For the purposes of point (b) where informed consent has been obtained from the legally designated representative, informed consent to continue the participation in the clinical investigation shall be obtained from the subject as soon as he or she is capable of giving informed consent.
Chun críocha phointe (b), i gcás ina mbeidh toiliú feasach faighte ón ionadaí arna ainmniú nó arna hainmniú de réir dlí, gheofar toiliú feasach ón ábhar chun leanúint de bheith rannpháirteach san imscrúdú cliniciúil a luaithe atá sé nó sí in ann toiliú feasach a thabhairt.