A Member State concerned shall refuse to authorise a performance study if it disagrees with the conclusion of the coordinating Member State as regards any of the grounds referred to in the second subparagraph of paragraph 8, or if it finds, on duly justified grounds, that the aspects addressed in Sections 1.13, 4.2, 4.3 and 4.4 of Chapter I of Annex XIV are not complied with, or where an ethics committee has issued a negative opinion in relation to that performance study which is valid in accordance with national law for that entire Member State.
Diúltóidh Ballstát lena mbaineann staidéar feidhmíochta a údarú má easaontaíonn sé le conclúid an Bhallstáit comhordúcháin maidir le haon fhoras dá dtagraítear sa dara fomhír de mhír 8, nó má fheictear dó, ar fhorais a bhfuil bonn cuí leo, nach bhfuil na gnéithe ar a dtugtar aghaidh i Ranna 1.13., 4.2., 4.3. agus 4.4. de Chaibidil I d'Iarscríbhinn XIV á gcomhlíonadh nó, más infheidhme, i gcás ina bhfuil tuairim dhiúltach eisithe ag coiste eitice maidir leis an staidéar feidhmíochta sin atá bailí i gcomhréir leis an dlí naisiúnta don Bhallstát sin ina iomláine.