Reliance Agreement Process

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 documents (e.g., delegation log, 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.

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Approval Process for Reviewing IRB Requests

The IRB must approve the addition of relying sites before study activities may begin at those sites. As noted above, the IRB typically uses what is called a parent-child model for approving relying sites. This means that the overall study is approved by the UW IRB first, with a list of relying sites approved in theory. This parent-child model is followed by most commercial IRBs and is used by the UW-Madison to provide maximum flexibility for study teams. Since relying sites are ready to be added to a study at different times (or may end up never being formally added), the parent-child model allows sites to be added as they are ready to move forward without holding up approval of the overall study.

After the overall study is approved, relying sites are formally approved as follows:

• For the protocol-based and non-protocol-based applications, study teams submit an expedited change to obtain formal approval for the relying sites. If a site is not already listed in the approved application, a full change may be required.
• For the sIRB application, study teams will submit an “add a site” form for each relying site to obtain formal IRB approval for that site. If a site is not already listed in the approved application, a change is required to add the new site before an “add a site” form can be submitted.

As part of the formal approval process, RELIANT will work with the relying site’s IRB to finalize a reliance agreement, including documenting any local requirements. Any site-specific documents (e.g., consent, recruitment materials) will be approved during the IRB review process. Sites are approved to begin study activities when the UW-Madison IRB has approved the site, the reliance agreement is complete, and the relying site study team has met any institutional requirements at their site.

NOTE: For studies involving only one or two other sites (e.g., studies involving UW-Madison and UnityPoint Health Meriter), please contact RELIANT for assistance in how best to obtain approval for those sites.

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Single IRB Review Platforms

Each IRB typically has an electronic platform to manage their review and submission process, including for single IRB arrangements. In addition, a few national electronic platforms exist to facilitate the reliance process and/or document management for multisite studies. Below is a general description of these platforms as well as how you may use them.

IRB-specific platforms

• ARROW is UW-Madison’s IRB platform for IRB submission and review. You will use ARROW to submit requests for UW-Madison to serve as the reviewing IRB and adding sites. Only UW-Madison study team members will need access to ARROW.
• ARROW cannot be used to disseminate IRB approvals or study documents to relying sites. As the lead study team, you are responsible for identifying a tool or process for sharing of documents with relying sites, which needs to be described in your study communication plan.
• IRB submission systems at other sites generally work similarly to ARROW. Some sites, however, require that the lead study team access their IRB system directly as part of the review process and/or sharing of documentation. What local sites require is something you should talk about with your collaborating sites when discussing their reliance process.

Reliance/Multisite-specific platforms

• IRB Reliance Exchange, or IREx, is a free web-based portal designed to support single IRB review processes and dissemination of study documents. If you are planning to conduct a study with more than 3 sites, IREx may be a good option for sharing and disseminating study documents. We can assist you in determining whether IREx or another document sharing tool would work well for your study.
• SMART IRB Online Reliance System (ORS) is hosted by SMART IRB and is designed solely to support the reliance review process among IRBs. UW-Madison typically does not use the ORS due to the administrative burden it places on study teams. If an external site asks you to use the ORS, please contact RELIANT to discuss alternatives.

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