Financial Conflict Of Interest (FCOI) Policy


    Objective research is of paramount importance to SAFEBVM Corp. (“SafeBVM”). SafeBVM’s financial conflict of interest (FCOI) policy meets the expectation that the design, conduct, and reporting of research will be free from bias resulting from financial interests. This policy provides a framework to comply with requirements of 42 CFR 50, Subpart F, “Responsibility of Applicants for Promoting Objectivity in Research” for which PHS Funding is Sought” (FCOI Regulation), of the Federal Register pertaining to PHS-funded research, and is intended to ensure the research is free from bias due to financial conflicts of interest, and that potential financial conflicts of interests are identified, managed, reduced, or eliminated.

  2. SCOPE

    This Policy describes types of Financial Conflict of Interest (FCOI), identifies when
    disclosure should be provided, and explains SafeBVM’s administration and enforcement
    procedures. The policy is applicable to Senior/Key Personnel/ Investigators as defined
    below, who participate in SafeBVM’s research. Participation includes having an active role
    in the development of protocols, the conduct of clinical trials, as well as the reporting
    of study results.


    Designated Official(s):Person(s) responsible for the implementation of the FCOI Policy, designated by
    Equity Interest:Any stock, stock option or other ownership interest, as determined through reference
    to public prices or other reasonable measures of fair market value.
    Financial Interest:Anything of non-trivial monetary value, regardless of whether the value is readily
    Financial Conflict of Interest (FCOI)A significant financial interest that could directly and significantly affect the
    design, conduct, or reporting of NIH-funded research.
    Immediate Family:Investigator/senior/key personnel’s spouse or domestic partner and dependent
    Investigator:The project director or principal investigator (PD/PI) and any other person, regardless of
    title or position, who is responsible for the design, conduct, or reporting of research
    funded by the PHS, or proposed for such funding, which may include subgrantees,
    contractors, consortium participants, collaborators or consultants.
    Institution:Any domestic or foreign, public or private, entity or organization (excluding a federal
    agency), including Medical Device companies, that submits a proposal, or that receives, PHS research funding. SafeBVM is considered an “Institution” for the purposes of this
    Institutional responsibilities:Any key/senior personnel/investigator’s professional responsibilities conducted on
    behalf of SafeBVM and as defined by SafeBVM, including, but not limited to, activities
    such as research, research consultation, teaching, professional practice,
    institutional committee memberships, and service on panels such as Institutional
    Review Boards (IRB) or Data and Safety Monitoring Boards (DSMB).
    PHS:Public Health Service of the U.S. Department of Health and Human Services, and any
    components of the PHS to which the authority involved may be delegated, including the
    National Institutes of Health (NIH).
    Regulation or FCOI regulation:42 CFR Part 50 Subpart F, Promoting Objectivity in Research, which applies to both grants
    and cooperative agreements.
    Remuneration:Salary and any payment for services, including consulting fees, honoraria, and paid
    Research:A systematic investigation, study, or examination designed to develop or contribute to
    generalizable knowledge relating broadly to public health including behavioral and
    social-sciences research. basic and applied research (e.g., a published article, book or
    book chapter) and product development (e.g., a diagnostic test or drug). The term includes
    any such activity for which research funding is available from PHS but excluding
    applications for Phase I under the Small Business Innovation Research (SBIR) and Small
    Business Technology Transfer (STTR) programs.
    Senior/Key Personnel:The Project Director/Principal Investigator (PD/PI) and any other person identified as
    senior/key personnel by the SafeBVM in the grant application, progress report, or any
    other report submitted to the PHS/NIH by SafeBVM under the regulation.
    Significant Financial Interest (SFI):Financial interest consisting of one or more of the following interests of the
    investigator/senior/key personnel (and those of the investigator/senior/key personnel ’s
    spouse and dependent children) that reasonably appears to be related to the
    Investigator/senior/key personnel’s institutional responsibilities:
    • With regard to any publicly traded entity a 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. For the 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 in
      stock, stock options or other ownership interest, as determined through reference
      to public prices and 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 remunerations from the entity in the twelve
      months preceding the disclosure, when aggregated, exceeds $5,000, or when the
      Investigator/senior/key personnel (or the Investigator/senior/key personnel ’s
      spouse or dependent children) holds any equity interests (e.g. stock, stock
      options, or other ownership interest) or

    • Intellectual property rights and interests (e.g. patents, copyrights), upon
      receipt of income related to such rights and interests.

    • Investigator/senior/key personnel s also must disclose the occurrence of any
      reimbursed or sponsored travel (i.e., that which is paid on behalf of the
      investigator/senior/key personnel and not reimbursed to the
      investigator/senior/key personnel so that the exact monetary value may not be
      readily available) related to their responsibilities to SafeBVM; 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, medical center, or research
      institute that is affiliated with an Institution of higher education. SafeBVM’s
      FCOI policy will specify the details of this 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 SafeBVM’s FCOI policy, SafeBVM
      Designated 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 a FCOI with the PHS-funded research.

    • The term significant financial interest (SFI) does not include the following types
      of financial interests: salaries, royalties or other remuneration paid by SafeBVM
      to the investigator/senior/key personnel if the investigator/senior/key personnel
      is currently employed or otherwise appointed by SafeBVM, including intellectual
      property rights assigned to SafeBVM and agreements to share in royalties related
      to such rights; any ownership interest in SafeBVM held by the
      investigator/senior/key personnel; income from investment vehicles, such as mutual
      funds and retirements accounts, as long as the investigator/senior/key personnel
      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, 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.

    Small Business Innovation Research (SBIR):

    The extramural research program for small businesses that is established by the Awarding
    Components of the Public Health Service and certain other Federal agencies under Public
    Law 97-219, the Small Business Innovation Development Act, as

    amended. For purposes of this subpart, the term SBIR Program also includes the Small
    Business Technology Transfer (STTR) Program, which was established by Public Law 102-564.


    A financial conflict of interest related to SafeBVM’s activities may occur when an
    investigator/senior/key personnel employed or appointed by SafeBVM has a significant
    financial interest that compromises, or appears to compromise, that individual’s
    independence and objectivity in the discharge of his/her SafeBVM responsibilities in the
    design, conduct, or reporting of SafeBVM’s research. Investigators/senior/key personnel
    should avoid conflicts and the potential for conflicts resulting from financial
    arrangements with third parties that could have a special interest in a SafeBVM protocol.

    Senior/key personnel/investigators are required to disclose SFIs (and those of the
    investigators, senior/key personnel’s immediate family). This disclosure will be made
    at least annually during the award period [to include any information that was not
    disclosed initially to SafeBVM or updated information regarding any previously
    disclosed SFI] and within 30 days of discovering or acquiring a new SFI (such as
    through purchase, marriage or inheritance).

    SafeBVM will name “Designated Official(s)” to manage the FCOI policy. The designated
    official(s) will take action to address a financial conflict of interest, which can
    include reducing 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

    If a determination is made that a FCOI exists SafeBVM’s Designated Official(s) will
    recommend a suitable action plan or management plan to eliminate or manage the FCOI
    consistent with the objectives of this policy.

    The action plan shall provide for its periodic review and updating at least annually. In
    the event that there is no reasonable way to manage a FCOI then the
    investigator/senior/key personnel may be prohibited from participating in the related
    Research until such a time as the FCOI is eliminated.

    Examples of conditions or restrictions that might be imposed to manage a financial
    conflict of interest include, but are not limited to:

    • Public disclosure of financial conflicts of interest (e.g., when presenting or
      publishing the research);

    • 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 disqualification 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

    • Severance of relationships that create financial conflicts; and

    • SafeBVM shall review the proposed action plan or management plan and can approve,
      modify and approve additional work. Final review and determination must be
      completed prior to the expenditure of any PHS funds for the applicable Research.

    A conflict should be managed, reduced, or eliminated within sixty (60) days of its
    identification by designated official(s). SafeBVM’s Designated Official(s) shall be
    responsible for monitoring and enforcing any management plan.

    This shall also apply when, in the course of an ongoing PHS-funded research project, an
    investigator/senior/key personnel who is new to participating in the research project
    discloses a significant financial interest or an existing investigator/senior/key
    personnel discloses a new significant financial interest to SafeBVM.


    If a senior/key personnel/investigator fails to comply with SafeBVM’s FCOI policy, within
    120 days of discovery by SafeBVM, SafeBVM shall complete a retrospective review of the
    senior/key personnel/investigator’s activities to determine potential bias.

    If a bias is found, SafeBVM shall submit a mitigation report to the NIH, in accordance
    with 42 CFR 50.605(b)(3), that shall address the impact of the bias on the research
    project and the actions it has taken to mitigate the bias.

    SafeBVM will work with the investigator/senior/key personnel to set up an FCOI management
    plan to mitigate the situation.

    Companywide, SafeBVM is required to mandate that senior/key personnel/investigator
    disclose the FCOI in each public presentation with research results if it was not reported
    up front. In extreme cases of bias, the investigator/senior/key personnel may lose the
    right to work on the project.


    All persons subject to the SafeBVM Financial Conflict of Interest Policy will be
    required to train on the policy by reading and affirming their understanding of, and
    intent to comply with the FCOI policy and every four (4) years thereafter. Immediate
    training will be required if SafeBVM revises this policy in a manner that affects the
    investigator/senior/key personnel, when an investigator/senior/key personnel is new to
    SafeBVM, or as a result of a finding of noncompliance with this policy or a management
    plan, or other related misconduct.

    SafeBVM’s senior/key personnel or investigators/study directors may also demonstrate
    understanding of FCOI by using the NIH web-based training which can be accessed online.

    Web-based Training:

    Unless otherwise covered by a third-party FCOI Policy as agreed with SafeBVM, each
    investigator/senior/key personnel is required to complete training on SafeBVM’s FCOI
    Policy by reading and affirming the policy or demonstrate training on the NIH web based
    training on the following occasions:

    • Prior to engaging in research related to any PHS-funded grant,

    • At least every 4 years, and

    • Immediately if:

      1. SafeBVM revises the FCOI Policy in a manner that affects requirements of
        investigator/senior/key personnel,

      2. An investigator/senior/key personnel is new to SafeBVM, or

      3. An investigator is not in compliance with the FCOI Policy or
        management plan.

        Reporting: As required by 42 CFR Part 50, Subpart F, SafeBVM shall file a
        report with the NIH providing information on every identified FCOI and
        the manner in which the FCOI is being or has been managed, reduced, or
        eliminated. Reports shall include the elements required by these
        regulations. SafeBVM will notify NIH promptly if bias is found with
        the design, conduct, or reporting of NIH-funded research, and file a
        Mitigation Report in accordance with federal regulations.

        Records Management: The records of all financial disclosures and all actions taken by
        SafeBVM will be maintained for at least three years from the date of
        submission of the final expenditures report.


    Subrecipients: When carrying out the PHS-funded research through a subrecipient (e.g.,
    subcontractors or consortium members), SafeBVM must incorporate by written agreement
    (e.g., subaward contract) that the investigator/senior/key personnel of the subrecipient
    institution is required to either:

    • Comply with the SafeBVM’s FCOI Policy, or

    • Comply with the FCOI Policy of the subrecipient institution and have said
      institution certify that its policy complies with 42 CFR Part 50 Subpart F. The
      written agreement, under either policy, must specify the time period for the
      subrecipient to provide investigator/senior/key personnel disclosure and report of
      any FCOI to SafeBVM.

      It is suggested that at least 30 days from the reporting deadline for SafeBVM’s
      annual disclosures, or in cases of discovery or acquiring new SFI a maximum of 10
      business days be considered to which the subrecipient is to report to SafeBVM, to
      enable SafeBVM to comply timely with its review, management, and reporting

      SafeBVM will provide FCOI reports to the PHS Awarding Component regarding all
      financial conflicts of interest of all subrecipient investigator/senior/key
      personnel s prior to the expenditure of funds and within 60 days of any
      subsequently identified FCOI.

  7. Public Accessibility

    SafeBVM’s Financial Conflict of Interest Policy shall be posted on the public portion of the
    SafeBVM website. In addition, upon receipt of a written request for information concerning
    identified FCOI’s held by Senior/Key Personnel (as defined by regulation), SafeBVM will make that
    information available within five (5) business days of the request. The information shall include
    all elements required by 42 CFR Part 50, updated through the date of the response.