Financial Statements

Scientific Conflict of Interest Policy

  • 1.0 Policy Overview

    It is the policy of the Texas Biomedical Research Institute that research be conducted in an atmosphere of openness and integrity, and that the integrity of research shall not be compromised by individual financial interests.  As an applicant for and recipient of U.S. Public Health Service (PHS) grants, Texas Biomed has an additional obligation to ensure compliance with federal conflict of interest regulations, including 42 CFR 50.601 et seq., as amended.

    Texas Biomed faculty and staff have a fundamental obligation to act in the best interests of the institution and must not let outside activities or outside financial interests interfere with that obligation. This policy is intended to educate faculty and staff about situations that create Conflicts of Interest, and to provide means for management of those conflicts.

    This policy is intended to establish a review procedure to identify conflicts of interest, real or perceived. When such conflicts are identified, this policy provides guidelines for management or reduction of such conflicts.

  • 2.0 Definitions
    • 2.1. Conflict of Interest means a situation where an individual has the opportunity to influence research, administrative, or business decisions in ways that could lead to personal financial advantage.
    • 2.2. Exempt entity means a Federal, state, or local government agencies, 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.
    • 2.3. Family means the Investigator’s spouse, parents, siblings, children, as well as the spouses of the parents, siblings or children as well as any other dependents of the Investigator.
    • 2.4. Financial conflict of interest (FCOI) means a significant financial interest that could directly and significantly affect the design, conduct, or reporting of PHS-funded research.
    • 2.5. Financial interest means anything of monetary value, whether or not the value is readily ascertainable.
    • 2.6. Institutional responsibilities means an Investigator’s professional responsibilities on behalf of the Institution, and as defined by the Institution in its policy on financial conflicts 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 or Data and Safety Monitoring Boards.
    • 2.7. Investigator means the Project Director or Principal Investigator, key personnel, and any other person, regardless of title or position, who is responsible for the design, conduct, or reporting of research, or proposed for such funding, which may include, for example, collaborators or consultants.
    • 2.8. Research means a systematic investigation, study or experiment designed to develop or contribute to generalizable knowledge relating broadly to public health, including behavioral and social-sciences research. The term encompasses basic and applied research and product development. As used in this policy, the term includes any such activity for which research funding is available from the NIH or PHS through a grant or cooperative agreement, such as a research grant, career development award, center grant, individual fellowship award, infrastructure award, institutional training grant, program project, research resources award, or a contract.
    • 2.9. 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.
    • 2.10. Significant financial interest means: (1) A financial interest consisting of one or more of the following interests of the Investigator (and those of the Investigator’s Family) that reasonably appears to be related to the Investigator’s institutional responsibilities:
      • 2.10.1 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.
      • 2.10.2 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).
      • 2.10.3 Intellectual property rights and interests (e.g., patents, copyrights), upon receipt of income related to such rights and interests.
      • 2.10.4 Travel, whether reimbursed or sponsored.
    • 2.11 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; 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 an Exempt Entity.
    • 2.12 Travel means 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 an Exempt Entity.
  • 3.0 Disclosure and Review of Significant Financial Interests
    • 3.1 Investigators shall disclose the existence of Significant Financial Interests to the Conflict of Interest Committee using a format approved by the Committee. Disclosures are required:
      • 3.1.1 No later than the time of application for externally funded research.
      • 3.1.2 Within thirty (30) days of discovering or acquiring (e.g., through purchase, marriage, or inheritance) a new significant financial interest.
      • 3.1.3 Within thirty (30) of the effective date of personnel action for Investigators added to existing externally funded projects.
      • 3.1.4 Updates are required at least annually, even if the Investigator has no Significant Financial Interest to report.
      • 3.1.5 Updates shall include any information that was not previously disclosed, and shall include updated information (e.g. number or value of shares) regarding any previously disclosed significant financial interest.
    • 3.2 All gifts with a total cumulative monetary value over $500.00 in any single year from an employee or representative of company with which Texas Biomed currently has or may in the future have a business relationship must be disclosed.
    • 3.3 The Conflict of Interest Committee shall be appointed by the President and shall report to the President through the Chief Scientific Officer. Membership of the Committee shall comprise at least three scientists and/or veterinarians and an institutional official who shall act as the PHS-required institutional Conflict of Interest Official.
    • 3.4 The Committee shall review disclosures that present, or appear to present, a financial conflict of interest to determine whether an Investigator’s significant financial interest is related to externally- supported research and, if so related, whether the significant financial interest is a financial conflict of interest.
    • 3.5 The Conflict of Interest Committee may seek additional information from the Investigator, the Department Chair, or any others persons as are necessary to make their determination.
    • 3.6 An Investigator’s significant financial interest is related to externally supported research when the Institution, through its designated official(s), reasonably determines that the significant financial interest:
      • 3.6.1 Could be affected by the research; or
      • 3.6.2 Is in an entity whose financial interest could be affected by the research.
    • 3.7 A financial conflict of interest exists when the Committee reasonably determines that the significant financial interest could directly and significantly affect the design, conduct, or reporting of the externally supported research.
    • 3.8 After the Conflict of Interest Committee has completed their review, a recommendation will be forwarded to the President and Chief Scientific Officer regarding disposition. Such recommendation may include a management or mitigation plan as described in section 4 of this Policy.
  • 4.0 Management and reporting of financial conflicts of interest
    • 4.1 Prior to expenditure of funds under an externally supported research project, should a financial conflict of interest exist, the institutional Conflict of Interest Official shall develop and implement a management plan that shall specify the actions that have been, and shall be, taken to manage such financial conflict of interest. Examples of such actions include, but are not limited to:
      • 4.1.1 Public disclosure of financial conflicts of interest (e.g., when presenting or publishing the research)
      • 4.1.2 For research projects involving human subjects research, disclosure of financial conflicts of interest directly to participants
      • 4.1.3 Appointment of an independent monitor capable of taking measures to protect the design, conduct, and reporting of the research against bias resulting from the financial conflict of interest
      • 4.1.4 Modification of the research plan
      • 4.1.5 Change of personnel or personnel responsibilities, or disqualification of personnel from participation in all or a portion of the research
      • 4.1.6 Reduction or elimination of the financial interest (e.g., sale of an equity interest)
      • 4.1.7 Severance of relationships that create financial conflicts
    • 4.2 Whenever, in the course of an ongoing externally funded research project, an Investigator who is new to participating in the research project discloses a significant financial interest or an existing Investigator discloses a new significant financial interest to the Institution, the designated official(s) of the Institution shall, within sixty days:
      • 4.2.1 implement, on at least an interim basis, a management plan that shall specify the actions that have been, and will be, taken to manage such financial conflict of interest.
    • 4.3 Whenever an Institution identifies a significant financial interest that was not disclosed timely by an Investigator or, for whatever reason, was not previously reviewed by the Institution during an ongoing PHS-funded research project (e.g., was not timely reviewed or reported by a subrecipient), the designated official(s) shall, within sixty days:
      • 4.3.1 Review the significant financial interest;
      • 4.3.2 Determine whether it is related to PHS-funded research;
      • 4.3.3 Determine whether a financial conflict of interest exists; and, if so:
        • 4.3.3.1 Implement, on at least an interim basis, a management plan that shall specify the actions that have been, and will be, taken to manage such financial conflict of interest going forward;
        • 4.3.3.2 In addition, whenever a financial conflict of interest is not identified or managed in a timely manner for any reason, Texas Biomed shall, within 120 days of the determination of noncompliance, complete a retrospective review of the Investigator’s activities and the externally supported research project to determine whether any externally supported research conducted during the time period of the noncompliance, was biased in the design, conduct, or reporting.
    • 4.4 The outcome of determinations of Financial Conflict of Interest, Management Plans or Mitigation Plans shall be reported to external research sponsors in cases where the sponsor stipulates or requires such reporting, in accordance with the format prescribed by the research sponsor.
  • 5.0 Responsibility for compliance
    • 5.1 Deliberate breach of this policy, including failure to fully disclose Significant Financial Interests, failure to provide additional information as reasonably required by the Conflict of Interest Committee for their review, or failure to comply with the terms of a management plan will be cause for disciplinary action up to and including dismissal from Texas Biomed.
    • 5.2 If the failure of an Investigator to comply with this policy has biased the design, conduct, or reporting of PHS-funded research, Texas Biomed is required to promptly notify the PHS of the corrective action taken or to be taken.