9. The 8 Exemption Categories and Limited IRB Review: 45 CFR 46.104
After this lesson you can
- State all eight exemption categories in 45 CFR 46.104(d) with their conditions
- Explain limited IRB review and when it is required
- Apply the restrictions on exemptions for research with children, prisoners, and pregnant women
- Distinguish exempt research from research that is not human subjects research
- Explain who may make exempt determinations and how they are documented
Video coming soon
Scheduled for release on September 23, 2026.
The 8 Exemption Categories and Limited IRB Review Explained walks through every category in 45 CFR 46.104 under the 2018 Requirements. Exempt does not mean unreviewed, and this lesson covers the three-condition tests in categories 2 and 3, limited IRB review, and the special rules for children and prisoners.
5 Key Facts from This Lesson
- Exempt research is still human subjects research, and someone other than the investigator must determine that it qualifies.
- Limited IRB review is required for exemption categories 2(iii), 3(iii), 7, and 8.
- Category 3, benign behavioral interventions, is limited to adults, and category 2 surveys and interviews are adults only, though tests and non-participant observation may include children.
- The exemptions do not apply to research involving prisoners, except research aimed at a broader population that only incidentally includes them.
- Exempt research has no expiration date and no continuing review, and FDA-regulated clinical investigations cannot use the 46.104 exemptions.
Exam traps
The distinctions exam questions on this topic are most often built to test. Know them cold.
Category 3 is adults only; category 2 surveys and interviews are adults only, but tests and non-participant observation are permitted with children
Category 4(iii) covers HIPAA-regulated identifiable health information even though it is identifiable
Limited IRB review is required for 2(iii), 3(iii), 7, and 8, and optional nowhere
Exempt research has no expiration and no continuing review
FDA-regulated clinical investigations cannot use the 46.104 exemptions
Practice quiz
- Question 1Which exemption category requires that subjects be adults?
- Question 2Limited IRB review is required for exemption (d)(2) when:
- Question 3Exemptions under 46.104 do NOT apply to research involving:
- Question 4Storage of identifiable biospecimens for future secondary research may be exempt under (d)(7) only when:
- Question 5Which is true of exempt research?
Recap
- Eight categories with their conditions, from educational practices through broad consent secondary use
- Limited IRB review for 2(iii), 3(iii), 7, and 8: privacy and confidentiality, broad consent, and scope
- Subpart restrictions: pregnant women unrestricted; prisoners barred except incidental inclusion; children barred from surveys, interviews, and category 3
- Exempt is human subjects research reviewed differently, not research that escapes review
- Determinations by staff, chair, or designee, documented by paragraph, with no expiration
Coming next
Lesson 10, the nine expedited categories, convened review, and continuing review.
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This course is for educational purposes only and is not legal, regulatory, or compliance advice. Regulations and guidance change, so confirm every requirement against the current eCFR text, OHRP and FDA guidance, and your institution's IRB policies before relying on it. CIP® is a registered certification mark of Public Responsibility in Medicine and Research (PRIM&R). This course is produced independently by Subthesis and is not affiliated with, endorsed by, or reviewed by PRIM&R or the CIP Council. The instructor is not a Certified IRB Professional. Completing this course does not confer CIP certification, satisfy CIP eligibility requirements, or count as CIP recertification continuing education.