Short form consent

An alternative method of documenting Informed Consent (IC) in which the elements of informed consent are presented orally to the participant, the participant’s Legally Authorized Representative (LAR), parent or guardian in conjunction with a short form. An impartial witness must be present to attest to oral presentation. Also, the Institutional Review Board (IRB) must approve a written summary of what is to be said to the person providing informed consent (the Informed Consent Form (ICF) that embodies all the required elements of informed consent, also known as the long form, may serve as the summary). Only the short form itself is to be signed by the person providing consent. The person obtaining consent must sign a copy of the summary. The witness shall sign both the short form and a copy of the summary. A copy of the summary is provided to the person providing consent in addition to a copy of the short form. Common Rule, 2018 Requirements: 45 CFR 46.117, Documentation of Informed Consent; FDA: 21 CFR Part 50.27, Documentation of Informed Consent

Short form consent may be used with persons with limited English proficiency. If short form consent is used for the purpose of consenting a participant with limited English proficiency, an interpreter, who is fluent in both English and the preferred language of the person providing consent is required. The interpreter may also serve as the witness. UNC-Chapel Hill OHRE SOP 1101