413 Reliance Agreements

Relying IRB: The IRB or Research Ethics Committee that will cede its review to another IRB or equivalent in order to cover the activities of its investigators.

Reviewing IRB: The IRB or Research Ethics Committee that will conduct appropriate ethics review of a human subjects research project on behalf of two or more institutions or organizations.

Reliance Agreement: Often called an Authorization Agreement or Institutional Authorization Agreement, a Reliance Agreement is an agreement entered into by two or more organizations or institutions who are engaged in the same human subjects research project. The Agreement outlines the duties and responsibilities of each of the parties, including the IRB, HRP staff, and the investigators who will complete work on the project.

Investigator: An individual involved in the performance of human subjects research activities who performs one or more of the following activities:

1. Obtaining information about or biospecimens from living individuals by intervening or interacting with them for research purposes
2. Obtaining identifiable biospecimens or private, identifiable information about a living individual for research purposes
3. Obtaining the voluntary informed consent of individuals participating in research
4. Studying, interpreting, analyzing, or using identifiable biospecimens or identifiable, private information for research purposes; or
5. Communicating with the IRB or other institutional review entity regarding the performance of the research project.

An investigator’s primary concern must be the protection of the rights and welfare of human participants in all research activities. All investigators must be trained and listed on an active protocol prior to carrying out any of the aforementioned activities.

Engagement: When an institution’s employees or agents are involved in human subjects research at a level of involvement that warrants two institutions entering into an agreement. Full guidance on the concept of "engagement" is available from the Office for Human Research Protections. Generally speaking, when a USU Principal Investigator or one of their study staff are:

1. The prime recipient of a federal funding award; or
2. Obtaining data about research participants through intervention or interaction with them; or
3. Accessing private, identifiable private information about the participants; or
4. Obtaining the informed consent of participants for the research. 

I. Scope

USU Policy 4103 states that the USU IRB shall determine the appropriate site for review of any project that involves a Utah State University investigator. Investigators are not permitted to self-determine the appropriate site for review; that determination must come from either the external sponsor, or via agreement between the appropriate IRBs. In general, the USU IRB will engage in a reliance agreement in order to avoid duplicative review and administrative burden, especially under the circumstances outlined in Section IV, below. However, Utah State University will not engage in Reliance for exempt protocols. 

Reliance Agreements are appropriate where an agent of USU is acting as an “investigator” on a project, and that investigator’s activities renders Utah State University “engaged” in the project. Reliance Agreements cannot be executed on behalf of students alone or emeritus faculty alone. Reliance Agreements must be executed on behalf of someone who meets the definition of a Principal Investigator, per SOP 302, and who will oversee the activities taking place under the Reliance Agreement. Emeritus faculty are generally not able to serve as a PI for Reliance Agreements, however. Finally, Reliance Agreements are generally only available where the external investigator is an agent of an institution, organization, or research center that holds its own Federalwide Assurance.

II. Process for Obtaining Reliance – USU is Reviewing IRB

When a protocol will be filed with and reviewed by USU’s Institutional Review Board, prior to seeking review from the USU IRB, the investigators should collaborate with the IRB they hope will become a Relying IRB to ensure that that IRB or HRPP will be amenable to a Reliance Agreement. If not, the research team should work with the USU IRB to determine whether it might be appropriate to shift the site of review so that USU can become the Relying IRB.

Instructions for requesting Reliance are embedded into each individual protocol in Kuali Protocols. Investigators should follow those instructions to properly request a Reliance Agreement, which are represented in the step-guide below: