Direct comparison
Exempt vs Expedited IRB Review
Exempt research is excused from Common Rule requirements by category. Expedited review is a faster procedure for research still fully subject to them.
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How do Exempt, Expedited compare side by side?
The table below compares Exempt, Expedited across 9 procurement-relevant dimensions, from governing citation through can a study be both?.
Side-by-side comparison
| Dimension | Exempt | Expedited |
|---|---|---|
| Governing citation | 45 CFR 46.104 | 45 CFR 46.110 |
| What it is | A category-based excusal from the Common Rule’s requirements | A streamlined review procedure for research still fully subject to the Common Rule |
| Basis for eligibility | Fits one of 8 defined exemption categories in 46.104(d) | No more than minimal risk, and fits a category on the HHS Secretary’s published expedited-review list |
| Who conducts the review | A designated exemption-determination reviewer (institutional policy; not the investigator) | The IRB chairperson, or one or more experienced reviewers the chair designates |
| Full convened board involved? | No, except where the category itself requires "limited IRB review" | No — that is the entire point of the procedure |
| Can the reviewer disapprove the research? | N/A — the determination is whether it qualifies as exempt, not an approval decision | No — disapproval requires referral to the full convened board |
| Ongoing Common Rule oversight | Generally sits outside continuing Common Rule requirements once determined exempt | Fully subject to Common Rule requirements — informed consent, reporting, etc. — just reviewed via a lighter procedure |
| Categories requiring extra scrutiny | Categories (2)(iii), (3)(i)(C), (7) and (8) require "limited IRB review" as a condition of exemption | The eligible-category list itself is reviewed by HHS at least every 8 years |
| Can a study be both? | No — exempt and expedited are mutually exclusive positions | No — a study must not qualify as exempt to be eligible for expedited review at all |
Common questions
Common questions about Exempt vs Expedited
Can an investigator determine their own study is exempt?
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The regulation itself does not spell out who must make the determination, but institutional policy overwhelmingly requires it to be someone other than the investigator — typically the IRB office or a designated reviewer — because self-determined exemption is a recognized compliance failure point. Check your own institution’s policy; it will state this explicitly.
If a study is exempt, does it get any IRB review at all?
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Sometimes. Four of the eight exemption categories — (2)(iii), (3)(i)(C), (7), and (8) — require a "limited IRB review" as an explicit condition of the exemption, even though the study is still classified as exempt overall. The other categories generally do not require this.
What can an expedited reviewer not do that a full board can?
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An expedited reviewer — the IRB chair or a designated experienced reviewer — can exercise essentially all IRB authorities except one: they cannot disapprove the research. If a study reviewed under the expedited procedure warrants disapproval, it must be referred to the full convened board.
Is expedited review a lower level of protection than full board review?
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No — it's a different procedure applied to research the Common Rule already treats as no more than minimal risk. The research remains fully subject to the same substantive requirements (informed consent, ongoing compliance, reporting) as anything reviewed by the full board; only the review mechanism itself is streamlined.
How often is the expedited-review category list updated?
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The HHS Secretary is required to review the list of eligible expedited-review categories at least every 8 years, and may amend it after consulting other federal departments and agencies and publishing proposed changes in the Federal Register for public comment.
