In the case of incapacitated subjects who have not given, or have not refused to give, informed consent before the onset of their incapacity, a performance study may be conducted only where, in addition to the conditions set out in Article 58(5), all of the following conditions are met:
I gcás ábhar éagumasaithe nach raibh toiliú feasach tugtha acu, ná nach raibh diúltaithe acu é a thabhairt, sular tháinig an t-éagumas orthu, ní fhéadfar staidéar feidhmíochta a dhéanamh ach amháin má chomhlíontar, sa bhreis ar na coinníollacha a leagtar amach in Airteagal 58(5), na coinníollacha seo a leanas ar fad: