The sIRB application is reviewed the same way as other studies, although the order in which the main application and sites are approved is different. For the sIRB application, the overall study protocol and UW-Madison activities are approved first via the usual initial review process. During initial review, the consent document for UW-Madison as well as the consent template for other sites are approved, as applicable. Template recruitment materials also will be approved as part of this review.

After IRB approval of the main study, you will add each relying site using the add a site form that is part of the overall study workspace in ARROW. To make sure you have the information needed to submit the add a site form, HRP-811 – FORM – Basic Site Information should be completed by the relying site study team and then provided to you.

The add a site form collects site-specific information, such as local context and site-specific study documents (e.g., consent and authorization forms). You will need to provide the following documents in the add a site form:

• Site-specific documents (e.g., consent forms, recruitment materials) based on the UW-Madison approved templates with all changes tracked.
• HRP-811 – FORM – Basic Site Information should be completed by the relying site study team and then provided to you to complete the add a site form for the sIRB application.

You can submit more than one add a site form at the same time. The add a site forms are reviewed as expedited changes by RELIANT. When the add a site form is submitted, RELIANT will reach out to the relying site IRB to work on the reliance agreement. Study activities at relying sites cannot begin until the reliance agreement is completed and the add a site form is approved. You will receive an approval letter when the site is approved. Do not submit an add a site form until the relying site study team has started the cede review process with their IRB.