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IRB review is not a one-size-fits-all process. Different types of studies, depending on their level of risk, are subject to various levels of review. These levels are defined in the federal regulations and include Exempt, Expedited, and Greater Than Minimal Risk. These terms do not refer to the pace or priority of a review, but simply to the category of review, as defined below.
The IRB makes the determination if a study is Exempt, Expedited, Greater Than Minimal Risk, or Not Human Subjects Research. This determination is dependent on the nature of the study and the level of risk present to study participants. This determination is also not final: it may change based on a revision or modification to the study.
Minimal risk studies present no greater risk to participants than if they had chosen not to participate in the study.
Greater than minimal risk (GTMR) studies, however, elevate the level of risk to a point where study-related harm could occur to study participants. For example, such studies could place participants at risk of criminal or civil liability; increase the level of risk to the participant's financial standing, employability, insurability, or reputation; or be stigmatizing. Studies in which the researcher is in a position of power over potential participants do not necessarily make the study GTMR. The specific topic of the study and how it relates to that power dynamic will be considered and the IRB will make a determination of risk on a case-by-case basis.
Exempt studies must be minimal risk and fall within one of the categories listed in the federal regulations. Although still operating under IRB oversight, Exempt studies do not have an expiration date. In addition, modifications that do not change the level of review do not require IRB approval (the IRB will make this determination in a modification pre-screening after submission). Exempt studies may be approved by a single IRB reviewer.
Expedited studies must be minimal risk and fall within one of the categories listed in the federal regulations. Expedited does not mean that a review is performed faster or given priority. Rather, it is a level of review above Exempt. Certain characteristics of the study, such as the risk present, nature of the study, and identifiability of participants from data are taken into consideration. Expedited studies have an expiration date 1 year from the date of IRB approval. In addition, an approved modification application is necessary for all modifications related to recruitment and/or data collection. Expedited studies may also be approved by a single IRB reviewer.
Studies that are determined to be Greater than Minimal Risk (GTMR) are reviewed by all IRB members. The board membership meets the federal requirements. By necessity, a GTMR study will leader to a longer timeline for IRB review as each submission/resubmission must be reviewed at a scheduled meeting. If a study is determined to be GTMR the IRB Chair and Director will contact the researcher and any supports (faculty chairs), to determine if mitigation can be done to reduce the level of risk (if the researcher chooses to modify the study), and therefore the timeline to approval. All studies are reviewed by two IRB members. If two members agree that the study is greater than minimal risk, they notify the IRB Chair and Director. The members then discuss the study and may share the study with all members in a meeting as a ‘pre-review’, so that other members can also provide feedback. If necessary, experts are called in to determine if the study is GTMR. Feedback is then provided to the researcher and if the study continues, it will be added to the agenda and deliberated on by all IRB members.
Studies determined by the IRB to be NHSR do not fall under any of the federally defined categories of research nor under the purview of the IRB. Studies derived solely from archival data are not always NHSR: this determination is dependent on the identifiability of the data. Once the IRB makes a determination of NHSR, the researcher does not need to submit any modifications to the IRB unless the modification would render the study no longer NHSR.
