Reliance on Non-Commercial IRB
Inclusion/Exclusion Criteria for Reliance on an External IRB:
The UC IRB may rely on external IRBs for review, after an Institutional Authorization Agreement is obtained. Only IRBs at institutions registered with the Office of Human Research Protections (OHRP) will be accepted for reliance.
If UC has a memorandum of understanding (MOU) in place with the participating institution, then an authorization agreement is not needed. Please see the list of institutions with current MOUs:
Consortium of Greater Cincinnati IRBs (CGCI):
- Christ Hospital
- St. Elizabeth Healthcare
- Jewish Hospital - Mercy Health
- Northern Kentucky University
Ohio CTSA (Clinical and Translational Science Awards) reliant IRBs:
- Ohio State University (studies reviewed by the biomedical IRBs only)
- Nationwide Children's Hospital
- University Hospitals Case Medical Center
- Cleveland Clinic
- Case Western Reserve University
- Cincinnati Children's Hospital Medical Center
UC may also rely on the National Cancer Institute (NCI) Central IRB, the NeuroNEXT IRB, and the PETAL Central IRB for review. There is no need for an MOU or authorization agreement when relying on these IRBs.
Note: All investigators will need to gain access to ePAS in order to submit through the electronic system. Click here for instructions on gaining access.
Required Forms to be Uploaded into ePAS 1. Personnel documents and training requirements:
For everyone listed as research staff members, the following documents/requirements are also needed:
- CITI Training (must be current)
- UC COI form (and explanation of any "yes" answers
- UC FDA training (only FDA regulated studies; must be current for PIs, Co-PIs, and study and coordinators
2. Other documents:
- CV for PI and Co-PI
- Consent document
- Advertisements, questionnaires, data collection tools, etc. - if applicable
- HIPAA waiver request or HIPAA authorization form - if applicable
- Indemnification or waiver - if applicable
- Institutional Authorization Agreement
Non-Commercial IRB Review Process
1. The UC HRPP office will check the ePAS submission for completeness.
- If the submission is not complete, comments will be sent back to the PI
- If the submission is complete, it will be forwarded to an IRB member for review
2. The site is responsible for ensuring the external IRB receives and reviews pertinent documents for initial approval, amendments, continuing reviews, and reportable events.
3. Adding Research Members:
- Follow the external IRB's procedures for adding personnel
- Notify UC's IRB by submitting an amendment through ePAS and provide COI documentation.
4. The external IRB will review all amendments, continuing reviews, and reportable events. Changes to key personnel, updates to conflict of interest forms, and continuing review submissions must be submitted the UC IRB via ePAS.
For more information contact:
Kareemah Mills, CIP