When the HS IRBs serve as the reviewing IRB for external (relying) sites, information about those sites needs to be included in the IRB application. In addition, the IRB must approve the addition of relying sites before study activities may begin at those sites. This document includes basic information about how to list sites and the process for obtaining IRB approval for relying sites. Study teams are encouraged to contact the HS IRBs Reliance Team (firstname.lastname@example.org) with any questions.
Where to List Relying Sites
Study teams must list all sites relying on the HS IRBs in the initial review application. For both the regular and single (sIRB) application, sites will be listed in the study location section on the sites page. If a site is not in the pick list provided, study teams can manually enter the site.
Obtaining IRB Approval for Relying Sites
The HS IRBs typically use what is called a parent-child model for approving relying sites. This means that the overall 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 as follows:
- For the regular application, 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. As with the regular application, a full change may be required to add a site if it is not already in the approved application.
This parent-child model is followed by most commercial IRBs and is used by the HS IRBs 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.
As part of the formal approval process, the Reliance Team 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 when a site is formally approved.
NOTE: For studies involving only one or two other sites (e.g, studies involving UW-Madison and UnityPoint Health Meriter), please contact the Reliance Team for assistance in how best to obtain approval for those sites.
Processing Reliance Agreements
For UW-Madison to serve as the reviewing IRB for another site, a reliance agreement between the two sites needs to be in place. This can be done via the SMART IRB agreement or an IRB authorization agreement (IAA). Regardless of the type of agreement, the HS IRBs’ Reliance Team manages the process for securing the appropriate 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 the request to cede IRB review and developing site-specific study documents, the Reliance Team will handle any communication with the relying site IRB.
Adding New Relying Sites
To add new relying sites not yet part of the approved overall study, the study team will need to submit a change of protocol. Whether a full or expedited is needed will depend on the nature of the study as well as what activities will be occurring at the site being added. Please contact the Reliance Team for assistance.
Removing Relying Sites
Relying sites that end up not participating in a study, whether listed in the overall study application or formally approved, should be removed at the earliest opportunity as follows:
- For sites not yet formally approved and only listed in the overall application, study teams may submit an expedited change to remove sites from the application.
- For sites formally approved and added to the study:
- For the regular application, study teams may submit an expedited change to remove the sites.
- For the sIRB application, study teams should use the “close site” activity in ARROW to close the site.
- Lists of external personnel from relying sites need to be provided in a delegation log, either uploaded to the initial review form (regular) or add a site form (sIRB).
- For guidance on drafting consent and authorization documents for relying sites, see How to Draft Consent and Authorization Documents for Relying Sites.
- For a copy of the add a site form for the sIRB application click here.