View source for Reference:USA Informed Consent - FDA Guidance for IRBs, Clinical Investigators, and Sponsors Aug-2023 V.

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{{:Document:USA Informed Consent - FDA Guidance for IRBs, Clinical Investigators, and Sponsors Aug-2023}}

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! colspan="2" class="gplx-infobox-header" | Reference Details
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! Scope
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! Document part
| V.
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! Language
| EN
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! Original entry by
| Florian Adragna
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! Contributors
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! Tags (original language)
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! Tags (FR)
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! Comment
| FAQs on enrolling children in clinical investigations
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== Content ==
V. FREQUENTLY ASKED QUESTIONS
[…]
1. What are some considerations for enrolling a child into a clinical investigation?
[...]
2. Are there any additional protections required when enrolling children who are wards of the state?
[...]
3. What are some considerations for enrolling non-English speaking subjects?
[...]
4. What process should be followed when it is expected that subjects who do not understand English will be enrolled?
[...]
5. What process should be followed when the enrollment of subjects who do not understand English is not expected?
[...]
6. What should be considered when enrolling subjects with low literacy and numeracy?
[...]
7. What should be considered when enrolling subjects with physical or sensory disabilities?
[...]
8. What should be considered when enrolling adult subjects with impaired consent capacity?
[...]
9. Who can serve as a legally authorized representative (LAR) and what is their role?
[...]
10. How can informed consent be obtained through electronic methods?
[...]
11. Can a subject participate in more than one clinical investigation simultaneously?
[...]
12. How should data be handled when an enrolled subject decides to withdraw from a trial?
[...]
13. What steps should be taken to inform subjects when a study is suspended or terminated?
[...]
14. Should subjects be informed of aggregate study results at the completion of a trial?
[...]
15. Is informed consent required to review patient records?
[...]
16. How should subjects be informed of new information that may affect their willingness to continue participation in the research?
[...]