Conflict of Interest in Research Policy

Op4.01-8 Conflict of Interest in Research Policy

Policy statement

A university employee or student engaged in research shall be responsible for disclosing any potential conflict of interest (COI) as outlined in this policy. Additionally, university employees and students engaged in research are responsible for complying with other applicable laws and university policies, including: COI and Financial Disclosure (G1.02), Article XII of the Bylaws of the Board of Governors (G1.01-12), and Missouri Revised Statute 105.450, et seq. A conflict of interest exists when significant financial interests or other personal considerations may compromise or appear to compromise professional judgment or integrity in the conduct or reporting of research or performance in administration, management, instruction and other university obligations. Federal regulations require full disclosure of significant financial interests, as defined by the National Institutes of Health (NIH), in externally sponsored research. The existence of such conflicts does not in any manner indicate wrongdoing on the part of the individual. In fact, in today’s research environment, it is understood that conflicts of interest can occur. However, if a conflict of interest exists, it must be reduced, managed, or eliminated as soon as one becomes aware of it.

The key to handling potential conflicts is to fully disclose significant financial interests and, if a conflict of interest is identified, to participate in the development and implementation of an appropriate management plan. The university is committed to advancing research and fostering an entrepreneurial spirit at Missouri State University while maintaining objectivity and integrity in research. If a conflicting situation arises that will require management, the Director of Research Administration will work in cooperation with the individual, their Department Head, and Dean to develop and implement an appropriate management plan.

Definitions

1. Disclosure means an investigator’s disclosure of financial interests to the university related to his or her institutional responsibilities.
2. Entity means a non-Missouri State University organization, whether public or private.
   Examples include the following: a company, partnership, professional association, voluntary health organization, etc.
3. Financial Conflict of Interest means a significant financial interest that is related to proposed university research (i.e., the interest reasonably appears to be affected by the research or is in an entity whose financial interest reasonably appears to be affected by the research) and that could directly and significantly affect the design, conduct, or reporting of research.
4. Financial Interest means anything of monetary value, whether or not the value is readily ascertainable, in any one of the following categories: compensation; equity (stock, stock options or other ownership interest) in a public or private company; royalty/licensing income; a position in a non-Missouri State University entity giving rise to a fiduciary duty such as director, officer, partner, trustee, employee or any position of management; or, for researchers with funding from the Public Health Service, any reimbursed or sponsored travel.
5. Institutional Responsibilities means an investigator’s professional responsibilities on behalf of the university, including, but not limited to, activities such as research, research consultation, teaching, professional practice, and institutional committee memberships.
6. Investigator means the principal investigator or project director and any other person, whether faculty, staff, or student and regardless of title or position, who has the authority to make independent decisions related to the design, conduct or reporting of university research. Also includes subgrantees, contractors, collaborators, or consultants of the university.
7. Manage means to take action to address a financial conflict of interest, which includes reducing or eliminating the financial conflict of interest, to ensure that the design, conduct, and reporting of research are free from bias or the appearance of bias.
8. Research means a systematic investigation designed to develop or contribute to generalizable knowledge and encompasses basic and applied research and product development.
9. Significant Financial Interest means anything of monetary value or potential monetary value held by an investigator (and by the investigator’s spouse and dependent children), and that reasonably appears to be related to the investigator’s institutional responsibilities, as follows:
   1. With regard to any publicly traded entity, 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 purposes of the definition of Significant Financial Interest, 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. With regard to any non-publicly traded entity, the value of any remuneration received from the entity in the calendar year preceding the disclosure, when aggregated, exceeds $5,000, or any equity interest (e.g., stock, stock option, or other ownership interest);
   3. Intellectual property rights and interests (e.g., patents, copyrights), upon receipt of income related to such rights and interests; or
   4. A position giving rise to a fiduciary duty, such as director, officer, partner, trustee, employee, or any position of management.
   5. For investigators applying for or conducting research funded by the PHS, any reimbursed or sponsored travel related to the investigator’s institutional responsibilities (i.e., travel is paid on behalf of the investigator and not reimbursed to the investigator so that the exact monetary value may not be readily available).
       
      Disclosure of this interest will include the purpose and duration of the trip, the identity of the sponsor/organizer, and the travel destination.
       
      The term "Significant Financial Interest" does not include salary or other remuneration paid by the university to the investigator if the investigator is currently employed or otherwise appointed by the university; 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, teaching engagements, or travel reimbursed or sponsored by a federal, state, or local government agency, an institution of higher education, an academic teaching hospital, medical center, or research institute 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 or institution of higher education.

Disclosing conflicts of interest

An investigator is responsible for completing and submitting an annual Conflict of Interest Disclosure Form to the Office of Research Administration (ORA). The investigator is also required to provide updates to the disclosure within 30 days of discovering or acquiring a new significant financial interest. Additionally, investigators are required to disclose conflict of interest information upon submittal of applications for externally funded research or other externally funded activities. If there is any doubt about the existence of an actual or apparent conflict of interest, the investigator should err on the side of disclosure.

Principal investigators are responsible for informing any co-investigators, staff, or students involved in the design, conduct, or reporting of the externally sponsored research project that they are required to complete a disclosure form.

When a conflict of interest is disclosed, the department head and the dean will assist in the review process by commenting on the substance of the disclosure based on their knowledge of the circumstances as well as assisting in the development and implementation of management plans.

Each disclosure that is forwarded to the ORA will be reviewed by the ORA director. The ORA director is responsible for determining whether an apparent or actual conflict of interest exists and thus whether further review and management is required. The ORA director may involve other institutional officials, such as the university’s general counsel, in the review process if deemed necessary.

Management plans

Conditions or restrictions that might be imposed by the university to manage, reduce or eliminate actual or potential conflicts of interest include but are not limited to:

• public disclosure of relevant significant financial interests (e.g., when presenting or publishing the research);
• for research projects involving human subjects research, disclosure of financial conflicts of interest directly to participants;
• monitoring of research by independent reviewers;
• modification of the research plan;
• disqualification from participation in the portion of the activity that would be affected by the significant financial interests;
• divestiture of significant financial interests; or
• severance of the relationships that create actual or potential conflicts.

The investigator must accept the management plan in writing before beginning work on the project. Copies of the signed management plan will also be provided to the investigator’s department head and dean.

Additional guidelines will be developed by the Office of Research Administration to assist researchers and administrators in addressing conflict of interest issues.

Confidentiality

When disclosure of current review status or outcome is required for internal coordination of approvals for research or educational activities, limited, non-specific information from the investigator’s disclosure form and/or management plan will be provided. The recipient of such information shall maintain confidentiality, except as required for the performance of university duties or as otherwise required by law.

Disclosure forms, management plans, and other records will be kept in locked file drawers and/or within electronic databases with firewall and password protection. Records will be maintained for at least three years from the date of submission of the final expenditures report or other time periods as required by law.

Specific provisions applicable to PHS-funded research

In addition to the requirements of this policy, the university will apply specific provisions to PHS-funded research detailed in the document, “Specific COI Provisions Applicable to PHS-Funded Research.” This document is maintained by the ORA.

Non-compliance

Individuals are expected to comply fully and promptly with the policy, including the requirements of disclosure. Individuals who deliberately or repeatedly fail to disclose fully and truthfully conflict of interest situations or fail to comply with any stipulated plan for managing the disclosed conflict will be subject to the applicable university disciplinary processes, which could include suspension of grant funding.

In addition to university sanctions, violations of full and prompt disclosure may result in the loss of grant funding and sanctions regarding future funding from federal agencies. Individuals may also be subject to criminal sanctions or civil liability under federal or state law.

In the event the university discovers that a failure to comply with this policy has biased the design, conduct or reporting of the research in accordance with the processes outlined above, the university will promptly notify the sponsor of the research as required by applicable law and describe the corrective action(s) taken or to be taken.

Reporting

The university will provide initial and ongoing reports of its management of financial conflicts of interest to external sponsors of university research as required by law and in accordance with this policy.

Records

The ORA is responsible for the retention of disclosure forms, management plans and other records for at least three years from the date of submission of the final expenditures report, or as otherwise required by law.