FCOI Policy

QUANTUMBIO INC.
FINANCIAL CONFLICT OF INTEREST (FCOI) POLICY
In accordance with the Code of Federal Regulation (42 CFR Part 50, Subpart F)
See: http://www.gpo.gov/fdsys/pkg/FR-2011-08-25/pdf/2011-21633.pdf

The 2011 revised regulation promotes objectivity in research by establishing standards that provide a reasonable expectation that the design, conduct, and reporting of research performed under National Institutes of Health (NIH) grants or cooperative agreements will be free from bias resulting from Investigator financial conflicts of interest. This regulation is commonly referred to as the Financial Conflict of Interest (FCOI) regulation.

Conflicts of Interest include financial or personal gains which may compromise or bias professional objectivity in biomedical research and have the potential to influence the outcome of study results or clinical trials. Such conflicts may result in experimental data that favors a particular commercial product or may lead to unnecessary risks in future trials. Conflicts of interest originate from research partnerships among industry, academia, and government; while equity interests in the form of company stocks may be biased towards the company’s products since the financial benefits are dependent upon the success of clinical studies and future marketing ventures.

An Investigator is defined as 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 the PHS (e.g., NIH), or proposed for such funding, which may include, for example, collaborators or consultants.

Investigators who are planning to participate in, or are participating in, NIH-funded research, with the exception of Phase I SBIR/STTR applications, are required to disclose to the designated official(s) of QuantumBio a listing of Significant Financial Interests (and those of his/her spouse and dependent children) that reasonably appear to be related to the Investigator’s institutional responsibilities.

Investigators are required to disclose their Significant Financial Interests (and those of the Investigator’s spouse and dependent children) that reasonably appear to be related to the Investigator’s institutional responsibilities:

  1. Investigators who are planning to participate in PHS-funded research must disclose their SFIs over the previous twelve-month period to their Institution no later than at the time of application for PHS-funded research.
  2. Each Investigator who is participating in PHS-funded research must submit an updated disclosure of SFIs at least annually, in accordance with the specific time period prescribed by QuantumBio, during the period of award.
  3. Each Investigator who is participating in the PHS-funded research must submit an updated disclosure of SFIs within 30 days of discovering or acquiring a new SFI (such as through marriage, inheritance, or purchase).

Each Investigator, including subrecipient Investigator(s), must complete training prior to engaging in NIH-funded research and at least every three (3) years, and immediately under the designated circumstances:

  1. Institutional Financial Conflict of Interest policies change in a manner that affects Investigator requirements
  2. An Investigator is new to an Institution
  3. An Institution finds that an Investigator is not in compliance with QuantumBio’s Financial Conflict of Interest policy or management plan.

The course is accessible at http://grants.nih.gov/grants/policy/coi/tutorial2011/fcoi.htm. Upon completion of the training, a certificate of completion must be submitted electronically via email to the CEO and the President. The Investigator should retain a copy for their records. Furthermore, the following Frequently Asked Questions page is provided by the NIH and should be reviewed on a regular basis in order for each Investigator to be familiar with the current regulations:

https://grants.nih.gov/faqs#/financial-conflict-of-interest.htm?anchor=alphaHeader3875

Significant Financial Interest is defined by the regulations as:

  1. 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:
    1. 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 (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;
    2. 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
    3. Intellectual property rights and interests (e.g., patents, copyrights), upon receipt of income related to such rights and interests.
  2. Investigators also must disclose the occurrence of any reimbursed or sponsored travel (i.e., that 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 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. Disclosure, which will include, at a minimum, the purpose of the trip, the identity of the sponsor/organizer, the destination, and the duration. In accordance with QuantumBio’s FCOI policy, the institutional official(s) 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.
  3. The term significant financial interest does not include the following types of financial interests: salary, royalties, or other remuneration paid by QuantumBio to the Investigator if the Investigator is currently employed or otherwise appointed by QuantumBio, including intellectual property rights assigned to QuantumBio and agreements to share in royalties related to such rights; any ownership interest in QuantumBio 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.

Reporting

Investigators have an ongoing obligation to disclose Significant Financial Interests throughout the awarded project period. Investigators must update financial disclosures of Significant Financial Interests to their Institutions within thirty (30) days of acquiring or discovering (e.g., through purchase, marriage, or inheritance) a new Significant Financial Interest. QuantumBio ’s designated official(s) will have sixty (60) days to review the Significant Financial Interest disclosure, determine whether the Significant Financial Interest is related to NIH-funded research, determine whether a Financial Conflict of Interest exists, and if so, implement, on at least an interim basis, a management plan that shall specify the actions that have been, or will be, taken to manage the Financial Conflict of Interest. If a Financial Conflict of Interest exists, QuantumBio must submit an FCOI report to the NIH within this same 60-day period.

Public Disclosure

With the issuance of the revised December 2019 NIH Grants Policy Statement, Section 4.1.10, Financial Conflict of Interest, each institution that is subject to the FCOI regulation shall maintain an up-to-date, written, enforced policy on FCOI that complies with the regulation and make the policy available via a publicly accessible website.

Prior to QuantumBio’s expenditure of any funds under a NIH-funded research project, QuantumBio shall ensure public accessibility, via a publicly accessible website or written response within five business days of a request, of information concerning any Significant Financial Interest disclosed to QuantumBio that meets the following three criteria:

  1. The Significant Financial Interest was disclosed and is still held by the senior/key personnel for the NIH-funded research project identified by QuantumBio in the grant application, progress report, or any other required report submitted to the NIH;

  2. QuantumBio determines that the Significant Financial Interest is related to the NIH-funded research; and

  3. QuantumBio determines that the Significant Financial Interest is a Financial Conflict of Interest.

The information that QuantumBio makes available via a publicly accessible website or written response shall include, at a minimum, the following:

  1. Investigator’s name;
  2. Investigator’s title and role with respect to the research project;

  3. Name of the entity in which the Significant Financial Interest is held;

  4. Nature of the Significant Financial Interest; and
  5. 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

The information shall be updated at least annually. In addition, QuantumBio shall update the  website within sixty (60) days of QuantumBio’s receipt or identification of information concerning any additional Significant Financial Interests of the senior/key personnel for the NIH-funded research project that was not previously disclosed, or upon the disclosure of a Significant Financial Interest of senior/key personnel; or upon the disclosure of a Significant Financial Interest of senior/key personnel new to the NIH-funded research, if QuantumBio determines that the Significant Financial Interest is related to the NIH-funded research and is a Financial Conflict of Interest. 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 of QuantumBio’s identification of a new Financial Conflict of Interest. If QuantumBio responds to written requests, QuantumBio will note in its written response that the information provided is current as of the date of the correspondence and is subject to updates, on at least an annual basis and within 60 days of QuantumBio’s identification of a new Financial Conflict of Interest, which should be requested subsequently by the requestor.

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