the clinical investigation has the potential to produce a direct benefit for the pregnant or breastfeeding woman concerned, or her embryo, foetus or child after birth, outweighing the risks and burdens involved;
tá d'acmhainn ag an imscrúdú cliniciúil sochar díreach a ghnóthú don bhean thorrach nó don bhean atá ag cothú linbh lena mbaineann, nó dá suth, dá féatas nó don leanbh tar éis breithe, agus gur mó an tairbhe í ná na rioscaí agus na hualaí lena mbaineann;