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;
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;