IRB Corner: Conditional Approvals

IRB Corner: Conditional Approvals

This month’s IRB Corner discusses conditional approvals. You will learn when the University of Phoenix IRB issues a conditional approval, how to lift conditions from the approval, and when research activities can begin if you receive a conditional approval decision from the UOPX IRB. In addition, you will learn when you might want to consider a reliance agreement in lieu of a conditional approval for your study.

What does a conditional approval mean?

A conditional approval is used when the University of Phoenix IRB reviews an IRB application and study material and determines that the study would be approved based on the federal regulations and institutional policies with the exception of one or more specific conditions. There are times when a researcher intends to recruit subjects or use data from another organization, and that organization may require the researcher to provide an IRB approval before the organization will consider providing permissions. For example, the other organization may be a school district that has an internal committee that reviews research proposals and determines whether the school district will provide permission to the researcher. The school district’s research committee may have an application process that asks the researcher to provide a copy of an IRB approval prior to beginning the review of the study. In this case, the researcher submits all material to the UOPX IRB in IRBNet and indicates under “Additional Institution, Organization, or Campus Project” on the Organizational Research Information page of the IRB application that the school district’s research review requires an IRB decision prior to reviewing the study and granting permissions. The UOPX IRB reviews the application and determines whether the study as designed meets all regulatory and policy criteria except for the missing permissions from the school district (the outstanding condition). The UOPX IRB then takes action on the submission in IRBNet and delivers a Conditional Approval decision, which includes a UOPX Conditional Approval Board Letter that the researcher can provide as part of his or her submission to the school district’s research committee.

How does a researcher lift conditions from a conditional approval?

Again, the researcher will receive a conditional approval decision letter that stipulates very specific conditions that need to be met and received by the UOPX IRB before these conditions will be lifted. It is the researcher’s responsibility to provide material to the UOPX IRB to verify that the conditions have been met. The researcher will provide the remaining material to the IRB using a “resubmission”—a subsequent package on the same project in IRBNet that edits the existing project. For more about how to complete a resubmission, see the GUIDANCE – IRBNet Instructions for Resubmissions document. The UOPX IRB will review the new material submitted in the resubmission and determine whether the conditions outlined in the conditional approval decision letter have been met. If the conditions are met, the UOPX IRB will then deliver an “Approved” decision or determine the study “Exempt,” depending on the level of risk and the study design.

In the earlier example with the school district research review, the researcher would need to provide the UOPX IRB with the school district’s decision indicating the researcher has permissions to conduct his or her study. Once the researcher provided the school district’s research review decision letter, the UOPX IRB would review the school district’s research decision letter to make sure the study has approval from the district. Once this has been determined, the UOPX IRB would issue a letter lifting the conditional approval. The researcher would then receive a Board letter from the UOPX IRB indicating “Approval” or an “Exempt” determination, depending on the level of risk and the study design.

When can I begin my research if I receive a “Conditional Approval”?

The IRB Conditional Approval Board letter will stipulate that you cannot begin research activities until the conditions have been met. In other words, you cannot begin research until the conditions are lifted and you receive an “Approval” or an “Exempt” determination from the UOPX IRB. For more information about IRB actions and decisions, see the GUIDANCE – Understanding IRB Actions and Decisions document.

Following the example from the school district, the researcher cannot begin any research activities until the school district’s research committee completes its review AND the researcher provides the school district’s decision letter to the UOPX IRB for review. The UOPX IRB must review the materials submitted and lift conditions by issuing an IRB Approval or Exempt. Research cannot begin until the researcher receives an IRB Approval or Exempt Determination Board letter that stipulates that research activities can begin and outlines the researcher’s responsibilities for conducting the research and communicating with the IRB Office.

When should I consider a reliance agreement instead of a conditional approval?

If your study involves the “engagement” of another organization that has an Institutional Review Board (IRB) with a federal wide assurance number (FWA#), then it is possible to have a reliance agreement between UOPX IRB and the IRB of the other institution. The FWA ensures an IRB is in agreement with the federal government to follow the federal human subjects research regulations (45 CFR 46). If you need more information about what it means for an institution to be considered “engaged,” please see the GUIDANCE – What Projects Require an IRB Review? and GUIDANCE – What is Human Subjects Research? documents.The UOPX IRB recommends that researchers interested in a reliance agreement contact them PRIOR to having either IRB conduct a review. For more on how to work with IRBs to obtain a reliance agreement, see the GUIDANCE – Reliance Agreements document. Please contact the IRB Office if you are considering pursuing a reliance agreement with the other organization. In the conditional approval example with the school district’s research review committee, a reliance agreement would not be an option unless that school district had an IRB with a FWA#.

All guidance documents, templates, and forms are available in the IRBNet Forms and Templates library (accessible from the left menu within IRBNet). After reviewing the guidance materials recommended in this article, please contact The University of Phoenix IRB Office at IRB@phoenix.edu if you have any questions about conditional approvals.

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