The federal regulations, Title 45 CFR Part 46 (2018), define three levels of IRB review as described below. The IRB will make the final determination whether your application is appropriate for full, expedited, or exempt review. Human subject research is reviewed by the IRB according to The Criteria for IRB Review as found in the federal regulations at 45CFR46.111. These criteria are used for both expedited and full board reviews; not all of the §46.111 criteria are applied to exempt research.
Only minimal risk research may be classified as exempt. The federal regulations identify EIGHT categories of research (new categories for 2018) that are exempt from the full application of The Criteria for IRB Review. The first four exempt categories are, by far, the most common at JCU.
The 8 Exempt Categories can be summarized as:
Exempt 1: Educational Research
Exempt 2: Minimal-Risk Tests, Surveys, Interviews, or Observations
Exempt 3: Benign Behavioral Interventions
Exempt 4: Secondary Research of Identifiable Private Information or Biospecimens
Exempt 5: Federally Supported Research for Public Benefit or Service Programs
Exempt 6: Taste and Food Quality Evaluations
Exempt 7: Creation of Data/Biospecimens Repositories for which Broad Consent is Required
Exempt 8: Secondary Research using Data Repositories for which Broad Consent is Required
See Exempt Research Categories document for the specifications.
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 eight 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 exempt 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.
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. Submission of an IRB Application for Human Participant Research is required for all human subjects research.
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. Expedited projects are reviewed by the IRB according to The Criteria for IRB Review.
There several categories of minimal risk 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.
Research that poses greater than minimal risk to research participants will be reviewed at a convened meeting of the IRB according to The Criteria for IRB Review. 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.