Instructions

The information on this page is intended for 

  • collaborator investigators on greater than minimal risk human subject (IRB) research, or 
  • collaborator investigators on animal subject (IACUC) research 

If you meet the criteria described herein and have been requested by Texas State University to review this webpage, please send confirmation of your review following the instructions provided at the bottom of this page. 

IMPORTANT: The procedures detailed here are required of subrecipients / collaborators as a condition of receiving funding and/or approval to participate on a research protocol.  Texas State University reserves the right to discontinue funding or withhold approval if a subrecipient / collaborator fails to comply. 

There are THREE PARTS to this webpage review: 

  • STEP ONE – review the Training Section and Texas State University's FCOI Policy 
  • STEP TWO – review the criteria and requirements for Reporting a Significant Financial Interest (SFI) 
  • STEP THREE – complete a SFI Form

Contact Information 

All questions concerning the FCOI Policy, Disclosures, management plans, or reports should contact Research Integrity and Compliance Office 512-245-1423.  Investigators can also refer to Significant Financial Disclosure website: https://www.research.txst.edu/orc/researcher-conflict-of-interest.html 

Expand FAQ List

  • Statement of Principles 

    It is the policy of Texas State University that no proposed, awarded or ongoing Research shall be biased by a FCOI. The University is committed to moving Research forward and fostering entrepreneurial spirit while maintaining objectivity and integrity. 

    Texas State University’s position is that with clear guidelines and principles, in conjunction with appropriate supervision and monitoring, it is possible for interaction between industry and the University to take place in a manner that is consistent with the highest traditions of scientific research and in a way that energizes scientific creativity. 

    Review important points about Texas State University’s FCOI program: Significant Financial Interest (SFI) and Financial Conflict of Interest (FCOI): Procedures and Guidance : Division of Research : Texas State University 
     

    Federal Regulations & Texas State University Policy 
     
    Texas State University complies with the Public Health Service (PHS) 2011 revised Federal regulation on Financial Conflict of Interest (FCOI) Promoting Objectivity in Research, 42 CFR Part 50 Subpart F. 
     
    The University policy prescribes an FCOI program intended to promote objectivity of research through a process of disclosure, review, mitigation, and monitoring. Review Texas State University's FCOI Policy, here. 
     
    Key Terms 

    • Research is defined as a systematic investigation, study or experiment designed to develop or contribute to generalizable knowledge. The term encompasses basic and applied Research (e.g., a published article, book or book chapter) and product development (e.g., a diagnostic test or drug). 
    • Investigator is defined as a person having responsibility over: the design of the research (such as developing objectives or procedures), the conduct of research (directing the procedures or progress), or reporting of the research (writing publications, reporting to granting agencies, etc.).  This definition could include any person, regardless of title, position, or status (faculty, staff, student) – their role (rather than their title) and the degree of independence with which they work should be considered.  Individuals that simply carry out procedures/tasks assigned to them that do not have actual responsibility over the design, conduct, or reporting of the research are not considered Investigators.  
    • Covered Family Member is defined as an Investigator's spouse, dependent children, or other dependents for purposes of determining federal income tax liability during the period covered by the FCOI Disclosure. 
    • Financial Interest is defined as anything of monetary value (existing or potential), whether or not the value is readily ascertainable. 
    • Financial Conflict of Interest (FCOI) is defined as a Significant Financial Interest that could directly and significantly affect the design, conduct, or reporting of Research. 
    • Remuneration is defined as salary or any payment for services not otherwise identified as salary (e.g., consulting fees, honoraria, paid authorship). 
    • Equity Interest is defined as any stock, stock option, or other ownership interest, as determined through reference to public prices or other reasonable measures of fair market value. 
    • Intellectual Property is defined as a work or invention that is the result of creativity, to which one has rights. Includes, but is not limited to, any invention, discovery, creation, know-how, trade secret, technology, scientific or technological development, research data, works of authorship, and computer software, regardless of whether subject to protection under patent, trademark, copyright, or other laws. 
    • Significant Financial Interest is defined as a financial Interest consisting of one or more of the following interests of the Investigator or the Investigator's Covered Family Members that reasonably appears to be related to the Investigator's Institutional Responsibilities: 
    1. Remuneration or Equity Interest in a Publicly Traded Entity: A Financial Interest in which 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; 
    2. Remuneration or Equity Interest in a Non-Publicly Traded Entity: A Financial Interest in which 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 holds any Equity Interest; 
    3. Intellectual Property: Any receipt of income for Intellectual property rights and interests (e.g. patents, copyrights); 
    4. Reimbursed or Sponsored Travel: Any reimbursed or sponsored travel in the twelve months preceding the disclosure in which the value (aggregated per entity that reimburses or sponsors the travel) exceeds $5,000. This does not apply to Investigators who do not receive PHS funding; See "SFI Exclusions" below for additional exclusions for travel that is not reportable. 

    SFI Exclusions: The term Significant Financial Interest (SFI) does not include the following types of financial interests (therefore, is not required to be reported): 
     

    1. Salary, royalties, or other Remuneration paid by Texas State University to the Investigator or Covered Family Member if the Investigator or Covered Family Member is currently employed or otherwise appointed by Texas State University, including Intellectual Property rights assigned to Texas State University and agreements to share in royalties related to such rights; 
    2. Income from investment vehicles, such as mutual funds and retirement accounts, as long as the Investigator or Covered Family Member does not directly control the investment decisions made in these vehicles; 
    3. 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; 
    4. 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; 
    5. 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; and 
    6. Travel not meeting the exceptions in part (5) above but is valued at less than $5,000 per entity that reimburses or sponsors the travel. 

    Subrecipients / Collaborators & Responsibilities 
    As the awardee/funded institution, UT Arlington is responsible for ensuring any subrecipient’s compliance with the PHS Conflict of Interest Regulations and is responsible for reporting identified financial conflicts of interests of Subrecipient Investigators: https://grants.nih.gov/faqs#/financial-conflict-of-interest.htm. 

    For human subject or animal research, Texas State University is responsible for ensuring that conflicts of interest do not bias the research or, compromise human subject/animal safety and welfare. 

    When a subrecipient / collaborator is an entity/organization, it will be determined (and documented through a formal agreement) whether the subrecipient / collaborating organization will apply its own FCOI policy to its “Investigators” (see definition in Key Terms above), or if it will adopt and adhere to Texas State University’s  FCOI Policy.  

    When a subrecipient / collaborator is an individual without an organizational affiliation for the specific work (e.g., consultant), the individual will adhere to Texas State University’s  FCOI Policy if they meet the federal definition of “Investigator” (see definition in Key Terms above). 

    When Texas State University’s FCOI Policy is applied to a subrecipient/collaborator, the subrecipient/collaborator Investigator(s) must comply with several requirements, including: 

    • Review and understanding of Texas State University’s FCOI Policy,
    • Completion of research conflict of interest training once every four years or more frequently at the University’s discretion, 
    • Reporting any existing or new Significant Financial Interests (see procedures in STEP TWO), 
    • Verifying completion of the above via a Review Confirmation Email (see STEP THREE). 

    University Oversight of the RCOI Program 
     
    Texas State University’s President designated the Institutional Official (IO) for conflict of interest to be the Vice President for Research.  In addition, a Financial Conflict of Interest Committee (FCOIC) was established to support the IO, the FCOI program, and its researchers.  The committee is comprised of faculty and staff with expertise and experience in research, commercialization, and conflict of interest standards.  The FCOIC advises the IO and President, reviews subrecipients’ FCOI Disclosures, and works in coordination with Investigators to develop FCOI Management Plans when necessary. 

    RCOI Management Plans   

    If the IO or FCOIC determines that a subrecipient / collaborator Investigator has an actual or potential financial conflict of interest, the official, in cooperation with the Investigator and the FCOIC, shall develop a Management Plan governing that conflict of interest.  The Management Plan shall be implemented before expenditure of funds or prior to initiation of human or animal research. The content of management plans will meet the minimum requirements of federal regulation (e.g., PHS 42 CFR Part 50 Subpart F). Key elements of a FCOI Management Plan include: 

    • Role and principal duties of the Investigator; 
    • Details of the financial interest, its value, and how it is related to the Investigator's responsibilities under the established work agreement/research with Texas State University; 
    • Control measures designed to safeguard the objectivity of the research project; and 
    • How the management plan and/or control measures will be monitored to ensure compliance. 

    For projects supported by PHS, details of the FCOI Management Plan must be reported to PHS and are subject to public availability requirements in accordance with 42 CFR Part 50 Subpart F. 

    Resources 

  • Subrecipient / Collaborator Investigators are responsible for reporting any existing or new Significant Financial Interests (SFI) as described in 1 – 4 of the definition of SFI (see Key Terms above).Investigators must report any new SFIs to Texas State University within 30 days of discovering or acquiring them.  Investigators that have a SFI and submit a disclosure will be required to update and/or recertify that disclosure annually.   

    Upon receipt of a Subrecipient/Collaborator Disclosure Form, Texas State University will be in contact if any additional information or action is required (such as development of a management plan). 

  • Subrecipient funding will not be released and/or participation in the research will not be approved until each individual meeting the definition of “Investigator” (see definition in Key Terms above) completes STEP ONE and TWO (if applicable) of this webpage and all compliance checks have cleared

    MFTRP Certification  

    Participation in a Malign Foreign Talent Recruitment Program (MFTRP) is strictly prohibited and will result in your ineligibility to receive federal funding. If you are applying for funding, or on a research team applying for funding, be aware of disclosure requirements for your proposal.