I. Purpose and Scope of the Policy

A. Purpose

The purpose of this policy is to avoid both actual and apparent conflicts of interest between Principal Investigator’s (PIs) federally sponsored project obligations and private financial interests.

Federal regulations require institutions to have policies and procedures that ensure that PIs disclose any significant financial interests that may present an actual or potential conflict of interest in relation to federally sponsored projects. Such disclosure must be made prior to the submission of a proposal for funding or at the time a potential conflict develops during the conduct of a funded project.

B. Scope

This policy shall apply to all federally funded projects. As described below, the University may elect to apply the disclosure requirements of the Policy to certain University managed programs if those programs so request, and if the Senior Vice President for Resource Development subsequently grants their requests.

Xavier University’s Conflict of Interest Policy is consistent with Public Health Service Regulations, “Objectivity in Research,” 42 CFR, Part 50.603; 45 CFR, Part 94.3; and National Science Foundation regulations, “Investigator Financial Disclosure Policy” as well as OMB Circular A-110, Subpart C – “Post Award Requirements and Procurement Standards.” These federal regulations require the University to maintain appropriate written policy on conflict of interest disclosure as a condition for receiving federal grants.

II. Definitions

Designated University Official “ (hereafter referred to as “Official”) is the responsible administrative official with immediate supervisory authority over the PI. Normally, the Official will be the department chair. For administrative units in which there are no departments, or if the PI is a department chair, the Official will be the Dean. For Directors and Deans, the appropriate Senior Vice President will serve as the Designated University Official.

“ Investigator” means the Principal Investigator and any other person at the University who is responsible for the design, conduct, and/or reporting of activities for the proposed or ongoing project. For the purposes of the requirements of the subpart relating to financial interests, “Investigator” includes the Investigator’s spouse and children.

“ Significant Financial Interests” (hereinafter referred to as “Interests”) 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. patents, copyrights, and royalties from such rights); and other related interests or activities of the Investigator that possibly could affect, or be perceived to affect, the result of the research or educational activities funded or proposed for funding. The Investigator’s interests are related to a project, if the work to be performed under the project, or the results of such work, can be expected to have an impact on the Investigator’s interests. Such relationships include project subcontracts, leases and purchases. The form used for the disclosure process is called the “Conflict of Interest Disclosure Form.”

1. Inclusions – The following Interests and activities apply with respect to federally sponsored projects.

a. Income including salary, consulting payments, honoraria, reimbursement of expenses, royalty payments, dividends, or any other payments or considerations from a single business entity or their nonprofit affiliate entity exceeding $10,000 per annum when aggregated for the Investigator, the Investigator’s spouse and dependent children.
b. Equity in the form of stock, stock options, real estate, or any other investment of ownership representing more than a 5% interest for any one entity when aggregated for the Investigator, the Investigator’s spouse and dependent children.
c. A position as director, officer, partner, trustee, or member of board of directors of any business entity.

2. Exclusions

a. Income from seminars, lectures, or teaching engagements sponsored by public or non-profit entities.
b. Income from service on advisory committees or review panels for public or non-profit entities.
c. Salary, royalties, or other remuneration from a single business entity or any ownership interests in that entity if the entity is an applicant under the Small Business Innovation Research Program or Small Business Technology Transfer Program.
d. Stock holdings such as diversified or mutual funds where the Investigator is unaware of specific stocks held.

The Office of the Senior Vice President for Resource Development will review all issues related to this policy.

III. Disclosure Requirements

Investigators must fully disclose to the Office of the Senior Vice President for Resource Development all Interests for each federal project at the time the proposal to fund the project is submitted. Disclosure must be made on the Proposal Clearance Form, indicating the possible conflict of interest. Likewise, Investigators must provide updates of such Interests on an annual basis and/or whenever they acquire new Interests.

IV. Review, Management or Elimination of Conflict of Interest

When an Investigator has Interests that would reasonably appear to be directly or significantly affecting the federally sponsored project, the Senior Vice President for Administration, based on recommendations from the Senior Vice President for Resource Development and Senior Vice President for Academic Affairs, may rule that the project may not proceed. In situations where reasonable doubt exists about the conflict of interest, certain conditions or restrictions may be imposed. These may include, but are not limited to:

a. Public disclosure of Interests;
b. Monitoring of the project by independent reviewers;
c. Modification of the project or plan;
d. Disqualification from participation in all or a portion of the project;
e. Divestiture of Interests; and/or
f. Severance of relationships that create actual or potential conflicts.

V. Appeal Process

An Investigator may appeal the decision made by the Senior Vice President for Administration. Such appeal should be brought before the University Research Committee whether the project involves research, education and/or program development. This Committee will review the conflict and make recommendations to the President to either accept the decision or suggest a modified plan.

VI. Sanctions

Failure to file a complete Conflict of Interest Disclosure Form for a federally sponsored project will be grounds for disciplinary action imposed by the Senior Vice President for Administration. In addition, failure to comply with requirements to file a complete and accurate disclosure may result in the termination of current awards and/or the Investigator becoming ineligible to receive future awards.

VII. Administration of Policy

This policy will be administered in the Office of the Senior Vice President for Resource Development.