University Procedure
Title
University of North Carolina at Chapel Hill Procedure for Individual Financial Conflict of Interest in Research
Introduction
Purpose
This procedure outlines what must be done to disclose, update, and manage Interests related to research at the University of North Carolina at Chapel Hill (“UNC-Chapel Hill” or “University”) in accordance with U.S. Public Health Service (PHS) financial conflict of interest regulations and the University of North Carolina at Chapel Hill Policy on Individual Financial Conflicts of Interest in Research (“FCOI Policy”).
Scope
This procedure applies to all Covered Individuals who are responsible for the design, conduct, or reporting of research funded by the U.S. Public Health Service (PHS) and other sponsored research projects, including but not limited to grants, cooperative agreements, contracts, training awards, fellowships, infrastructure awards, and program projects.
This procedure applies regardless of whether the research involves human participants, vertebrate animals, or other research activities.
This procedure does not address institutional conflicts of interest, which are governed separately under the University policy on Institutional Conflicts of Interest in Human Subjects Research.
Definitions
Definitions below are key terms reproduced from the University’s FCOI Policy. Refer to the policy for the full list of definitions. References to “this policy” refer to that policy.
Conflict of Interest (COI): A situation in which an individual’s Interests may compromise, may involve the potential for compromising, or may appear to compromise the objectivity of the design, conduct or reporting of research conducted under this Policy.
Covered Individual: The Project Director/Principal Investigator (PD/PI) and any other individual, regardless of title, role, or position, who is responsible for the design, conduct, or reporting of research. For purposes of this policy, 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.
- Covered Individuals are not individuals who primarily provide technical or administrative support.
Immediate Family: Covered Individual's spouse, dependent children, or any person cohabitating with the Covered Individual, sharing mutual responsibility for each other's welfare and financial obligations. In certain circumstances as dictated by specific federal funding agencies or other sponsors, this term may have a broader definition.
Institutional Responsibilities: An individual’s professional responsibilities on behalf of the University. These may include, but are not limited to, research, research consultation, teaching, professional practice, institutional committee memberships, and service on panels such as Institutional Review Boards or Data and Safety Monitoring Boards. Institutional Responsibilities for subrecipients refer to the work being done for the University under the relevant subaward between the University and the subrecipient when the subrecipient agrees to rely on the University’s COI policies and programs.
Interest: A personal, professional, financial, or other connection to an entity, involving either a Covered Individual or their Immediate Family that relates to the Covered Individual’s Institutional Responsibilities and must be disclosed under this policy.
Procedure
1. Annual Training
- Complete COI training as part of the COI disclosure process before engaging in research activities covered by the FCOI Policy.
- Complete the University’s COI Training at least annually.
- Complete additional COI training when required by the COI Office, including when:
- The University revises its COI policies in ways that affect Covered Individuals
- Noncompliance triggers mandatory retraining.
2. Disclosure of Interests
A. Who Must Disclose
Submit a disclosure if you are responsible for the design, conduct, or reporting of research or other sponsored projects covered by the FCOI Policy.
B. When and How to Disclose
- Complete and certify a COI disclosure in AIR before engaging in research activities covered by the FCOI Policy.
- Update and certify the COI disclosure at least annually during the annual disclosure period, even if you have no interests to report.
- Update the COI disclosure before submitting new, renewal, or revised PHS applications.
- Update disclosures within 30 calendar days of acquiring or discovering a new interest or a change in an existing interest.
- Update disclosures when requested by the University or the COI Office.
- Respond promptly to requests from the COI Office for clarification or additional information.
C. What to Disclose
- Disclose all domestic and foreign Interests, including those held by Immediate Family, related to your Institutional Responsibilities, as defined in the FCOI Policy. This includes, but is not limited to (see the FCOI Policy for full requirements):
- Remuneration (e.g., consulting fees, honoraria, paid authorship)
- Equity interests in public or private entities
- Intellectual property and related income
- Sponsored or reimbursed travel (include purpose, sponsor, destination, and duration)
- External professional or leadership roles (paid or unpaid)
- Gifts that directly support research
- Include current, newly acquired, and reasonably anticipated Interests within the next 12 months.
- Submit an Interest or contact the COI Office if you are unsure whether it must be disclosed.
D. Research Activities While Disclosures are Pending or Unsubmitted
- Do not initiate new research activities until required disclosures are submitted, reviewed, and finalized, unless the COI Office provides written authorization. New research activities include subject interaction, data collection, data analysis, or access to identifiable research data.
- Continue ongoing research activities while a disclosures is under review, unless the COI Office requires a pause or other restriction.
- Pause research activities if a required disclosure has not been submitted or if directed by the COI Office. Resume only after the disclosure is submitted, reviewed, and finalized.
- Continue administrative or preparatory activities during COI review or during a directed pause, unless the COI Office directs otherwise.
3. Review of Disclosures
Refer to the FCOI Policy for the University’s review process.
4. Responsibilities
- 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.
5. Adherence to Management Plans
- Comply with all terms of the COI management plan issued by the COI Office.
- Follow required restrictions or monitoring.
- Participate in required oversight or reporting
- Provide updates on compliance at least annually or as requested.
- Report changes in Interest or research activities that may affect the management plan.
- Request clarification from the COI Office if you do not understand any part of your management plan.
6. Appeals
- Submit a written appeal with supporting documentation to dispute a determination or management plan.
- Respond to any follow-up requests from the COI Office.
7. Noncompliance
- Promptly report any failures to disclose interests, complete required training, or comply with management plans to the COI Office.
- Complete corrective actions required by the COI Office.
- Complete remedial training or update disclosures when necessary.
Noncompliance may result in suspension of research privileges, inability to participate in research, or other corrective actions consistent with University policy.
Related Requirements
University Policies, Standards, and Procedures
Contact Information
Primary Contacts
Conflict of Interest Office
Phone: (919) 843-9953
Email: coi@unc.edu
Name: Raha Khademi
Title: Director of the Conflict of Interest Office, Conflict of Interest Officer
Unit: Conflict of Interest Office, OVCR Research Compliance services
Email: khademi@unc.edu
Other Contact
Name: Quinton Johnson
Title: Assistant Vice Chancellor for Research Compliance
Unit: Office of the Vice Chancellor for Research (OVCR)
Email: quinton@unc.edu