Conflict of Interest on Federally Sponsored Projects-Sponsored by Public Health Services (PHS)

I. Scope

The following statement of policy applies to all University personnel applying to or holding grants from Public Health Services (PHS) and its agencies (Agency for Healthcare Research and Quality (AHRQ), Agency for Toxic Substances and Disease Registry (ATSDR), Centers for Disease Control and Prevention (CDC), Food and Drug Administration (FDA), Health Resources and Services Administration (HRSA), Indian Health Service (IHS), National Institutes of Health (NIH) and Substance Abuse and Mental Health Administration (SAMHSA)).

II. Purpose

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 PHS 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 University’s employee who is a Dependent of that employee or of whom the employee 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 investigators, project director, co-projector directors and any other person at the University who is responsible for design, conduct, or reporting of research or educational activities funded or proposed funding by NIH. Contractors, consultants, and unpaid collaborators may also be considered as Investigators depending on their role and responsibilities.
6. Significant Financial Interests.

a. Publicly Traded-Entities – With regard to any publicly traded entity, a significant financial interest exists if the value of any remuneration received from the entity in the twelve months preceding the disclosure and the value of any equity interests as of the date of disclosure, when aggregated, exceeds $5,000. For purposes of this definition, remuneration includes salary and any payment for services not otherwise identified as salary (e.g., consulting fees, honoraria, paid authorship); equity interest includes any stock, stock options, or other ownership interests, as determined through reference to public prices or other reasonable measures of fair market value.
b. Privately Held Entities – With regard to any non-publically traded entity, a significant financial interest exists if the value of any remuneration received from the entity in the twelve months preceding the disclosure, when aggregated, exceeds $5,000, or when the Investigator or their Immediate Family holds any equity interests (e.g., stock, stock options, or other ownership interests).

7. Intellectual Property – Intellectual property rights and interests (e.g., patents, copyrights), upon receipt of income related to such rights and interests.
8. Travel Reimbursements – Investigators also must disclose the occurrence of any reimbursed or sponsored travel not paid through the University by for- and non-profit agencies excluding recognized institutes of education and their affiliations (20 USC 1001(a)).

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 Sponsored by Public Health Service (PHS) (hereinafter referred to as University Disclosure). This document must be turned in to the Institutional OfficialOn 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:

  1. public disclosure of Significant Financial Interests;
  2. monitoring of research by independent reviewers;
  3. modification of the research plan;
  4. disqualification from participation in all or a portion of the federally-funded research;
  5. divestiture of Significant Financial Interests;
  6. severance of relationships that create actual or potential conflicts; or
  7. 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 related to the Investigator or their subrecipients 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

The Office of Sponsored Scholarship and Programs (OSSP) shall be responsible for ensuring that each Investigator receives conflict of interest training. This program will include the following components:

a. this policy;
b. the Investigator’s responsibilities regarding disclosure of Significant Financial Interests; and
c. mandatory on-line training or program recognized by OSSP.

Each Investigator will demonstrate compliance by providing 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

OSSP 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.

6. Public Access to Information

OSSP maintains a website addressing how the public may receive PHS conflict of interest disclosure information regarding University Investigators. Information will identify that OSSP will respond to written requests within five business days of receiving a request. All requestors for information must submit using the University’s PHS Financial Conflict of Interest Information Request Form. Failure to use the University’s PHS Financial Conflict of Interest Request Form will result in OSSP not responding to the requestor.

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