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The purpose of an Informed Consent Document is to provide subjects with a written source of information for future reference and to document the fact that the process of informed consent occurred prior to the subject's participation. The form generally serves as a basis for the initial presentation of the study to the potential subject. Typically, informed consent is documented by using the written Informed Consent Document approved by the IRB and signed and dated by the subject or the subject's legally authorized representative at the time of consent. The subject or the Legally Authorized Representative (LAR) must always be provided adequate opportunity to read the consent document, consider their participation, and ask questions before the consent document is signed. A copy of the Informed Consent Document should be given to the subject. Unless the investigator has requested and been granted a waiver of documentation of consent, the subject's signature on an Informed Consent Document is required prior to beginning any study procedures.
Although the research study and Informed Consent Document must be reviewed and approved by the IRB at least once per year, subjects enrolled in the study generally sign the Informed Consent Document only once, when initially enrolled. The exception to this is when the IRB or study sponsor requires subjects to sign a revised Consent Document due to a modification in the protocol or adding new information that may affect the subject's willingness to participate further in the study.