Investigator Financial Conflict of Interest (FCOI) for Funded Projects

 I. Purpose and Scope

Central encourages faculty and staff to engage in externally funded research, instruction, and public service. To maintain public trust and protect the integrity of the university's academic and research enterprises, Central must ensure that the design, conduct, and reporting of sponsored projects are completely free from bias resulting from investigator financial conflicts of interest.

This document establishes standards and procedures to ensure compliance with federal regulations, specifically 42 CFR Part 50 Subpart F (Responsibility of Applicants for Promoting Objectivity in Research) and 45 CFR Part 94 (Responsible Prospective Contractors). These requirements apply to all investigators proposing or executing projects funded by an external sponsor.

II. Definitions

• Investigator: The Principal Investigator (PI), Project Director (PD), Co-Investigators, and any other person at Central, regardless of title or position, who is responsible for the design, conduct, or reporting of research, educational, or service activities funded or proposed for funding by an external sponsor. This definition includes the investigator's spouse and dependent children.
• Significant Financial Interest (SFI): Anything of monetary value received by an investigator (aggregated with their spouse and dependent children) from an outside entity that reasonably appears related to the investigator’s institutional responsibilities (teaching, research, administrative duties).
• Financial Conflict of Interest (FCOI): An SFI that could directly and significantly affect the design, conduct, or reporting of externally funded research or sponsored projects.

III. Significant Financial Interest (SFI) Thresholds

Outside financial interests must be disclosed if they meet or exceed the following federal standard thresholds:

A. What Must Be Disclosed ($5,000 Threshold)

1. Publicly Traded Entities: Any remuneration (salary, consulting fees, honoraria, paid authorship) received from the entity in the twelve months preceding the disclosure, combined with the value of any equity interest (stocks, stock options) as of the date of disclosure, that when aggregated exceeds $5,000.
2. Privately Held/Non-Publicly Traded Entities: Any remuneration received in the preceding twelve months that exceeds $5,000, OR any equity interest regardless of value or percentage (a $0 threshold for stock ownership or options in a private startup).
3. Intellectual Property: Income received from intellectual property rights and interests (e.g., patents, copyrights, royalties), upon receipt of such income.
4. Sponsored/Reimbursed Travel: Any travel related to institutional responsibilities that is reimbursed or sponsored by an outside entity. Exemptions: Travel reimbursed by US Federal/state/local government agencies, US higher education institutions, or research institutes affiliated with a US higher education institution.

B. What Is Excluded from Disclosure

• Salary, royalties, or other remuneration paid by Central to the investigator.
• Income from investment vehicles (mutual funds or retirement accounts) where the investigator does not directly control the investment decisions.
• Income from seminars, lectures, teaching engagements, or service on advisory committees sponsored by US Federal/state/local governments, US higher education institutions, or academic teaching hospitals.

IV. Investigator Disclosure Obligations and Procedures

A. Timing of Disclosures

1. Pre-Proposal: All investigators must submit an updated SFI Disclosure Form to the Grants & Funded Research Office prior to or at the time of submitting a proposal for external funding.
2. Annual Updates: Investigators actively working on externally funded projects must submit an updated disclosure annually during the period of the award.
3. New Interests: If an investigator acquires a new SFI during an active project (e.g., joins a corporate board, sells a patent), an updated disclosure must be filed within 30 days of acquiring the interest.

B. Review and Management of Conflicts

1. The Grants and  Funded Research Administrator  (or designee) serves as the reviewing official to determine if an investigator's SFI is related to the sponsored research and constitutes an FCOI.
2. If an FCOI is identified, the university will develop and implement a written Management Plan incorporated into a Memorandum of Agreement (MOA) signed by the investigator, Dean, and the Provost/Designee.
3. Management strategies may include:
   • Public disclosure of the financial conflict in publications and presentations.
   • Direct disclosure to human subjects participating in the research.
   • Monitoring of the research by independent reviewers.
   • Modification of the research plan or removal of the investigator from the project.
   • Divestiture of the conflicting financial interest.

C. Mandatory FCOI Training

All investigators executing projects funded by the PHS, NIH, or sponsors with matching regulations must complete mandatory FCOI training (via the CITI Program) prior to engaging in the research and at least every four (4) years thereafter. Training is also triggered immediately if regulations change or an investigator is found non-compliant with a management plan.

D. Public Accessibility Mandate

For PHS/NIH-funded research, if an FCOI is identified and managed, information concerning the SFI must be made available to the public within five (5) business days of a written request or posted directly on a public-facing university compliance webpage.

E. Enforcement and Sanctions

Failure to file required disclosures, or failure to comply with an executed FCOI Management Plan, constitutes a violation of university policy. Such instances will be referred to the Provost and may result in administrative sanctions, up to and including the suspension of research privileges, notification to the federal funding agency, and disciplinary action governed by the CSU-AAUP or CSU-AFSCME collective bargaining agreements.