To request that UW-Madison serve as the reviewing IRB for an external site, you must include this request in your IRB submission, whether via an initial review application or a change. Before submitting your application, please do the following:

• Ensure your study protocol or application describes the role of any external sites. See HRP 503-TEMPLATE-Biomdedical Protocol, HRP 503a – TEMPLATE – Registries and Repositories Protocol, the NIH clinical trial protocol template, and the NIH behavioral and social sciences protocol template for more information on how to include external sites/personnel in your protocol document.
  • A protocol is not required for the Non-Protocol-Based application (nPBA).
• Confirm that external study teams or individuals have consulted with their own IRB to a) ensure that the site would be willing to cede IRB review to UW-Madison and b) understand what steps are required to cede IRB review to UW-Madison. Every site has its own process for relying on another IRB. The reliance process goes more smoothly if you work with your collaborators to understand their site’s requirements in advance. The same process applies to individuals affiliated with an entity with its own IRB.

The IRB will typically use what is called a parent-child model for approving the main study and relying sites. This means that the overall study (including UW-Madison’s role in the study) is approved by the IRB first, with a list of relying sites approved in theory. After the overall study is approved, relying sites are formally approved via a change (see below) and a reliance agreement is put in place at that time. Note that for some studies involving one or two external sites or individuals (e.g., UPH Meriter), it may be more efficient for the sites to be approved with the initial review application if the sIRB application is not used.

Although where sites are listed in the application is similar, where the actual reliance process starts differs.

• Where to list sites in the initial application
  • For all application types, list external sites and individuals in the external collaborations section.
• Changes
  • For the regular initial review application, sites not formally approved as part of the initial review process need to be added via a change. With the change, you will need to upload the applicable site-specific study documents (e.g., consent documents).
  • For the sIRB application, approval for sites will not be finalized until add a site forms are submitted after the UW-Madison IRB approves the study. You will submit one add a site form for each site and upload site-specific documentation in the add a site form.

Upon submission of the request to add a site, RELIANT manages the process for securing the appropriate reliance agreement, including working with the relying site’s IRB. While the UW-Madison study team will need to work with the relying site’s study team on their request to cede IRB review and developing site-specific study documents, RELIANT will handle any communication with the relying site IRB. Please note we recommend not submitting a change to add a site until the relying study team has started the cede review process at their own institution. The reliance agreement process cannot begin until the relying site’s IRB has received a cede request from their study team and submitting a change before this has happened may cause unnecessary delays for your study.