Lesson 20 · IRB and HRPP Administration: From Coordinator to CIP

20. From Intake to Approval Letter: Three IRB Protocols Worked End to End

60 min

After this lesson you can

  • Sequence the determinations an IRB office makes on a new submission from intake to approval letter
  • Apply the Domain 2 rules to three worked protocols of different types
  • Produce the documentation trail each determination requires
  • Identify the FDA overlay when a protocol involves a regulated product
  • Consolidate the Domain 2 exam traps into a single review sheet

Video coming soon

Scheduled for release on October 7, 2026.

From Intake to Approval: 3 IRB Protocols Worked End to End turns twelve lessons of rules into one workflow. This lesson walks a survey study, a Phase II drug trial, and a pediatric device study from intake to approval letter and gathers the most-tested Domain 2 numbers on one sheet.

5 Key Facts from This Lesson

  1. Every review starts with the same questions in order: is it research, does it involve human subjects, is the institution engaged, and is it FDA-regulated.
  2. A minimal risk survey study can move through exemption with limited IRB review or through expedited category 7, with documentation of consent waived.
  3. A Phase II drug trial needs convened review, a full signed and dated consent form, and continuing review at least annually under FDA.
  4. An NIH-funded pediatric device study falls under both HHS and FDA rules, requires Subpart D findings, and is reviewed by a single IRB for all sites.
  5. Unanticipated adverse device effects are reported by the investigator to the sponsor and the reviewing IRB within 10 working days.

Exam traps

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

  • 5 minimum members; 1 scientist, 1 nonscientist, 1 unaffiliated; majority quorum with a nonscientist; majority of those present to approve

  • 8 exemption categories; 9 expedited categories; 550 mL in 8 weeks, twice a week, 110 pounds; 50 mL or 3 mL per kg for others

  • 8 criteria for approval plus paragraph (b); 9 basic and 9 additional consent elements; 5 waiver criteria; 3 HHS and 2 FDA documentation waiver criteria; 60 days to post

  • 3 HIPAA waiver criteria; 16 limited data set identifiers; 18 Safe Harbor identifiers; 6-year HIPAA retention; 8 PPRA topics; FERPA rights at 18

  • 10 Subpart B conditions; 7 Subpart C findings; 4 Subpart C categories; 4 Subpart D categories; 1 or 2 parents

  • 3-part UP test; 7 and 15 calendar days; 10 working days; 60 and 120 days for misconduct; 6-year misconduct limit

  • 5 minute elements; 3-year record retention; 3-year IRB registration; 5-year FWA

  • HHS versus FDA: exemptions exist only under HHS; continuing review has exceptions only under HHS; broad consent and posting only under HHS; consent waiver under both since 2024; documentation waiver 3 versus 2; sanctions on IRBs only under FDA

  • Expedited reviewer may approve but never disapprove; the institution may disapprove but never approve over the board

  • Nonscientist must be present for quorum; the unaffiliated member need not be

  • Assent is affirmative agreement, not failure to object; permission is the parent's act; consent is for adults

  • 404 and 405 one parent; 406 and 407 both; wards need an advocate for 406 and 407

  • UP is unexpected, related, and greater risk; serious is outcome; unexpected is against the documents

  • Serious or continuing noncompliance is reported; minor is not; misconduct is FFP only

  • Minutes need counts for, against, and abstaining, and controverted issues even when unanimous

Practice quiz

  1. Question 1
    A federally funded, minimal-risk adult interview study with identifiable sensitive responses that does not qualify for exemption would most likely be reviewed under:
  2. Question 2
    For an FDA-regulated Phase II drug trial, continuing review must occur:
  3. Question 3
    In a pediatric device study approved under 46.406, parental permission must be obtained from:
  4. Question 4
    Which determination must an IRB make and document for a device study that the sponsor labels nonsignificant risk?
  5. Question 5
    A protocol using PHI from a covered entity without individual authorization requires the IRB or Privacy Board to document:

Recap

  • Thirteen steps from intake to letter, each tied to a lesson
  • Protocol A: survey, exempt with limited IRB review or expedited category 7, documentation waived, no continuing review
  • Protocol B: Phase II drug trial, dual coverage, convened review, full consent under both rule sets, HIPAA authorization and screening waiver, annual continuing review
  • Protocol C: pediatric device study, NSR determination, Subpart D by component with both parents and an advocate for wards, single IRB reliance
  • Two trap sheets for the whole domain

Coming next

Lesson 21 begins Domain 3 with single IRB review and reliance.

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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.