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.
Only minimal risk research may be classified as exempt. The federal regulations identify six categories of research that are exempt from IRB review. The IRB does not formally “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. After the exempt determination, the IRB office will then evaluate the protocol for 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. Note: if the IRB Office determines that a research project is exempt, that research activity cannot begin until the IRB Office completes their evaluation and issues an Exemption Notice to the Principal Investigator. Minor revisions to a protocol may be required before an Exemption Notice can be issued.
EXAMPLES of Exempt Projects: Research on the effectiveness of instructional techniques; minimal risk anonymous surveys where the subjects are not from a vulnerable population group; research using pre-existing data, databases, or public information.
(Beware of The Exemption Misconception. Exempt research does NOT mean that the investigator is exempt from being required to submit an application! “Exempt” is the name given in the regulations for certain categories of minimal risk research that is “exempt” from formal IRB review.)
Expedited review is a process by which certain types of minimal risk research may be reviewed and approved without convening a meeting of the full 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 receive expedited review. Typical expedited reviews are completed in 2-3 weeks from the time the application is first received. However, applications that require heavy revision may take longer to be approved by an expedited review.
EXAMPLES of Expedited Projects: Minimal risk research involving the use of audio or videotapes or previously collected and usually recorded anonymously; minimal risk behavioral research using cognitive tests, focus groups, surveys, or program evaluations. Note that unmanaged risk, risk that is not acknowledged by the researcher, or the study of vulnerable populations may bump up the review category.
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 of Full Board Reviews: Non-minimal risk projects that may investigate, for example, sexual orientation, substance abuse, eating disorders, religious identity, illegal activities, veteran or wartime experiences, or which reveal social security numbers, salary, or criminal history or which employ deception; research with children, the homeless, the handicapped, or prisoners. Note that risk may be managed by altering the method of data collection or storage.