Legally designated representative

This is used when a subject cannot give informed consent, for example a minor or an incapacitated adult. National law decides who can act in this role.

individual, judicial, or other body authorized under applicable law to consent, on behalf of a prospective subject (3.50), to the subject's participation in the clinical investigation (3.8) Note 1 to entry: “legally authorized representative” or “legally acceptable representative” are other terminologies used under national regulations for “legally designated representative.”

ISO 14155:2020, clause 3.32