The initial and continuing review approval letters for Expedited and Full Board protocols indicate when the approval expires. Projects approved in these categories can only be approved for a maximum of one year. Riskier research is often approved for a shorter period.

As indicated in our approval letter, the Principal Investigator is responsibile for to seeking re-approval of the research before it expires. If the project expires, you may not do any of the following:

1. enroll or screen any new subjects,
2. perform any study interventions, unless the IRB finds that it is in the best interest of individual subjects to continue participating in research interventions or interactions,
3. collect, use, or report any data, and/or
4. receive any study funding.

Once you receive your approval letter you should place a reminder in your calendar well in advance of the expiration date in order to insure not only that you have time to complete our Continuing Review paperwork but also allow adequate time for the IRB to review the paperwork. The IRB strongly recommends the following:

1. Expedited Projects: submit your Continuing Review report no later than 3 weeks prior to the expiration date.
2. Full Board Projects: submit your Continuing Review report so that it is reviewed two meetings prior to the expiration date in order to decrease the possibility of your project expiring (this gives you an extra meeting in the event that the submission is tabled). Visit our Deadlines page in order to see our meeting dates and the corresponding deadlines.

Be sure to follow all of the instructions and to fulfill all of the requirements in the Continuing Review/Study Closure form. All appropriate questions should be answered in full, the form must be signed by the Principal Investigator, and all additional, appropriate paperwork must be attached. Failure to comply with all submission requirements could prevent the review of your submission, possibly even resulting in your submission being returned to you. Be sure to familiarize yourself with all of the instructions/requirements listed on our Forms and Submitting Paperwork to the IRB web pages.

While it is the Principal Investigator's responsibility to submit the Continuing Review report in a timely manner, the IRB does take a number of steps to assist researchers in this task:

• Expiration notices are sent via campus mail at roughly 90 and 45 days prior to the expiration date, on the expiration date, and then 30 days after the expiration date (to notify you that the study is non-renewable at that time). We do not recommend relying on these notices as your sole form of remembering to prepare/submit your Continuing Review. Often we are not appraised of mailing address changes, notices can be lost or delayed in campus mail, investigators can fail to forward notices to staff charged with preparing the continuing review report, etc. It is important to note that these notices are sent as a courtesty to investigators and that a failure to receive any of these notices will not afford any special considerations by the IRB for processing/reviewing/approving Continuing Review paperwork.
• The Web-Based Tracking System allows staff associated with the project to view realtime information on their projects, including a priority sorted list with studies slated to expire the soonest on top and latest on bottom. Visit the Tracking System page for more information.
• The IRB Web Functions also allows the Principal Investigator the ability to view a priority sorted list with studies slated to expire the soonest on top and latest on the bottom. In order to access the Shands hosted Web Functions the Principal Investigator must submit a password request to the IRB. Visit the Web Functions page for more information.

Some researchers have developed spreadsheets or database programs to track expirations and approvals. As mentioned earlier, a simply way to remind yourself is to place a reminder in your e-mail program calendar that prompts action on an early enough date to complete the paperwork and have it reviewed before the study expires. Remember: it is the Principal Investigator's responsibility to obtain re-approval for the research.

Once a project expires you have 30 days to submit a Continuing Review/Study Closure report. Failure to submit a Continuing Review Report within 30 days will automatically cause the protocol to be become non-renewable. (Note: the Continuing Review does not have to be approved within 30 days, simply received in the office). If the project moves to expired/non-renewable you will have to re-submit your study as a new project (on whatever forms are currently required) in order to conduct any additional research on it.

Repeated failure to obtain timely Continuing Review could result in a limitation, suspension, or revocation of research privileges.