Federal regulations require the IRB to conduct substantive and significant continuing review of human subjects' research. The IRB has the authority to examine, or request a third party review the consent process and the activity of any approved application.
Projects must be renewed annually, unless otherwise stated on the approval form. The IRB can approve studies for no more than 365 days in duration.
The IRB will conduct continuing review of all research depending on the degree of risk associated with a given project. The IRB may require continuing review more often than once per year.
New applications are required every five years for ongoing projects.
Unless the information received during the prior approval period, or at the time of renewal, suggests that a project's review category (administrative, expedited, full committee) must be changed, the renewal materials will be reviewed in the same manner as the initial application. Allow two weeks for the paperwork to be processed.
Projects are closed by the IRB if the continuing/termination form is not received by the expiration date. Once the researcher receives a notice of closure, all activities involving human subjects must stop immediately.
Reactivations will not be considered once the expiration of the approval is past. No human subjects' research can be conducted after the expiration of the study and a new application must be filed with the IRB.