the clinical investigation relates directly to the subject's medical condition because of which it is not possible within the therapeutic window to obtain prior informed consent from the subject or from his or her legally designated representative and to supply prior information, and the clinical investigation is of such a nature that it may be conducted exclusively in emergency situations;
baineann an t-imscrúdú cliniciúil go díreach le riocht sláinte an ábhair agus dá bharr sin ní féidir laistigh den fhuinneog theiripeach toiliú feasach a fháil roimh ré ón ábhar nó óna ionadaí nó óna hionadaí arna ainmniú nó arna hainmniú de réir dlí agus faisnéis roimh ré a chur ar fáil agus is imscrúdú é de chineál nach féidir a dhéanamh ach amháin i staideanna éigeandála;