Published October 20, 2021
All human research studies conducted by personnel affiliated with the University at Buffalo must be submitted to the Institutional Review Board (IRB) for review and approval.
Research cannot commence until approval is granted by the IRB. The UB IRB uses the Click module to receive and review all submissions, and to communicate with principal investigators and study staff.
Your research study or submission could follow different paths after it is submitted in Click. Is your study a clinical trial? Is it likely to be no greater than minimal risk? Is it a continuing review or a modification? Click has a helpful flow chart in each submission to show where it is in the review process, with a bubble filled in orange highlighting its status. But what is going on at the IRB when the submission is in that status? And what if you need help to submit your study in the first place?
This edition of “Research Roundtable” sheds some light on the IRB submission flow from start to finish. (Read about the submission flow from Central Study Registration to IRB here.)
The process for creating a new study depends on whether your study requires Central Study Registration (CSR).
If your new research study requires CSR and was submitted in the CSR system before starting the IRB process, a submission in Click will have been automatically created for you and some information will transfer over. If you have completed CSR for your study, do not create a new study in Click as this will result in a duplicate study entry.
Ideally, you will complete the CSR process before creating your IRB submission. CSR is the initial single point of entry for the various processes, workflows and software platforms for clinical research at UB. The data required for several systems, once entered into the CSR Form, will flow to each system that requires the information. CSR is mandatory for the following:
Please note the following exceptions where Central Study Registration does not apply:
If you create your IRB submission in Click first, an IRB coordinator will send you instructions on how to proceed.
If your study does not require CSR, you can choose “Create New Study” in the IRB tab of Click after logging in. This should also be accessible from the “My Inbox” tab. From there, you would answer the questions and upload documents in the appropriate Click Smart Form pages and sections.
Continuing reviews and modifications for already-approved studies can be created from the original study page. On the left side of your study page (STUDY00009999), under “Next Steps,” choose the option to “Create Modification/CR.”
NOTE: Make sure to save your submission while you are working on it. There is a “save” button in the top-center of each Click Smart Form page. When you get to the last page of your submission, be sure to click “Finish.” However, this does not complete your submission. For details, see the next section, “Submit to the IRB.”
There is a “Library” tab in Click, followed by a “General” tab that includes documents to aid you as you maneuver the Click system. Some initial documents when getting started in Click include the “Intro to Click” PowerPoint presentation and the “Tips From the IRB — Where to Upload Documents in Click” tip sheet.
After completion of Central Study Registration, the staff member processing your CSR will notify you when your automated Click entry is ready to review and submit. Only the PI (or a PI-assigned proxy) will have the “submit” button available in their Click workspace. Make sure you click the Submit button! If you do not, your study will be in the “Pre-Submission” phase in the Click flow chart, and the submission will not enter the IRB workflow. The IRB receives a notification of a submission only when the “Submit” button is clicked. This will be found under “Next Steps” on the left side of your study page.
This will put the submission into the Pre-Review stage.
When your study is first submitted, it goes to an intake coordinator who will:
If more information or changes are needed, the intake coordinator can put the submission into “Clarifications Requested,” which places the submission back in the hands of the investigator/study team. The researchers can then choose “Submit Response” to re-submit the study back to the IRB.
If the intake coordinator believes your study is no greater than minimal risk, it is sent to an IRB administrator for Non-Committee Review. The study will still be in “Pre-Review” in the Click flow chart, but the orange box in the top-left of your study page will say “Pre-Review Completed.”
The meeting coordinator will conduct a more thorough Pre-Review, and will look for details such as:
If more information is needed, the meeting coordinator will put the submission in “Clarifications Requested,” which places the submission back in the hands of the investigator/study team. The researchers can then choose “Submit Response” to re-submit the study back to the IRB.
When a study is ready for review, the meeting coordinator will place the submission on a board meeting agenda. The Conflict of Interest review must be complete before the study is assigned to an agenda. There are typically four board meetings per month — usually the first Monday, second Tuesday, third Wednesday, and fourth Thursday. You may contact the IRB for a meeting schedule.
The board will review your submission at the meeting, and either approve the study, require modifications to secure approval, defer the submission, or disapprove the submission.
After the board review is complete, the study will move to the “Post-Review” stage in the Click flow chart, regardless of the board’s determination.
If a study requires modifications to secure approval or is deferred, it will be sent back to the study team with a letter detailing the revisions or additional information required. If a study is in “modifications required,” it will be in the stage of the same name in the Click flow chart. But if the study is deferred, it will revert back to the “IRB Review” stage of the flow chart.
Modifications Required — After the study team chooses “Submit Response” to send the submission back to the IRB, the study can be reviewed and approved by an IRB administrator if the board’s requested revisions are made. If anything additional is changed or added to the submission, or if the requested changes are not made, it will be sent back to the board for another review at a future meeting.
Deferred — After the study team chooses “Submit Response” to send the submission back to the IRB, the study must go back to a future board meeting for another review.
When the study is approved, it will move to the “Review Complete” stage of the Click flow chart.
When the intake coordinator sends a study to an IRB administrator, it goes into their queue for review. The study will still be in the “Pre-Review” stage in Click at this time, but the orange box in the top-left of the study page will say “Pre-Review Completed.” The study may sit in an administrator’s queue in this stage while the administrator works through submissions made prior to yours. In most cases, submissions are reviewed in the order in which they came.
The IRB administrator will conduct a full review of the submission. When the administrator assigns themselves as “Designated Reviewer” the study will move from “Pre-Review” stage to the “IRB review” stage in the Click flow chart. This means the study is now being reviewed by the administrator.
If revisions are required to approve the submission, the IRB administrator will send a “Clarifications Request” back to the study team. The study may go back and forth several times depending on the type and amount of revisions that are needed. The study will remain in the hands of the research team until “Submit Response” is selected.
When the administrator has completed the review, the study will move into the “Post-Review” stage in the flow chart. When the approval letter is sent, the study moves to “Review Complete” and final approval has been granted.
If you have questions about the status of your submission in Click, contact Valerie Bailoni at 716-888-4888 or email@example.com.
You may also contact the person assigned to your submission at the time via email or phone. In most cases, the person currently assigned to the submission will be labeled as the “IRB Coordinator” in the top-right of your submission page, whether it is a new study, continuing review, or modification. You may also add a comment, but make sure to check the “IRB Coordinator” box, which will send an email notification to that IRB staff member.
For Conflict of Interest questions, contact Kyle Mann at 716-645-0311 or firstname.lastname@example.org.