the clinical investigation is essential with respect to incapacitated subjects and data of comparable validity cannot be obtained in clinical investigations on persons able to give informed consent, or by other research methods;
tá an t-imscrúdú cliniciúil sár-riachtanach maidir le hábhair éagumasaithe agus ní féidir sonraí atá inchomparáide ó thaobh bailíochta de a fháil ó imscrúduithe cliniciúla ar dhaoine atá in ann toiliú feasach a thabhairt nó ó mhodhanna eile taighde;