By Emily Shultz, CIP 

At the University of Iowa (UI), an Institutional Review Board (IRB) must review and approve all human subjects research prior to the start of the research. The type of IRB review is based on the Federal Policy for the Protection of Human Subjects (known as 45 CFR 46 or the Common Rule). Any project that meets the regulatory definition of human subjects research is subject to the review and approval of the UI IRB or an external IRB. 

The Common Rule outlines three types of IRB review that are based on the potential for risk to subjects. Each review type has its own unique requirements, designed to provide the guardrails for the protection of participants and the maintenance of research ethics. 

In Section IV.1 of the New Project form in HawkIRB, the investigator selects the type of review that they think applies to their project. There are four options, but for the purposes of this article we will focus on:  

Ultimately, the Human Subjects Office (HSO) or the IRB will determine the type of review that is allowed by the regulations. The UI IRB uses the type of review with the lowest possible regulatory burden for the researcher. 

Expedited review is conducted by an IRB Chair. Expedited review does not mean a quicker review process. It only means that the study meets the regulatory definition of a minimal risk study that qualifies for review by an IRB Chair or Chair Designee rather than the full IRB. Full board review means the study involves more than minimal risk to subjects and must be reviewed at a convened IRB meeting. 

Depending upon the study design, level of risk to participants, and the designation indicated in the application, an IRB chair or chair designee may approve the project by the exempt or expedited review process. If the study does not meet the criteria for exempt or expedited review, the project will be referred to the convened IRB for full board review. 

To be considered eligible for exempt or expedited review, the research must not be ‘greater than minimal risk’ to the participants. According to guidance from the Office of Human Research Protections (OHRP): 

To satisfy the definition of minimal risk, the estimate of the anticipated harms and discomforts of the research for the proposed study population may not be greater than an estimate of "the harms and discomforts ordinarily encountered in daily life or during the performance of routine medical and psychological examinations or tests.  

Exempt Review 

To be reviewed at the exempt level, the project must be categorized under at least one exempt category. The IRB still considers projects in these categories to be human subjects research requiring IRB review and oversight. The project is not “exempt” from submitting an IRB application. But once the IRB grants exempt status, the research is not required to comply with the rest of the federal regulations for human subjects research. 

There are eight categories of exemption in the federal regulations, however, the UI IRB has only adopted the first six of these categories: 

Note: if minors are included in the recruitment pool, exempt categories 2 and 3 cannot be applied and the project will need to be reviewed at the expedited or full board level. At the University of Iowa, the IRB Chair or designee is the sole authority for determining whether the research meets the exempt criteria.  

If the study is minimal risk but does not fall under one of the exempt categories, the IRB Chair may elect to review the project using expedited review procedures. 

Expedited Review  

A single IRB chair, rather than the full convened board, can approve research that qualifies for expedited review. Contrary to the definition and common usage of the word “expedited,” this type of review is not necessarily faster. Based on the HawkIRB application, the IRB chair determines whether the research meets one or more of the expedited review criteria. Even when the project appears to meet the criteria for expedited review, the IRB chair may refer the application for full board review if they have any concerns about approval of the project. An IRB chair can approve a project using expedited review procedures, but they cannot disapprove a project.  

An IRB chair or designee can also use expedited review of modifications to previously approved research projects if the modification involves only minor changes to the approved project. For projects that were initially reviewed by the full board, the IRB can use expedited review procedures for modifications that are considered minimal risk. The IRB can also use expedited review procedures for the continuing review of greater than minimal risk research under the following circumstances: 

Full Board Review 

The full IRB must review human subjects research that is greater than minimal risk for participants at a convened meeting. A research study undergoes full board review after the IRB chair, or their designee, reviews the entire application and determines that the project constitutes human subjects research which is greater than minimal risk.  

Full board review is required in the following instances: 

Summary 

The categories of review allow the IRB to assess the potential for risk to the human subjects and to provide the appropriate level of oversight as proscribed by federal regulations and institutional policies. Although there are sometimes nuances involved in assessing the category of review, the driving force behind the assessment is the ethical conduct of research and the protection of participants. 

Questions about this topic? You can email the HSO Education and Outreach team, or come to Office Hours to speak directly to a member of the HSO team.  

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