Kuhler Technologies, Inc.

Financial Conflict of Interest Policy for PHS/NIH-Funded Research

Effective Date: 5/22/2026
Institution: Kuhler Technologies, Inc.
Public URL: https://getkuhler.com/pages/fcoi-policy
Institutional Signing Official: Braeden Ostepchuk, Cofounder, braeden@getkuhler.com
Designated FCOI Official: Braeden Ostepchuk, Cofounder, braeden@getkuhler.com

1. Purpose

The purpose of this Financial Conflict of Interest Policy is to promote objectivity in research by establishing standards to identify, disclose, review, manage, reduce, or eliminate financial conflicts of interest that could directly and significantly affect the design, conduct, or reporting of research funded by the U.S. Public Health Service, including the National Institutes of Health.

This policy is intended to comply with applicable PHS financial conflict of interest regulations, including 42 CFR Part 50 Subpart F, and applicable NIH guidance.

2. Scope

This policy applies to all Investigators who are planning to participate in, or are participating in, PHS/NIH-funded research conducted by or through Kuhler Technologies, Inc.

For purposes of this policy, an Investigator means the project director, principal investigator, and any other person, regardless of title or position, who is responsible for the design, conduct, or reporting of PHS/NIH-funded research. This may include employees, officers, consultants, collaborators, subcontractors, subrecipients, and other individuals as determined by Kuhler Technologies, Inc.

3. Definitions

Financial Conflict of Interest

A Financial Conflict of Interest, or FCOI, exists when Kuhler Technologies, Inc., through its Designated FCOI Official, reasonably determines that an Investigator’s Significant Financial Interest could directly and significantly affect the design, conduct, or reporting of PHS/NIH-funded research.

Significant Financial Interest

A Significant Financial Interest, or SFI, means a financial interest consisting of one or more of the following interests of the Investigator, the Investigator’s spouse, or the Investigator’s dependent children that reasonably appears to be related to the Investigator’s institutional responsibilities:

1. Publicly traded entity:
   A financial interest in a publicly traded entity if the value of remuneration received from the entity in the twelve months preceding disclosure, plus the value of any equity interest in the entity as of the date of disclosure, exceeds $5,000.
2. Non-publicly traded entity:
   A financial interest in a non-publicly traded entity if the value of remuneration received from the entity in the twelve months preceding disclosure exceeds $5,000, or when the Investigator holds any equity interest, including stock, stock options, ownership interest, or other ownership rights.
3. Intellectual property rights and interests:
   Intellectual property rights and interests, including patents, patent applications, copyrights, royalties, licensing income, or agreements to receive such income.
4. Sponsored or reimbursed travel:
   Sponsored or reimbursed travel related to institutional responsibilities, unless excluded under this policy.

Exclusions from Significant Financial Interest

Significant Financial Interest does not include:

1. Salary, royalties, or other remuneration paid by Kuhler Technologies, Inc. to the Investigator if the Investigator is currently employed or otherwise appointed by Kuhler Technologies, Inc.
2. Income from investment vehicles such as mutual funds or retirement accounts, provided the Investigator does not directly control the investment decisions.
3. Income from seminars, lectures, teaching engagements, advisory committees, or review panels sponsored 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 a U.S. institution of higher education.
4. Travel reimbursed or sponsored 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 a U.S. institution of higher education.

4. Investigator Disclosure Requirements

Each Investigator must disclose all domestic and foreign Significant Financial Interests of the Investigator, the Investigator’s spouse, and dependent children that reasonably appear to be related to the Investigator’s institutional responsibilities.

Disclosures must be submitted:

1. Before submission of a PHS/NIH-funded research application, as applicable;
2. At least annually during the period of the award;
3. Within 30 days of discovering or acquiring a new Significant Financial Interest;
4. Prior to participating in PHS/NIH-funded research if the individual is newly added as an Investigator.

Investigators must submit disclosures using Kuhler Technologies, Inc.’s Significant Financial Interest Disclosure Form or another written format approved by the Designated FCOI Official.

5. Review of Disclosures

The Designated FCOI Official will review each Investigator’s disclosure to determine:

1. Whether the disclosed interest is a Significant Financial Interest;
2. Whether the Significant Financial Interest is related to PHS/NIH-funded research;
3. Whether the Significant Financial Interest could directly and significantly affect the design, conduct, or reporting of the research;
4. Whether a Financial Conflict of Interest exists.

A Significant Financial Interest is related to PHS/NIH-funded research when the Designated FCOI Official reasonably determines that the interest 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, Kuhler Technologies, Inc. will develop and implement a written management plan before expenditure of PHS/NIH funds.

Management strategies may include, but are not limited to:

1. Public disclosure of the FCOI;
2. Disclosure of the FCOI to research participants, when appropriate;
3. Appointment of an independent monitor;
4. Modification of the research plan;
5. Change of personnel or personnel responsibilities;
6. Disqualification from participation in portions of the research;
7. Reduction or elimination of the financial interest;
8. Severance of relationships that create the conflict.

The Investigator must agree in writing to comply with any management plan. Kuhler Technologies, Inc. will monitor compliance with the management plan on an ongoing basis until completion of the research.

7. Reporting to NIH

For PHS/NIH-funded research, Kuhler Technologies, Inc. will submit FCOI reports to NIH through the eRA Commons FCOI Module as required.

When an FCOI is identified, Kuhler Technologies, Inc. will submit an initial FCOI report to NIH:

1. Prior to expenditure of funds under a new award;
2. Within 60 days of identifying an FCOI for an Investigator who is newly participating in the project;
3. Within 60 days of identifying a new FCOI for an existing Investigator.

For any previously reported FCOI, Kuhler Technologies, Inc. will submit annual FCOI reports to NIH for the duration of the project period, including extensions with or without funds, in the time and manner specified by NIH.

If an FCOI is eliminated before funds are expended, no FCOI report is required.

8. Retrospective Review and Mitigation

If Kuhler Technologies, Inc. identifies an SFI that was not disclosed timely or was not previously reviewed, or if an Investigator fails to comply with an FCOI management plan, Kuhler Technologies, Inc. will, within 60 days:

1. Review the SFI;
2. Determine whether it is related to PHS/NIH-funded research;
3. Determine whether an FCOI exists;
4. Implement, on at least an interim basis, a management plan if needed.

If an FCOI was not identified or managed in a timely manner, Kuhler Technologies, Inc. will complete a retrospective review within 120 days to determine whether the research was biased in design, conduct, or reporting.

The retrospective review will be documented and will include, at minimum, the project number, project title, PD/PI or Contact PD/PI, name of the Investigator with the FCOI, name of the entity with which the Investigator has an FCOI, reason for the retrospective review, methodology used, findings, and conclusions.

If bias is found, Kuhler Technologies, Inc. will notify NIH promptly and submit a mitigation report as required.

9. Investigator Training

Each Investigator must complete FCOI training:

1. Prior to engaging in PHS/NIH-funded research;
2. At least every four years thereafter;
3. Immediately when Kuhler Technologies, Inc. revises this policy in a manner that affects Investigator requirements;
4. When an Investigator is new to Kuhler Technologies, Inc.;
5. When an Investigator is found not to be in compliance with this policy or an FCOI management plan.

Training may include NIH-provided FCOI training or other training approved by Kuhler Technologies, Inc.

10. Public Accessibility

Kuhler Technologies, Inc. will make this FCOI policy publicly accessible on its website.

Before expenditure of PHS/NIH funds, Kuhler Technologies, Inc. will ensure public accessibility of information concerning any Significant Financial Interest disclosed to the institution that meets all of the following criteria:

1. The SFI was disclosed and is still held by senior/key personnel;
2. Kuhler Technologies, Inc. determines that the SFI is related to PHS/NIH-funded research;
3. Kuhler Technologies, Inc. determines that the SFI is an FCOI.

Publicly accessible FCOI information will include, at minimum:

1. Investigator’s name;
2. Investigator’s title and role with respect to the research project;
3. Name of the entity in which the SFI is held;
4. Nature of the SFI;
5. Approximate dollar value of the SFI, 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.

This information will be updated at least annually and within 60 days of Kuhler Technologies, Inc.’s receipt or identification of information concerning any additional SFI that is determined to be an FCOI.

Kuhler Technologies, Inc. will make information concerning identified FCOIs held by senior/key personnel publicly accessible either by posting the information on a publicly accessible website or by providing a written response within five business days of a written request, as permitted by applicable NIH/PHS requirements. Such information will remain available for at least three years from the date it was most recently updated.

11. Subrecipient Requirements

If Kuhler Technologies, Inc. carries out PHS/NIH-funded research through a subrecipient, contractor, collaborator, or consortium partner, Kuhler Technologies, Inc. will take reasonable steps to ensure that the subrecipient complies with applicable PHS/NIH FCOI requirements.

A written agreement with the subrecipient will specify whether Kuhler Technologies, Inc.’s FCOI policy or the subrecipient’s own PHS-compliant FCOI policy applies.

If the subrecipient’s policy applies, the subrecipient must certify that its policy complies with PHS/NIH FCOI regulations. The written agreement will specify timelines for the subrecipient to report identified FCOIs to Kuhler Technologies, Inc. in sufficient time for Kuhler Technologies, Inc. to meet its NIH reporting obligations.

If Kuhler Technologies, Inc.’s policy applies, the written agreement will specify timelines for subrecipient Investigators to submit SFI disclosures to Kuhler Technologies, Inc. in sufficient time for review, management, and reporting.

12. Noncompliance

Failure to comply with this policy may result in disciplinary or corrective action, which may include removal from the research project, suspension of research activities, modification of responsibilities, notification to NIH, or other appropriate action.

If the failure of an Investigator to comply with this policy or an FCOI management plan appears to have biased the design, conduct, or reporting of PHS/NIH-funded research, Kuhler Technologies, Inc. will promptly notify NIH and take appropriate corrective action.

13. Records Retention

Kuhler Technologies, Inc. will maintain records of all Investigator disclosures, reviews, determinations, management plans, retrospective reviews, mitigation reports, and related actions for at least three years from the date of submission of the final expenditures report, or longer if required by applicable law, regulation, NIH policy, or award terms.

14. Designated Institutional Responsibilities

The Designated FCOI Official is responsible for:

1. Soliciting and reviewing Investigator SFI disclosures;
2. Determining whether disclosed SFIs constitute FCOIs;
3. Developing and monitoring FCOI management plans;
4. Ensuring required FCOI training is completed;
5. Submitting required FCOI reports to NIH through the appropriate eRA Commons module;
6. Maintaining FCOI records;
7. Ensuring this policy is publicly accessible;
8. Coordinating with subrecipients regarding FCOI compliance.

15. Questions

Questions regarding this policy should be directed to:

Designated FCOI Official:
Braeden Ostepchuk
Cofounder
Kuhler Technologies, Inc.
braeden@getkuhler.com
856-515-2772