top of page

Financial Conflict of Interest (FCOI) Policy

Purpose

​

This Financial Conflict of Interest Policy describes certain legal obligations applicable to Investigators’ disclosure of potential Financial Conflicts of Interest (“FCOI”). The purpose of this Policy is to comply with applicable law and to ensure the objectivity of the research conducted by EmpoweRx, Inc and its employees, contractors, and consultants.

 

Investigators applying for and working on Public Health Services (“PHS”), National Institutes of Health (“NIH”), or National Science Foundation (“NSF”) funded research must disclose significant financial interests that are related to the Investigator’s institutional responsibilities. Investigators are all persons, regardless of title or position, who are responsible for the design, conduct, or reporting of research proposed for funding by the PHS, NIH, or NSF (the foregoing agencies, together with any other organizations providing funding through grant or contract to which the regulations contemplated herein apply, collectively, the “Funding Agencies”), including collaborators or consultants. This Policy provides the framework to identify, evaluate and correct or remove real, apparent and potential conflicts of interest.

 

This Policy requires that each Investigator, subrecipient, subgrantee and collaborator affiliated with EmpoweRx, Inc on a Funding Agency project be in compliance with 42 CFR Part 50, Subpart F for grants and cooperative agreements (and 45 CFR Part 94 for contracts). In addition, these regulations describe NIH’s commitment to preserving the public’s trust that the research supported by the NIH is conducted without bias and with the highest scientific and ethical standards. EmpoweRx, Inc intends to comply with these regulations for all other Federal agency grant and contract efforts, as tailored or amended accordingly.

 

Abbreviations and Definitions

 

The following abbreviations and definitions are used in this Policy:

  • CFR - Code of Federal Regulations

  • FCOI - Financial Conflict of Interest

  • NIH - National Institutes of Health

  • NSF - National Science Foundation

  • PHS - Public Health Services

  • SBIR - Small Business Innovation Research

  • SFI - Significant Financial Interest

  • STTR - Small Business Technology Transfer

  • USC - United States Code

 

A “Financial Conflict of Interest” or “FCOI” exists when EmpoweRx, Inc reasonably determines that a significant financial interest could directly and significantly affect the design, conduct or reporting of Funded Research.

 

“Funded Research” means any research funded by a Funding Agency but excludes applications for Phase I support under the SBIR and STTR programs.

“Investigator” means any person (including subrecipients, subgrantees, and collaborators) who is responsible for the design, conduct, or reporting of Funded Research.

 

“Management” of an FCOI means taking action to address an FCOI, which can include reducing or eliminating the FCOI, to ensure, to the extent possible, that the design, conduct, and reporting of Funded Research will be free from bias.

 

“Designated Official” is the individual designated by EmpoweRx, to oversee the financial conflicts of interest process, including solicitation and review of disclosures of significant financial interests.

 

“Significant Financial Interest” or “SFI” means a foreign or domestic financial interest of the Investigator consisting of one or more of the interests described below (including those of the Investigator’s spouse and dependent children) that reasonably appears to be related to the Investigator’s institutional responsibilities.

 

An “SFI Disclosure” is a report that each Investigator shall submit to the Policy Coordinator: (a) at the time of application for Funded Research and prior to the expenditure of any Funding Agency funds therefor; (b) annually thereafter; (b) in the event of certain sponsored travel, as set forth below; and (c) within thirty (30) days of the discovery or acquisition by an Investigator of any SFI.

 

Significant Financial Interests (SFIs)

 

What is an SFI?

  • With regard to any publicly traded entity, an SFI exists if the value of any remuneration received by the Investigator (or the Investigator’s spouse or dependent children) from the entity in the twelve months preceding the disclosure and the value of any equity interest in the entity as of the date of disclosure, when aggregated, exceeds $5,000.

  • With regard to any privately held company, a SFI exists if the value of any remuneration received by the Investigator (or the Investigator’s spouse or dependent children) from the entity in the twelve months preceding the disclosure, when aggregated, exceeds $5,000, or when the Investigator (or the Investigator’s spouse or dependent children) holds any equity interest in the entity (e.g. stock, stock options, or other ownership interest).

  • For purposes of the definition of an SFI, remuneration includes salary and any payment for services not otherwise identified as salary (e.g. consulting fees, honoraria, paid authorship); and equity interest includes stock, stock options, or other ownership interest, as valued through reference to the public trading price or other reasonable measures of fair market value.

  • An SFI exists with respect to intellectual property rights and interests (e.g. patents, trademarks, copyrights) upon receipt of (or right to receive) any income or other value related to such intellectual property rights and interests.

  • With respect to a Significant Financial Interest, Investigators also must disclose (and such disclosure shall constitute an SFI Disclosure) any reimbursed or sponsored travel (i.e., travel which is paid on behalf of the Investigator and not reimbursed to the Investigator so that the exact monetary value may not be readily available) related to their institutional responsibilities; provided, however, that this disclosure requirement does not apply to travel that is reimbursed or sponsored by a federal, state, or local government agency, an institution of higher education as defined at 20 USC 1001(a), an academic teaching hospital, a medical center, or a research institute that is affiliated with an institution of higher education. This disclosure will include, at a minimum, the purpose of the trip, the identity of the sponsor/organizer, the destination, and the duration. Upon receipt of this disclosure, the Policy Coordinator will determine if further information is needed, including a determination or disclosure of monetary value, in order to determine whether the travel constitutes a FCOI.

 

What is not an SFI?

An SFI does not include the following types of financial interests:

  • salaries, royalties, or other remuneration paid by EmpoweRx, Inc to the Investigator if the Investigator is currently employed or otherwise appointed by EmpoweRx, Inc, including with respect to intellectual property rights assigned to EmpoweRx, Inc and agreements to share in royalties related to such rights;

  • any ownership interest in EmpoweRx, Inc held by the Investigator;

  • income from investment vehicles, such as mutual funds and retirements accounts, as long as the Investigator does not directly control the investment decisions made by these vehicles;

  • income from seminars, lectures, or teaching engagements sponsored by a federal, state or local government agency, an institution of higher education as defined at 20 USC 1001(a), an academic teaching hospital, a medical center, or a research institute that is affiliated with an institution of higher education; or

  • income from service on advisory committees or review panels for a federal, state or local government agency, an institution of higher education as defined at 20 USC001(a), an academic teaching hospital, a medical center, or a research institute that is affiliated with an institution of higher education.

 

SFI Disclosures and Reporting Process

 

Each Investigator shall submit SFI Disclosures (using the EmpoweRx, Inc SFI Disclosure Form appended to this Policy) to the Policy Coordinator as follows:

  • at the time of hire or engagement of such Investigator with respect to any Funded Research on which such Investigator shall be working;

  • at the time of application for Funded Research on which such Investigator shall be working and prior to the expenditure of any Funding Agency funds therefor;

  • annually on or before the anniversary date of such Investigator’s initial SFI Disclosure;

  • promptly in the event of reimbursed or sponsored travel that exceeds $5,000, as set forth above; and

  • within thirty (30) days of the discovery or acquisition of any SFI by such Investigator.

 

The Designated Official will review each SFI Disclosure and evaluate whether any such SFI Disclosure has given rise to an FCOI. An FCOI exists when the SFI could directly and significantly affect the design, conduct, or reporting of research.

 

If it is determined that there is no FCOI, the SFI Disclosure will be filed with the Policy Coordinator’s SFI Disclosure records. If a FCOI is identified, it will be included in EmpoweRx, Inc’s FCOI report submitted via the online eRA Commons FCOI module (or, where EmpoweRx, Inc is a subgrantee or subawardee, then EmpoweRx, Inc will report the FCOI as required under the applicable subgrant or subaward agreement) prior to the expenditure of any Funding Agency funds therefor. EmpoweRx, Inc will disclose financial conflicts of interest as required by applicable laws or regulations. Before expending any funds under a Funding Agency award, EmpoweRx, Inc will ensure public accessibility by posting financial conflicts of interest information on a publicly available web site or by responding in a timely manner to written requests as required under the regulations. The Designated Official will also report to the Funding Agency Awarding Component, as detailed in the regulations, the existence of any financial conflict of interest that has not been eliminated and will ensure that EmpoweRx, Inc has implemented a plan to manage the conflict. If a financial conflict of interest is identified after its initial reporting and during ongoing research (e.g., through participation of a new Investigator) and has not been eliminated, EmpoweRx, Inc will provide the Funding Agency Awarding Component with an update within 60 days and ensure that it has implemented a plan to manage the conflict. If the financial conflicts of interest report involves a significant financial interest that was not disclosed by an Investigator or not previously reviewed or managed by EmpoweRx, Inc (e.g., not reviewed or reported by a subrecipient in a timely manner), EmpoweRx, Inc will undertake a retrospective review. Such retrospective review will determine whether there was bias in the design, conduct, or reporting of the Funding Agency-funded research, or portion thereof, conducted prior to the identification and management of the conflict. If bias is found, EmpoweRx, Inc will promptly notify the Funding Agency Awarding Component and submit a mitigation report. Upon request, EmpoweRx, Inc will provide the Funding Agency with information relating to any Investigator disclosure of significant financial interests; EmpoweRx, Inc’s review of, and response to, such disclosure; and whether the disclosure resulted in EmpoweRx, Inc’s determination of a financial conflict of interest.

 

Training

 

All Investigators are required to complete training related to this Policy and applicable law as follows:

  • Upon joining EmpoweRx, Inc;

  • Prior to engaging in Funded Research;

  • At least once every four years;

  • In the event of any modifications to this Policy that affects an Investigator’s obligations hereunder; and

  • In the event EmpoweRx, Inc determines that an Investigator is not in compliance with this Policy or any FCOI management plan. 

  • NIH web-based training can be accessed through the NIH website at https://grants.nih.gov/grants/policy/coi/tutorial2018/story_html5.html, and participants are required to provide EmpoweRx, Inc with proof of completion.

 

Public Disclosure and Records Management

 

This policy will be publicly available on EmpoweRx, Inc’s website at www.EmpoweRx-Inc.com, and certain information regarding FCOIs will be available within five days of a qualified written request. EmpoweRx, Inc will maintain records of all SFI disclosures, and records of resulting EmpoweRx, Inc management or other action with respect to the respective FCOI, for at least three years from the date of submission of the final expenditures report for the applicable Funded Research. Identified FCOIs held by senior/key personnel will be publicly available on EmpoweRx, Inc’s website, and will be updated at least annually, or within 60 days of a newly identified FCOI, and will remain available for 3 years.

 

The Designated Official or their designee shall be responsible for the following: 

  • Informing EmpoweRx, Inc Investigators of their obligations under this policy and any related regulations; 

  • Reviewing disclosures of significant financial interest with EmpoweRx, Inc’s Administrator to determine whether they are related to the subject research and, if so, whether they constitute financial conflicts of interest; 

  • Screening and managing potential financial conflicts of interest; 

  • Maintaining all records relating to disclosures of financial interests, EmpoweRx, Inc’s review of and response to such disclosures, and any related actions under this policy; 

  • Ensuring inclusion of any required certifications in applications for funding or contract proposals; and 

  • Reporting and disclosure as required under this policy and applicable regulations.

  • Taking reasonable steps to ensure that Investigators for subrecipients (e.g., subgrantees, subcontractors, or collaborators) fully comply with this policy or provide EmpoweRx, Inc with sufficient assurances to enable EmpoweRx, Inc’s compliance with all applicable laws or regulations. To this end, the written agreement between EmpoweRx, Inc and the subrecipient will specify whether EmpoweRx, Inc’s or the subrecipient’s financial conflicts of interest policy will apply to the subrecipient’s Investigators and, if the subrecipient’s policy will apply, the Designated Official will: 

    • Obtain certification from the subrecipient that its policy complies with EmpoweRx, Inc’s policy and the applicable regulations (absent such certification, EmpoweRx, Inc’s policy will apply to the subrecipient’s Investigators, and

    • Establish time periods for subrecipient reporting of financial conflicts of interest to EmpoweRx, Inc that enable EmpoweRx, Inc to report such conflicts in a timely manner, as required under its policy and the applicable regulations.

 

Subrecipients

 

With respect to subrecipients, EmpoweRx, Inc shall establish, via a written agreement, whether a subrecipient will follow the FCOI policy of EmpoweRx, Inc or the FCOI policy of the subrecipient. If applicable, EmpoweRx, Inc shall obtain a certification from a subrecipient that its FCOI policy complies with the applicable regulation. If applicable, EmpoweRx, Inc shall include in the written subrecipient agreement a requirement for the subrecipient to report identified FCOIs for its Investigators in a time frame that allows EmpoweRx, Inc to report identified FCOIs to the applicable Funding Agencies as required by the regulation. Alternatively, if applicable, EmpoweRx, Inc shall include in the written agreement a requirement to solicit and review subrecipient Investigator disclosures that enable EmpoweRx, Inc to identify, manage and report identified FCOIs to the Funding Agency.

 

Compliance and Penalties for Non-Performance

 

Within 120 days of any determination by EmpoweRx, Inc that an Investigator has failed to comply with this Policy, failed to disclose an SFI, or failed to comply with the FCOI management plan, then EmpoweRx, Inc shall complete a retrospective review of such Investigator’s activities to determine the possibility of any bias in such Investigator’s research activities. The retrospective review shall include, at minimum, the following key elements:

  • Project number

  • Project title

  • PD/PI (or contact PD/PI if multiple PD/PI model is used)

  • Name of the Investigator with the FCOI

  • Name of the entity with which the Investigator has an FCOI

  • Reasons for the retrospective review 

  • Detailed methodology used for the retrospective review 

  • Findings of the review

  • Conclusion of the review

 

If EmpoweRx, Inc determines that there has been any such bias, EmpoweRx, Inc shall submit a mitigation report to the applicable Funding Agency, in accordance with 42 CFR 50.605(b)(3), that shall address the impact of the bias on the Funded Research and the actions EmpoweRx, Inc has taken to mitigate the bias and manage the FCOI. EmpoweRx, Inc will work with the Investigator to establish an FCOI management plan, and the Investigator shall disclose the FCOI in each public presentation related to the results of the applicable Funded Research if not previously disclosed, or request an addendum to previously published presentations. In certain instances the Investigator may be prohibited from continuing to work on the project or receiving any NIH funding in the future.

​

​

Updated 8.25.25

COPYRIGHT © 2025, EMPOWERX, INC. ALL RIGHTS RESERVED. | FCOI POLICY

bottom of page