The UH IRB has agreed to rely on the Jaeb IRB for certain trials involving eye disorders or Type 1 diabetes. The UH investigator submits directly to the Jaeb IRB for these studies while concurrently working with the UH IRB to submit an external/abbreviated protocol in ICON. Work may not commence at the UH site until the UH IRB has provided the PI with a formal letter in ICON acknowledging the Jaeb IRB approval.
Here is the process required of UH investigators relying on the Jaeb IRB:
- Contact the UH IRB Office to request reliance on Jaeb IRB.
- 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 UH 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 here 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 NIAID and NIDA
- Financial Conflict of Interest Form. Note: The UH PI is still required to submit the necessary COI certifications to the Division of Research.
- Handbook Attestation Form
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 UH
5. The UH investigator then attaches the Jaeb approval letter and complete protocol (including
recruitment materials, consent documents, etc.) to the external IRB application in ICON.
6. The UH investigator submits the external IRB protocol to the UH IRB in ICON.
7. If the submission is complete, the UH IRB office will provide an acknowledgment letter through
ICON system. Once received, UH engagement in the research may begin.
8. The UH investigator must promptly notify the UH IRB (using the “Update” activity in ICON) of
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