Financial Conflict of Interest Report

This Conflict of Interest and Disclosure Report is an annual, supervisor-filed record for directors and officers to disclose financial interests that intersect with their employment and obligations. It gathers qualitative and quantitative data about sources of income, investments, lobbying, professional services, and loans so the institution can identify and manage financial interest conflicts. The report reaches beyond the employee to include the spouse and dependent children, recognizing that a significant financial interest disclosed by immediate family members may affect the individual's institutional responsibilities.

The form requests disclosure of remuneration, including salary, consulting fees, paid authorship, and income from seminars, lectures, or teaching engagements sponsored by outside entities, when aggregated, that exceed the reporting threshold. It addresses investments and ownership interest over $5,000 or 5%, including equity interest in a publicly traded entity or a non publicly traded entity, such as stock, stock option, or other ownership interest. If the fair market value or exact monetary value cannot be readily determined through reference to public prices, the filer supplies an approximate dollar value or dollar ranges.

It also calls for intellectual property rights and interests, e.g., patents, copyrights, and royalties related to professional practice. Lobbying and retainer fees, professional services (e.g., attorney, accountant, consultant), and loans over $1,000 are disclosed, along with any additional information on offices, positions, or public service and advisory committees.

Organizations that conduct basic and applied research, including a research institute, academic teaching hospital, medical center, higher education institution, or a local government agency, can use these disclosures to support Public Health Service compliance. When research funded by the public health service or the National Institutes of Health is involved, investigator disclosures help the institution's designated official determine whether a significant financial interest exists, whether the financial interest relates to the investigator's institutional responsibilities, and whether it could directly and significantly affect the design, conduct, or reporting of a research project. If a new significant financial interest arises or was not disclosed in a timely manner, the institution may update an FCOI report, implement an interest management plan, and, if necessary, conduct a retrospective review and submit a mitigation report to safeguard objectivity in such research.

Use cases include clinical research and human subjects research on a medical device or diagnostic test, NIH-funded research project administration for a PD/PI and key personnel, subrecipient investigator onboarding, or general corporate ethics oversight.

Proposal Kit helps organizations operationalize this process with document assembly, an extensive template library for policies and management plans, automated line-item quoting for proposals linked to research activity, and an AI Writer to build supporting documents, making it easier to keep disclosures up to date and consistent across the project period.

Beyond basic disclosures, this report anchors a disciplined compliance cycle for any PHS-funded research project. Institutions can convert these entries into an institution's initial FCOI report, provide annual FCOI reports, and submit revised FCOI reports in a timely manner when an existing investigator discloses an additional significant financial interest or a new financial conflict arises. For ongoing PHS-funded research, the awardee institution uses such disclosures to make an institution's determination of whether a significant financial interest SFI exists, whether the financial interest relates to the investigator's professional responsibilities, and whether it could directly and significantly affect the design, conduct, and reporting of the research project. The institution posts public disclosure summaries on a publicly accessible website and reports to the PHS or other federal agencies as required.

The term significant financial interest covers financial interest consisting of remuneration paid, value of any equity, and intellectual property rights assigned, plus reimbursed or sponsored travel, considering the months preceding the disclosure and the date of disclosure. Equity interest includes stock, stock option, or other ownership interest; investment vehicles like mutual funds or retirement accounts are often not disclosed when the investigator does not directly control investment decisions. Disclosures also capture the investigator's spouse and dependent interests, previously disclosed equity interest updates, the investigator's title and role, personnel responsibilities, and the investigator's activities, such as research consultation, seminars, or previously published presentations and public presentations relevant to such funding.

When an investigator fails to comply in a timely manner or a subsequently identified FCOI is found, the institution conducts an institution's retrospective review with detailed methodology, documents reviewed, composition of the review panel, and key topics documented, and then may submit a mitigation report. If bias is found, actions taken to eliminate or mitigate it may include changes to the management plan pursuant to interest policy, reduction or elimination of the conflicted investigator's participation, an independent monitor capable of review, or other reasonable measures. The institution implements an FCOI management plan and reasonable steps to ensure investigator compliance, monitors investigator compliance on an ongoing basis, and, if necessary, completes a retrospective review if appropriate within sixty days. Institutions may use the ERA Commons FOI module and promptly notify the PHS awarding component, tying each FOI report required to a project number, project title, principal investigator or project director, and the project period, including extensions, through the final expenditures report.

Use cases include cooperative agreements and research grants where a research plan or research project discloses an SFI; multi-year progress report administration; subrecipient investigators consistent with the awardee institution's policy via written agreement; and management and reporting of investigator financial conflicts that could be affected by the research or cause actual or future harm to generalizable knowledge. Reasonable measures of fair market and prices or other reasonable references can support approximate values when exact values are not readily ascertainable.

Proposal Kit supports these workflows by helping teams assemble written agreement packages, interest management plan content with the following key topics, and FCOI report narratives, and by producing consistent policy and contract proposal documents. Its AI Writer, document assembly, automated line-item quoting, and extensive template library streamline creating such documentation so organizations can manage financial conflicts and reporting obligations with clarity.

A robust disclosure process does more than record income and investments; it enables conflict of interest management across a PHS-funded project or research grant. By disclosing significant financial interests on an annual FCOI report, organizations can submit FCOI reports annually and provide timely FCOI reports when circumstances change. If an investigator's significant financial interest is related to the investigator's responsibilities and the institution determines an FCOI exists, the institution's management plan sets out how to manage the financial conflict, including additional interim measures when needed. Such a financial conflict may arise from remuneration received, equity interest, intellectual property rights, institutional committee memberships, or other financial conflicts tied to the investigator's professional responsibilities and principal duties.

Operationally, an awardee institution's financial conflicts process links each such FCOI report to the project title, the name of the investigator, and the funds awarded. When an existing investigator discloses an interest previously reported or a new interest directly related to a systematic investigation, the institution conducts its review, makes a written determination, and, where appropriate, updates a previously submitted FOI report. If an investigator fails to comply, an enforced administrative process may require review of the investigator's activities, a sixty-day review, and employee sanctions.

The institution's identification of all identified financial conflicts is timely reviewed; the institution responds with an interest management plan, including key topics, taking measures to protect the design, conduct, and reporting of the research or portion thereof. The plan may be necessarily limited to personnel responsibilities or disqualification of personnel, use of an independent monitor, or severance of relationships that create bias resulting in actual or future harm to generalizable knowledge relating broadly to the field.

Institutions also track subrecipients' financial conflicts to ensure a subrecipient investigator complies with the FCOI policy. The fcoi report involves senior key personnel and the investigator involved in the research project, e.g., medical device or treatment studies.

If a conflicting subsequent interest is reported pursuant to the disclosure requirement, the institution makes a written response, may submit an updated report, and documents the review process composition and review panel documents reviewed. Public accessibility is served when the institution posts sufficient information, including the name of the entity and the nature of the significant interest, so stakeholders can assess whether the financial interest could affect the results of the research.

Proposal Kit helps teams assemble the institution's plan, interest management plan, and such documentation into clear, reusable packages. Its document assembly, AI Writer for supporting narratives, automated line-item quoting for related proposals, and template library streamline how organizations manage, report, and communicate FCOI materials to the public health service PHS and other stakeholders.

Writing the Financial Conflict of Interest Report document - The Narrative

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