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ARCHE VR

Arche XR Financial Conflict of Interest (FCOI) Policy

Effective Date: January 1st, 2026

Adopted pursuant to 42 CFR Part 50, Subpart F, Promoting Objectivity in Research, and NIH Grants Policy Statement Section 4.1.10

  

1. Purpose and Applicability

Arche XR, LLC (“the Company”) is committed to promoting objectivity in research by ensuring that the design, conduct, and reporting of research funded under Public Health Service (PHS) grants and cooperative agreements, including National Institutes of Health (NIH) awards, will be free from bias resulting from Investigator financial conflicts of interest. This policy implements the requirements of 42 CFR Part 50, Subpart F. It applies to all PHS-funded research at the Company other than Phase I Small Business Innovation Research (SBIR) or Small Business Technology Transfer (STTR) awards, and to each Investigator who is planning to participate in, or is participating in, such research. This policy is posted on the Company's publicly accessible website and has been submitted to NIH via the eRA Commons Institution Profile Module. To the extent any standard in this policy is more stringent than the regulation, the Company will adhere to this policy and will provide FCOI reports to NIH in accordance with the Company's own standards and within the timeframes prescribed by the regulation.


2. Definitions

Investigator means the project director or principal investigator and any other person, regardless of title or position, who is responsible for the design, conduct, or reporting of PHS-funded research, which may include collaborators or consultants.

Institutional responsibilities means an Investigator's professional responsibilities on behalf of the Company, including research, research consultation, and related administrative activities.

Significant Financial Interest (SFI) means 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, an SFI exists if the value of any remuneration received 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 non-publicly traded entity, an SFI exists if the value of any remuneration received from the entity in the twelve months preceding the disclosure, when aggregated, exceeds $5,000, or when the Investigator, spouse, or dependent children hold any equity interest.

• Intellectual property rights and interests (for example, patents or copyrights), upon receipt of income related to such rights and interests.

The term SFI does not include: salary, royalties, or other remuneration paid by the Company to the Investigator if the Investigator is currently employed or otherwise appointed by the Company, including intellectual property rights assigned to the Company and agreements to share in royalties related to such rights; any ownership interest in the Company held by the Investigator, the Company being a commercial or for-profit organization; income from investment vehicles such as mutual funds and retirement accounts, so long as the Investigator does not directly control the investment decisions made in 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 U.S.C. 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 such entities.

Financial Conflict of Interest (FCOI) means an SFI that could directly and significantly affect the design, conduct, or reporting of PHS-funded research.

Senior/key personnel means the project director or principal investigator and any other person identified as senior/key personnel by the Company in a grant application, progress report, or any other report submitted to the PHS by the Company under 42 CFR Part 50, Subpart F.

Disclosure obligations under this policy apply to foreign and domestic financial interests alike. The exclusions above for income from seminars, lectures, teaching engagements, or service on advisory committees or review panels apply only to United States federal, state, or local government agencies, United States institutions of higher education as defined at 20 U.S.C. 1001(a), and academic teaching hospitals, medical centers, or research institutes affiliated with United States institutions of higher education. Remuneration or other financial interests from foreign institutions of higher education or from the government of another country (including local, provincial, or equivalent governments of another country) must be disclosed when they meet the thresholds in the SFI definition.


3. Designated Official

The Chief Executive Officer serves as the Company's Designated Official (DO) responsible for the solicitation and review of Investigator disclosures, determination of relatedness and of whether an FCOI exists, development and monitoring of management plans, reporting to NIH, and maintenance of records under this policy. Where a disclosure is made by the Designated Official, or where the Designated Official holds an interest in the matter under review, the review and determination shall instead be performed by a Signing Official of the Company, registered as such in NIH eRA Commons, other than the Designated Official, provided that the reviewing Signing Official has no financial interest in the matter under review. If no such Signing Official is available, the Company will designate an independent external reviewer with no financial interest in the matter, such as outside counsel or a qualified independent consultant with research compliance experience. The reviewing official holds the same review, determination, and management authority as the DO with respect to that disclosure, and the DO shall comply with any management plan so established.


4. Investigator Disclosure Requirements

Each Investigator must disclose to the Designated Official all SFIs (including those of a spouse and dependent children) related to the Investigator's institutional responsibilities:

• No later than at the time of application for PHS-funded research;

• At least annually during the period of the award; and

• Within thirty days of discovering or acquiring a new SFI (for example, through purchase, marriage, or inheritance).

Investigators must also disclose the occurrence of any reimbursed or sponsored travel related to their institutional responsibilities, including the purpose of the trip, the identity of the sponsor or organizer, the destination, and the duration. There is no monetary threshold for travel disclosure. This travel disclosure requirement does not apply to travel reimbursed or sponsored by a federal, state, or local government agency, an institution of higher education as defined at 20 U.S.C. 1001(a), an academic teaching hospital, a medical center, or a research institute affiliated with an institution of higher education. The Designated Official will determine whether any disclosed travel requires further information to determine whether it constitutes an FCOI.


5. Review and Determination

The Designated Official (or, where applicable, the reviewing Signing Official) will review each disclosure to determine whether the SFI is related to PHS-funded research and, if so related, whether the SFI constitutes an FCOI. An SFI is related to PHS-funded research when it could be affected by the research or is in an entity whose financial interest could be affected by the research. An FCOI exists when the SFI could directly and significantly affect the design, conduct, or reporting of the research. For any Investigator who is new to a PHS-funded project, or for any new SFI disclosed by an existing Investigator during an ongoing project, the review, determination, and, if warranted, implementation of at least an interim management plan will be completed within sixty days. Likewise, whenever the Company identifies an SFI that was not disclosed timely by an Investigator or, for whatever reason, was not previously reviewed by the Company during an ongoing PHS-funded project (including an SFI not timely reviewed or reported by a subrecipient), the Designated Official will, within sixty days, review the SFI, determine whether it is related to the PHS-funded research, determine whether an FCOI exists, and, if so, implement, on at least an interim basis, a management plan specifying the actions that have been and will be taken to manage the FCOI going forward. Such cases are additionally subject to the retrospective review requirements of Section 8.


6. Management of Financial Conflicts of Interest

Prior to the Company's expenditure of any funds under a PHS-funded project, the Designated Official will, for any identified FCOI, develop and implement a written management plan specifying the actions that have been and will be taken to manage the conflict. Examples of conditions or restrictions that may be imposed include: public disclosure of the FCOI (for example, in publications and presentations of the research); disclosure of the FCOI to research participants for research involving human subjects; appointment of an independent monitor capable of taking measures to protect the design, conduct, and reporting of the research against bias; modification of the research plan; change of personnel or personnel responsibilities, or disqualification from participation in all or a portion of the research; reduction or elimination of the SFI; or severance of relationships that create the conflict. The Designated Official will monitor Investigator compliance with each management plan on an ongoing basis until completion of the project.


7. Reporting to NIH

The Company will submit FCOI reports to NIH through the eRA Commons FCOI Module as follows: prior to the expenditure of funds under a newly funded project, for any FCOI identified at that time; within sixty days of the identification of any FCOI for an Investigator newly participating in the project or newly disclosed or identified during an ongoing project; annually, at the same time the Company submits its annual progress report or at the time of extension, providing the status of each previously reported FCOI and any changes to the management plan; and following any retrospective review, to update a previously submitted report where applicable. Each FCOI report will include the information required by 42 CFR 50.605(b): the grant or contract number; the PD/PI or contact PD/PI; the name of the Investigator with the FCOI; the name of the entity with which the Investigator has the FCOI; the nature of the SFI (for example, equity, consulting fees, travel reimbursement, honoraria); the approximate dollar value of the SFI, stated within the following ranges: $0 to $4,999; $5,000 to $9,999; $10,000 to $19,999; amounts between $20,000 and $100,000 by increments of $20,000; amounts above $100,000 by increments of $50,000; 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; a description of how the financial interest relates to the PHS-funded research and the basis for the Company's determination that the financial interest conflicts with such research; and a description of the key elements of the management plan, including the role and principal duties of the conflicted Investigator in the research project, the conditions of the management plan, how the management plan is designed to safeguard objectivity in the research project, confirmation of the Investigator's agreement to the management plan, how the management plan will be monitored to ensure Investigator compliance, and other information as needed. An FCOI that is identified and eliminated prior to the expenditure of PHS-awarded funds need not be reported.


8. Retrospective Review and Mitigation

In cases of noncompliance, including an Investigator's failure to timely disclose an SFI later determined to constitute an FCOI, the Company's failure to timely review or manage such an FCOI, or an Investigator's failure to comply with a management plan, the Company will, within one hundred twenty days of its determination of noncompliance, complete and document a retrospective review of the Investigator's activities and the PHS-funded project to determine whether any research conducted during the period of noncompliance was biased in the design, conduct, or reporting of the research. Documentation of the retrospective review will include, at a minimum: the project number; the project title; the PD/PI or contact PD/PI if a multiple PD/PI model is used; the name of the Investigator with the FCOI; the name of the entity with which the Investigator has the FCOI; the reasons for the retrospective review; the detailed methodology used for the retrospective review (including the methodology of the review process, the composition of the review panel, and the documentation reviewed); the findings of the review; and the conclusions of the review. If bias is found, the Company will promptly notify NIH and submit a mitigation report, which will include the key elements documented in the retrospective review, a description of the impact of the bias on the research project, and the Company's plan of action or actions taken to eliminate or mitigate the effect of the bias. If an Investigator's failure to comply with this policy or a management plan appears to have biased the design, conduct, or reporting of the PHS-funded research, the Company will promptly notify NIH of the corrective action taken or to be taken. In any case involving a PHS-funded clinical research project whose purpose is to evaluate the safety or effectiveness of a drug, medical device, or treatment, and in which a noncompliant Investigator's FCOI is not managed or reported as required, the Company will require the Investigator to disclose the FCOI in each public presentation of the results of the research and to request an addendum to previously published presentations.


9. Training

Each Investigator must complete FCOI training, addressing this policy, the Investigator's disclosure responsibilities, and the requirements of 42 CFR Part 50, Subpart F, prior to engaging in PHS-funded research and at least every four years thereafter. Training must additionally be completed immediately when the Company revises this policy in a manner that affects Investigator requirements, when an Investigator is new to the Company, or when the Company finds that an Investigator is not in compliance with this policy or a management plan. The NIH online FCOI training tutorial satisfies this requirement. The Designated Official maintains records of training completion.


10. Subrecipients

When the Company carries out PHS-funded research through a subrecipient (including subawardees, consortium participants, contractors, or collaborators), the Company will incorporate into the written agreement with the subrecipient terms establishing whether this policy or the subrecipient's financial conflict of interest 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 the agreement will require the subrecipient to report all identified FCOIs of its Investigators to the Company within forty-five days of identification, a period sufficient to enable the Company to provide timely FCOI reports to NIH. If the subrecipient cannot so certify, its Investigators will be subject to this policy, and the agreement will specify time periods for the subrecipient's Investigators to submit disclosures to the Company sufficient to enable the Company to comply with its review, management, and reporting obligations. The Company will report to NIH all FCOIs of subrecipient Investigators prior to the expenditure of funds and within sixty days of any subsequently identified FCOI.


11. Public Accessibility

This policy is posted on the Company's publicly accessible website. Prior to the expenditure of funds under any PHS-funded project, and on an ongoing basis, the Company will ensure public accessibility of information concerning any FCOI held by senior/key personnel, as defined in 42 CFR 50.603, by written response to any requestor within five business days of a request. The response will include, at minimum: the Investigator's name, title, and role with respect to the research project; the name of the entity in which the SFI is held; the nature of the SFI; and the approximate dollar value of the SFI, stated within the following ranges: $0 to $4,999; $5,000 to $9,999; $10,000 to $19,999; amounts between $20,000 and $100,000 by increments of $20,000; amounts above $100,000 by increments of $50,000; 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. Each written response will reflect information current as of the date of the response, including any FCOI identified within the preceding sixty days. Requests may be directed to the Designated Official at the contact address on the Company's website. Information will remain available for three years from the date it was most recently updated.


12. Records

The Company will maintain records of all Investigator disclosures of financial interests, the Company's review of and response to each disclosure (whether or not the disclosure resulted in a determination of an FCOI), and all actions under this policy or any retrospective review, for at least three years from the date of submission of the final expenditures report for the relevant award, or for such longer periods as required by 45 CFR 75.361.


13. Enforcement

Failure by an Investigator to comply with this policy, including failure to disclose, complete training, or comply with a management plan, may result in sanctions determined by the Designated Official (or, for the Designated Official's own noncompliance, by the reviewing Signing Official), which may include a letter of reprimand, mandatory retraining, restriction on the use of award funds, suspension from participation in the research, or removal from the PHS-funded project, in addition to the retrospective review, reporting, and mitigation requirements of Section 8. The Company acknowledges that the HHS may at any time inquire into Investigator disclosures and the Company's review process, and that the Company must make information available to HHS upon request.


Approved by the Chief Executive Officer of Arche XR, LLC. Questions regarding this policy may be directed to info@archexr.com


Copyright © 2022-2026 Arche XR, LLC - All Rights Reserved.

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