Body
University Policy
Title
University of North Carolina at Chapel Hill Policy on Individual Financial Conflict of Interest in Research
Introduction
Consistent with its research mission, the University of North Carolina at Chapel Hill (“University” or “UNC-Chapel Hill”) supports appropriate research collaborations with industry, government, and nonprofit partners. The University is committed to promoting objectivity in research and maintaining public trust in the design, conduct, and reporting of research.
Interests related to a Covered Individual’s Institutional Responsibilities must be disclosed, reviewed, and, when necessary, managed in accordance with this policy so that research covered by this policy is free from bias resulting from Financial Conflicts of Interest (FCOI).
This policy addresses individual FCOI in research and is distinct from other University policies that address institutional conflicts of interest or other types of conflicts involving University personnel.
Purpose
This policy establishes the University’s framework for identifying, reviewing, and managing individual FCOI that may arise from the Interests of Covered Individuals who participate in research supported by the U.S. Public Health Service (PHS) and other sponsored research projects. It implements the requirements of the federal FCOI regulation at 42 CFR Part 50 Subpart F, Promoting Objectivity in Research, which applies to research funded through PHS grants and cooperative agreements.
These requirements protect research integrity, safeguard human and animal subjects, and maintain public trust in federally sponsored research, including research supported by the PHS and National Institute of Health (NIH).
This policy also supports compliance with other sponsors that require equivalent or more stringent COI protections. Consistent with this commitment, the University certifies in each PHS grant application that it maintains a compliant COI policy and will promote compliance with disclosure and management requirements.
Scope
This policy applies to research funded by the PHS through grants and cooperative agreements, including career development awards, center grants, institutional training grants, individual fellowships, infrastructure awards, research contracts, research resource awards, and program projects.
The policy applies regardless of whether the research involves human participants, vertebrate animals, or other research activities.
This policy governs all Covered Individuals, as defined in this policy, who are responsible for the design, conduct, or reporting of research or sponsored projects covered by these regulations.
Definitions
Activities, Interests, and Relationships Management System (“AIR”): The University’s electronic platform for disclosure and management of Interests.
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.
COI Committee: The committee designated by the Vice Chancellor for Research or their designee responsible for the review and management of COI.
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.
COI Officer: The University official responsible for overseeing the COI Program.
COI Office: The administrative unit within the Office of the Vice Chancellor for Research (OVCR) responsible for managing University COI requirements.
COI Program: The University’s framework for identifying, assessing, and managing COI in research and other institutional activities. It includes the COI Policy, disclosure process, training requirements, and oversight procedures. The program is designed to promote transparency, protect research integrity, and comply with applicable laws and sponsor requirements.
Disclosure: A form completed by Covered Individuals to report Interests, as defined under this policy, to the University.
Financial Interest: Any Interest of monetary value, whether or not the value is readily ascertainable. A financial interest becomes a Significant Financial Interest (SFI) when it meets the monetary thresholds or criteria described under this policy.
Financial Conflict of Interest (FCOI): A Significant Financial Interest (SFI) that could directly and significantly affect the design, conduct, or reporting of the research.
Human Subjects Research: Research involving human participants, as defined by federal regulations (45 CFR 46, 21 CFR 50 & 56).
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.
Institutional Review Board (IRB): An independent body of medical, scientific, and non-scientific members designated by UNC-Chapel Hill to review, approve the initiation of, and conduct periodic review of research involving human participants. The primary purpose of this review is to protect the rights, safety, and welfare of human participants in research.
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.
Office of Human Research Ethics (OHRE): An office within the UNC-Chapel Hill OVCR that is responsible for ethical and regulatory oversight of research that involves human subjects. OHRE administers, supports, and guides the work of the Institutional Review Board (IRB) and all related activities.
Office of Sponsored Programs (OSP): An office within the UNC-Chapel Hill OVCR that facilitates sponsored research.
Project Director/Principal Investigator (PD/PI): The person with primary responsibility for the design, conduct, and reporting of a funded research project.
Public Health Service (PHS): A division of the U.S. Department of Health and Human Services (HHS) focused on public health. It includes several key agencies such as the National Institutes of Health (NIH), the Centers for Disease Control and Prevention, and the Food and Drug Administration (FDA).
PHS Awarding Component: The organizational unit of the PHS that funds research subject to FCOI regulations.
Research relatedness: The extent to which a Financial Interest or non-financial interest is related to the sponsor, investigational drug/device, or research project.
Senior/Key Personnel: The Principal Investigator and any other Covered Individuals who contribute to the scientific development or execution of a project, regardless of whether they receive compensation from the award.
- Individuals designated by the University as Senior/Key Personnel in a grant application, progress report, or any other report submitted to a PHS awarding component, and who have a determined FCOI, are subject to applicable public accessibility requirements.
Significant Financial Interest (SFI): A domestic or foreign Financial Interest of a Covered Individual or their Immediate Family that reasonably appears to be related to the Covered Individual’s Institutional Responsibilities and consists of one or more of the following:
- Publicly traded entity: The total value of any remuneration received from the entity in the twelve months preceding the disclosure and the value of any equity Interest in the entity as of the date of disclosure, when aggregated, exceeds $5,000. Equity Interest includes any stock, stock option, or other ownership Interest, as determined through reference to public prices or other reasonable measures of fair market value;
- Remuneration from a single entity: The total value of any remuneration received from the entity in the twelve months preceding the 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);
- Any equity interest in a non-publicly traded entity: Remuneration received from the entity in the twelve months preceding the disclosure, when aggregated, exceeds $5,000, or the Covered Individual (or Immediate Family member) holds any equity Interest (e.g., stock, stock option, or other ownership Interest); or
- Intellectual property rights and interests (e.g., patents, copyrights, royalties), upon receipt of income related to such rights and Interests.
- Sponsored or reimbursed travel: Any domestic or foreign travel related to Institutional Responsibilities that is paid for or reimbursed by a third party, unless paid for by:
- a federal, state, or local government agency located in the United States,
- a United States institution of higher education, as defined at 20 U.S.C. 1001(a), an academic teaching hospital, a medical center, or a research institute that is affiliated with a United States institution of higher education.
Sponsor: An individual or organization that takes responsibility for the initiation, management, and/or financing of a research project.
Subrecipient: A legal entity that receives a subcontract or subaward from a pass-through entity to carry out part of a funded project award (scope of work).
Policy
Policy Statement
1. Training
Covered Individuals must complete University COI Training annually in conjunction with their annual disclosure, before engaging in research, when the University revises its COI policy in a way that affect Covered Individuals, when Covered Individuals are new to the University, when compliance findings necessitate retraining, or as otherwise required by the University.
The training will address applicable federal FCOI regulations, the institution’s FCOI policy, the Covered Individual’s responsibility to disclose Interests, including those of the Covered Individual’s Immediate Family, that are related to their Institutional Responsibilities.
2. Disclosure of Interests
A. Who Must Disclose
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.
B. How and When to Disclose
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.
C. What to Disclose
Covered Individuals must disclose any foreign or domestic Interests, including those of their Immediate Family, that relate to the Covered Individual’s Institutional Responsibilities.
Examples of foreign financial Interest include income from seminars, lectures, or teaching engagements, income from service on advisory committees or review panels, and reimbursed or sponsored travel received from any foreign entity, including foreign Institutions of higher education or foreign governments (including local, provincial, or equivalent governments of another country).
Disclosures must cover Interests currently held, newly acquired or changed since the last submission, and any Interests anticipated within the next 12 months.
Disclosable Interests include:
- Any remuneration, including salary and any payment for services not otherwise identified as salary (e.g., consulting fees, honoraria, paid authorship)
- Equity Interests in publicly or privately held companies
- Intellectual property rights and any related income
- Sponsored or reimbursed travel from non-University sources, including all international travel. Disclosure must include the purpose of the trip, the identity of the sponsor/organizer, the destination, and the duration.
- Service in external executive, advisory, or board roles (whether compensated or not)
- Gifts that directly support the Covered Individual’s research
D. What NOT to Disclose
Covered Individuals are not required to disclose:
- Salary or other remuneration (not listed above) from the University
- Income from seminars, lectures, or teaching engagements sponsored by or for a federal, state, or local government agency located in the United States, a United States institution of higher education, an academic teaching hospital or a medical center, or a research institute that is affiliated with a United States institution of higher education
- Income from service on advisory committees or review panels sponsored by or for a federal, state, or local government agency located in the United States, a United States institution of higher education, an academic teaching hospital or a medical center, or a research institute that is affiliated with a United States institution of higher education
- Income from investment vehicles, such as mutual funds or retirement accounts, as long as the Covered Individual does not directly control the investment decision made in these vehicles
3. Review of Disclosures
The University follows a structured, step-by-step process to evaluate whether disclosed Interests constitute an FCOI or other forms of COI. The process includes the following steps:
- Identification: The COI Office reviews the disclosed Interests submitted through the AIR system to determine whether they meet the threshold for SFI. Reviews are conducted in the context of human subjects research protocols, sponsored research awards, and licensed intellectual property.
- Preliminary Assessment: The COI Officer or designee reviews the disclosure to determine if the SFI:
- is related to the research (i.e., could the SFI be affected by the research or is the SFI in an entity whose Financial Interest could be affected by the research), and
- could directly and significantly affect the design, conduct, or reporting of the research.
- Review Pathway Assignment: The COI Officer assigns the case to one of two pathways:
- Expedited Review by the COI Office for low-risk Interests that can be managed using a standard plan.
- Full COI Committee Review for high-risk, complex, or appealed cases. The COI Committee may consult with the OHRE, OSP, or other relevant offices as needed.
- Committee Review and Deliberation: Upon request from the COI Officer or a COI Committee chair, the Committee reviews all relevant materials, requests additional information if needed, and determines whether the SFI constitutes an FCOI and requires management. Any Committee member with a real or perceived COI must recuse themselves from deliberations.
- FCOI Determination: Each case is evaluated in accordance with University policy and applicable regulations, considering:
- The nature and extent of the SFI
- The Covered Individual’s role and level of influence in the research
- The relationship between the SFI and research outcomes
- Potential risks to research integrity or human subjects
- Whether the conflict can be effectively managed
- Documentation: The COI Office records the final determination in the AIR system. If the research is allowed to proceed, a written management plan is developed.
Travel Disclosure Review
The COI Office will review the disclosure and determine, consistent with FCOI regulation, whether additional information (including monetary value) is required and whether the travel constitutes an FCOI related to NIH-funded research.
4. Management of FCOI
If an FCOI, or other COI that must be managed, is identified, a management plan must be developed to address:
- The nature and scope of the conflict
- Potential impact on human subjects or research integrity
- Reputational risks to the University
Management strategies may include:
- Public disclosure (e.g., in informed consent documents; in publications and presentations; to staff working on the project; to institutional oversight committees such as the IRB or IACUC; and other forms of public dissemination)
- Disclosure to students or research participants
- Independent monitoring or review
- Modification of the research plan
- Change to personnel or personnel responsibilities, or disqualification of personnel from participation in all or a portion of the research;
- Investigator recusal or removal
- Reduction or elimination of the Financial Interest
- Declining the award
The IRB has final authority over human subjects protocols and may impose additional safeguards or deny approval.
The COI Office will implement and monitor each management plan for compliance throughout the duration of the project, including at least an annual review.
5. Appeals
Covered Individuals may appeal an expedited determination or a required management plan if they believe the decision is inappropriate or not aligned with policy. Appeals must be submitted in writing with supporting documentation. The COI Office will coordinate the appeal process. The COI Committee will review and issue a final decision.
6. Internal Notification
The COI Office notifies the Covered Individual and the appropriate institutional offices and personnel when it makes an FCOI determination and implements a management plan. Notifications include:
- OSP
- OHRE
- Department chair, division chief, and/or school dean
- The Principal Investigator (if not the conflicted individual)
- Other offices and individuals, as determined by the COI Officer
The conflicted Covered Individual must report on management plan adherence at least annually and as requested.
7. External Reporting and Disclosure
The COI Office is responsible for reporting FCOIs to external sponsors and related entities, as required by federal regulations and sponsor policies.
The University submits FCOI reports before funds are expended, within 60 days of identifying a new or newly identified FCOI, including when a Covered Individual joins an ongoing project, and annually through eRA Commons FCOI module for NIH awards, at the same time as the Research Performance Progress Report (RPPR), multi-year progress report, or at the time of a grant extension. These reports are not submitted as part of the RPPR. Each annual report provides the current status of the FCOI (i.e., whether the FCOI is being managed or no longer exists) and any updates to the management plan, if applicable, until the project is complete or until the FCOI no longer exists.
In addition, whenever an FCOI is not identified or managed in a timely manner due to (1) failure by the Investigator to disclose a Financial Interest that is determined by the University to constitute an FCOI, (2) failure by the University to review or manage an FCOI, or (3) failure by the Investigator to comply with an FCOI management plan, the University shall conduct a retrospective review within 120 days of the noncompliance determination. Institutions are not required to provide the results of the review unless new information is discovered or bias is found. In that case, the University updates the FCOI report to include the review results. If research bias is identified, the University submits a Mitigation Report that describes the findings of the review, the nature and impact of the bias, and the actions taken or planned to eliminate or minimize it, consistent with PHS requirements. Additional procedures for retrospective review and mitigation reporting are described in Section 9.
The University also:
- Notifies the NSF Office of General Counsel only when an identified FCOI cannot be managed.
- Provides relevant FCOI information and management plans to external IRBs when they serve as the IRB of record.
- Responds within five business days to public requests for information about identified FCOIs held by Senior/Key Personnel, including providing the information required under 42 CFR § 50.605(a)(5), such as the investigator’s name, title and role on the project, the name of the entity in which the SFI is held, the nature of the SFI, and the approximate dollar value (or a statement that the value cannot be readily determined).
8. Subrecipient Compliance
UNC-Chapel Hill must ensure that subrecipient entities comply with applicable federal COI requirements. OSP, in coordination with the COI Office, is responsible for overseeing subrecipient compliance, including documentation, certification, and reporting, in accordance with 42 CFR § 50.604(c).
- If UNC-Chapel Hill is the prime awardee, it will:
- Confirm through a written agreement whether the subrecipient will follow UNC-Chapel Hill’s COI policy or its own FCO-compliant policy.
- If the subrecipient relies on UNC-Chapel Hill’s policy, UNC will provide oversight to ensure identification and management of the subrecipient’s FCOI in accordance with this policy.
- Verify that subrecipient FCOI policy meet sponsor requirements and obtain applicable certifications for PHS-funded research.
- Ensure timely submission of any required FCOI reports to the sponsor.
- If UNC-Chapel Hill is the subrecipient, it will:
- Disclose FCOIs to the prime awardee in accordance with sponsor requirements or as otherwise applicable.
All subrecipient COI obligations are documented in the subaward agreement and monitored throughout the project’s duration.
9. Noncompliance, Enforcement, and Sponsor Remedies
UNC-Chapel Hill must timely respond to any failure to disclose, review, or manage FCOIs in accordance with PHS regulations (42 CFR § 50.605(a)(3)) and applicable University requirements.
A. Institutional Oversight and Enforcement
The Vice Chancellor for Research is responsible for overseeing the implementation of this policy and investigating any potential noncompliance.
Violations of this policy will be evaluated based on their severity, scope, and impact. Depending on the circumstances, one or more of the following consequences may apply, in accordance with University policies and procedures:
- Required remedial training or education
- Formal written warning or reprimand
- Removal from oversight or supervisory roles related to research
- Suspension of research privileges
- Sequestration of relevant research records, data, or communications
- Withholding of funding
- Referral to Human Resources for potential disciplinary action
- Termination of employment or dismissal from the University
The Vice Chancellor for Research may also revoke access to research facilities, resources, or the ability to lead or participate in research activities.
In addition to these institutional actions, the University’s compliance units will coordinate any required notifications to sponsors or other entities, as applicable.
B. PHS-Funded Research
When an SFI in PHS-funded research is not disclosed or managed on time, UNC must:
- Review the SFI within 60 days
- Determine if it is related to the research and if it constitutes an FCOI
- Submit an FCOI report to the PHS awarding component, if applicable
- Implement an interim management plan
The University must also, within 120 days of determining noncompliance, complete and document a retrospective review of the Covered Individual’s activities and the PHS-funded research project consistent with the PHS regulations. If bias is found, a mitigation report must be submitted to PHS.
If Department of Health and Human Services determines that a PHS-funded clinical research project designed to evaluate the safety or effectiveness of a drug, medical device, or treatment has been designed, conducted, or reported by a Covered Individual with an FCOI that was not managed or reported as required, the University will require the individual to:
- Publicly disclose the FCOI in each public presentation of the research results; and
- Request an addendum or correction to any previously published presentations.
10. Records and Retention
Records of Covered Individuals’ disclosures, the University's review and response, and any documentation related to retrospective reviews and mitigation reports must be kept secure and confidential. Access to this information is limited to individuals responsible for the review process and to University offices with a legitimate business need.
These records must be retained for at least three years from the date the final expenditure report is submitted to the PHS or as required by applicable regulations or the sponsor, whichever is longer, in accordance with 2 CFR § 200.334.
Related Requirements
External Regulations
University Policies, Standards, and Procedures
Contact Information
Primary Contact
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