Reference:USA Informed Consent - FDA Guidance for IRBs, Clinical Investigators, and Sponsors Aug-2023 V.
From GxPlex
| 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? [...]
