if during a clinical investigation the minor reaches the age of legal competence to give informed consent as defined in national law, his or her express informed consent shall be obtained before that subject can continue to participate in the clinical investigation.
más rud é, le linn imscrúdú cliniciúil, go slánaíonn an mionaoiseach aois na hinniúlachta dlíthiúla chun toiliú feasach a thabhairt mar a shainmhínítear é sa dlí náisiúnta, gheofar toiliú feasach an mhionaoisigh sular féidir leis an ábhar sin leanúint de bheith rannpháirteach san imscrúdú cliniciúil.