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

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|DocReference=USA  Informed Consent - 
FDA Guidance for IRBs, Clinical Investigators, and Sponsors  Aug-2023
|DocValidityArea=USA
|DocScopes=G
|DocName=Informed Consent - 
FDA Guidance for IRBs, Clinical Investigators, and Sponsors
|DocVersion=Aug-2023
|DocStatus=Current
|DocType=Official recommendation
|DocLanguage=EN
|DocDescription=Informed Consent
Guidance for IRBs, Clinical Investigators, and Sponsors
|DocRestricted=No
|DocSubmittedBy=Florian Adragna
|DocContributors=
}}</noinclude>

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|reference=USA  Informed Consent - 
FDA Guidance for IRBs, Clinical Investigators, and Sponsors  Aug-2023
|validity_area=USA
|scopes=G
|doc_name=Informed Consent - 
FDA Guidance for IRBs, Clinical Investigators, and Sponsors
|version=Aug-2023
|status=Current
|doc_type=Official recommendation
|language=EN
|description=Informed Consent
Guidance for IRBs, Clinical Investigators, and Sponsors
|official_link=https://www.fda.gov/media/88915/download
|restricted=No
|submitted_by=Florian Adragna
|contributors=
}}

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== References ==
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! Reference !! Scope !! Document part !! Language !! Preview
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| [[Reference:USA Informed Consent - FDA Guidance for IRBs, Clinical Investigators, and Sponsors Aug-2023 II. Introduction]] || G || II. Introduction || EN || 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 ...
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| [[Reference:USA Informed Consent - FDA Guidance for IRBs, Clinical Investigators, and Sponsors Aug-2023 II. Advertising-001]] || G || II. Advertising || EN || II. SUMMARY OF THE CONSENT PROCESS […] FDA considers advertising used to recruit subjects into the clinical trial to be the start of the ongoing consent process, and the information provided in any ...
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| [[Reference:USA Informed Consent - FDA Guidance for IRBs, Clinical Investigators, and Sponsors Aug-2023 III.]] || G || III. || EN || III. FDA INFORMED CONSENT REQUIREMENTS AND DISCUSSION […] E. Documentation of Informed Consent [...] b. Short Form An IRB may approve a short form to be used in appropriate situations where the ...
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| [[Reference:USA Informed Consent - FDA Guidance for IRBs, Clinical Investigators, and Sponsors Aug-2023 IV.]] || G || IV. || EN || 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 ...
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| [[Reference:USA Informed Consent - FDA Guidance for IRBs, Clinical Investigators, and Sponsors Aug-2023 V.]] || G || V. || EN || 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 ...
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| [[Reference:USA Informed Consent - FDA Guidance for IRBs, Clinical Investigators, and Sponsors Aug-2023 II. Advertising-002]] || G || II. Advertising || EN || II. SUMMARY OF THE CONSENT PROCESS […] FDA considers advertising used to recruit subjects into the clinical trial to be the start of the ongoing consent process, and the information provided in any ...
|}
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