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StrideTech — Empowering Movement. Encouraging Safer Steps.
Policy on Financial Conflicts of Interest in Public Health Service Funded Research
Stride Tech Medical, Inc. | Adopted pursuant to 42 CFR Part 50, Subpart F
Effective Date: September 1, 2026 | Version 1.0 | Review Cycle: Annual
1. Purpose
Stride Tech Medical, Inc. (the "Company" or the "Institution") is committed to ensuring that the design, conduct and reporting of research funded by the Public Health Service ("PHS"), including the National Institutes of Health ("NIH"), is free from bias resulting from the financial interests of the individuals who carry out that research. This Policy establishes the Company's requirements for the disclosure, review, management, reporting and public accessibility of financial conflicts of interest, as required by 42 CFR Part 50, Subpart F, "Promoting Objectivity in Research."This Policy is written, enforced and maintained up to date, and is made available on the Company's publicly accessible website at www.stridetechmedical.com, in satisfaction of 42 CFR 50.604(a).
2. Scope and Applicability
This Policy applies to every Investigator, as defined in Section 3, who is planning to participate in, or is participating in, PHS-funded research conducted by or through the Company, whether the funding is received directly or through a subaward, contract or other arrangement. It applies to employees, officers, directors acting as Investigators, consultants, collaborators and subrecipient personnel.The Small Business Innovation Research ("SBIR") carve-out at 42 CFR 50.602 excludes only SBIR Program Phase I applications from this subpart. A Direct to Phase II application is not a Phase I application, and a Direct to Phase II award is a Phase II award; it is therefore subject in full to Subpart F. The Company applies this Policy to its Direct to Phase II application to the National Institute on Aging and to any resulting award.
3. Definitions
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-funded research, or proposed for such funding. This includes, where applicable, the Investigator's spouse and dependent children for purposes of financial interest disclosure. The Company's determination of who is an Investigator is made by the Designated Official and is not limited to individuals listed as senior or key personnel.
Financial Interest means anything of monetary value, whether or not the value is readily ascertainable.
Significant Financial Interest ("SFI") means a Financial Interest that reasonably appears to be related to the Investigator's Institutional Responsibilities and that consists of one or more of the following:
With regard to any publicly traded entity, the aggregate value of any remuneration received from the entity in the twelve months preceding disclosure and the value of any equity interest in the entity as of the date of disclosure, when aggregated, exceeds $5,000. Remuneration includes salary and any payment for services such as consulting fees, honoraria and 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.With regard to any non-publicly traded entity, the aggregate value of any remuneration received from the entity in the twelve months preceding disclosure exceeds $5,000, or the Investigator (or the Investigator's spouse or dependent children) holds any equity interest in the entity, including any stock, stock option, membership interest, partnership interest, convertible instrument, simple agreement for future equity or other ownership interest, of any value.Intellectual property rights and interests, such as patents and copyrights, upon receipt of income related to those rights and interests.Reimbursed or sponsored travel related to the Investigator's Institutional Responsibilities, disclosed as provided in Section 6.4.
SFI does not include:Salary, royalties or other remuneration paid by the Company to the Investigator, if the Investigator is currently employed or otherwise appointed by the Company, including intellectual property rights assigned to the Company and agreements to share in royalties related to those rights.Any ownership interest in the Company held by the Investigator, because the Company is a for-profit organization and is the applicant Institution. This exclusion is set out at 42 CFR 50.603 and it means that founder equity, stock options and shares in Stride Tech Medical, Inc. held by an Investigator are not Significant Financial Interests and are not disclosable under this Policy. It does not extend to an ownership interest an Investigator holds in a third party entity that in turn holds an interest in the Company; such interests are disclosable under Section 6.Income from investment vehicles, such as mutual funds and retirement accounts, in which the Investigator does not directly control the investment decisions.Income from seminars, lectures or teaching engagements sponsored by, or service on advisory or review panels for, a federal, state or local government agency, an institution of higher education as defined at 20 U.S.C. 1001(a), an academic teaching hospital, a medical center, or a research institute affiliated with an institution of higher education.
Institutional Responsibilities means an Investigator's professional responsibilities on behalf of the Company, including research, research consultation, product development, engineering, clinical activity, regulatory activity, teaching, professional practice, service on Company committees, and service on internal or external review panels or boards.
Financial Conflict of Interest ("FCOI") means a Significant Financial Interest that the Designated Official reasonably determines could directly and significantly affect the design, conduct or reporting of the PHS-funded research.
Manage means to take action to address an FCOI, which may include reducing or eliminating the conflict, to ensure that the design, conduct and reporting of the research will be free from bias.
PHS-funded research means research for which funding is available from a PHS awarding component through a grant or cooperative agreement, whether authorized under the PHS Act or other statutory authority.
4. Designated Institutional Official
The Chief Executive Officer of Stride Tech Medical, Inc. is the Designated Official responsible for soliciting and reviewing disclosures of Significant Financial Interests, determining whether an SFI is related to the PHS-funded research, determining whether a related SFI constitutes an FCOI, developing and monitoring management plans, and submitting FCOI reports to the PHS awarding component.Recusal. Where the disclosure under review is that of the Chief Executive Officer, or where the Chief Executive Officer has a personal interest in the matter, the Chief Executive Officer shall recuse himself and the Board of Directors of the Company, acting through a director who is not an Investigator on the project and who has no interest in the matter, shall serve as the Designated Official for that disclosure. The recusal, the identity of the reviewing director, and the determination shall be documented in writing and retained under Section 11. Because the Company's Chief Executive Officer serves as a Program Director / Principal Investigator on the project to which this Policy is first applied, this recusal provision is expected to be exercised at the outset and the Company has adopted it deliberately for that reason.
5. Investigator Training
Each Investigator shall complete training on this Policy, on the Investigator's disclosure responsibilities, and on the requirements of 42 CFR Part 50, Subpart F: prior to engaging in research related to any PHS-funded grant; at least every four years thereafter; immediately when the Company revises this Policy or its related procedures in a manner that affects the requirements of Investigators; immediately when an Investigator is new to the Company; and immediately when the Company finds that an Investigator has not complied with this Policy or with a management plan.The Company accepts completion of the NIH Financial Conflict of Interest tutorial, or an equivalent course, as satisfying this requirement. The Designated Official shall retain a record of completion for each Investigator.
6. Disclosure of Significant Financial Interests
6.1 Timing. Each Investigator who is planning to participate in PHS-funded research shall disclose to the Designated Official all of the Investigator's Significant Financial Interests, and those of the Investigator's spouse and dependent children, that reasonably appear to be related to the Investigator's Institutional Responsibilities. Disclosure shall be made: no later than the time of application for PHS-funded research; at least annually during the period of the award, on a date specified by the Designated Official, which disclosure shall include any information not previously disclosed and shall update the status of previously disclosed interests; and within thirty days of discovering or acquiring a new Significant Financial Interest, whether by purchase, marriage, inheritance, grant of equity, commencement of a consulting relationship or otherwise.
6.2 Form. Disclosure shall be made on the Company's Significant Financial Interest Disclosure Form, signed and dated by the Investigator. An Investigator with no SFI to report shall so state on the form; a negative disclosure is required of every Investigator.
6.3 Completeness. The Investigator, not the Company, bears the obligation to disclose. An Investigator who is uncertain whether an interest is disclosable shall disclose it and allow the Designated Official to make the determination.
6.4 Travel. Each Investigator shall disclose the occurrence of any reimbursed or sponsored travel related to the Investigator's Institutional Responsibilities, including the purpose of the trip, the identity of the sponsor or organizer, the destination and the duration. Travel that is reimbursed or sponsored by a federal, state or local government agency, an institution of higher education, an academic teaching hospital, a medical center or an affiliated research institute is excluded. The Designated Official shall determine whether further information, including the monetary value, is needed to determine whether the travel constitutes an FCOI.
7. Review, Relatedness and FCOI Determination
7.1 Relatedness. The Designated Official shall review each disclosure and determine whether the disclosed SFI is related to the PHS-funded research. An SFI is related to the research if the 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.
7.2 FCOI determination. If an SFI is related to the research, the Designated Official shall determine whether it constitutes an FCOI, that is, whether the interest could directly and significantly affect the design, conduct or reporting of the research. In making that determination the Designated Official shall consider the nature and monetary value of the interest, the relationship between the interest and the research, the Investigator's role in the research, the degree to which the interest could be affected by the outcome of the research, and the degree to which the interest could be viewed by a reasonable person as compromising objectivity.
7.3 Timing. The Designated Official shall complete the review of disclosures made at the time of application before the Company expends any funds under the resulting award, and shall complete the review of a disclosure of a newly acquired SFI within sixty days of the disclosure.
7.4 Documentation. Each determination, including a determination that no FCOI exists, shall be recorded in writing with the reasons for it, signed by the Designated Official and retained under Section 11.
8. Management of Financial Conflicts of Interest
Where the Designated Official determines that an FCOI exists, the Company shall develop and implement a written management plan before the expenditure of funds under the award, and shall monitor Investigator compliance with the plan until the completion of the research. A management plan shall specify the actions taken to manage the FCOI and may include one or more of the following: public disclosure of the FCOI, including in presentations and publications arising from the research; disclosure of the FCOI directly to research participants in the informed consent process; appointment of an independent monitor capable of taking measures to protect the design, conduct and reporting of the research from bias; modification of the research plan; change of personnel or change of the Investigator's role in the research, including limitation of the Investigator's participation in specified activities such as data analysis, outcome adjudication, or interaction with the clinical test provider or trial sites; reduction or elimination of the Financial Interest, by sale, divestiture or termination of the relationship; and severance of the relationship that creates the FCOI.Each management plan shall be signed by the Investigator, who thereby agrees to its terms, and by the Designated Official. The Designated Official shall review each active management plan at least annually and shall document that review.
9. Reporting to the PHS Awarding Component
9.1 Initial report. Prior to the Company's expenditure of any funds under a PHS award, the Company shall submit to the PHS awarding component, through the eRA Commons FCOI Module, an FCOI report for each FCOI identified. The report shall contain, at a minimum: the grant number; the project title; the name of the Program Director / Principal Investigator; the name of the Investigator with the FCOI; the name of the entity in which the Investigator holds the Significant Financial Interest; the nature of the interest, such as equity, consulting fee, honorarium, royalty or travel; the approximate dollar value of the interest in ranges, or a statement that the value cannot be readily determined; a description of how the interest relates to the PHS-funded research and the basis for the determination that it could directly and significantly affect the design, conduct or reporting of the research; and a description of the key elements of the management plan. Where the Company identifies an FCOI and eliminates it before the expenditure of PHS-awarded funds, the Company shall not submit an FCOI report for that interest. The elimination and the basis for it shall be documented and retained under Section 11.
9.2 Ongoing reports. For any FCOI previously reported, the Company shall submit an annual FCOI report for the duration of the project period, including any extension with or without additional funds, at the same time as the Company submits its annual progress report or multi-year progress report, or at the time of extension. The annual report shall specify whether the financial conflict of interest is still being managed, or shall explain why the financial conflict of interest no longer exists, and shall describe any changes to the management plan.
9.3 Newly identified FCOI. For an FCOI identified during the period of the award, whether because of a newly acquired SFI, a newly participating Investigator or a failure to disclose, the Company shall complete its review and, if an FCOI is found, implement a management plan on an interim basis and submit an FCOI report within sixty days of the identification.
9.4 Retrospective review. If an SFI is not disclosed in a timely manner, or is not reviewed or reported in a timely manner, or if an Investigator fails to comply with a management plan, the Company shall, within one hundred twenty days of determining the noncompliance, complete a retrospective review of the Investigator's activities and of the PHS-funded research to determine whether the research conducted during the period of noncompliance was biased in its design, conduct or reporting. The Company shall document the retrospective review, including the project number and title, the names of the Program Director / Principal Investigator and the Investigator with the FCOI, the entity in which the SFI is held, the reasons for the review, the detailed methodology, the findings and the conclusions. The Company shall update any previously submitted FCOI report to specify the actions it will take going forward. If bias is found, the Company shall promptly notify the PHS awarding component and submit a mitigation report.
9.5 Clinical research reporting. If the FCOI relates to PHS-funded research whose purpose is to evaluate the safety or effectiveness of a drug, medical device or treatment, and the Company determines that bias occurred, the Company shall notify the PHS awarding component promptly and submit a mitigation report. If the PHS awarding component determines that such a clinical research project was designed, conducted or reported by an Investigator with an FCOI that was not managed or reported as required, the Investigator shall disclose the FCOI in each public presentation of the results and shall request an addendum to any previously published presentation.
10. Public Accessibility
Before the Company expends funds under a PHS award, the Company shall ensure public accessibility of information concerning any Significant Financial Interest that meets all of the following: the interest was disclosed and is still held by the Investigator; the Designated Official determines that the interest is related to the PHS-funded research; and the Designated Official determines that the interest is a Financial Conflict of Interest. Public accessibility applies to the SFI of any Investigator who is the Program Director / Principal Investigator or any other Investigator whom the Company identifies as senior or key personnel.The Company shall make this information available on its publicly accessible website, at www.stridetechmedical.com, and shall include the Investigator's name, title and role with respect to the research project, the name of the entity in which the SFI is held, the nature of the SFI, and the approximate dollar value of the SFI in ranges, being $0 to $4,999; $5,000 to $9,999; $10,000 to $19,999; amounts between $20,000 and $100,000 by increments of $20,000; and amounts above $100,000 by increments of $50,000; or a statement that the interest is one whose value cannot be readily determined. The information shall remain available for at least three years from the date it was most recently updated, shall be updated at least annually, and shall be updated within sixty days of the Company's identification of a new FCOI. The web page shall state that the information provided is current as of the date listed on the page and is subject to updates on at least an annual basis and within sixty days of the Company's identification of a new financial conflict of interest.
11. Records
The Company shall maintain records of all Investigator disclosures of Financial Interests, of the Designated Official's review of and response to those disclosures, whether or not a disclosure resulted in a determination of an FCOI, of all management plans and monitoring records, of all FCOI reports submitted, of all retrospective reviews and mitigation reports, and of all training completions, for at least three years from the date the final expenditures report is submitted to the PHS, or, where litigation, claim, financial management review or audit is started before the expiration of the three year period, until the completion and resolution of that action, whichever is later. Records shall be maintained in a secure, access-controlled location under the custody of the Designated Official.
12. Subrecipients, Contractors and Consultants
If the Company carries out PHS-funded research through a subrecipient, the Company shall take reasonable steps to ensure that any subrecipient Investigator complies with 42 CFR Part 50, Subpart F, and shall incorporate as a term of the subaward agreement whether this Policy or the subrecipient's own FCOI policy applies to the subrecipient Investigators. If the subrecipient's Investigators are to comply with the subrecipient's own FCOI policy, the subrecipient shall certify, as part of the subaward agreement, that its policy complies with 42 CFR Part 50, Subpart F. If the subrecipient cannot provide that certification, the agreement shall state that the subrecipient's Investigators are subject to this Policy for purposes of disclosing Significant Financial Interests that are directly related to the subrecipient's work for the Company.If the subrecipient's policy applies, the agreement shall specify the time period, not later than forty-five days before the date on which the Company is required to submit its own FCOI report, by which the subrecipient shall report to the Company any FCOI it identifies. If this Policy applies, the agreement shall specify the time period, not later than forty-five days before the Company's reporting deadline, by which subrecipient Investigators shall submit their disclosures to the Designated Official. The Company shall itself provide FCOI reports to the PHS awarding component covering all financial conflicts of interest of all subrecipient Investigators, prior to the expenditure of funds and within sixty days of any subsequently identified FCOI.A consultant, contractor or vendor who is responsible for the design, conduct or reporting of the PHS-funded research is an Investigator for purposes of this Policy, irrespective of the form of the engagement, and shall disclose accordingly. The Company shall include a disclosure obligation in the written agreement with any such person or entity, including any clinical test provider engaged to conduct the clinical trial.
13. Enforcement and Sanctions
Compliance with this Policy is a condition of employment or engagement with the Company and a condition of participation in PHS-funded research. An Investigator who fails to disclose a Significant Financial Interest, who makes an incomplete or inaccurate disclosure, or who fails to comply with a management plan, is subject to administrative action by the Company, which may include any of the following, alone or in combination: written warning; required additional training; removal from the PHS-funded research project; suspension of the Investigator's authority to expend or commit Company or grant funds; ineligibility to serve as an Investigator on future applications; suspension of research activity; withholding of a performance-based payment; and, for employees, disciplinary action up to and including termination of employment. For a consultant or contractor, sanctions may include suspension of payment and termination of the agreement.The Designated Official shall document any enforcement action taken and shall notify the PHS awarding component where required by Section 9.4. The Company acknowledges that the Department of Health and Human Services may take its own action, including suspension of funding or a requirement that the Investigator disclose the FCOI in each public presentation of the research results.
14. Confidentiality
Disclosures made under this Policy shall be treated as confidential to the extent permitted by law, and shall be shared only with those persons who have a need to know in order to carry out this Policy, or with the Department of Health and Human Services upon its request, or as required by law. Nothing in this Section limits the public accessibility requirements of Section 10 or the reporting requirements of Section 9.
15. Certification
By adopting this Policy, and in each application for PHS funding, Stride Tech Medical, Inc. certifies that:it has in effect at the Company an up-to-date, written and enforced administrative process to identify and manage Financial Conflicts of Interest with respect to all research projects for which funding is sought or received from the PHS;it shall promote and enforce Investigator compliance with the requirements of 42 CFR Part 50, Subpart F, including those pertaining to disclosure of Significant Financial Interests;it shall manage Financial Conflicts of Interest and provide initial and ongoing FCOI reports to the PHS awarding component consistent with 42 CFR Part 50, Subpart F;it shall, to the extent permitted by law, make information available promptly to the Department of Health and Human Services, upon request, relating to any Investigator disclosure of Financial Interests and the Company's review of, and response to, that disclosure, whether or not the disclosure resulted in a determination of an FCOI; andit shall fully comply with the requirements of 42 CFR Part 50, Subpart F.
16. Policy Administration and Review
The Designated Official shall review this Policy at least annually and shall recommend revisions to the Board of Directors as required by changes in law or in the Company's circumstances. The current version of this Policy shall at all times be posted on the Company's publicly accessible website. Questions about this Policy should be directed to the Chief Executive Officer, Stride Tech Medical, Inc.Adopted by the Board of Directors of Stride Tech Medical, Inc., effective September 1, 2026.George Douaire, Chief Executive Officer, for and on behalf of the Board of Directors.
