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FCOI Policy


Financial Conflict of Interest (FCOI) per 42 CFR Part 50 Subpart F

 

I. Purpose

The purpose of this policy is to provide appropriate safeguards to assure that the potential for conflicts of interest, particularly those with a financial implication, are not allowed to inappropriately influence the design, conduct, review, oversight or sound judgment of its Investigators performing Public Health Service (PHS)-funded research at Nephropathology Associates, PLC d/b/a Arkana Laboratories (herein referred as Arkana). This policy sets forth Arkana’s position and provides a mechanism to ensure the integrity of research when such conflicts arise. (42 CFR Part 94; 45 CFR Part 50, Subpart F). This policy does not apply to SBIR or STTR Phase I grants.

 

II. Scope of Policy

This policy applies to all individuals at Arkana who meet the definition of Investigator (see III – Definitions below) and applies to all activities meeting the definition of research where the activity is funded by the PHS (including the National Institutes of Health). Other federal agencies such as the Food and Drug Administration or the National Science Foundation are subject to agency-specific regulations relating to financial conflicts of interest in research. Investigators are advised to review such regulations prior to submission of a research proposal or application.

This policy is overseen by the Executive Director of Arkana, who will appoint a Conflict of Interest Officer (COIO) as Arkana’s official responsible for implementation of this policy. The COIO will review all disclosures of conflict of interest from investigators prior to the submission/initiation of If financial conflicts of interest (FCOI) are determined, the COIO will work with the Investigator/s to develop a management plan to mitigate the FCOI. The management plan will be submitted to the Institutional Research Oversight Committee for review and, if applicable, revisions. The revised management plan will be signed and dated by the Investigator as a confirmation of agreement.

 

IV. Definitions

Disclosure means an investigator’s disclosure of financial interests to Arkana related to his or her institutional responsibilities.

Entity means an outside organization, whether public or private which may include a company, partnership, professional association, voluntary health organization, etc.

Human Subjects Research means research conducted with a living individual about whom an investigator obtains 1) data through intervention or interaction with the individual or 2) identifiable private information.

Institutional Responsibilities means an investigator’s professional responsibilities on behalf of Arkana, including, but not limited to, activities such as research, research consultation, teaching, professional practice, or institutional committee memberships.

Investigator means 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 Public Health Service (PHS), or proposed for such funding, which may include, for example, collaborators or consultants.

Manage means to take action to address a financial conflict of interest, which includes reducing or eliminating the financial conflict of interest, to ensure that the design, conduct, and reporting of research are free from bias or the appearance of bias.

Public Health Service (PHS) means 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 means the organizational unit of the PHS that funds the research.

Research means 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 Awarding Component through a grant or cooperative agreement, whether authorized under the PHS 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.

Significant Financial Interest means 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: (i) 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; (ii) 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 (iii) Intellectual property rights and interests (e.g., patents, copyrights), upon receipt of income related to such rights and interests.

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. Arkana’s FCOI policy requires 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. Arkana’s official 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.

The term significant financial interest does not include the following types of financial interests: salary, royalties, or other remuneration paid by Arkana to the Investigator if the Investigator is currently employed or otherwise appointed by Arkana, including intellectual property rights assigned to Arkana and agreements to share in royalties related to such rights; any ownership interest in Arkana held by the Investigator, if it 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, 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, 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 means 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. The term SBIR Program also includes the Small Business Technology Transfer (STTR) Program, which was established by Public Law 102–564.

 

V.  Institution Responsibilities (45 CFR Part 94.4)

Arkana will:

  1. Maintain an up-to-date, written, enforced policy on financial conflicts of interest that complies with Part 94.4, and make such policy available via Arkana’s Website in accordance with 42 CFR Section 604(a).
  2. Inform each Investigator of the policy on financial conflicts of interest, the Investigator’s responsibilities regarding disclosure of significant financial interests, and of these regulations, and require each Investigator to complete training regarding the same prior to engaging in research related to any PHS-funded contract and at least every four years, and immediately when any of the following circumstances apply (42 CFR 604(b)):
    1. Revision of the financial conflict of interest policies or procedures in any manner that affects the requirements of Investigators;
    2. An Investigator is new to Arkana; or
    3. An Investigator is found to be not in compliance with Arkana’s financial conflict of interest policy or management
    4. If Arkana carries out the PHS-funded research through a sub-recipient (e.g., subcontractors, or consortium members), it will take reasonable steps to ensure that any sub-recipient Investigator complies with PHS requirements by:
      1. Incorporating as part of a written agreement with the sub-recipient terms that establish whether the financial conflicts of interest policy of Arkana or that of the sub-recipient will apply to the sub-recipient’s
      2. If the sub-recipient’s Investigators must comply with the sub-recipient’s financial conflicts of interest policy, the sub-recipient shall certify as part of the agreement referenced above that its policy complies with 42 CFR 604(c)(1)(i)-(iii). If the sub-recipient cannot provide such certification, the agreement shall state that sub-recipient Investigators are subject to the financial conflicts of interest policy of Arkana for disclosing significant financial interests that are directly related to the sub-recipient’s work for Arkana;
      3. Additionally, if the sub-recipient’s Investigators must comply with the sub- recipient’s financial conflicts of interest policy, the agreement referenced above will specify time period(s) for the sub-recipient to report all identified financial conflicts of interest to Arkana. Such time period(s) will be sufficient to enable Arkana to provide timely FCOI reports, as necessary, to the PHS;
      4. Alternatively, if the sub-recipient’s Investigators must comply with Arkana’s financial conflicts of interest policy, the agreement referenced above willl specify time period(s) for the sub-recipient to submit all Investigator disclosures of significant financial interests to Such time period(s) will be sufficient to enable Arkana to comply timely with its review, management, and reporting obligations to the PHS.
  3. Providing FCOI reports to the PHS Awarding Component regarding all financial conflicts of interest for Investigators including sub-recipient Investigators, i.e., prior to the expenditure of funds and within 60 days of any subsequently identified 42 CFR 50.604(h) and 42 CFR 50.605(b)
  4. The COIO will solicit and review disclosures of significant financial interests from each Investigator including sub-recipients who are planning to participate in, or are participating in, the PHS-funded 42 CFR 50.604(d,g); 42 CFR 50.605(a)(4)
  5. Arkana will further: 42 CFR 603 and 42 CFR 50.604(e)(1)-(3)
    1. Require that each Investigator who is planning to participate in the PHS-funded research disclose to the COIO the Investigator’s significant financial interests (and those of the Investigator’s spouse and dependent children) no later than date of submission of Arkana’s proposal for PHS-funded
    2. Require each Investigator who is participating in the PHS-funded research to submit an updated disclosure of significant financial interests at least annually, to Arkana, during the period of the award. Such disclosure shall include any information that was not disclosed initially to Arkana or in a subsequent disclosure of significant financial interests (e.g., any financial conflict of interest identified on a PHS-funded project that was transferred from another Institution), and shall include updated information regarding any previously disclosed significant financial interest (e.g., the updated value of a previously disclosed equity interest).
    3. Require each Investigator who is participating in the PHS-funded research to submit an updated disclosure of significant financial interests within thirty days of discovering or acquiring (e.g., through purchase, marriage, or inheritance) a new significant financial interest to the COIO.
  6. Arkana’s COIO will determine whether an Investigator’s significant financial interest is related to PHS-funded research and, if so related, whether the significant financial interest is a financial conflict of interest. The COIO will determine if the significant financial interest could be affected by the PHS-funded research; or is in an entity whose financial interest could be affected by the research if it is found that the significant conflict of interest could directly and significantly affect the design, conduct, or reporting of the PHS-funded 42 CFR 50.604(f)
  7. COIs related to PHS-funded research shall be identified, managed and reported to the PHS-Awarding Component prior to the expenditure of any funds under the research project. Any related COIs that arise after the project begins shall be managed and reported within sixty (60) days of disclosure. PHS reports shall be updated on an annual basis for the duration of the research 42 CFR 50.605(a)(3)(iii)
  8. Arkana will take such actions as necessary to manage Investigator financial conflicts of interest, including any financial conflicts of a sub-recipient Management of an identified financial conflict of interest requires development and implementation of a management plan which may require modification of the research plan, public disclosure in publications and presentations, disclosure to human subjects participating in the research, severance of relationships that create financial conflicts, informing other research team members, separation of responsibilities or other appropriate mitigation strategies. All management plans will be reviewed by the IROC as stated in section III above. 42 CFR 50.605(a)(2)
  9. Failure to disclose a conflict and/or comply with required management strategies constitutes a violation of this policy. Employees may be subject to sanctions for violation of this policy, including disciplinary action up to and including termination of Investigator noncompliance will be reported to the appropriate PHS Awarding Component within 10 business days of learning of the noncompliance along with a corrective action plan as approved by the IROC. 42 CFR 50.606(a)
  10. In the event Arkana identifies a significant financial interest that was not disclosed in a timely manner by an Investigator or, for whatever reason, was not previously reviewed by Arkana’s COIO during an ongoing research project, Arkana will implement a management plan for the project within 60 days of identification of that Furthermore, within 120 days of the determination of noncompliance, the COIO will complete a retrospective review of the Investigator’s research activities associated with the project to determine whether the research conducted during the period of the noncompliance was biased in the design, conduct, or reporting of such research. 42 CFR 50.605(a)(3)
  11. If the COIO determines in the conduct of the retrospective review of PHS-funded research that the research or any part of it was biased, he will recommend a mitigation plan to the Institutional Research Oversight Committee (IROC) to address any such issues. The IROC will give its written recommendations and/or comments to the COIO who will notify the PHS Awarding Component of Arkana’s determination and subsequently follow up with the mitigation report for the Management/mitigation plans will be updated annually if there are any changes.
  12. Maintain records relating to all Investigator disclosures of financial interests and Arkana’s review of, and response to, such disclosures (whether or not a disclosure resulted in the determination of a financial conflict of interest), and all actions under this policy or retrospective review, if applicable, for at least three years from the date of final 42 CFR 50.604(i)
  13. Arkana will certify the following in each contract proposal:
    1. Has in effect an up-to-date, written, and enforced administrative process to identify and manage financial conflicts of interest with respect to all research projects for which funding is sought or received from the PHS;
    2. Shall promote and enforce Investigator compliance including those pertaining to disclosure of significant financial interests;
    3. Shall manage financial conflicts of interest and provide initial and ongoing FCOI reports to the PHS Awarding Component;
    4. Agrees to make information available, promptly upon request, to the HHS relating to any Investigator disclosure of financial interests and Arkana’s review of, and response to, such disclosure, whether or not the disclosure resulted in a determination of a financial conflict of

VI. Investigators Responsibilities 42 CFR 604(b)

Investigator will:

  1. Become familiar with the PHS regulations and Arkana’s FCOI
  2. Complete FCOI training prior to engaging in research related to any PHS-funded grant but no less than every four
  3. Disclose significant financial interests (SFIs) to Arkana annually and within thirty days of discovering or acquiring a new
  4. If an Investigator is found to have a FCOI for which the COIO of Arkana has developed a management plan approved by the IROC, the Investigator is required to confirm agreement with the plan by his/her signature and date. The Investigator understands that the management plan will be monitored on an annual basis during the period of the award. Therefore, it is the responsibility of the Investigator to verify compliance by retaining documents such as notices to journal editors or conference audiences, consent forms from human subject research or notices to research personnel.

Investigator is not required to disclose:

  1. Salary, royalties, or other remuneration paid to the investigator from the institution that currently employs the investigator. Any ownership interest in the institution held by the investigator, if the institution is a commercial for-profit
  2. Income from investments in mutual funds or retirement accounts, as long as the investigator does not make the investment
  3. Income for services (honoraria, advisory committees, review panels, ) and travel expenses paid by a federal, state, or local government agency, a U.S. institution of higher education or a research institute affiliated with a U.S. institution of higher education, a medical center, or an academic teaching hospital.

VII. Management and Reporting of FCOIs

The initial report will be reported to the PHS Awarding Component and will include the following information:

  1. The grant/contract number
  2. The name of the project director, principal investigator, or contact person (when there are multiple project directors or principal investigators)
  3. The name of the investigator with the FCOI
  4. The name of the entity with which the researcher has the FCOI
  5. The nature of the FCOI (equity, consulting fees, travel reimbursement, honoraria, )
  6. The value of the financial interest in specific intervals: $0-4,999, $5,000-9,999, $10,000-19,999, amounts between $20,000 and $100,000 by increments of $20,000, and 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 fair market value.
  7. A description of how the SFI relates to the PHS-funded research and the basis for the institution’s determination that the SFI conflicts with the research

The annual FCOI report will be completed by June 30 for each year of a PHS-funded grant or until the FCOI no longer exists. The annual FCOI report will include the following information:

  1. Status of the FCOI
  2. Changes to the management plan, if applicable

 

Elements of a Management Plan to Promote Objectivity in Research

Management plans will be developed as the situation warrants but will include the following in accordance with the regulations that a management plan must describe the:

  1. Role and principal duties of the conflicted Investigator in the research project;
  2. Conditions of the management plan;
  3. How the management plan is designed to safeguard objectivity in the research project;
  4. Confirmation of the Investigator’s agreement to the management plan;
  5. How the management plan will be monitored to ensure Investigator compliance;
  6. Other information as needed.

 

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