Financial Conflict of Interest Policies

UVAS Adopted Financial Conflict of Interest Policies

Introduction and Purpose

This policy outlines UCLA’s procedures for identifying, managing, and reporting Financial Conflicts of Interest (FCOI) to ensure transparency, maintain research integrity, and comply with federal and institutional regulations. It is designed to protect the objectivity of research and ensure that financial interests do not improperly influence research activities. This policy applies to all Principal Investigators, Key Personnel, and other research team members involved in the design, conduct, or reporting of research. It also extends to subrecipients engaged in externally funded research through UCLA.

Definitions

  1. Financial Conflict of Interest (FCOI): A significant financial interest (SFI) that could directly and significantly affect the design, conduct, or reporting of research.
  2. Significant Financial Interest (SFI): Includes:
    • Any financial interest exceeding $5,000 (salary, consulting fees, equity, intellectual property rights).
    • Any sponsored or reimbursed travel over $5,000.
    • Excludes: salary from UCLA, mutual funds, or U.S. government income sources.
  3. Investigator: Any individual responsible for designing, conducting, or reporting research, regardless of title or position.
  4. Institutional Responsibilities: Includes professional duties performed on behalf of UCLA, such as research, teaching, and consulting.
  5. Conflict of Interest Review Committee (CIRC): A UCLA faculty committee responsible for reviewing financial disclosures and determining whether FCOIs exist.
  6. Key Personnel: Principal Investigators and other personnel deemed essential to research activities.

Disclosure Requirements

Investigators are required to disclose all significant financial interests related to their research activities. Disclosures must be submitted before the proposal submission for funding, at the time of IRB approval for research involving human subjects, annually during the award period, and within 30 days of acquiring a new financial interest. These disclosures must include financial interests held by the Investigator, their spouse, and dependent children. UCLA provides a designated system for reporting disclosures, and the CIRC is responsible for reviewing them to determine their impact on research objectivity.

Review and Management of Financial Conflicts of Interest

The Conflict of Interest Review Committee (CIRC) assesses all disclosed financial interests to determine whether they pose a conflict. If an FCOI is identified, the CIRC develops a management plan to address the conflict. Management plans may include restrictions on the Investigator’s role in research activities, adding independent oversight or monitoring, or requiring public disclosure of the conflict in publications or presentations. If an FCOI cannot be effectively managed, the research may be modified or discontinued to ensure compliance with UCLA and federal standards.

Training Requirements

All Investigators engaged in research subject to Public Health Service (PHS) regulations must complete training on financial conflicts of interest. Training must be completed before engaging in PHS-funded research, at least every four years, and immediately if an Investigator is found non-compliant or fails to adhere to an FCOI management plan. UCLA provides online training modules to fulfill this requirement.

Public Accessibility of the FCOI Policy

UCLA’s FCOI policy is publicly available on its Research Policy and Compliance website to ensure transparency. In addition, information about identified financial conflicts involving senior or key personnel will be provided upon request within five business days, as required by NIH regulations.

Reporting to NIH

UCLA is responsible for reporting FCOIs to NIH and other federal agencies through the NIH eRA Commons FCOI Module. Reports must be submitted before funds are spent on a project, within 60 days of identifying a new FCOI during the award period, and annually to update the status of previously reported conflicts. If an Investigator fails to disclose an FCOI in a timely manner, UCLA conducts a retrospective review to determine whether bias occurred. If bias is detected, a mitigation report is submitted to NIH, including details of the impact and a corrective action plan.
 

Subrecipient Requirements

When UCLA collaborates with subrecipients on externally funded research, subrecipients must either certify compliance with NIH FCOI regulations or adopt UCLA’s FCOI policy. UCLA ensures compliance by monitoring subrecipients’ FCOI procedures and requiring written agreements that specify compliance expectations. Subrecipients are also required to report all identified FCOIs to UCLA, which will then report them to NIH if applicable.

Noncompliance and Retrospective Review

If an FCOI is not disclosed or managed in a timely manner, UCLA conducts a retrospective review of the research within 120 days to determine if bias occurred. If bias is identified, UCLA submits a mitigation report to NIH detailing the impact and the corrective action plan. Failure to comply with FCOI requirements may result in disciplinary actions, including restrictions on research activities.

Maintenance of Records

UCLA maintains all FCOI-related records for at least three years following the final expenditure report. If an audit or legal review occurs, records are retained beyond three years as required. This ensures compliance with federal and institutional policies on accountability.

Clinical Research Requirements

For research involving human subjects, Investigators must disclose FCOIs in publications reporting research findings and public presentations of research results. This ensures transparency when conflicts may impact research validity or participant safety.