Member States shall assess whether the clinical investigation is designed in such a way that potential remaining risks to subjects or third persons, after risk minimization, are justified, when weighed against the clinical benefits to be expected.
Déanfaidh na Ballstáit measúnú an mbeidh an t-imscrúdú cliniciúil deartha ar bhealach go mbeidh bonn cirt, tar éis íoslaghdú riosca, leis na rioscaí ionchasacha a bheidh fágtha d'ábhair nó do thríú daoine, nuair a mheastar iad i bhfianaise na sochar cliniciúil a mbeifí ag súil leo.