which it is to be conducted and has also been informed of his right to withdraw from the trial at any time;