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Significant Financial Interest (SFI) and Conflicts of Interest (COI): Procedures and Guidance

All Texas State researchers are required to submit a disclosure of Significant Financial Interests (SFI) at least once annually. In order to submit a proposal, initiate a contract or open a grant account, researchers must have a current SFI Disclosure on file with the Office of Research Integrity & Compliance (ORIC).

The SFI Disclosure doesn't require the researcher to submit documentation or provide private financial data. The online form walks the researcher through a series of Yes/No questions based on definitions and thresholds outlined in the University's FCOI policy.

Key points for all faculty researchers:

  • Researcher are asked to disclose all Significant Financial Interests (SFI) rather than Financial Conflicts of Interest (FCOI) related to their current sponsor. Researchers do not need to submit additional disclosures or update their current disclosure unless their financial interests change during the year.
  • A Significant Financial Interest (SFI) does not necessarily indicate the existence of a Financial Conflict of Interest (FCOI).
  • Annual SFI Disclosures are required from all researchers, regardless of funding source or funding status. Researchers submitting proposals to, or receiving awards from, PHS agencies will need to complete additional procedures, and should contact ORIC to ensure that the PHS compliance requirements are fulfilled on time.
  • Since SFI may not relate to specific funders, researchers are encouraged to submit their SFI Disclosure at the beginning of each fall semester, rather than waiting until they submit a proposal or receive funding. However, if researchers have not yet filed an SFI Disclosure, they will be required to do so as needed before proposal submission or account set up.
  • PHS-supported researchers must complete a brief FCOI training prior to account set up. Contact ORIC for more info.

The ORIC welcomes the opportunity to discuss this issue with researchers. Please contact Becky Northcut for additional information or assistance. 

Frequently Asked Questions

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What does "PHS Funding" mean?

The following agencies are PHS Awarding Components, also often collectively referred to as “PHS agencies,” “PHS funding components,” or “PHS funders.”

 
Non-PHS Agencies that have adopted PHS regulations
Alliance for Lupus Research
American Cancer Society
American Heart Association
Arthritis Foundation
Susan G. Komen for the Cure
 

Do these procedures apply to all research at Texas State?

As stated in UPPS 02.02.07, to ensure the highest level of objectivity in research, Texas State University applies the PHS standards for definition of Substantial Financial Interest to all research, regardless of funding source or funding status.

As long as the PHS minimum standards are met, per PHS guidance, "The Institution may have more stringent financial disclosure requirements."

Depending on the contents of their disclosure, PHS-funded researchers may have to complete additional items or processes not required of researchers who do not receive PHS funds

What is a Significant Financial Interest?


The 2011 revised regulation defines a “Significant Financial Interest” as follows:
“

(1) 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:


(i) With regard to any publicly traded entity, a significant financial interestexists 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;


(ii) 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); or


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


(2) 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 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.”


The Institution may have more stringent financial disclosure requirements.  Please refer to the Institution’s conflict of interest policy and confer with the Institution’s designated official(s) to determine the Institution’s disclosure requirements.

 

 

What is a Financial Conflict of Interest?

 A Financial Conflict of Interest exists when the Institution, through its designated official(s), reasonably determines that an Investigator’s Significant Financial Interest is related to a NIH-funded research project and could directly and significantly affect the design, conduct or reporting of the NIH-funded research.

 

For purposes of the Financial Conflict of Interest regulation, what is an "Institution?"

Institution means any domestic or foreign, public or private, entity or organization (excluding a Federal agency) that is applying for or that receives NIH research funding.

 

What is an “Entity” as used in the Financial Conflict of Interest regulation?

Entity means any domestic or foreign, public or private, organization (excluding a Federal agency) from which an Investigator (and spouse and dependent children) receives remuneration or in which any person has an ownership or equity interest.


 

Who is considered an “Investigator” for the purpose of this regulation? Is it only the Principal Investigator?


No.  “Investigator” means the project director or principal investigator and any other person, regardless of title or position, who is responsible for the design, conduct, or reporting of research, which may include, for example, collaborators or consultants.  Institutions should consider the role, rather than the title, of those involved in research and the degree of independence with which those individuals work.  When the definition of investigator is limited to titles or designations (e.g., to principal investigators, key personnel, faculty) the risk is that an unidentified FCOI may compromise the research enterprise increases.
In addition, the Investigator’s spouse and dependent children have been eliminated from the definition of “Investigator” under the 2011 revised regulation; however, they are referenced in the definition of “Significant Financial Interest” because the Investigator must also disclose Significant Financial Interests of his/her spouse and dependent children. (see definition of Significant Financial Interest).


 

What are “institutional responsibilities?”

“Institutional responsibilities” are defined by the 2011 revised regulation as an   Investigator’s professional responsibilities on behalf of the Institution, and as defined by the Institution in its policy on Financial Conflict of Interest, which may include, for example, activities such as research, research consultation, teaching, professional practice, Institutional committee memberships, and service on panels such as Institutional Review Boards.  The Institution can include other professional responsibilities within the definition, as appropriate.

 

What financial interests are covered by the regulation?

 The regulation covers all financial interests that have monetary value, whether or not the value is readily ascertainable.    

Does this apply to SBIR/STTR programs?

The regulations and Texas State policy exempt Phase I SBIR/STTRs, but not Phase II SBIR/STTR applications/awards. 

 

Do all researchers now have to take FCOI training?

There are two levels of training. The first is very brief, is required of everyone,  and is accomplished during the SFI disclosure process:  Texas State is required to have a process to inform all researchers of Investigator responsibilities for disclosure of Significant Financial Interests and of the Institution’s specific policy on financial conflicts of interests.

The second level of training is only required for PHS-funded researchers. It must be completed prior to account set up and engaging in research. PHS-awarded researchers must complete a brief online training that covers NIH/PHS-specific procedures and policy.  

SFI & FCOI Help Files

pdf icon#25.PHSfund : Definition of “PHS Funding” (PDF, 159.9 KB)
Definition of “PHS Funding”
(Applicability of PHS 2011 Revised Regulations on FCOI)