Reference:USA Informed Consent - FDA Guidance for IRBs, Clinical Investigators, and Sponsors Aug-2023 II. Advertising-001

Document Information

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

Scope	G
Document part	II. Advertising
Language	EN
Original entry by	Florian Adragna
Contributors
Tags (EN)
Tags (original language)
Tags (FR)
Comment	Repeated entry: 3.1.1 ++ 3.2.1 Advertising for subject recruitment as part of informed consent process

Text

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 online or hard copy recruitment materials should be consistent with the informed consent document. Generally, FDA recommends that any advertisement to recruit subjects be limited to the information the prospective subjects need to determine their interest and potential eligibility. The FDA information sheet “Recruiting Study Subjects” includes information regarding scripts for those who will interface with subjects to determine basic eligibility.13 [...]