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Conflict of Interest in Research

Conflict of Interest Screening Form from Office of Research is available on the forms page.

I. Policy
Faculty members and others responsible for the design, conduct, or reporting of research or other projects carried out under the auspices of the University of Notre Dame using funds provided by individuals or entities external to the University are subject to this policy and must adhere to standards concerning conflict of interest. These standards are the same as those applicable to trustees, officers and exempt employees of the University, supplemented by any conflict of interest standards that may be required by the provider of the funds. The University standards are given immediately below in section II and supplementary standards are discussed in section III.

II. University Standards
- University Conflict of Interest Policy from Rev. Timothy R. Scully, C.S.C. July 29, 2002
- Human Resources Policy Manual(C-9) regarding Conflict of Interest

The University of Notre Dame du Lac policy with respect to conflict between the interest of the University and the personal interest of each trustee, officer and exempt employee conducting the University business with others is as follows:

General Information:
1. Trustees, officers and exempt employees have a duty to the University to be entirely free from the influence of any personal considerations when negotiating for the University with third parties, making recommendation with respect to such negotiations, or passing judgment on such negotiations.

2. Trustees, officers and exempt employees shall perform the responsibilities of their position solely on the basis of what is in the best interest of the University and wholly free from influence of personal considerations or relationships.

3. The requirements of freedom from conflict of interest set forth in this policy apply with equal force to the spouse, children and other close relatives of each trustee, officer and exempt employee.

4. The Executive Vice President of the University has the ultimate authority and responsibility to determine applicability of this policy to the fact situation of each trustee, officer and exempt employee and decisions as to corrective measures and disciplinary action in the enforcement of this policy.

Prohibited Conduct:
1. Trustees, officers and exempt employees are precluded from having a material financial interest in, a significant indebtedness to, or a personal contract or understanding with any concern with which they do business or negotiate to do business on behalf of the University. As used in this policy statement, "a material financial interest" means any interest other than ownership of one percent or less of the outstanding securities of a corporation traded on a recognized stock exchange or over the counter; and "significant indebtedness" means an obligation to anyone other than a bank or other qualified lending institution.

2. Trustees, officers and exempt employees shall not accept for themselves, or the benefit of any relative or friend, any payments, loans, services, favors involving more than ordinary social amenity, or gifts of more than token value, from any person or organization doing or seeking to do business with the University.

3. Trustees, officers and exempt employees may not perform work or services, outside the course of their normal employment by the University, for an organization doing or seeking to do business with the University without prior written approval obtained through the University General Counsel and the Executive Vice President.

4. Trustees, officers and exempt employees may not be a director, officer, partner or consultant of any organization doing or seeking to do business with the University, nor may they permit their names to be used in a way indicating a business connection with such an organization without prior written approval obtained through the University General Counsel and the Executive Vice President.

III. Other Standards
Adherence to Notre Dame's high standards, listed above, will also satisfy most external standards. At present, the National Institutes of Health and the National Science Foundation are two federal agencies that have regulations concerning conflict of interest and these have been restricted to financial conflicts of interest. The regulations require that the University establish and enforce a conflict of interest policy. These regulations and others as they are proposed will be available in paper copy from the Office of Research, from the NSF Grant and Agreement Conditions, or see the list of Frequently Asked Questions Concerning the DHHS (NIH) Objectivity in Research Regulations and the NSF Investigator Financial Disclosure Policy.

IV. Definitions
CONFLICT OF INTEREST
A potential or actual Conflict of Interest exists when a significant financial interest could affect the design, conduct, or reporting of the research or educational activities.

SIGNIFICANT FINANCIAL INTEREST
The term "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). It also encompasses all situations described in Section III (3) of the University standards, above.

The term does not include:
• salary, royalties or other remuneration from the University; income from seminars, lectures, or teaching engagements sponsored by public or nonprofit entities; income from service on advisory committees or review panels for public or nonprofit entities; or
• financial interests in business enterprises or entities if the value of such interests does not exceed $5,000 or represent more than a 1% ownership interest for any one enterprise or entity when aggregated for the trustees, officers and exempt employees and their spouse and dependent children.

This definition of Significant Financial Interest is a combination of Notre Dame, NIH, and NSF standards. The NIH/NSF standards are in a state of change and should be checked in case of doubt.

V. Procedures
1. Faculty members and all other individuals who are responsible for the design, conduct, or reporting of externally supported research are required to complete a screening questionnaire at least once per year. If the results of the screening questionnaire indicate the possibility of a conflict of interest, these individuals are required to make annual confidential disclosures to their supervisors of all outside remunerative activities related to their University responsibilities.

They must also disclose equities and positions of members of their immediate family which could create a conflict or the perception of a conflict of interest between their academic obligations and their outside interests.

2. Faculty members principal investigators and co-principal investigators are ordinarily responsible for the design, conduct and reporting of sponsor/donor funded research and other efforts at Notre Dame. In cases in which other individuals are permitted to exercise these responsibilities, the department chair or other supervisor must insure that the individuals have filed forms required by this policy.

3. Forms Required: Financial disclosures from faculty are made using standard forms. Forms will be distributed to faculty annually with active research awards.

"CONFLICT OF INTEREST DISCLOSURE FORM" - This form is distributed to those faculty who answer "yes" to any of the screening questions. This form is keyed to the screening questions and requests information as to nature of activities, for whom services are rendered, and the amount of time expected to be spent on the activity.

The Disclosure Form is to be routed through the Department Chair and Academic Dean to the Office of Research, which will keep completed forms. Each level of review requires judgment of level of conflict of interest (from none to serious) and original signatures (no per signatures allowed). A copy of the Conflict of Interest Screening Form is located on the forms page.

VI. ENFORCEMENT
If the Department Chairs or Academic Deans deem that an actual or potential significant conflict of interest exists, they should attach an explanation to the financial disclosure form and forward it to the Office of Research where a decision will be made as to whether a conflict of interest exists and, if so, how to manage, reduce, or eliminate the conflict. Examples of actions that may be required include:

public disclosure of financial interests; monitoring of research by independent reviewers; modification of research plan; disqualification from participation in portion of research that would be affected by the significant financial interest;
divestiture of significant financial interests;
severance of relationships that create actual or potential conflicts.

Note that the above list is taken from NSF/NIH regulations; these regulations also require that the University establish an enforcement procedure.

The required actions would be reduced to a written statement and discussed with the faculty member who would be asked to sign it as an indication of his/her concurrence. If the faculty member disagrees with the actions he/she may follow Faculty Grievance Procedures as set forth in the Faculty Handbook. If the faculty member violates the agreed upon conditions, the Chair, Dean, or administrative head of the Office of Research shall inform the Provost. The Provost will use normal university disciplinary procedures to consider sanctions. Such sanctions might range from a letter of reprimand to termination of employment.

If a faculty member submits false and/or misleading information on the financial disclosure form, he/she would be subject to the University Policy and Procedures on Violations in Integrity in Scholarship and Research or to other University disciplinary procedures.

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Date last revised April 2007