The reliance agreement process involves several steps that RELIANT facilitates. For information on how you can help make the reliance process go as smoothly as possible, see the “How You Can Help with the Reliance Process” section. (For information on the process for establishing agreements with external individuals, see the “When UW-Madison Will Review for External Individuals” section.) Note that the steps below reflect the most commonly used reliance process; these steps may differ depending on the external sites involved.

Step 1: Study team submits formal request for UW-Madison to serve as the reviewing IRB (typically via a change).

Step 2: RELIANT reviews the request to determine all required site-specific documents have been submitted with the request.

Step 3: RELIANT reaches out to the relying IRB to confirm it is willing to cede IRB review and what type of agreement is needed.

Step 4:

  • If the relying institution has received a cede request from its study team, the reliance agreement process continues.
  • If the cede request has not been received, the reliance process is on hold until that application is submitted.

Step 5:

  • If either institution requires revisions to study documents (often the consent or authorization document), it will work with its own study team to make those changes. The next step of the reliance process will be on hold until these modifications have been made.
  • As the lead study team, you will need to work with the relying site study team to address any request for modifications as needed.

Step 6: Once all modifications have been addressed, the reliance agreement is finalized:

  • If the SMART IRB agreement is used, RELIANT provides the relying IRB with a memo documenting reliance.
  • If an IAA is required, the relying site will sign the agreement first and then send to RELIANT, who will then forward it to the UW-Madison institutional official for signature. The agreement is complete when all necessary signatures have been obtained. Note that if a relying institution requires use of an IAA that is complex or uses language atypical for such agreements, review by legal counsel is required before the IAA can be signed by either site.

Step 7: After the agreement is completed, RELIANT or the IRB will approve the change and study activities can then begin at that site.