Financial Conflict of Interest Policy

Document Number CPOL-0002
Document Revision 01
Effective Date 08/16/2018
DCR Number DCR-2269

I.      Purpose

This document describes the requirements and responsibilities of identifying and managing financial conflicts of interest to ensure integrity of DxTerity research in compliance with federal regulations.

This document was developed to promote objectivity in research by establishing standards that provide a reasonable expectation ensuring the design, conduct and reporting of research funded by the government will be free from any bias resulting from a Financial Conflict of Interest of any investigator.

II.     Scope

This policy applies to DxTerity’s clinical research activities performed under government contracts or company-sponsored funds and each investigator who is planning to participate or participating in any funded research.

This policy was written in accordance with 45 CFR Part 94 PHS Regulations for Responsible Prospective Contractors and 42 CFR Part 50 Subpart F Responsibility of Applicants for Promoting Objectivity in Research for Which PHS Funding is Sought.

III.     Definitions

Word/Abbreviation Definition
Contractor An entity that provides property or services under contract for the direct benefit or use of the Federal Government.
Disclosure of significant financial interests An investigator’s disclosure of significant financial interests to an institution.
FCOI Financial conflict of interest means a significant financial interest that could directly and significantly affect the design, conduct or reporting of Public Health Service (PHS) funded research.
FCOI report An Institution’s report of a financial conflict of interest to a PHS Awarding Component or other responsible awarding entity.
Financial interest Anything of monetary value, whether or not the value is readily ascertainable.
Institution Any domestic or foreign, public or private, entity or organization (excluding a federal agency) that submits a proposal, or that receives, PHS research funding.
Investigator The Project Director (PD) or Principal Investigator (PI), any senior/key personnel as determined by an Institution, and any other person, regardless of title or position, who is responsible for the design, conduct or reporting of research funded by the PHS.
Key Personnel Includes the Project Director/Project Investigator and any other personnel considered to be essential to work performance.
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).
SFI A Significant Financial Interest(s) consisting of one or more of the following interests of an employee’s (and those of the employee’s spouse, registered domestic partner, siblings and dependent children) that reasonably appears to be related to such Investigator’s Institutional Responsibilities:
a) 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. b) 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 Intellectual property rights and interests (e.g., patents, copyrights), upon receipt of income related to such rights and interests.

 

IV.     Roles and Responsibilities

  1. Head of Finance is responsible for:
    1. Designating an individual to review, manage and report all noted significant financial interest (SFI) in accordance with this policy.
  1. Clinical Operations is responsible for:
    1. Informing each investigator and key personnel about the following:
      1. Information about this policy and corresponding federal regulations.
      2. Responsibility of the investigator and key personnel to disclose any significant financial interest.
      3. Training requirements to include:
        1. Initial training for existing and new staff.
        2. Re-training every four (4) years.
        3. Additional training when there is non-compliance or revisions to the policy.
  1. Marketing is responsible for ensuring that this policy is available on the DxTerity website.
  2. Finance is responsible for the reporting, monitoring and ensuring compliance to this policy.
  3. Quality is responsible for maintaining and updating this policy consistent with the changes in the regulations, if any.
  4. All Employees are responsible for complying with this policy.

V.     General Procedures and Guidelines

  1. Identification of Persons Required to Disclose a Significant Financial Interest (SFI)
    1. It shall be the responsibility of the Principal Investigator (PI) of a clinical study to identify all investigators and key personnel who have a significant financial interest requiring disclosure under this policy and to ensure that disclosure is properly documented.
    2. The Principal Investigator is likewise responsible for ensuring that annual updates and new or increased financial interests are disclosed.
  1. Disclosure, Review and Monitoring of Financial Conflict of Interest (FCOI)
    1. All investigators (including their spouse and dependent children) having a SFI requiring disclosure under this policy are required to prepare a fully-completed CFORM-0102 Significant Financial Conflict of Interest Disclosure and Management Plan Form that will be submitted to the Head of Finance or designee.
    2. An initial review of the SFI will be conducted by the Head of Finance or designee to determine whether a potential for financial conflict of interest exists.
    3. If a potential conflict of interest is determined, steps will be taken to identify what measures are needed to address the SFI in the disclosure form.
    4. The actions required to manage the financial conflict of interest shall be detailed in the management plan section of CFORM-0102 and monitored on an ongoing basis until completion of the study.
    5. Actions to manage the financial conflict of interest may include but not limited to:
      1. Public disclosure of the financial conflict of interest when submitting articles for publication or presenting a paper about the study;
      2. Informing human subject participants directly about the financial conflict of interest;
      3. Appointment of an independent monitor that is capable of taking appropriate measures to protect the design, conduct, and reporting of the research against bias resulting from the financial conflict of interest;
      4. Modifying the study protocol;
      5. Changing the staff or staff responsibilities in all or part of the study;
      6. Disqualifying staff from participating in the study;
      7. Reducing or eliminating the financial interest; or
      8. Severing relationships that create the financial conflict;
    6. All disclosure and management plans are required to be signed by the investigator and the Head of Finance or designee. Compliance to the management plan shall be monitored by Finance.
  1. Violations of Conflict of Interest Policy
    1. Investigators are expected to have full and timely compliance with this policy.
    2. If an individual is found to have violated this policy, including failure to disclose financial interests or non-compliance to the management plan, the Head of Finance or designee shall make recommendations to Executive Management regarding the impositions of sanctions or disciplinary proceedings against the individual in violation.
    3. In addition, DxTerity shall follow federal regulations regarding the notification of the sponsoring agency in the event an investigator or key personnel failed to comply with this policy.
    4. The federal agency may take its own action as it deems appropriate, including the suspension of the funding for the study until the matter is resolved.
  1. Sub-recipient Requirements
    1. Sub-award recipients must comply with this policy or provide certification that their organization is in compliance with the Federal Policy (42 CFR Part 50 subpart F) and that their portion of the research project, as detailed in their sub-award agreement, is in compliance with their institutional policies.
    2. If a SFI is identified by the sub-award recipient, they are required to notify the Head of Finance of the existence of the conflicting interest within 30 days of the identification of the interest.
    3. The sub-award recipient must certify and assure that any reported conflicting interest has been managed, reduced or eliminated in accordance with federal regulations.
  1. Federal Reporting
    1. Finance is responsible for the submission of reports to the sponsoring agency involving disclosures of SFI in accordance with applicable federal requirements. The following reports are required:
      1. Initial Report: Prior to DxTerity’s expenditure of any funds under a government-funded study, DxTerity must provide to the sponsoring agency, a FCOI report regarding any investigator with SFI found to have a financial conflict of interest in accordance with the regulation.
      2. After Acquired or New Disclosures:
        1. If the investigator acquires a new or increased SFI, a new SFI Disclosure Form must be submitted within 30 days of determining or acquiring the new SFI.
        2. DxTerity shall submit a FCOI report within 60 days after determination of a new FCOI.
      3. Annual FCOI Report: DxTerity shall provide an annual FCOI report for any FCOI previously reported to address the status of the FCOI and the related management plan.
        1. Clinical Operations will ensure required or annual disclosures of SFI’s for external (non-DxTerity employees) investigators.
        2. Finance will ensure compliance to required or annual disclosure of SFI’s for investigators or key personnel within DxTerity.
  1. Record-Keeping
    1. Records of Investigator SFI Disclosure Forms and the management plan shall be retained by Finance for a minimum of three (3) years from the date the final expenditure is submitted.
  1. Public Accessibility to FCOI Information
    1. Prior to the expenditure of any funds under a government-funded research project, the Head of Finance or designee must respond in writing within five (5) days to a requestor for information concerning any significant financial interest disclosures that meet the following criteria:
      1. Any significant financial interest disclosed and is still held by the investigator or key personnel;
      2. The significant financial interest was determined to be related to the PHS-funded research project; and
      3. The significant financial interest was determined to be an FCOI.
    2. The information released to the requestor must include the following:
      1. Investigator or key personnel name and title;
      2. Role of the investigator or key personnel in the research project;
      3. Name of the entity in which the significant financial interest is held;
      4. Nature of the significant financial interest and approximate dollar range of the significant financial interest; and
      5. A statement that the value cannot be readily determined through reference to public prices or other reasonable measures.
    3. Information concerning significant financial interests that meet the criteria in 6.7.1. shall remain available for public information requests for at least three (3) years from the date that the information was most recently updated.

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