If your study requires continuing review, you must submit your continuing review no later than 45 days prior to the last day of approval to allow sufficient time for IRB review. When completing the continuing review form, if your study enrolls subjects, you will be required to specify enrollment totals. Enrollment is defined as eligible, appropriately informed individuals agreeing to participate in a study who have provided informed consent and initiated study procedures. Alternatively, your protocol can define enrollment as is appropriate for the study. In both cases, enrollment totals should be reported consistently from year to year. For data and/or specimen only protocols, this number should reflect the total number of data and/or specimens accessed for research purposes. This number should not exceed the total number of subjects requested in the approved protocol. If you wish to request additional subjects, you should submit a change for review.

If the approval of human research expires because you have failed to submit the continuing review application or you submitted the continuing review application without enough time for IRB review prior to expiration, all human research procedures related to the protocol or study under review must cease, including recruitment, advertisement, screening, enrollment, consent, interventions, interactions, and collection or analysis of private identifiable information.

If current subjects will be harmed by stopping human research procedures that are available outside the human research context, provide these on a clinical basis as needed to protect current subjects. If current subjects will be harmed by stopping human research procedures that are not available outside the human research context, immediately contact the IRB office and provide a written list of the currently enrolled subjects and why they will be harmed by stopping human research procedures. If current subjects will be harmed by stopping human research procedures that are not available outside the human research context, these should continue as necessary for subject safety. Any ongoing procedures that were not able to safely stop should be summarized in the continuing review application.

If the IRB reviewed your continuing review application, but requires modifications to secure approval, you should submit those modifications in a timely fashion so they can be reviewed before study approval lapses.

For more information, see How to Submit a Continuing Review, FDA Regulations and IRB Review, and HRP 314-WORKSHEET-Critera for Approval.