The typical progression of a submission through the IRB application process begins when the Investigator submits an Initial Application in the WRG-HS system. That then sets off a number of processes that must be complete before IRB analyst review.
The flowchart below represents a simplified process for a study submission to provide an idea of what happens once an Initial Application is submitted.
Flowchart Description
Step 1: Any investigator conducting human subjects research must apply for IRB approval. The first step in this process is to submit an Intake Form to WRG-HS.
Step 2: Once the Intake Form is submitted, several steps occur:
- The protocol is checked for gross inaccuracies, incomplete items, or other major issues
- The protocol is assigned to an IRB analyst for pre-review within two business days of receipt.
Step 3: Pre-review
An IRB analyst audits the application to ensure all regulatory requirements have been met.
- IF all regulatory requirements have not been met, the PI will receive a notice of stipulation through WRG-HS, which must be addressed and submitted.
Note: A delay in responding to the analyst's request results in an overall delay in turnaround time!
- If/Once all regulatory requirements have been met, the analyst determines whether the protocol is "greater than minimal risk" or "minimal risk" and the submission is assigned to a member of the appropriate WCM IRB for formal IRB review.
Step 4: The complete application is then recieved by the IRB.
Step 5: The IRB members review the entire application and discuss any item of concern during a convened IRB meeting, or if expedited, with their Chair.
- The IRB may, at this time, defer their decision and ask the PI for more information or to address concerns raised by the IRB membership
- The IRB may, at this time, conclude that the submission can be approved and will take a vote.
Step 5: The IRB Determination Letter is released and entered into the WRG-HS system.
Did your submission go to Expedited or Full Board review?
How to confirm review category in WRG
- Log into WRG
- Click on the 'Human Subjects' landing page
- Find the protocol you would like to find the status of under 'My Protocols'
- Click the 'expand' arrow to show details under the 'My Protocols' widget
- Find the specific submission you are looking for an update on
- Find the 'Review Category row
How to confirm Review Category in the Initial Approval Letter
- Log into WRG
- Enter the protocol number in the 'Quick Find' search box
- Hover over the Protocol Number
- Find the 'Initial' submission and go into the Submission Package
- Find the 'Communications' in the lower left corner of the page
- This is where you will find the 'approval letter' for the initial submission.
