É«»¨ÌÃ

The É«»¨Ìà IRB has agreed to rely on the Jaeb IRB for certain trials involving eye disorders or Type 1 diabetes. The É«»¨Ìà investigator submits directly to the Jaeb IRB for these studies while concurrently working with the É«»¨Ìà IRB to submit an external/abbreviated protocol in ICON. Work may not commence at the É«»¨Ìà site until the É«»¨Ìà IRB has provided the PI with a formal letter in ICON acknowledging the Jaeb IRB approval.  

Here is the process required of É«»¨Ìà investigators relying on the Jaeb IRB:

1. Contact the É«»¨Ìà IRB Office to request reliance on Jaeb IRB.  
   
   
2. Start working on the ICON external study submission; however, you must wait to submit it until you receive the approval letter and approved consent(s), assent(s), recruitment materials and protocol from Jaeb. The É«»¨Ìà investigator is always required to prepare and submit an external IRB submission in ICON prior to beginning research. Follow these instructions for completing this submission.
   
   

See for the Jaeb Center log in directory. Each new Jaeb Investigator must submit the following documents to the Jaeb IRB:

• Main Application
  
  
• C2 - Application to Review Site Investigator
  
  
• Application Attachments
  
  
• Good Clinical Practice Training (JCHR will accept an Institution’s GCP training that meets the NIH’s requirements, or Institutions may use the free training shared by and 
  
  
• Financial Conflict of Interest Form. Note: The É«»¨Ìà PI is still required to submit the necessary COI certifications to the Division of Research.
  
  
• Handbook Attestation Form
  
  

See for the Jaeb Investigator handbook.
See here for the Jaeb Human Research Protection Program Policy Manual.

   3. Jaeb IRB will conduct its review and issue an approval letter once all items have been 
       addressed by the reviewing site's PI.

   4. Jaeb IRB will provide the approval letter, protocol, consent forms and assent forms to the É«»¨ÌÃ
       investigator.

   5. The É«»¨Ìàinvestigator then attaches the Jaeb approval letter and complete protocol (including

       recruitment materials, consent documents, etc.) to the external IRB application in ICON.

   6. The É«»¨Ìà investigator submits the external IRB protocol to the É«»¨Ìà IRB in ICON.

   7. If the submission is complete, the É«»¨Ìà IRB office will provide an acknowledgment letter through

       ICON system. Once received, É«»¨Ìà engagement in the research may begin.

   8. The É«»¨Ìà investigator must promptly notify the É«»¨Ìà IRB (using the “Update” activity in ICON) of
       the following:

a. Notification that Jaeb has renewed its approval at continuing review
b. Any findings by Jaeb of serious or continuing non-compliance
c. Changes of the financial status of study team members that may require review for
   conflict of interest
d. Closure of the study