What does the IRB stamp mean on a consent document?
The approval stamp date corresponds with the date that the IRB gave the study approval (e.g., the IRB meeting date). The approval termination is the date that IRB approval of the study expires (typically one year from the approval date, but could be less). If a consent document was modified during the approval period, the stamp would also have the date that the change was approved (it corresponds with the date that the IRB signed a change-in-protocol form.) Subjects who enroll on a study must sign a valid consent document (i.e., the study approval has not expired). This consent is valid for the duration of the subject’s participation unless changes to a study require a subject to be re-consented with the modified document.
