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.

IRB Review Flowchart

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

    1. Log into WRG
    2. Click on the 'Human Subjects' landing page
    3. Find the protocol you would like to find the status of under 'My Protocols'
    4. Click the 'expand' arrow to show details under the 'My Protocols' widget
    5. Find the specific submission you are looking for an update on
    6. Find the 'Review Category row

    WRG Instructions for review category for FB studies

    Review category for Expedited Study

    How to confirm Review Category in the Initial Approval Letter

    1. Log into WRG
    2. Enter the protocol number in the 'Quick Find' search box
    3. Hover over the Protocol Number
    4. Find the 'Initial' submission and go into the Submission Package
    5. Find the 'Communications' in the lower left corner of the page
    6. This is where you will find the 'approval letter' for the initial submission.

    Screenshot of Approval Letter for FB review

    Approval Letter for Exp review

    For additional information, please contact us at irb@med.cornell.edu