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Effective Date: 04-21-2026 Last Reviewed: 04-21-2026
This policy establishes the standards and procedures by which Auxigen LLC ("Auxigen") identifies, discloses, and manages financial conflicts of interest to protect the integrity of research conducted under grants and cooperative agreements funded by the National Institutes of Health (NIH) and the Public Health Service (PHS). This policy is designed to comply with 42 CFR Part 50, Subpart F, Promoting Objectivity in Research and the NIH Grants Policy Statement Section 4.1.10, Financial Conflict of Interest.
This policy applies to all Investigators — defined as any person, regardless of title or position, who is responsible for the design, conduct, or reporting of NIH/PHS-funded research — including the Principal Investigator, Co-Investigators, key personnel, and any consultants or subrecipients engaged in funded research activities.
This policy applies to all NIH grants and cooperative agreements. In accordance with federal regulation, Phase I SBIR applications and awards are currently exempt from the requirements of 42 CFR Part 50, Subpart F. However, Auxigen adopts this policy voluntarily to establish consistent standards across all funding stages and to ensure readiness for Phase II compliance requirements.
Significant Financial Interest (SFI) means a financial interest of the Investigator (and/or their spouse or dependent children) that reasonably appears related to the Investigator's institutional responsibilities, consisting of one or more of the following:
With regard to any publicly traded entity: remuneration received in the twelve months preceding disclosure and the value of any equity interest that, when aggregated, exceeds $5,000
With regard to any non-publicly traded entity: remuneration received in the twelve months preceding disclosure that, when aggregated, exceeds $5,000, or any equity interest of any value
Intellectual property rights and interests (e.g., patents, copyrights) upon receipt of income related to such rights
Reimbursed or sponsored travel related to the Investigator's institutional responsibilities — meaning travel paid on behalf of the Investigator and not reimbursed directly to the Investigator, such that the exact monetary value may not be readily available. Disclosure of reimbursed or sponsored travel must include, at a minimum: the purpose of the trip, the identity of the sponsor or organizer, the destination, and the duration.
Foreign financial interests: financial interests received from a foreign institution of higher education or the government of another country when such income meets the applicable disclosure threshold (e.g., income in excess of $5,000). This applies to all remuneration, equity interests, and sponsored travel from foreign sources related to the Investigator's institutional responsibilities.
SFI does not include:
Salary, royalties, or other remuneration paid by Auxigen to the Investigator
Income from seminars, lectures, or teaching engagements sponsored by U.S. federal, state, or local government agencies or U.S. institutions of higher education as defined under 20 U.S.C. 1001(a)
Income from investment vehicles such as mutual funds or retirement accounts over which the Investigator does not exercise direct control
Financial Conflict of Interest (FCOI) means a Significant Financial Interest that could directly and significantly affect the design, conduct, or reporting of PHS-funded research.
All Investigators must complete NIH's FCOI training prior to engaging in any NIH/PHS-funded research. Training must be completed:
Prior to engaging in funded research
At least every four years thereafter
Immediately upon any of the following circumstances:
A new Investigator joins funded research activities
Auxigen's FCOI policy is revised in a manner that alters Investigator requirements
An Investigator is found to be out of compliance with this policy or a related management plan
Training is available through the NIH Financial Conflict of Interest Training. Certificates of completion must be submitted to the Designated Official (defined in Section 5) and retained on file.
Auxigen designates the Chief Executive Officer (or a delegated representative) as the Designated Official (DO) responsible for:
Administering this policy
Receiving and reviewing Investigator disclosures
Making FCOI determinations
Implementing and monitoring management plans
Reporting FCOIs to NIH as required
Contact: [email protected]
Each Investigator must disclose all Significant Financial Interests to the Designated Official. Disclosures must be submitted:
Prior to applying for NIH/PHS funding
At least annually during the period of any active award
Within thirty (30) days of acquiring or discovering any new SFI
Disclosures must include all SFIs that are related to the Investigator's institutional responsibilities, regardless of whether the Investigator believes a conflict exists. The Designated Official will review each disclosure within sixty (60) days of receipt.
Upon receipt of a disclosure, the Designated Official will review the SFI and determine whether it constitutes an FCOI — that is, whether the interest could directly and significantly affect the design, conduct, or reporting of the funded research.
If no FCOI is identified, the determination will be documented and retained on file.
If an FCOI is identified, the Designated Official will develop and implement a management plan prior to the expenditure of any awarded funds.
Management plans may include, but are not limited to:
Public disclosure of the FCOI in relevant research publications and presentations
Modification of the research plan
Independent monitoring of the research by qualified reviewers
Disqualification of the Investigator from participation in the affected portion of the research
Divestiture of the conflicting financial interest
Severance of the relationship giving rise to the conflict
The affected Investigator must formally agree to and sign the written management plan before participating in or continuing participation in any related PHS-sponsored activity. The Designated Official will document the basis for the management plan and monitor Investigator compliance throughout the award period.
Auxigen will report identified FCOIs to NIH through the eRA Commons FCOI Module:
Prior to expenditure of any funds under a new award
Within sixty (60) days of identifying an FCOI for a newly engaged Investigator or a newly identified financial interest
Annually during the award period, as required by 42 CFR Part 50, Subpart F
FCOI reports will include a description of how the financial interest relates to the funded research, the basis for the FCOI determination, and the key elements of any management plan implemented.
When an SFI is not disclosed timely, not previously reviewed, or when an FCOI is not identified or managed in a timely manner, Auxigen will complete a retrospective review within 120 days of the Institution's determination of noncompliance. Triggers requiring retrospective review include:
Failure by an Investigator to disclose an SFI that is determined to constitute an FCOI
Failure by Auxigen to review or manage such an FCOI
Failure by an Investigator to comply with an FCOI management plan
Required elements of the retrospective review documentation:
Project Number
Project Title
PD/PI or contact PD/PI name
Name of the Investigator with the FCOI
Name of the entity with which the Investigator has the FCOI
Reasons for the retrospective review
Detailed methodology used for the review (e.g., review process, composition of review panel, documentation reviewed)
Findings of the review
Conclusions of the review
Mitigation Report: If the retrospective review determines that bias has occurred in the design, conduct, or reporting of NIH-funded research, Auxigen will notify NIH promptly and submit a Mitigation Report. The Mitigation Report will include all key elements of the retrospective review plus a description of the impact of the bias on the research project and Auxigen's plan of action to eliminate or mitigate the effect of the bias.
If the Department of Health and Human Services determines that an NIH-funded clinical research project whose purpose is to evaluate the safety or effectiveness of a drug, medical device, or treatment has been designed, conducted, or reported by an Investigator with an FCOI that was not managed or reported as required, Auxigen shall require the Investigator to disclose the FCOI in each public presentation of the results of the research and to request an addendum to previously published presentations.
When Auxigen carries out NIH-funded research through subrecipients, Auxigen will incorporate FCOI compliance requirements into each written subrecipient agreement. The agreement will:
Establish whether Auxigen's FCOI policy or the subrecipient's institutional policy applies to subrecipient Investigators
Require the subrecipient to provide written certification that its FCOI policy complies with 42 CFR Part 50, Subpart F
Require the subrecipient to notify Auxigen of any identified FCOI within a timeframe that allows Auxigen to report to NIH as required — and in no case later than thirty (30) days of identification
Confirm that the subrecipient's portion of the research is conducted in compliance with 42 CFR Part 50, Subpart F
Auxigen will take such actions as necessary to manage FCOIs of subrecipient Investigators and monitor compliance with any applicable management plans until completion of the project.
Auxigen will maintain records of all Investigator disclosures, FCOI determinations, management plans, and related documentation for at least three years following the submission of the final expenditure report for the applicable award, or as otherwise required by 45 CFR Part 75.
Failure to comply with this policy may result in remedial action including but not limited to letters of reprimand, restriction on the use of funds, suspension from the project, or removal from the research project. Auxigen will establish adequate enforcement mechanisms to ensure Investigator compliance as required under 42 CFR § 50.604(j).
When noncompliance results in an unmanaged or unreported FCOI, Auxigen will complete a retrospective review as described in Section 10. Auxigen will notify NIH promptly if an Investigator or subrecipient Investigator fails to comply with this policy or if noncompliance appears to have biased the design, conduct, or reporting of NIH-funded research, and will take corrective action as required under 42 CFR § 50.606(a).
In addition to this policy being publicly posted at https://auxigen.co/fcoi-policy, information concerning identified FCOIs held by senior/key personnel will be made publicly accessible prior to the expenditure of any award funds, in accordance with 42 CFR § 50.605(a)(5).
Publicly accessible FCOI information will include at minimum the following elements as required by regulation:
Investigator's name
Investigator's title and role with respect to the NIH-funded research
Name of the entity in which the SFI is held
Nature of the SFI (e.g., equity interest, consulting fees, travel reimbursement)
Approximate dollar value of the SFI within the ranges specified in the regulation, or a statement that the value is not readily determinable
This information will be:
Posted on this website or made available within five (5) business days of a written request submitted to [email protected]
Updated at least annually
Updated within sixty (60) days of any newly identified FCOI
Retained and available for three (3) years from the date the information was most recently updated
To request FCOI information in writing, contact: [email protected]
This policy is publicly available at
Any person may request information regarding this policy, FCOI procedures, or reported conflicts of interest by contacting:
Auxigen LLC
3 Summit Road
Conway, AR 72032
[email protected]
42 CFR Part 50, Subpart F — Promoting Objectivity in Research
NIH Grants Policy Statement Section 4.1.10 — Financial Conflict of Interest
NIH FCOI Policy Topics Page
NIH FCOI Training
eRA Commons FCOI Reporting Module
45 CFR Part 75 — Uniform Administrative Requirements
NIH Guide Notice NOT-OD-22-210 — FCOI Reminders
This policy was last reviewed on 04-21-2026. Auxigen LLC reserves the right to update this policy as regulatory requirements evolve. Questions regarding this policy should be directed to the Designated Official at [email protected].