What Qualifies for Expedited Review Under 45 CFR 46.110?

Most researchers have a rough sense of what exempt determinations and full board review are. The middle option, expedited review, gets less attention, which is a shame because it applies to a huge number of studies and can cut weeks off your timeline. If your study is minimal risk, you should know how this works.

How expedited review fits in

IRB review has three tiers. At the lightest end, some research qualifies for an exempt determination, where the IRB confirms your study fits one of the exempt categories and issues a letter. At the other end, full board review requires a convened meeting of the full IRB committee with a quorum, formal discussion, and a vote. That's for research involving more than minimal risk.

Expedited review is the middle tier. Your study gets reviewed against all the same approval criteria as full board (45 CFR 46.111), but by the IRB chair or one or more experienced reviewers rather than the whole committee. The reviewer can approve the study or require modifications. They cannot disapprove it, though. Only the full board can do that.

The regulatory basis is 45 CFR 46.110. OHRP also publishes a list of expedited review categories that spell out which types of research procedures are eligible.

The minimal risk standard

Before anything else, your study has to involve "no more than minimal risk." 45 CFR 46.102(j) defines minimal risk as: the probability and magnitude of harm or discomfort anticipated in the research are not greater than those ordinarily encountered in daily life or during routine physical or psychological examinations. If your study clears that bar and the research procedures fall within one of the nine categories below, expedited review applies.

The nine expedited review categories

OHRP defines nine categories of research eligible for the expedited procedure. The regulatory language is dense, so here they are in plainer terms:

1. Clinical studies of drugs and devices where an IND or IDE isn't required, or the study uses a cleared/approved device according to its labeling. Usability studies on an FDA-cleared wearable fit here, as do studies of a marketed drug at standard doses.

2. Blood sample collection by finger stick, heel stick, ear stick, or venipuncture. There are limits on amount and frequency (especially for children), but routine research blood draws generally qualify.

3. Prospective collection of biological specimens by noninvasive means. Think saliva, swabs, hair and nail clippings, sweat, urine. If you're not cutting into anyone, you're probably here.

4. Data collection through noninvasive procedures used routinely in clinical practice. EKG, EEG, MRI without contrast, moderate exercise testing, body composition assessment (DEXA), and the like. Anything involving general anesthesia or sedation is excluded.

5. Research involving materials already collected (data, documents, records, specimens). If the materials were collected for non-research purposes or in a prior study, secondary analysis may qualify.

6. Voice, video, digital, or image recordings made for research purposes. Basically, recording interviews, focus groups, or observations where participants can be identified from the recording.

7. Research on individual or group characteristics or behavior. Surveys, interviews, oral histories, focus groups, program evaluations, human factors evaluations, quality assurance studies. This is probably the single most common expedited category for digital health companies.

8. Continuing review of previously approved research where remaining activity is limited to data analysis, or the study is permanently closed to enrollment and all interventions are complete.

9. Continuing review where the reviewer determines the research involves no more than minimal risk. This is a narrow one. It applies when a study that was before the full board comes up for continuing review and the reviewer finds the risk profile has changed.

The full official list is on the OHRP website.

Studies that commonly qualify

We see a lot of the same study types come through expedited review:

• Wearable device and digital health studies where participants use a cleared device per its labeling and you're collecting physiological data (Categories 1 and 4)
• Surveys and interviews with identifiable data that go beyond what's exempt, for instance when sensitive topics are involved or the data linkage itself could pose risks (Category 7)
• Low-risk clinical data collection: chart reviews, observational studies, registry analyses involving identifiable records (Category 5)
• Usability and human factors studies where participants interact with a prototype or device and give feedback (Category 7, sometimes Category 1)
• Biospecimen collection involving routine draws or noninvasive sampling (Categories 2 and 3)

The line between exempt and expedited trips people up. Our post on exempt determinations under 45 CFR 46.104(d) goes into more detail, but the rough rule: purely surveys or secondary data analysis with no identifiable risk is often exempt. Add identifiable sensitive data, any kind of intervention (even low-risk), or procedures beyond basic observation, and you're in expedited territory.

What doesn't qualify

If your study involves more than minimal risk, expedited review is off the table and you need full board. Some examples:

• Investigational drugs under an IND at above-standard dosing
• Surgical or significantly invasive procedures done for research purposes
• Studies where a breach of confidentiality could result in criminal liability or serious social harm

Worth noting: the designated reviewer can always refer a study to the full board if they think the risk warrants it, even if the study technically fits an expedited category.

Getting through expedited review faster

Almost every delay we see comes from an incomplete submission, not the review itself. A few things that really help:

State your risk assessment up front. Don't make the reviewer piece it together. Say explicitly why your study is minimal risk and cite the specific expedited category you think applies. This alone eliminates most back-and-forth.

Get your consent form right. The same informed consent requirements apply whether one reviewer reads it or the full board does. Vague risk descriptions and missing required elements are the top reasons for revision requests. [edit] Check out our blog post about informed consent for dos and don'ts.

Use a checklist. Our submission readiness checklist covers what the IRB needs to see regardless of review type. It sounds boring, but a complete submission is the single fastest way through the process.

Spell out your data handling. For digital health and remote studies especially, reviewers want to see the data flow from collection to storage, who has access, and how you protect privacy. Don't leave them guessing.

Expedited review at Tempus IRB

Tempus IRB turns around expedited reviews within 8 business hours of submission typically (excluding submitter revisions). Pricing is flat-rate: $3,000 for expedited studies, $7,500 for high-risk, $500 for amendments. No hourly billing or complicated a la carte pricing. If you're not sure which review category fits your study, email us and we'll help you figure it out before you submit. You can also sign up and submit directly.

This post is for informational purposes only and does not constitute legal advice.