Lesson 23 · IRB and HRPP Administration: From Coordinator to CIP

23. Conflict of Interest in Research: 42 CFR 50 Subpart F, 21 CFR 54, and IRB Members

55 min

After this lesson you can

  • 1. State the PHS FCOI rule: SFI threshold, disclosure, determination, management, reporting
  • 2. State the FDA financial disclosure requirements in 21 CFR 54
  • 3. Apply the IRB member conflict rule in 46.107(e) and 56.107(e)
  • 4. Describe institutional conflicts of interest and management strategies
  • 5. Explain how COI information reaches the IRB and the consent form

Video coming soon

Scheduled for release on October 10, 2026.

Research Conflict of Interest: PHS, FDA, and IRB Member Rules sorts out three conflict of interest rulebooks with different thresholds and different duty holders. This lesson shows how financial conflicts reach the IRB, the consent form, and the meeting room.

5 Key Facts from This Lesson

  1. Under the PHS rule at 42 CFR 50 Subpart F, remuneration plus publicly traded equity exceeding $5,000 in twelve months is a significant financial interest, and any equity in a non-public company counts regardless of value.
  2. FDA's 21 CFR 54 thresholds are 25,000 in other payments, and both extend one year after the study ends.
  3. PHS conflict of interest training is required at least every four years, and investigators update disclosures within 30 days of acquiring a new significant financial interest.
  4. The PHS rule binds the institution, while the FDA rule binds the applicant or sponsor, who collects disclosures from investigators.
  5. IRB members with a conflict may provide information if the board asks, but they may not deliberate or vote on that study.

Exam traps

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

  • $5,000 is the PHS SFI threshold for publicly traded equity plus remuneration; any equity in a non-public company counts regardless of value

  • $50,000 publicly traded equity and $25,000 other payments are FDA 21 CFR 54 thresholds, and they extend one year after study completion

  • PHS FCOI training is at least every four years; PHS disclosure updates within 30 days of a new SFI

  • The PHS rule binds the institution; the FDA rule binds the applicant collecting from investigators

  • IRB members with conflicts may provide information if asked but may not deliberate or vote

  • Sponsored travel is disclosed under the PHS rule even though it is not summed toward $5,000

Practice quiz

  1. Question 1
    Under 42 CFR 50 Subpart F, a significant financial interest for a publicly traded entity exists when remuneration plus equity value in the preceding twelve months exceeds:
  2. Question 2
    Under 21 CFR 54, a significant equity interest in a publicly traded sponsor is one exceeding:
  3. Question 3
    PHS-funded investigators must complete FCOI training at least every:
  4. Question 4
    Under 45 CFR 46.107(e), an IRB member with a conflicting interest in a protocol:
  5. Question 5
    Which document certifies to FDA that a clinical investigator has no disclosable financial arrangements?

Recap

  • PHS rule: institution is the duty holder; SFI over $5,000 or any private equity or IP income; disclose at application, annually, and within 30 days; relatedness and FCOI determinations; management plan before spending; reports to the awarding component; public accessibility; training every 4 years; 120-day retrospective review
  • FDA rule: applicant is the duty holder; four arrangements; 25,000 other payments through one year after completion; Forms 3454 and 3455
  • IRB members: 46.107(e) and 56.107(e); provide information only; recusal procedure and quorum recheck
  • Institutional COI: separate committee, rebuttable presumption, AAMC and AAU
  • COI reaches the IRB through the COI committee and the consent form through the IRB's conditions

Coming next

Lesson 24 covers reporting to OHRP and FDA, compliance oversight, and the education program.

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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.