Reference:USA Informed Consent - FDA Guidance for IRBs, Clinical Investigators, and Sponsors Aug-2023 IV.: Difference between revisions
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| | |has_document=Document:USA Informed Consent - FDA Guidance for IRBs, Clinical Investigators, and Sponsors Aug-2023 | ||
| | |module=3 | ||
| | |unit=3.1.1 | ||
| | |scope=G | ||
| | |doc_part=IV. | ||
| | |language=EN | ||
| | |entry_by=Florian Adragna | ||
|contributors= | |||
 | |tags=TAG-00029-Inf-rte ++ TAG-00246-Inv-hte ++ TAG-00329-Saf-lne ++ TAG-00320-Foo-eri | ||
|tags_display=[[Glossary:TAG-00029-Inf-rte|Informed consent]], [[Glossary:TAG-00246-Inv-hte|Investigator responsibilities]], [[Glossary:TAG-00329-Saf-lne|Safety]], [[Glossary:TAG-00320-Foo-eri|FDA]] | |||
 | |comment=Clinical investigator responsibilities for informed consent | ||
|content=IV. RESPONSIBILITIES FOR INFORMED CONSENT | |||
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IV. RESPONSIBILITIES FOR INFORMED CONSENT | |||
[…] | […] | ||
B. The Clinical Investigator | B. The Clinical Investigator | ||
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FDA regulations require that the investigator obtain the legally effective informed consent of subjects (21 CFR 50.20, 312.60 and 812.100). If the investigator delegates this responsibility, FDA expects that the individual to whom the responsibility is delegated be qualified by education, training, and experience to perform this activity. The individual obtaining informed consent should be knowledgeable about the clinical investigation and have the appropriate training and credentials to be able to address any questions or concerns the subject may have about the study and/or alternative procedures or courses of treatment, if any, that might be advantageous to the subject. The investigator should have a detailed plan for the supervision and training of staff, and oversight of the clinical investigation, including the informed consent process.65 Even when a task is delegated to another individual, the investigator remains responsible for ensuring that legally effective informed consent is obtained for all subjects in accordance with 21 CFR part 50. | FDA regulations require that the investigator obtain the legally effective informed consent of subjects (21 CFR 50.20, 312.60 and 812.100). If the investigator delegates this responsibility, FDA expects that the individual to whom the responsibility is delegated be qualified by education, training, and experience to perform this activity. The individual obtaining informed consent should be knowledgeable about the clinical investigation and have the appropriate training and credentials to be able to address any questions or concerns the subject may have about the study and/or alternative procedures or courses of treatment, if any, that might be advantageous to the subject. The investigator should have a detailed plan for the supervision and training of staff, and oversight of the clinical investigation, including the informed consent process.65 Even when a task is delegated to another individual, the investigator remains responsible for ensuring that legally effective informed consent is obtained for all subjects in accordance with 21 CFR part 50. | ||
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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 3.1.1 |
| Scope | G |
| Document part | IV. |
| Language | EN |
| Original entry by | Florian Adragna |
| Contributors | |
| Tags | Informed consent, Investigator responsibilities, Safety, FDA |
Content
IV. RESPONSIBILITIES FOR INFORMED CONSENT […] B. The Clinical Investigator The clinical investigator is responsible for protecting the rights, safety, and welfare of subjects during a clinical investigation, and for ensuring that, unless an exception applies, legally effective informed consent is obtained from each subject or the subject’s LAR before that subject takes part in the clinical investigation (see 21 CFR 50.20(a), 312.60, and 812.100). Legally effective informed consent includes meeting all applicable Federal, State, and local laws that require additional information in the informed consent form beyond what FDA regulations require. Sponsors and investigators may wish to seek legal guidance regarding specific local consent requirements applicable to their research. [...] 1. Delegation of Consent Discussion FDA regulations require that the investigator obtain the legally effective informed consent of subjects (21 CFR 50.20, 312.60 and 812.100). If the investigator delegates this responsibility, FDA expects that the individual to whom the responsibility is delegated be qualified by education, training, and experience to perform this activity. The individual obtaining informed consent should be knowledgeable about the clinical investigation and have the appropriate training and credentials to be able to address any questions or concerns the subject may have about the study and/or alternative procedures or courses of treatment, if any, that might be advantageous to the subject. The investigator should have a detailed plan for the supervision and training of staff, and oversight of the clinical investigation, including the informed consent process.65 Even when a task is delegated to another individual, the investigator remains responsible for ensuring that legally effective informed consent is obtained for all subjects in accordance with 21 CFR part 50. [...]
