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The exempt research categories are the eight specific, numbered classes of human-subjects research set out at 45 CFR 46.104(d) of the revised Common Rule, each describing a narrow combination of activity and built-in safeguard that regulators judged carries little enough risk to exempt it from most of the Common Rule’s procedural requirements. They are not a general “low-risk” waiver — a study qualifies only if it fits one of the eight categories’ specific wording, and several categories carry their own conditions before the exemption applies. This page walks through all eight, explains who actually gets to decide that a study is exempt (it is not the investigator), and flags which categories are new since the 2018 revision. For how the exempt pathway differs from the next tier of review, see CASRAI’s Exempt vs. Expedited IRB Review comparison.
Last verified August 25, 2026 against the eCFR text of 45 CFR 46.104 (Exempt research).
The Eight Exempt Categories at a Glance
All eight categories live at § 46.104(d). The summaries below are plain-language paraphrases meant for orientation — the parenthetical conditions matter, and the regulation itself should be checked before an exemption is relied on. Note also that four of the eight categories — (d)(2)(iii), (d)(3)(i)(C), (d)(7), and (d)(8) — are only available if an IRB completes a required “limited review,” so “exempt” and “no IRB touches it” are not the same thing even within this list.
| Category | What it covers | Plain-language summary |
|---|---|---|
| (d)(1) | Normal educational practices | Research on standard instructional strategies, curricula, or classroom-management methods in established educational settings, provided it won’t adversely affect students’ opportunity to learn required content or educators’ assessment. |
| (d)(2) | Educational tests, surveys, interviews, public observation | Cognitive/diagnostic/achievement tests, survey procedures, interview procedures, or observation of public behavior — exempt if subjects aren’t readily identifiable, disclosure risk to them is low, or (when identifiable) an IRB completes a limited review. |
| (d)(3) | Benign behavioral interventions (new, 2018) | Brief, harmless interventions with adult subjects who prospectively agree — the regulation’s own examples are an online game, a puzzle task, or deciding how to split a small cash amount — combined with response collection, under the same three identifiability options as (d)(2). |
| (d)(4) | Secondary research without new consent | Using already-collected identifiable private information or biospecimens for new research, where the data is publicly available, effectively de-identified to the investigator, governed by specific HIPAA provisions, or certain federal-government-generated data under strict conditions. |
| (d)(5) | Federal public-benefit demonstration projects | Research or demonstration projects conducted or approved by a federal department or agency to study, evaluate, or improve public benefit or service programs, provided the project is posted to a public list before human-subjects research begins. |
| (d)(6) | Taste and food quality evaluation | Consumer taste and food-quality studies using wholesome foods without additives, or foods with ingredients, agricultural chemicals, or contaminants at levels already found safe by FDA, EPA, or USDA’s Food Safety and Inspection Service. |
| (d)(7) | Storage/maintenance for future secondary research (new, 2018) | Banking identifiable private information or biospecimens for potential future secondary research, contingent on an IRB’s limited review making the determinations required at § 46.111(a)(8). |
| (d)(8) | Secondary research use under broad consent (new, 2018) | Actually using banked identifiable private information or biospecimens for a specific secondary study, where broad consent was obtained and documented, an IRB’s limited review confirms the study is within that consent’s scope, and returning individual results to subjects isn’t part of the plan. |
Risk plays a role in several of these categories even though “minimal risk” isn’t the exemption test itself — see CASRAI’s Minimal Risk vs. Greater Than Minimal Risk comparison for how that separate threshold is defined and where it applies elsewhere in the Common Rule.
Who Determines Whether Research Is Exempt
“Exempt” does not mean “no IRB involvement,” and it does not mean the research team gets to self-certify. The regulatory text itself only says an exempt activity “must comply with the requirements of this section and as specified in each category” — it doesn’t name who has to make that call. But OHRP’s longstanding, explicit recommendation is that investigators should not be given authority to independently determine that their own research is exempt, precisely because that creates a conflict of interest. OHRP instead recommends that every institution adopt a written policy naming who is authorized to make exemption determinations — typically the IRB office, a designated IRB chair or vice chair, or another individual with documented human-subjects-protections training — and most institutions with a Federalwide Assurance do exactly that.
Practically, this means a study a researcher believes fits one of the eight categories still needs to go through an institutional intake or determination process, distinct from both full board review and the separate expedited review pathway used for minimal-risk non-exempt research. Four of the eight categories go a step further and require the reviewer to complete a formal “limited IRB review” under § 46.111(a)(7) or (a)(8) before the exemption applies at all — that is a substantive review of specific privacy/confidentiality or broad-consent-scope criteria, not a rubber stamp.
What Changed in the 2018 Revised Common Rule
The pre-2018 Common Rule listed six exempt categories. The 2018 Requirements expanded that to eight, and the additions are worth flagging by name because they’re a common source of outdated guidance still circulating in older institutional materials:
- (d)(3), benign behavioral interventions, is entirely new. It didn’t exist as an exemption category before the 2018 revision; brief, low-burden behavioral studies with adult subjects previously had to fit elsewhere or go through expedited/full review.
- (d)(7) and (d)(8) are both new and are built around broad consent (§ 46.116(d)), a consent mechanism the same 2018 revision introduced. (d)(7) covers banking identifiable data/biospecimens for possible future secondary use; (d)(8) covers actually running a secondary study on data or biospecimens banked that way. Neither category is usable without broad consent already in place.
- Limited IRB review became a formal gateway for several categories — (d)(2)(iii), (d)(3)(i)(C), (d)(7), and (d)(8) all require it, tying certain exemptions to a documented, though lighter-weight, IRB determination rather than a pure administrative sign-off.
For the fuller regulatory picture — how these exemptions interact with the Common Rule’s other subparts, and the rest of what the 2018 revision changed beyond the exempt categories — see CASRAI’s 45 CFR 46 and the Common Rule: What Each Subpart Covers.
