An Informed Consent Form (ICF) is the document a participant signs to confirm voluntary agreement to join a research study after receiving required information.
It explains the study purpose, procedures, key risks, potential benefits, alternatives, confidentiality, and participant rights in plain language. IRBs review and approve the ICF before enrollment begins and require updates when new risk information or protocol changes affect what participants should know. The ICF supports ethical enrollment by documenting that consent was informed and not coerced. Ongoing consent may be needed during the trial when new information could influence participation decisions.