7.1.1 Significant Interest Disclosure

Policy

These guidelines define general University policy and procedures regarding significant financial conflicts of interest in relationship to sponsored projects involving research, education, and university service. Their purpose is to protect the credibility and integrity of the University’s faculty and staff so that public trust and confidence in the University’s sponsored activities is ensured.

In accordance with Federal regulations and State laws, the University has a responsibility to manage, reduce, or eliminate any conflicts of interest that may be presented by certain kinds of financial interest(s) of an investigator. See Federal regulations (National Science Foundation, Investigator Financial Disclosure Policy, and Health and Human Services, Objectivity in Research Policy) and State laws (Illinois Purchasing Act - 505 ILCS 11.1-11.5). Thus, the University requires that investigators disclose any significant financial interest that may present a conflict of interest in relation to a sponsored project.

The value of the results of sponsored projects must not be compromised by any financial interest that will--or may reasonably be expected to--bias the design, conduct or reporting related to the projects. This policy seeks to: (1) maintain a reasonable balance between these competing interests, (2) to give Illinois State University the ability to identify and manage financial interests that may bias the outcomes of sponsored projects, and (3) to minimize reporting requirements and other burdens on the investigators.

Definitions

A conflict of interest exists when an institutional review determines that a significant financial interest could directly and significantly affect or be affected by the design, conduct, assessment, and/or reporting of sponsored projects.

An investigator (PI) is the principal investigator/project director, co-principal investigators, and any other person at the University who is responsible for the design, conduct, assessment, and/or reporting of research, educational, or service activities funded (or proposed for funding) by an external sponsor. In this context, the term "Investigator" includes the investigator’s spouse/partner and family members.

Sponsored projects are projects awarded to Illinois State University supported by funds external to the University. These projects require the signature of an individual with designated institutional signatory.

Significant financial interest means anything of monetary value, including, but not limited to:

• salary or other payments for services (e.g., consulting fees, honoraria, gifts, or employment with an outside organization);
• equity interests (e.g., stocks, stock options or other ownership interests);
• intellectual property rights (e.g., patents, copyrights and royalties from such rights); and
• membership on a governing board.

The term does not include:

1. Salary, royalties, or other remuneration from Illinois State University;
2. Income from seminars, lectures, or teaching engagements sponsored by public or nonprofit entities;
3. Income from service on advisory committees or review panels for public or nonprofit entities;
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 contemporary published prices or other reasonable measures of fair market value, or, does not constitute 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 family members over the next twelve months, are not expected to exceed $10,000.

The exclusions in items (1), (4), and (5) shall not apply if the compensation or transfer of an equity interest is conditioned upon a particular outcome in a sponsored project.

Guidelines

1. Each investigator is required to disclose the following significant financial interests:
   1. Any significant financial interest of the investigator that would reasonably appear to affect or be affected by the research, service, or educational activities funded, or proposed for funding, by an external sponsor;
   2. Any significant financial interest of the investigator in entities whose financial interest would reasonably appear to be affect or be affected by the research, service, or educational activities funded, or proposed for funding, by an external sponsor;
   3. Regardless of the above minimum requirements, a faculty or staff member, in his or her own best interest, may choose to disclose any other financial or related interest that could present an actual conflict of interest or be perceived to present a conflict of interest. Disclosure is a key factor in protecting one’s reputation and career and in protecting the university from potentially embarrassing or harmful allegations of misconduct.
2. Each investigator who has significant financial interest requiring disclosure shall complete a Significant Financial Interests Disclosure Form and attach all required supporting documentation. The completed Significant Financial Interests (SFI) Disclosure Form must be submitted to the Research and Sponsored Programs (RSP) with the proposal along with the Research and Sponsored Programs Proposal Submission Form.  Supporting documentation that identifies the business enterprise or entity involved and the nature and amount of the interest should be submitted in a sealed envelope marked confidential and should accompany the Disclosure Form and the Proposal Submission Form.
3. As required by State and Federal regulations, all significant financial interests must be disclosed and also must be managed, reduced, or eliminated prior to Illinois State University’s expenditure of any funds. During the period of the award, on an annual basis and as new reportable significant financial interests are obtained, all financial disclosures must be updated by investigators. All cooperative or contractual agreements with Illinois State University will stipulate that all parties must be in compliance with Federal regulations and State laws cited in this document.
4. The Associate Vice President for Research, or official designee, shall conduct an initial review of all financial disclosures to determine whether a conflict of interest may exist. If the initial determination is made that there may be a potential for conflict of interest covered by this policy, then the disclosure material will be referred to the  University Significant Financial Interest Review Committee (SFIRC). Committee members are appointed by the Associate Vice President for Research. The SFIRC shall include a member of the office of Research and Sponsored Programs and at least four faculty members representing a relevant cross section of academic disciplines. Membership will be drawn from the University Research Committee with supplemental appointments to be made from the University and the community as necessary. The SFIRC shall determine what conditions or restrictions, if any, should be imposed by Illinois State University to manage conflicts of interest arising from disclosed significant financial interests.
5. After initial review and concurrence as to potential conflict of interest by the SFIRC, the investigator, in cooperation with the academic unit or College, shall develop and present to the SFIRC a Conflict of Interest Resolution Plan that details proposed steps that will be taken to manage, reduce, or eliminate any conflict of interest presented by a significant financial interest. At a minimum the Resolution Plan shall address such issues as:
   1. Public disclosure of significant financial interests;
   2. Review of research, instructional, or service protocol by independent reviewers; and
   3. Periodic monitoring of project by independent reviewers.
      The SFIRC shall review the Resolution Plan for approval and recommendation to the Associate Vice President for Research with the authority to add conditions or restrictions, including the following:
      1. Modification of the plan for research, teaching, or service projects;
      2. Disqualification from participation in all or a portion of the project funded;
      3. Divestiture of significant financial interests; or
      4. Severance of relationships that create conflicts of interest.
   If the SFIRC determines that imposing the above referenced conditions or restrictions would be inequitable, or 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 SFIRC may recommend that, to the extent permitted by State and Federal regulations, the project go forward without imposing such conditions or restrictions. The Associate Vice President for Research shall make the final decision regarding resolution.  The Associate Vice President for Research (or designee) shall be responsible for management of such cases. Conflicts of interest which cannot be successfully managed, reduced or eliminated must be disclosed to the sponsoring agency as required by federal regulations and shall be subject to additional agency review and action. (For example, by the National Science Foundation.)
6. The approved Resolution Plan shall be incorporated into a Memorandum of Understanding (MOU) between Illinois State University and the investigator that details the conditions or restrictions imposed upon the investigator in the conduct of the project or in the relationship with the business enterprise or entity. The Memorandum of Understanding shall be signed by the investigator, and, on behalf of the University, the Associate Vice President for Research (or designee). Copies of the Memorandum of Understanding will be sent to the investigator’s Department Chair or Unit Head and relevant University administrator (usually a Dean or Director). The SFIRC review process and completed Memorandum of Understanding shall be concluded within 30 calendar days. Conflicts of interest must be satisfactorily managed, reduced, or eliminated in accordance with these guidelines prior to any expenditure of funds.
7. Records of the investigator’s financial disclosures and of actions taken to manage conflicts of interest shall be retained by the University Research Office until three years after the termination or completion of the award to which they relate, or the resolution of any government or legal action involving those records.
8. The SFIRC shall review claims for violation of this policy or the terms of the Memorandum of Understanding for findings of fact. If the SFIRC finds cause to believe there has been noncompliance with this policy or with the terms of the Memorandum of Understanding, the SFIRC shall refer evidence of such noncompliance to the Associate Vice President for Research. The Associate Vice President for Research may recommend sanctions which may include disciplinary action ranging from a public letter of reprimand to dismissal and termination of employment or may refer the matter to the Ethics and Grievance Committee for review. The recommendations for sanctions shall be presented to the Provost who, in consultation with investigator’s relevant University official, shall enforce any appropriate disciplinary action. An affected faculty member may file a grievance with the Ethics and Grievance Committee in response to any sanctions or disciplinary action that are imposed.
9. Collaborators from outside Illinois State University must either expressly comply with this policy or provide certification that their institution or organization is in compliance with State and Federal policies regarding significant financial interest disclosure and that their portion of the project is in compliance with their institution’s or organization’s policies.