Purpose and Scope
Virtici, LLC (“Virtici”) is committed to protecting the integrity and objectivity of its research activities by ensuring that the design, conduct, and reporting of research will not be biased or appear to be biased by a personal financial conflict of interest. This Financial Conflict of Interest Policy (“Policy”) is implemented to identify, manage, reduce, or eliminate financial conflicts of interest. This Policy describes certain legal obligations applicable to Investigators’ disclosure of potential financial conflicts of interest. The policy and the associated procedures are derived from the final rules on Objectivity in Research promulgated by the PHS and the NSF as implemented in the 2011 Final Rule for grants and cooperative agreements. This policy and the associated procedures are applicable to all PHS sponsored program activity carried out by Virtici Employees. These procedures will be followed whenever Virtici or its employees submit a request for funding from any external agency, whether it is the PHS, the NSF or another Federal agency.
Definitions
The following definitions apply to this policy:
Disclosure of Significant Financial Interests means an Investigator's significant financial interests (“SFI”) disclosure.
Family Member means the Virtici Employee's spouse and children or other adults who qualify as dependents under the Internal Revenue Code definitions.
Financial Conflict of Interest (FCOI) means a significant financial interest that could directly and significantly affect the design, conduct, or reporting of PHS-funded research.
FCOI Report means Virtici’s report of a financial conflict of interest to a PHS Awarding Component.
Financial Interest means anything of monetary value, whether or not the value is readily ascertainable.
Investigator is defined as the Project Director (PD), Principal Investigator (PI), consultants, or any other person, regardless of title or position, who is responsible for the design, conduct, or reporting of research funded by the PHS, or proposal for such funding.
Manage means taking action to address a financial conflict of interest, which can include reducing or eliminating the financial conflict of interest, to ensure, to the extent possible, that the design, conduct, and reporting of research will be free from bias.
PHS Awarding Component means the organizational unit of the PHS that funds the research that is subject to 42 CFR Part 50, Subpart F.
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.
Virtici Employee means any individual employed on a full- or part-time basis by Virtici and is receiving, or will receive, compensation (including consultants, agents, and research collaborators of Virtici).
Significant financial interest means any item of monetary value including, but not limited to: 1) salary or other payments for services rendered such as consulting fees, 2) equity interests such as stocks, stock options, or other ownership interest; and 3) intellectual property rights such as patents, copyrights, and royalties from such intellectual property rights. Significant Financial Interest does not include: 1) Virtici remuneration such as salary or royalties, 2) consulting fees from service on advisory committees or review panels for public or nonprofit entities; or 3) financial interest in business enterprise or entities where the value of such interests would not be anticipated to exceed $5,000 per annum or represent more than a five per cent (5%) ownership interest. The value of such equity interests is to be determined because of public prices or other reasonable measures of fair market value.
Process
An Investigator is required to comply with the policy and procedures outlined below. Investigators also include collaborators and consultants. Investigators are required to: 1) disclose any significant financial interests (SFIs) at the time of application for federal PHS funding by completing and signing a disclosure form, and submitting this to the Designated Official at Virtici, 2) disclose SFIs using the disclosure form at least on an annual basis during the course of an award, 3) disclose within 30 days of discovering or acquiring (e.g., through purchase, marriage, or inheritance) any new SFI, and 4) take part in FCOI training at least once every four years.
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. Virtici requires Investigators to complete such training every four years, and when: 1) Virtici revises its financial conflicts of interest policy or procedures in any manner that affects the Investigator’s obligations, 2) an Investigator is new to Virtici, or 3) Virtici finds that an Investigator is not in compliance with this policy or a financial conflicts of interest management plan.
To identify conflicts of financial interest, the following procedures will be followed: 1) all investigators involved in the project/proposal are required to complete, sign and submit the SFI Disclosure Form, 2) the Investigator must list all of their SFIs (and those of the Investigator's Family Members) that reasonably appear to be related to the Virtici Research; 3) the form requires the Investigator to include, at minimum, the name of the entity, the nature of the financial interest (e.g., equity, consulting fee), the monetary value of the financial interest or its approximate value if the interest is one whose value cannot readily be determined. If needed, the Virtici may request supporting documentation to determine whether an FCOI exists; 4) for SFI disclosures related to sponsored or reimbursed travel, the disclosure must include, at minimum, the purpose of the trip, the identity of the sponsor/organizer, the destination, the duration, and the approximate monetary value, 5) the Investigator is required to submit an updated SFI Disclosure during the period of the award at least annually, and within 30 days of discovering or acquiring a new SFI.
In conjunction with the administrative review of applications for grants, the CEO will review each SFI disclosure submitted and shall make the determination of whether a conflict of significant financial interest exists. An Investigator's SFI is related to PHS-funded research when Virtici, through its designated official, reasonably determines that the SFI could be affected by the PHS-funded research or is in an entity whose financial interest could be affected by the research. An FCOI exists when the institution reasonably determines that the SFI could directly and significantly affect the design, conduct, or reporting of the PHS-funded research. If the CEO determines that no conflict of significant financial interest exists, the resulting negative finding will be filed in Virtici's Legal and/or Human Resource files. For negative findings no further review is required.
In cases in which Virtici identifies a financial conflict of interest and is able to resolve the matter, Virtici is not required to submit an FCOI report to the PHS Awarding Component. For any significant financial interest that the Virtici identifies as conflicting and is not able to resolve, Virtici will, within 60 days, submit an FCOI report regarding the financial conflict of interest and ensure that Virtici has implemented a management plan. Any FCOI report required by PHS will include sufficient information to enable the PHS Awarding Component to understand the nature and extent of the financial conflict, and to assess the appropriateness of the Virtici’s management plan. For any financial conflict of interest previously reported, Virtici will provide an annual FCOI report that addresses the status of the financial conflict of interest and any changes to the management plan. The annual FCOI report will specify whether the financial conflict is still being managed or explain why the financial conflict of interest no longer exists. Virtici will provide annual FCOI reports for the duration of the project period (including extensions with or without funds) in the time and manner specified by the PHS Awarding Component.
Noncompliance
If an Investigator who is required under this policy to file a SFI disclosure fails to do so or fails to disclose a significant financial interest on the disclosure form, the Investigator may be subject to company inquiry. If an unreported significant financial interest involves a research project administered by Virtici, appropriate administrative action required by the funding agency will also be taken. Virtici will promptly notify the funding agency if it is determined that the company is unable to manage satisfactorily any conflict of significant financial interest. Intentional disregard for this policy, including non-adherence to the agreed upon management plan, shall constitute serious misconduct and may be the basis for further administrative inquiry.
Records
Virtici will maintain all SFI disclosures, training certifications, management plans, reports and all related records of actions taken by Virtici with respect to disclosures of financial interests for a period of three years from the date of submission of the final expenditures report to the PHS as governed by 42 CFR Part 50 Subpart F, and from other dates specified in 45 CFR 75.361, where applicable.