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 59;
thug an t-ábhar don imscrúdú toiliú feasach i scríbhinn i gcomhréir le hAirteagal 59 nó, i gcás nach raibh an t-ábhar in ann toiliú feasach a thabhairt, thug a ionadaí nó a hionadaí arna ainmniú de réir dlí é;