POLICY OWNERS

This policy is jointly owned by the Vice President for Research and the Provost/Executive Vice President.

PURPOSE OF THIS POLICY

Federal funding agencies have issued regulations that apply to federally funded Research projects at Colorado State University (CSU). Among other things, the regulations aim to promote objectivity in Research by establishing standards that provide a reasonable expectation that the purpose, design, conduct, interpretation, and Reporting of federally funded Research will be free from bias resulting from Financial Conflicts of Interest.

The purpose of this policy is to follow requirements from federal agencies and to set up and implement policies concerning disclosures of Financial Interests held by persons engaged in Research funded by federal agencies. Compliance is needed for the University to maintain eligibility for federal funding. Regulations on Financial Conflicts of Interest include specific requirements for disclosing, Reporting and managing Financial Conflicts of Interest to ensure there is no reasonable expectation that the purpose, design, conduct, interpretation, or Reporting of Research funded under federal grants, cooperative agreements, or contracts will be biased by any conflicting Financial Interest of an Investigator (“Investigator” is defined broadly and encompasses more persons than principal investigators—see the definitions section below).

This policy is also intended to protect Investigators from unwarranted or mistaken charges of not disclosing Financial Conflicts of Interest by providing an approved, institutional mechanism for objective review and approval of Investigators’ Financial Interests.

APPLICATION OF THIS POLICY

This policy applies to Investigators who are engaged in activities funded in whole, or in part, by federal funding, including when CSU is a subrecipient of federal funds.

EXEMPTIONS FROM THIS POLICY

None.

DEFINITIONS USED IN THIS POLICY

Conflict of Interest Committee (COIC): The University's Conflict of Interest Committee (including appointed subcommittees), appointed by the Provost.

Dependent: An Investigator's unemancipated child(ren), including stepchildren and adoptees, under the age of 18, or anyone who receives more than one-half of their financial support during a year from an Investigator.

Designated Official: A person authorized by the University to find whether an Investigator has an outside activity that requires management.

Disclose (Disclosure): To supply relevant information about one’s Financial Interests to the appropriate personnel within the institution, in order to assure full awareness of potential conflicts and to foster institutional efforts to address them. A “Disclosure” is made when an Outside Activity Report (OAR) or supplementary material is submitted in compliance with the requirements of this policy, and current procedures.

Equity Interest: Any ownership interest in a company or business external to the University, including, but not limited to, partnership interests or rights, shares, stocks, options or warrants, or similar interests.

Financial Conflict of Interest (FCOI): A Significant Financial Interest that could directly and significantly affect the purpose, design, conduct, interpretation, or Reporting of Research.

Financial Interest: Anything of monetary value, whether or not the value is capable of being determined.

Institutional Official: An individual within the institution who handles the solicitation and final review of disclosures made under this policy. For the purposes of this policy, the primary Institutional Officials are the Provost and the Provost’s designees.

Investigator: The principal Investigator and any other person who is responsible for the purpose, design, conduct, interpretation, or Reporting of Research funded by a federal agency, or proposed for such funding, including Investigators working for subgrantees, contractors, subcontractors, and collaborators. Investigators include those individuals named as Key Personnel on a federal award; as such, “Investigator” may include postdoctoral associates, Research associates, graduate students, and other University employees involved in the sponsored project, as well as collaborators and consultants.

Investigator’s Institutional Responsibilities: An Investigator's professional responsibilities on behalf of Colorado State University, including, but not limited to Research, Research consulting, teaching, professional practice, institutional committee memberships, and service on panels such as an Institutional Review Board.

Management Plan: A written plan for taking action to address an FCOI, which can include reducing or eliminating the FCOI, to ensure, to the extent possible, that the purpose, design, conduct, interpretation, and Reporting of Research will be free from bias.

Outside Activities Report (OAR): A form approved by the Institutional Official for Investigators to disclose their Financial Interests, including significant Financial Interests.

Procedures: The guidelines, Procedures, and forms adopted by the University pursuant to this policy now or as updated in the future to meet the needs of the University.

Remuneration: salary and any payment for services not otherwise identified as salary (e.g., consulting fees, honoraria, paid authorship, equity interests, and certain intellectual property rights as further set forth in the Procedures).

Report: To supply information to proper officials external to the University, e.g., to a Public Health Service (PHS) agency, concerning a person’s disclosed or undisclosed external commitments and Financial Interests, in order to meet an obligation imposed by law or policy.

Research: A systematic investigation, study, or experiment designed to develop or contribute to generalizable knowledge relating broadly to public health, including behavioral and social sciences Research, including (but not limited to) basic and applied Research (e.g., a published article, book, or book chapter) and product development (e.g., a diagnostic test or drug), and any such activity for which Research funding is available from a PHS grant, cooperative agreement, or contract.

Senior Administrator: The Provost, Deans, and Vice Presidents, as defined in section D.7.7.4.2 of the Academic Faculty/Administrative Professional Manual.

Senior/Key Personnel: The Project Director or Principal Investigator, and any other person identified as Senior/Key Personnel by the University in the grant application, progress report, or other report sent to the PHS agency.

Significant Financial Interest (SFI): Any Financial Interest of an Investigator (or their spouse, registered domestic partner, or Dependent) that reasonably appears to be related to an Investigator’s Institutional Responsibilities and that meets one or more of the following conditions:

• if with a publicly traded entity, the aggregate value of any salary or other payments for services received during the 12-month period preceding the Disclosure, and the value of any equity interest during the 12-month period preceding or as of the date of Disclosure, exceeds $5,000; or
• if with a non-publicly traded entity, the aggregate value of any salary or other payments for services received during the 12-month period preceding the Disclosure exceeds $5,000; or
• if with a non-publicly traded company, is an equity interest of any value during the preceding 12-month period or as of the date of Disclosure; or
• is income related to intellectual property rights and interests not reimbursed through the Institution.

Additionally, under this policy, leadership positions that assume fiduciary responsibilities toward outside organizations will be treated as Significant Financial Interests, regardless of whether the persons in those leadership positions are compensated.

Significant Financial Interests do not include:

• Salary, royalties, or other payment paid by the University to an Investigator if an Investigator is currently employed or otherwise appointed by the institution;
• Intellectual property rights assigned to the University, and agreements to share in royalties related to such rights;
• Income from investment vehicles, such as mutual funds and retirement accounts, if an Investigator does not directly control the investment decisions made in these vehicles;

Income from seminars, lectures, or teaching engagements sponsored by a U.S. federal, state, or local government agency; a U.S. institution of higher education; or a U.S.-based Research institute affiliated with a U.S.-based institution of higher education; or income from service on advisory committees or review panels for a U.S. federal, state, or local government agency or a U.S. institution of higher education or affiliated Research institute.

POLICY STATEMENT

Colorado State University is committed to the principle of conducting Research in a manner that promotes the integrity of the Research process and maintains the trust of the public and of sponsors. This commitment requires the University to ensure that there is no reasonable expectation that Research results may be biased by the external commitments and Financial Interests of Investigators who are responsible for the purpose, design, conduct, interpretation, Reporting, or direct administration of the Research.

The University’s general conflict of interest requirements for employees are set forth in the Academic Faculty and Administrative Professional Manual, section D.7.7, and are managed under the institution’s Annual Role and Responsibility Disclosure process. Investigators who are responsible for the purpose, design, conduct, interpretation, or Reporting of federally funded sponsored projects additionally will be held to the requirements set forth in this policy.

The University will not accept or enter into agreements, contracts, gifts, or purchases that give rise to an FCOI unless the conflict can be eliminated or appropriately managed to protect the interests of the University.

CSU will follow all Reporting responsibilities imposed by state or federal laws or regulations with respect to Financial Interests that have been disclosed, while protecting the personal privacy of affected employees to the extent permissible under applicable law or policy.

Per this policy and the Procedures developed for its implementation, Investigators will report their external commitments and Financial Interests in a timely manner, and real and apparent Financial Conflicts of Interest of Research personnel will be identified and responsibly managed.

POLICY PROVISIONS

Duty to Disclose Significant Financial Interests

An Investigator must make timely, accurate, and specific Disclosures of all relevant Financial Interests in accordance with this policy and its Procedures. Required Disclosures include:

• Completion of an annual OAR, which must be completed no later than the time of application for federally funded Research;
• Completion of a supplementary OAR within 30 days of relevant changes to an Investigator’s outside activities; and
• Reporting sponsored travel reimbursements prospectively or within 30 days after beginning travel (see section 4 below).

Every Principal Investigator (including a Co-PI) is responsible for identifying the persons involved in a project as an “Investigator” (see Definitions section above) in order to ensure that Disclosure and Management Procedures are timely implemented and followed by those persons.

Investigators are responsible for completing required training on conflicts of interest. Training shall be required:

• Prior to engaging in Research related to any federally funded grant that requires training;
• At least once every 4 years; and
• Immediately, if:
  • The University revises this policy in a way that affects requirements of Investigators;or
  • An Investigator is new to the University; or
  • An Investigator is not in compliance with this policy or a management plan—including failure to make timely Disclosures.

Responsibilities of the Institutional Official

Financial Disclosure are made by Investigators through CSU’s Outside Activities Reporting system, which is managed by the Vice President for Research (VPR) via the Office of the Vice President for Research (OVPR). The OVPR is responsible for ensuring that Investigators and their supervisors are made aware of these requirements and for helping with the development and management of FCOIs in response to an identified conflict or potential conflict of interest.

Prior to the expenditure of federal funding, the OVPR is responsible for reviewing Disclosures and determining if management or other actions are needed under this policy. OVPR must determine whether an SFI is related to federally funded Research. The office will do so when it reasonably determines that the SFI:

• Could be affected by the federally funded/PHS-funded Research; or
• Is an entity whose Financial Interests could be affected by the Research.

The OVPR will also determine that an FCOI exists if the SFI could directly and significantly affect the design, conduct, or Reporting of the federally funded/PHS-funded Research. If an FCOI exists, the office will assign a Management Plan that eliminates or sufficiently manages the conflict in accordance with this policy. The OVPR is also responsible for monitoring compliance with assigned Management Plans, promptly notifying federal agencies about noncompliance, and taking corrective action when noncompliance is identified. If a conflict cannot be managed, the OVPR will contact the funding agency.

Additionally, if an Investigator is newly participating in a project, if an Investigator discloses a new SFI, or if Colorado State University identifies an undisclosed SFI, the process above must be completed within sixty days of the Investigator’s disclosure or the University’s identification of the SFI.

Travel Reimbursement Reporting

Investigators must disclose, for themselves and their family members, any travel related to CSU duties that is sponsored by or reimbursed by an external entity other than a U.S. federal, state, or local government agency; a U.S. institution of higher education; a U.S. academic teaching hospital; a U.S. medical center; or a  U.S.-based Research institute affiliated with a U.S. institution of higher education or government. Travel sponsored by these U.S.-based entities does not require Disclosure.

For all other travel, the employee must disclose and maintain a record of the purpose of the trip, the sponsor/organizer, the destination, and the duration. This Disclosure may be made prospectively when the travel is planned, or, if not made prospectively, must be submitted within 30 days after the trip begins. The Office of the Vice President for Research shall review such Disclosure and make an initial determination as to whether the value of the travel (or reimbursement for travel) could directly and significantly affect the design, conduct, or Reporting of PHS-funded Research. Travel Disclosures indicating that such circumstances may exist shall be handled in the same manner as Significant Financial Interests.

Reporting FCOIs

Each FCOI subject to a Management Plan must be reported in accordance with federal regulations and as further set forth in the Procedures. At a minimum, CSU shall, for any federal Research funding subject to agency regulations on conflicts of interest:

• When required, report FCOIs to the awarding component of the funding agency prior to the expenditure of funds, within sixty days of identification for an Investigator who is newly participating in a project, within sixty days for new or newly identified FCOIs for existing Investigators, and at least annually thereafter while the FCOI continues to exist; and
• Maintain records related to Investigator Disclosures and the institution’s review of, and response to, such Disclosures and all actions under this policy for at least three years from the date of the final expenditure report or, where applicable, from other dates specified in 45 CFR 75.361.

Subrecipient Requirements

When required, the University shall include in each subaward agreement subject to federal regulations on conflicts of interest terms that show whether this policy or that of the subrecipient will apply to the subrecipient’s Investigators and shall provide FCOI reports regarding subrecipient Investigators to the awarding federal funding agency.

Public Accessibility Requirements

This policy, the Procedures, and certain Disclosures made under this policy shall be made publicly accessible.

With respect to the Disclosures subject to this requirement, the University will either:

• Publish those Disclosures on a publicly accessible website prior to the expenditure of any funds under a PHS-funded Research project; or
• Provide a written response, within five business days, to any request for information concerning an SFI that was disclosed and is still held by the Senior/Key Personnel for the affected Research project, if the SFI was determined to be an FCOI.

COMPLIANCE WITH THIS POLICY

Compliance with this policy is required. For help with interpretation or application of this policy, contact the Office of the Vice President for Research.

REFERENCES

Public Health Service Regulations

• Responsibility of Applicants for Promoting Objectivity in Research for which PHS Funding is Sought (42 C.F.R. Part 50. Subpart F)
• Responsible Prospective Contractors (45 C.F.R. Part 94)
• Financial Conflict of Interest (NIH 4.1.10)

FDA Regulations

• FDA Guidance: Financial Disclosure by Clinical Investigators

National Science Foundation

• Proposal & Award Policies & Procedures Guide (PAPPG), June 2020

NASA

• Conflict of Interest Policy for Recipients of NASA Financial Assistance Awards

Department of Energy

• Department of Energy Interim Conflict of Interest Policy Requirements for Financial Assistance

Other Resources

• 2 CFR part 200, e.g., 200.112, 200.318
• 2 CFR 400.2 Conflict of Interest
• 2 CFR part 910, Department of Energy (DOE) Financial Assistance Regulations
• NIH Financial Conflicts of Interest Page
• NIH Frequently Asked Questions Regarding PHS Funding and COI (July 29, 2009)
• NIH Guide on Objectivity in Research (July 14, 1995)
• Recognizing and Managing Personal Financial Conflicts of Interest (COGR – Winter 2002)
• DHHS Office of Technology Transfer Policies and Reports

FORMS AND TOOLS

Conflict of Interest form

APPROVALS

Approved by Anthony A. Frank, President, August 22, 2012

Revision approved by Dave Ryan, Co-Interim, Vice President for University Operations on July 29, 2022

Revision approved by Brendan Hanlon, Vice President for University Operations, on October 21, 2025