This month in the IRB Corner, we discuss IRB reliance agreements. We explain what a reliance agreement is, why you might need one, and the process of obtaining and submitting a reliance agreement to the UOPX IRB Office.
What is an IRB reliance agreement?
A reliance agreement is an agreement between one or more IRB Offices with Federalwide Assurances (FWA). A reliance agreement stipulates the conditions to rely on the review and oversight of a single IRB Office. The Office for Human Research Protection (OHRP) has encouraged the use of a single IRB of record for collaborative research.
Why would I need a reliance agreement?
An IRB is responsible for the review of research when the institution is considered “engaged” in human subjects research. Typically, an institution is engaged if an employee or agent of the institution interacts with any human subject for research purposes. For example, if the employee or agent of the institution intervenes or manipulates the environment, conducts interviews or surveys, obtains informed consent, or obtains identifiable private information from any source for research, then the institution is considered engaged in research. For more information, see the OHRP guidance "(Engagement of Institutions in Human Subjects Research".
When more than one institution is engaged in the research, the multiple IRBs can agree to have one IRB conduct the review and provide the OHRP regulatory oversight of the research. The two or more IRB offices involved agree to rely upon a single IRB office to manage the study. A reliance agreement reduces redundancy and use of multiple IRB resources across institutions. If your project involves an individual principal investigator who is affiliated with multiple institutions, or if there are multiple principal investigators affiliated with different institutions, you may discuss the possibility of using a reliance agreement across the multiple IRBs.
How do I get a reliance agreement and submit it to the UOPX IRB?
The UOPX IRB has adopted a standard template for a reliance agreement per OHRP guidance. You can find the reliance agreement template in the IRBNet Forms and Templates library from the left menu when you log in to IRBNet (see FORM – Reliance Agreement). Please contact the UOPX IRB at IRB@phoenix.edu and inquire if you are interested in establishing a reliance agreement between the UOPX IRB and another IRB.
The UOPX IRB can serve as the IRB of record for a study, or the UOPX IRB can rely on another IRB to be the IRB of record for a study. Depending on the type of study being conducted, the UOPX IRB can advise on whether the UOPX IRB has a preferred role. In some cases it may make sense to set up a reliance agreement for multiple studies, but the UOPX IRB typically establishes a reliance agreement for a single study. Once we advise about the UOPX IRB’s preferred role for the researcher’s study, the researcher is responsible for modifying the Form – Reliance Agreement template to adequately represent the relationship between IRBs. The researcher must then obtain ink signatures from the Institutional Official (IO) for the agreeing IRBs listed on the reliance agreement. The UOPX IRB Office will facilitate getting the UOPX IO signature if the researcher sends the completed reliance agreement to our office at IRB@phoenix.edu.
UOPX researchers who are using reliance agreements must submit a project for review in IRBNet even when UOPX will not be the IRB of record. In the cases where another IRB will be the IRB of record, the project submitted to IRBNet only needs to include (1) a completed UOPX IRB application form, (2) the signed reliance agreement, and (3) the decision letter from the IRB of record.
If the UOPX IRB will be the IRB of record for the research study, the researcher submits a complete project to IRBNet including (1) the completed UOPX IRB application form, (2) all supplementary materials, and (3) the signed reliance agreement. If UOPX IRB is the IRB of record, the researcher should provide the UOPX IRB project decision letter to the other IRBs involved in the reliance agreement once the UOPX IRB completes the review.
The University of Phoenix IRB Office is available to answer questions about reliance agreements and to facilitate getting the necessary IO signature for the UOPX IRB. For a copy of the FORM – Reliance Agreement, see the UOPX IRBNet Forms and Templates library (accessible from the left menu within IRBNet). Additional questions about reliance agreements should be directed to the IRB Office at IRB@phoenix.edu.