Legally effective informed consent

Informed Consent (IC) obtained from the participant or the participant’s Legally Authorized Representative (LAR) and documented in a manner that is consistent with federal human subjects regulations and with applicable laws of the jurisdiction in which the research is conducted. In general terms, the regulations stipulate that informed consent is sought only under circumstances that provide the prospective participant or LAR sufficient opportunity to consider whether to participate and that minimize the possibility of coercion or undue influence. The information provided should be in language that is understandable to the participant or the LAR and that is not serving to exculpate (exculpatory language). It is important to note that the informed consent requirements in the regulations are not intended to preempt any applicable federal, state, or local laws that require additional information to be disclosed for consent to be legally effective. OHRP Informed Consent FAQs