Conflict of interest disclosure

The institutional process by which investigators report significant financial interests, fiduciary relationships, and other competing interests that could directly and significantly affect the design, conduct, or reporting of their research, enabling the institution to assess and manage, reduce, or eliminate identified conflicts.

ByCASRAI Editorial Board

· Last updated 21 May 2026

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.

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.

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.

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

Use in your systems

JATS XML <role> element

xml

<role vocab="credit"
      vocab-identifier="https://casrai.org/dictionary/"
      vocab-term="Conflict of interest disclosure"
      vocab-term-identifier="https://casrai.org/dictionary/term/conflict-of-interest-disclosure" />

Schema.org DefinedTerm (JSON-LD)

json

{
  "@context": "https://schema.org",
  "@type": "DefinedTerm",
  "name": "Conflict of interest disclosure",
  "identifier": "https://casrai.org/dictionary/term/conflict-of-interest-disclosure",
  "description": "The institutional process by which investigators report significant financial interests, fiduciary relationships, and other competing interests that could directly and significantly affect the design, conduct, or reporting of their research, enabling the institution to assess and manage, reduce, or eliminate identified conflicts.",
  "inDefinedTermSet": "https://casrai.org/dictionary/domain/compliance-and-regulatory/",
  "url": "https://casrai.org/dictionary/term/conflict-of-interest-disclosure",
  "sameAs": [
    "COI disclosure",
    "financial conflict of interest disclosure",
    "FCOI disclosure"
  ],
  "license": "https://creativecommons.org/licenses/by/4.0/"
}