Lesson 10 · IRB and HRPP Administration: From Coordinator to CIP

10. Expedited, Full Board, and Continuing Review: The 9 Categories and 46.109(f)

60 min

After this lesson you can

  • State the nine expedited review categories and the conditions for using the expedited procedure
  • Explain who may conduct expedited review and what they may and may not decide
  • Describe convened review and when it is required
  • Apply the continuing review rules, including the 46.109(f) exceptions and the FDA annual requirement
  • Explain approval periods, expiration, lapses, and review of modifications

Video coming soon

Scheduled for release on September 24, 2026.

Expedited vs Full Board IRB Review and Continuing Review Rules covers every review pathway above exempt, including the nine expedited categories and the continuing review changes that arrived with the 2018 Requirements. You will learn the one power an expedited reviewer never has and how risk decides the pathway.

5 Key Facts from This Lesson

  1. An expedited reviewer may exercise every authority of the IRB except disapproval, which only the convened board can do.
  2. Expedited category 2 allows up to 550 mL of blood in 8 weeks, no more than twice a week, for healthy nonpregnant adults weighing at least 110 pounds.
  3. Expedited category 4 covers noninvasive clinical procedures but excludes those using x-rays or microwaves.
  4. Under HHS since the 2018 Requirements, expedited research needs no continuing review unless the reviewer documents why it should, while FDA always requires review at least annually.
  5. There is no grace period after IRB approval expires, and changes without prior approval are allowed only to eliminate apparent immediate hazards to subjects.

Exam traps

The distinctions exam questions on this topic are most often built to test. Know them cold.

  • An expedited reviewer may not disapprove

  • 550 mL in 8 weeks, no more than twice a week, for healthy nonpregnant adults of at least 110 pounds; the lesser of 50 mL or 3 mL per kg for everyone else

  • Category 4 excludes x-rays and microwaves

  • Under HHS since 2018, expedited-eligible research needs no continuing review unless the reviewer documents otherwise; under FDA, annual review is always required

  • There is no grace period after expiration

  • Changes without prior approval are permitted only to eliminate apparent immediate hazards

Practice quiz

  1. Question 1
    Under the expedited procedure, a designated reviewer may NOT:
  2. Question 2
    For healthy, nonpregnant adults weighing at least 110 pounds, expedited category 2 permits blood collection of up to:
  3. Question 3
    Since the 2018 Requirements, continuing review under 45 CFR 46 is NOT required for:
  4. Question 4
    When IRB approval of a study lapses:
  5. Question 5
    An investigator may implement a change to approved research before IRB approval only when:

Recap

  • Expedited procedure: on the Secretary's list and minimal risk, or minor changes, or limited IRB review; by the chair or experienced designated members; all authorities except disapproval
  • Nine categories with their conditions and numbers
  • Convened review for greater than minimal risk, research not on the list, disapprovals, prisoner research, and Secretary referrals
  • Continuing review at least annually with the three 2018 exceptions under HHS; always annual under FDA; no grace period; lapse stops research
  • Changes require prior approval except to eliminate apparent immediate hazards

Coming next

Lesson 11, the eight criteria for approval in 46.111.

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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.