Expedited IRB Review
Expedited review covers minimal-risk research that does not qualify as exempt, reviewed by the IRB chair or a designated reviewer rather than the full convened board.
Typical approval time: 2–4 weeks
Expedited review is the middle pathway. The research still poses no more than minimal risk, but it involves procedures, populations, or identifiers that disqualify it from exempt review. Instead of the full convened board meeting monthly, a single experienced reviewer (usually the IRB chair or a designee) evaluates the protocol.
Expedited review is authorized under 45 CFR 46.110. The nine expedited categories are defined in a federal notice last updated in 1998 and preserved under the 2018 revised Common Rule.
The nine expedited categories under 45 CFR 46.110
Category 1 — Clinical studies of drugs or devices
Clinical investigations of marketed drugs where an IND is not required, or medical devices that are cleared/approved and used within the cleared indication.
Category 2 — Blood collection by finger stick, heel stick, ear stick, or venipuncture
Subject to per-subject volume and frequency limits (healthy adults: up to 550 mL in 8 weeks, no more than twice per week).
Category 3 — Prospective non-invasive biological specimen collection
Hair, nail clippings, deciduous teeth, permanent teeth if indicated for extraction, excreta, saliva, placenta, amniotic fluid at delivery, dental plaque, mucosal/skin cells by swab, sputum.
Category 4 — Non-invasive data collection
Procedures routinely used in clinical practice that do not involve anesthesia or sedation — physical sensors, weighing, MRI, ECG, EEG, ultrasound, moderate exercise, and similar.
Category 5 — Research involving existing data, documents, or records
Materials collected for non-research purposes (e.g., medical records, school records) that are identifiable and therefore outside exempt Category 4.
Category 6 — Voice, video, digital, or image recordings
Research recordings made for research purposes, where participants are identifiable from the recording itself.
Category 7 — Research on individual or group characteristics or behavior
Surveys, interviews, focus groups, program evaluation, and similar research where identifiers are retained or topics are sensitive enough to exceed exempt criteria.
Category 8 — Continuing review of previously approved research
Continuing review of research where the study is permanently closed to enrollment, all participants have completed interventions, or only long-term follow-up or data analysis remains.
Category 9 — Continuing review of minimal-risk research
Continuing review of studies not covered by Categories 1–8 where the IRB has determined no additional risks have been identified.
Typical timeline
Common examples
- Interview study with patients about chronic illness experiences, with audio recording and identifiers retained for follow-up
- Finger-stick blood draw for glucose measurement in adult volunteers
- Chart review of de-identifiable clinic records that nonetheless include dates of service and rare diagnoses
- Survey of nurses about workplace burnout, with email addresses collected for a follow-up wave
- Observational gait study using wearable sensors in healthy adults
Eligibility checklist
- Study involves no more than minimal risk
- Fits one of the nine categories under 45 CFR 46.110
- No prisoners enrolled (expedited is unavailable when prisoners are the target population)
- Does not involve classified research or activities requiring full board consideration per institutional policy
- Identifiable data are protected with appropriate security (see data management guide)
What to submit
- Complete protocol (background, aims, design, population, procedures, risks, benefits, analysis)
- Informed consent document meeting 45 CFR 46.116 elements — see consent form guide
- All instruments and recruitment materials
- Data management plan describing storage, access, retention
- CITI training certificates for all study personnel — see CITI guide
- Letters of cooperation from external sites
"Minimal risk" is a regulatory term, not a judgment call
If your survey asks about suicidal ideation, substance use, or immigration status, the probability of psychological or legal harm may exceed daily life — which can push the study into full-board review regardless of the data collection method.
How expedited differs from exempt
Both pathways require minimal risk, but expedited review is triggered by any of: retained identifiers, audio/video recording, sensitive topics, minor physical procedures, or access to existing records not covered by exempt Category 4. When in doubt, draft the application as if it is expedited — reviewers will downgrade to exempt if appropriate.
Expedited approval does not mean "rushed." It means the study is routed through a streamlined review path rather than the full convened board. Prepare the same quality of documentation you would prepare for full-board review.