Reliance Agreements

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How to enter into an IRB reliance agreement with collaborating institutions

Teachers College Reliance Agreements

 

Faculty researchers at the Teachers College, Columbia University frequently collaborate with external investigators and institutions. In an effort to reduce duplicate submission and oversight by multiple IRBs for the same protocol, the Teachers College IRB offers reliance agreement opportunities.

A reliance agreement (also called an IRB Authorization Agreement) is a document signed by two or more institutions engaged in human subjects research that permit one or more institutions to cede review to another IRB. The signed agreement permits a single IRB to review human subject research activities for more than one site.

 

It’s important to remember that reliance agreements for single IRB review are used to cede ONLY the IRB review of protocols.  All institutionally required ancillary reviews must still be obtained locally. For example, Conflict of Interest will still require local review and approval regardless of ceding IRB review.

 

Requests for Teachers College as lead IRB:

  1.  Complete the form “Template_Reliance Agreement” and submit IRB@tc.edu. This form will prompt you to provide information about the study, the funding source, and the IRB you are requesting to rely upon. 
  2. Your information will be reviewed to determine if the TC IRB is willing to be the lead institution based upon the details provided. If it is determined TC IRB is willing to lead, you will be contacted about additional details and the type of agreement required. Institutional Officials will be involved in the decision making process and in drafting the reliance agreement.

 

Requests for ceding IRB review to an external IRB:

  1. Reach out to the external IRB institution for this research project.
  2. Coordinate with their IRB department on the required paperwork for the Reliance Agreement.
  3. Your information will be reviewed to determine if the TC IRB is willing to cede review based upon the details provided. If it is determined TC is willing to cede, you will be contacted about additional details and the type of agreement required.  Institutional Officials will be involved in the decision making process and in drafting the reliance agreement.

 

Reliance agreements vary by study. Roles and responsibilities of each site will be specified in the agreement. This includes defining the reporting responsibilities for unanticipated problems as well as responsibilities for monitoring the study.