There are four levels of review for IRB applications: Not Human Subjects Research, Exempt, Expedited, and Full review. The level of risk to the research participant and the types of research procedures used will determine which level of review is required.

Not Human Subjects

Certification of Not Human Subjects Status Projects in this category do not meet the federal definition of research. Projects can be reviewed by the IRB to obtain formal designation as “Not Human Subjects” research, which may be required by academic programs or for dissemination purposes. This category is most appropriate for non-generalizable evidence-based practice projects.

Exempt

Exempt research projects are projects that meet specific federal criteria and fall into one of six categories of research. Although studies in this category are technically exempt from the need for IRB oversight, all Exempt research must be initially reviewed and certified as to the Exempt status of the study by the IRB (45 CFR § 46.104), which requires the submission of an application for Exempt Review.

Expedited

Research studies which pose no more than minimal risk to subjects, as assessed by the IRB, may qualify for an expedited review process. This does not meet a “faster” review process—it simply means that the application may be reviewed through a process other than a full board review as designated by the chair of the IRB.

“Minimal risk means that the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests” (45 CFR § 46.102(j)).

Full

Research studies that pose more than minimal risk to subjects must be reviewed by the full IRB. Initial, continuing (renewal) and amendment (modification) applications that involve greater than minimal risk to subjects, must be reviewed via the Full Committee review process and submitted at least two weeks prior to the monthly scheduled IRB meeting.

A full IRB review is a very rare occurrence at USD. Consult your designated IRB Representative or the IRB Administrator prior to submitting your application for full review.