Reliance Agreements

Columbia IRB Serving as the sIRB 

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 [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. 

  2. Submit protocol event via RASCAL indicating that Columbia's IRB will serve as a single IRB for the multicenter protocol.  

    a.Upon IRB approval, Columbia will be the only active site to start.  

  3. Communicate Columbia IRB determinations to relying institutions and provide necessary documents (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 i 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 relying PIs will submit a modification via RASCAL to add a relying site  

  5. Provide relying site materials (approval from relying organization to move with reliance, approved consent(s), local recruitment document and other applicable relying organization’s study materials).  

      The HRPO reliance team will help coordinate communication with the relying organizations to ensure obtaining reliance documents.   

6. Communicate Columbia IRB determinations to relying institutions.  The PI needs to pass all IRB approvals and approved docs 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 multisite study with a single IRB of record?  

Yes. Columbia University PI and Research Team: The Columbia PI handles all modifications, unanticipated problems, and renewal submissions to the Columbia IRB using updates collected from participating sites.   

Always submit study renewals on time; if 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.