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 clinical investigation may be conducted only where, in addition to the conditions set out in Article 62(4), 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 imscrúdú cliniciúil a dhéanamh ach amháin má chomhlíontar, de bhreis ar na coinníollacha a leagtar amach in Airteagal 62(4), na coinníollacha seo a leanas ar fad: