A Reliance Agreement (also called an Institutional Authorization Agreement, or IAA) is an agreement signed by two or more institutions engaged in the same human subjects research project. The Agreement permits one or more institutions to cede review to another central, or single, IRB. Generally speaking, this means that only one IRB will review a single project for several collaborators across institutions. Select a tab in the menu to learn more about when and how to incorporate a Reliance Agreement to your project.
What Kind of Agreement Do I Need?
There are many ways to incorporate a non-USU researcher into your project, and not all of them are via a Reliance Agreement. This flowchart will help you determine which agreement is appropriate for your external colleague(s). All documents referenced for upload into Kuali are built into the Kuali Protocol template.
When to use a Reliance Agreement
A Reliance Agreement is needed if one of the following is true:
- You are a Principal Investigator (PI) on a human subjects research project reviewed at USU, and you plan to have non-USU investigators engaged in the project as well.
1. You are USU researcher and you will be an investigator on a human subjects research project, but the PI is at another institution, then you will submit a “Reliance Request” to ask USU to rely on the PI’s IRB to review and oversee the project. There are two ways to do this:
- Using SMART IRB. If the other institution is signed on to SMART IRB and would like to use the SMART IRB system (this requires you to reach out to them first!), the PI at the Reviewing Institution should initiate a Reliance Agreement in SMART IRB. At a minimum, USU needs to see:
- The protocol
- Informed consent documentation
- Recruitment material
- Data collection instruments
- Using Kuali. Your “submission type” in Kuali will be “Reliance on Another IRB’s Review.” Once that is submitted by the USU PI, USU’s IRB will review the materials, make a determination about the eligibility for reliance, and send off appropriate requests for Reliance to the other IRB. You can view the status of your Reliance Request in the Admin Notes & Files section of your Reliance Request.
How to Request a Reliance Agreement
- If you are Requesting that the USU IRB rely on Another Institution’s IRB:
- If you are Requesting that Another Institution’s IRB rely on the USU IRB:
- Check to see if the other institution uses SMART IRB. If they do, the request should be made through SMART IRB. See Instructions for getting started with SMART IRB.
- If the Reviewing IRB does NOT use SMART IRB, request a Reliance Agreement through Kuali, by following the instructions in your USU protocol.
Institutions vary as to whether and how they will utilize Reliance Agreements. Determinations regarding Reliance Agreements are highly specific to each institution and each protocol. For example, many IRBs will not enter into these kinds of agreements for Exempt projects. Other institutions may have created review types and standards that are specific to their human research protection program, and will not engage in Reliance activities for projects that utilize those review structures.
Here are the details of USU’s Reliance Agreement process:
- Utah State University will engage in Reliance for any level of review. Exempt, Expedited, and Convened IRB/Full Board protocols are all eligible for Reliance.
- The only exception to this is the FERPA Exemption under Exempt Category 4. Because this is a USU-specific exemption, it cannot be utilized in a Reliance Agreement; researchers wishing to involve collaborators from other institutions should seek Expedited review for work that would ordinarily fall under that exemption.
- Utah State University will engage in Reliance for any institution holding a Federal Wide Assurance with HHS. This includes international institutions.
- Utah State University will not engage in Reliance with institutions that do not hold a Federal Wide Assurance. External researcher agreements or separate IRB oversight should be sought in those cases.
- Utah State University is a member of SMART IRB. In general, USU prefers to use the SMART IRB Online Reliance System (ORS) to engage in Reliance Agreements that will use the SMART IRB Agreement. However, we will be flexible with the other institutions’ preferences, so researchers should always check with the other institution to determine what platform will be utilized for the Reliance Agreement process. Begin by checking to see if the Reviewing or Relying Institution is a Participating Member of SMART IRB. If so, Request Investigator Access as soon as possible in your review process.
- USU’s FWA# is FWA00003308 (expires 08/27/2024) and its IRB Registration, or IORG, number is 0000121.