Objectivity in Research

  1. Introduction:

    The purpose of this policy is to promote objectivity in research by establishing standards that provide an expectation that the design, conduct, and reporting of research will be free from bias resulting from Investigator financial conflicts of interest. This policy is consistent with the Public Health Service (PHS) regulations, “Objectivity in Research,” 42 CFR Part 50 Subpart F and 45 CFR Part 94.

  2. Purpose:

    Veterans Bio-Medical Research Institute, Inc. (VBRI) established standards to prevent principal investigators from using their decision making authority for purposes that are, or give the appearance of being, motivated by a desire for private financial gain while performing VBRI administered research.

  3. Applicability:

    This policy is applicable to VBRI and each Investigator (see definitions) who is planning to participate in, or is applying for, receives, or participates in PHS research funding by means of a grant or cooperative agreement. This policy applies to prime awards and subawards administered by VBRI. This policy also applies to funding from other sources who adopted the PHS Financial Conflict of Interest (FCOI) regulations.

  4. Definitions:

    1. Disclosure – A complete listing of financial and employment relationships between the investigator, their immediate families (spouse and dependent children), and (1) the sponsor of a project or (2) a profit or not-for-profit entity with a potential financial interest in the conduct or outcome of the research.
    2. Financial Conflict of Interest (FCOI) – A Financial Conflict of Interest exists when the Institution, through its designated official(s), reasonably determines that an Investigator’s Significant Financial Interest is related to a research project and could directly and significantly affect the design, conduct or reporting of the research.
    3. Institutional Responsibilities – An Investigator’s professional responsibilities on behalf of VBRI, in the conduct of VBRI administered research projects.
    4. 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, which may include, for example, collaborators or consultants. It is not intended to apply to individuals who provide primarily technical support or who are purely advisory and without direct access to data (e.g., control over its collection or analysis), unless they are in a position to influence the study’s design, reporting or results or have privileged information as to the outcome. Senior or key personnel identified on a grant application or progress report, consultants, and post-doctoral fellows may or may not be included as Investigators.
    5. Significant Financial Interest (SFI) –
      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:
        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 options (valued on best estimate on the day of submission of Financial Conflict of Interest Disclosure), or other ownership interest, as determined through reference to public prices or other reasonable measures of fair market value;
        1. 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 options (valued on best estimate on the day of submission of Financial Conflict of Interest Disclosure), or other ownership interest); or
        2. 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, an academic teaching hospital, a medical center, or a research institute that is affiliated with an Institution of higher education.
      3. A significant financial interest does not include:
        1. Salary, royalties, or other remuneration paid by the Institution to the Investigator if the Investigator is currently employed or otherwise appointed by the Institution, including intellectual property rights assigned to the Institution and agreements to share in royalties related to such rights;
        2. Income from investment vehicles, such as mutual funds and retirement accounts, as long as the Investigator does not directly control the investment decisions made by these vehicles;
        3. Income from seminars, lectures, or teaching engagements sponsored by a federal, state, or local government agency, an Institution of higher education, an academic teaching hospital, a medical center, or a research institute that is affiliated with an Institution of higher education; or
        4. Income from service on advisory committees or review panels for a federal, state, or local government agency, an Institution of higher education, an academic teaching hospital, a medical center, or a research institute that is affiliated with an Institution of higher education.
  5. Responsibilities:

    1. Investigator

      1. It is the responsibility of the Principal Investigator to submit the Disclosure forms for all project Investigators, annually or in sufficient time prior to expenditure of applicable grant funds, to allow for review of projects in which an investigator has disclosed a significant financial interest.
      2. Investigators must disclose, in writing, all SFIs which must include:
        1. Any financial arrangement between the investigator and sponsor in which the value of the compensation to the investigator could be influenced by the outcome of the study
        2. Any significant payment of other sorts from the sponsor of the study, such as a grant to fund ongoing research, compensation in the form of equipment, retainer for ongoing consultation, or honoraria
        3. Any proprietary interest in the tested product held by any investigator involved in a study
        4. Any significant financial interest in the sponsor of the study held by any investigator involved in a study
    2. VBRI-Administration

      1. 1. VBRI is responsible to complete all necessary initial and annual reports to the funding agency.
      2. VBRI will conduct a retrospective review in those cases of non-compliance with the regulation. As required by the funding agency, VBRI will notify the funder promptly and submit a report only in cases where bias is found. The report will address the impact of the bias on the research project and the actions the Institution has taken, or will take, to eliminate or mitigate the effect of the bias.
      3. VBRI will implement and maintain training requirements as required per regulation.
      4. VBRI will implement and maintain procedures to adequately communicate and monitor adherence to regulatory FCOI requirements in its collaboration and participation with its subrecipient(s) on applicable funded research.
      5. Potential conflicts of interest for research for VBRI administered studies are reviewed through the VANJHCS Research and Development (R&D) Committee. The committee reviews disclosures of financial conflict of interest related to research and makes recommendations regarding management of conflicts of interest.
  6. Disclosure of Financial Interests
    Investigators and VBRI are under a continuing obligation to disclose any potential conflict of interest as soon as it is known or reasonably should be known.
    1. A Financial Conflict of Interest Disclosure is required from all Investigators for applicable funded projects at the time of application submission. Disclosures will be reviewed for actual, potential, or apparent COI to determine if outside activities or interest may conflict with the investigator’s responsibilities to the research project.
    2. An updated disclosure of SFI is required at least annually during the period of the award.
    3. Within thirty days of discovering or acquiring (e.g., through purchase, marriage, or inheritance) a new SFI, submission of an updated disclosure is required.
    4. Within thirty days of an Investigator newly participating in the project, submission of a disclosure form is required.
  7. Management, Reduction or Elimination of Conflicts of Interest

    Under certain circumstances, the R&D Committee may conclude that a conflict or potential conflict could directly affect the design, conduct, or reporting of the project, and the project will be placed on hold from any activity, until the R&D Committee can recommend a management plan acceptable to the VANJHCS Director, VBRI Executive Director, the PI and (if applicable) the sponsor. VBRI will report to any applicable funding agency the existence of a conflicting interest (but not the nature of the interest or other details) that is found. VBRI will also assure the funding agency that the interest has been managed, reduced or eliminated.

  8. FCOI Compliance Failures

If an Investigator fails to comply with the VBRI Financial Conflict of Interest policy or the management plan, VBRI will, in collaboration with the R&D Committee, and within 120 days:

  1. Complete a retrospective review of the Investigator’s activities and the research project to determine any bias in the design, conduct or reporting of research;
  2. Document the retrospective review consistent with regulation; and
  3. Document VBRI’s determination as to whether any funded research, or portion thereof, conducted during the period of time of the Investigator’s non-compliance with VBRI’s Financial Conflict of Interest policy or a Financial Conflict of Interest management plan, was biased or might appear to be biased in the design, conduct, or reporting of such research. The VBRI Executive Director will submit such evaluation request to the R&D Committee for further action as necessary.
    • If bias is found, the Institution shall notify the sponsor promptly and submit a mitigation report that shall address the impact of the bias on the research project, and VBRI’s plan of action or actions taken to eliminate or mitigate the effect of the bias. Thereafter, VBRI will submit FCOI reports annually, in accordance with the regulation.
    • FOR NIH FUNDED CLINCIAL RESEARCH PROJECTS whose purpose is to evaluate the safety or effectiveness of a drug, medical device or treatment, that has been designed, conducted or reported by an Investigator with a Financial Conflict of Interest that was not managed or reported by VBRI, VBRI shall require the Investigator involved to disclose the Financial Conflict of Interest in each public presentation of the results of the research and to request an addendum to previously published presentations.
  1. Investigator Training
    • Each Investigator must complete training prior to engaging in research related to any funded VBRI administered research or contract governed by federal conflict of interest regulation and immediately following the circumstances identified below.
      1. Institutional FCOI policies change in a manner that affects Investigator requirement
      2. An Investigator is new to an Institution
      3. An Institution finds an Investigator noncompliant with Institution’s FCOI policy or management plan.
    • VBRI will accept documentation of the completion of NIH’s FCOI training to fulfill investigators’ training requirement. VBRI requires that investigator who completed NIH training to forward the training certification as proof of completion to VBRI.
    • VBRI incorporates as part of a written agreement language regarding whether the FCOI policy of the VBRI or that of the subrecipient will apply to subrecipient investigators. This includes time periods to meet SFI disclosure, if applicable, and FCOI reporting requirements.
    • Subrecipient Institutions who rely on their FCOI policy must report identified FCOIs to VBRI in sufficient time to allow VBRI to report the FCOI to the PHS Awarding Component to meet FCOI reporting obligations.
  2. VBRI will make required information on identified FCOIs held by Investigators available to requestors within five calendar days of receipt date of a written request.

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