Il incombe aux États membres de fixer des règles assurant la garantie de la protection des personnes, tels que les mineurs et les incapables majeurs, qui ne sont pas en mesure de donner leur consentement; il convient que ce consentement soit donné par une personne ou un organisme prévu par la loi.
It is incumbent on Member States to lay down rules to safeguard the protection of individuals who are incapable of giving their consent, such as minors and incapacitated adults. Since such persons are incapable of giving their free consent to taking part in a clinical trial, consent to their participation must be given by a person or body provided for by law.