Financial Conflict of Interest (FCOI) Policy

Third Floor Materials, Inc.

1. Scope

The National Institutes of Health (NIH) has adopted regulations (42 CFR Part 50 Subpart F and 45 CFR Part 94) on Promoting Objectivity in Research. These regulations describe the actions an individual and an organization must take to promote objectivity in research. The regulations apply to all NIH funded grants, cooperative agreements, research contracts (but not Phase 1 Small Business Innovation Research or Small Business Technology Transfer program grants), and subawards where the originating sponsor is NIH.

The purpose of this FCOI (Financial Conflict of Interest) Policy is to ensure compliance with the 2011 revised FCOI regulation, as outlined in 42 CFR Part 50 Subpart F, which promotes objectivity in research funded by the National Institutes of Health (NIH). This policy applies to all NIH grants and cooperative agreements received by Third Floor Materials, excluding Phase I Small Business Innovative Research (SBIR) and Small Business Technology Transfer (STTR) applications and awards. The policy covers all Investigators, as defined by the regulation, who are planning to participate in or are participating in Public Health Service (PHS) funded research.

2. Definitions

  • Investigator: The Project Director (PD), Principal Investigator (PI), or any other person, regardless of title or position, who is responsible for the design, conduct, or reporting of research funded by the PHS/NIH, or proposed for such funding. This may include collaborators or consultants.
  • Institutional Responsibilities: An Investigator’s professional responsibilities on behalf of Third Floor Materials, Inc., including, but not limited to, research, research consultation, product development, training, professional practice, and committee memberships.
  • Designated Official (DO): The individual designated by Third Floor Materials, Inc. to solicit and review disclosures of significant financial interests related to the Investigator’s institutional responsibilities. For the purposes of this policy, the Designated Official is: Christopher T. Shelton.
  • Financial Conflict of Interest (FCOI): A Significant Financial Interest that could directly and significantly affect the design, conduct, or reporting of PHS-funded research.
  • Significant Financial Interest (SFI): A 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. Publicly Traded Entities: Remuneration received in the twelve months preceding the disclosure and the value of any equity interest in the entity as of the date of disclosure that, when aggregated, exceeds $5,000.
    2. Non-Publicly Traded Entities (e.g., Startups): Any remuneration received in the twelve months preceding the disclosure that exceeds $5,000, OR when the Investigator (or their spouse or dependent children) holds any equity interest (e.g., stock, stock option, or other ownership interest, regardless of dollar value).
    3. Intellectual Property: Intellectual property rights and interests (e.g., patents, copyrights) upon receipt of income related to such rights and interests that exceeds $5,000.
    4. Sponsored Travel: Any reimbursed or sponsored travel (i.e., paid on behalf of the Investigator) that exceeds $5,000 per entity in a 12-month period, subject to certain exclusions (e.g., travel sponsored by a U.S. federal, state, or local government agency, or a U.S. institution of higher education).

Exceptions: SFI does not include salary, royalties, or other remuneration paid by Third Floor Materials, Inc. to the Investigator if the Investigator is currently employed or otherwise appointed by the Company, nor does it include income from investment vehicles (like mutual funds) where the Investigator does not directly control investment decisions.

3. Training Requirements

All Investigators must complete FCOI training regarding this policy, their disclosure responsibilities, and the PHS regulations (e.g., via the NIH FCOI Tutorial):

  • Prior to engaging in research related to any PHS-funded grant.
  • At least every four (4) years.
  • Immediately when Third Floor Materials, Inc. revises its FCOI policy in a manner that affects Investigator requirements, when an Investigator is new to the Company, or when an Investigator is found to be in noncompliance with this policy or a management plan.

4. Disclosure Requirements

Investigators must disclose all domestic and foreign SFIs (and those of the Investigator’s spouse and dependent children) related to their institutional responsibilities to the Designated Official:

  • Initial: No later than at the time of application for PHS-funded research.
  • Annual: At least annually during the period of the award.
  • New SFIs: Within thirty (30) days of discovering or acquiring a new SFI (e.g., through purchase, marriage, or inheritance).

5. Review and Management of FCOIs

Prior to the Company’s expenditure of any funds under a PHS-funded research project, the Designated Official will review all SFI disclosures. If an SFI is determined to be related to the PHS-funded research and constitutes an FCOI, the DO will develop and implement a written management plan.

If a new SFI is disclosed during an ongoing PHS-funded project, the DO will review the disclosure and implement a management plan within sixty (60) days. Management conditions may include, but are not limited to:

  • Public disclosure of the FCOI (e.g., when presenting or publishing the research).
  • Appointment of an independent monitor capable of taking measures to protect research design, conduct, and reporting against bias.
  • Modification of the research plan.
  • Change of personnel or personnel responsibilities.
  • Reduction or elimination of the financial interest.

6. Subrecipient Monitoring

If research is carried out through a subrecipient (e.g., subcontractors or consortium members), Third Floor Materials, Inc. will incorporate terms into the written subaward agreement establishing whether the FCOI policy of the Company or the FCOI policy of the subrecipient will apply to the subrecipient’s Investigators. If the subrecipient’s policy applies, the agreement will specify time periods for the subrecipient to report all identified FCOIs to Third Floor Materials, Inc. in sufficient time to allow the Company to meet its reporting obligations to the NIH.

7. Reporting to NIH

For non-exempt awards, Third Floor Materials, Inc. will submit initial, annual, and revised FCOI reports to the NIH via the eRA Commons FCOI Module:

  • Prior to the expenditure of funds.
  • Within 60 days of identification of an FCOI for an Investigator who is newly participating in the project.
  • Within 60 days for new, or newly identified, FCOIs for existing Investigators.
  • At least annually (at the same time as the annual progress report) for the duration of the project period.

8. Retrospective Review and Noncompliance

If an FCOI is not identified or managed in a timely manner (e.g., failure of the Investigator to disclose an SFI, failure of the Company to review or manage the FCOI, or failure of the Investigator to comply with a management plan), Third Floor Materials, Inc. will complete a retrospective review of the Investigator’s activities and the NIH-funded research within 120 days to determine whether the research was biased.

If bias is found, the Company will notify the NIH promptly and submit a Mitigation Report as required by 42 CFR 50.605(a)(3)(iii). The report will include the impact of the bias and the corrective actions taken.

9. Public Accessibility

  • Web Posting & IPF Upload: In compliance with NIH Notice NOT-OD-21-002 and NIH GPS 4.1.10, this written and enforced FCOI policy is made publicly accessible on the Third Floor Materials, Inc. website.
  • Public Requests for Info: Prior to the expenditure of any funds under a PHS-funded research project, Third Floor Materials, Inc. will ensure public accessibility of information concerning any SFI disclosed that meets all three of the following criteria: (1) it is held by Senior/Key Personnel; (2) it is related to the PHS-funded research; and (3) it is determined to be an FCOI. The Company will provide a written response to any requestor within five (5) business days of a request, detailing the Investigator’s name, title, nature of the SFI, and approximate dollar value of the SFI.

10. Record Retention

Records regarding all Investigator disclosures of financial interests and the Company’s review of, and response to, such disclosures (whether or not resulting in the institution’s determination of an FCOI) will be retained for at least three (3) years from the date the final expenditures report is submitted to the PHS/NIH, or as otherwise required by applicable federal regulations.

11. Enforcement Actions for Investigator Noncompliance

Compliance with this policy is a condition of employment and/or participation for all applicable Investigators. Investigators who fail to comply may be subject to disciplinary action, which can include termination of employment or contract, formal warning letter or official notice of disciplinary action, restrictions on the use of research funds, and/or disqualification from further participation in any PHS/NIH-funded research, as deemed appropriate.