the performance study is intended to investigate treatments for a medical condition that only occurs in minors or the performance study is essential with respect to minors to validate data obtained in performance studies on persons able to give informed consent or by other research methods;
tá sé beartaithe go ndéanfaidh an staidéar feidhmíochta imscrúdú ar chóireálacha do riocht sláinte a bhíonn ar mhionaoisigh amháin nó tá an staidéar feidhmíochta sár-riachtanach chun bailíochtú a dhéanamh ar shonraí a fuarthas ó staidéir feidhmíochta ar dhaoine a bhí in ann toiliú feasach a thabhairt nó ó mhodhanna eile taighde;