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 employes 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 Compliance will work in cooperation with the individual, their Department Head, and Dean to develop and implement an appropriate management plan.
An investigator is responsible for completing and submitting an annual Conflict of Interest Disclosure Form to the Office of Sponsored Research & Programs (OSRP). 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 OSRP will be reviewed by the Director of Research Compliance. The Director of Research Compliance is responsible for determining whether an apparent or actual conflict of interest exists and thus whether further review and management is required. The Director of Research Compliance may involve other institutional officials, such as the University’s General Counsel, in the review process if deemed necessary.
If it is determined that an actual or apparent conflict of interest exists, the investigator may be required to comply with a management plan to ensure the reduction, management, or elimination of the conflict.
The Director of Research Compliance will work with the applicable Department Head and Dean to resolve how the conflict should be managed, reduced, or eliminated. The Director of Research Compliance may involve other institutional officials in the management process if deemed necessary.
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:
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 Compliance and Office of Sponsored Research and Programs to assist researchers and administrators in addressing conflict of interest issues (http://orc.missouristate.edu/89220.htm).
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.
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 ORC & the OSRP and can be found at http://orc.missouristate.edu/84656.htm.
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.
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.
The Office of Sponsored Research & Programs, under the direction of the Director of Research Compliance 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.
This policy is intended to assist faculty members and/or investigators in structuring their relationships with industry and other outside entities in ways that will not compromise their academic and integrity obligations. Thus, this policy addresses situations in which a potential financial or personal conflict of interest between the outside interests of a researcher and the researcher’s responsibility to Missouri State University may exist, such that the researcher’s profit or advantage may occur, or appear to occur, to the detriment of the University. This policy is also intended to maintain public trust in the research community and to support institutional compliance with PHS 42 CFR Part 50, Subpart F, NSF Rule 59 FR 3308, NSF Rule 60 FR 35820, and other relevant government regulations.
This policy applies to all Missouri State University faculty members, research assistants, professional staff members, administrators, consultants, contractors, or the employees involved in the design, conduct, and reporting of externally sponsored research.
Approved by Administrative Council and Interim President Smart