Lesson 24 · IRB and HRPP Administration: From Coordinator to CIP

24. Reporting to OHRP and FDA, Compliance Oversight, and HRPP Education Programs

55 min

After this lesson you can

  • 1. State what an institution must report to OHRP and FDA, when, and through whom
  • 2. Describe OHRP and FDA compliance oversight processes and possible outcomes
  • 3. Identify intersecting reporting obligations: ClinicalTrials.gov, FCOI, misconduct, state law
  • 4. Describe the components of an HRPP education program and the federal expectations behind them
  • 5. Describe quality assurance and quality improvement as HRPP functions and their metrics

Video coming soon

Scheduled for release on October 11, 2026.

Reporting to OHRP and FDA, Compliance Oversight, and Education covers what gets reported, to whom, and how fast. One undefined word, prompt, sets the clock and two agencies inspect, and this lesson also shows how to build the HRPP education program that prevents the reports.

5 Key Facts from This Lesson

  1. Three categories must be reported promptly to OHRP and FDA: unanticipated problems, serious or continuing noncompliance, and suspensions or terminations of IRB approval.
  2. The regulations never define prompt, and OHRP guidance suggests a written report within about one month of the IRB's determination.
  3. OHRP oversees HHS-supported research and FDA oversees FDA-regulated research, and both can apply to the same study.
  4. A Form FDA 483 is a list of inspectional observations, not a final agency action, and a Warning Letter follows only if FDA concludes significant violations occurred.
  5. Applicable clinical trials must register on ClinicalTrials.gov within 21 days of first enrollment and report results within one year of primary completion.

Exam traps

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

  • Three reportable categories to OHRP and FDA: UPs, serious or continuing noncompliance, suspensions or terminations

  • "Prompt" is undefined in the regulation; OHRP guidance suggests about one month from the IRB's determination

  • OHRP oversees HHS-supported research; FDA oversees FDA-regulated research; both may apply to one study

  • NIH GCP training refreshes every three years; PHS FCOI training every four; NIH human subjects education has no federally fixed refresh

  • Form FDA 483 is an inspectional observation, not a final agency action

  • ClinicalTrials.gov registration within 21 days of first enrollment; results within one year of primary completion

Practice quiz

  1. Question 1
    Which of the following must an institution promptly report to OHRP under 45 CFR 46.108(a)(4)?
  2. Question 2
    FDA administrative actions against a noncompliant IRB, including disqualification, are found in:
  3. Question 3
    NIH requires Good Clinical Practice training for investigators and staff on NIH-funded clinical trials to be refreshed at least every:
  4. Question 4
    Under FDAAA section 801, an applicable clinical trial must be registered on ClinicalTrials.gov within how many days of enrolling the first participant?
  5. Question 5
    Which body issues determination letters after evaluating compliance with 45 CFR 46?

Recap

  • Report three categories to the IRB, institutional officials, and OHRP or FDA; prompt means about one month from the IRB's determination per OHRP guidance
  • OHRP evaluates and issues determination letters, may restrict or suspend the FWA; FDA inspects under BIMO, issues 483s and Warning Letters, and may act against IRBs under 56.120 to 56.124 and investigators under 312.70 and 812.119
  • Intersecting obligations: ClinicalTrials.gov 21 days and one year, FCOI, misconduct, state mandatory reporting
  • Education program: NIH human subjects education, GCP every 3 years, FCOI every 4 years, RCR; investigator, member, staff, and community components
  • QA and QI: monitoring, self-assessment, metrics, root cause, CAPA, feedback

Coming next

Lesson 25, the capstone, with exam strategy, a mixed review, and recertification.

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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.