Columbia Ceding Review to an External IRB

Columbia Ceding Review to an External IRB 

This page applies when Columbia University will rely on another IRB, such as another academic IRB, central IRB, or commercial IRB, for review of human subjects research.

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, central, or commercial IRB.  

Approval from the external IRB does not by itself authorize research to begin at Columbia. Columbia researchers may begin only after Columbia HRPO completes local review and issues the applicable authorization or approval in RASCAL.

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 (ceding IRB review to) 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:  

a. Approved multicenter protocol  

b.Informed consent documents (model/template consent and a version with tracked changes for local use)  

c.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 

d.Recruitment materials that will be used at Columbia University  

e.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. 

f. 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 a 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 of the protocol in RASCAL, the HRPO will issue approval in RASCAL for the study to commence at Columbia University.  

Do I need to submit modifications in RASCAL 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
  • Any change that would require local ancillary review (e.g. COI, IBC, Radiation Safety, Stem Cell Committee, etc.)
  • Local recruitment changes
  • Adding minors, adults lacking capacity, targeting affiliates
  • Consent modifications that require locally specific language (e.g. human subject payment, subject cost/injury)
  • When Columbia University is serving as the Privacy Board, changes in HIPAA authorization forms or waivers

If the study team is unsure whether a modification requires Columbia review, they should contact the HRPO Reliance Team for guidance.

Do I need to submit Renewals to Columbia University if there is reliance on an sIRB? 

Annually, you’ll submit the current version of the protocol, consent form(s) and Renewal approval letter from the sIRB, if applicable. No substantive modifications should be done at the time of this administrative check in, other than study personnel changes.  

Do I need to submit Closures via RASCAL when Columbia research activities end?

Yes. When Columbia research activities end, submit the appropriate closure or update in RASCAL and include site closure documentation from the external IRB, if available.

Do I need to submit non-compliance and unanticipated problems to Columbia University if there is reliance on an sIRB? 

Yes. In addition to reporting any instances of major protocol violations, serious non-compliance and/or unanticipated problems to the sIRB, you must report them in RASCAL within 5 business days. Columbia University will conduct a local assessment, and when appropriate provide input to the sIRB’s review of the event.  Additionally, all suspensions or terminations of the study or Columbia University as a site must be promptly reported to the Columbia University HRPO in RASCAL.