Options for Exchange of Information
OPTION 3: Informed Consent Addendum
An informed consent addendum is a document which updates the previously signed consent form. This type of information exchange typically means that there is a substantive change to the risk/benefit profile. The consent addendum is reviewed, signed and dated by the subject and the researcher in the same manner as the original consent document. The subject’s signature indicates their willingness to continue participation in the study. Informed consent addendums require IRB review and approval and must have an IRB stamp with an expiration date to be valid.
OPTION 4: Full Consent
In some cases, study sponsors require that the subject be fully re-consented to meet their requirements. The IRB prefers that a consent addendum be used instead of requesting that the subject sign a fully revised consent, as this may cause potential confusion for the subject.