POLICY

Financial Conflict of Interest (FCOI) Policy

Autonomous Healthcare Inc. · Established September 22, 2023 · Last revised July 6, 2026

Purpose

This Policy has been established on September 22, 2023, and was last revised on July 6, 2026, to comply with the requirements of 42 CFR Part 50 Subpart F federal regulations on the Responsibility of Applicants for Promoting Objectivity in Research for which PHS Funding is Sought and Responsible Prospective Contractors, commonly known as the Financial Conflict of Interest regulations (the “Regulations”). Autonomous Healthcare (“Institution”) shall update this Policy periodically as needed to comply with changes in the Regulations.

Applicability

Except for Phase I SBIR and Phase I STTR grants (“Exempted Research”), this Policy applies to all Investigators and Subrecipients who participate in research funded by grants, contracts, and cooperative agreements with the Public Health Service (PHS), including the National Institutes of Health (NIH), and other research funded by a government contract that incorporates the Regulations in its terms (collectively, “PHS-funded research”). PHS-funded research specifically excludes Phase I SBIR and Phase I STTR grants/contracts.

The term “Investigator” is defined as 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-funded research, or proposed for such funding, which may include, for example, collaborators or consultants.

The term “Subrecipient” means a grant subrecipient, subcontractor, or other person or entity who has responsibility for the design, conduct, or reporting of research proposed for funding, or actually funded, under PHS-funded research. Unless special circumstances apply, vendors of supplies and equipment to Autonomous Healthcare and vendors who provide routine testing services to Autonomous Healthcare without any significant knowledge of the PHS-funded research are not Subrecipients.

Investigator Disclosure Requirements

Investigators who are planning to participate in, or are participating in, PHS-funded research are required to disclose to the designated official(s) of Autonomous Healthcare (“Official(s)”) a listing of Significant Financial Interests (and those of his/her spouse and dependent children) that reasonably appear to be related to the Investigator’s institutional responsibilities.

  1. Investigators who are planning to participate in PHS-funded research must disclose their SFIs over the previous twelve-month period to their Institution no later than at the time of application for PHS-funded research.
  2. Each Investigator who is participating in PHS-funded research must submit an updated disclosure of SFIs at least annually, in accordance with the specific time period prescribed by Autonomous Healthcare, during the period of award.
  3. Each Investigator who is participating in the PHS-funded research must submit an updated disclosure of SFIs within 30 days of discovering or acquiring a new SFI (such as through marriage, inheritance, or purchase).

Autonomous Healthcare Designated Official(s)

Autonomous Healthcare will appoint a designated official(s) (“Official(s)”), who will be responsible to solicit and review disclosures of SFIs of the Investigator (and those of the Investigator’s spouse and dependent children) related to an Investigator’s institutional responsibilities. Official(s) determines whether an Investigator’s significant financial interest is related to PHS-funded research and, if so related, whether the significant financial interest is a financial conflict of interest.

A financial conflict of interest (FCOI) exists when the institution’s Official(s) reasonably determines that an Investigator’s SFI could directly and significantly affect the design, conduct, or reporting of the PHS-funded research. Autonomous Healthcare is required to review each Investigator SFI disclosure to determine if a SFI:

  1. is related to the PHS-funded research (i.e., could the SFI be affected by the research or is the SFI in an entity whose financial interest could be affected by the research); and
  2. could directly and significantly affect the design, conduct, or reporting of the PHS-funded research.

Autonomous Healthcare may involve the Investigator in the designated official(s)’s determination of whether a significant financial interest is related to the PHS-funded research.

Conflict Management and Disclosure

If a FCOI exists, then the Official(s) shall take the following actions prior to any expenditure of funds under the PHS-funded research to which the FCOI relates or, if the PHS-funded research is in progress and the FCOI is newly disclosed, then not later than 60 days after the FCOI is disclosed:

  1. Develop, implement, and administer a management plan that specifies the actions that have been taken, and shall be taken, to manage the FCOI during the period of the PHS-funded research. The Regulations provide the following non-limiting examples of conditions or restrictions that might be imposed by the Official(s) to manage a FCOI:
    1. public disclosure of the FCOI (e.g., when presenting or publishing the research);
    2. for research projects involving human subjects research, disclosure of the FCOI directly to participants;
    3. appointment of an independent monitor capable of taking measures to protect the design, conduct, and reporting of the research against bias resulting from the FCOI;
    4. modification of the research plan; or
    5. change of personnel or personnel responsibilities, or disqualification of personnel from participation in all or a portion of the research.
  2. Ensure public accessibility of information concerning any FCOI involving a significant financial interest that was disclosed and is still held by senior/key personnel (i.e., the PD/PI and any other person identified as senior/key personnel by Autonomous Healthcare in the grant application, progress report, or any other report submitted to the PHS) by providing a written response to any requestor within five business days of a request, as permitted by 42 CFR 50.605(a)(5). The written response shall include the following information: the Investigator’s name; the Investigator’s title and role with respect to the research project; the name of the entity in which the significant financial interest is held; the nature of the significant financial interest; and the approximate dollar value of the significant financial interest (dollar ranges are permissible: $0–$4,999; $5,000–$9,999; $10,000–$19,999; amounts between $20,000–$100,000 by increments of $20,000; amounts above $100,000 by increments of $50,000), or a statement that the interest is one whose value cannot be readily determined through reference to public prices or other reasonable measures of fair market value. The written response shall 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 Autonomous Healthcare’s identification of a new FCOI, which should be requested subsequently by the requestor. This information shall remain available for responses to written requests for at least three years from the date the information was most recently updated.
  3. Provide to the appropriate PHS agency a report regarding the FCOI. The report shall include sufficient information to enable the PHS agency to understand the nature and extent of the financial conflict, and to assess the appropriateness of the management plan. Elements of the FCOI report shall include, but are not necessarily limited to the following:
    1. project number;
    2. PD/PI or Contact PD/PI if a multiple PD/PI model is used;
    3. name of the Investigator with the FCOI;
    4. name of the entity with which the Investigator has a FCOI;
    5. nature of the financial interest (e.g., equity, consulting fee, travel reimbursement, honorarium);
    6. value of the financial interest (dollar ranges are permissible: $0–$4,999; $5,000–$9,999; $10,000–$19,999; amounts between $20,000–$100,000 by increments of $20,000; amounts above $100,000 by increments of $50,000), or a statement that the interest is one whose value cannot be readily determined through reference to public prices or other reasonable measures of fair market value;
    7. a description of how the financial interest relates to the PHS-funded research and the basis for Autonomous Healthcare’s determination that the financial interest conflicts with such research; and
    8. a description of the key elements of Autonomous Healthcare’s management plan, including:
      1. role and principal duties of the conflicted Investigator in the PHS-funded research;
      2. conditions of the management plan;
      3. how the management plan is designed to safeguard objectivity in the PHS-funded research;
      4. confirmation of the Investigator’s agreement to the management plan;
      5. how the management plan will be monitored to ensure Investigator compliance; and
      6. other information as needed.

Training

Autonomous Healthcare shall inform each Investigator of this Policy, the Investigator’s responsibilities regarding disclosure of Significant Financial Interests, and of the Regulations, and shall require each Investigator to complete training regarding this Policy prior to engaging in PHS-funded research and thereafter at least every four years, and immediately when any of the following circumstances apply:

  1. Autonomous Healthcare revises this Policy or any procedures in a manner that affects the requirements of Investigators;
  2. an Investigator is new to Autonomous Healthcare; or
  3. Autonomous Healthcare finds that an Investigator is not in compliance with this Policy or a management plan instituted by the Official(s).

Training shall consist of a review of this Policy and of Autonomous Healthcare’s FCOI training document, which summarizes the requirements of the Regulations and the Investigator’s responsibilities regarding disclosure of Significant Financial Interests, including both domestic and foreign interests. Upon completion of the training, the Investigator shall sign and return an acknowledgment of the training to the Official(s), which shall be retained in Autonomous Healthcare’s FCOI records. Where training is required due to a revision of this Policy, such training may consist of a review of the revised Policy together with a summary of the changes, acknowledged in the same manner. NIH’s FCOI training resources, which Investigators may consult as an additional reference, are available at https://grants.nih.gov/policy-and-compliance/policy-topics/fcoi/fcoi-training. Investigators may also consult the Frequently Asked Questions provided by the NIH (see the Financial Conflict of Interest section) at: https://grants.nih.gov/faqs

Definition of Significant Financial Interest

Significant Financial Interest is defined by the Regulations as:

  1. A significant 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. With regard to any publicly traded entity, a significant financial interest exists if the value of any remuneration received from the entity in the twelve months preceding the disclosure and the value of any equity interest in the entity as of the date of disclosure, when aggregated, exceeds $5,000. For purposes of this definition, remuneration includes salary and any payment for services not otherwise identified as salary (e.g., consulting fees, honoraria, paid authorship); equity interest includes any stock, stock option, or other ownership interest, as determined through reference to public prices or other reasonable measures of fair market value;
    2. With regard to any non-publicly traded entity, a significant financial interest exists if the value of any remuneration received from the entity in the twelve months preceding the disclosure, when aggregated, exceeds $5,000, or when the Investigator (or the Investigator’s spouse or dependent children) holds any equity interest (e.g., stock, stock option, or other ownership interest); or
    3. Intellectual property rights and interests (e.g., patents, copyrights), upon receipt of income related to such rights and interests that, when aggregated over the twelve months preceding the disclosure, exceeds $5,000.
  2. Investigators also must disclose the occurrence of any reimbursed or sponsored travel (i.e., that which is paid on behalf of the Investigator and not reimbursed to the Investigator so that the exact monetary value may not be readily available), related to their institutional responsibilities; provided, however, that this disclosure requirement does not apply to travel that is reimbursed or sponsored by a U.S. federal, state, or local government agency, a U.S. institution of higher education as defined at 20 U.S.C. 1001(a), a U.S. academic teaching hospital, a U.S. medical center, or a U.S. research institute that is affiliated with a U.S. institution of higher education. Disclosure, which will include, at a minimum, the purpose of the trip, the identity of the sponsor/organizer, the destination, and the duration. Consistent with NIH Guide Notice NOT-OD-13-004, disclosure of reimbursed or sponsored travel is required only when the aggregate value of such travel received from a single entity exceeds $5,000 in the twelve months preceding the disclosure; if the monetary value of the travel is not known and cannot reasonably be estimated by the Investigator, the travel must be disclosed. In accordance with Autonomous Healthcare’s FCOI policy, the Official(s) will determine if further information is needed, including a determination or disclosure of monetary value, in order to determine whether the travel constitutes an FCOI with the PHS-funded research.

The term significant financial interest does not include the following types of financial interests:

  1. salary, royalties, or other remuneration paid by Autonomous Healthcare to the Investigator if the Investigator is currently employed or otherwise appointed by Autonomous Healthcare, including intellectual property rights assigned to Autonomous Healthcare and agreements to share in royalties related to such rights;
  2. any ownership interest in Autonomous Healthcare held by the Investigator;
  3. income from investment vehicles, such as mutual funds and retirement accounts, as long as the Investigator does not directly control the investment decisions made in these vehicles;
  4. income from seminars, lectures, or teaching engagements sponsored by a U.S. federal, state, or local government agency, a U.S. institution of higher education as defined at 20 U.S.C. 1001(a), a U.S. academic teaching hospital, a U.S. medical center, or a U.S. research institute that is affiliated with a U.S. institution of higher education; or
  5. 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 as defined at 20 U.S.C. 1001(a), a U.S. academic teaching hospital, a U.S. medical center, or a U.S. research institute that is affiliated with a U.S. institution of higher education.

The exclusions above apply only to the U.S. entities described. Investigators must disclose all foreign financial interests that are related to their institutional responsibilities and that meet the disclosure thresholds set forth in this Policy, including income from seminars, lectures, or teaching engagements, income from service on advisory committees or review panels, and reimbursed or sponsored travel, received from any foreign entity, including foreign institutions of higher education and foreign governments (which includes local, provincial, or equivalent governments of another country), consistent with the NIH Grants Policy Statement and NIH Guide Notice NOT-OD-19-114.

Reporting to NIH

Autonomous Healthcare shall send initial, annual (i.e., ongoing) and revised FCOI reports, including all reporting elements required by the Regulation, to the NIH for the Institution and its subrecipients, if applicable, as required by the Regulation:

  1. Prior to expenditure of funds;
  2. Within 60 days of identification for an Investigator who is newly participating in the project;
  3. Within 60 days for new, or newly identified, FCOIs for existing Investigators;
  4. At least annually (at the same time as when the Institution is required to submit the annual progress report, multi-year progress report, if applicable, or at time of extension) to provide the status of the FCOI and any changes to the management plan, if applicable, until the completion of the project; and
  5. Following a retrospective review to update a previously submitted report, if appropriate.

Autonomous Healthcare shall notify NIH promptly if bias is found with the design, conduct or reporting of PHS-funded research and will submit a Mitigation Report with all reporting elements in accordance with the regulation 42 CFR 50.605(a)(3)(iii).

Autonomous Healthcare shall notify NIH promptly if an Investigator fails to comply with the Institution’s FCOI policy or a FCOI management plan appears to have biased the design, conduct, or reporting of the NIH-funded research. Autonomous Healthcare will take corrective action for noncompliance with the Institution’s policy or the management plan.

Records

Records of FCOI documentation shall be maintained by the Official(s) and retained for at least 3 years after submission of the project final expenditure report or other dates specified in 2 CFR 200.334, where applicable.

Enforcement and Noncompliance

If Autonomous Healthcare discovers that an Investigator has failed to disclose a Significant Financial Interest within the timelines set forth in this Policy, or if an Investigator fails to comply with a management plan established under this Policy, then Autonomous Healthcare shall remedy such noncompliance and conduct a retrospective review within 120 days of the Institution’s determination of noncompliance for SFIs not disclosed timely or previously reviewed or whenever an FCOI is not identified or managed in a timely manner and to document the reviews consistent with the regulation.

Autonomous Healthcare shall ensure that in any case in which the Department of Health and Human Services determines that a PHS-funded research 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 an FCOI that was not managed or reported by the Institution as required by the regulation, the Institution shall require the Investigator involved to:

  1. Disclose the FCOI in each public presentation of the results of the research, and
  2. Request an addendum to previously published presentations.

Any violation of this Policy by an Investigator may result in sanctions or other administrative actions by Autonomous Healthcare.

Subrecipients

Subrecipients of Autonomous Healthcare project funding related to PHS-funded research shall, as applicable provide certification of a FCOI policy in compliance with the regulation.

Autonomous Healthcare shall include in the written subrecipient agreement a requirement for the subrecipient to report identified FCOIs for its Investigators in a time frame that allows Autonomous Healthcare to report identified FCOIs to the NIH as required by the regulation; or include in the written agreement a requirement to solicit and review subrecipient Investigator disclosures that enable Autonomous Healthcare to identify, manage and report identified FCOIs to the NIH.

Public Disclosure

Prior to Autonomous Healthcare’s expenditure of any funds under a PHS-funded research project, Autonomous Healthcare shall post the FCOI Policy on its public website.

If a FCOI involving a significant financial interest that was disclosed and is still held by senior/key personnel is identified, Autonomous Healthcare shall make information concerning the FCOI available by providing a written response to any requestor within five business days of a request. The written response shall include, at a minimum, the following:

  1. the Investigator’s name;
  2. the Investigator’s title and role with respect to the research project;
  3. the name of the entity in which the significant financial interest is held;
  4. the nature of the significant financial interest; and
  5. the approximate dollar value of the significant financial interest (dollar ranges are permissible: $0–$4,999; $5,000–$9,999; $10,000–$19,999; amounts between $20,000–$100,000 by increments of $20,000; amounts above $100,000 by increments of $50,000), or a statement that the interest is one whose value cannot be readily determined through reference to public prices or other reasonable measures of fair market value.

The written response shall 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 Autonomous Healthcare’s identification of a new FCOI, which should be requested subsequently by the requestor. This information shall remain available for responses to written requests for at least three years from the date the information was most recently updated.