COI Training for Annual Disclosure

COI Training for Annual Disclosure

The University of North Carolina at Chapel Hill is committed to promoting objectivity in research and maintaining public trust in the design, conduct, and reporting of research. We also support appropriate research collaborations with industry, government, and nonprofit partners, as consistent with our research mission.

Completing your Annual Disclosure in the Activities, Interests, and Relationships Management System (AIR) system is an important part of your research responsibilities towards the public trust. After completing this training, you should be able to:

  1. Identify the University policies and processes managing COI and COC.
  2. Complete your Annual Disclosure.

This section provides a background on Financial Conflict of Interests necessary to complete an Annual Disclosure. For more information, visit Types of COI, Relatedness, and Transition to an Annual Model.

About Financial Conflicts of Interest

A Financial Conflict of Interest (FCOI) may arise when a Covered Individual has a Significant Financial Interest (SFI) that may affect the design, conduct, or reporting of research.

Definitions

Conflict of Interest (COI)

When personal, financial, or professional interests may “compromise, involve the potential for compromising, or have the appearance of compromising” your ability to carry out your University responsibilities objectively. (Conflicts of Interest for University Employees Policy)

Financial Conflict of Interest (FCOI)

A specific type of COI, defined by Public Health Service (PHS) regulations and reflected in University Policy. (Conflicts of Interest in Research Policy, 42 CFR 50.603)

An individual has a Financial Conflict of Interest (FCOI) if a Significant Financial Interest (SFI) could directly and significantly affect the design, conduct, or reporting of research.

Notes:

  • The term Covered Individual corresponds to the term Investigator as defined in FCOI regulation.
  • Covered Individuals may be, but are not limited to:
    • senior/key personnel,
    • co-investigators,
    • subrecipient investigators,
    • collaborators,
    • consultants,
    • students,
    • trainees, or
    • research coordinators.

Responsibilities

All covered individuals must:

  • Provide complete and accurate disclosures at least annually and as required by the University.
  • Respond promptly to COI Office inquiries.
  • Provide supporting documentation when requested.
  • Cooperate with COI Office and COI Committee review processes.
  • Adhere to any FCOI Management Plans

This section differentiates COC policy and management from COI. For more information, visit the Policy on Conflicts of Commitment.

About Conflicts of Commitment

A Conflict of Commitment may arise when your external activities, whether paid or unpaid, may interfere with your primary University responsibilities and schedule, such as teaching, research, or service.

Examples of COC

  • Consulting or advisory work during UNC work hours
  • Operating a private business that conflicts with University duties
  • Serving in an external leadership or board role without prior approval

Responsibilities

Faculty and EHRA non-faculty employees must

  • Faculty and EHRA non-faculty employees must report external professional activities through the External Professional Activities for Pay (EPAP) form in AIR
  • SHRA employees report secondary employment through Human Resources
  • Provide complete and accurate disclosures at least annually and as required by the University.

Governing Policy

Conflicts of Commitment are governed by

COI Annual Disclosure Process

All Covered Individuals must disclose and update financial interests in the AIR system and abide by any management plan from the COI Office.

Covered Individuals who are responsible for the design, conduct, or reporting of research or other sponsored projects covered by this policy must submit disclosures.

The PD/PI is responsible for designating all Covered Individuals associated with each covered project and ensuring that all Covered Individuals complete the required disclosures.

Covered Individuals are responsible for submitting disclosure forms through AIR in all of the following situations: 

  • At least annually and prior to the submission of an application for funded research (including renewals and revisions)
  • Within 30 calendar days of acquiring and/or discovering (e.g., through purchase, marriage, inheritance) a new Interest or a change in a previously reported Interest.
  • As prompted by the University

When disclosures are required under this policy, research activities may not proceed until the disclosures are reviewed and resolved by the University.

In relatedness, “relatedness” refers to connection between your personal financial interests, and your institutional responsibilities. These responsibilities vary based on one’s expertise. Visit the Relatedness page for further information, and to review the relatedness screening questions.

Question #8 of the disclosure allows you to associate your research projects with potentially-related projects. Answer this question broadly to expedite the review process.

COI Financial Interests Disclosure Chart

Select below to view what you must disclose, and what you should not disclose, during your Annual Disclosure. Contact the COI Office with questions.

Disclosure Category Chart

  • Review the chart below to determine what external financial interests you must disclose and what you should not disclose.
  • Contact the COI Office with any questions.

Disclose:

#1: Salary
  • Salary or other payments for services, e.g.,
    • consulting fees,
    • honoraria, or
    • remuneration for holding a position in a company
#2: Income
  • Income from:
    • seminars
    • lectures
    • service or
    • speaking/teaching engagements

Sponsored by for-profit, non-profit, or individual entities (domestic or foreign)

  • Income from:
    • royalties
    • individual gifts
#3: Equity Interests
  • Equity interests (e.g., equity, equity options, stocks, stock options, or bonds) that are directly controlled by the discloser or their immediate family members.
    • “Direct control” means the owner of the equity interests has investment power, which includes the power to buy, sell, or direct the purchase or sale of the equity interests.
#4: Unpaid External Positions
  • Service in an external executive, board, volunteer, or advisory position.
#5: Ownership of a Business
  • Ownership of a business, regardless of the business’s profitability.
#6: Intellectual Property
  • Intellectual property (e.g., inventions, patents, trademarks, copyrights, etc.) and license-related payments from such rights that are paid external to UNC.
#7: Travel
  • Disclose travel only if you have U.S. Public Health Service (PHS)-funded projects.
    • Disclose travel that is paid or reimbursed by a non-University entity and related to a submitter’s institutional responsibilities.
#8: Gifts
  • Gifts to the University that benefit the discloser’s research.

Do not Disclose:

#1: Salary from the University
  • Salary, reimbursement, or remuneration originating from the University.
#2: Income from U.S. Governmental and Educational Entities
  • Income (including honoraria) from seminars, lectures, or teaching/speaking engagements sponsored by a:
    • federal,
    • state, or
    • local government agency;
    • an institution of higher education/affiliated research institute; or
    • an academic teaching hospital/medical center in the U.S.

Note: this exclusion only applies to income from U.S. domestic entities.

#3: Income from advisory service on U.S. governmental or educational entities
  • Income (including honoraria) from seminars, lectures, or teaching/speaking engagements sponsored by a:
    • federal,
    • state, or
    • local government agency;
    • an institution of higher education/affiliated research institute; or
    • an academic teaching hospital/medical center in the U.S.

Note: this exclusion only applies to income from U.S. domestic entities.

#4: Mutual Funds
  • Mutual funds or other investment vehicles over which the discloser has no direct control over the selection of holdings.
#5: Travel paid through University sources
  • Travel that was paid for by the University or by a project processed through the Office of Sponsored Programs.

Conflict of Interest Office:

[email protected] | 919-843-9953

COI Officer:

Raha Khademi 
Conflict of Interest Director, Conflict of Interest Officer
Conflict of Interest
[email protected] | 919-843-9953