We have a couple resources to help determine when RELIANT should be consulted:

• Multi-site Triage Flowchart
  
  This is an internal resource of staff to identify when multi-site questions/inquiries should be triaged to RELIANT.
  
  
• Appendix A of the Reliance Manual
  
  This is a resource available to researchers, similar to the internal flowchart but starts with the assumption that the project constitutes human subjects research. 

If any of the following show up in your new study or change, RELIANT will handle that piece of the review. Contact RELIANT (irbreliance@wisc.edu) to give us a heads up and to work out next steps, if we are not already in contact with you about it. 

• SMART IRB agreement and IRB authorization agreement (IAA). These are agreements that authorize one institution to provide IRB review for another institution. For more information, see Types of Reliance Agreements in the RELIANT Manual. 
• Delegation Logs (new and edits). When there is an IAA and we are the reviewing IRB, this form documents the individuals who are on the study team at the other institution. 
• New individual reliance agreements: Individual Investigator Agreement (IIA) or Collaborating Investigator Responsibilities Summary (CIS), depending on funding. These agreements are used when our IRB agrees to serve as the IRB of record for an individual investigator Engaged in Human Research, but who is not affiliated with an institution that has its own IRB. 
• Add-a-site forms associated with the single IRB application. For more information, see Using the Single IRB Application in the RELIANT Manual. 
• Revisions to external site-specific documents (e.g., recruitment materials, consent documents). These are materials that will be used by an external site for whom we are serving as IRB of record. The site-specific documents are based on previously-approved templates that the study team created for their study. For more information, see Prepare and Submit Site-Specific Documents in the RELIANT Manual. 

At initial review and for a full board or complex change, the assigned IRB Analyst and RELIANT Analyst will coordinate on review of the reliant components. The IRB Analyst should confirm with RELIANT that all reliance matters have been addressed prior to finalizing the initial or change review. When possible, a staff member with a joint IRB/Reliance appointment will be assigned the review item.   

For an expedited change that includes a reliance component as well as any other very minor changes, a RELIANT Analyst will process the entire change. 

UW-Madison will not serve for every collaborating site who asks. In brief, we will only serve if the study is externally funded and not exempt. We will also only serve if the external site is engaged in human subjects research and the external site has a robust HRPP. (For more information see Appendix A and B of the RELIANT manual as well as HRP-803 and HRP-833) Because this is so complex, RELIANT requires a consult prior to submission of the request in ARROW to serve. RELIANT has a separate consultation request form found here. Note that these restrictions apply to sites, not individuals (i.e. collaborators unaffiliated with an institution that has an FWA), for whom the UW often serves regardless of funding.

Study teams must consult with RELIANT when they are planning a multi-site trial; one of the pieces on which RELIANT will advise them is whether the sIRB application type would work best for their study.  

Once an sIRB application is submitted, as stated in the “Using the Single IRB Application” section of the Reliance Manual, the sIRB application is reviewed by IRBS the same way as other application types. UW-Madison is the IRB of record, which means that we are responsible for any regulatory determinations that apply. Here are some pieces for IRBS to consider as they are reviewing an sIRB application: 

• Reliance Agreements: RELIANT should be notified via an automatic ARROW generated email of any sIRB applications. If you’re not already in touch with a RELIANT analyst about the multi-site project, please email RELIANT to figure out who the RELIANT point person is. RELIANT will review whether UW would likely be willing to serve for the sites listed.  However, reliance agreements will not be finalized until after initial review approval, and the study team submits an “Add a Site” application for that site. 
• “Reviewing IRB: Sites” page: Any known external sites that are engaged in research should be listed here. As described in the bullet above (and unlike the nPBA and PBA application types), the reliance agreements will not be finalized until the study team submits an “Add a Site” form for that site. 
• Protocol:  
  • For a multi-site study, there must be a protocol that details the involvement of all sites listed on the Reviewing IRB Sites page. 
  • Consider broad language in protocol areas such as recruitment plan and documents, assent plan and documents, and enrolling individuals who lack capacity to consent, to allow for differences in institutional policy and state law between UW-Madison and external sites. For example, institutions may have differing policies on the order of legally authorized representatives (LARs).  The order of the enrolling institution should be followed. 
• HRP-830-Communication Plan: If the protocol does not detail how sites will communicate (e.g., section 26 of HRP-503 Protocol Template) then HRP-830 Communication and Responsibilities should be uploaded as a separate document with the protocol. 
• Template Consent Document(s): If the protocol indicates other sites will be consenting, ensure a Template Consent Document is uploaded in Q1 on the “Consent and Authorization Forms” page of ARROW. A template assent should also be uploaded if appropriate and the study enrolls children. This is a separate document from the UW site consent. It is very important that the consent template is uploaded if external sites will be consenting, as this impacts the “Add a Site” form when sites are added later. See guidance in the RELIANT manual on how to Write a Consent Template. 
  • Do NOT stamp Templates. The template is a guide, not a complete document; subjects will not see the consent template. 
• UW consent form(s): If subjects are being enrolled at UW then there must be a local consent form that meets all of our regular consent criteria. There would also be assent form(s), if appropriate and the study enrolls children. The study team would have to answer YES to the question “Will you be enrolling any participants at UW Madison/UWHC?” and upload the UW consent/assent form(s) there. 
  • If subjects are being enrolled at UW and at other sites, then there will be both a Template consent and a UW consent uploaded. The UW consent should be the same as the Template consent, but with all of the contact and other site-specific information filled in for UW-Madison.
  • Once the study is approved, you will stamp UW site consent. 

Once the study is approved, enrollment may proceed at UW only. In order to move forward with the external sites, the study team will submit an Add-A-Site form for each site, which includes submitting the Delegation Log for that site. That is when Reliant will work on the actual Reliant agreements for that site. Reliant may process the Add-A-Site forms by expedited review.

There are certain organizations affiliated with UW-Madison/UWHC but for whom UW-Madison IRBs are not their default IRBs (e.g., Swedish American, UW System administration). See the Hospitals and Clinics Under the Purview of the UW and IRB Review for UW-Extension, UW System administration, UW System campuses documents in Box for the full list of these sites. When a UW-Madison/UWHC investigator is collaborating with someone who is engaged in research and an employee at one of these affiliated organizations, please contact the Reliant team for support and follow-up.