View source for Reference:ICH ICH E11 Guideline R1 (2017) 8

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| Florian Adragna
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| Parental consent, assent and guardian definitions
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== Content ==
8. GLOSSARY

Parental (legal guardian) consent/permission:
Expression of understanding and agreement by fully informed parent(s) or legal guardian to permit the investigator/sponsor of a clinical study to enroll a child in a clinical investigation. The choice of the terms parental consent or parental permission in different regions may reflect local legal/regulatory and ethical considerations.

Child assent:
The affirmative agreement of a child to participate in research or to undergo a medical intervention. Lack or absence of expression of agreement or disagreement must not be interpreted as assent.