Policy

It is the policy of Artisight 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.  

Artisight Illinois Officials will manage, review, and mitigate all financial conflicts of interest for Artisight research personnel.

All investigators for Government Awards must disclose any Significant Financial Interests (SFI) to Artisight. 

If Artisight determines that a SFI causes a Financial Conflict of Interest, Artisight will establish a committee and action plan to manage or eliminate the conflict of interest.  

 

Purpose

To establish the standards that provide a reasonable expectation that research will be free from bias resulting from Investigator financial conflicts of interest. 

Artisight works to ensure that all work performed under Government Awards meets the highest standards of integrity and is free of any real or perceived conflicts of interest that could harm patients, the reputation of Artisight, the Government agency providing the funding, and our external partners.  

As Artisight 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 (titled Promoting Objectivity in Research) and 45 CFR Part 94 (titled Responsible Prospective Contractors) and the Federal Acquisition Regulation FAR 52.203-16 (collectively referred to as the “Financial Conflict of Interest Rules”).

Definitions

• 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 NIH, or proposed for such funding, which may include, for example, collaborators or consultants. “Investigator” also includes the investigator’s family members.
• 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.
• 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
• Significant financial interest (SFI) – anything of monetary value, whether the value is readily ascertainable, that:  1) is related to the investigator’s professional responsibilities on behalf of the institution including, but not limited to, activities such as research, research consultation, teaching, professional practice, institutional committed memberships, and service on panels; and 2) belongs to the investigator or the investigator’s spouse or dependent children.
• Reimbursed or sponsored travel – travel 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.
• Financial conflict of interest (FCOI) – A significant financial interest (SFI) that could directly and significantly affect the design, conduct, or reporting of PHS-funded research.
• Key Research Personnel – All persons who will have a significant role in the design or conduct of the research, and includes at a minimum all Principal Investigators and Co-Investigators, and any individuals who are individually named on a grant or contract application, who are listed on an FDA form 1572, who are named as contact persons in the informed consent documents or recruitment materials for research, or who provide supervision of the persons who are obtaining informed consent to participate in research.
• 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 NIH.
• PHS Awarding Component – Organizational unit of the PHS that funds the research that is subject to 42 CFR 50 subpart F.
• 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). As used in 42 CFR 50 subpart F, 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.
• Subrecipient – Federal funds flow down from or through an awardee Institution to another individual or entity and the subrecipient will be conducting a substantive portion of the NIH-funded research project and is accountable to the awardee institution for programmatic outcomes and compliance matters.

 

Training Requirements

1. Artisight key research personnel will receive training on this material at time of implementation and whenever this policy is updated.
2. New key research personnel will receive training as part of their orientation.
3. Training will be conducted immediately if this policy is revised and affects the requirements of Investigators, an Investigator is new to an Institution or if an Investigator is not in compliance with the policy or management plan.

 

Disclosure, Review, and Monitoring

All investigators, senior or key personnel requesting PHS funding—whether grant, cooperative agreement, or contract—are required to have submitted to the company official a Financial Interest Disclosure Form. These completed forms either indicate that the investigators, senior or key personnel, have no significant financial interests (SFI) or include a listing of known SFIs (and those of the spouse and dependent children) in entities whose financial interests would reasonably appear to be affected by the research for which PHS funding is sought. Financial disclosures must be updated by all investigators, senior or key personnel on an annual basis during the award period or as new reportable SFIs are obtained, whichever occurs first.

Reporting Requirements

Artisight will comply with federal regulations regarding reporting of financial conflicts of interest (e.g. by submitting FCOI reports to the awarding institution, as required). Artisight 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. 

Maintenance

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

Enforcement Mechanisms and Noncompliance

Failure to comply with the Artisight’s 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 company official 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, and/or (4) termination of employment. 

Public Accessibility

This policy will be publicly accessible on Artisight’s website (www.artisight.com/FCOI). The policy will be updated annually on the website, and will remain available for three years from the date the information was most recently updated.