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Reference:USA Informed Consent - FDA Guidance for IRBs, Clinical Investigators, and Sponsors Aug-2023 V.: Difference between revisions

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|comment=FAQs on enrolling children in clinical investigations
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|content=V. FREQUENTLY ASKED QUESTIONS
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! colspan="2" class="gplx-infobox-header" | Reference Details
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== Content ==
V. FREQUENTLY ASKED QUESTIONS
[…]
[…]
1. What are some considerations for enrolling a child into a clinical investigation?
1. What are some considerations for enrolling a child into a clinical investigation?
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16. How should subjects be informed of new information that may affect their willingness to continue participation in the research?
16. How should subjects be informed of new information that may affect their willingness to continue participation in the research?
[...]
[...]
}}

Latest revision as of 13:49, 16 July 2026



Document information
Reference USA Informed Consent -

FDA Guidance for IRBs, Clinical Investigators, and Sponsors Aug-2023

Validity area USA
Scope(s) G
Document name Informed Consent -

FDA Guidance for IRBs, Clinical Investigators, and Sponsors

Version / Revision Aug-2023
Status Current
Document type Official recommendation
Language(s) EN
Description Informed Consent

Guidance for IRBs, Clinical Investigators, and Sponsors

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 V.
Language EN
Original entry by Florian Adragna
Contributors
Tags Minor / Paediatric, Assent, Legal representative, Clinical investigation

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? [...]

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