Lesson 18 · IRB and HRPP Administration: From Coordinator to CIP

18. Noncompliance, Research Misconduct, and IRB Suspensions Explained

55 min

After this lesson you can

  • Define noncompliance, serious noncompliance, and continuing noncompliance and describe how an IRB handles each
  • Distinguish protocol deviations from violations and from unanticipated problems
  • Explain research misconduct under 42 CFR 93: definition, standard of proof, process, and the roles of the RIO and ORI
  • Apply suspension and termination authority under 46.113 and 56.113 and the associated reporting
  • Describe post-approval monitoring, audits, and complaint handling as HRPP functions

Video coming soon

Scheduled for release on October 5, 2026.

Noncompliance, Research Misconduct, and IRB Suspension Rules separates three problems that often land on the same desk. A missed visit is a deviation, a pattern of enrolling ineligible subjects is continuing noncompliance, and falsified dates are misconduct, and this lesson shows where each one is reported.

5 Key Facts from This Lesson

  1. Serious noncompliance and continuing noncompliance must be reported to OHRP and FDA, while minor noncompliance is not.
  2. Research misconduct is limited to fabrication, falsification, and plagiarism, and honest error or differences of opinion are not misconduct.
  3. A finding of research misconduct requires a preponderance of the evidence, not proof beyond a reasonable doubt.
  4. The IRB handles noncompliance through its written procedures, while the institution's Research Integrity Officer handles research misconduct under 42 CFR 93.
  5. Suspensions and terminations of IRB approval must be reported to the investigator, institutional officials, and the department or agency head, but holds an investigator places on their own study are not IRB suspensions.

Exam traps

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

  • Serious and continuing noncompliance are the two categories reportable to OHRP and FDA; minor noncompliance is not

  • Research misconduct is fabrication, falsification, or plagiarism only; honest error, differences of opinion, and authorship disputes are not misconduct

  • Preponderance of the evidence, not beyond a reasonable doubt

  • Inquiry precedes investigation; ORI is notified before the investigation begins; 60 days and 120 days

  • Suspensions and terminations are reportable; investigator-initiated holds are not

  • 56.120 to 56.124 apply to IRBs; investigator disqualification is 312.70 and 812.119

Practice quiz

  1. Question 1
    Under 42 CFR 93, research misconduct means:
  2. Question 2
    The standard of proof for a finding of research misconduct under 42 CFR 93 is:
  3. Question 3
    Which categories of noncompliance must be reported to OHRP under 45 CFR 46.108(a)(4)?
  4. Question 4
    When an IRB suspends approval of a study, it must report the suspension to:
  5. Question 5
    In the research misconduct process, the step that determines whether a full investigation is warranted is the:

Recap

  • Noncompliance: failure to follow the regulations, the IRB's requirements, or the protocol; serious increases risk or affects rights or data; continuing is a pattern or repeated failure to respond; both are reported
  • Deviations are any departure; violations affect rights, welfare, or data; the same act may also be a UP
  • Misconduct: fabrication, falsification, plagiarism; not honest error; significant departure, intent or recklessness, preponderance; inquiry 60 days, investigation 120 days, ORI oversight, six-year limit
  • Suspension and termination under 46.113 with reasons and reports to the investigator, the IO, and the agency; FDA sanctions on IRBs and investigators
  • Post-approval monitoring, audits, and complaints are how the board finds out

Coming next

Lesson 19, what the minutes must contain.

Saved in your browser only: no account, no server.

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.