Financial Conflicts of Interest (FCOI)

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SCOPE

This policy covers all projects conducted with government funds at Fischer Imaging and is applicable to all employees, sub recipients, consultants, or any other covered organizations or persons involved in government awards.

PURPOSE

Under this policy, Fischer Imaging strives to ensure that all work performed under Government Awards meets the highest standard of integrity and is free of any real or perceived conflicts of interest that could harm patients, the reputation of Fischer Imaging, the governmental agency providing the funding, and/or external partners. As Fischer Imaging must comply with government regulations when making expenditures with Government Awards, this policy governs the disclosure of individual financial interests and the management and reporting of individual financial conflicts of interest in Governmental Awards.  It is intended to comply with the requirements of federal regulations,  including , but not limited to, the conflict-of-interest regulations of the U.S. Department of Health and Human Services Public Health Service (“the PHS FCOI Rules”) as found in 42 CFR Part 50 Part F (Promoting Objectivity in Research) and 45 CFR Part 94 (Responsible Prospective Contractors) and the Federal Acquisition Regulation FAR 52.203-16 (collectively referred to as the “Financial Conflict of Interest Rules”).

DEFINITIONS

For purposes of this policy, the following definitions shall apply:

Conflict Management Plan (CMP) refers to the document specifying the actions to be taken to manage a Financial Conflict of Interest.

Designated Official is the individual designated by Fischer Imaging to oversee the financial conflicts of interest process, including solicitation and review of disclosures of significant financial interests.

Disclosure refers to the investigator’s disclosure of SFI to Fischer Imaging.

External Partner refers to  a consultant, subcontractor, or sub-recipient performing work under a Government Award who is not employed by Fischer Imaging.

Financial conflict of interest (FCOI) means a significant financial interest that could directly and significantly affect the design, conduct, or reporting of research as determined by Fischer Imaging through the Designated Official.

Financial interest means anything of monetary value, whether or not the value is readily ascertainable.

Immediate family refers to an Investigator’s spouse, domestic partner, child or step-child, parent or step-parent, or sibling or step-sibling.

Investigator means the project director/principal investigator and any other person who is responsible for the design, conduct, or reporting of the research, including subgrantees, contractors, consortium participants, collaborators, or consultants.

Public Health Service (PHS) means the U.S. Public Health Service, an operating division of the U.S. Department of Health and Human Services (HHS), and any components of the PHS to which the authority involved may be delegated, including the National Institutes of Health.

Remuneration includes, for example, salary and any payment for services not otherwise identified as salary (e.g., consulting fees, honoraria, paid authorship).

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). For PHS-Funded Research, the term includes any such activity for which research funding is available from a PHS Awarding Component through a grant, cooperative agreement, or contract, whether authorized under the PHS Act or other statutory authority.

Significant Financial Interest (SFI):

  1. A financial interest consisting of one or more of the following interests of the Investigator or their Immediate Family Member that reasonably appears to be related to the Investigator’s Institutional Responsibilities:
    1. The value of any remuneration received from a public 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; or
    2. The value of any remuneration received from a non-publicly traded entity in the twelve months preceding the disclosure, when aggregated, exceeds $5,000, or when the Investigator (or their immediate family) holds any equity interest (e.g., stock, stock option, or other ownership interest); or
    3. Intellectual property rights and interests (e.g., patents, copyrights), upon receipt of income related to such rights and interests.
  2. Investigators must disclose the occurrence of any reimbursed or sponsored travel related to their Institutional Responsibilities. The disclosure will include, at a minimum, the following details: (i) the purpose of the trip; (ii) the identity of the sponsor/organizer; (iii) the destination; and (iv) the trip duration. (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 the following:
    1. Salary, royalties, or other remuneration paid by Fischer Imaging to the Investigator if the Investigator is currently employed or otherwise appointed by Fischer Imaging;
    2. Intellectual property rights assigned to Fischer Imaging and agreements to share in royalties related to such rights;
  4. 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;
    1. Income from seminars, lectures, or teaching engagements sponsored by a federal, state, or local government agency, an institution of higher education as defined in 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; and
    2. Income from service on advisory committees or review panels for a federal, state, or local government agency, or 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.

Significant Financial Interest Disclosure (SFID) Form refers to the form that will be used by any investigator to report SFI to Fischer Imaging and can be obtained by email at info@fischerimaging.com.

POLICY

It is the policy of Fischer Imaging to comply with the Financial Conflict of Interest Rules (“FCOI Rules”) to ensure that the work performed under Government Awards is carried out in a manner that is free from any bias which may result from financial conflicts of interest.  All Investigators for Government Awards must disclose any Significant Financial Interests (SFI) to Fischer Imaging. Investigators must complete or update a disclosure survey at least annually during the period of the award and must disclose any new SFI’s within thirty days of discovering or acquiring the SFI.  Investigators also must ensure that the disclosure survey is completed or updated no later than the time of application for a Government Award.

PROCEDURES

The Designated Official or his/her designee shall be do the following:

  • Inform Fischer Imaging Investigators of their obligations under this policy and any related regulations;
  • Review disclosures of significant financial interest with Fischer Imaging’s Administrator to determine whether they are related to the subject research and, if so, whether they constitute financial conflicts of interest;
  • Screen and manage potential financial conflicts of interest;
  • Maintain all records relating to disclosures of financial interests, Fischer Imaging’s review of and response to such disclosures, and any related actions under this policy;
  • Ensure inclusion of any required certifications in applications for funding or contract proposals; and
  • Report and disclose as required under this policy and applicable regulations.

For PHS-funded research, the Designated Official shall also have the following responsibility:

  • Taking reasonable steps to ensure that Investigators for subrecipients (e.g., subgrantees, subcontractors, or collaborators) fully comply with this policy or provide Fischer Imaging with sufficient assurances to enable Fischer Imaging’s compliance with all applicable laws or regulations. To this end, the written agreement between Fischer Imaging and the subrecipient will specify whether Fischer Imaging’s or the subrecipient’s financial conflicts of interest policy will apply to the subrecipient’s Investigators and, if the subrecipient’s policy will apply, the Designated Official will:
  • Obtain certification from the subrecipient that its policy complies with Fischer Imaging’s policy and the applicable regulations (absent such certification, Fischer Imaging’s policy will apply to the subrecipient’s Investigators, and
  • Establish time periods for subrecipient reporting of financial conflicts of interest to Fischer Imaging that enable Fischer Imaging to report such conflicts in a timely manner, as required under its policy and the applicable regulations.

If Fischer Imaging’s policy will apply to the subrecipient Investigators, Fischer Imaging will be responsible for meeting the requirements of this policy and the reporting obligations reflected in the applicable regulations.

Internal Reporting Requirements

For PHS-funded research in particular, as part of the funding application or proposal and prior to performing any work on the research, each Investigator who is planning to participate in the research is required by regulation to complete a Significant Financial Interest Disclosure (SFID) Form and submit the SFID Form to Fischer Imaging’s Administrator. This requirement also applies to Investigators who are or who work for subgrantees, subcontractors, or collaborators on PHS-funded research. SFID Forms will be provided to Investigators in conjunction with the annual training and will be otherwise made available. Fischer Imaging’s Administrator will review SFID submissions with the Designated Official. The information reported on the SFID Form includes a listing of the Investigator’s known significant financial interests and those of his/her immediate family that reasonably appear to be related to the research or that are in entities whose financial interests could be affected by the research.

Fischer Imaging Investigators in non-PHS-funded research who have any significant financial interest that may reasonably appear to be affected by the research are also expected to complete the SFID Form and submit it to Fischer Imaging’s Administrator.

Investigators are expected to submit an updated SFID Form during the period of the award as necessary (at least annually for PHS-funded research). The annual update will typically be done in conjunction with completion of the annual training. Such disclosures shall include any information that was not previously disclosed; any change in information regarding any previously disclosed significant financial interest; or, within 30 days of discovery or acquisition, any new significant financial interest (e.g., an interest acquired through purchase, marriage, or inheritance).

Determination and Management of Financial Conflicts of Interest

Upon receipt of a completed SFID Form, the Designated Official shall determine whether an Investigator’s significant financial interest is related to the subject research and, if so, whether the interest constitutes a financial conflict of interest under this policy and any applicable regulations. The Investigator may be required to submit additional information as part of the process. A disclosed interest may be related to the subject research either because the interest could be affected by the research or because it is in an entity whose financial interest could be affected by the research. A financial conflict of interest exists if the significant financial interest could directly and significantly affect the design, conduct, or reporting of the research.

If Fischer Imaging determines that a financial conflict of interest exists, a conflict management plan (CMP) will be implemented and monitored on an ongoing basis. The management plan will include appropriate steps to manage, reduce, or eliminate the conflict. The following are examples of conditions or restrictions that might be imposed:

  • Disclosure to research participants or the public of significant financial interests (e.g., when presenting or publishing the research);
  • Monitoring of research by independent reviewers;
  • Modification of the research plan;
  • Disqualification of staff from participation in all or a portion of the research;
  • Reduction or divestiture of a financial interest; or
  • Severance of relationships that create actual or potential conflicts.

In addition to the conditions or restrictions described above, Fischer Imaging may require the management of conflicting financial interests in other ways as it deems appropriate.

External Reporting Requirements

Fischer Imaging will disclose financial conflicts of interest as required by applicable laws or regulations. Before expending any funds under a PHS award, Fischer Imaging will ensure public accessibility by posting financial conflicts of interest information on a publicly available web site or by responding in a timely manner to written requests as required under the regulations. The Designated Official will also report to the PHS Awarding Component, as detailed in the regulations, the existence of any financial conflict of interest that has not been eliminated and will ensure that Fischer Imaging has implemented a plan to manage the conflict.

If a financial conflict of interest is identified after its initial reporting and during ongoing research (e.g., through participation of a new Investigator) and has not been eliminated, Fischer Imaging will provide the PHS Awarding Component with an update within 60 days and ensure that it has implemented a plan to manage the conflict. If the financial conflicts of interest report involves a significant financial interest that was not disclosed by an Investigator or not previously reviewed or managed by Fischer Imaging (e.g., not reviewed or reported by a subrecipient in a timely manner), Fischer Imaging will undertake a retrospective review. Such retrospective review will determine whether there was bias in the design, conduct, or reporting of the PHS-funded research, or portion thereof, conducted prior to the identification and management of the conflict. If bias is found, Fischer Imaging will promptly notify the PHS Awarding Component and submit a mitigation report. Upon request, Fischer Imaging will provide HHS with information relating to any Investigator disclosure of significant financial interests; Fischer Imaging’s review of, and response to, such disclosure; and whether the disclosure resulted in Fischer Imaging’s determination of a financial conflict of interest.

Confidentiality

Fischer Imaging will, to the extent possible, protect the confidentiality of disclosures. In every instance, Fischer Imaging will endeavor to balance the privacy interests of individuals with its responsibility and obligation to identify and manage conflicts of interest. Disclosures will be available to Fischer Imaging staff only on a need-to-know basis and will not be disclosed outside of Fischer Imaging unless necessary to comply with contractual, legal, or regulatory requirements.

Investigator Noncompliance

If an Investigator knowingly fails to comply with this policy (e.g., fails to identify an actual or potential financial conflict of interest), Fischer Imaging may take appropriate disciplinary action, which may include, without limitation, termination of the Investigator’s participation in the research. In addition, for PHS-funded research, failure to comply with this policy or the applicable regulations shall result in the following:

  • If the Investigator’s failure to comply with this policy or a financial conflicts of interest management plan has biased the design, conduct, or reporting of the PHS-funded research, Fischer Imaging shall promptly notify the PHS Awarding Component of the corrective action taken or to be taken;
  • Fischer Imaging will make available to HHS all records pertinent to financial conflicts of interest and the management of those conflicts; and
  • If HHS determines that a clinical PHS-funded research project whose purpose is to evaluate the safety or effectiveness of a drug, medical device, or treatment has been designed, conducted, or reported by an Investigator with a financial conflict of interest that was neither disclosed nor managed, Fischer Imaging shall require disclosure of the conflicting interest in each public presentation of the results of the research and shall request an addendum to previously published presentations, if necessary.
Training and Education

Investigators receive training to promote objectivity in research and to ensure Investigator compliance with regard to the applicable regulations and significant financial interest disclosure obligations. The training module and other resources developed by NIH will be updated as appropriate and can be accessed through the NIH Web site.

Fischer Imaging requires Investigators to complete such training annually, and when any of the following occurs:

  • Fischer Imaging revises its financial conflicts of interest policy or procedures in any manner that affects the Investigator’s obligations;
  • An Investigator is new to Fischer Imaging; or
  • Fischer Imaging finds that an Investigator is not in compliance with this policy or a financial conflicts of interest management plan.
Retention of Records

The Designated Official will retain financial conflicts of interest disclosure forms and other supporting information consistent with Fischer Imaging’s Record Retention policy. For PHS-funded research, records of all financial disclosures, whether or not they result in a reporting obligation, and all actions taken by Fischer Imaging with respect to each financial conflict of interest will be retained for at least 3 years from the date of submission of the final expenditures report or final payment on the contract or, where applicable, from other dates specified in 45 C.F.R. 75.361.

Point of Contact

If you have a conflict of interest or if you have a question to discuss, contact the Fischer Imaging Administrator at FCOI at www.FischerImaging.com or email at info@fischerimaging.com