‘informed consent’ means a subject's free and voluntary expression of his or her willingness to participate in a particular clinical investigation, after having been informed of all aspects of the clinical investigation that are relevant to the subject's decision to participate or, in the case of minors and of incapacitated subjects, an authorisation or agreement from their legally designated representative to include them in the clinical investigation;
ciallaíonn “toiliú feasach” nochtadh saor agus deonach an ábhair, gur toil leis nó léi páirt a ghlacadh in imscrúdú cliniciúil ar leith, tar éis dó nó di a bheith curtha ar an eolas faoi gach gné den imscrúdú cliniciúil atá ábhartha maidir le cinneadh an ábhair a bheith rannpháirteach nó, i gcás mionaoiseach agus ábhar atá ar éagumas, údarú nó comhaontú óna n-ionadaí a ainmnítear de réir dlí, go bhféadfar iad a áireamh san imscrúdú cliniciúil;