Conflict of interest disclosure

Under the US Public Health Service regulations at 42 CFR Part 50 Subpart F, PHS-funded investigators must disclose significant financial interests to their institution at the time of application and at least annually thereafter, and must update disclosures within thirty days of acquiring a new interest. The institution evaluates whether the interest is related to the research and constitutes a financial conflict of interest, then implements a management plan that may include public disclosure, modification of the research plan, monitoring by independent reviewers, divestiture, or removal from the project. Universities also operate broader institutional COI policies covering non-financial interests, outside employment, and conflicts of commitment.

Institutional conflict of interest (ICOI) is a related but distinct category: it arises where the institution itself — not an individual investigator — holds a financial interest, such as equity in a sponsor or licensing revenue tied to the research outcome, that could affect the institution’s objectivity in overseeing the study. The National Academies’ 2009 Institute of Medicine consensus report Conflict of Interest in Medical Research, Education, and Practice is the standard reference distinguishing ICOI from individual investigator COI, and many institutions route ICOI review through a separate committee from the one that manages individual disclosures, precisely because the institution cannot credibly police a conflict in which it is itself the interested party. See the dedicated guide on institutional conflict of interest for how that review typically works.

References

• PHS regulations on financial conflict of interest 42 CFR Part 50 Subpart F (2011 revision)
• NIH NOT-OD-11-019 and FCOI implementation guidance
• ICMJE Recommendations on Conflicts of Interest

The threshold, and who owns disclosure at the institution

The PHS financial conflict of interest regulation sets its “significant financial interest” reporting threshold at $5,000 in aggregated payments, equity, or intellectual-property income from a single publicly traded entity over the prior twelve months, with no floor at all for equity in a non-publicly-traded entity — any amount must be disclosed (42 CFR 50.603). Before the 2011 revision of the regulation, the reporting threshold was $10,000; a local COI policy still citing that older figure is working from a superseded standard. Day-to-day administration of these disclosures — collecting the annual and update-triggered forms, running the relatedness determination, and drafting management plans — sits with the institution’s Research Integrity Officer or a dedicated COI office, not with the IRB or the sponsored-programs office, though all three coordinate when a disclosed interest touches a specific protocol. What a federal auditor or an NIH compliance reviewer checks first is whether the disclosure was filed on time (at application, annually, and within 30 days of acquiring a new interest) and whether the relatedness determination and management plan are documented in writing — a late or undocumented determination is treated as a compliance gap even in cases where the underlying interest would not have required a management plan on its own.

Checking this against the current guidance

The $5,000 threshold in the PHS conflict-of-interest regulation is a floor, not a full answer — whether a specific interest counts, and whose interests count toward it, depends on the relationship and the institution’s own policy.

Ask CASRAI: Does the PHS financial-conflict-of-interest regulation’s $5,000 significant-financial-interest threshold at 42 CFR 50.603 require reporting a spouse’s equity in a company that would benefit from the funded research, even though the disclosure form itself only asks about the investigator’s own holdings?

It searches CASRAI’s indexed corpus of research-administration guidance and cites the passage behind each claim, so you can open the source and check it rather than take its word — and it says so when the corpus does not cover something instead of guessing. Two questions a day are free while you are signed out, no account and no card. Everything CASRAI publishes stays free to read.

Frequently asked questions

What dollar threshold makes a financial interest “significant” under the PHS conflict of interest regulation?

Payments, equity, or intellectual-property income totaling more than $5,000 from a single publicly traded entity over the prior twelve months. For a non-publicly-traded entity, there is no dollar floor — any equity interest must be disclosed.

Who at a university actually reviews a financial conflict of interest disclosure?

The institution’s Research Integrity Officer or a dedicated conflict-of-interest office typically runs the relatedness determination and drafts any management plan, coordinating with the IRB or sponsored-programs office only when a disclosed interest touches a specific protocol. Institutional conflicts of interest, where the institution itself holds the interest, are usually routed to a separate committee.

How often does a PHS-funded investigator have to submit a new disclosure?

At the time of application, at least annually thereafter, and within 30 days of acquiring a new significant financial interest — the disclosure is not a one-time, application-stage event.

What happens if an investigator discloses a significant financial interest late?

The institution is expected to complete a retrospective review of the investigator’s activities during the period of noncompliance and, where the review finds the research was biased, to notify the funding agency and put a mitigation plan in place — the obligation runs to the institution, not just the individual.