Informed Consent Form (ICF)

A written form approved by the Institutional Review Board (IRB) and signed (including in an electronic format) by the participant, the participant’s Legally Authorized Representative (LAR), parent or guardian that is used to explain the details of the research study and document Informed Consent (IC). The informed consent form may be either of the following:

• A written consent document that embodies the required elements of informed consent. Also referred to as the long form.
• A short form written consent document stating that the required elements of informed consent have been presented orally to the subject or the subject’s legally authorized representative.

Common Rule, 2018 Requirements: 45 CFR 46.117, Documentation of Informed Consent; FDA: 21 CFR 50.27, Documentation of Informed Consent