Conflict of Interest on Federally Sponsored Projects-Not Sponsored by Public Health Services (PHS)

Printer-friendly version
Policy Code: 
Approval Authority: 
Policy Type: 
University Policy
Policy Owner: 
Academic Affairs
Responsible Office: 
Academic Affairs - 828.251.6470

I. Scope

The following statement of policy applies to all University personnel applying to or holding grants from federal agencies other than Public Health Services (PHS).

II. Purpose and Scope

The UNC Asheville community serves the public trust and thus has a clear obligation to conduct the business of the University in a manner consistent with these responsibilities. All decisions of the board, officers of the University, faculty, and staff are to be made solely on the basis of a desire to promote the best interests of the University and the public good.

In the spirit of the public trust, faculty or staff proposing to receive funds from a federal agency for research or educational activities must disclose – before submitting a proposal – any substantial financial conflict of interest that may reasonably affect how the project is carried out. A possible conflict of interest does not preclude acceptance of federal funding, but appropriate safeguards may need to be implemented in certain situations.

III. Definition of Terms

  1. Conflict of Interest (COI). A situation occurring when the professional, commercial, or Financial Interests or activities of a professional employee outside the University have the potential to or actually influence their professional obligations to the University – including but not limited to, research, educational activities, clinical practice, and procurement.
  2. Dependent. Any person, whether or not related by blood or marriage who receives more than one-half of their financial support from another individual.
  3. Immediate Family. One’s spouse, dependent children, and any other person residing in the same household as the Investigator who is a Dependent of the Investigator or of whom the Investigator is a Dependent.
  4. Institutional Official. The University designates the Chief Research Officer as the institutional official who reviews financial disclosure statements from each investigator who is proposing or carrying out a federally sponsored project.
  5. Investigator. The principal investigator, co-principal investigator, project directors, co-project directors, and any other person at the University who is responsible for the design, conduct, or reporting of research or educational activities funded or proposed for funding by the federal government.  
  6. Significant Financial Interest. Anything of monetary value, including, but not limited to, salary or other payments for services (e.g., consulting fees or honoraria); equity interest (e.g., stocks, stock options, or other ownership interests); and intellectual property rights (e.g., patents, copyrights, and royalties from such rights).

The term does not include:

a. salary, royalties or other remuneration from the applicant institution;
b. any ownership interests in the institution, if the institution is an applicant under the Small Business Innovation Research Program or Small Business Technology Transfer Program;
c. income from seminars, lectures, or teaching engagements sponsored by public or non-profit entities;
d. income from service on advisory committees or review panels for public or non-profit entities;
e. any equity interests that, when aggregated for the investigator and their immediate family, meets both of the following tests: does not exceed $10,000 in value as determined through reference to public prices or other reasonable measures of fair market value, and does not represent more than a 5% ownership interest in any single entity; or
f. salary, royalties or other payments that, when aggregated for the investigator and their immediate family are not expected to exceed $10,000 during the coming twelve-month period.

IV. Procedure

1. Disclosure

Before submitting a grant proposal or contract scope of work to a federal agency, the investigator must complete the Disclosure of Significant Financial Interests and Obligations Related to Projects Not Sponsored by Public Health Service (PHS) agencies including National Institutes of Health (NIH) (hereinafter referred to as University Disclosure). This document must be turned in to the Institutional Official. On the form, the investigator must report all significant financial interests (including those of their immediate family):

a. that would reasonably appear to be affected by the research or educational activities; or
b. in entities whose financial interests would reasonably appear to be affected by such activities.

The institutional official will not sign off on the proposal until the University Disclosure has been completed and turned in.

In addition to disclosing any financial conflict of interest at the time of the proposal submission, investigators are required to update their disclosures during the period of the award, either on an annual basis or as new significant financial interests are obtained.

If the investigator has no significant financial interests to disclose, they must still certify the lack of such interests.

2. Resolution of Conflicts

In situations in which an Investigator has a significant financial interest that would reasonably appear to present a Conflict of Interest, the Chief Research Officer shall recommend to the Associate Provost the formation of an ad hoc committee (IAW OSSP SOP 009). This committee will review the documents to make recommendations to manage, reduce or eliminate the conflict. Examples of conditions or restrictions that might be considered include, but are not limited to:

a. public disclosure of Significant Financial Interests;
b. monitoring of research by independent reviewers;
c. modification of the research plan;
d. disqualification from participation in all or a portion of the federally-funded research;
e. divestiture of Significant Financial Interests;
f. severance of relationships that create actual or potential conflicts; or
g. any other action deemed necessary by the committee to manage, reduce, or eliminate the conflict of interest.

The solution shall be set forth in a written management plan. A copy of all such management plans shall be provided to the Chief Research Officer, the Investigator, and the Investigator’s organizational unit head.

3. Reporting and Monitoring

The Chief Research Officer shall report any conflict of interest to the appropriate federal agency as required by federal regulations.

Any conflict of interest disclosure after the initial report shall be subject to review as set forth in this policy. The University shall complete its review and report the existence of the conflict of interest and the measures taken to reduce, manage, or eliminate it within sixty (60) days of disclosure.

The appropriate organizational unit head or designee is responsible for overseeing the implementation of the disclosure, the review process, and for monitoring compliance with any conflict management plan. These persons or their designee will address all breaches of this policy including:

a. failure to comply with the disclosure requirement, whether by virtue of an Investigator’s refusal to respond or by their responding with incomplete or inaccurate information;
b. failure to remedy conflicts; and
c. failure to comply with conditions in a prescribed conflict management plan.

4. Training

When required by a sponsor, Office of Sponsored Scholarship and Programs (OSSP) shall be responsible for providing opportunities for each Investigator / Project Director to receive the appropriate training. The University program will include, at a minimum, the following components:

a. this policy; and
b. the Investigator’s / Project Director's responsibilities regarding disclosure of Significant Financial Interests;

The Office of Sponsored Scholarship and Programs will provide the certification letter to all individuals completing FCOI training conducted by the research operation. Investigators / Project Directors completing this training at other institutions shall provide a certificate or letter of certification to OSSP. Investigators will complete this requirement once every four (4) years or changes occur in their Disclosure of Significant Financial Interests and Obligations

5. Record Keeping

The Office of Sponsored Scholarship and Programs will maintain records for all financial disclosures and of all actions taken to resolve conflicts of interests for at least three years beyond the termination or completion of the grant to which they relate, or until the resolution of any federal agency action involving those records, whichever is longer.