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

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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
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Reference Details

Scope	G
Document part	III.
Language	EN
Original entry by	Florian Adragna
Contributors
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Tags (FR)
Comment	FDA documentation requirements for informed consent

Text

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 elements of informed consent required by 21 CFR 50.25 are presented orally to the subject or the subject’s LAR (21 CFR 50.27(b)(2)). For example, IRBs may consider approving the use of a short form in situations where the subject or the subject’s LAR is unable to read due to low literacy or visual impairment.52

When the short form is used, the IRB is required to approve a written summary of the information to be presented orally (21 CFR 50.27(b)(2)). The information presented orally should be as thorough as the information contained in the long form. 53 A copy of the short form and the written summary must be given to the person signing the form (that is, the subject or the subject’s LAR) (21 CFR 50.27(b)(2)).

Use of the short form requires that there be a witness to the oral presentation of information to the subject or the subject’s LAR (21 CFR 50.27(b)(2)). FDA recommends that an impartial third party not otherwise connected with the clinical investigation (for example, clinical staff not involved in the research, a patient advocate or an independent interpreter) serve as the witness. The witness must be present physically or by some other means, for example, by phone or video conference, during the oral presentation, not just the signing of the consent form (21 CFR 50.27(b)(2)). The purpose of the witness is generally to attest to the voluntariness of the subject’s consent and the adequacy of the consent process by ensuring that the information was accurately conveyed and that the subject’s questions were answered.

The subject or the subject’s LAR signs and dates only the short form (21 CFR 50.27(a) and (b)(2)). The witness must sign both the short form and the summary, and the person obtaining consent must sign the summary (21 CFR 50.27(b)(2)). Due to the additional requirements of having a witness and providing a written summary of the consent discussion, use of the short form may not ease or expedite the consent process. [...]