J04 Financial Conflict of Interest - University of Houston-Victoria

Financial Conflicts of Interest in Research

Section: Financial Conflict of Interest
Index: J-04

The University of Houston-Victoria is dedicated to maintaining public confidence that supported research is carried out objectively and following the highest scientific and ethical standards. The Public Health Service (P.H.S.) [1], the National Science Foundation [2], and other regulatory and ethical bodies require organizations to apply a financial conflict of interest and disclosure policy to manage federally funded projects. The Conflict of Interest (C.O.I.) policy applies to individual(s) applying for or receiving funds to be administered through the University.

Policy

The policy's purpose is to promote objectivity in research by establishing standards to ensure the integrity of the research's design, conduct, or reporting is not compromised by a conflicting financial interest. By exercising this policy, the University will impose appropriate management of actual or potential financial interest. The University is responsible for managing, reducing, or eliminating conflict of interest presented by the Investigator before the expenditures of the award funds. Investigators are required to disclose any significant financial interests that may present a potential or actual conflict of interest with a sponsored project: (i) that would reasonably appear to be affected by the research or educational activities funded or proposed for funding; or (ii) in entities whose financial interests would appear to be affected by such activities.

Definitions

The definitions for this policy follow 42 C.F.R. part 50.603 - Definitions
Financial Conflict of Interest means a significant financial interest that could directly and significantly affect research design, conduct, or reporting.
Certification/Disclosure Process means at least once a year at minimum, all individuals who satisfy the description of an investigator as specified herein must certify their understanding of and compliance with this policy. The procedure entails either a certification that no major financial interest exists or the disclosure of any existing significant financial interests to the Institution. In addition to the annual obligation, new financial interests must be disclosed within 30 days after acquisition or discovery. Refer to section C for the full disclosure process.
Designated Official is the individual within the University that is responsible for the solicitation and review of disclosures of significant financial interests from each Investigator who is participating in, or is planning on participating in, research. The Designated Official for the University of Houston-Victoria is the Director of Grants and Contracts.
Institutional responsibilities - it's the investigators' professional responsibilities on behalf of the Institution, which include but are not limited to research, consultation, teaching, professional practice, and membership on institutional committees such as the Institutional Review Boards, as described in the faculty manual chapter 3, Faculty Roles and Responsibilities.
Investigator refers to the Principal Investigator/Principle Director (PI/PD), co-PI/co-PD, and any other person identified on the proposed project who is responsible for the design, conduct, or reporting of research or educational activities funded or proposed for funding including subgrantees, contractors, consortium participants, collaborators, or consultants. The term "investigator" includes the Investigator's spouse and dependent children.
Research means any activity that satisfies the definition of research specified by the sponsoring agency it is considered research. If not funded or not otherwise defined, the following definitions apply.

A systematic investigation, including research development, testing, and evaluation, is designed to develop or contribute to generalizable knowledge. Activities that meet this definition constitute research for purposes of this policy, whether or not they are conducted or supported under a program that is considered research for other purposes [3].
A systematic study directed toward fuller scientific knowledge or understanding of the subject studied. Research is classified as either primary or applied according to the objectives of the sponsoring agency [4].

Significant financial interest of the Investigator (and those of the Investigator's spouse and dependent children) that reasonably appears to be related to the Investigator's institutional responsibilities.

With regard to any publicly traded entity, a Significant Financial Interest exists if the value of any remuneration received from the entity in the twelve months preceding the disclosure and the value of any equity interest in the entity as of the date of disclosure, when aggregated exceeds $5,000. For the purposes of this definition, remuneration includes salary and any payments for services not otherwise identified as salary (e.g., consulting fees or honoraria, paid authorship); equity interest includes any stock, stock option, or other ownership interests as determined through reference to public prices or other reasonable measures of fair market value; and intellectual property rights (e.g., patents, copyrights, and royalties from such rights).
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 more, or when the Investigator (or the Investigator's spouse of dependent children) holds any equity interest (e.g., stock, stock option or other ownership interest); or
Intellectual property rights and interest (e.g., patents, copyrights) upon receipt of income above $5,000 related to such rights and interests.

A Potential Conflict of Interest may exist when an observer reasonably determines that a significant financial interest could directly and significantly affect the design, conduct, or reporting of research or educational activities resulting in the individual's personal gain, financial or otherwise.

The following is a list of common conflicts of interest related to sponsored program activity.

The Investigator has a financial interest in an entity, and the sponsored project proposed is to subcontract a portion of the work, lease property, make a referral of participants to, or make purchases from the entity.
The Investigator has a financial interest in an entity that is part of a consortium, or that will otherwise participate in the sponsored project.
The Investigator alters the focus of the research program for the benefit of his/her outside interests.
The Investigator uses or releases privileged information for personal or third-party gains.
The Investigator accepts gratuities or special favors in return for influencing the conduct of research.

Certificate of Compliance

At least annually, all Investigators involved in sponsored projects must certify to the Director of Grants and Contracts their knowledge of and compliance with the financial disclosure policy as outlined herein. The certification form also requires the same information about members of the academic staff member's immediate family. Investigators must supply this information for confidential review by completing the Certificate of Compliance. Certifications must be updated at the time of a new funding submission or within 30 days of acquiring or discovering either through procurement, inheritance, or marriage of a new significant financial interest.

Investigators, including their immediate family members, must disclose all major financial interests, including

Remuneration in excess of $5,000 from a publicly-traded entity during the preceding 12 months. 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 (stock, stock options, or other ownership interest) in a publicly traded company valued in excess of $5,000 at the time of certification;
Any combination of the above two items (equity and income) that exceeds $5,000 during the preceding 12 months;
Any amount of equity (stock, stock options, or other ownership interest) in a non-publicly traded entity, including a start-up company;
Remuneration that exceeds $5,000 from a non-publicly traded entity in the past 12 months, or Intellectual property rights and interests (e.g., patents and copyrights), upon receipt of such income related to such rights and interests. Income-related to intellectual property rights in excess of $5,000 paid by any source other than the Investigator's current Institution.
A PHS funding investigator must disclose travel reimbursement or sponsor paid travel by a third-party entity, even if a nonprofit organization is involved in the preceding 12 months. The disclosure must include the purpose of the trip, the identity of the sponsor/organization, the destination, and the duration of the trip.
The value of gifts received in the preceding twelve months that exceed $50 in value, or multiple gifts from an outside entity that, in the aggregate, exceed $50 in value.
Investigators, as defined in item B.6., must disclose if they plan to purchase or recommend or approve the purchase of goods or services from an entity with which they or a family member has a direct or indirect financial or other interest and in accordance with Texas Government Code 2261.252.

The term significant financial interest does not include:

Salary, royalties, or other remuneration from the proposing organization;
Income from seminars, lectures, or teaching engagements sponsored by a federal, state, or local government agency, or an institution of higher education within the United States 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 or Institution of higher education within the United States 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 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;
Any ownership interests in the organization, if the organization is an applicant under the Small Business Innovation Research Program or Small Business Technology Transfer Program;
Intellectual Property Rights assigned to the Institution and agreements to share in royalties related to such rights
Disclosure is not required for travel sponsored by or reimbursed by a government agency, a U.S. Institution of higher education or a research institute affiliated with such, a U.S. medical center, or a U.S. academic teaching hospital.

The disclosure must include:

The Investigator's current or pending relationship with the outside enterprise or entity in which a significant financial interest exists;
The relationship of the research to the enterprise or entity;
The means by which the Investigator proposes to address actual or potential conflicts of interest that arise from his/her (or members of the family) dual University and enterprise or entity roles, and
The dollar amount of the financial interest in specified ranges.

Common sense should prevail in these interpretations, such as whether a reasonable, disinterested person would question the relationship. If that is the case, it should be disclosed, and approval sought for the proposed arrangement.

The Office of Research and Sponsored Programs will disseminate the forms annually or in preparation for application submission, and the director will review the financial disclosure forms. If a potential conflict of interest exists, the information will be presented to the Dean of the presiding school and the Chair of the presiding program to determine whether an actual conflict of interest exists and determine what conditions or restrictions if any, should be imposed by the Institution to manage, reduce, or eliminate the conflict. An actual or potential conflict of interest exists when the reviewer(s) reasonably determines that a significant financial interest could affect the design, conduct, or reporting of the research or educational activities in question.
Examples of conditions or restrictions that might be imposed to manage, reduce, or eliminate actual or potential conflicts of interest include:

Public disclosure of significant financial interests;
Monitoring of research by independent reviewers;
Modification of the research plan;
Disqualification from participation in that portion of the research that would be affected by the significant financial interests;
Divestiture of the significant financial interests;
Severance of relationships that create actual or potential conflicts.

If the Dean or Chair determines that imposing conditions or restrictions would be either ineffective or inequitable and that the potential negative impacts that may arise from a significant financial interest are outweighed by interests of scientific progress, technology transfer, or the public health and welfare, then the Dean or Chair may recommend that the research go forward without imposing such conditions or restrictions. Such a recommendation will be forwarded to the Vice President for Academic Affairs/Provost for his or her approval or disapproval.
If the Investigator desires to appeal the conditions or restrictions supported by the Vice President for Academic Affairs/Provost, he or she may present the appeal to the President, who then forms the ad hoc appeals committee. The ad hoc appeals committee comprises one faculty from each school selected by the dean of that school, one member from Administration & Finance, and one nonacademic position appointed by the Provost. The ad hoc appeals committee will make a recommendation to the Provost, who has final authority.

Failure of any academic staff member to comply with this policy shall constitute grounds for disciplinary action.

Training
At least once every four years, all individuals meeting the definition of Investigator must complete FCOI training modules 1 and 2 offered by the Collaborative Institutional Training Initiative (CITI) before utilizing research funds (42 CFR 50.604(b)). Under certain circumstances, failure to disclose significant financial interests, or noncompliance with approved management plans, additional training may be required.

Awardees and Subrecipients
When the University of Houston-Victoria is the lead awardee of a collaborative P.H.S. or N.S.F. funding project, it must ensure that all subrecipients' financial interests are examined and properly managed. All subrecipients/potential subrecipients will be required to certify at the proposal stage and throughout the project that the entity manages Significant Financial Conflicts of interest, meeting regulatory requirements through a subrecipient agreement. If the awardee lacks an FCOI policy, it must adhere to the UHV FCOI policy.

Record Retention
The Office of Research and Sponsored Programs will maintain records related to all Investigator discloses, related to the review and/or response to the disclosures, and related actions under the University's policy or retrospective review for a minimum of three years from the date of the financial expenditure report is submitted to N.I.H.

Reporting
When the University determines that an FCOI exists involving an N.I.H. funded project, the University must report to the N.I.H. awarding Institution or Center through the submission of an initial (original) and annual FCOI report using the eRA Commons FCOI Module. Furthermore, U.H.V. agrees to make information available promptly upon request to the N.I.H. relating to any investigator disclosure of financial interest and the Institution's review of or response to such disclosure, whether or not the disclosure resulted in the Institution's determination of an FCOI.

When the University determines that it is unable to satisfactorily manage a conflict of interest involving an N.S.F. funding project, the University must contact the N.S.F. Office of General Counsel through N.S.F. FastLane System/Research.gov.

Supporting Documents

Approved by:

[signature obtained]
Robert K. Glenn, Ph.D.
President

Date:

12/20/2022