Financial Conflict Of Interest

For this purpose, NKU defines Investigator to mean the Principal Investigator, Project Director and any other person, regardless of title or position, who is responsible for or involved in the design, conduct or reporting of research.  

Investigator includes, but is not limited to, the Principal Investigator, project director, co-principal investigator, and may also include other Senior/Key Personnel, graduate students, trainees, staff members, collaborators, or consultants, depending on the person’s role in the Research.

The primary factors to be used in determining who is an Investigator are the significance of the tasks assigned to the individual about the design, conduct and reporting of the Research and the degree of independence that individual may have in performing such Research-related tasks.

The Principal Investigator will determine which personnel listed on a grant fit the definition of an Investigator. Both internal and external personnel can fit the definition of an Investigator.

As an Investigator, the financial interest of your spouse, dependent children or persons who share financial interests, which could reasonably influence professional responsibilities, is required to be included in your disclosure.

Additional Help for Determining if a Personnel is an Investigator

Always Considered an Investigator

Some individuals with specific roles are ALWAYS considered Investigators and must disclose Significant Financial Interest (SFI).

• Principal Investigator (PI)
  • Includes multiple PIS and Administrative PI (e.g. Project/Program Director)
• Co-PI
• Co-Investigator

Subrecipients, while also always considered investigators, must comply with the FCOI policy of their home institution. If their institution does not have a policy, the subrecipients should follow NKU’s policy.

If you still aren’t sure if your personnel fits the definition of an Investigator, consult the checklist below, or contact RGC.

Investigator Checklist

• If ANY of the following questions can be answered “YES” for individuals they ARE considered an Investigator.
• Is the individual responsible for the design of the research?
• Is the individual responsible for the conduct of the research?
• Is the individual responsible for the reporting of research?
• Is the individual responsible for the programmatic outcomes?
• Will the individual be a collaborator on a publication related to the research? For example: Will they be listed as an author on a publication that cites the grant as a ‘Funding Source’?

 If you have any questions regarding the definition of “Investigator,” please contact the Manager of Research Compliance, Anita Southwick, at (859) 572-5168 or compliance@nku.edu.

It is the responsibility of the Principal Investigator to determine if the new personnel fits the definition of an Investigator, even if that personnel is added in a subsequent project period of the grant. In addition, it is the responsibility of the Principal Investigator to alert the Office of Research, Grants and Contracts of the new personnel by sending an
email to grants@nku.edu, so that we can ensure that they complete an FCOI disclosure form, as well as the FCOI training. This applies to both internal and external Investigators. If additional personnel are deemed to fit the definition of an investigator, they must complete the FCOI disclosure and the FCOI training within 30 days of their Investigator status.

A financial interest is anything of monetary value, related to an Investigator's University responsibilities, whether or not the value is readily ascertainable, in any of these categories:

• Remuneration or compensation (e.g., salary, consulting fees, honoraria, etc.) from a public or private company.

• Equity (e.g., stock, stock options or other ownership interest) in a public or private company.

• Intellectual property rights (e.g., patents, copyrights) and any royalties and licensing income from such rights.

• A position in an outside entity that gives rise to a fiduciary duty, such as director, officer, partner, trustee, employee or any position of management.

• Any reimbursed or sponsored travel for Investigators with Public Health Service (PHS) funding.

A financial interest DOES NOT include:

• Salary, royalties or other remuneration from NKU.

• Income or travel from seminars, lectures or teaching engagements sponsored or paid by a public government agency, an Institution of higher education, an academic teaching hospital, a medical center or a research institute that is affiliated with an Institution of higher education.

• Income or travel from service on advisory committees or review panels sponsored or paid by a public government agency, an Institution of higher education, an academic teaching hospital, a medical center or a research institute that is affiliated with an Institution of higher education.

• Income from investment vehicles, such as mutual funds and retirement accounts, as long as the Investigator does not directly control the investment decisions made in these vehicles (e.g. 403b plan or target date retirement fund).

Disclosures should be made in the NKU Research Financial Conflict of Interest/Foreign Interest Disclosure system.

Please note, you will receive notifications via email when your disclosure is approaching expiration.

If you indicated no potential conflict, the form remains on file per federal regulation.

If you indicated a potential conflict (yes), the Institutional Official (IO) or designee, in the Office of Research, Grants and Contracts will review the form for potential significant financial conflicts of interest and contact you.

If it is determined that a significant FCOI exists, the Institutional Official will take action to eliminate, reduce or manage the conflict, as appropriate. If it is deemed appropriate by the IO, a Financial Conflict of Interest Committee (FCOIC) will be convened and will be asked to review the specific situation.

A significant FCOI occurs when the IO or assigned designee determines that a Significant Financial Interest (SFI) could directly and significantly affect the design, conduct or reporting of research within NKU or of sub-recipient Investigators. If the IO or assigned designee determines that there is an FCOI that can be managed, he or she must require and approve a written management plan before any related research goes forward. The affected Investigator, in conjunction with the IO or assigned designee, is responsible for developing and submitting the proposed management plan. If an SFI was not disclosed, promptly, by the Investigator or was not previously reviewed by the IO, a management plan will be implemented within sixty days as required by NKU and PHS regulations.

All Investigators are required to complete the following CITI training course:

• Financial Conflicts of Interest: Overview, Investigator Responsibilities, and COI Rules

Please click here to launch the CITI training portal.

Click here to find the instructions for how to register in CITI and load the NKU CITI training courses.

A passing grade of at least 80% is required on the individual course.

Non-completion or expiration of your Financial Conflict of Interest/Foreign Interest disclosure or training will result in the withholding or suspension of funds.

Among the definitions listed at 42 CFR 50.603 are seven key definitions that you must know to understand the Financial Conflict of Interest (FCOI) regulation. They are Institution, Investigator, Institutional Responsibilities, Financial Interest, Financial Conflict of Interest, Manage and Significant Financial Interest.

Institution refers to any domestic or foreign, public or private, entity or organization (excluding a Federal agency) that is applying for or that receives PHS/NSF and other federal agency research funding.

Institutional Responsibilities means an Investigator’s professional responsibilities on behalf of the Institution, and as defined by the Institution, including, but not limited to, activities such as research, research consultation, teaching, professional practice, institutional committee memberships, and service on panels such as Institutional Review Boards or Data and Safety Monitoring Boards.

Investigator, as defined by NKU, means the Principal Investigator, Project Director, and any other person, regardless of title or position, who is responsible for or involved in the design, conduct or reporting of research.  This may include collaborators or consultants.

Financial Interest means anything of monetary value, whether or not the value is readily ascertainable.

Financial Conflict of Interest (FCOI) means a significant financial interest that could directly and significantly affect the design, conduct or reporting of research.

Manage means taking action to address a financial conflict of interest, which can include reducing or eliminating the financial conflict of interest to ensure, to the extent possible, that the design, conduct and reporting of research will be free from bias.

Significant Financial Interest (SFI) is defined by the regulation as:
A financial interest consisting of one or more of the following interests of the Investigator (and those of the Investigator’s spouse and dependent children) that reasonably appears to be related to the Investigator’s institutional responsibilities.

With regard to any publicly traded entity, a significant financial interest exists if the value of any remuneration received from the entity in the twelve months preceding the disclosure and the value of any equity interest in the entity as of the date of disclosure, when aggregated, exceeds $5,000. For purposes of this definition, remuneration includes salary and any payment for services not otherwise identified as salary (e.g., consulting fees, honoraria, paid authorship); equity interest includes any stock, stock option or other ownership interest, as determined through reference to public prices or other reasonable measures of fair market value.

With regard to any non-publicly traded entity, a significant financial interest exists if the value of any remuneration received from the entity in the twelve months preceding the disclosure, when aggregated, exceeds $5,000 or when the Investigator (or the Investigator’s spouse or dependent children) holds any equity interest (e.g., stock, stock option or other ownership interest).

Intellectual property rights and interests (e.g., patents, copyrights), upon receipt of income related to such rights and interests.

Investigators also must disclose the occurrence of any reimbursed or sponsored travel (i.e., that which is paid on behalf of the Investigator and not reimbursed to the Investigator so that the exact monetary value may not be readily available) related to their institutional responsibilities, provided, however, that this disclosure requirement does not apply to travel that is reimbursed or sponsored by a federal, state, or local government agency, an Institution of higher education as defined at 20 U.S.C. 1001(a), an academic teaching hospital, a medical center or a research institute that is affiliated with an Institution of higher education. The Institution’s FCOI policy will specify the details of this disclosure, which will include, at a minimum, the purpose of the trip, the identity of the sponsor/organizer, the destination, and the duration. In accordance with the Institution’s FCOI policy, the institutional official(s) will determine if further information is needed, including a determination or disclosure of monetary value, to determine whether the travel constitutes an FCOI with the PHS-funded research.

A Significant Financial Interest (SFI) of the Investigator’s spouse, dependent children or persons who share financial interests which could reasonably influence professional responsibilities is required to be included in the initial disclosure prior to submission for funding.

Note: The term significant financial interest does not include the following types of financial interests: salary, royalties or other remuneration paid by the Institution to the Investigator, if the Investigator is currently employed or otherwise appointed by the Institution, including intellectual property rights assigned to the Institution and agreements to share in royalties related to such rights, any ownership interest in the Institution held by the Investigator, if the Institution is a commercial or for-profit organization, income from investment vehicles, such as mutual funds and retirement accounts, as long as the Investigator does not directly control the investment decisions made in these vehicles, income from seminars, lectures or teaching engagements sponsored by a federal, state, or local government agency, an Institution of higher education as defined at 20 U.S.C. 1001(a), an academic teaching hospital, a medical center, or a research institute that is affiliated with an Institution of higher education or income from service on advisory committees or review panels for a federal, state or local government agency, an Institution of higher education as defined at 20 U.S.C. 1001(a), an academic teaching hospital, a medical center, or a research institute that is affiliated with an Institution of higher education.

If the sub-recipient institution has a conflict of interest policy for research it should be followed. If the sub-recipient institution does not have a policy, the Investigators of the subrecipient institution shall follow the NKU FCOI policy.

Department of Health and Human Services “Objectivity in Research for which Public Health Service (PHS) Funding is Sought” promulgated by the U.S. Public Health Service 42 CFR Part 50 and 45 CFR Part 94

National Institutes of Health Financial Conflict of Interest Policy

National Science Foundation’s (NSF) “Investigator Financial Disclosure” Policy

Questions about policies, procedures or training? Contact the Manager of Research Compliance, Anita Southwick, at (859) 572-5168 or compliance@nku.edu.