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.