Columbia IRB Serving as the sIRB

This information on this page applies when Columbia University will serve as the single IRB, or sIRB, for a multi-site or cooperative study. In this role, Columbia IRB is the IRB of record for the study and reviews the research for Columbia and participating relying sites.

When should I request that Columbia University serve as a sIRB for a multicenter research study where Columbia is either a primary site or otherwise engaged in human subject research?  

Request Columbia as your sIRB early. Submit a Qualtrics request during grant proposal stage so the HRPO team can confirm Columbia can act as the sIRB and help establish budgeting fees.  

What do I do at JIT or when I receive an award to establish Columbia as sIRB?  

1. At JIT, contact the HRPO at [email protected] to advise them of the JIT status; include the Qualtrics survey number in the email. The HRPO will meet with the Columbia PI and research team to review the roles and responsibilities of the sIRB and of the Lead research team, the reliance agreement process, and the steps needed to onboard relying sites. 
2. Submit a protocol event via RASCAL indicating that Columbia's IRB will serve as the single IRB for the multicenter protocol. Upon IRB approval, the Columbia study team can initiate the onboarding process for relying sites and if applicable, begin research activities at the Columbia site.
3. Communicate the Columbia IRB’s determinations and provide necessary documents to relying institutions (approval letter, approved informed consent documents, and recruitment materials).

The HRPO reliance specialists can help guide the site onboarding: Specialists will reach out to relying institutions directly to set up reliance agreements (via SMART IRB or Columbia's master agreement).   

4. When relying organizations complete their local context review, the Columbia PIs will submit a modification via RASCAL to add a relying site. The modification should include the materials to be used at the relying site (approval from the relying organization to move forward with reliance, approved consent(s), local recruitment document and other applicable relying organization’s study materials). Relying sites may not begin research until the Columbia IRB has approved the site. 

 The HRPO Reliance Team will help coordinate communication with the relying organizations to ensure the reliance documents are obtained. 

5. Communicate the Columbia IRB’s determinations to relying institutions.  The Columbia PI needs to provide all IRB approvals and approved documents to relying investigators, who will share them with their local IRBs.   

Are there additional responsibilities for a Columbia PI who is an overall PI for a multisite study with a single IRB of record?  

Yes, the Columbia PI and research team are responsible for coordinating IRB submissions for the overall study. This includes modifications, reportable events (including unanticipated problems, protocol deviations or violations, and complaints), renewal submissions, and closures.   

Always submit study renewals on time; if IRB approval expires, all research activities at every site must stop immediately.  

Does Columbia University HRPO have additional responsibilities?  

Yes, the HRPO Reliance Team will be in direct communication with the relying organizations to establish reliance and provide instructions on what information HRPO needs to onboard sites.