Request a Reliance Agreement

To obtain a Reliance Agreement, you (the NIH Principal Investigator or your designee) need to submit an NIH Reliance Request Form. This form collects important details about the planned collaboration and allows you to request up to 10 Participating Sites (pSites) to rely on the NIH IRB with a single submission. Here’s what you need to know about submitting the form: 

• Complete in One Go: You must fill out the form in one sitting since you can't save and complete it later. Use the PDF below that lists the questions to make sure you have all the needed information before you start. 
• No Edits After Submission: Once you submit the form, you can't make any changes to it. 
• Consultation Needed for More than 5 Sites: If you want the NIH IRB to oversee a study with more than 5 relying sites, you must talk to the NIH IRB office before submitting the form. 

The NIH Reliance Specialist will handle your request and work with the external institution to complete the reliance arrangement using a Reliance Agreement. Only NIH OHSRP can sign a Reliance Agreement and it usually uses one of these methods: 

The SMART IRB v3 Agreement 

• This is a national reliance template signed by over 1300 institutions. NIH has signed version 3 of the agreement and can only make reliance arrangements with other version 3 signatories. 
• If using SMART, we will document the reliance either through the SMART online platform or a SMART Letter of Authorization. 
• Do not submit a request in the SMART online platform unless the Reliance Specialist asks you to. 

The NIH's Reliance Agreement Template 

• We use this template when the Participating Site institution is not a SMART signatory. 

An Existing Programwide Reliance Agreement 

• NIH has existing reliance agreements with commercial IRBs and some local institutions. 

Note: When relying on an external IRB, the external IRB decides how to document the reliance arrangement. 

For new multi-site studies: 

• Submit reliance requests at the same time as the initial protocol submission if the Participating Site (pSite) is not a SMART IRB signatory. 
• Submit reliance requests after the initial review is approved if the pSite is a SMART IRB signatory. 

For studies already approved: 

• Submit reliance requests before adding the proposed pSites to the protocol. 

Note: You can only add pSites to the protocol after the Reliance Agreement is finalized. 

If the External IRB is WCG or Advarra: 

• Submit the reliance request after the protocol has been approved, unless NIH is the lead site drafting the protocol and model consents. 

For other External IRBs: 

• Submit the reliance request when the protocol has been submitted for initial review or after it has been approved.