Compliance
Policy on Financial Conflicts of Interest in PHS-Funded Research
1. Purpose and scope
CardiaTex, Inc. ("CardiaTex") is committed to research free from bias caused by the financial interests of the people who design, conduct or report it. This policy applies to every Investigator who works on research funded, or proposed for funding, by the Public Health Service (PHS), including the National Institutes of Health (NIH), whether through a grant, cooperative agreement, SBIR/STTR award or contract. It meets the requirements of 42 CFR Part 50, Subpart F (grants and cooperative agreements) and 45 CFR Part 94 (contracts).
2. Definitions
- Investigator: the Project Director/Principal Investigator (PD/PI) and any other person, regardless of title or position, who is responsible for the design, conduct or reporting of PHS-funded research, including collaborators, consultants and subrecipient personnel.
- Institutional responsibilities: an Investigator's professional responsibilities on behalf of CardiaTex, such as research, product development, clinical activities, administration and service on company or external committees.
- Significant Financial Interest (SFI): a financial interest of the Investigator, or the Investigator's spouse and dependent children, that reasonably appears related to the Investigator's institutional responsibilities and consists of: (a) remuneration from, plus equity in, a publicly traded entity that together exceed $5,000 in the 12 months before disclosure; (b) remuneration exceeding $5,000 from a non-publicly traded entity in the prior 12 months, or any equity interest in a non-publicly traded entity (this includes equity in CardiaTex itself); (c) intellectual property rights and interests (patents, copyrights) upon receipt of income related to them; or (d) reimbursed or sponsored travel related to institutional responsibilities, except travel paid by a 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 one of these.
- SFI does not include: salary, royalties or other remuneration paid by CardiaTex to an Investigator it employs; income from investment vehicles such as mutual funds or retirement accounts the Investigator does not directly control; income from seminars, lectures, teaching, advisory committees or review panels for a government agency or the academic institutions listed above.
- Financial Conflict of Interest (FCOI): an SFI that the Designated Official finds could directly and significantly affect the design, conduct or reporting of PHS-funded research.
3. Designated Official
CardiaTex designates Justin P. McMurray, President & CEO, as the Designated Official responsible for administering this policy: soliciting disclosures, tracking training, maintaining records, reporting to the PHS awarding component and responding to public requests. Contact: justin.mcmurray@cardiatex.com.
CardiaTex is a small company whose two officers are also Investigators. No person may review or decide on his or her own disclosures. Disclosures by the Designated Official are therefore reviewed by Gerard L. Coté, Ph.D., Secretary & Treasurer (gerard.cote@cardiatex.com), who determines whether an FCOI exists and approves any management plan for them. Disclosures by Dr. Coté, and by any other Investigator, are reviewed by the Designated Official. If CardiaTex later adds an officer, director or advisor who is not an Investigator, the Board of Directors may assign review of both officers' disclosures to that person.
4. Training
Each Investigator must complete training on this policy and on the federal FCOI regulations (the NIH FCOI online tutorial is acceptable) before engaging in PHS-funded research, and at least every four years after that. Training must also be repeated promptly when this policy changes in a way that affects Investigators, when a new Investigator joins CardiaTex, or when an Investigator is found not in compliance with this policy or a management plan. The Designated Official keeps records of completed training.
5. Disclosure
Each Investigator must disclose all of his or her SFIs (and those of spouse and dependent children) to the Designated Official on the CardiaTex disclosure form:
- no later than the time an application for PHS funding is submitted;
- at least annually during the period of the award, including any information not previously disclosed and updated values for previously disclosed interests; and
- within 30 days of discovering or acquiring a new SFI.
Travel disclosures must include, at minimum, the purpose of the trip, the sponsor or organizer, the destination and the duration.
6. Review and management
Before CardiaTex spends any funds under a new PHS award, and within 60 days of any new disclosure, the reviewer assigned in Section 3 will review each disclosure, decide whether the SFI is related to the PHS-funded research and, if so, whether it is an FCOI. For each FCOI, CardiaTex will put in place a written management plan, which may include any of the following:
- public disclosure of the FCOI, for example when presenting or publishing the research;
- for research projects involving human subjects, disclosure of the FCOI directly to participants;
- appointment of an independent monitor able to take measures to protect the design, conduct and reporting of the research;
- modification of the research plan;
- change of personnel or personnel responsibilities, or disqualification of personnel from participation in all or part of the research;
- reduction or elimination of the financial interest; or
- severance of relationships that create the conflict.
Because CardiaTex is commercializing technology developed by its founders, CardiaTex expects that equity held by founders who are also Investigators will typically be an SFI and may be an FCOI. In that case the management plan will, at minimum, adopt the measures in any conflict-of-interest management plan Texas A&M University has in place for the same Investigators, and will require disclosure of the interest in publications, presentations and consent documents, and review of the primary research data and conclusions by a co-investigator or analyst who holds no financial interest in CardiaTex. Where research is also conducted at a university, CardiaTex will coordinate with that university's own conflict-of-interest management plan.
The Designated Official will monitor compliance with each management plan until the project is complete.
7. Reporting to the PHS awarding component
CardiaTex will report through the eRA Commons FCOI module:
- before spending funds under a new award, any FCOI identified and managed;
- within 60 days, any FCOI identified during the award (for a newly participating Investigator or a newly identified SFI);
- annually, at the same time as the annual progress report or extension request, the status of each FCOI and any changes to its management plan; and
- any additional information the awarding component requests.
Each FCOI report will include the information required by 42 CFR 50.605(b), including the project number, PD/PI, the name of the Investigator with the FCOI, the name of the entity in which the interest is held, the nature of the interest, its value (in ranges permitted by the regulation, or a statement that a value cannot be readily determined), a description of how the interest relates to the research, and the key elements of the management plan.
8. Noncompliance and retrospective review
If an SFI was not disclosed or reviewed in time, or an Investigator did not comply with a management plan, the reviewer assigned in Section 3 will, within 60 days, review the SFI, determine whether it is an FCOI and implement an interim management plan. Within 120 days of determining noncompliance, CardiaTex will complete and document a retrospective review of the Investigator's activities and the research to determine whether any research conducted during the period of noncompliance was biased. If bias is found, CardiaTex will promptly notify the awarding component and submit a mitigation report as required by 42 CFR 50.605(a)(3).
If HHS determines that a PHS-funded clinical research project evaluating the safety or effectiveness of a drug, medical device or treatment was designed, conducted or reported by an Investigator with an FCOI that was not managed or reported as required, CardiaTex will require that Investigator to disclose the FCOI in each public presentation of the research and to request an addendum to previously published presentations.
Investigators who fail to comply with this policy are subject to corrective action, which may include removal from the project, suspension of research activities, or other measures up to and including termination of employment or engagement.
9. Subrecipients
When CardiaTex carries out PHS-funded research through a subrecipient (such as a university subaward), the written subaward agreement will state whether the subrecipient's FCOI policy or this policy applies to the subrecipient's Investigators. If the subrecipient's policy applies, the subrecipient must certify that its policy complies with 42 CFR Part 50, Subpart F and must report identified FCOIs to CardiaTex in time for CardiaTex to meet its reporting deadlines. If this policy applies, subrecipient Investigators will disclose their SFIs directly to CardiaTex's Designated Official.
10. Public accessibility
This policy is available on CardiaTex's public website at cardiatex.com/fcoi. Before spending funds under a PHS award, CardiaTex will make available, within five business days of a written request, information about any SFI held by senior/key personnel that CardiaTex has determined is related to the PHS-funded research and is an FCOI. That information will include the Investigator's name, title and role on the project; the name of the entity in which the SFI is held; the nature of the SFI; and its approximate value in the ranges set by 42 CFR 50.605(a)(5). The information will be updated at least annually and within 60 days of identifying a new FCOI, and will remain available for three years from the most recent update. Requests may be sent to justin.mcmurray@cardiatex.com.
11. Records
CardiaTex will keep all Investigator disclosures, reviews, determinations, management plans and actions taken under this policy for at least three years from the date the final expenditure report is submitted for the award, or longer if required by federal record-retention rules (2 CFR 200.334, as adopted by HHS).
12. Adoption
Adopted by CardiaTex, Inc. on October 13, 2026.
Approved by Justin P. McMurray, President & CEO.