Written and maintained by CASRAI Editorial Board
Last updated
Financial conflict of interest (FCOI) for research funded by the Public Health Service (PHS) — including NIH — is governed by a single federal regulation: 42 CFR Part 50, Subpart F, “Promoting Objectivity in Research” (the parallel 45 CFR Part 94 covers PHS contracts rather than grants and cooperative agreements). It sets a specific dollar threshold for what counts as a reportable financial interest, a fixed disclosure timeline, and a required institutional process for reviewing and managing any conflict it finds. This page works through all three in the order an institutional FCOI office actually applies them: what has to be disclosed, when, and what happens once a conflict is identified.
Last verified 2026-08-16 against the regulatory text at 42 CFR Part 50 Subpart F (law.cornell.edu / eCFR) and NIH’s FCOI policy guidance at grants.nih.gov. Re-check the $5,000 figure directly against 42 CFR 50.603 if citing this page more than about 18 months after that date — it is the number most likely to move in a future rulemaking.
The significant financial interest (SFI) threshold
An institution’s FCOI policy only has to act on interests that meet the federal definition of a significant financial interest (SFI), set out at 42 CFR 50.603. The threshold differs depending on whether the entity is publicly traded:
| Entity type | What triggers disclosure |
|---|---|
| Publicly traded entity | Aggregated remuneration in the prior 12 months (salary, consulting fees, honoraria, paid authorship) plus the value of any equity interest, together exceeding $5,000 |
| Non-publicly-traded entity | Remuneration exceeding $5,000 in the prior 12 months, or any equity interest at all, regardless of value |
| Intellectual property | Intellectual property rights and royalty income, when the investigator holds them directly (not through the institution) |
| Sponsored/reimbursed travel | Travel paid or reimbursed by an outside entity in connection with the investigator’s institutional responsibilities, subject to certain regulatory exclusions |
What is excluded. Money the investigator’s own employing institution pays them — salary, royalties, or other remuneration, including intellectual property assigned to the institution and royalty-sharing agreements tied to that IP — does not count toward the SFI threshold, regardless of amount or the ultimate federal funding source. This is the operative distinction for institutional stipends and RA/TA pay: a T32 or F31/F32 stipend paid by the investigator’s own institution is excluded outright, while a comparable payment from an outside company, foreign university, or unaffiliated foundation is not, and is evaluated against the $5,000/equity thresholds above. Also excluded: income from federal, state, or local government agencies; institutions of higher education; academic teaching hospitals; medical centers; or research institutes affiliated with an institution of higher education.
Who has to disclose
The disclosure duty attaches to the PHS regulatory definition of Investigator, which is broader than just the PI: it covers the project director/principal investigator and anyone else — co-investigators, senior/key personnel, and in some cases trainees — who is responsible for the design, conduct, or reporting of the PHS-funded research. Whether a given graduate student or postdoc independently meets that definition depends on their actual role on the project; many institutions apply their own FCOI policy more broadly than the federal floor requires, so the institutional policy, not just the regulation, determines who is asked to disclose.
When disclosure is required
42 CFR 50.604 sets three disclosure points, not one:
- At the time of proposal or application submission, and before an award is issued
- At least annually for as long as the PHS-funded project continues
- Within 30 days of discovering or acquiring a new SFI — the regulation’s own language covers events like a new consulting arrangement, marriage, or inheritance that newly brings the investigator over the threshold
Institutional review and the management plan
Once an investigator discloses an SFI, 42 CFR 50.605 requires a designated institutional official to review it and determine two things: whether the interest is related to the PHS-funded research, and if so, whether it constitutes an actual financial conflict of interest. If the institution determines a conflict exists, it must eliminate it or reduce it to a manageable level by implementing a written management plan — and it must report the FCOI to the PHS awarding component before expending any award funds on the affected project (institutions typically submit this as an FCOI Report through the eRA Commons FCOI module).
NIH’s own policy guidance (NIH Grants Policy Statement, and the FCOI guidance at grants.nih.gov) identifies the conditions a management plan commonly draws from, though institutions have discretion to add further terms:
- Public disclosure of the significant financial interest
- Independent review or monitoring of the research’s design, conduct, and reporting
- Modification of the research plan itself
- Disqualifying the investigator from the portion of the research the interest relates to, or changing personnel/responsibilities
- Reducing or eliminating the financial interest (divestiture)
- Severing the outside relationship that creates the conflict
The management plan is not a one-time document — institutions are expected to monitor investigator compliance with it on an ongoing basis for as long as the conflict, and the funded project, continue.
Institutional conflicts are a separate question
Everything above concerns an individual investigator’s financial interest. A related but distinct concept is institutional conflict of interest (ICOI): per the Institute of Medicine’s 2009 consensus report Conflict of Interest in Medical Research, Education, and Practice, an ICOI arises either from the institution’s own financial interests in research conducted there (equity or patent positions in a sponsoring company, licensing revenue tied to a discovery under study, company gifts or endowed positions), or from a senior official — a department chair, dean, or technology-transfer officer — exercising personal financial interest through their institutional authority over hiring, lab space, purchasing, or contract approval. Federal FCOI regulation does not separately mandate ICOI management the way it does individual SFI disclosure, but many institutional policies address both under the same governance structure. See CASRAI’s overview of the broader NIH/PHS FCOI policy for how the two fit together.
How this compares to NSF’s FCOI policy
Investigators who hold both PHS and NSF funding sometimes assume one FCOI standard applies everywhere — it doesn’t. NSF’s conflict-of-interest policy (PAPPG Chapter IX) uses a materially different threshold: salary, royalty, and other payments aggregating under $10,000 in the prior 12 months are excluded outright, and an equity interest is excluded only if it is both under $10,000 in value and no more than 5% ownership in the entity. NSF has no equivalent to the PHS “any equity interest at all” trigger for non-publicly-traded entities. An investigator’s outside interest can fall under NSF’s threshold while still triggering PHS disclosure, or vice versa — the two have to be evaluated separately. See CASRAI’s guide on faculty conflicts of interest in startups for a worked comparison.
Related requirements
- Training: Investigators must complete FCOI training before engaging in PHS-funded research and at least every four years afterward, with earlier retraining required after a policy revision, a new investigator joining a project, or a noncompliance finding. Full detail: FCOI training frequency.
- Trainee stipends: whether a stipend counts toward the SFI threshold depends on who is paying it. See conflict of interest and trainee stipends.
- Disclosure forms: for the practical mechanics of a disclosure form and what fields it typically collects, see the conflict of interest disclosure form guide.
Frequently asked questions
What is the FCOI threshold at NIH?
$5,000: for a publicly traded entity, aggregated remuneration plus equity value exceeding $5,000 in the prior 12 months; for a non-publicly-traded entity, remuneration exceeding $5,000, or any equity interest at all regardless of value. This is set by 42 CFR 50.603, not by NIH policy alone — it applies across all PHS-funded research, not NIH specifically.
What is a conflict of interest management plan?
A written plan an institution implements once it determines an investigator’s disclosed significant financial interest is both related to PHS-funded research and constitutes an actual conflict. It specifies the conditions — public disclosure, independent oversight, research-plan modification, personnel changes, divestiture, or severance of the outside relationship — under which the research may proceed, and the institution monitors the investigator’s ongoing compliance with it.
When must an institution report an FCOI to NIH?
Before expending any funds on the affected award. 42 CFR 50.605 requires the institution to report the FCOI to the PHS awarding component, and to have a management plan in place, before drawing down or spending award funds on the project the conflicting interest relates to.
Does a university salary count as a significant financial interest?
No. 42 CFR 50.603 excludes salary, royalties, or other remuneration the investigator’s own employing institution pays them, including institutionally assigned intellectual property and related royalty-sharing agreements, regardless of amount.
Sources
42 CFR Part 50, Subpart F and 42 CFR 50.603-50.605 (eCFR / law.cornell.edu); the parallel PHS-contract regulation at 45 CFR Part 94; NIH Grants Policy Statement Section 4.1.10 and the FCOI policy guidance at grants.nih.gov; NSF PAPPG Chapter IX (Recipient Standards); Institute of Medicine, Conflict of Interest in Medical Research, Education, and Practice (2009).
