Legal

Financial Conflict of Interest Policy

InChemico LebrunLabs Inc. Effective August 19, 2026

1. Purpose and Scope

This Financial Conflict of Interest (FCOI) Policy establishes standards to ensure that the design, conduct, and reporting of research funded by the U.S. Public Health Service (PHS) and other federal agencies will not be biased by any conflicting financial interest of an Investigator.

This policy applies to all Investigators at InChemico LebrunLabs Inc. who are responsible for the design, conduct, or reporting of research funded by PHS or other applicable federal agencies, including subcontractors and collaborators where required by the funding agency.

2. Definitions

Financial Conflict of Interest (FCOI)

A significant financial interest that could directly and significantly affect the design, conduct, or reporting of federally funded research.

Investigator

The principal investigator and any other person, regardless of title or position, who is responsible for the design, conduct, or reporting of research funded by a federal agency, or proposed for such funding. This includes collaborators and consultants.

Significant Financial Interest (SFI)

A financial interest consisting of one or more of the following interests of the Investigator (and those of the Investigator's spouse and dependent children) that reasonably appears to be related to the Investigator's institutional responsibilities:

  • With regard to any publicly traded entity: 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.
  • With regard to any non-publicly traded entity: remuneration received from the entity in the twelve months preceding the disclosure, when aggregated, exceeds $5,000, or when the Investigator holds any equity interest.
  • Intellectual property rights and interests (e.g., patents, copyrights), upon receipt of income related to such rights and interests.
  • Reimbursed or sponsored travel related to the Investigator's institutional responsibilities.

Excluded Interests

The following are not considered Significant Financial Interests under this policy:

  • Salary, royalties, or other remuneration paid by InChemico LebrunLabs Inc. to the Investigator.
  • Income from seminars, lectures, or teaching engagements sponsored by a federal, state, or local government agency, an institution of higher education, an academic teaching hospital, a medical center, or a research institute affiliated with an institution of higher education.
  • Income from service on advisory committees or review panels for a federal, state, or local government agency, an institution of higher education, an academic teaching hospital, a medical center, or a research institute affiliated with an institution of higher education.
  • Equity interests or income from investment vehicles, such as mutual funds and retirement accounts, as long as the Investigator does not directly control the investment decisions.

3. Disclosure Requirements

3.1 Initial Disclosure

Each Investigator must disclose all Significant Financial Interests (and those of the Investigator's spouse and dependent children) that reasonably appear to be related to the Investigator's institutional responsibilities no later than the time of application for federally funded research.

3.2 Annual Disclosure

Each Investigator must submit an updated disclosure at least annually during the period of the award. The annual disclosure must include any information that was not disclosed initially and any information that was previously disclosed but is no longer accurate.

3.3 Updated Disclosure

Each Investigator must submit an updated disclosure within thirty (30) days of discovering or acquiring a new Significant Financial Interest (e.g., through purchase, marriage, or inheritance).

3.4 Disclosure Process

Disclosures must be submitted in writing to the Designated Official (DO) at InChemico LebrunLabs Inc. using the approved FCOI Disclosure Form. Disclosures are confidential to the extent permitted by law.

4. Review and Determination

The Designated Official will review all SFI disclosures to determine whether a financial conflict of interest exists. An FCOI exists when the DO reasonably determines that the SFI could directly and significantly affect the design, conduct, or reporting of the federally funded research.

The review will be completed prior to the expenditure of any funds under the award, or within sixty (60) days of any newly identified SFI.

5. Management of FCOI

If an FCOI is identified, the Designated Official will implement a management plan prior to the expenditure of any funds under the award. Management strategies may include, but are not limited to:

  • Public disclosure of the FCOI in publications and presentations.
  • Monitoring of the research by independent reviewers.
  • Modification of the research plan.
  • Disqualification of the Investigator from participation in all or a portion of the research.
  • Divestiture of the conflicting financial interest.
  • Severance of relationships that create actual or potential conflicts.

The Investigator must comply with any FCOI management plan imposed by InChemico LebrunLabs Inc. Failure to comply may result in suspension of the research activity, removal of the Investigator from the project, or other appropriate action.

6. Reporting to Funding Agencies

InChemico LebrunLabs Inc. will report identified FCOIs to the relevant funding agency prior to the expenditure of any funds under the award and within sixty (60) days of any newly identified FCOI. Reports will include the information required by applicable federal regulations, including 42 CFR Part 50, Subpart F (for PHS-funded research).

InChemico LebrunLabs Inc. will provide annual FCOI reports to the funding agency for the duration of the project period.

7. Retrospective Review

If an FCOI is not identified or managed in a timely manner, InChemico LebrunLabs Inc. will, within 120 days of the determination of noncompliance, complete a retrospective review of the Investigator's activities and the research to determine whether any research conducted during the period of noncompliance was biased in its design, conduct, or reporting.

If bias is found, InChemico LebrunLabs Inc. will notify the funding agency promptly and submit a mitigation report.

8. Subrecipients

When InChemico LebrunLabs Inc. engages a subrecipient (e.g., subcontractor or collaborator) to conduct federally funded research, InChemico LebrunLabs Inc. will take reasonable steps to ensure that any subrecipient Investigator complies with applicable FCOI regulations. This will be accomplished by incorporating appropriate terms and conditions into the subaward agreement.

9. Training

Each Investigator must complete FCOI training prior to engaging in federally funded research and at least every four years thereafter. Training must also be completed immediately when:

  • This policy is revised in a manner that affects the requirements of Investigators.
  • An Investigator is new to InChemico LebrunLabs Inc.
  • InChemico LebrunLabs Inc. finds that an Investigator is not in compliance with this policy or an FCOI management plan.

10. Public Accessibility

InChemico LebrunLabs Inc. will make information concerning any identified FCOI held by a senior/key personnel Investigator publicly accessible upon request within five (5) business days of the request. This information will remain available for three years from the date the information was most recently updated.

Requests for FCOI information should be directed to the Designated Official at the contact information provided below.

11. Enforcement and Sanctions

Failure to comply with this policy may result in disciplinary action, up to and including termination of employment or engagement, suspension or termination of the research project, and notification of the funding agency. InChemico LebrunLabs Inc. reserves the right to take any action necessary to ensure compliance with applicable federal regulations.

12. Policy Administration

This policy is administered by the Designated Official at InChemico LebrunLabs Inc. Questions regarding this policy or the disclosure process should be directed to:

InChemico LebrunLabs Inc.

Designated Official, Research Compliance

Email: info@lebrunlabs.com

13. Effective Date and Revisions

This policy is effective as of August 19, 2026. InChemico LebrunLabs Inc. reserves the right to amend this policy at any time. Investigators will be notified of material changes and may be required to complete additional training or submit updated disclosures.