INTERO BIOSYSTEMS INC.
Financial Conflict of Interest Policy
Applicable to NIH-Funded Research
Effective Date: May 1, 2026
1. Purpose and Scope
Intero Biosystems Inc. (“Intero” or “the Institution”) is committed to ensuring that the design, conduct, and reporting of research performed under NIH grants and cooperative agreements is free from bias resulting from Investigator financial conflicts of interest. This policy is established pursuant to 42 CFR Part 50 Subpart F, “Promoting Objectivity in Research,” and the NIH Grants Policy Statement Section 4.1.10.
This policy applies to all Investigators who are planning to participate in, or who participate in, NIH-funded research at Intero Biosystems, except as noted in Section 3 below.
2. Definitions
Investigator: The Principal Investigator and any other person, regardless of title or position, who is responsible for the design, conduct, or reporting of research funded by the NIH, or proposed for such funding, including collaborators and subcontractors.
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:
- With regard to any publicly traded entity: a remuneration received from the entity in the twelve months preceding the disclosure and the value of equity interest in the entity as of the date of disclosure, when aggregated, exceeds $5,000;
- With regard to any non-publicly traded entity: a remuneration received from the entity in the twelve months preceding the disclosure, when aggregated, exceeds $5,000, or when the Investigator holds any equity interest;
- Intellectual property rights and interests (patents, copyrights) upon receipt of income related to such rights.
Financial Conflict of Interest (FCOI): A Significant Financial Interest that could directly and significantly affect the design, conduct, or reporting of NIH-funded research.
FCOI Officer: The designated institutional official responsible for administering this policy. At Intero Biosystems, the FCOI Officer is the Chief Executive Officer, or a designee appointed by the CEO.
3. Applicability and Exemptions
This policy applies to all NIH-funded research except Phase I Small Business Innovative Research (SBIR) and Small Business Technology Transfer (STTR) applications and awards, which are exempt from the FCOI regulatory requirements per 42 CFR Part 50 Subpart F.
The following are not considered Significant Financial Interests for purposes of this policy:
- Salary, royalties, or other remuneration paid by Intero Biosystems to the Investigator;
- Income from investment vehicles such as mutual funds and retirement accounts where the Investigator does not directly control the investment decisions;
- Income from seminars, lectures, or teaching engagements sponsored by a federal, state, or local government agency, or an institution of higher education;
- Income from service on advisory committees or review panels for a federal, state, or local government agency, or an institution of higher education.
4. Investigator Disclosure Requirements
4.1 Disclosure Timing
Investigators must disclose all Significant Financial Interests to the FCOI Officer:
- At the time of application for NIH funding;
- Prior to engaging in NIH-funded research;
- Annually during the period of award; and
- Within 30 days of acquiring or discovering a new Significant Financial Interest.
4.2 Disclosure Content
Disclosures must include the name of the entity, the nature of the financial interest, and the approximate dollar value of the interest, or a statement that the value cannot be readily determined through reference to public prices or other reasonable measures of fair market value.
4.3 Foreign Financial Interests
Investigators must also disclose significant financial interests in foreign entities or from foreign sources, consistent with NIH requirements and applicable federal regulations governing foreign financial interests.
5. Institutional Review and Determination
The FCOI Officer will review each disclosure within 60 days of receipt and determine: (1) whether the SFI is related to the NIH-funded research, and (2) if related, whether the SFI constitutes an FCOI. An SFI is related to NIH-funded research when the FCOI Officer 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.
6. Management of Financial Conflicts of Interest
If an FCOI is identified, Intero Biosystems will develop and implement a written management plan prior to the expenditure of any NIH funds. Management strategies may include, but are not limited to:
- Public disclosure of the FCOI;
- Modification of the research plan;
- Disqualification of the Investigator from participation in the portion of the NIH-funded research that would be affected by the FCOI;
- Divestiture of the Significant Financial Interest;
- Severance of the relationship that creates the conflict.
The FCOI Officer will monitor Investigator compliance with the management plan on an ongoing basis.
7. Reporting to NIH
Intero Biosystems will report identified FCOIs to the NIH via the eRA Commons FCOI Module prior to the expenditure of any NIH award funds, and within 60 days of identifying any new or previously undisclosed FCOI. Reports will include all information required by 42 CFR 50.605, including the name of the Investigator, the nature of the FCOI, and a description of the management plan.
8. Investigator Training Requirements
All Investigators must complete FCOI training prior to engaging in NIH-funded research and at least every four years thereafter. Training must also be completed immediately when: (1) this policy is revised in a manner that affects Investigator requirements; (2) an Investigator is new to Intero Biosystems; or (3) an Investigator is not in compliance with this policy or an FCOI management plan. Completion of the NIH FCOI Training Module at https://grants.nih.gov/grants/policy/coi/index.htm satisfies this requirement.
9. Subrecipients
When Intero Biosystems carries out NIH-funded research through a subrecipient, Intero will take reasonable steps to ensure that subrecipients comply with 42 CFR Part 50 Subpart F by incorporating FCOI compliance terms into each subaward agreement. Subrecipients must either certify that their FCOI policy complies with the regulation or agree to comply with this policy.
10. Public Accessibility
This policy is publicly accessible on the Intero Biosystems website (https://www.interobiosystems.com/NIH_FCOI). Upon request, information regarding identified FCOIs held by senior or key personnel will be made available within five business days, as required by 42 CFR 50.605(a)(5).
11. Enforcement and Consequences of Non-Compliance
Failure to comply with this policy may result in disciplinary action up to and including termination of employment or engagement, as well as remediation actions required by NIH including retrospective review of research conducted during any period of non-compliance. If bias is found as a result of non-compliance, Intero Biosystems will notify the NIH promptly and provide a mitigation report as required by 42 CFR 50.605(a)(3).
12. Record Retention
Intero Biosystems will maintain records of all Investigator disclosures of financial interests, institutional reviews and determinations, FCOI management plans, and monitoring activities for at least three years beyond the date the final expenditure report is submitted to NIH for the applicable award.
13. Policy Review and Updates
This policy will be reviewed at least every four years and updated as necessary to remain compliant with applicable NIH regulations and guidance. All revisions will be communicated to Investigators and updated on the public website.
Approved By:
Charlie Childs, Ph.D.
Chief Executive Officer and Co-Founder
Intero Biosystems Inc.
Date: 05/01/2026