Financial Conflict of Interest (FCOI) Policy
Invenio Imaging, Inc. Financial Conflict of Interest Policy for Investigators and Subrecipients on Public Health Service Grants, Contracts, and Cooperative Agreements
This Policy has been established as of February 17, 2023 to comply with the requirements of 42 CFR Part 50 Subpart F federal regulations on the Responsibility of Applicants for Promoting Objectivity in Research for which PHS Funding is Sought and Responsible Prospective Contractors, commonly known as the Financial Conflict of Interest regulations (the “Regulations”). Invenio shall update this Policy periodically as needed to comply with changes in the Regulations.
Except for Phase I SBIR and Phase I STTR grants (“Exempted Research”), this Policy applies to all Investigators and Subrecipients who participate in research funded by grants, contracts, and cooperative agreements with the Public Health Service (PHS), including the National Institutes of Health (NIH), and other research funded by a government contract that incorporates the Regulations in its terms (collectively, “Covered Research”). The term “Investigator” means an employee, consultant, collaborator, or agent of Invenio who, regardless of title or position, is responsible for the design, conduct, or reporting of research proposed for funding, or actually funded, under Covered Research. The term “Subrecipient” means a grant subrecipient, subcontractor, or other person or entity who has responsibility for the design, conduct, or reporting of research proposed for funding, or actually funded, under Invenio Covered Research. Unless special circumstances apply, vendors of supplies and equipment to Invenio and vendors who provide routine testing services to Invenio without any significant knowledge of the Covered Research are not Subrecipients.
The CEO of Invenio shall designate an employee of Invenio who is not an Investigator to administer this Policy. Such employee shall be referred to in this Policy as the “Administrator” and shall fulfill all obligations that are assigned to the Institutional Official under the Regulations.
IV. Existence of Financial Conflict of Interest.
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 significant financial interest 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. For purposes of this definition, remuneration includes salary and any payment for services not otherwise identified as salary; equity interest includes any stock, stock option, or other ownership interest, as determined through reference to public prices or other reasonable measures of fair market value;
With regard to any non-publicly traded entity, a significant financial interest 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 (or the Investigator’s spouse or dependent children) holds any equity interest; or
Intellectual property rights and interests, upon receipt of income related to such rights and interests.
Investigators also must disclose the occurrence of any reimbursed or sponsored travel, 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 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. This disclosure will include the purpose of the trip, the identity of the sponsor/organizer, the destination, and the duration. Invenio’s officials will determine if further information is needed, including a determination or disclosure of monetary value, in order to determine whether the travel constitutes an FCOI with the PHS-funded research.
The term significant financial interest does not include the following types of financial interests: salary, royalties, or other remuneration paid by the Institution to the Investigator if the Investigator is currently employed or otherwise appointed by the Institution, including intellectual property rights assigned to the Institution and agreements to share in royalties related to such rights; any ownership interest in Invenio held by the Investigator; income from investment vehicles, such as mutual funds and retirement accounts, as 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 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.
Investigators must disclose all foreign financial interests (which includes income from seminars, lectures, or teaching engagements, income from service on advisory committees or review panels, and reimbursed or sponsored travel) received from any foreign entity, including foreign Institutions of higher education or a foreign government (which includes local, provincial, or equivalent governments of another country) when such income meets the threshold for disclosure (e.g., income in excess of $5,000).
All Investigators must submit to the Administrator a report that discloses all Significant Financial Interests in Covered Research: (1) when planning to participate in the Covered Research, not later than the submission of the application for the Covered Research, (2) annually if participating in Covered Research, on or about June 30, and (3) as soon as possible, but not later than 30 days, after discovering or acquiring (e.g., through purchase, marriage, or inheritance) a new Significant Financial Interest. The Administrator shall review each report promptly after submission by the Investigator and shall inform the Investigator if a FCOI exists. If the Investigator eliminates the FCOI (which is not always possible or desirable) and revises and resubmits the report to the Administrator, then no further action is needed. However, if the FCOI continues, then the Administrator shall take the actions described below in this Policy.
VI. Conflict Management and Disclosure.
If a FCOI exists, then the Administrator shall take the following actions prior to any expenditure of funds under the Covered Research to which the FCOI relates or, if the Covered Research is in progress and the FCOI is newly disclosed, then not later than 60 days after the FCOI is disclosed:
Develop, implement, and administer a management plan that specifies the actions that have been taken, and shall be taken, to manage the FCOI during the period of the Covered Research. The Regulations provide the following non-limiting examples of conditions or restrictions that might be imposed by the Administrator to manage a FCOI (i) public disclosure of the FCOI (e.g., when presenting or publishing the research); (ii) for research projects involving human subjects research, disclosure of the FCOI directly to participants; (iii) appointment of an independent monitor capable of taking measures to protect the design, conduct, and reporting of the research against bias resulting from the FCOI; (iv) modification of the research plan; or (v) change of personnel or personnel responsibilities, or disqualification of personnel from participation in all or a portion of the research.
Disclose on the Invenio website the following information: the Investigator’s name; the Investigator’s title and role with respect to the research project; the name of the entity in which the significant financial interest is held; the nature of the significant financial interest; and the approximate dollar value of the significant financial interest (dollar ranges are permissible: $0–$4,999; $5,000–$9,999; $10,000–$19,999; amounts between $20,000–$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. This information shall be updated annually and within 60 days after a new FCOI is disclosed to the Administrator. The website shall note that the information provided is current as of the date listed and is subject to updates, on at least an annual basis and within 60 days after Invenio identifies a new FCOI. The information posted on the website will remain for at least 3 years after the initial post.
Provide to the appropriate PHS agency a report regarding the FCOI. The report shall include sufficient information to enable the PHS agency to understand the nature and extent of the financial conflict, and to assess the appropriateness of the management plan. Elements of the FCOI report shall include, but are not necessarily limited to the following: (i) project number; (ii) PD/PI or Contact PD/PI if a multiple PD/PI model is used; (iii) name of the Investigator with the FCOI; (iv) name of the entity with which the Investigator has a FCOI; (v) nature of the financial interest (e.g., equity, consulting fee, travel reimbursement, honorarium); (vi) value of the financial interest (dollar ranges are permissible: $0–$4,999; $5,000–$9,999; $10,000–$19,999; amounts between $20,000–$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; (vii) a description of how the financial interest relates to the Covered Research and the basis for Invenio’s determination that the financial interest conflicts with such research; and (viii) a description of the key elements of Invenio’s management plan, including: (A) role and principal duties of the conflicted Investigator in the Covered Research; (B) conditions of the management plan; (C) how the management plan is designed to safeguard objectivity in the Covered Research; (D) confirmation of the Investigator’s agreement to the management plan; (E) how the management plan will be monitored to ensure Investigator compliance; and (F) other information as needed.
In addition, for any FCOI previously reported by Invenio with regard to ongoing Covered Research, Invenio shall provide to the appropriate PHS agency an annual FCOI report that addresses the status of the FCOI and any changes to the management plan for the duration of the Covered Research. The annual FCOI report shall specify whether the FCOI is still being managed or explain why the FCOI no longer exists. Invenio shall provide annual FCOI reports to the appropriate PHS agency for the duration of the Covered Research (including extensions with or without funds) in the time and manner specified by the PHS agency.
VII. Training Requirement.
Invenio shall inform each Investigator of this Policy, the Investigator’s responsibilities regarding disclosure of Significant Financial Interests, and of the Regulations, and shall require each Investigator to complete training regarding this Policy prior to engaging in Covered Research and thereafter at least every four years, and immediately when any of the following circumstances apply: (1) Invenio revises this Policy or any procedures in a manner that affects the requirements of Investigators; (2) an Investigator is new to Invenio; or (3) Invenio finds that an Investigator is not in compliance with this Policy or a management plan instituted by the Administrator.
VIII. Procedures for Subrecipients.
If Invenio conducts Covered Research through a subrecipient (e.g., subcontractors), Invenio must take reasonable steps to ensure that any subrecipient Investigator complies with this Policy and the Regulations by incorporating as part of a written agreement with the subrecipient terms that establish (1) that this Policy will apply to Investigators of the subrecipient, (2) time periods for the subrecipient to submit disclosures of Significant Financial Interests, which time periods shall allow sufficient time for Invenio to comply with its requirements under this Policy, (3) that the subrecipient will accept any determination by the Administrator that a FCOI exists and shall enforce on its Investigators any management plan established by the Administrator. Alternatively, at the discretion of the Administrator, Invenio may accept the FCOI policy of a subrecipient, provided that such policy complies with the Regulations, and that Invenio and the subrecipient enter into a written agreement in which the subrecipient provides written certification that the policy complies with the Regulations, the subrecipient agrees to the other requirements set forth above, and the subrecipient agrees to any other terms and conditions required by the Administrator to ensure that Invenio complies with the Regulations.
If Invenio discovers that an Investigator has failed to disclose a Significant Conflict of Interest within the timelines set forth in this Policy, or if an Investigator fails to comply with a management plan established under this Policy, then Invenio shall remedy such noncompliance and conduct a retrospective review as required under the Regulations. In such event, the Administrator shall refer to the Regulations for all necessary details and procedures.
Any violation of this Policy by an Investigator may result in disciplinary action by Invenio, up to and including termination of employment.
XI. Retrospective Review and Mitigation.
Whenever a Financial Conflict of Interest is not identified or managed in a timely manner, including:
Failure by the Investigator to disclose a Significant Financial Interest that is determined by Invenio to constitute a Financial Conflict of Interest;
Failure by Invenio to review or manage such a Financial Conflict of Interest; or
Failure by the Investigator to comply with a Financial Conflict of Interest management plan;
Invenio shall, within 120 days of Invenio’s determination of noncompliance, complete a “retrospective review” of the Investigator’s activities and the NIH-funded research project to determine whether any NIH-funded research, or portion thereof, conducted during the time period of the noncompliance was biased in the design, conduct, or reporting of such research.
If bias is found, Invenio must notify NIH promptly and submit a mitigation report, which must include, at a minimum, the key elements documented in the retrospective review above and a description of the impact of the bias on the research project and Invenio’s plan of action or actions taken to eliminate or mitigate the effect of the bias.
XII. Public Disclosure and Record Retention.
Invenio shall publicly disclose this Policy on its website, as required by the Regulations.
Invenio will keep all records of all Investigator disclosures of financial interests and the Institution’s review of, or response to, such disclosure (whether or not a disclosure resulted in the Institution’s determination of a Financial Conflict of Interest), and all actions under the Institution’s policy or retrospective review, if applicable, as follows:
Records of financial disclosures and any resulting action will be maintained by Invenio for at least three years from the date of submission of the final expenditures report or, where applicable, from other dates specified in 45 C.F.R. 75.361, for different situations. Such records shall be available for audit by the PHS as set forth in the Regulations.