Jillion Therapeutics Inc.

Financial Conflict of Interest (FCOI) Policy

Effective: July 1, 2026

 

Table of contents:

 

1. Introduction

2. Applicability

3. Definitions

4. Significant Financial Interest (SFI) Disclosure Requirements

5. Review of SFI Disclosures

6. Relatedness of SFIs to PHS/NIH-Funded Research and FCOI

7. Management of SFIs that Pose an FCOI

8. Monitoring Investigator Compliance

9. Public Accessibility of the FCOI Policy and FCOIs Held by Senior/Key Personnel

10. Reporting Identified Financial Conflicts of Interest

11. Training Requirements for Investigators

12. Noncompliance With FCOI Policy and Corrective Actions

13. Clinical Research Requirements

14. Subrecipient Requirements

15. Maintenance of Records

16. Enforcement Actions for Investigator Noncompliance

17. Useful FCOI and NIH Resources

18. Point Of Contact

 

 

1. Introduction

The purpose of this policy is to ensure that research funded by the National Institutes of Health (NIH) is designed, conducted, and reported objectively and without bias resulting from Investigator financial conflicts of interest (FCOI). The 2011 revised regulations are 42 CFR Part 50 Subpart F, “Promoting Objectivity in Research” and 45 CFR Part 94, “Responsible Prospective Contractors”, which set requirements for promoting objectivity in Public Health Service (PHS)–funded research for grants, cooperative agreement, and research contracts, respectively. The regulations and this policy do not apply to SBIR or STTR Phase I applications or awards. This policy implements the regulatory requirements for PHS/NIH grants and cooperative agreements. Jillion Therapeutics Inc. adopts this policy for all Investigators (as defined below) engaged in PHS/NIH-funded research. It establishes processes to identify, disclose, and manage Investigator financial conflicts of interest to protect research integrity, ensure the safety of human and animal subjects, and maintain public trust in PHS/NIH supported research.

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2. Applicability

This policy implements the regulatory requirements provided in 42 CFR Part 50 Subpart F for grants and cooperative agreements issued by the NIH. This policy applies to individuals who meet the regulatory definition of “Investigator” (as defined below) who are planning to participate in or who participate in PHS/NIH-funded research.

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3. Definitions

For the purpose of these policies and procedures, the following definitions apply:

Financial Conflict of Interest (FCOI): A significant financial interest that is related to the PHS/NIH- funded research (i.e., the SFI could be affected by the research or the SFI is in an entity whose financial interest could be affected by the research) and could directly and significantly affect the design, conduct, or reporting of PHS-funded research.

Financial Interest: Anything of monetary value, whether or not its value is readily ascertainable.

Institutional Responsibilities: The professional activities or responsibilities an Investigator performs on behalf of Jillion Therapeutics Inc., including research, product development and testing, publication and communication of research, consulting, clinical or regulatory activities, fundraising, and service on advisory panels or review boards.

Designated Official (DO): The individual appointed by Jillion Therapeutics Inc. to solicit and review disclosures of significant financial interests, determine FCOIs in accordance with 42 CFR 50.604(f) and this policy, and develop management plans for identified FCOI.

Institution: Any public or private organization, domestic or foreign (excluding a federal agency) that is applying for or receiving, PHS/NIH research funding.

Investigator: The Project Director (PD) or Principal Investigator (PI), and any other person, regardless of title or position, who is responsible for the design, conduct, or reporting of research funded by PHS/NIH or proposed for such funding, which may include, for example, collaborators or consultants. The institution determines who is responsible for the design, conduct, or reporting of PHS/NIH-funded research. The Institution will consider the individual’s role, rather than the title (e.g., senior/key personnel, faculty, MD, PHD, etc.), of those individuals involved in the research and the degree of independence in carrying out the work when determining who is responsible for the design, conduct, or reporting of the PHS/NIH-funded research.

Manage: means taking action to address a financial conflict of interest, which can include reducing or eliminating the financial conflict of interest, to ensure, to the extent possible, that the design, conduct, and reporting of research will be free from bias.

Research: means a systematic investigation, study, or experiment designed to develop or contribute to generalizable knowledge relating broadly to public health, including behavioral and social-sciences research.

The term encompasses basic and applied research (e.g., a published article, book, or book chapter) and product development (e.g., a diagnostic test or drug). As used in the regulation, the term includes any such activity for which research funding is available from a PHS Awarding Component through a grant, cooperative agreement, whether authorized under the PHS Act or other statutory authority, such as a research grant, career development award, center grant, individual fellowship award, infrastructure award, institutional training grant, program project or research resources award.

PHS-Funded Research: Any activity supported by a Public Health Service (PHS) Awarding Component through a grant, cooperative agreement, or contract, whether funded under the PHS Act or other statutory authority.

PHS: The Public Health Service of the U.S. Department of Health and Human Services, and any components of the PHS to which the authority involved may be delegated, including the National Institutes of Health (NIH).

NIH: The biomedical research agency within the Public Health Service (PHS) that funds and conducts research to improve health and advance scientific knowledge.

Senior/Key Personnel: The PD/PI and any other individual identified as senior/key personnel by the Institution in a grant application, progress report, or any other report submitted to PHS/NIH. For this policy, the term applies specifically to the public accessibility requirement, which mandates disclosure only of financial conflicts of interest held by these senior/key personnel, as described in Section 9.

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Significant Financial Interest (SFI):

1. A domestic or foreign financial interest consisting of one or more of the following interests of the Investigator, and those of the Investigator’s spouse, domestic partner, and dependent children, that reasonably appears to be related to the Investigator’s Institutional responsibilities performed on behalf of Jillion Therapeutics Inc., and that consists of one or more of the following:

• Publicly traded entity: An SFI exists if the total of remuneration received from the entity in the previous 12 months and the value of any equity interest in the entity on the disclosure date exceeds $5,000. Remuneration includes salary and payments for services (e.g., consulting fees, honoraria, paid authorship). Equity interest includes stock, stock options, or other ownership interests measured by public prices or other reasonable market value.

• Non-publicly traded entity: An SFI exists if the aggregated value of remuneration received from the entity in the 12 months preceding the disclosure exceeds $5,000, or if the Investigator (or their spouse or dependent children) holds any equity interest in the entity (e.g., stock, stock options, or other ownership interest).

• Intellectual property: An SFI exists if receipt of income related to intellectual property rights or interests (e.g., patents, copyrights), exceeds $5,000 during the 12 months preceding the disclosure, related to such rights and interests. 

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  2. Investigators must disclose the occurrence of any reimbursed or sponsored travel related to their institutional responsibilities with a value exceeding $5,000. Such travel includes trips paid on behalf of the Investigator rather than reimbursed directly, where the exact monetary value may not be readily available to the Investigator. The initial disclosure must cover the previous 12 months and include, at minimum, the purpose, sponsor or organizer, destination, and duration of each trip. 

The disclosure requirement does not apply to travel that is reimbursed or sponsored by the following: 

• a federal, state, or local government agency located in the United States,

• a United States Institution of Higher Education,

• an academic teaching hospital,

• a medical center, or

• a research institute affiliated with a United States Institution of Higher Education.

 

  3. The term “significant financial interest” does not include, and therefore investigators are not required to disclose, the following types of financial interests:

• Salary, royalties, or other remuneration paid by Jillion Therapeutics Inc. to the Investigator if the Investigator is currently employed or otherwise appointed by Jillion Therapeutics Inc., including intellectual property rights assigned to Jillion Therapeutics Inc. and any agreements to share royalties related to those rights.

• Any ownership interest in Jillion Therapeutics Inc. held by the Investigator, since Jillion Therapeutics Inc. is a commercial or for-profit organization. This exclusion applies only if the applicant or recipient (including a sub-recipient) is a for-profit or commercial institution.

• Income from investment vehicles such as mutual funds and retirement accounts, provided the Investigator does not directly control the investment decisions for those vehicles.

• Income from seminars, lectures, or teaching engagements sponsored by a US. 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.

• Income from service on advisory committees or review panels for 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.

 

Foreign Financial Interests: Investigators must disclose all financial interests originating outside the United States, including income from seminars, lectures, teaching engagements, service on advisory committees or review panels, and reimbursed or sponsored travel, received from any foreign entity. This includes foreign institutions of higher education and foreign governments (including local or provincial governments). Disclosure is required when the aggregated amount of such income meets the threshold for disclosure (e.g., income in excess of $5,000).

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4. Significant Financial Interest (SFI) Disclosure Requirements

Investigators will disclose their SFIs that are related to their “institutional responsibilities” as defined in the policy.

The disclosure will not be limited to an Investigator’s research responsibilities or their funded research as this is too narrow in scope and not consistent with the 2011 regulation.

The Investigator SFI Disclosures will be retained by the Institution as part of the record maintenance requirements.

 

Investigators are required to disclose SFIs at the following times:

1. At the time of application: The PI and all other individuals who meet the definition of “Investigator” must disclose their SFIs to the DO(s). Any new Investigator who joins the project after the NIH application has been submitted or during the course of the research must also disclose their SFI(s) to the DO(s) promptly and before participating in the project, using the SFI Disclosure Form.

2. Annual disclosure: Each Investigator participating in research under an NIH award must submit an updated SFI disclosure at least annually as prescribed by Jillion Therapeutics Inc.  (on or before July 1st) during the award period. The annual disclosure must include:

   • any new information that was not previously disclosed to the DO under this policy, including SFIs associated with NIH-funded projects transferred from another institution.

   • updated details for any previously disclosed SFI, such as changes in the value of an equity interest.

3. Ad hoc basis during the award: Each Investigator participating in PHS/NIH-funded research must submit an updated SFI disclosure within 30 days of discovering or acquiring a new SFI (e.g., through purchase, marriage, or inheritance). Updated disclosure of reimbursed or sponsored travel must also be submitted within 30 days of each occurrence.

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5. Review of SFI Disclosures

The CEO serves as the Designated Official (DO) responsible for reviewing all SFI disclosures. Each SFI will be evaluated in relation to every PHS/NIH research application or award on which the Investigator is responsible for the design, conduct, or reporting of research, to determine whether the SFI is related to the funded research and, if so, whether it constitutes a Financial Conflict of Interest (FCOI).

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The SFI disclosures will be reviewed as described below:

1. Prior to the issuance of a new award or before any expenditure of any awarded funds (e.g., during Just-in-Time stage): The DO will review the Investigator’s SFIs before NIH issues a new award. If an FCOI is identified, an FCOI report will be submitted to NIH via the eRA Commons FCOI Module prior to any expenditure of funds.

2. Annual SFI disclosure: As part of the annual disclosure process, Investigators must provide updated information on any previously disclosed SFIs (e.g., revised value of an equity interest). The DO will review these updates to determine whether changes to an existing management plan are needed. Any modifications will be reflected in the next Annual FCOI report submitted to NIH, if applicable.

3. Ad hoc basis during award period: If a new Investigator joins a project or an existing Investigator acquires or discovers a new SFI during the project, the DO will, within 60 days:

   • review the disclosure;

   • determine whether the SFI is related to the PHS/NIH-funded research;

   • determine whether an FCOI exists; and, if so,

   • implement, on at least an interim basis, a management plan.

    An FCOI report will be submitted to NIH within 60 days of identifying the FCOI.

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6. Relatedness of SFIs to PHS/NIH-Funded Research and FCOI

The DO is responsible for assessing the relatedness of SFIs to NIH-funded research and determining when they constitute a FCOI.

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Relatedness Test: The DO determines whether an Investigator’s SFI is related to research under an NIH award. An SFI is considered “related” when the DO reasonably determines that:

• The SFI could be affected by the PHS/NIH-funded research, or

• The SFI is in an entity whose financial interests could be affected by the PHS/NIH funded research.

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INVESTIGATOR INVOLVEMENT: The DO may consult with the Investigator when assessing whether an SFI is related to the research.

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Designated Official FCOI Determination: An FCOI exists when the DO reasonably determines that the SFI could directly and significantly affect the design, conduct, or reporting of the PHS/NIH- funded research (“significantly” meaning that the financial interest would have a material effect on the research)

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7. Management of SFIs that Pose an FCOI

When an FCOI is identified, the DO will determine and implement management strategies to ensure the research is conducted objectively. Examples of management conditions include, but are not limited to:

1. Public disclosure of the FCOI (e.g., in publications or presentations, to study personnel, to the IRB, IACUC, or Data Safety Monitoring Board).

2. For human subjects research, disclosure of the FCOI to participants in the informed consent document

3. Appointment of an independent monitor to protect against bias in the design, conduct, and reporting of the research

4. Modification of the research plan

5. Change of personnel roles or removal from portions of the research

6. Reduction or elimination of the financial interest (e.g., divesting equity)

7. Severance of relationships that create financial conflicts

The DO will communicate the determination and the management plan in writing to the Investigator, the PD/PI, and the appropriate supervisor, as appropriate.

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No expenditures on an NIH award may occur until the Investigator has met all disclosure requirements and agreed in writing to comply with the management plan. The DO will submit an FCOI report to NIH via the eRA Commons FCOI Module.

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8. Monitoring Investigator Compliance

Jillion Therapeutics Inc. and its DO will monitor Investigator compliance with the management plan for the duration of the NIH award.

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As part of this monitoring process, the DO may request and review documentation demonstrating compliance with required FCOI disclosures, including publications, presentation materials, abstracts, posters, and written communications to study personnel. Investigators must provide copies of such materials, including relevant emails or other written disclosures, to the DO for recordkeeping. These records will be maintained to document compliance with the management plan and to support institutional review and audit activities.

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9. Public Accessibility of the FCOI Policy and FCOIs Held by Senior/Key Personnel

FCOI Policy: A copy of this FCOI policy is available on Jillion Therapeutics Inc.’s public website (www.JillionTherapeutics.com), as required by Section 4.1.10 Financial Conflict of Interest of the NIH Grants Policy Statement.

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Identified FCOIs held by Senior/Key Personnel: Before any funds are spent under an NIH award, Jillion Therapeutics Inc. will ensure public accessibility, by providing a written response within five (5) business days to requests for information about any SFI that meets all three of the following criteria:

• The SFI was disclosed, is still held by Senior/Key Personnel (the PD/PI and any other individual identified by Jillion Therapeutics Inc. as senior/key personnel in the application, progress report, or other NIH submission).

• Jillion Therapeutics Inc. has determined that the SFI is related to the NIH-funded

• Jillion Therapeutics Inc. has determined that the SFI constitutes an FCOI

When applicable, Jillion Therapeutics Inc. will make available at least the following information:

• Investigator’s name

• Investigator’s title and role with respect to the research project

• Name of the entity in which the SFI is held

• Nature of the SFI

• Approximate dollar value of the SFI in the following ranges: $0–$4,999; $5,000–$9,999; $10,000–$19,999; amounts between $20,000 and $100,000 by increments of $20,000; amounts above $100,000 by increments of $50,000; or a statement that the value cannot be readily determined by public prices or reasonable fair market value measures

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The written response will note that the information provided is current as of the date of the correspondence and is subject to updates on at least an annual basis and within 60 days of the institution’s identification of a new FCOI, which should be requested subsequently by the requestor.

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If Jillion Therapeutics Inc. uses a publicly accessible website to meet this requirement, the information will be updated at least annually and within 60 days of:

• Receiving or identifying an additional SFI of Senior/Key Personnel related to the NIH-funded research that was not previously disclosed, or

• A new SFI being disclosed by Senior/Key Personnel joining the project and determined by the DO to be related and an FCOI.

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Information on SFIs subject to public accessibility will remain available for at least three years from the most recent update.

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10. Reporting Identified Financial Conflicts of Interest

Prior to spending any funds under an NIH-funded award, Jillion Therapeutics Inc. will submit an identified FCOI report to NIH, in accordance with NIH regulations, for any Investigator’s SFI determined to be an FCOI. Jillion Therapeutics Inc. will also ensure that the Investigator has agreed to and begun implementing the associated management plan.

Jillion Therapeutics Inc. will designate an institutional official to act as the FCOI Signing Official (FCOI SO) in the eRA Commons FCOI Module. The FCOI SO is authorized to submit FCOI reports to NIH. FCOI reports are submitted only when an award is active and an FCOI has been identified (i.e., no award means no FCOI report, and no FCOI means no FCOI report).

The NIH eRA Commons FCOI Module User Guide, available at the following location, provides instructions for preparing and submitting FCOI reports.

https://www.era.nih.gov/files/fcoi_user_guide.pdf

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The institution will submit the following types of reports as explained below:

1. Initial (Original) FCOI Reports: The report must include all information required under 42 CFR 50.605(b)(3) or as outlined in the NIH FAQH.5 (https://grants.nih.gov/faqs#/financial-conflict-of-htm?anchor=52888). The Original Report will be submitted at the following times:

   • Prior to the expenditure of funds: If an FCOI is identified at the time a new NIH award is issued, the FCOI SO will submit an “Original” FCOI report (2011 FCOI) through the eRA Commons FCOI Module before any funds are spent.

   • Within 60 days during the award: If an FCOI is identified during the award period (e.g., a new SFI is disclosed or a new Investigator joins the project), the Institution must submit an Original FCOI report within 60 days of identifying the FCOI.

2. Annual FCOI Reports: For the duration of an award, including any extensions with or without funds, the Institution must submit an annual FCOI report to NIH. This report will indicate whether each previously reported FCOI is still being managed or no longer exists and describe any changes to the management plan, if applicable.

   • The annual report must be submitted at the same time as the Research Performance Progress Report (RPPR) or multi-year progress report, and at the time of any grant extension, following NIH guidance (see NIH’s FAQ H.2) (https://grants.nih.gov/faqs#/financial-conflict-of-htm?anchor=52885). NIH creates the opportunity for the FCOI SO to submit the Annual report 75 days prior to the next budget period start date for continuation awards. NIH will notify the Institution by email when an annual report is due.

   • Annual FCOI reports are not required at grant closeout.

3. Revision (or Mitigation) FCOI Reports: After completing a retrospective review, the Institution will submit a Revision report to NIH if new information about the FCOI is discovered, or a Mitigation report if the review finds that bias has occurred.

 

Types of FCOI Reports Summary Chart for NIH:

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