ChrononAI, LLC Financial Conflict of Interest (FCOI) Policy

1. Introduction

Chronon AI, LLC ("CAI", "The Institution") is committed to maintaining integrity, transparency, and objectivity in all research activities. CAI’s financial conflict of interest (FCOI) policy is to ensure that research funded by the National Institutes of Health (NIH) and carried out by CAI is designed, conducted, and reported free from bias resulting from Investigator financial conflicts of interest.

This policy provides a framework to comply with the regulatory requirements for applicant and recipient institutions seeking Public Health Service (PHS) awards, including NIH SBIR and STTR grants, as set forth in 42 CFR Part 50 Subpart F “Promoting Objectivity in Research” and 45 CFR Part 94 “Responsible Prospective Contractors”.

2. Applicability

This policy applies to:

All Investigators participating in NIH-funded research conducted by or on behalf of CAI. This includes employees, subcontractors, consultants, or collaborators on NIH-funded projects.
All NIH SBIR/STTR awards and related extensions.
All phases of research, development, and commercialization supported by NIH funds.

3. Definitions

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

3.0 Institution

Any domestic public or private organization that is applying for or receives PHS research funding.

3.1 Investigator

The Project Director (PD), Principal Investigator (PI), or any other individual, regardless of title or position, who is responsible for the design, conduct, or reporting of NIH-funded research performed by or on behalf of CAI.

3.2 Institutional Responsibilities

Professional activities performed on behalf of CAI, including but not limited to research and development, consultation, intellectual property development, management or advisory roles, product development and testing, development of datasets and models, publication and communication of research results, commercialization activities, and other professional services performed on behalf of ChrononAI in relation to the NIH-funded research.

3.3 Financial Interest

Anything of monetary value, whether or not the value is readily ascertainable.

3.4 Significant Financial Interest (SFI)

A SFI is a financial interest that consists of one or more of the following interests held by the Investigator (and those of the Investigator’s spouse or dependent children) and reasonably appears related to an Investigator’s institutional responsibilities:

Publicly Traded Entities
- A SFI exists if the total 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-Publicy Traded Entities
- A SFI exists if the Investigator holds any equity interest in the entity, regardless of value, or if the remuneration received from the entity in the 12 months preceding the disclosure exceeds $5,000.
- Equity interest includes stock, stock options, or other ownership interests measured by public prices or other reasonable market value.
Intellectual Property
- A SFI exists if the income received from patents, copyrights, licenses, or royalties with a value exceeds $5,000 during the 12 months preceding the disclosure.
Reimbursed or Sponsored Travel
- Any reimbursed or sponsored travel related to the Investigator's institutional responsibilities, including trips paid on behalf of the Investigator rather than reimbursed directly, with a value exceeding $5000 during the 12 months preceding the disclosure.
- The disclosure will include at a minimum the purpose of the trip, identity of the sponsor/organizor, destination, and duration.
Foreign Financial Interests
- All financial interests received from any foreign entity, including foreign institutions of higher education or a foreign government (local, provincial, or equivalent government of another country) whose aggregate amount exceeds $5,000.
- Such interests include income from seminars, lectures, teaching engagements, income from service on advisory committees or review panels, and reimbursed or sponsored travel.

3.5 Exclusions

The following are not considered significant financial interest, and therefore Investigators are not required to disclose the following types of financial interests:

Salary, royalties, or other remuneration paid by CAI to the Investigator if the Investigator is currently employed or appointed by CAI. This includes intellectual property rights assigned by CAI and agreements to share in royalties related to such rights.
Any ownership interests in the CAI held by the Investigator, given the applicant or recipient (including sub-receipient) is a commercial or for-profit organization.
Income from service on advisory committees or review panels for a federal, state, or local government agency located in the U.S., a U.S. Institution of higher education, an academic teaching hospital, medical center, or research institute that is affiliated with a U.S. Institution of higher education.
Income from seminars, lectures, or teaching engagements sponsored by a federal, state, or local government agency located in the U.S., a U.S. Institution of higher education, an academic teaching hospital, medical center, or research institute that is affiliated with a U.S. Institution of higher education.
Income from investment vehicles, such as mutual funds or retirement accounts, where the Investigator does not control the investment decisions made in these accounts.
Travel reimbursed or sponsored by a federal, state, or local government agency located in the U.S., a U.S. Institution of higher education, an academic teaching hospital, medical center, or research institute that is affiliated with a U.S. Institution of higher education.

3.6 Financial Conflict of Interest (FCOI)

Exists when an investigator’s significant financial interest (SFI) is related to PHS-funded research and can directly affect the design, conduct, or reporting of the research.

3.7 Public Health Service (PHS)

A collection of agencies of the U.S. Department of Health and Human Services and includes the National Institutes of Health (NIH).

3.8 National Institutes of Health (NIH)

The primary biomedical and public health research agency of the PHS.

3.9 Designated Official (DO)

The official appointed by CAI responsible for managing the FCOI process, including reviewing SFI disclosures, determining FCOI, and developing management plans for identified FCOIs.

3.10 Signing Official (SO)

The official who has the authority to legally bind CAI in grant administration matters by providing signature approval. The SO is responsible for assigning the FCOI, FCOI_ASST, and FCOI_VIEW roles using the Account Management System in eRA Commons. The individual in the FCOI role would be able to initiate, edit, submit, revise, view, and delete records and documents concerning FCOI. The FCOI_ASST role will assist the FCOI role in everything but submission while the FCOI_VIEW role will have read-only access to FCOI report data.

3.11 Subrecipient

Subcontractor or consortium participant who may indirectly receive grant funding through CAI, who holds the prime contract with the PHS agency, for carrying out a portion of a PHS-funded research project.

3.12 Senior/Key Personnel

The PD, PI, and any other individual identified as senior/key personnel by CAI in a grant application, progress report, or other submission to NIH. For this policy, the term applies specifically to the public accessibility requirement which requires disclosure only of FCOIs held by senior/key personnel.

3.13 Manage

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.

3.14 Research

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.

4. Significant Financial Interests (SFI) Disclosure Requirements

Investigators are required to disclose all significant financial interests as defined in the policy. The disclosure will not be limited to an Investigator's research responsibilities or their NIH-funded research as this is too narrow a scope.

Investigators are required to disclose SFIs at the following intervals:

4.1 Initial Disclosure

Investigators must disclose all SFIs to the DO prior to proposal submission and expenditure of NIH funds. Any new Investigator who joins the project after the proposal submission or during the course of the research must also disclose SFIs to the DO before participating in the project. Investigators will submit the SFIs using the SFI Disclosure Form.

4.2 Annual Disclosure

Investigators must submit an updated SFI disclosure at least once every 12 months (on or before April 1) during the award period, even if no changes have occurred. The annual disclosure must include (1) any new information not previously disclosed to the DO under this policy and (2) updated details for any previously disclosed SFI.

4.3 Ad Hoc Disclosure

Investigators must disclose new or acquired SFIs within 30 days of discovery or acquisition. Updated disclosure of reimbursed or sponsored travel must be submitted within 30 days of each occurrence.

Disclosures must include interests held by the Investigator’s spouse and dependent children. Disclosures will be retained by the Institution as part of the record maintenance requirements.

5. SFI Disclosure Review Process

5.1 Designated Official Responsibilities

The Designated Official (DO) will evaluate all SFI disclosures in relation to each PHS proposal or award to determine if the SFI is related to the funded research and if so, whether it constitutes a financial conflict of interest. In cases where the DO has a disclosed SFI related to the research under review, or where additional independence is warranted, the DO will recuse themselves from the review and determination. In such cases, an alternate qualified designee or external advisor may be appointed to perform the review. The use of such alternative review arrangements will be documented.

The SFI disclosures will be reviewed as follows:

Initial Disclosure: The DO will review the Investigator’s SFIs before issuance of a new NIH award or before expenditure of any awarded funds (e.g., during Just-inTime stage). If a FCOI is identified, a FCOI report will be submitted to NIH through the eRA Commons FCOI module prior to any expenditure of funds.
Annual Disclosure: Investigators must provide updated information to any previously disclosed SFIs. The DO will review the updated SFI disclosures to determine whether changes to an existing management plan are needed. Modifications will be reflected in the next annual FCOI report, if applicable.
Ad Hoc Disclosure: Within 60 days of a new Investigator joining a NIH-funded project or an existing Investigator acquires or discovers a new SFI during the project, the DO will, within 60 days:
1. review the disclosure
2. determine if the SFI is related to the NIH-funded research
3. determine if a FCOI exists, and if so,
4. implement a management plan
5. submit a FCOI report to NIH within 60 days of identifying the FCOI

5.2 Determination of Relatedness

The DO is responsible for assessing the relatedness of SFIs to NIH-funded research and

determining when they constitute a FCOI. The DO may consult with the Investigator when assessing whether an SFI is related to the research.

Relatedness Test: A SFI is considered “related” when the DO reasonably determines that:

1) The SFI could be affected by the NIH-funded research, OR

2) The SFI is an entity whose financial interests could be affected by the NIH-funded

research

5.3 Determination of FCOI

A FCOI exists when the DO reasonably determines that the SFI could directly and significantly affect the design, conduct, or reporting of the NIH-funded research, where "significantly” means that the financial interest would have a material effect on the research.

6. Management of FCOIs

6.1 Management Plan

When a FCOI is identified, the DO will develop and implement a written management plan to ensure the NIH-funded research is conducted objectively. A management plan may include but are not limited to:

Public disclosure of the FCOI (e.g., publications, presentations, to study personnel). While public posting of FCOIs is required only for senior/key personnel, the DO may require disclosure of any Investigator’s FCOIs as a condition of the management plan.
Disclosure of the FCOI in the informed consent document to participants in a human subjects research.
Appointment of an independent monitor to protect against bias in the design, conduct, and reporting of the research.
Modification of the research plan.
Change of personnel roles or restriction of the Investigator’s role
Reduction or elimination of the financial interest (e.g., divesting equity)
Severance of conflicting relationships

The DO will communicate the determination of the FCOI and the management plan in writing to the Investigator, the PI/PD, and the appropriate supervisor. The DO will submit a FCOI report to NIH via the eRA Commons FCOI Module.

6.2 Monitoring Investigator Compliance

CAI will monitor Investigator compliance with the management plan for the duration of the NIH award or until the FCOI no longer exists. Monitoring includes verifying required public disclosures of the FCOI are made with copies of the disclosures sent to the DO for record keeping.

7. Reporting Identified FCOIs

CAI will submit a FCOI report to NIH for any Investigator's SFIs determined to be a FCOI. In addition, CAI will designate an institutional official who will act as the FCOI Signing Official (SO) in the eRA Commons FCOI Module. The FCOI SO will be authorized to submit FCOI reports to NIH. FCOI reports are submitted only when an award is active and an FCOI has been identified.

The NIH ERA Commons FCOI Module User Guide provides information on how to prepare and submit FCOI reports: https://www.era.nih.gov/files/fcoi_user_guide.pdf

7.1 Original FCOI Reports

An Original FCOI report will be submitted through the eRA Commons FCOI module at the time when:

A new NIH award is issued and before any funds are spent. The report will include all information required under 42 CFR 50.605(b)(3) and as outlined in NIH’s grant FAQ H.5.
Within 60 days of identifying a FCOI newly disclosed for an existing Investigator or for an Investigator newly participating in the project during the award period.

7.2 Annual FCOI Reports

CAI must submit an Annual FCOI report for the duration of the award, including any extensions with or without funds. The report will indicate if each previously reported FCOI is still being managed or no longer exists, and describe any changes to the management plan if applicable. The annual FCOI report must be submitted to the NIH at the same time when the annual progress report is required, including multi-year funded progress reports, or at the time of a project extension with or without funds. Note that the annual FCOI report is to be submitted separately from the progress report and is not a grant closeout requirement.

7.3 Revised FCOI Reports

A Revised FCOI report is only required following the completion of a Retrospective Review and when CAI needs to provide:

New FCOI information that results in a change to the previously submitted FCOI report (e.g., increase in value of a previously reported SFI, discovery of a new SFI, and changes to the management plan), or
A Mitigation report if bias is found after completing the Retrospective Review

7.4 Mitigation Reports

CAI will submit a Mitigation report if Investigator bias is found following completion of the Retrospective Review. The Mitigation report will include key elements documented in the Retrospective Review, a description of the impact of the bias on the research, and CAI’s plan of action to eliminate or mitigate the effect of the bias.

Table of Required FCOI Reports to NIH

Report

Content

Required When

New FCOI report (initial submission)

Grant number, PI, name of entity with FCOI, value of the financial interest (in required increments), description of how the financial interest relates to the research, key elements of the management plan

Prior to expenditure of funds on a new award; within 60 days of identifying any new FCOI during the award period

Annual FCOI report

Status of the FCOI (whether it no longer exists or is still being managed), any changes to the management plan

Submitted annually at the same time as the annual progress report, multi-year progress report, or at the time of a grant extension

Revised FCOI report

If applicable, updates to a previously submitted FCOI report to describe actions that will be taken to manage the FCOI going forward or to revise the original report

After a retrospective review if noncompliance with the regulation is found

Mitigation report

Project number, project title, contact info of PI/PD, name of Investigator with FCOI, name of entity with FCOI, reason for review; detailed methodology, findings, and conclusions

After a retrospective review if bias is found

8. Training Requirements

All Investigators will be informed of CAI’s FCOI policy and must complete NIH-compliant FCOI training:

Prior to engaging in NIH-funded research
At least once every four years
Upon FCOI policy revision that affects Investigator requirements
When an Investigator is new to CAI
If CAI determines the Investigator has not complied with the FCOI policy or with a management plan issued under it

To meet NIH training requirements, Investigators must read and affirm their understanding of CAI’s FCOI policy and complete the NIH FCOI Training Module. The Investigator will retain the completion certificate and will send a copy via email to the DO for audit purposes.

9. Noncompliance with FCOI Policy

If CAI identifies a SFI that was not disclosed, reviewed, or managed in a timely manner, the DO will within 60 days review the SFI, determine whether it constitutes an FCOI, and if so, implement a management plan. CAI will also submit a FCOI report to NIH.

In cases of noncompliance, including:

Failure to disclose a SFI that is later determined to constitute a FCOI
Failure by CAI to review or manage the FCOI
Failure by the Investigator to comply with the established management plan

CAI will, within 120 days of identifying noncompliance:

Conduct a retrospective review of the Investigator’s activities to determine whether the research conducted during the period of non-compliance was biased in its design, conduct, or reporting.
Document the retrospective review in accordance with 42 CFR 50.605(a)(3)(ii)(B) and as outlined in NIH’s grant FAQ I.2.

If Investigator bias is found, CAI will promptly notify the NIH and submit a mitigation report, that includes key elements as outlined in NIH’s grant FAQ I.3, to the eRA Commons FCOI Module. The report will include:

The impact of the bias on the research project, and
The plan of action or corrective steps taken to eliminate or mitigate the effect of the bias

Upon submitting the mitigation report, CAI will thereafter submit FCOI reports annually. If the FCOI was previously reported, the mitigation report is submitted as a Revised FCOI report.

If no bias is found following the retrospective review, no further action is required. If applicable,

the Institution will update an existing FCOI report to specify the actions that have been, and

will be, taken to manage the FCOI going forward or update a previously submitted report

information (e.g., increase in value of the SFI or add any newly identified SFIs) following the

completion of the retrospective review.

10. Actions for Noncompliance

Compliance with CAI’s FCOI policy is a condition of employment and/or participation in NIH-funded research for all applicable Investigators. Investigators who fail to comply may be subject to disciplinary action, including but not limited to:

Restriction on research activities
Suspension from NIH-funded research
Disciplinary action up to and including termination
Notification to NIH

10. Clinical Research Requirements

If the Department of Health and Human Services (HHS) determines that a PHS-funded project of clinical research 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 a FCOI that was not managed or reported by CAI, then CAI must require the Investigator(s) involved to disclose the FCOI in each public presentation of the research results and to request an addendum to previously published presentations.

11. Subrecipient Requirements

CAI will take reasonable steps to ensure that all subrecipient Investigators comply with NIH’s FCOI regulations. CAI will include in each written agreement with a subrecipient terms specifying whether CAI’s FCOI policy or the subrecipient’s FCOI policy will apply to the subrecipient Investigators.

When the subrecipient’s FCOI policy applies: The subrecipient institution must certify in the agreement that its policy complies with federal FCOI regulations. The agreement will specify the timeframe for the subrecipient to report identified FCOIs to CAI in time for NIH reporting deadlines, i.e., before funds are spent and within 60 days of the subrecipient identifying an FCOI. CAI will then submit the subrecipient FCOI report to NIH through the eRA Commons FCOI Module.
If CAI’s FCOI policy applies or the subrecipient cannot certify compliance: The agreement will specify that CAI’s FCOI policy applies. The subrecipient Investigators must disclose their SFIs that are directly related to the subrecipient’s work for CAI. The agreement will allow sufficient time for CAI to review, manage, and report any FCOIs. When a FCOI is identified, CAI will implement a management plan, monitor compliance by the subrecipient investigator, and submit the FCOI report to NIH.

12. Public Accessibility

12.1 FCOI Policy

CAI will make a copy of this FCOI policy available on CAI’s public website: www.chrononai.com/fcoi.

12.2 Identified FCOIs Held by Senior/Key Personnel

CAI will ensure public accessibility, either by posting on CAI’s publicly accessible website or providing a written response within five business days of such a request, for information about SFI that meets the following criteria:

The SFI was disclosed and is still held by senior/key personnel.
CAI has determined the SFI is related to the NIH-funded research
CAI has determined that the SFI constitutes a FCOI

When applicable, CAI will make available at least the following information:

Investigator’s name, title, and role with respect to the NIH-funded 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

The written response will provide information that is current as of the date of the correspondence and is subject to updates at least on an annual basis and within 60 days of CAI’s identification of a new FCOI.

If CAI uses a publicly available website to meet public accessibility requirements, the information will be updated at least annually and within 60 days of:

Receiving or identifying a senior/key personnel’s SFI that was not previously disclosed and determined to be a FCOI.
A SFI disclosed by a senior/key personnel newly joining the NIH-funded project and determined to be a FCOI.

Additionally, information on the FCOI will remain available on the website for at least three years from the most recent update.

13. Record Retention

CAI will maintain all FCOI-related records, including Investigator disclosures, CAI’s review and response to the disclosures, and any actions taken under this policy or retrospective review, for at least three years from the date of submission of the final expenditures report, or from other dates specified in 45 C.F.R. 75.361, and outlined in NIH’s grant FAQ A.11, for different situations.

14. Useful FCOI and NIH Resources

NIH e-mail address for FCOI-related inquiries: fcoicompliance@mail.nih.gov
FCOI Regulation 42 CFR Part 50 Subpart F - Promoting Objectivity in Research
Financial Conflict of Interest · FCOI Training

15. Policy Administration

If you have any questions regarding CAI’s FCOI policy or would like to disclose a financial interest, please contact us at info@chrononai.com.

Effective Date: May 10, 2026