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  • To foster a research environment grounded in the highest standards of integrity and ethics, Texas State University has established UPPS No. 02.02.07, Research Conflicts of Interest in Research and Sponsored Program Activities. This policy is designed to promote objectivity in research and ensure that all research and sponsored program activities are free from bias resulting from conflicts of interest (COI). 

    It is essential that faculty and staff identify, disclose, and appropriately manage or eliminate any personal or familial interests that could compromise—or appear to compromise—their objectivity as educators, researchers, or administrators. A strong COI policy not only protects the integrity and reputation of university personnel but also ensures compliance with federal and other regulatory requirements. 

    Texas State University is committed to advancing research and encouraging entrepreneurial innovation while maintaining transparency and ethical standards. In alignment with this commitment, the university’s policy states that no proposed, awarded, or ongoing research shall be biased by a Financial Conflict of Interest (FCOI). 

    With clear guidelines, active oversight, and responsible engagement, interactions between academia and industry can thrive in a way that upholds the highest traditions of scientific inquiry and fuels creative discovery. 

     

  • To comply with the 2011 revised federal regulations on Financial Conflicts of Interest (FCOI) — 42 CFR Part 50 Subpart F: Promoting Objectivity in Research — Texas State University has implemented a fully electronic Financial Research Conflict of Interest Disclosure Form.  

    Texas State University adheres to the requirements set forth by the Public Health Service (PHS) and other sponsoring agencies that have adopted or aligned with these federal regulations. In response to the 2011 revisions, the university updates its policy every three years or as needed in response to changing regulations to establish a comprehensive FCOI program focused on disclosure, review, mitigation, and monitoring of potential conflicts. 

    Per UPPS No. 02.02.07, all Covered Individuals are required to: 

    • Submit the RCOI/FCOI Disclosure Form at least annually, and 
    • Update their disclosure within 30 days of discovering or acquiring a new significant financial interest (SFI) related to their university responsibilities. 

     

    Texas State is committed to maintaining research integrity while supporting innovation and collaboration. The university will comply with the specific conflict of interest requirements of each sponsoring agency, including those that follow or adapt the PHS regulations. 

    For more information or assistance, please contact the Office of Research Integrity and Compliance. 

  • The FCOI Policy and these Procedures govern the disclosure of individual Significant Financial Interests and the management and reporting of an individual Financial Conflict of Interest in Research performed at the University.  

    The FCOI Policy and Procedures apply to Covered Individuals (as defined in Key Terms below).  Covered Individuals must disclose Significant Financial Interests as defined within the Policy and Procedures. 

    Texas State University  Investigators are expected to make reasonable inquiry as to whether their relationships and activities fall within the provisions of the Policy.  

  • Texas State University’s President has designated the Institutional Official (IO) for Financial Conflict of Interest to be the Vice President for Research. In addition, a Financial Conflict of Interest (FCOI) Committee is 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 FCOI Committee advises the IO and President, reviews FCOI Disclosures, and works in coordination with Investigators to develop RCOI Management Plans when necessary. The FCOI Committee meets as needed to conduct these activities. 

    The Research Conflict of Interest Program is coordinated and maintained by Division of Research – Research Integrity and Compliance (RIC) administrations: 

     

    Sean Rubino, Director of Research Integrity and Compliance 

    Monica Gonzales, Assistant Director Research Integrity and Compliance 
     
    RIC  

    Main Line: 512-245-1423 
    RIC website: https://www.research.txst.edu/orc.html 

     

  • 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 Individual is defined as any Investigator who proposes or conducts: 

    • Sponsored research; 
    • Human Subject Research; and/or 
    • Animal research 

    Covered Family Member is defined as an Investigator's spouse and dependent children. 

    Sponsored Research is defined as any research for which a proposal is submitted or awarded by a sponsor for extramural funding, or any gift designated for research received by UT Arlington. Sponsored research (both awards and gifts) can include research, training, and instructional projects involving funds, materials, or other compensation from external sources.  

    Human Subject Research is defined as research (see Key Term above) that involves Investigators obtaining data from a living individual through intervention or interaction with the individual or, obtaining data that is identifiable private information (even if no intervention or interaction with the researcher occurs).  This policy does not apply to Human Subject Research that has been determined by the University’s IRB to be exempt. (Note: Both exempt and non-exempt Human Subject Research requires review by the University) 

    Animal Research is defined as any live, vertebrate animal used or intended for use in research, training, experimentation, teaching, exhibition, biological testing, or for related purposes. (Note: Animal Research requires review and approval by the University) 

    Investigator's Institutional Responsibilities are defined as an Individual’s professional responsibilities and activities on behalf of the Institution, including but not limited to: research, research consultation, teaching, professional practice, institutional committee memberships, and service on panels such as Institutional Review Boards. 

    Financial Interest is defined as anything of monetary value (existing or potential), whether or not the value is readily ascertainable. 

    Conflict of Interest 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 (SFI) is defined as financial interest consisting of one or more of the following interests of the Investigator and 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 Covered Individual must report a financial interest in which the value of any remuneration received from the entity in the twelve (12) 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 Covered Individual must report a financial interest in which the value of any remuneration received from the entity in the twelve (12) months preceding the disclosure, when aggregated, exceeds $5,000, or when the Investigator holds any equity interest; 
    3. Intellectual Property (IP): A Covered Individual must report receipt of income related to intellectual property, and any equity or business participation in an entity that sponsors the individual's research or licenses the IP. 
    4. Reimbursed or Sponsored Travel: A Covered Individual that submits to or is awarded funding by the PHS must report the occurrence of any reimbursed or sponsored travel which occurred in the twelve (12) months preceding the disclosure and with a value (aggregated per entity that reimburses or sponsors the travel) that 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 - Significant Financial Interest does not include the following types of financial interests: 

    • salary paid by Texas State University to the Investigator if the Investigator is currently employed or otherwise appointed by the Institution; 
    • 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;  
    • 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; 
    • 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. (Travel for a subrecipient that is reimbursed/sponsored by UT Arlington is not required to be reported.) 

    PHS means the Public Health Service of the U.S. Department of Health and Human Services, and any components of the PHS to which the authority involved may be delegated, including the National Institutes of Health (NIH). Also includes agencies such as DHHS, FDA, CDC, HRSA, etc. 

    Institutional Official (IO) is the individual designated as responsible for ensuring compliance with federal and state regulations pertaining to conflict of interest. The IO is responsible for the delegation of authority for the establishment and enforcement of relevant University policies and procedures including solicitation of disclosures, review and determination of financial conflicts of interest, management of identified financial conflicts of interest, and reporting of financial conflicts of interest as required by federal regulations. The President has designated the Vice President for Research (VPR) as the Institutional Official (IO) for the Research Conflict of Interest Program at Texas State University.

    Financial Conflict of Interest (COI) Disclosure refers to the University’s Conflict of Interest Disclosure form available in electronically. . Covered Individuals must submit a COI Disclosure annually, or within 30 days of a newly identified or reportable Significant Financial Interest.  

     If you encounter any issues with submitting the FCOI Disclosure Forms please contact mailto:r_integirty@txstate.edu

    Financial Conflict of Interest (FCOI) Committee is defined as the review body charged with oversight of Texas State University's Conflict of Interest Program. The FCOI Committee reviews disclosures to determine if an actual or potential conflict of interest exists, advises the IO and President, and works in coordination with Investigators to develop COI Management Plans when necessary. 

    Conflict of Interest Management Plan is defined as a written document describing an actual or potential conflict of interest, control measures designed to safeguard the objectivity of research, and methods of monitoring the potential conflict of interest. 

     

  • Purpose 

    Covered Individuals 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). The tool used to report SFIs is the FCOI Disclosure Form. The FCOI Disclosure form will automatically prompt users to supply appropriate information in regard to SFI.  The FCOI Disclosure form fulfills federal regulatory requirements, University and UT System Board of Regents policies, and requirements set forth by many funding agencies for reporting and documenting financial conflicts of interest. 

    Covered Individuals required to submit a RCOI Disclosure form will be identified at the time of:  

    1) submission of a Blue Sheet for funding,  

    2) submission of an IRB (human subject) protocol, or 

    3) submission of an IACUC (animal subject) protocol. 

    The FCOI Disclosure Form complies with the 2011 COI regulations. It is fully electronic and accessible here: https://txstate.kuali.co/dashboard/  

    If you encounter any issues while submitting the FCOI Disclosure forms please contact Research Integrity and Compliance 

    Timing of RCOI Disclosure Submission 

    Initial Disclosure: 

    1. Covered Individuals Conducting PHS, PHS Compliant Agency, or Department of Energy (DOE)- Sponsored Research, Greater than Minimal Risk Human Subject Research, or Animal Research: Must submit or have a current FCOI Disclosure on file no later than the time of application for sponsorship or at the time of the Research protocol submission [(i.e., submission to the Institutional Review Board (IRB) or the Institutional Animal Care & Use Committee (IACUC)]. 
    2. Covered Individuals conducting research not included in part 1 above: Must submit or have a current FCOI Disclosure on file prior to the expenditure of sponsor funds. 
    3. New Covered Individuals: When an Investigator becomes a Covered Individual (e.g., is added to an ongoing Sponsored Research project or a human/animal subject protocol), the individual must submit or have a current FCOI Disclosure on file before engaging in the Research.  

    Subsequent Disclosures:  
     
    Following initial disclosure, Covered Individuals must submit an updated FCOI Disclosure at least annually, or within 30 days of discovering or acquiring a new reportable Significant Financial Interest. The President or the RCIO may require additional disclosures for clarity or transparency. 

     

    Content of a FCOI Disclosure 

    Each Covered Individual must acknowledge at least annually, via the FCOI Disclosure, that the individual is aware of and has read this policy, and is aware of a Covered Individual’s responsibilities regarding disclosure of Significant Financial Interests and of applicable federal regulations. If a Covered Individual discloses Remuneration, Intellectual Property interest or royalties, related documents may be requested and reviewed by the President, the FCIO, or any other person with administrative responsibility for reviewing the FCOI Disclosure or management plans. Significant Financial Interests will be disclosed in reportable ranges. 

    Covered Individuals must report each Significant Financial Interest that reasonably appears to be related to the individual’s Texas State University's institutional responsibilities through disclosure in Texas State University’s online Research FCOI Disclosure form: Disclosure updates (annual or more frequent) will include any 

    Significant Financial Interest that was not disclosed initially and will include updated information regarding any previously disclosed Significant Financial Interest (e.g. the updated value of a previously disclosed Equity Interest). 

    The electronic FCOI Disclosure form will automatically prompt users to identify and submit information pertaining to a Significant Financial Interest as defined in the Key Terms above: 

    1. PAYMENTS RECEIVED FROM OR EQUITY INTEREST IN A PUBLICLY TRADED ENTITY:  the total amount and source of payments received in the preceding twelve months from a publicly traded entity and the value of any equity interest held in the entity on the date of disclosure that, when aggregated, exceed $5,000, including: 
      (A)  as to payments received: 
      (i) salary; and 
      (ii) any payment for services other than salary, such as consulting fees, honoraria, or paid authorship; and 
      (B)  as to equity interests held, any stock, stock options, or other ownership interest or entitlement to such an interest, valued by reference to public prices or other reasonable measures of fair market value; 
    2. PAYMENTS RECEIVED FROM A NON-PUBLICLY TRADED ENTITY OR EQUITY INTEREST IN A NON-PUBLICLY TRADED ENTITY: 
      (A)  the total amount and source of payments received in the preceding twelve months from an entity that is not publicly traded that, when aggregated, exceed $5,000, including (i) salary; and (ii) any payment for services other than salary, such as consulting fees, honoraria, or paid authorship; and 
      (B)  a description of any equity interest held in an entity that is not publicly traded, including any stock, stock options, or other ownership interests or entitlement to such an interest; 
    3. INTELLECTUAL PROPERTY AND ROYALTIES: 
      (A)  a description of intellectual property rights held and any agreements to share in royalties related to those rights; and 
      (B) the amount and source of royalty income that the covered individual or covered family member received or had the right to receive in the preceding twelve months; 
    4. TRAVEL for a Covered Individual that submits to or is awarded funding by the PHS: reimbursed or sponsored travel in the preceding 12 months, including the purpose of the trip, the identity of the sponsor/organizer, the destination, and the duration; 

    Additionally, the electronic FCOI Disclosure form will prompt users to identify and submit information pertaining to any other relationships, commitments, or activities that are related to their Institutional Responsibilities and might present or appear to present a Conflict of Interest involving research. 

    • FCOI Disclosures with negative responses (no items to disclose) will automatically be marked as “Complete,” however, it is a Covered Individual’s responsibility to update their FCOI Disclosure in the future when a new SFI is discovered or acquired (within 30 days).  
    • FCOI Disclosures with positive responses (items disclosed) will automatically be marked as “Approved” and will forward to the Office of Research Administration for review.  Research Administration staff will review the Pending Disclosure to determine if the information provided on the Disclosure is sufficient.  Investigators may be contacted for additional information, or a Disclosure may be returned to an Investigator (via the electronic system) for addition of information, editing, or clarification.  When an Investigator has a FCOI Disclosure returned to them, changes or information requested will be noted in the Comments or Notes section of the FCOI Disclosure.  Investigators should promptly respond to returned FCOI Disclosures.  A FCOI Disclosure will not be considered as active/submitted until it contains sufficient information as determined by Research Administration staff. 
    • Following initial review of a Pending FCOI Disclosure, Research Administration staff shall determine if the Disclosure requires further review by the Financial i Conflict of Interest Committee (FCOIC), or if it can be marked as “Complete” with no further review.  FCOI Disclosures that require review by the FCOIC will be marked as such in the electronic system.     
    • The FCOIC has been designated by the Institutional Official (Vice President for Research) to review disclosures of Significant Financial Interests, to determine if they constitute an actual or potential Research Conflict of Interest.  The FCOIC may review or request (from the Investigator) additional information or documentation in order to make this determination.  The FCOIC may also request a meeting with an Investigator to discuss and gain a clear understanding of a particular activity. Investigators shall respond and provide any information requested by the FCOIC in a prompt manner, in order to meet the review deadlines mandated by the federal regulations. 
    • The FCOIC shall review each financial interest disclosure statement and make two determinations: (1) whether any significant financial interest disclosed is related to research in which the covered individual is engaged; and (2) if so, whether a financial conflict of interest exists. 
    • A financial conflict of interest exists when the significant financial interest could directly and significantly affect the design, conduct, or reporting of research. The FCOIC will determine whether an Investigator's significant financial interest is related to research when it reasonably determines that the significant financial interest: could be affected by the research; or is in an entity whose financial interest could be affected by the research.

  • AI merged suggestion: 

    SFI disclosures are reviewed during both the annual submission period and, if an SFI is disclosed, at the time of a grant award. If a Financial Conflict of Interest (FCOI) is identified, the Conflict of Interest (COI) Official will convene a COI Review Committee to develop a Management Plan. This plan outlines processes and conditions to ensure that the design, conduct, and reporting of research are free from bias or the appearance of bias. 

    The COI Review Committee typically includes: 

    • The Investigator, 
    • An administrator from the Investigator’s department or college, 
    • The Director of Research Integrity and Compliance (RIC). 
    • If the Institutional Official (IO) or the Responsible COI Committee (COIC) determines that an Investigator has an actual or potential FCOI, a Management Plan will be developed collaboratively by the IO, the Investigator, and the COIC. This plan must be implemented: 
    • Prior to the expenditure of funds for sponsored research, and 
    • Before protocol approval for research involving human or animal subjects. 
    • The COIC will prioritize timely and efficient resolution of Management Plans to avoid unnecessary delays or adverse impacts on research activities. All Management Plans will meet the minimum requirements outlined in federal regulations, such as PHS 42 CFR Part 50 Subpart F. 

    Key Elements of a COI Management Plan Include: 

    • The Investigator’s role and principal duties, 
    • Details of the financial interest, including its value and relevance to the Investigator’s responsibilities at Texas Strate University, 
    • Control measures to safeguard the objectivity of the research, 
    • Procedures for monitoring compliance with the Management Plan. 

    For projects funded by Public Health Service (PHS) agencies (e.g., NIH, DHHS, FDA, CDC, HRSA), Management Plan details will be reported to the PHS and made publicly available in accordance with 42 CFR Part 50 Subpart F. 

    Examples of Conditions or Restrictions to Manage FCOIs May Include: 

    1. Public disclosure of the financial conflict (e.g., in publications or presentations), 
    2. Disclosure of the conflict directly to human research participants, 
    3. Appointment of an independent monitor to oversee the research for bias,
    4. Modification of the research plan, 
    5. Reassignment or disqualification of personnel from specific research activities,
    6. Reduction or elimination of the financial interest (e.g., divestiture), 
    7. Severance of relationships that create conflict

    MONITORING OF RCOI MANAGEMENT PLANS (MP) 

    The Research COI Committee performs monitoring of approved MPs. The frequency and type of monitoring that occurs is at the discretion of the Committee and/or Texas State University’s Research Administration and may be dependent upon risk factors such as funding status, personnel involved, research subject matter, or other factors. Potential monitoring activities include: 

    Monitoring Reports - Investigators with approved MPs are required to submit a Monitoring Report by the anniversary date of their most recently approved MP. There are two versions of Monitoring Reports, a standard version and an abbreviated version. Investigators will be notified in advance by the Research Integrity and Compliance which version is required. 

    Abbreviated Monitoring Report - Investigators will be required to provide an update on the status of their outside activities and certify compliance with the requirements of their approved MP over the past year. Abbreviated Monitoring Reports may be reviewed and approved by FCOI Staff unless MP deviations have been reported by the Investigator. In those cases, the Abbreviated Monitoring Report along with supplemental materials from the Investigator describing the deviation will be reviewed at a convened meeting of the FCOI Committee. 

    Standard Monitoring Report - Investigators will be required to provide additional details pertaining to their Texas State University research and outside activities in the past year, such as presentations, publications, disclosures made, funding, and intellectual property. The Standard Monitoring Report will be reviewed at a convened meeting of the FCOI Committee. 

    Periodic Reports - The FCOI Committee may request reports to be submitted more frequently than, or in addition to, the Monitoring Report as described above. Periodic Reports may be reviewed by either FCOI Staff or the FCOI Committee. 

    Investigator Meetings - Investigators may be requested to meet with FCOI Staff and/or the FCOI Committee to provide a status update and discuss fulfillment of the terms of the approved MP. 

    Oversight Manager - In cases where an oversight and/or academic oversight manager is assigned to an Investigator in an approved MP, the Oversight Manager may be responsible for monitoring fulfillment of the terms of the MP and reporting back to the FCOI Committee. 

     

  • If you are receiving an award from the NIH or another Public Health Service (PHS) agency, you are required to complete the online “Conflicts of Interest in Research: Disclosure, Management, and Reporting” training module through the Collaborative Institutional Training Initiative (CITI). 

    Texas State University subscribes to this nationally recognized program, which offers expert-developed content that is regularly updated. The training is available online 24/7, allowing users to log in/out, save progress, and complete modules at their own pace. Each module includes instructional content followed by short multiple-choice quizzes. 

    To begin, visit the CITI Program website and click “Log in through my institution.” You will be guided through a brief questionnaire to help you enroll in the appropriate Learner Group based on your research activities. 

    Training Requirements 

    Mandatory for Covered Individuals: 

    Training must be completed: 

    • Before engaging in any research funded by NIH, other PHS-compliant agencies, or the Department of Energy (DOE), 
    • At the initiation of a Management Plan (if applicable), 
    • Every three (3) years thereafter, 
    • Immediately, and no later than 30 business days, if: 
    • Texas State University  revises its COI policy affecting training requirements, 
    • The individual is found non-compliant with the policy or their Management Plan, 
    • Determined necessary by the Responsible COI Official (FCOI). 

    New Covered Individuals must complete training before beginning PHS/DOE-funded research at Texas State University or provide documentation of having completed equivalent training within the prior four years. 

    Investigators with active Management Plans (regardless of funding source) must complete training at plan initiation and every four years for the duration of the plan. 

    Recommended for Other Investigators 

    All other investigators are strongly encouraged to complete the training voluntarily. It provides valuable insights into research integrity, key terminology, and best practices. 

    Need Help? 

    Please contact Research Integrity and Compliance (RIC) as soon as you receive a Notice of Award to ensure all NIH and PHS compliance requirements are met promptly.

  • As the awardee institution in a PHS-funded or proposed project, Texas State University 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: http://grants.nih.gov/grants/policy/coi/coi_faqs.htm#3222. 

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

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

     The policy determination will be made before a sub-award agreement is finalized or before funds are approved/expended for a subrecipient.  During the time of agreement negotiation, a subrecipient organization/entity will either certify use of its own PHS-compliant conflict of interest policy, or it will elect to adopt Texas State University’s COI Policy.  Individual subrecipients will be identified through the APS form process.  Before the Office of Grant & Contract Services approves an APS request, staff will verify 1) if the project is PHS-funded, and 2) if the individual meets the definition of “Investigator” (see definition in Key Terms above).  Individuals meeting the two criteria will be covered by Texas State University’s COI Policy. 

    When Texas State University’s COPI policy is applied to a subrecipient, the subrecipient Investigator(s) must comply with several requirements, including: 

    • review and understanding of Texas State University’s  COI Policy, 
    • completion of conflict of interest training once every four years or more frequently at the University’s discretion, 
    • reporting any existing or new Significant Financial Interests, 
    • verifying completion of the above by sending a Review Confirmation Email to Texas State University 

    When Texas State University’s  FCOI Policy is applied to a subrecipient, the FCOI Policy, Training, criteria for reporting a Significant Financial Interest, and instructions for submitting a Review Confirmation Email are communicated to Subrecipient Investigators via special webpage. Subrecipient Investigators must report any existing SFIs to Texas State University in advance of, or in attachment to, their Review Confirmation Email.  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. SFI disclosures must be submitted on the Subrecipient Disclosure Form to Texas State University, Research Administration.  Review of Subrecipient Disclosures will follow the procedures above for Review of a FCOI Disclosure. 

    When a subrecipient organization/entity elects to apply its own PHS-compliant RCOI Policy to its Investigators, the organization must report any identified financial conflicts of interest of its Investigators to Texas State University before approval of the sub agreement. In accordance with federal regulation, Texas State University will provide reports to the PHS awarding component of all financial conflicts of interest prior to the expenditure of funds and within 60 days of any subsequently identified financial conflict of interest. 

  • In accordance with PHS Title 42, Part 50, Subpart F, the Institution will maintain this policy as up-to-date, make the policy available on its publicly accessible website (http://www.uta.edu/research/administration/), and make information related to research conflicts of interest available upon request. 

    Requests for public information will be honored when all three of the following criteria are met: 

    The significant financial interest was disclosed and is still held by the senior/key personnel as related to the PHS-funded project, 

    The Institution determines that the Significant Financial Interest is related to the PHS-funded research, and 

    The Institution determines that the Significant Financial Interest is a Financial Conflict of Interest. 

    Once complete information regarding a request has been received, written disclosure will be sent via U.S. Postal Service to the address provided in the request, and postmarked within five business days. 

     

    Public requests may be submitted via email to: 

    Sean Rubino 
    Director of Research Integrity and Compliance 
    Texas State University 


    All other public requests for information (not meeting the criteria described above) must follow the procedures of an Open Records request, described on the following webpage: https://www.uta.edu/administration/legal-affairs/public-information-records-retention/public-information. 

  • Federal regulations require that each application for funding to the PHS include specific certifications, agreements, and reports in regard to this policy and financial conflicts of interest.  Before the expenditure of any funds under a PHS-funded research project, the appropriate institutional officials will make the Financial Conflict of Interest Report to the PHS awarding component in compliance with 42 CFR Part 50 Subpart F, and 45 CFR Part 94.  The institution will comply with PHS requirements for conducting, documenting, and reporting retrospective reviews where applicable. 

    Whenever a financial conflict of interest related to PHS-funded research is not identified or managed in a timely manner including failure by the Investigator to disclose a significant financial interest that is determined by the Institution to constitute a financial conflict of interest; failure by the Institution to review or manage such a financial conflict of interest; or failure by the Investigator to comply with a financial conflict of interest management plan, the Institution shall, within 120 days of the Institution's determination of noncompliance, complete a retrospective review of the Investigator's activities and the PHS-funded research project to determine whether any PHS-funded research, or portion thereof, conducted during the time period of the noncompliance, was biased in the design, conduct, or reporting of such research.  The Institution will document the retrospective review with all of the following key elements: Project number; project title; PD/PI or contact PD/PI if a multiple PD/PI model is used; name of the Investigator with the FCOI; name of the entity with which the Investigator has a financial conflict of interest; reason(s) for the retrospective review; detailed methodology used for the retrospective review (e.g., methodology of the review process, composition of the review panel, documents reviewed); findings of the review; and conclusions of the review. 

    Based on the results of the retrospective review, if appropriate, the Institution shall update the previously submitted FCOI report, specifying the actions that will be taken to manage the financial conflict of interest going forward. If bias is found, the Institution is required to notify the PHS Awarding Component promptly and submit a mitigation report to the PHS Awarding Component. The mitigation report must include, at a minimum, the key elements documented in the retrospective review above and a description of the impact of the bias on the research project and the Institution's plan of action or actions taken to eliminate or mitigate the effect of the bias (e.g., impact on the research project; extent of harm done, including any qualitative and quantitative data to support any actual or future harm; analysis of whether the research project is salvageable). Thereafter, the Institution will submit FCOI reports annually, as specified elsewhere in this subpart. Depending on the nature of the financial conflict of interest, an Institution may determine that additional interim measures are necessary with regard to the Investigator's participation in the PHS-funded research project between the date that the financial conflict of interest or the Investigator's noncompliance is determined and the completion of the Institution's retrospective review. 

    If the failure of an Investigator to comply with an Institution's financial conflicts of interest policy or a financial conflict of interest management plan appears to have biased the design, conduct, or reporting of the PHS-funded research, the Institution shall promptly notify the PHS Awarding Component of the corrective action taken or to be taken. The PHS Awarding Component will consider the situation and, as necessary, take appropriate action, or refer the matter to the Institution for further action, which may include directions to the Institution on how to maintain appropriate objectivity in the PHS-funded research project. PHS may, for example, require Institutions employing such an Investigator to enforce any applicable corrective actions prior to a PHS award or when the transfer of a PHS grant(s) involves such an Investigator. 

    In any case in which the HHS determines that a PHS-funded project of clinical research whose purpose is to evaluate the safety or effectiveness of a drug, medical device, or treatment has been designed, conducted, or reported by an Investigator with a financial conflict of interest that was not managed or reported by the Institution as required by this subpart, the Institution shall require the Investigator involved to disclose the financial conflict of interest in each public presentation of the results of the research and to request an addendum to previously published presentations.

  • Enforcement 

    Under institutional authority and, in some cases, pursuant to Federal regulations ( 42 CFR Part 50 Subpart F), the Texas State University is responsible to maintain and enforce a policy on financial conflicts of interest in research. Under these policies, the University is required to obtain information from investigators on outside financial or business interests, review the information for potential conflicts of interest, manage identified conflicts where possible, eliminate conflicts where management is not possible, and report existing conflicts to research sponsoring agencies as required by sponsoring agency rules and regulations. The University may suspend research and/or impose remedial measures on investigators who fail to disclose interests where required, or who fail to comply with their approved management plan. The Financial Conflict of Interest (FCOI) Committee is responsible for investigations into alleged noncompliance, and for findings of noncompliance, and is supported by the Office of Research Integrity and Compliance in this process.

    Applicability 

    The following procedures apply to all research activities of faculty, staff, students and others who are subject to the disclosure requirements of UPPS 02.02.07 “Researcher Conflicts of Interest in Research and Sponsored Program Activities ”. 

     Definitions 

    Allegation of Noncompliance is an unproven assertion of noncompliance. 

    Noncompliance is defined as failure to comply with Federal regulations, Financial Conflict of Interest (FCOI) policy, an approved FCOI management plan or the determinations or requirements of the FCOI Committee. 

    1. Non‐serious and non‐continuing noncompliance involves isolated incidents, e.g., an unintentional mistake, an oversight or a misunderstanding. The issue is not serious or continuing in nature. 
    2. Serious noncompliance is an action or omission taken by an investigator, that is noncompliant with Federal regulations, FCOI policy, a FCOI management plan or the determinations or requirements of the FCOI Committee, and that any other reasonable investigator would have foreseen as increasing the potential for bias or perceived bias in research, or otherwise compromising the integrity of research at Texas State University. Information which can be used to evaluate the seriousness of noncompliance includes, but is not limited to: An established record of noncompliance by the same researcher(s); An existing knowledge of FCOI policies on the part of the same researcher(s) as evidenced by and documented in 
    • past compliance, or 
    • efforts to mitigate the present alleged noncompliance 
    • A failure to timely disclose information relating to financial or business interests which was clearly requested in a grant/contract application or award or in Texas State University’s FCOI Disclosure Form; 
    • Internal forms and documents relating to disclosure of significant financial or business interests; 
    • Changes in relationships with companies or research personnel that are inconsistent with the original research plan without notification to and approval from the FCOI Committee;
    • Communications with the researcher(s) during the course of investigating the noncompliance

    3. Continuing noncompliance is a pattern of repeated actions or omissions taken by an investigator that indicates a deficiency in the ability or willingness to comply with Federal regulations, FCOI policy, a FCOI management plan or determinations or requirements of the FCOI Committee. 

     

    Procedures for Handling Alleged Noncompliance 

    A. FCOI staff, as designees of the FCOI committee, may become aware of alleged noncompliance during review of disclosures or other information submitted by researchers or other administrative offices, or as a result of an allegation made by a third party. 

    B. When alleged noncompliance comes to the attention of FCOI staff, the staff will review the information to determine whether it is valid. If it is valid, then FCOI staff will undertake an inquiry and determine if the alleged noncompliance appears to be serious or non-serious 

    C. During the inquiry, FCOI staff will evaluate and compile information related to the researcher’s FCOI and management plan (if available), previous disclosures on file, and funding sources. FCOI staff may request additional information from the researcher for clarification. 

    D. After conducting an inquiry, if FCOI staff are able to determine that the alleged non‐compliance is non‐serious and non‐continuing: 

    1. The issue will be resolved by FCOI staff in coordination with the FCOI Committee Chair. 
    2. FCOI staff and the FCOI Chair will document the outcome in writing, including any remedial measures required. This documentation may be in the form of email communications with the researcher(s), a letter or memo, or notes to the file. Remedial measures for non‐serious or non‐continuing noncompliance can include: 
    • Required correction of omissions and/or errors in the FCOI disclosure; 
    • A request to the researcher(s) to fulfill obligations under the management plan and/or FCOI policies; 
    • A reminder to the researcher(s) to adhere to management plan requirements and FCOI policies in the future; 
    • A meeting between FCOI staff and the researcher(s) to explain RCOI requirements and policies; 
    • Issuance of a letter to the researcher(s) signed by the Financial Conflict of Interest Official outlining the findings and any remedial measure(s), sent to the researcher(s), and others as deemed appropriate.

    3. The researcher must reply to FCOI program notifications of noncompliance within the timeframe established by the committee, to acknowledge the noncompliance and agree to any remedial measures, if 

    4. The inquiry findings and remedial measures will be reported to the FCOI Committee at the next scheduled meeting. 

    E. If, after conducting an inquiry, FCOI staff determines that the alleged non‐compliance may be serious or continuing, FCOI staff will present the information to the FCOI Committee Chair. 

    F. If the FCOI Committee Chair determines that the alleged noncompliance may be serious and/or continuing: 

    1. FCOI staff or a subcommittee of FCOI Committee members may undertake a further inquiry. Other staff may be requested by the FCOI Committee to assist and/or provide information for the inquiry. 
    2. If the related research involves human participants, FCOI staff will notify the IRB that the FCOI Program has received an allegation of noncompliance, and that it will keep the IRB informed of developments in the inquiry and determination as appropriate. The FCOI Staff will notify the IRB if, after the inquiry and determination of noncompliance, any part of the noncompliance or remedial measures is/are related to the protection of human subjects. 
    3. FCOI staff will document and compile the information and present the findings to the FCOI Committee. The Committee will receive copies of any existing management plan(s), disclosures, and any communications and discussions concerning the alleged noncompliance from the inquiry 
    4. The Committee will review the findings at a scheduled meeting. The researcher(s) alleged of noncompliance will be invited to attend the Committee meeting to discuss the alleged noncompliance with the Committee. 
    5. The Committee may ask for further investigation if necessary. 
    6. The Committee will make a determination regarding whether there was serious and/or continuing noncompliance. 
    7. If serious or continuing noncompliance is found to exist, the Committee will determine if remedial measures are necessary to encourage future compliance with FCOI policies and/or management plans. Examples of remedial measures include, but are not limited to: 
    • Required training on research ethics, the content and number of hours of which to be determined by the Committee based on the severity of the noncompliance; 
    • A requirement that the researcher(s) work with FCOI Staff to organize a FCOI information session for their lab, department or college; 
    • Required disclosure to a broader audience than previously required under the existing management plan, if any; 
    • Increased monitoring, (e.g., quarterly instead of annually); 
    • Referral to the IRB if, as a result of the finding of noncompliance, any part of the noncompliance or remedial measures is/are related to the protection of human subjects; 
    • Suspension of funds on sponsored research projects pending resolution of the noncompliance matter; 
    • Reporting of the noncompliance to Texas State University Administration where appropriate, such as department Chairs, college deans, Human Resources, Office of Legal Affairs, Office of the Vice President for Research, and/or Office of the President; 
    • Reporting of the noncompliance to external agencies where required, such as research sponsoring agencies

    8. The researcher will be issued a letter signed by the FCOI Committee Chair outlining the findings and any remedial measure(s). The letter will be sent to the researcher(s), the researcher’s department chair, the Vice President for Research, and others as deemed appropriate. The researcher must reply to FCOI program notifications of noncompliance to acknowledge the noncompliance and agree to any remedial measures, if applicable, within the timeframe established by the FCOI committee. 

    9. If, in the course of investigating or evaluating alleged noncompliance with FCOI policies, FCOI staff or the FCOI Committee receive or discover other information which may form the basis of a potential research misconduct matter, the staff or Committee will follow steps for reporting such possible misconduct according to the requirements of policy UPPS 02.02.11 or any other pertinent policies. 

    Appeal 

    A. Researchers may appeal a determination of non-compliance once. The appeal request consists of sending the Research Integrity and Compliance Director a letter outlining the basis for the appeal and the document(s) that support the appeal.  

    B. The appeal is heard at a convened meeting of the FCOI Committee. At the discretion of the FCOI Committee Chair, the researcher may also present the appeal in person to the Committee. 

    C. Following discussion, the FCOI Committee votes whether to take one of the following actions: 

    1. Approve the appeal and modify the original determination; 
    2. Disapprove the appeal and uphold the original determination; or 
    3. Defer the appeal to obtain additional information or consultation in order to make a final decision. 

    D. The FCOI Committee’s appeal determination, and any other considerations or requirements associated with it, are communicated to the researcher in writing within 10 business days. 

    E. The concluding FCOI Committee decision of an appeal is final and cannot be appealed again. 

  • Cooperation Amongst Committees 

    The Financial conflict of interest (FCOI) official and the appropriate IRB, IACUC, IBC, IP Committee, and other relevant committees shall cooperate in consideration of whether a covered individual has a financial conflict of interest in regard to research and in the development and implementation of a Management Plan for that conflict of interest. 

    Investigator Disclosures as a Condition of Employment or Relationship to Institution 

    Timely, complete, and accurate disclosure of activities and financial interests consistent with Texas State FCOI Policy and these Operating Procedures is a condition of employment at the institution, and a covered individual who does not comply with this policy is subject to discipline, including termination of employment. For a covered individual who is not an employee of the institution, compliance with Texas State's policies and procedures is a condition of participating with the institution in the capacity that qualifies the person as a covered individual.  

    In order to ensure alignment with federal, state, System, and Institutional policies and regulations, FCOI Staff and/or the FCOIC may request clarifying information about an investigators outside activity or institutional responsibilities to help determine FCOI applicability or to finalize required documentation (e.g., management plans, monitoring reports). In accordance with Texas State University FCOI Policy and Standards of Conduct Policy, investigators must respond to such requests in a timely manner. 

    Investigator Cooperation and RCOI Committee Enforcement 

    Many FCOI issues are very time-sensitive; some are required to be addressed or resolved prior to submitting a grant proposal or finalizing a contract or agreement. Should an investigator be unresponsive, provide incomplete submissions or insufficient information or go past due on a deadline set for submission of requested information, one additional follow-up communication (via email) will be issued. The investigator's Department Chair, the Director of Regulatory Services, and the Associate Director of Regulatory Services will be copied on the follow-up communication. If an investigator is more than 2 weeks past due on providing the requested information, the actions may be reviewed at the next regularly scheduled FCOIC meeting for "Potential Non-Compliance". The investigator will be notified by email of the "Potential Non-Compliance" and will be given an opportunity to attend the meeting in which the actions are reviewed. 

     

  • Records will be maintained in accordance with federal and state regulations and the institution’s policies and procedures for records management and retention. 

    For PHS-funded research, the institution will maintain records relating to all Investigator disclosures of financial interests and the Institution's review of, and response to, such disclosures (whether or not a disclosure resulted in the Institution's determination of a financial conflict of interest) and all actions under the Institution's policy or retrospective review, if applicable, for at least three years from the date the final expenditures report is submitted to the PHS or, where applicable, from other dates specified in 45 CFR 74.53(b) and 92.42 (b) for different situations. 

  •  

    • Standards of Conduct),  (Standards of Conduct), 30104 (Conflict of Interest), Series 90000 (Rules for Intellectual Property)2021 PHS Conflict of Interest Regulations, 42 CFR Part 50, Subpart F  
    • Texas State University UPPS 04.04.06 Outside Employment and Activities 
    • Texas State University UPPS 04.04.07 Nepotism and Related Employment 

     

Contact Information

All questions concerning this policy, FCOI Disclosures, Management Plans, or reports should be directed to Research Integrity and Compliance phone: 512-245-1423  

Website: /administration https://www.research.txst.edu/orc/researcher-conflict-of-interest.html