Reference:ICH ICH E11 Guideline R1 (2017) 8: Difference between revisions
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| | |has_document=Document:ICH ICH E11 Guideline R1 (2017) | ||
| | |module=3 | ||
| | |unit=3.1.4 | ||
| | |scope=G | ||
| | |doc_part=8 | ||
| | |language=EN | ||
| | |entry_by=Florian Adragna | ||
|contributors= | |||
|tags=TAG-00028-Leg-ich ++ TAG-00112-Ass-nve ++ TAG-00026-Min-isc ++ TAG-00244-Def-ini ++ TAG-00029-Inf-rte | |||
|tags_display=[[Glossary:TAG-00028-Leg-ich|Legal representative]], [[Glossary:TAG-00112-Ass-nve|Assent]], [[Glossary:TAG-00026-Min-isc|Minor / Paediatric]], [[Glossary:TAG-00244-Def-ini|Definition]], [[Glossary:TAG-00029-Inf-rte|Informed consent]] | |||
|comment=Parental consent, assent and guardian definitions | |||
|content=8. GLOSSARY | |||
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8. GLOSSARY | |||
Parental (legal guardian) consent/permission: | Parental (legal guardian) consent/permission: | ||
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Child assent: | 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. | 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. | ||
}} | |||
Latest revision as of 13:49, 16 July 2026
| Document information | |
|---|---|
| Reference | ICH ICH E11 Guideline R1 (2017) |
| Validity area | ICH |
| Scope(s) | G |
| Document name | ICH E11 Guideline |
| Version / Revision | R1 (2017) |
| Status | Current |
| Document type | International guideline |
| Language(s) | EN |
| Description | CLINICAL INVESTIGATION OF MEDICINAL PRODUCTS IN THE PEDIATRIC POPULATION |
| Official source | Official link |
| Restricted access | No |
| Submitted by | Florian Adragna |
| Contributors | |
| Reference Details | |
|---|---|
| Module | Module 3 — Unit 3.1.4 |
| Scope | G |
| Document part | 8 |
| Language | EN |
| Original entry by | Florian Adragna |
| Contributors | |
| Tags | Legal representative, Assent, Minor / Paediatric, Definition, Informed consent |
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.
