View source for Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 2.8.12

{{ReferenceData
|has_document=Document:ICH ICH E6 Guideline R3 (2025)
|module=3
|unit=3.1.4
|scope=G
|doc_part=III. Annex 1
2.8.12
|language=EN
|entry_by=Florian Adragna
|contributors=
|tags=TAG-00112-Ass-nve ++ TAG-00026-Min-isc ++ TAG-00032-Inf-ngs ++ TAG-00029-Inf-rte
|tags_display=[[Glossary:TAG-00112-Ass-nve|Assent]], [[Glossary:TAG-00026-Min-isc|Minor / Paediatric]], [[Glossary:TAG-00032-Inf-ngs|Consent process]], [[Glossary:TAG-00029-Inf-rte|Informed consent]]
|comment=Age-appropriate assent information for minors
|content=2.8.12 Where a minor is to be included as a participant, age-appropriate assent information should be provided and discussed with the minor as part of the consent process, and assent from the minor to enrol in the trial should be obtained as appropriate. A process for consent should be considered if, during the course of the trial, the minor reaches the age of legal consent, in accordance with applicable regulatory requirements.
}}