IRB Review Process

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.

For an overview of the IRB review process at WCM, please review the recording of our recent presentation, IRB101: Introduction to the WCM IRB, available on our Human Research Compliance Monthly Education and Training Series (METS) page.

Step 1: Any investigator conducting human subjects research must apply for IRB approval.  The first step in this process is to complete an Intake Form in WRG-HS. 

Step 2: Once the intake form is completed, an application to the PRMC (or equivalent) must be submitted.

Step 3: Once PRMC (or equivalent) approval has been obtained, complete an initial submission in WRG-HS.  Once your initial submission is submitted, several steps occur:

• PRMC (or equivalent) approval will be verified in SASP.
• 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 4: 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 5: The complete application is assigned to an IRB agenda for review.  

Step 6: The IRB member(s) review the entire application and discuss any item of concern during a convened IRB meeting., or if expedited, issues a request for modification(s) letter. 

• 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 7: The IRB Determination Letter is released and entered into the WRG-HS system.