Title
University of North Carolina at Chapel Hill Policy on Institutional Conflict of Interest in Human Subjects Research
Introduction
An Institutional Conflict of Interest (ICOI) arises when the financial interests of the University of North Carolina at Chapel Hill (“UNC-Chapel Hill” or the “University”) or a Senior Administrative Official, acting within their institutional role, may affect or appear to affect the design, conduct, reporting, review, or oversight of human subjects research. ICOIs can undermine the safety of research participants and compromise the University’s mission of research integrity, education, and public trust. This policy establishes safeguards to identify, manage, and, where necessary, eliminate ICOIs in human subjects research.
Purpose
This policy implements a consistent framework for identifying, reviewing, and managing ICOI in all human subjects research conducted under the auspices of UNC-Chapel Hill.
Scope
This policy applies to:
- All human subjects research conducted under the auspices of UNC-Chapel Hill, regardless of location or funding source.
- Senior Administrative Officials with financial or fiduciary interests that could impact such research.
Individual conflicts of interest are governed by the University of North Carolina at Chapel Hill Policy on Individual Conflicts of Interest and Commitment.
Definitions
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 conflicts of interest 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: The process by which a Senior Administrative Official or University Office reports financial or fiduciary interests that could reasonably appear to affect human subjects research conducted under the auspices of UNC-Chapel Hill.
Human Subjects Research: Research involving human participants, as defined by federal regulations (45 CFR 46, 21 CFR 50 & 56).
ICOI Committee: The committee responsible, as needed, for the review and management of ICOI in research.
ICOI Management Plan: A written plan specifying measures to mitigate, manage, or eliminate an identified ICOI in Human Subjects Research.
Institutional Conflict of Interest (ICOI) in Human Subjects Research: A situation where the financial and fiduciary interest of the University or of its senior administrative official may affect, or reasonably appear to affect, the objectivity of institutional processes for the design, conduct, reporting, review, or oversight of human subjects research.
- Institutional interests that may create an ICOI include situations where the University holds equity in a company involved in a research project, owns intellectual property or licensing arrangements connected to a study, or receives royalties, milestone payments, or other revenue that could increase in value based on the results of the research. An ICOI may also arise when a faculty founded company is involved in a study and the University has an ownership stake or a licensing relationship with that company. Similar concerns can occur when Senior Administrative Officials have financial or fiduciary interests in entities connected to the research. These interests can create real or perceived incentives that may influence or appear to influence research decisions or oversight.
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.
Office of Human Research Ethics (OHRE): An office within 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 IRB and all related activities.
Senior Administrative Officials: University leaders who have decision-making authority that could affect human subjects research. These leaders are defined as the chancellor and vice chancellors of UNC-Chapel Hill.
Sponsor: An individual or organization that takes responsibility for the initiation, management, and/or financing of a research project.
Statement of Economic Interest (SEI): A disclosure form required by the North Carolina State Ethics Act and administered by the North Carolina State Ethics Commission. Senior Administrative Officials at UNC-Chapel Hill must file an SEI annually to report financial, fiduciary, and personal interests that could create or appear to create a conflict of interest with their University duties. SEIs are public records, with limited confidential information redacted, and are used by the University to identify and evaluate potential ICOI in Human Subjects Research. Additional information and filing instructions are available through the North Carolina State Ethics Commission SEI Filing Portal.
University Offices: Administrative or academic units of UNC-Chapel Hill authorized to carry out official University functions. For the purposes of this policy, University Offices include units that maintain financial, fiduciary, or research-related information relevant to identifying or managing ICOI in Human Subjects Research (e.g., the Office of Technology Commercialization, the Office of Sponsored Programs, and Finance and Operations).
Policy
1.Sources of Information for Identifying ICOIs
ICOIs may be identified through the following sources:
- Annual Disclosures: Financial and fiduciary interests reported by Senior Administrative Officials as required by the North Carolina State Ethics Commission through the Statement of Economic Interest (SEI). These disclosures are a primary source of information for identifying potential ICOI. Additional disclosures may be collected through University systems to ensure a complete and accurate review.
- Administrative data from University Offices: Information maintained by relevant administrative units, including but not limited to:
- Office of Technology Commercialization: License-related payments and University-held equity.
- Finance and Operations: Investments in non-public entities.
These sources collectively inform the identification and review of financial or fiduciary interests that may create institutional conflicts related to human subjects research.
2.Types of Financial and Fiduciary Interests Reviewed
The COI Program evaluates both University-held and individual interests held by Senior Administrative Officials for potential ICOI.
Covered University Interests Related to licensed University Intellectual Property or equity in an entity licensing University IP
- University-held non-publicly traded equity in entities that are commercializing or developing intellectual property arising from human subjects research conducted under the auspices of the University.
- University-held publicly traded equity valued at $100,000 or more in such entities.
- Royalty, milestone or licensing revenue exceeding $100,000 annually derived from University-owned or University-licensed intellectual property related to human subjects research.
Individual Interests of Senior Administrative Officials
- Equity holdings or membership interest of at least $10,000 in entities involved in human subjects research conducted under the auspices of the University.
- Compensation exceeding $10,000 annually from such entities.
- Fiduciary roles (e.g., board membership) in entities with a research interest.
- Participation in advisory boards of such entities.
3. Review Process
The COI Program reviews all submitted disclosures and relevant administrative data to identify potential ICOI. This review follows the step-by-step process outlined below.
3.1 Identification
The COI Office flags any potential ICOIs based on submitted disclosures and administrative data. Any COI Program staff with a real or perceived conflict must recuse themselves from all stages of the review.
3.2 Preliminary Assessment
The COI Officer or designee determines whether the identified issue may present a possible ICOI.
3.3 Classification of Review Pathway
The COI Officer or designee assigns each case to the appropriate review path and may consult the ICOI Committee Chair:
- Expedited Review: Used when the identified conflict presents a low and clearly manageable risk. The COI Officer and ICOI Committee Chair conduct this review.
- Full ICOI Committee Review: Required for complex or high-risk situations that cannot be adequately addressed through expedited review.
3.4 ICOI Committee Composition and deliberation
The ICOI Committee is a group with relevant expertise, including required community representation, appointed by University leadership and governed by a formal committee charter. Members must be free of related financial or fiduciary conflicts. The Committee reviews all relevant materials and may request additional documentation or expert input, as needed. Based on its review, the Committee determines whether a management plan is required and defines its scope and elements.
Application of the Rebuttable Presumption Standard
The Committee begins its review with the presumption that significant financial or fiduciary interests require careful mitigation and, in some cases, may warrant elimination of the interest, or modification of the research. This presumption may be reconsidered when circumstances support the conduct of research with appropriate safeguards, including implementation of a robust management plan.
Factors Considered
- The importance and uniqueness of the research.
- The nature and magnitude of the institutional interest.
- The degree of overlap between interest and research outcomes.
- The potential risk to human subjects.
- The feasibility of managing the conflict.
- Whether the research could be reasonably conducted in an alternative setting
3.5 Determination and Documentation
Following review, the COI Program issues a formal determination. When an ICOI is identified and the research is permitted to proceed, a written management plan is required. Final approval of ICOI management plans is vested in the Vice Chancellor for Research (VCR).
If the Vice Chancellor for Research has a real or perceived conflict related to a specific management plan, final approval authority for that management plan will be escalated to the Provost or Chancellor.
4. Management of ICOI
Each identified ICOI must be managed through a documented management plan. Every management plan must address the following elements:
- The nature and scope of the conflict.
- Potential impact on human subjects or research integrity.
- Reputational risks to the University.
Management plans may incorporate one or more of the following strategies:
- Disclosure of the ICOI during the informed consent process.
- Recusal of conflicted Senior Administrative Officials from decisions affecting the research, including those involving investigator salary, promotion, or space allocation.
- Appointment of a neutral, non-conflicted senior leader.
- Use of an external Institutional Review Board (IRB).
- Independent monitoring of study endpoints and results.
- Oversight by an independent Data Safety Monitoring Board (DSMB).
- Disclosure of the ICOI in publications, presentations, and to collaborating sites.
All management plans must identify responsible parties and include mechanisms for monitoring compliance.
5. Notification
The COI Program communicates ICOI determinations and management plans to:
- The involved Senior Administrative Official
- The Vice Chancellor for Research (VCR)
- The Provost or Chancellor, as determined by the Vice Chancellor for Research, when the nature or magnitude of the institutional conflict warrants senior leadership awareness or when escalation is required
- The Office of Sponsored Programs (if applicable)
- The Office of Human Research Ethics/IRB
- Other relevant oversight bodies
6. Compliance and Enforcement
The OVCR, under the direction of the Vice Chancellor for Research, is responsible for implementing and enforcing this policy.
Violations of this policy by Senior Administrative Officials or other personnel will be evaluated based on their nature, severity, and impact on the research enterprise. Possible consequences include:
- Issuance of a formal letter of concern or reprimand.
- Mandatory training or education on ICOI.
- Restrictions on involvement in research governance, funding decisions, or administrative oversight.
- Revocation of authority to approve or influence research protocols or appointments.
- Removal from decision-making roles affecting human subjects research.
- Sequestration of related research materials, data, or communications.
- Public disclosure of the violation and remedial measures taken, where appropriate.
- Referral to the relevant human resources unit for disciplinary proceedings in accordance with University policies and procedures.
- Reassignment, demotion, or in cases of egregious or repeated noncompliance, termination from administrative leadership positions.
Corrective actions will be monitored by the COI Program to ensure timely resolution and ongoing compliance.
Related Requirements
External Regulations
University Policies, Standards, and Procedures
Contact Information
Primary Contacts
Name: Quinton Johnson
Title: Conflict of Interest Officer
Unit: Office of the Vice Chancellor for Research (OVCR)
Email: quinton@unc.edu
Name: Raha Khademi
Title: Deputy Director, Conflict of Interest Office
Unit: Conflict of Interest Office, OVCR Research Compliance services
Email: khademi@unc.edu