the subject or, where the subject is not able to give informed consent, his or her legally designated representative has given informed consent in accordance with Article 63;
thug an t-ábhar don imscrúdú toiliú feasach i scríbhinn i gcomhréir le hAirteagal 63 nó, i gcás nach raibh an t-ábhar sin in ann toiliú feasach a thabhairt, thug a ionadaí dlíthiúil nó a hionadaí dlíthiúil é;