Direct comparison
Expedited vs. Full Board IRB Review
IRB expedited vs. full board review compared: 45 CFR 46.110 eligibility, who can disapprove, timelines, and what triggers a mid-study switch.
Side-by-side comparison
| Dimension | Expedited Review | Full Board Review |
|---|---|---|
| Who reviews | IRB Chair, or one or more Chair-designated experienced reviewers | The full convened IRB, quorum present (majority of members, including at least one non-scientist) |
| Risk threshold | No more than minimal risk | Greater than minimal risk, OR minimal risk that does not fit an expedited category |
| Eligibility basis | Must satisfy BOTH the minimal-risk standard AND fit one of OHRP's enumerated expedited categories (45 CFR 46.110 / 21 CFR 56.110) | Default pathway for any non-exempt, non-expedited-eligible human subjects research (45 CFR 46.108) |
| Can it disapprove a study? | No -- disapproval is reserved for the convened board | Yes -- the only pathway that can disapprove |
| Typical timeline | Days to roughly 1-2 weeks; not tied to a meeting date | Weeks to a month or more, tied to the IRB’s scheduled (commonly monthly) meeting calendar and submission deadlines |
| Continuing review | Often exempt from the continuing-review requirement entirely under 45 CFR 46.109(f) (2018 Common Rule revisions) | Required at least annually per 45 CFR 46.109(e) for as long as the study needs convened-board review; FDA-regulated research (21 CFR 56.109(f)) has no equivalent exception |
| Can change mid-study | Can be elevated to full board by a risk-increasing amendment, new safety information, or a reviewer eligibility determination | Can move to expedited only in narrow, defined circumstances (e.g., certain minor changes to previously approved research) |
Common questions
FAQ
Can one reviewer disapprove a study under expedited review?+
No. An expedited reviewer can approve or require modifications, but disapproval is reserved exclusively for a convened meeting of the full IRB under 45 CFR 46.108(b).
Who decides whether a study qualifies for expedited review?+
IRB staff typically make an initial screening determination, which the IRB Chair or a designated experienced reviewer confirms when the review begins, checking both the minimal-risk standard and category fit.
Is expedited review the same as exempt research?+
No. Exempt research is excused from most IRB oversight requirements under specific Common Rule categories; expedited research still receives a full substantive IRB review, just by one or a few reviewers instead of the convened board.
Does expedited review mean less scrutiny?+
Not in principle -- the substantive approval standard is the same. What differs is who reviews it and whether disapproval is possible at that level.
