Policy and Procedures
Policy
Invizyne Technologies, Inc. (“Invizyne”) is committed to promoting objectivity in research. We support this commitment by complying with National Science Foundation and the Department of Health and Human Services’ Public Health Service (“PHS”) regulations requiring disclosure of Significant Financial Interests and management of all actual and perceived conflicts of interest under sponsored programs. Compliance with this Financial Conflicts of Interest Policy and Procedures (“FCOI Policy”) is a requirement for all outgoing proposals to, and all incoming awards from external sponsors. This FCOI Policy serves as a supplement to Invizyne’s general policy related to conflicts of interest and other policies in the company’s handbook.
Purpose
The purpose of the FCOI Policy is to promote objectivity in research by establishing standards that provide a reasonable expectation that the design, conduct, and reporting of research funded under federal grants or cooperative agreements will be free of bias resulting from Investigator financial conflicts of interest.
More specifically, the procedures outlined below are designed to enforce the FCOI Policy to identify and manage FCOIs as defined by 42 CFR Part 50 Subpart F. This FCOI Policy serve to:
Promote and ensure enforcement of investigator compliance with the regulation, including requiring appropriate training of investigators
Manage FCOIs and provide initial and ongoing FCOI reports
Make FCOI and Significant Financial Interest (“SFI”) information (including related institutional reviews and determinations) available to HHS, NSF and the public, promptly, upon request
Ensure full compliance with the requirements of the federal regulations and Invizyne COI and FCOI Policy
Investigators (as defined below) who fail to fully and truthfully disclose actual or perceived conflicts of interest or fail to comply with any plan for managing and/or eliminating the conflicts are subject to ordinary disciplinary processes of Invizyne, up to and including termination of employment. Such actions of an Investigator also will be considered in deliberations on contract renewal and promotions.
Definitions
Conflict Monitoring: The President & CEO reviews financial conflict of interest disclosures and then works with the Grants Manager and Investigator to formulate a management plan.
Financial Conflict of Interest (“FCOI”): A financial interest that could directly and significantly affect the design, conduct, or reporting of funded research, or the performance of duties and responsibilities performed on behalf of Invizyne.
Financial Interest: Anything of monetary value or potential monetary value received from a non-Invizyne domestic or foreign source that reasonably appears to be related to the
individual’s duties and responsibilities including, but not limited to payment from a nonInvizyne source, travel, stock, or intellectual property.
Institutional Responsibilities: An Investigator’s professional responsibilities to and on behalf of Invizyne.
Investigator: Any person who is responsible for the design, conduct, or reporting of research funded by external sponsors, or proposed for such funding, which may include Invizyne staff, collaborators, consultants, subcontractors, subgrantees and subrecipients.
Management Plan: A plan of action to address a financial conflict of interest, which can include reducing, manage, or eliminating the financial conflict of interest, to ensure to the extent possible that the design, conduct, and reporting of research will be free from bias. The Management Plan may also include a retrospective review and mitigation report, if necessary.
Public Health Service (“PHS”): The Public Health Service of the U.S. Department of Health and Human Services (“PHS”), and any components of the PHS to which the authority involved may be delegated including the National Institutes of Health (“NIH”) or as hereafter amended.
Significant Financial Interest (“SFI”): A financial interest that reasonably appears related to the Investigator’s institutional responsibilities. SFI does not include salary, royalties, bonuses or other remuneration paid by Invizyne directly or as assignee, income from investments such as mutual funds and retirement accounts where the Investigator does not control investment decisions, or income from review panels or advisory committees for Federal or state government agencies, or institutions of higher education in the U.S. or their affiliated academic teaching hospitals, medical centers or research institutes.
Further definitions are included below for PHS-specific and NSF-specific SFIs:
SFI under PHS: 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:
(1) Remuneration and/or equity interest in any publicly traded entity in the
twelve (12) preceding months exceeding $5,000 per year in value.
Remuneration as used in this definition consists of salary and other payments for services not otherwise identified as salary (e.g., consulting fees, honoraria, paid authorships. Equity interest as used in this definition consists of stock, stock options, or other ownership interests.
(2) Remuneration and/or equity interest in any non-publicly traded entity in
the twelve (12) preceding months exceeding $5,000 per year in value.
Remuneration as used in this definition consists of salary and other
payments for services not otherwise identified as salary (e.g., consulting
fees, honoraria, paid authorships. Equity interest as used in this definition consists of stock, stock options, or other ownership interests.
(3) Intellectual property rights and interests upon receipt of income related
to such rights or interests.
(4) All sponsored or reimbursed travel regardless of the amount paid by any
entity other than Invizyne, the state, the Federal government, an institution of higher education in the U.S. or its affiliated academic teaching hospitals, medical centers or research institutes.
SFI under NSF: Anything of monetary value including, but not limited to, salary or other
payments for services (e.g., honoraria, consulting service fees), equity interests (e.g.,
stocks, stock options), and intellectual property rights (e.g., patents, copyrights, and
royalties from such rights).
SFI does NOT include:
Salary, royalties or other compensation or remuneration from Invizyne;
Ownership interests in a business if the business is an applicant under a Federal Phase 1 Small Business Innovation Research (“SBIR”) or Small Business Technology Transfer (“STTR”) program;
Income from seminars, lectures or teaching engagements sponsored by a public or non-profit entity;
Income from review panels or advisory committees for Federal or state government agencies, or non-profit entities.
An equity interest, when aggregated when aggregated for the Investigator and the Investigator’s spouse and dependent children, meets both of the following tests: does not exceed $10,000 in value as determined through reference to public prices or other reasonable measures of fair market value, and does not represent more than a 5% ownership interest in any single entity; or
Salary, royalties or other payments that, when aggregated for the Investigator and the Investigator’s spouse and dependent children, are not expected to exceed $10,000 during the twelve (12) month period.
PROCEDURE FOR REPORTING FINANCIAL CONFLICTS OF INTEREST
UNDER SPONSORED PROGRAMS
Disclosure
All Investigators are required to identify and disclose SFIs before a proposal is submitted to an external sponsor, and within 30 days of identifying a new SFI. Disclosures will be required via an emailed Conflict of Interest Disclosure. Disclosures are also required annually.
Review
At the time of award, Invizyne’s Grants Manager will re-certify the SFI with the Investigator and send an email communication to Invizyne’s President & CEO for review. If it is determined that a management plan is needed to eliminate or mitigate the SFI, the President & CEO will work with the Grants Manager and/or Investigator to create one. For federally funded awards, Invizyne’s Grants Manager will submit an FCOI disclosure as prescribed by the regulations.
Training
All Investigators supported by NSF or PHS will complete FCOI training:
Prior to engaging in research related to any NSF-funded or PHS-funded grant;
At least every four (4) years while funded;
Immediately, if:
Invizyne revises its FCOI Policy affecting requirements of Investigators
An Investigator is new to Invizyne or new to an externally sponsored project
The Investigator will be responsible for ensuring that all other project Investigators have undergone the required training prior to engaging in any federally funded project.
Subrecipient Procedures
At the time of proposal, Invizyne’s Grants Manager will request certification from a subrecipient institution’s authorized organizational representative that the subrecipient institution is in compliance with federal FCOI policies. The subrecipient institution will have the option of certifying to and following its own FCOI policy, or absent one, may elect to follow Invizyne’s FCOI Policy.