Financial Conflict of Interest Policy

The purpose of this policy is to promote objectivity in research by establishing standards that provide a reasonable expectation that the design, conduct, and reporting of research funded by PHS will be free from bias resulting from Investigator financial conflicts of interest. Lebrun Labs is committed to ensuring that financial interests do not compromise, or appear to compromise, the integrity of its research activities.

This policy applies to all Investigators at Lebrun Labs who are responsible for the design, conduct, or reporting of PHS-funded research, including:

• Principal Investigators (PIs) and co-investigators on NIH grants and contracts
• Collaborators, subcontractors, and consultants who are responsible for the design, conduct, or reporting of research
• Any other individual who holds a senior or key role on a PHS-funded project as defined in the applicable Notice of Award

This policy applies to all phases of PHS-funded research, including proposal preparation, active award periods, and post-award reporting obligations.

Each Investigator must disclose to the Designated Institutional Official (DIO) 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. Disclosures must be made:

• At the time of application for PHS funding
• Annually during the period of the award
• Within 30 days of acquiring or discovering a new Significant Financial Interest
• Prior to engaging in any new PHS-funded research activity

Disclosures must be submitted using the Lebrun Labs FCOI Disclosure Form and directed to the Designated Institutional Official. All disclosures are treated as confidential to the extent permitted by law.

The Designated Institutional Official (DIO) will review all Investigator disclosures within 60 days of receipt and determine whether a disclosed SFI constitutes an FCOI with respect to PHS-funded research. In making this determination, the DIO will assess whether the SFI could directly and significantly affect the design, conduct, or reporting of the research.

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

• Public disclosure of the FCOI in publications and presentations
• Monitoring of research by independent reviewers
• Modification of the research plan
• Disqualification from participation in the portion of the research that gives rise to the conflict
• Divestiture of the financial interest
• Severance of relationships that create the conflict

If an FCOI is not identified or managed in a timely manner, including when an Investigator fails to disclose an SFI or when a new SFI is identified during an active award, Lebrun Labs will, within 120 days of the determination of noncompliance, conduct 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, Lebrun Labs will notify the NIH awarding component promptly and submit a mitigation report in accordance with 42 CFR § 50.605(a)(3).

All Investigators must complete FCOI training prior to engaging in PHS-funded research and at least every four years thereafter. Training must also be completed:

• When this policy is revised in a manner that affects Investigator requirements
• When an Investigator is found to be noncompliant with this policy or a management plan
• When a new Investigator joins a PHS-funded project

Training may be completed through the NIH FCOI online training module or an equivalent program approved by the DIO. Completion records are maintained by Lebrun Labs.

When Lebrun Labs carries out PHS-funded research through a subrecipient (e.g., subcontractor or collaborating institution), Lebrun Labs will incorporate FCOI compliance terms into the written agreement with the subrecipient. The subrecipient must either (a) certify that its FCOI policy complies with 42 CFR Part 50 Subpart F, or (b) agree to comply with Lebrun Labs' FCOI policy. Subrecipients must report identified FCOIs to Lebrun Labs in sufficient time to allow reporting to the NIH awarding component.

In accordance with 42 CFR § 50.604(a), Lebrun Labs makes this FCOI policy publicly accessible via its website. Additionally, information regarding identified FCOIs held by senior/key personnel on PHS-funded projects is available upon written request within five business days. Requests should be directed to the Designated Institutional Official at the contact information below.

Lebrun Labs will maintain records of all Investigator disclosures of SFIs, reviews conducted, determinations made, and management plans implemented for at least three years beyond the date of submission of the final expenditures report for the applicable PHS-funded research, or as otherwise required by 45 CFR Part 75.

Failure to comply with this policy, including failure to disclose SFIs, failure to complete required training, or failure to adhere to a management plan, may result in disciplinary action up to and including removal from the research project, termination of employment or engagement, and reporting to the NIH awarding component as required by regulation.

Questions regarding this policy, disclosure requirements, or FCOI determinations should be directed to the Designated Institutional Official:

This policy is reviewed annually and updated as necessary to reflect changes in applicable regulations or institutional practices.