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It is the Principal Investigator's responsibility to submit an application for continuing review in sufficient time to permit the IRB chair or full board to review and approve the application prior to its expiration date. The date by which the continuing review must be approved is available on the project’s Summary page on HawkIRB. As a service to investigators, the HawkIRB system sends the reminders to the Principal Investigator, and all contact persons listed for a given application. The reminder schedule is based on the Last Possible Submission Date (LPSD) of the project. The LPSD is the date that the investigator will need to have the project submitted to the Human Subjects Office to ensure that the project can obtain review and approval PRIOR to the project expiration date. The Principal Investigator, his or her delegates, and contact persons will receive automated reminders on the following schedule:
A reminder memo is sent via email 60, 30, 14, 7 and 1 day before the LPSD of the project.
On the day prior to the date of expiration, the Principal Investigator, his or her delegates, and contact persons will receive notice that the project will lapse and that no human subjects activity may take place after 12:01 a.m. on the expiration date. The Principal Investigator will have 10 working days from the date of this notice to obtain review and approval of the continuing review for the project or it will be administratively closed by the IRB through the Human Subjects Office.
On the day of the LPSD (if a continuing review application has not yet been received by the HSO) the investigator and his/her HawkIRB contacts will receive notice by email that there will not be sufficient time prior to the expiration of the project for review and approval. This notice will state that IRB approval will lapse as of 12:01 a.m. on the expiration date and no further research activity may occur on or after that date. The Principal Investigator will be asked to submit a continuing review application or a project closure form in HawkIRB to close the project.
No human subjects activity (which includes the enrollment and follow-up of subjects and the collection and/or use of research data) may take place on or after the expiration date unless there is an over-riding safety concern (as determined by an IRB Chair) and until the continuing review application is approved by the IRB and released by the HSO. In the event a Continuing Review lapses for studies greater than minimal risk, the Principal Investigator must immediately submit to the IRB chair a list of research participants who could be harmed by stopping study procedures. The IRB chair, with appropriate consultation with the chief of staff for any studies enrolling VA subjects, determines whether participants on the list may continue participating in the research interventions or interactions. In these situations, IRB approval of a continuing review must be obtained immediately.
If the HSO closes the study due to no response, the HSO sends the Principal Investigator a notification via email of study closure. The investigator's departmental executive officer (DEO) may also receive notification of closure. In cases of on-going externally funded projects, the Division of Sponsored Programs also receives a copy of the closure notice and make an independent determination regarding the need to notify the sponsor. Once the HSO closes a project, the only way for the project to resume is for the investigator to submit a New Project Application (via the HawkIRB system) for IRB review and approval.