Introduction:

This document establishes and defines polices on individual conflicts of interest. It is the policy of Sonavi Labs, “the Company”, to ensure that personnel avoid situations in which personal interests may affect, or have the appearance of affecting, their professional judgment in exercising their duties or responsibilities, or in conducting or reporting research. This policy provides guidance to help personnel manage situations in their personal affairs, employment outside the Company’s, and financial activities that may appear to conflict with their responsibilities and to ensure the Company and its employees comply with applicable federal laws when participating in research funded by the Public Health Service (PHS). The Company’s personnel should promptly disclose the circumstances of any situation that might be covered by this policy. This policy applies to any Company member acting as Investigator or as a Senior/Key personnel on any PHS research project and any Sub-recipient of that project.

 

Sonavi Labs, Inc. is a for-profit company producing medical devices and associated applications.  It has attracted investors and intends to conduct business in an exemplary fashion to provide maximum value for customers and investors, to reassure research funding agencies, and to meet its goals of saving lives and improving medical outcomes.  For this reason, the activities of Sonavi Labs, Inc. are conducted with minimized or managed conflict of interest.

 

Procedure Statement(s)

This procedure is designed to comply with PHS regulations (42 CFR Part 50 Subpart F, Promoting Objectivity in Research, 45 CFR Part 94, Responsible Prospective Contractors). These standards and procedures are intended to ensure that the design, conduct, or reporting of research funded under PHS grants, cooperative agreements, or contracts will be free from bias resulting from Investigator FCOIs. The Company’s Conflict of Interest Policy implements the requirements of these federal regulations.

 

Availability of the Policy

The Company will maintain an up-to-date written, enforced policy on financial conflicts of interest that complies with applicable regulations, including any federal financial conflict of interest regulations. The policy will be posted and available via the Company’s publicly accessible website. The Company will inform covered individuals of the policy and of their responsibilities regarding disclosure. The Company will inform covered individuals in the event the policy is revised and updated.

 

Who is Covered by this Policy?

The conflict of interest policy applies to members of the Board of Directors and employees that are involved in PHS-funded research projects or are applying for PHS funding (“Covered Individuals”).

 

Federal regulations require Institutions to have policies and procedures in place to ensure that individuals disclose any Financial Interests in relationship to research projects funded by the United States Department of Health and Human Services (HHS), Public Health Service (PHS), and National Institutes of Health (NIH).

 

All individuals listed on a protocol or grant, regardless of title or position, who may be responsible for the designing, conducting, or reporting of Research, must complete a “Financial Disclosure” form in order to disclose all Financial Interests that would reasonably appear to be related to their Institutional Responsibilities.

  • Generally, this includes all individuals listed on a grant budget, Research protocol or other Research activity. It always includes the Principal Investigator, Co-Investigators and Key scientific Personnel.
  • In some cases it may include other Research personnel (such as technologists or Research fellows) if they are responsible for the design, conduct, or reporting of the activity funded by the Research project. For the purposes of disclosure, the term “Investigator” includes the Investigator, his/her spouse or domestic partner and dependent children.

 

Disclosure Requirements

Covered individuals must disclose known financial interests (and those of the spouse and dependent children) to the Company Official (CO), including:

  • Proposed outside activities whether or not they are compensated,
  • Proposed financial interests,
  • All reimbursed or sponsored travel for Sonavi Labs if the value received from any third party exceeds $5000 in a year.

Disclosure should be made:

  • Within 30 days of identification,
  • Before a covered individual acquires a financial interest,
  • When a previously disclosed financial interest changes,
  • Prior to the submission of a proposal for funding,
  • Prior to submission of a Research protocol to an IRB,
  • Within 30 days for travel reimbursed by a third party for research that is Public Health Service agency funded.

All Financial Disclosures must be updated on an annual basis.

Disclosure may be made to management in any written form.  Management will respond in writing within two weeks.

 

Specific Prohibited Activities

There are certain types of financial interests that create such strong appearances of actual conflicts of interest that they are prohibited under this policy.  These include:

  • Use of Sonavi Labs proprietary information with any other company or any non-covered individual without a nondisclosure agreement duly approved by management.
  • Involvement in a business decision when the covered individual’s financial interest may create the appearance of a conflict of interest in decision-making.
  • Service on the board of a competing company or organization, working for, or receiving compensation in any form from an identified competing company or organization.

 

SFI Review Process

The Company Official (CO) reviews each SFI received from Company personnel. If necessary, the CO collects additional information from the disclosing individual and/or from other individuals who possess relevant information. The CO determines whether the disclosed financial interests are significant, whether they are related to the individuals research responsibilities at the Company, and whether a management plan is required. In conducting this review, the CO considers factors such as the value of the individual’s financial interest and how it could affect their ability to objectively complete their research with the Company.

 

If a significant financial interest is deemed to be a financial conflict of interest, the CO will develop a management plan in consultation with the Investigator. The goal of the management plan is to reduce or eliminate the financial conflict of interest, which can include reducing or eliminating the financial conflict of interest and to ensure that the design, conduct and reporting of research will be free from bias. The management plan may include, but is not limited to: (1) requiring the individual to recuse him/herself from particular decisions or activities related to the research, (2) requiring the individual to inform certain persons or institutions about the conflict of interest and the management plan (e.g. relevant review bodies, research sponsors, co-investigators, journals to which manuscripts about the research are submitted, media, etc.), (3) requiring others to review decisions in which the individual participates, (4) requiring the individual to reduce, modify or eliminate a financial interest (e.g. divesting ownership, restricting the sale or exercise of stock and stock options, and deferring or waiving royalties or milestone payments), (5) requiring the individual to vacate a position.

 

The management plan is presented to the covered individual in writing and signed by the CO and individual.  All aspects of the plan may be reviewed if circumstances change.  The covered individual may request a review of the management plan at any time if that individual views it as interfering with their ability to work or inappropriate.

 

Reporting

The Company will comply with federal regulations regarding reporting of financial conflicts of interest (e.g. by submitting FCOI reports to the awarding institution, as required). The Company will comply with federal FCOI regulations regarding making publicly available information on identified FOCIs held by investigators and key personnel on PHS-funded research projects.

 

Record Keeping

The Company complies with federal regulations regarding maintaining records relating to all disclosures of financial interests and the Company’s review of, and response to, such disclosures.

 

 

 

Confidentiality

All disclosures or information obtained in reviewing a potential FCOI is kept confidential, except where disclosure is required by federal regulations.

 

Sanctions

Failure to comply with the Company’s FCOI policy includes failing to submit a required disclosure, providing false information, omitting required information, failing to maintain confidentiality, failure to carry out duties prescribed by these policies, and refusal or failure to comply with a management plan adopted under these policies. A failure to comply with these policies may result in a decision by the CO to suspend the research project or to refuse to approve a new research project for the individual who fails to comply. A failure to comply is also subject to: (1) formal admonition, (2) ineligibility of the individual to apply for federal research grants, (3) additional sanctions per research funding agency (such as requiring investigator financial conflict of interest training), up to and including sponsor suspension of function per application federal regulations (note: the Company will comply with federal financial conflict of interest requirements regarding non-compliance retrospective review and corrective action), and/or (4) termination of employment.

 

Responsibilities

 

PHS-Funded Investigators/Senior/Key Personnel:

  • Must complete FCOI training prior to engaging in a PHS research project and thereafter, every four years.
  • Must complete and submit to the CO a Financial Interest Disclosure Form prior to working on PHS-funded projects.
  • Must update the Financial Interest Disclosure Form annually or within 30 days of a change in financial status (acquisition of new financial interest), whichever occurs first.
  • Must follow management plan as prescribed by the CO for FCOIs.

 

Sub-Recipient:

  • Must complete and submit to the CO a Sub-Recipient FCOI disclosure form prior to working on PHS funded projects.
  • Sub-recipient organization will certify that it has a PHS FCOI compliant policy in place or that it intends to have one in place at the time of the award or that it will abide by The Company policy.
  • Sub-recipient organization will certify that the investigators, senior and/or key personnel will complete required training.

 

Company Official (CO):

  • Must record and review all Financial Interest Disclosure forms from PHS-funded researchers to determine whether a FCOI exists.
  • Must provide required information concerning FCOIs to the expenditure of PHS funds, and must update such information at least annually and within 60 days of changes to Statement of Financial Interest Disclosure forms, whichever occurs first.
  • Must prepare the Public Financial Conflict of Interest Disclosure Form, including the following information, for reported FCOIs such that it can be made publicly available upon request:

❏ Project/Contract number

❏  Investigator’s name

❏  Investigator’s title and role with respect to the research project

❏  Name of the entity in which the relevant significant financial interest (SFI) is held

❏  Nature of the relevant SFI (e.g., equity, consulting fees, travel reimbursement, honoraria, etc.)

❏  Approximate dollar value of the relevant SFI (dollar ranges are permissible: $5,000- $9,999; $10,000-$19,999; etc.)

  • For reported FCOIs, must develop a FCOI management plan to include:
    • role and principal duties of the Investigator with the FCOI, including limits to the engagement of the covered individual in roles that might exacerbate the perception of a conflict of interest,
    • how the FCOI Management Plan is designed to safeguard objectivity in the PHS research project;
    • confirm that Investigator agrees with the FCOI Management Plan;
    • how the FCOI Management Plan will be monitored through an oversight plan, including appointment of a disinterested party to monitor activities
  • Must maintain for three years records of all Statement of Financial Interest Disclosure form records and FCOI Management Plans.
  • Maintains the FCOI Policy and Procedure on the The Companys’ external website.
  • Must ensure compliance with FCOI policy and procedures.
  • In cases where a potential FCOI exists, assists in the development and implementation of FCOI

 

Management Plan for FCOI is developed in consultation with the CO and Investigator. The FCOI Management Plan must be completed in advance of the Company’s spending PHS funds and a summary of the management plan must be included in the FCOI Report.

 

 

Definitions:

 

Company Official: An individual within the Company that is responsible for the solicitation and review of disclosures of significant financial interests including those of the Investigator’s family related to the Investigator’s Company Responsibilities.

 

Company Responsibilities: The Investigator’s responsibilities associated with his or her Company appointment or position, such as research, teaching, administration, and internal and external professional committee service.

 

Covered Individual: Any person who is employed by Sonavi Labs full time or part time, serves an officer of the company or a member of its board, or a major investor in the company (with more than 20% ownership).

 

Financial Conflict of Interest (FCOI): A Significant Financial Interest that could directly and significantly affect the design, conduct, or reporting of PHS/NIH-funded Research.

 

Financial Interest: Anything of monetary value, whether or not the value is readily ascertainable.

 

Health and Human Services (HHS): The United States Department of Health and Human Services, and any components of the Department to which the authority involved may be delegated.

 

Institution: Any domestic or foreign, public or private, entity or organization (excluding a Federal agency) that is applying for, or that receives, PHS/NIH Research funding.

 

Institutional Responsibilities: An Investigator’s professional responsibilities on behalf of the Institution, and as defined by the Institution in its policy on Financial Conflicts of Interest, which may include for example: activities such as Research, Research consultation, teaching, professional practice, institutional committee memberships, and service on panels such as Institutional Review Boards or Data and Safety Monitoring Boards.

 

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 the PHS/NIH, or proposed for such funding, which may include, for example, collaborators or consultants. For the purposes of disclosure, “Investigator” includes the Investigator, his/her spouse or domestic partner and dependent children.

 

Manage: Taking 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 bias.

 

Project Director (PD)/Principal Investigator (PI): A Project Director or Principal Investigator of a PHS/NIH-funded Research project; the PD/PI is included in the definitions of Senior/Key Personnel and Investigator under this subpart.

 

Public Health Service (PHS): The 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).

 

PHS Awarding Component: The organizational unit of the PHS that funds the Research that is subject to this subpart.

 

Public Health Service Act (PHS Act): The statute codified at 42 U.S.C. 201 et seq.

 

Rebuttable Presumption: A Rebuttable Presumption is an assumption of fact accepted until disproved. All presumptions can be characterized as rebuttable. It is an assumption that is made in the law that will stand as a fact unless someone comes forward to contest it and prove otherwise.  As applied to human subjects Research, the Rebuttable Presumption means that the Institution will presume, in order to ensure that all potentially problematic circumstances are reviewed, that a financially interested individual and/or institution may not conduct the human subjects Research in question.

This rule is not intended to be absolute; a financially interested individual and/or institution may rebut the presumption by demonstrating facts that, in the opinion of the CO, constitute compelling circumstances for the financially interested individual to conduct the Research in question.  The individual and/or Institution would then be allowed to conduct the Research under conditions specified by the CO and approved by management.

 

Research: A systematic investigation, study or experiment designed to develop or contribute to generalizable knowledge relating broadly to public health, including behavioral and social-sciences Research.

The term encompasses 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 a PHS/NIH Awarding Component through a grant or cooperative agreement, whether authorized under the PHS/NIH Act or other statutory authority, such as a Research grant, career development award, center grant, individual fellowship award, infrastructure award, institutional training grant, program project, or Research resources award.

 

Senior/Key Personnel: The PD/PI and any other person identified as Senior/Key Personnel by the institution in the grant application, progress report, or any other report submitted to the PHS/NIH by the Institution under this subpart.

 

Significant Financial Interest: A Financial Interest consisting of one or more of the following interests of the Investigator (and those of the Investigator’s spouse or domestic partner 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 (e.g., consulting income, 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;
  • 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 domestic partner or dependent children) holds any equity interest (e.g., stock, stock option, or other ownership interest); or
  • Intellectual property rights and interests (e.g., patents, copyrights), upon receipt of fees related to such rights and interests.

The term Significant Financial Interest does not include the following types of financial interests: salary, royalties, or other remuneration paid by the Company to the Investigator if the Investigator is currently employed or otherwise appointed by the Company, including intellectual property rights assigned to the Company and agreements to share in royalties related to such rights; any ownership interest in the Institution held by the Investigator, if the Company is a commercial or for-profit organization; 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

 

Small Business Innovation Research (SBIR) Program: 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

 

Sub-recipient: Any party that has entered into an Agreement with The Company as a sub-grantee, subcontractor, collaborator, contractor, or consultant.