Union College HSRC Reliance Agreement Information

What is an IRB Reliance Agreement?

An IRB Reliance Agreement, also known as an Institutional Authorization Agreement (IAA), is a formal, written contract between two or more institutions engaged in collaborative research. This agreement allows the Institutional Review Board (IRB) of one institution (the "IRB of Record" or "Reviewing IRB") to provide the ethical review and oversight for research conducted at another institution (the "Relying Institution").

Essentially, instead of each institution's IRB reviewing the same study independently, the Relying Institution agrees to "rely" on the review and approval of the IRB of Record.

Why Use a Reliance Agreement?

The primary goal of a reliance agreement is to streamline the IRB review process for multi-site studies. The benefits include:

• Efficiency: Eliminates redundant IRB reviews, saving time and resources for researchers and IRB offices.
• Consistency: Ensures all research sites are following the same approved protocol, leading to more uniform human subjects protections.
• Compliance: Helps institutions comply with federal mandates, such as the National Institutes of Health (NIH) policy for single IRB (sIRB) review of multi-site research.

Key Terminology

• Reviewing IRB (or IRB of Record): The IRB that assumes responsibility for ethical review and oversight for all participating sites under the agreement. This is typically the IRB at the lead research site or an independent IRB.
• Relying Institution: An institution that cedes IRB review authority to the Reviewing IRB for a specific study.
• Local Context: Information specific to a Relying Institution that the Reviewing IRB must consider. This includes state/local laws, institutional policies, and knowledge of the local subject population.

Principal Investigator (PI) at the Relying Institution: While the IRB review is ceded, the PI at the relying site remains responsible for the day-to-day conduct of the study at their location and for adhering to both the Reviewing IRB's determinations and their own institution's policies.

1. Initial Consultation: Before initiating a request, the Union College PI must contact our HSRC Office to discuss the study and determine if a reliance agreement is appropriate.
2. Submit Request Form: The PI completes and submits the "Request to Rely on an External IRB Form" (see below) to the Union College HSRC.
3. Institutional Review: Our HSRC will review the request, assess the suitability of the proposed Reviewing IRB, and communicate with the corresponding IRB office to establish the reliance agreement.
4. Agreement Execution: Once both institutions sign the agreement, Union College’s HSRC will provide the PI with a formal acknowledgment letter. Research activities at Union College may not begin until this letter is received.
5. Submission to Reviewing IRB: After the agreement is in place, the PI is responsible for submitting all study documents, modifications, and continuing reviews directly to the Reviewing IRB as required. The PI must also copy the Union College HSRC (hsrc@union.edu) on key submissions and approval notices.

Your Responsibilities as a PI at a Relying Site

When Union College relies on an external IRB, you, the PI, are still responsible for:

• Obtaining all required institutional approvals (e.g., Conflict of Interest, Radiation Safety) at Union College.
• Ensuring that you have completed required CITI training and sent the certificate to the HSRC chair (current a one-time requirement).
• Reporting any local unanticipated problems, potential non-compliance, or subject complaints to both the Union College HSRC and the Reviewing IRB.
• Following all determinations and requirements of the Reviewing IRB.