This section of the Reliance Manual includes single IRB review requirements, a single IRB plan template, and information about using the single IRB application.
Federally funded, multisite studies that are not exempt are required to use a single IRB review model. This section provides information about review requirements, letters of support, and when to use the single IRB application.
Single IRB Review Requirements
NIH
All sites participating in multi-site studies funded by NIH must use a single IRB to review these studies. The NIH single IRB policy became effective in January 2018. This policy applies to the domestic (not international) sites where each site will conduct the same protocol involving non-exempt human research, whether supported through grants, cooperative agreements, contracts, or the NIH Intramural Research Program. It does not apply to career development, research training or fellowship awards.
Common Rule
The revised Common Rule – the primary federal regulations governing human subjects research – now requires that federally funded, multisite studies that are not exempt use a single IRB review model. Studies to which the sIRB mandate applies are:
- Not exempt
- Federally funded
- Multisite, defined as sites engaged in non-exempt human subjects research within the United States; and
- Not otherwise legally prohibited from using a single IRB.
Single IRB Plan Template
Grant and other funding applications may require that you include a single IRB plan. If this is required, please reach out to RELIANT. We will provide you with a template plan and can review the plan with you before you submit your funding application.
Using the Single IRB Application
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.
- A signed delegation log for that site. For a template delegation log, see HRP 812 – FORM – Site Delegation Log. (You may also use a template log you have already developed if it includes the same elements as HRP 812.)
- 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.