16.12.3.3 CONFLICT OF INTEREST POLICY FOR SPONSORED PROJECTS

The purpose of this policy is to implement the requirements adopted by the U.S. Public Health Service (PHS), which includes the National Institutes of Health (NIH), and the National Science Foundation (NSF) concerning the prevention of bias in the design, conduct or reporting of research by managing, reducing, or eliminating actual or potential conflicts of interest. The Texas Government Code prohibits conflicts of interest for all state employees, including university faculty and staff.

It is the policy of the University of North Texas (“UNT”) that no proposed, awarded, or ongoing UNT research project or educational activity shall be biased by any significant financial interest of any investigator responsible for the design, conduct, or reporting of that research or activity.

All UNT investigators who apply for external funding from any entity for a research project or educational activity shall comply with the requirements of this policy. If research at UNT is carried out through a subcontractor or collaborator, UNT shall require the subcontractor or collaborator to certify that all investigators working on the project are in compliance with a conflict of interest policy that satisfies the requirements of this policy.

“Conflict of interest” exists when the reviewer(s) reasonably determines that a Significant Financial Interest could directly and significantly affect the design, conduct, or reporting of externally funded research or other educational activity.

“Investigator” means the principal investigator or any other person who is responsible for the design, conduct, or reporting of research or other educational activity externally funded or proposed for such funding. For the purposes of determining Significant Financial Interests, “Investigator” includes the investigator’s spouse and dependent children.

“PHS” means the U.S. Public Health Service, an operating division of the U.S. Department of Health and Human Services, and components of the U.S. Public Health Service to which the authority involved may be delegated.

“Significant Financial Interest” means anything of monetary value, including but not limited to, salary or other payments for services (e.g., consulting fees or honoraria); equity interests (e.g., stocks, stock options or other ownership interests); and intellectual property rights (e.g., patents, copyrights and royalties from such rights). The term does not include:

2. income from seminars, lectures, or teaching engagements sponsored by public or nonprofit entities; or

3. income from service on advisory committees or review panels for public or nonprofit entities; or

4. an equity interest that when aggregated for the investigator and the investigator’s spouse and dependent children, meets both of the following tests: does not exceed $10,000 in value as determined through reference to public prices or other reasonable measures of fair market value, and does not represent more than a five percent ownership interest in any single entity; or

5. salary, royalties or other payments that, when aggregated for the investigator and the investigator’s spouse and dependent children over the next twelve months, are not expected to exceed $10,000.

When an investigator submits a proposal for external funding of a research project or educational activity to the Office of Research Services, the investigator shall complete and provide to the Associate Vice Provost for Research a “Significant Financial Interests Disclosure” form (the “disclosure”). In the disclosure the investigator shall indicate the general category of any Significant Financial Interests held by the investigator, the investigator’s spouse, or his or her dependent children:

1. that would reasonably appear to be affected by the research or educational activity proposed for funding; or

2. in entities whose financial interests would reasonably appear to be affected by the research or educational activity proposed for funding.

For any categories marked, the investigator shall attach to the disclosure supplemental documentation (in a sealed envelope marked “Confidential”) that identifies the entity involved and the nature and the amount of the interest.

If the investigator does not disclose any Significant Financial Interests in the disclosure, the Office of Research Services shall process the proposal in the ordinary manner.

If the investigator discloses any Significant Financial Interests in the disclosure, the Associate Vice Provost for Research shall review the supporting documentation and the proposal to determine if there is a potential conflict of interest. If there is sufficient evidence to indicate a possible conflict of interest, the Associate Vice Provost for Research shall forward the disclosure, the supporting documentation, and the proposal to the Conflict of Interest Review Committee (the “Committee”) within five business days of receipt of the disclosure. The Committee shall consist of at least three members from the faculty, staff, or administration appointed by the UNT President, with one member designated as Chair of the Committee. If more than three Committee members are appointed, the total number of members shall be an odd number. The term for each Committee member shall be three years with staggered terms. Within ten (10) business days of receipt of the disclosure, the Committee shall meet and determine whether the Significant Financial Interest(s) disclosed could directly and significantly affect the design, conduct, or reporting of the proposed research or educational activity and determine what modifications or conditions, if any, should be imposed to manage, reduce, or eliminate such conflict of interest.

The Committee may require the investigator to submit more detailed information regarding the Significant Financial Interest(s) that relates to the project proposed for funding and may require the investigator to meet with the Committee. The Committee shall take one of the following actions on each proposal referred for review:

2. require modifications, conditions, or administrative oversight for the proposed project; or

Examples of conditions or restrictions that might be imposed by the Conflict of Interest Review Committee include, but are not limited to:

4. disqualification of the investigator from participation in all or a portion of the research;

6. severance of relationships that create actual or potential conflicts of interest.

The Conflict of Interest Review Committee shall notify the investigator and the Associate Vice Provost for Research of the Committee’s decision in writing. If the investigator does not agree with any modifications or conditions imposed by the Committee or with the Committee’s recommendation that the proposed project be withdrawn, the investigator shall have ten (10) business days following receipt of such notice to appeal the decision to the UNT Provost and Vice President for Academic Affairs.* The procedures for all such appeals shall be determined by the Committee. Within ten (10) business days of receipt of an appeal, the Provost and Vice President for Academic Affairs shall notify the investigator, the Conflict of Interest Review Committee, and the Associate Vice Provost for Research of his or her decision in writing. The decision of the Provost and Vice President for Academic Affairs shall be final. A copy of any conflict management plan adopted by the Conflict of Interest Review Committee or the Provost and Vice President for Academic Affairs shall be maintained in the records of the Office of Research Services. Any conditions or restrictions to resolve or manage conflicts of interest must be implemented before UNT’s expenditure of any funds awarded under a grant or contract.

The investigator must update the Disclosure on an annual basis during the period of the award and upon acquisition of any new reportable Significant Financial Interests. The investigator shall submit a new Disclosure to the Office of Research Services by August 31 of each year and within 30 days of obtaining a new financial interest that may be affected by the research or educational activity.

The Conflict of Interest Review Committee shall have the responsibility to annually review the Conflict of Interest Policy for Sponsored Projects and recommend changes to the Vice Provost for Research.*

Prior to the expenditure of any funds under a PHS award, UNT shall report to the PHS awarding component the existence of a conflicting interest (but not the nature of the interest or other details) found by UNT and assure that the interest has been managed, reduced or eliminated. For any conflicting interest identified subsequent to a PHS award, UNT shall advise the PHS awarding component of the manner in which the conflict will be managed, reduced, or eliminated, at least on an interim basis, within 60 days of such identification. If the failure of an investigator to comply with this policy has biased the design, conduct, or reporting of PHS-funded research, UNT shall promptly notify the PHS awarding component of the corrective action taken or to be taken.

If a PHS-funded project involves evaluation of the safety or effectiveness of a drug, medical device, or treatment and the study has been designed, conducted or reported by an investigator with a conflicting interest that was not disclosed or managed under this policy, the investigator(s) involved must disclose the conflicting interest in each public presentation of the results of the research.

If UNT is unable to satisfactorily manage a conflict of interest relating to NSF-funded research, UNT shall notify the NSF of the circumstances.

The Office of Research Services shall maintain records of all financial disclosures and of all actions taken to resolve actual or potential conflicts of interest until the later of: (1) a minimum of three years after the termination or completion of the award to which they relate; (2) the resolution of any governmental action involving those records; (3) the date specified by applicable federal or state law; or (4) the UNT Records Retention Schedule.

UNT anticipates that its investigators will fully comply with this Policy. Failure to comply with this Policy will be grounds for disciplinary action in accordance with the UNT Faculty Discipline Policy (number 15.1.33) for faculty members, the UNT Performance Counseling and Discipline Policy (number 1.7.1) for staff members, and the UNT Code of Student Conduct for students.

Any suspected violation of this policy may be reported to the Research Compliance Coordinator at 565-3941 or to the UNT Compliance Office at www.unt.edu/compliance

U.S. Public Health Service

“Responsibility of Applicants for Promoting Objectivity in Research for which PHS Funding is Sought,” 42 C.F.R. Part 50, Subpart F

National Science Foundation

NSF Grant Policy Manual (NSF 95-26), Conflict of Interest Policies, Chapter V, GPM 510

Texas Government Code

“Personal Financial Disclosure, Standards of Conduct, and Conflict of Interest,” Chapter 572, TEX. GOV’T CODE ANN. Sec. 572.001 et seq.

* Upon appointment of the Vice President for Research and Technology Transfer, the Vice President for Research and Technology Transfer shall fulfill the responsibilities of the Provost and Vice President for Academic Affairs and the Vice Provost for Research set forth in these paragraphs.