Financial Conflict of Interest Policy for PHS/NIH-Funded Research

ACatechol, Inc.

Financial Conflict of Interest Policy for PHS/NIH-Funded Research

Effective Date: June 1, 2026
Institution: ACatechol, Inc.
FCOI Institutional Official / Designated Official: Eunmee Cho, Manager
FCOI Contact Email: acatecholusa@gmail.com

 

1. Purpose

ACatechol, Inc. (“ACatechol” or the “Institution”) is committed to promoting objectivity in research and maintaining the public’s trust that research supported by the U.S. Public Health Service (“PHS”), including the National Institutes of Health (“NIH”), is conducted without bias resulting from Investigator financial conflicts of interest.

This Financial Conflict of Interest Policy (“Policy”) establishes ACatechol’s process for identifying, reviewing, managing, reducing, eliminating, and reporting financial conflicts of interest (“FCOI”) in accordance with 42 CFR Part 50 Subpart F, “Promoting Objectivity in Research,” and applicable NIH Grants Policy Statement requirements.

 

2. Applicability

This Policy applies to each Investigator who is planning to participate in, or is participating in, PHS/NIH-funded research at ACatechol.

For the current NIH-funded project, ACatechol has identified the following Investigator:

Kollbe Ando Ahn, Ph.D.
Principal Investigator
ACatechol, Inc.
kollbe@acatechol.com

For purposes of this Policy, “Investigator” includes the Principal Investigator and any other person, regardless of title or position, who is responsible for the design, conduct, or reporting of PHS/NIH-funded research or proposed PHS/NIH-funded research.

This Policy applies to NIH grants and cooperative agreements, including NIH SBIR/STTR awards when applicable. This Policy does not apply to Phase I SBIR or Phase I STTR applications or awards to the extent excluded by applicable federal regulation.

For subrecipients, collaborators, contractors, or consultants involved in PHS/NIH-funded research, ACatechol will take reasonable steps to ensure compliance with applicable FCOI requirements through written agreements. Such agreements will state whether the subrecipient’s FCOI policy or ACatechol’s FCOI policy applies to the subrecipient’s Investigators and will include reporting timelines sufficient to allow ACatechol to meet NIH reporting requirements.

 

3. Definitions

3.1 Financial Conflict of Interest

A Financial Conflict of Interest (“FCOI”) exists when ACatechol, through its FCOI Institutional Official / Designated Official, reasonably determines that an Investigator’s Significant Financial Interest could directly and significantly affect the design, conduct, or reporting of PHS/NIH-funded research.

3.2 Investigator

“Investigator” means the project director or principal investigator and any other person, regardless of title or position, who is responsible for the design, conduct, or reporting of PHS/NIH-funded research, or proposed PHS/NIH-funded research. This may include employees, consultants, collaborators, contractors, or subrecipient personnel.

For purposes of financial disclosure, Investigator includes the Investigator’s spouse and dependent children.

3.3 Institutional Responsibilities

“Institutional Responsibilities” means an Investigator’s professional responsibilities on behalf of ACatechol, including research, research consultation, product development, professional practice, regulatory strategy, institutional service, and other activities related to ACatechol’s research and development programs.

3.4 Significant Financial Interest

A “Significant Financial Interest” or “SFI” means 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:

  1. Publicly Traded Entity: With regard to any publicly traded entity, an SFI exists if the value of remuneration received from the entity in the twelve months preceding the disclosure plus the value of any equity interest in the entity as of the date of disclosure, when aggregated, exceeds $5,000.

  2. Non-Publicly Traded Entity: With regard to any non-publicly traded entity, an SFI exists if the value of remuneration received from the entity in the twelve months preceding the disclosure, when aggregated, exceeds $5,000, or when the Investigator, spouse, or dependent children hold any equity interest.

  3. Intellectual Property: Intellectual property rights and interests, including patents, copyrights, royalties, or licensing income, upon receipt of income related to such rights and interests.

  4. Sponsored or Reimbursed Travel: Reimbursed or sponsored travel related to the Investigator’s Institutional Responsibilities, including travel paid on behalf of the Investigator, unless excluded under applicable federal regulations. The disclosure must include, at minimum, the purpose of the trip, sponsor or organizer, destination, and duration.

SFIs may be domestic or foreign. Investigators must disclose both foreign and domestic financial interests that meet the definition of SFI.

3.5 Exclusions from Significant Financial Interest

The following are not considered Significant Financial Interests for purposes of this Policy:

  1. Salary, royalties, or other remuneration paid by ACatechol to the Investigator if the Investigator is currently employed or otherwise appointed by ACatechol.

  2. Intellectual property rights assigned to ACatechol and agreements to share royalties related to such rights.

  3. Any ownership interest in ACatechol held by the Investigator, if ACatechol is the commercial or for-profit applicant or awardee institution.

  4. Income from investment vehicles, such as mutual funds or retirement accounts, provided the Investigator does not directly control investment decisions made in those vehicles.

  5. Income from seminars, lectures, teaching engagements, service on advisory committees, or service on review panels sponsored by a U.S. federal, state, or local government agency, a U.S. institution of higher education, an academic teaching hospital, a medical center, or a research institute affiliated with a U.S. institution of higher education, to the extent excluded by applicable federal regulations.

 

4. Responsibilities of Investigators

Each Investigator must:

  1. Read and comply with this Policy.

  2. Complete FCOI training before engaging in PHS/NIH-funded research, at least every four years thereafter, and immediately when required by this Policy or applicable regulation.

  3. Disclose all Significant Financial Interests to ACatechol’s FCOI Institutional Official / Designated Official no later than the time of application for PHS/NIH-funded research.

  4. Update SFI disclosures at least annually during the award period.

  5. Submit an updated SFI disclosure within thirty days of discovering or acquiring a new Significant Financial Interest, including through purchase, marriage, inheritance, new consulting arrangements, new equity interests, new intellectual property income, or sponsored/reimbursed travel.

  6. Comply with any FCOI management plan issued by ACatechol.

  7. Provide additional information when requested by the FCOI Institutional Official / Designated Official to allow ACatechol to determine whether an SFI is related to PHS/NIH-funded research and whether it constitutes an FCOI.

 

5. FCOI Training

ACatechol will inform each Investigator of this Policy, the Investigator’s disclosure responsibilities, and applicable federal FCOI requirements.

Each Investigator must complete FCOI training:

  1. Before engaging in PHS/NIH-funded research;

  2. At least every four years;

  3. Immediately when ACatechol revises this Policy in a manner that affects Investigator requirements;

  4. When an Investigator is new to ACatechol; or

  5. When ACatechol determines that an Investigator is not in compliance with this Policy or an FCOI management plan.

Completion of NIH’s FCOI training module may be used to satisfy the federal regulatory training component. ACatechol will also provide or document training on ACatechol’s institutional policy and disclosure procedures.

 

6. Disclosure and Review Process

ACatechol designates Eunmee Cho, Manager, as the FCOI Institutional Official / Designated Official responsible for soliciting and reviewing Investigator SFI disclosures.

Before expenditure of PHS/NIH funds, the FCOI Institutional Official / Designated Official will:

  1. Review each Investigator’s SFI disclosure;

  2. Determine whether any disclosed SFI is related to PHS/NIH-funded research;

  3. Determine whether any related SFI constitutes an FCOI; and

  4. If an FCOI exists, develop and implement a written management plan before expenditure of funds.

An SFI is related to PHS/NIH-funded research when the FCOI Institutional Official / Designated Official reasonably determines that the SFI could be affected by the research or is in an entity whose financial interest could be affected by the research.

An FCOI exists when the FCOI Institutional Official / Designated Official reasonably determines that the related SFI could directly and significantly affect the design, conduct, or reporting of the PHS/NIH-funded research.

The FCOI Institutional Official / Designated Official may request additional information from the Investigator and may consult with legal counsel, compliance advisors, board members, scientific advisors, or other appropriate independent reviewers.

If the FCOI Institutional Official / Designated Official has a conflict or is an Investigator on a specific PHS/NIH-funded project, ACatechol will designate an alternate official to perform the review.

 

7. Management of Financial Conflicts of Interest

If ACatechol determines that an FCOI exists, ACatechol will develop and implement a written management plan designed to ensure, to the extent possible, that the design, conduct, and reporting of the research will be free from bias.

A management plan may include, as appropriate:

  1. Public disclosure of the FCOI, including in publications and presentations;

  2. Disclosure of the FCOI to research participants, if human subjects research is involved;

  3. Appointment of an independent monitor;

  4. Modification of the research plan;

  5. Change of personnel or personnel responsibilities;

  6. Disqualification from participation in all or part of the research;

  7. Reduction or elimination of the financial interest; or

  8. Severance of relationships that create the conflict.

The FCOI Institutional Official / Designated Official will monitor Investigator compliance with any management plan on an ongoing basis until completion of the PHS/NIH-funded research project.

 

8. Reporting to NIH

Before expenditure of PHS/NIH funds, ACatechol will submit an FCOI report to NIH through the eRA Commons FCOI Module for any Investigator SFI that ACatechol determines is an FCOI.

For any FCOI identified after the initial review, ACatechol will submit an FCOI report to NIH within sixty days of identification and will implement a management plan on at least an interim basis.

For any previously reported FCOI, ACatechol will submit annual FCOI reports to NIH for the duration of the project period, including any extensions, in the time and manner specified by NIH.

If ACatechol identifies an FCOI that was not disclosed, reviewed, or managed in a timely manner, ACatechol will complete and document a retrospective review within 120 days of determining noncompliance. If bias is found, ACatechol will promptly notify NIH and submit a mitigation report as required.

If no FCOI is identified, no FCOI report will be submitted to NIH, but ACatechol will maintain internal documentation of the disclosure, review, and determination.

 

9. Public Accessibility

ACatechol will make this FCOI Policy publicly available on its website.

Before expenditure of PHS/NIH funds, ACatechol will also ensure public accessibility of information concerning any SFI disclosed by senior/key personnel that meets all of the following criteria:

  1. The SFI was disclosed and is still held by the senior/key personnel;

  2. ACatechol determines that the SFI is related to PHS/NIH-funded research; and

  3. ACatechol determines that the SFI is an FCOI.

Such information will be made available either by posting on a publicly accessible website or by written response to any requestor within five business days of the request.

The information made available will include, at minimum:

  1. Investigator’s name;

  2. Investigator’s title and role with respect to the research project;

  3. Name of the entity in which the SFI is held;

  4. Nature of the SFI; and

  5. Approximate dollar value of the SFI using permitted dollar ranges, or a statement that the value cannot be readily determined.

If ACatechol uses a public website for this information, the information will be updated at least annually and within sixty days of identifying a new FCOI involving senior/key personnel. Information will remain available for at least three years from the date it was most recently updated.

 

10. Subrecipient Compliance

When ACatechol carries out PHS/NIH-funded research through a subrecipient, contractor, collaborator, or consultant, ACatechol will include written FCOI terms in the applicable agreement.

The written agreement will specify whether the subrecipient’s FCOI policy or ACatechol’s FCOI policy applies to subrecipient Investigators.

If the subrecipient’s policy applies, the subrecipient must certify that its policy complies with 42 CFR Part 50 Subpart F and must report identified FCOIs to ACatechol within a timeframe that allows ACatechol to meet NIH reporting deadlines.

If ACatechol’s policy applies, the subrecipient must submit Investigator SFI disclosures to ACatechol within a timeframe that allows ACatechol to review, manage, and report any FCOI as required.

 

11. Record Retention

ACatechol will maintain records relating to all Investigator financial disclosures, ACatechol’s review of and response to such disclosures, and all actions taken under this Policy or any retrospective review for at least three years from the date the final expenditures report is submitted to PHS/NIH, or longer if required by applicable law, regulation, award terms, audit, litigation hold, or other applicable record retention requirement.

 

12. Enforcement and Sanctions

Failure to comply with this Policy may result in corrective or disciplinary action, including additional training, suspension of participation in PHS/NIH-funded research, modification of research responsibilities, termination of consulting or employment arrangements, or other administrative action deemed appropriate by ACatechol.

If an Investigator’s failure to comply with this Policy or an FCOI management plan appears to have biased the design, conduct, or reporting of PHS/NIH-funded research, ACatechol will promptly notify NIH and take corrective action.

 

13. Institutional Certification

By submitting applications for PHS/NIH-funded research, ACatechol certifies that it:

  1. Maintains an up-to-date, written, and enforced administrative process to identify and manage financial conflicts of interest;

  2. Promotes and enforces Investigator compliance with FCOI disclosure requirements;

  3. Manages identified FCOIs and provides initial and ongoing FCOI reports to NIH as required;

  4. Agrees to make information available promptly to HHS/NIH upon request regarding Investigator disclosures and ACatechol’s review and response; and

  5. Will comply with 42 CFR Part 50 Subpart F and applicable NIH Grants Policy requirements.

 

14. Questions

Questions regarding this Policy or Investigator disclosure obligations should be directed to ACatechol’s FCOI Institutional Official / Designated Official:

Eunmee Cho
Manager, ACatechol, Inc.acatecholusa@gmail.com

 

15. Policy Review and Updates

ACatechol will review this Policy periodically and update it as needed to remain consistent with applicable federal regulations, NIH policy requirements, and institutional practices.

Any updated version of this Policy will be posted on ACatechol’s public website and, when required, submitted through the eRA Commons Institution Profile Module.

 

End of Policy