Examples
Worked examples
- Is an instance
A PI discloses equity holdings in a start-up that licenses the technology being evaluated in their clinical trial; the institution implements a management plan including independent data review and disclosure to participants in the consent form.
- Is an instance
A faculty member receiving consulting fees from a device manufacturer above the de minimis threshold updates their annual disclosure and the institution determines the work is unrelated to their NIH-funded research.
Counter-examples
Looks similar, but isn't
- Not an instance
Reimbursement of travel costs by a non-profit professional society for an invited lecture is typically excluded from significant financial interest under the federal de minimis threshold.
- Not an instance
An undisclosed equity interest discovered only after publication is a compliance failure, not a properly executed disclosure.
Editorial commentary
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
Also known as
COI disclosure · financial conflict of interest disclosure · FCOI disclosure
Machine-readable encodings
Use in your systems
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