FCOI Policy

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Geneial Financial Conflict of Interest (FCOI) Policy

The National Institutes of Health (NIH) has adopted regulations (42 CFR Part 50 Subpart F and 45 CFR Part 94) on Promoting Objectivity in Research. These regulations describe the actions an individual and an organization must take to promote objectivity in research. The regulations apply to all NIH funded grants, cooperative agreements, research contracts (but not Phase 1 Small Business Innovation Research or Small Business Technology Transfer program grants), and subawards where the originating sponsor is NIH.

Introduction

The purpose of this FCOI (Financial Conflict of Interest) Policy is to ensure compliance with the 2011 revised FCOI regulation, as outlined in 42 CFR Part 50 Subpart F, which promotes objectivity in research funded by the National Institutes of Health (NIH). This policy applies to all NIH grants and cooperative agreements received by Geneial, excluding Phase I Small Business Innovative Research (SBIR) and Small Business Technology Transfer (STTR) applications and awards. The policy covers all Investigators, as defined by the regulation, who are planning to participate in or are participating in Public Health Service (PHS) funded research.

Definitions

Financial Interest: Any interest, including but not limited to, salary, remuneration, royalties, consulting fees, honoraria, equity interests, intellectual property rights, or other financial benefits received or expected to be received by an individual or their immediate family members, which could be reasonably expected to directly or indirectly influence their professional judgment in the conduct, reporting, or communication of research, education, or other activities related to Geneial.,

Significant Financial Interest (SFI): A financial interest meeting or surpassing an annual (rolling calendar basis) threshold of $5,000 or greater that could reasonably be expected to directly or indirectly affect the design, conduct, or reporting of research, education, or other activities related to Geneial. This may include financial interests of the individual, as well as those of their immediate family members. Specifically, a Significant Financial Interest exists:

(i) With regard to any publicly traded entity, when 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 for the investigator, investigator’s spouse and dependent children, exceeds $5,000. For purposes of this definition, remuneration includes salary and any payment for services not otherwise identified as salary (e.g., consulting fees, honoraria, paid authorship); 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;

(ii) 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 (e.g., stock, stock option, or other ownership interest); or

(iii) With regard to intellectual property rights and interests (e.g., patents, copyrights), a significant financial interest exists upon receipt of income of greater than $5,000 related to such rights and interests.

(iv) Third party reimbursed or sponsored travel (i.e., that which is paid on behalf of the Investigator and/or the Investigator’s spouse/dependent children) of greater than $5,000 that is related to the Investigator’s institutional responsibilities (i.e., administrative, teaching, research, or clinical activities) must be disclosed to APS. The details of this disclosure will include at a minimum, the purpose of the trip, the identity of the sponsor/organizer, the destination, and the duration. This disclosure requirement excludes travel paid for by APS and does not apply to travel that is reimbursed or sponsored by an U.S. federal, state, or local government agency, an U.S. 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.

The term significant financial interest does not include the following types of financial interests:

(i). Salary, royalties, or other remuneration paid by APS to the Investigator if the Investigator is currently employed or otherwise appointed by APS, including intellectual property rights assigned to APS and agreements to share in royalties related to such rights;

(ii). 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;

(iii). Income from seminars, lectures, or teaching engagements sponsored by an U.S. 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

(iv). Income from service on advisory committees or review panels for an U.S. 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.

Investigator: 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 research funded by award, or proposed for such funding, which may include, for example, collaborators or consultants. Principal Investigators/Project Directors, upon consideration of the individual’s role and degree of independence in carrying out the work, will determine who is responsible for the design, conduct, or reporting of the research.

Financial Conflicts of Interest: situations in which an investigator has a significant financial interest that may compromise, or have the appearance of compromising, professional judgment in the design, conduct, or reporting of research. A Financial Conflict of Interest exists when Investigator’s Significant Financial Interest is:

• Related to PHS funded research. An SFI is related to PHS-funded research when the SFI could be affected by the research or is in an entity whose financial interest could be affected by the research, and

• An SFI is considered a FCOI when the SFI could directly and significantly (i.e., have a material effect) affect the design, conduct, or reporting of the NIH-funded research.

If it is determined that there is a potential conflict of interest, then steps will be taken to determine what measures are needed to manage, reduce or eliminate specific SFI to prevent the potential to compromise or bias professional judgment or objectivity regarding the design, conduct or reporting of research.

Policy Development and Certification

Geneial has developed and maintains an up-to-date, written, and enforced administrative process to identify and manage FCOIs. This FCOI policy is made publicly accessible on the Geneial website and a copy has been submitted to the NIH via the eRA Commons Institution Profile Module. Geneial agrees to promote and enforce Investigator compliance with the FCOI regulation and provide initial and ongoing FCOI reports to the NIH via the FCOI Module. Additionally, Geneial agrees to make FCOI and Significant Financial Interest (SFI) information available to the NIH promptly upon request (within 5 business days) and fully comply with all regulatory requirements.

Training Requirements

Geneial shall train each Investigator on the institution’s FCOI policy and the Investigator’s disclosure responsibilities regarding foreign and domestic SFIs. Training shall be provided on the federal regulation, including the FCOI Training resources available on NIH’s FCOI Training website. All PHS-supported Investigators must complete FCOI training before engaging in research related to any PHS/NIH-funded grant. Training will be completed at least every four years, immediately upon revision of the FCOI policy affecting Investigators, and when a new Investigator joins the institution or fails to comply with the policy or management plan.

Disclosure, Review, and Monitoring Requirements

Geneial requires each Investigator to disclose all foreign and domestic SFIs related to their institutional responsibilities that meet or exceed the regulatory definition of SFI or the definitions of SFIs as provided above, using the linked disclosure form. Disclosures will be made to Geneial’s designated FCOI contact. Disclosures will be made at the time of application for PHS/NIH-funded research, annually during the award period, and within thirty (30) days of acquiring a new SFI. The designated institutional official(s) shall solicit and review these disclosures to determine if an SFI is related to PHS/NIH-funded research and whether it constitutes an FCOI. Examples of conditions or restrictions that might be imposed to manage conflicts of interest include public disclosure of financial conflicts of interest (e.g. when presenting research), disclosure of financial conflicts to research participants, monitoring by external or independent reviewers, modification of the research plan, implementing changes in personnel responsibilities or personnel, reduction or elimination of financial interest, or severance of relationships causing conflicts.

The designated official(s) shall review all Investigator SFI disclosures before the expenditure of funds and develop and implement a management plan to address any identified FCOIs. If an Investigator is new to the research project or discloses a new SFI, the designated official(s) shall review the disclosure within sixty (60) days, determine the relationship to PHS/NIH-funded research, and implement an interim management plan. Similar reviews and actions shall be conducted whenever an SFI is identified but not previously reviewed, including those of subrecipient Investigators. Geneial shall take necessary actions to manage FCOIs and monitor Investigator compliance with management plans throughout the project.

Subrecipient Monitoring

Geneial shall take reasonable steps to ensure that any subrecipient Investigators comply with the NIH FCOI regulation. Geneial shall include appropriate terms and conditions in agreements with subrecipients to establish that the subrecipient’s Investigators will comply with the regulation, provide FCOI reports, and adhere to a mutually agreeable management plan if FCOIs are identified.

Recordkeeping

Geneial shall maintain records related to all Investigator disclosures of SFIs and the institution’s review and response to such disclosures. These records shall be retained for at least three years from the date of the final FCOI report or, where applicable, from other dates specified in 45 CFR 75.361 for different situations.

Public Accessibility

Geneial shall make certain information related to FCOIs accessible to the public through our website within 5 days of identification of FCOIs. This information includes 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 value of the SFI. Geneial may choose to redact certain information as permitted by applicable laws and regulations.

Non-Compliance and Investigator Sanctions

Geneial is committed to ensuring Investigator compliance with the Financial Conflict of Interest (FCOI) policy. To enforce compliance and provide appropriate remedies for noncompliance, the following mechanisms and actions shall be implemented:

 

    1. Investigator Sanctions: In the event of noncompliance, Geneial shall impose appropriate sanctions or administrative actions on Investigators. These may include but are not limited to letters of reprimand, restrictions on the use of funds, suspension of research activities, removal from the project, reassignment of responsibilities, and other disciplinary measures as deemed necessary and proportionate to the nature and severity of the noncompliance. Sanctions shall be enforced in accordance with applicable regulations and institutional policies.
    2. Retrospective Review: Within 120 days of determining noncompliance or instances where a significant financial interest (SFI) was not timely disclosed or previously reviewed (e.g. when the investigator fails to disclose a new or updated SFI within 30 days, when Geneial fails to take action within 60 days of an investigator disclosure, or when an investigator fails to comply with a management plan), Geneial shall conduct a retrospective review. The retrospective review will also be conducted whenever a financial conflict of interest (FCOI) is not identified or managed in a timely manner. The review will include the following key elements:
        • Project Number
        • Project Title
        • Principal Investigator (PI) or contact PI if multiple 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 review, including the review process, composition of the review panel, and documentation reviewed
        • Findings of the review
        • Conclusions of the review
    3. Financial Conflict of Interest Management Plan: In cases where an FCOI is identified, Geneial shall develop and implement a management plan in accordance with applicable regulations. The Investigator involved shall be required to comply with the provisions outlined in the FCOI management plan. Failure to comply with the plan may result in additional sanctions or actions, as deemed appropriate. The management plan is to be implemented prior to the company’s expenditure of PHS funds awarded for the research project. The management plan will specify the actions that are required to manage the Financial Conflict of Interest, and will include a description of the key elements outlined below:
        • The role and principal duties of the conflicted Investigator in the research project
        • 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
        • Other information as needed.

A management plan may include:

 

    • Public disclosure of financial conflicts of interests (e.g., when presenting or publishing the research, to staff members working on the project, etc.)
    • For research projects involving human subjects research, disclosure of financial conflicts of interest directly to participants
    • Appointment of an independent monitor capable of taking measures to protect the design, conduct, and reporting of the research against bias resulting from the Financial Conflict of Interest
    • Modification of the research plan
    • Change of personnel or personnel responsibilities, or disqualifications of personnel from participation in all or a portion of the research.
    • Reduction or elimination of the financial interest (e.g., sale of an equity interest), or
    • Severance of relationships that create financial conflicts

 

    1. Investigators must formally agree to the proposed management strategies. All management plans are required to be signed by the Investigator, the PI and CEO. Compliance of the management plan will be monitored by the Principal Investigator.
    2. Public Disclosure and Addendum: If the Department of Health and Human Services determines that a PHS/NIH-funded research project, specifically a clinical research project evaluating the safety or effectiveness of a drug, medical device, or treatment, was conducted or reported by an Investigator with an FCOI that was not managed or reported as required, Geneial shall take the following steps:
        • The Investigator involved shall disclose the FCOI in each public presentation of the research results.
        • The Investigator shall request an addendum to previously published presentations to disclose the FCOI.

Policy Review

Geneial shall review this FCOI policy at least every three years or more frequently as required by changes in federal regulations or institutional needs. The policy shall be updated as necessary to ensure compliance with applicable laws and regulations.

Reporting Requirements to NIH

Geneial shall submit initial, annual, and revised FCOI reports to the NIH via the eRA Commons FCOI Module. Reports will be sent prior to the expenditure of funds, within sixty (60) days of an Investigator’s participation in a project, and annually along with other required reports. If new information is discovered following a retrospective review, Geneial shall promptly update the previously submitted FCOI report when new SFIs are disclosed, and within 30 days of the identification of a new FCOI, provide an updated FCOI report to the NIH. The FCOI report shall include sufficient information to enable the NIH to understand the nature and extent of the FCOI and any actions taken to manage, reduce, or eliminate the conflict.

Other Reporting Requirements

If bias is found the Institution will notify and submit a mitigation report to the sponsor. The mitigation report will include, at a minimum, the key elements documented in the retrospective review and a description of the impact of the bias on the research project and the Institution’s plan of action or actions taken to eliminate or mitigate the effect of the bias (e.g., impact on the research project; extent of harm done, including any qualitative and quantitative data to support any actual or future harm; analysis of whether the research project is salvageable). Thereafter, the Institution will submit FCOI reports annually.

If an Investigator fails to comply with the Institution’s FCOI policy or a FCOI management plan appears to have biased the design, conduct, or reporting of the PHS/NIH-funded research the institution will take corrective action further described in 42 CFR 50.606(a).

Policy Distribution

This FCOI policy shall be provided to all Investigators engaged in PHS/NIH-funded research and shall be made readily accessible on the Geneial website. Geneial shall ensure that Investigators are aware of their obligations and responsibilities under this policy.

This FCOI Policy is effective as of July 3, 2023 and supersedes any previous FCOI policies issued by Geneial.