Columbia Ceding Review to an External IRB

What does "ceding review" to a single IRB mean?   

Ceding review occurs when an institution defers regulatory oversight of a proposed research study to an sIRB  by establishing a reliance agreement with another academic or commercial IRB.  

What studies are eligible for ceding to an sIRB? 

  • Federally funded, non-exempt, domestic collaborative research where Columbia University is engaged in human subject research 
  • If not federally funded, sIRB use must be a documented sponsor requirement 

 

How do I request reliance on an external IRB?  

To request reliance on a non-Columbia sIRB follow these steps: 

  1. Submit a RASCAL application: Indicate request to rely on a non-Columbia IRB of record (sIRB). 
  2. Only submit the  following required documentation:  
  3. Provide the approved multicenter protocol  
  4. Informed consent documents (model/template consent and a version with tracked changes for local use)  
  5. The initial approval letter from the sIRB and the approval letter for the current version of the multicenter protocol and informed consent documents if they were modified after initial approval of the study 
  6. Recruitment materials that will be used at Columbia University  
  7. Reliance agreement or if a reliance agreement is in place (e.g. SMART IAA), reliance implementation checklist, and local context form or questionnaire from the sIRB. 
  8.  Any required protocol-specific ancillary review appendices (MR Safety, IBC, JRSC other ancillary committees as applicable) 

What happens after I submit my reliance request?  

Once all local ancillary reviews are completed and approved, and the review of local context information is complete, the HRPO will authorize reliance by sending correspondence through RASCAL. 

 At that point, the sIRB can officially add Columbia University as a relying site. 

Steps for the Columbia PI when authorization for reliance is received from the Columbia University HRPO:  

  1. Follow the steps provided by the sIRB or the lead site PI to have Columbia University added as relying site.  
  2. Upon approval of Columbia University as a relying site by the sIRB, submit via RASCAL the sIRB’s approval letter, final approved consents and recruitment materials. 
  3. Upon resubmission in RASCAL, the HRPO will issue approval in RASCAL for the study to commence at Columbia University.  

Do I need to submit modifications to CU if there is reliance on an sIRB? 

You are required to submit a modification to the Columbia IRB only if the modification requires a local context review. These modifications should be submitted locally before  submission to the sIRB. 

  • Change in PI and local personnel 
  • Change in funding 
  • Change in Location where study procedures will be performed 
  • Change in frequency/addition/removal of study procedures