This Regulation is without prejudice to national law requiring that, in addition to the informed consent given by the legally designated representative, a minor who is capable of forming an opinion and assessing the information given to him or her, shall also assent in order to participate in a clinical investigation.
Ní dochar an Rialachán seo don dlí náisiúnta lena gceanglaítear go dtabharfaidh mionaoiseach, atá in ann tuairim a thabhairt agus measúnú a dhéanamh ar an bhfaisnéis a thugtar dó nó di, aontú freisin chun páirt a ghlacadh in imscrúdú cliniciúil de bhreis ar an toiliú feasach a thabharfaidh a ionadaí nó a hionadaí arna ainmniú nó arna hainmniú de réir dlí.