The federal regulations, Title 45 CFR Part 46, describe three levels of IRB review (see below). Note that the IRB will make the final determination whether your application is appropriate for full, expedited, or exempt review. The IRB may request additional information or revision of materials or procedures before approval. A quicker response time is dependent, in part, on whether the application is neatly and completely filled out, avoids the use of jargon, and includes copies of all pertinent materials attached in a logical order.
- Exempt: Only minimal risk research may be classified as exempt. Note that unmanaged risk or risk that is not acknowledged by the researcher may bump up the review category. The federal regulations identify six categories of research that are exempt from IRB review. The IRB does not approve research that is classified as exempt, rather it makes a determination that the research meets the criteria for at least one of the six exempt categories. At that point, the IRB office will do a cursory “review” which includes general confidentiality and data security issues, informed consent format, experimental design methodology, and ethical considerations. The IRB does not conduct continuing reviews of exempt research, but any changes to the exempted project should be reviewed by the IRB to ensure the exemption still applies.
EXAMPLES: Research on the effectiveness of instructional techniques; minimal risk surveys where the researchers identify themselves and the
research and the subjects are not from a vulnerable population group.
- Expedited: Expedited review is a process by which certain types of minimal risk research may be reviewed and approved without convening a meeting of the IRB. Expedited reviews are not “quicker” or conducted with less rigor, but fewer reviewers are required for approval. There are several types of research that may be reviewed in an expedited manner.
EXAMPLES: Minimal risk research involving the use of audio or videotapes or previously collected and usually recorded anonymously; minimal risk behavioral research such as oral history, focus group, or program evaluation. Note that unmanaged risk or risk that is not acknowledged by the researcher may bump up the review category.
- Full Board: Research that poses greater than minimal risk to research participants will be reviewed at a convened meeting of the IRB. Three IRB meetings are scheduled in the fall and spring semesters; note that the IRB does not meet during the summer. Check with the IRB administrator for meeting dates.
EXAMPLES: Non-minimal risk projects may investigate, for example, sexual orientation, substance abuse, eating disorders, religious orientation, veteran or wartime experiences, or which reveal social security numbers, salary, or criminal history or which employ deception. Note that risk may be managed by altering the method of data collection or storage.