When Should You Submit Your Continuing Review Report?
You must have IRB approval to conduct your research. Federal regulations limit IRB approval to a maximum of one year for Expedited and Full Board projects. Therefore investigators must obtain reapproval for research before the prior approval runs out (expires). If your project expires your research activities must stop (see below for more information). If you wish to insure continuous approval do not wait until the last minute to seek reapproval. You should factor in time not just for the IRB to review the project, but also to allow you adequate time to address any issues the IRB might raise in their review. Federal guidance explains that Continuing Review should be a reassessment of the study, so it is quite possible for the IRB to identify new issues with your research – even if nothing has changed or no one has been enrolled. With this in mind, the IRB has the following suggestions for when to submit your Continuing Review paperwork.
- Expedited Projects: IRB-01 strongly recommends submitting your Continuing Review report no later than 3 weeks prior to the expiration date. 4 weeks is ideal.
- Full Board Projects: IRB-01 strongly recommends submitting your Continuing Review report before the deadline for two meetings prior to the expiration date. This affords you time to still obtain timely approval if your project requires Explicit Changes, is tabled, or has other issues. Please visit http://irb.ufl.edu/irb01/deadlines.htm
Please be sure to follow all of the instructions and to fulfill all of the requirements on the Continuing Review/Study Closure form. All appropriate questions should be answered in full, the form must be signed by the PI, 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. Please visit the IRB-01 website at http://irb.ufl.edu/irb01/formsubmit in order to read all submission requirements.
If Your Project Expires
- Collect, use, or report of any data;
- Perform any study interventions, unless the IRB finds that it is in the best interests of individual subjects to continue participating in research interventions or interactions;
- Enroll or screen any new subjects; and/or
- Receive any study funding.
- If a study expires and enrolled subjects are undergoing study interventions, the PI must contact the IRB (and for VA Research, the VA Chief of Staff) who will determine if it is in the best interest of the subject to continue participation There is no grace period extending approval for the conduct of research beyond the expiration date. Once a project expires, IRB review and re-approval must occur before re-initiation of research occurs. According to federal regulations you may not conduct research without an effective IRB approval. Subsequent IRB approval does not authorize you to retroactively collect or use any data that occurred during a period without IRB approval.
Once your project expires, you have 30 days from the expiration date to submit the Continuing Review/Study Closure report. Failure to provide this information within 30 days will automatically move your project to Expired-Nonrenewable status. You will need to re-submit your study as a new project if you wish to continue the research or to receive additional funding.