Research With Carle

Important Notice: Submit Your Blanket Principal Investigator Statement of Assurance

Researchers can submit their one-time blanket assurance to onboard to the Carle + Illinois streamlined IRB process at any time. This is a brief acknowledgment of your responsibilities as PI, ensuring compliance with the University of Illinois Urbana-Champaign policies, ethical standards, and Carle IRB protocols. Submit once, and it will be retained for all applicable studies—no repeats needed. 

Please review and submit here: https://forms.illinois.edu/sec/939381863 

This helps formalize the Carle + Illinois reliance process. For questions, contact OPRS at IRB-Reliance@illinois.edu.

Working Together to Streamline the IRB Review Process: Carle Health + University of Illinois Urbana-Champaign

Starting January 2026, Carle Health and Illinois OPRS are piloting a new single-path process for most joint human subjects research (both non-exempt and exempt).

Investigators will no longer submit separate applications to both IRBs. One process. One point of entry. 

New Simplified Process - One Pathway for Illinois + Carle Studies

Illinois investigators do NOT submit anything directly to OPRS for joint Carle studies under this pilot unless Illinois is designated as the reviewing IRB.

How to Start - Your First Action 

1. Complete the Carle Research Services Request Form 
   
   This is the single-entry point for all research involving Carle Health resources or patients. 

   Submit the Carle Research Services Request Form
   
   Important: This is NOT an IRB submission. Once a project is submitted to the Carle Research Services process, it will undergo reviews before the project can be formally submitted to an IRB.
    

2. Early Determination of Reviewing IRB
    

   While your project is in the Carle Research Services process, a Carle contact will notify the Carle IRB with basic study details. This helps decide if Carle IRB or Illinois IRB will lead the review. You'll receive clear instructions on which IRB to submit to and the process to follow.
    

3. Submit Your Application 
    

   • If Carle IRB is designated: Submit directly to Carle IRB. They will forward materials to Illinois OPRS, who will create a facilitated review record in IRBOnline.

   • If Illinois IRB is designated: Submit through Illinois' standard process (no Carle-specific steps apply).
      

4. Document the Reliance Agreement 
    

   Once the reviewing IRB is set, a formal reliance agreement will be documented between the Carle and Illinois IRBs.
    

5. Approval and Acknowledgement
    

   • Upon approval by the Carle IRB, the Carle IRB will notify the Illinois IRB (sharing all materials, including approvals, consents, waivers, etc.).

   • Illinois OPRS acknowledges the approval in IRBOnline and sends a confirmation email to the Illinois PI via IRBOnline.

   • Important: This acknowledgment does not activate the study at Carle. Coordinate with your Carle Research Services contact for final activation. Research at Carle cannot begin without explicit confirmation.

Amendments, Adding Personnel, and Progress Reports

• Amendments: Submit directly to the reviewing IRB (Carle or Illinois). The IRBs will collaborate to keep records synchronized.
   
• Adding Illinois-Affiliated Researchers: If Carle is reviewing, submit a modification to Carle IRB with updated training and Appendix K. (Note: Carle Illinois College of Medicine (CICOM) students are always Illinois-affiliated and must be included in the facilitated review.).
   
• Progress Reports: Illinois requires annual reports to keep studies active. The reviewing IRB will notify the other if a study closes. 
   

What Still Applies at Illinois (Automated in IRBOnline) 

Even with facilitated review, ancillary reviews route automatically: 

• Conflict of Interest (COI) 
  
  
• Institutional Biosafety (IBC)/Division of Research Safety (DRS) 
  
  
• Other unit-specific reviews as applicable (e.g., radiation safety)

Respond to these as usual.

Exceptions - When the Streamlined Process May Not Apply

Use the standard reliance process for: 

• Industry-sponsored clinical trials where Illinois is the lead site. 
   
• Federally funded multi-site studies where Illinois is the sIRB. 
   
• Projects where Carle agrees to cede review to Illinois. 
   

For these, submit a Reliance Consultation Request first: https://oprs.research.illinois.edu/research-topics/reliance-consultation-request

Contact Information

• Carle Research Services: researchservices@carle.com; Dr. Linda Owens, PhD, for CICOM/med student project development: linda.owens@carle.com.
  
  
• Carle IRB: IRB@carle.com 
   
• Illinois OPRS: IRB@illinois.edu 

Pilot Disclaimer

This streamlined process is a pilot launching in January 2026. Adjustments may be made as we gain experience. All changes will be reflected on this page. Please check back or contact OPRS with questions.