One of the first questions on any IRB application is the level of review. Pick the wrong one and your study can sit in the queue longer than it needs to, or come back asking for a different submission. Here is how the three levels work under the federal Common Rule (45 CFR 46), and how to tell which one fits.
The short version
- Exempt: minimal-risk research that fits one of the federal exemption categories. Lightest review.
- Expedited: minimal-risk research that does not qualify for an exemption but fits one of the federal expedited categories. Reviewed by one or more experienced board members.
- Full board: research that involves more than minimal risk, or does not fit the other two. Reviewed by the convened board.
“Minimal risk” means the chance and size of harm are no greater than what people run into in daily life or during routine exams and tests.
Exempt review
Exempt does not mean the study skips the IRB. It means the study falls into a category the regulations treat as low risk, so it gets a lighter review. Someone other than the researcher should make that call. Most institutions and funders expect the IRB to issue the exemption determination.
Common examples:
- Research on normal educational practices in classrooms, such as comparing two teaching methods
- Anonymous surveys and interviews where responses could not reasonably harm participants if disclosed
- Observation of public behavior
- Benign behavioral interventions with adults, such as brief games or decision tasks
- Secondary analysis of existing data that is publicly available or recorded without identifiers
- Taste and food quality evaluations
There are limits. For example, the survey and interview exemption works differently when participants are children, and identifiable sensitive data can push a study out of exempt status.
Expedited review
Expedited review is for minimal-risk research that does not fit an exemption. “Expedited” refers to who reviews it, not necessarily how fast. Instead of the full board, one or more experienced reviewers handle it.
Common examples:
- Surveys or interviews that collect identifiable information on topics that could be sensitive
- Studies that use audio or video recordings of participants
- Research using existing records or data that were collected for other purposes and are identifiable
- Studies of individual or group behavior, perception, or attitudes that do not fit an exemption category
Full board review
Full board review is for research that carries more than minimal risk. The convened board discusses the study and votes on it. This takes the longest and usually involves the most back and forth.
Studies often land here when they involve:
- Sensitive topics, such as illegal behavior or trauma, with identifiable participants
- Vulnerable groups, such as prisoners, in ways that raise risk
- Deception that could cause distress
- Interventions with real potential for psychological or social harm
How to tell which one fits
Ask three questions in order:
- Is the risk minimal? If not, plan on full board review.
- Does it fit an exemption category exactly? If yes, it is likely exempt. Read the category language closely, because small details like identifiers or the age of participants change the answer.
- If not exempt, does it fit an expedited category? If yes, expedited. If not, full board.
When in doubt, ask before you submit. A short pre-submission conversation with a board member is the fastest way to confirm the level and avoid a resubmission.
How review level affects cost and timing
The level of review drives both what you pay and how long it takes. At TIER, social-behavioral studies typically take about two weeks for exempt and expedited review and about four weeks for full board. You can see every fee on our IRB fees and submission page.
Not sure where your study lands? Contact us and we will help you sort it out before you apply, or learn more about our IRB review services.
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