an ethics committee in that Member State has issued a negative opinion in relation to the substantial modification to the performance study, which, in accordance with national law, is valid for that entire Member State.
má tá tuairim dhiúltach eisithe ag an gcoiste eitice sa Bhallstát sin maidir leis an modhnú substaintiúil ar an staidéar feidhmíochta, atá bailí don Bhallstát ina iomláine i gcomhréir leis an dlí náisiúnta.