Institutional Review Board (IRB)

Frequently Asked Questions about Continuation Application Submissions

1. How do I submit a continuation application?
   

   Carefully follow the instructions on the IRB's Continuation Checklist.

   Continuation applications need to be signed off by Department Chairs (and if you're making revisions that require a change in your pharmacy sheets, the Pharmacy), as well as signatures from the PI and all the co-investigators. When planning your continuation application submission, keep in mind the various turnaround times relating to each of these parties. The completed submission needs to be logged in directly with the Grants and Contracts Office (not the IRB) by 5:00 P.M. on the deadline day (avoid the last minute rush if possible). The deadline schedule is available at www.mssm.edu/pphs/app_info/ item D.

2. When should I submit a continuation application?

   You should aim to submit your continuation application eight to nine weeks prior to the expiration date of IRB approval (for projects that require full board review) or six weeks prior to expiration (for projects requiring expedited review). [If you don't know which kind of review your project requires, please contact the IRB to answer that question for you.] Submitting within this time window is intended to provide a cushion of time to resolve any outstanding issues before your current IRB approval expires, permit a second review at an IRB meeting should the project be "deferred" at its first meeting, and keep your project on its annual review cycle. If you anticipate any unusual issues with the timing of your continuation, please contact the PPHS.

   If you have made an error and submitted your project too late to be reviewed before its expiration, or if there is a possibility that your project might expire before receiving re-approval, you should contact the IRB immediately to discuss whether you have any active subjects whose care must be managed during the expired period.

3. What if my project is sponsored by a foundation or agency that requires me to submit my progress report/continuation application earlier than 8-9 weeks?

   You may submit your application earlier, but the IRB will not be able to "officially review" the submission until it is within 30 days of the expiration of IRB approval. The source for this practice is a guidance from the Office of Human Research Protections. If you have a particular concern about the timing of your review contact the IRB. Also, if you plan to make a major modification of your project close to the time of your IRB expiration, we also advise contacting the IRB, as you may be advised to submit a separate modification prior to the submission of a continuation application, to allow greater time for the modification to make its way through the review process.

4. If I have to submit a progress report to an external agency (e.g. NIH), do I need to complete the IRB's progress report also?

   The IRB must ask specific questions of PI's in order to be in compliance with federal regulations. Although there may be some overlap in the questions we ask, there are also special questions that are usually specific to human subject protection review. If you have already addressed any of the IRB progress report questions in another progress report, you may make a specific reference (i.e. page and paragraph number, as opposed to "see progress report") in your IRB progress report to identify where the question has already been answered. Make certain all the questions that are asked on the IRB's progress report (listed on the Continuation application Checklist) are completely answered.

5. If I haven't received a reminder to submit my continuation application from the GCO or IRB, is it still my responsibility to submit on time?

   Yes. The PPHS sends out reminder notices generated by the GCO to each department to distribute to their PI's, but for various reasons these notices sometimes may not reach investigators. Some researchers find it helpful, when they receive their initial IRB approval, to immediately place the date to start preparing a continuation application on their calendar. If you anticipate it taking a week to prepare the application, mark your calendar to remind you 10 weeks (full board projects) or 7 weeks (expedited projects) prior to approval end date to start preparing your application.