Reference:USA Informed Consent - FDA Guidance for IRBs, Clinical Investigators, and Sponsors Aug-2023 II. Introduction: 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=II. Introduction | |||
|language=EN | |||
|entry_by=Florian Adragna | |||
|contributors= | |||
|tags=TAG-00032-Inf-ngs ++ TAG-00029-Inf-rte ++ TAG-00149-Sig-nds ++ TAG-00030-Inf-onu | |||
|tags_display=[[Glossary:TAG-00032-Inf-ngs|Consent process]], [[Glossary:TAG-00029-Inf-rte|Informed consent]], [[Glossary:TAG-00149-Sig-nds|Signature]], [[Glossary:TAG-00030-Inf-onu|Consent form]] | |||
|comment=Common misunderstanding of informed consent as a document | |||
|content=II. SUMMARY OF THE CONSENT PROCESS | |||
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II. SUMMARY OF THE CONSENT PROCESS | |||
To many, the term informed consent is mistakenly viewed as synonymous with obtaining a subject’s signature on the consent form;9 however, obtaining documentation of a subject’s informed consent is only part of the consent process. Informed consent involves providing a prospective subject, or their legally authorized representative (LAR), with adequate information to allow for an informed decision about participation in the clinical investigation prior to enrollment. Informed consent also involves facilitating the prospective subject’s understanding of the information, providing adequate opportunity for the prospective subject to ask questions and to consider whether to participate, obtaining the prospective subject’s voluntary agreement to participate prior to enrollment, and continuing to provide information as the clinical investigation progresses or as the enrolled subject or situation requires.10 | To many, the term informed consent is mistakenly viewed as synonymous with obtaining a subject’s signature on the consent form;9 however, obtaining documentation of a subject’s informed consent is only part of the consent process. Informed consent involves providing a prospective subject, or their legally authorized representative (LAR), with adequate information to allow for an informed decision about participation in the clinical investigation prior to enrollment. Informed consent also involves facilitating the prospective subject’s understanding of the information, providing adequate opportunity for the prospective subject to ask questions and to consider whether to participate, obtaining the prospective subject’s voluntary agreement to participate prior to enrollment, and continuing to provide information as the clinical investigation progresses or as the enrolled subject or situation requires.10 | ||
[...] | [...] | ||
}} | |||
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 | II. Introduction |
| Language | EN |
| Original entry by | Florian Adragna |
| Contributors | |
| Tags | Consent process, Informed consent, Signature, Consent form |
Content
II. SUMMARY OF THE CONSENT PROCESS To many, the term informed consent is mistakenly viewed as synonymous with obtaining a subject’s signature on the consent form;9 however, obtaining documentation of a subject’s informed consent is only part of the consent process. Informed consent involves providing a prospective subject, or their legally authorized representative (LAR), with adequate information to allow for an informed decision about participation in the clinical investigation prior to enrollment. Informed consent also involves facilitating the prospective subject’s understanding of the information, providing adequate opportunity for the prospective subject to ask questions and to consider whether to participate, obtaining the prospective subject’s voluntary agreement to participate prior to enrollment, and continuing to provide information as the clinical investigation progresses or as the enrolled subject or situation requires.10 [...]
