BECARE LINK LLC – Financial Conflict of Interest (FCOI) Policy
Purpose of Policy – This document establishes policies on individual conflicts of interest. It is the policy of BECARE LINK LLC., the (“Company”) to ensure that employees and other personnel avoid situations where personal interests may affect, or have the appearance of affecting, their professional judgment, or in conducting or reporting research. This policy provides guidance to help personnel manage situations in their personal affairs, employment outside the Company, and financial activities that may appear to conflict with their responsibilities and to ensure the Company and its employees comply with applicable federal laws when participating in research funded by the government. The Company’s personnel should promptly disclose the circumstances of any situation that might be covered by this policy. This policy applies to any Company member acting as Investigator or as a Senior/Key personnel on any government research project and any Sub-recipient of that project.
Implementation of Policy – The Company’s policy requires that each investigator, subrecipient, subgrantee and collaborator affiliated with the Company, by NIH or any other applicable grant or contract, be in compliance with 42 CFR Part 50, Subpart F for PHS grants and cooperative agreements (and 45 CFR Part 94 for contracts). In addition, this legislation spells out NIH’s commitment to preserving the public’s trust that the research supported by them is conducted without bias and with the highest scientific and ethical standards. Company intends to use this same FCOI standard for all other Federal agency grant and contract efforts, as tailored or amended accordingly.
Key Definitions – The following are key definitions and Company’s policy guidance for principal or program investigators, subrecipients, subgrantees and collaborators affiliated with Company. This policy is also available at https://becarelink.com/FCOI/ so that all interested parties, including the general public, have access to this Company policy.
Investigator – An Investigator is any person (including subrecipients, subgrantees and collaborators) who is responsible for the design, conduct, or reporting of research funded by PHS.
Significant Financial Interest (SFI) – Significant Financial Interest is defined by the regulations as:
- 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 Investigators 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 the 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 in stock, stock options or other ownership interest, as determined through reference to public prices and other reasonable measures of fair market value;
- 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 interests (e.g. stock, stock options, or other ownership interest); or
- 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 related to their Company 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 as defined at 20 U.S.C. 1001(a), an academic teaching hospital, medical center, or research institute that is affiliated with an institution of higher education. The disclosure must include, the purpose of the trip, the identity of the sponsor/organizer, the destination and the duration. In accordance with the Company’s FCOI policy, the Company official(s) will determine if further information is needed, including a determination or disclosure of monetary value, in order to determine whether the travel constitutes a FCOI with the PHS-funded research.
- The term Significant Financial Interest does not include the following types of financial interests:
- salaries, royalties or other remuneration paid by the Company to the Investigator if the Investigator is currently employed or otherwise appointed by the Company, including intellectual property rights assigned to the Company and agreements to share in royalties related to such rights;
- any ownership interest in the Company held by the investigator, if the Company is a commercial or for-profit organization;
- income from investment vehicles, such as mutual funds and retirements 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 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; or
- income from service on advisory committees or review panels for a federal, state or local government agency, 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.
Financial Conflict of Interest (FCOI) – A financial conflict of interest exists when the Company reasonably determines that a Significant Financial Interest (defined above) could directly and significantly affect the design, conduct, or reporting of NIH-funded research (“Research”).
Management of a FCOI – Means taking action to address a FCOI, which may include reducing or eliminating the FCOI to ensure, to the extent possible, that the design, conduct, and reporting of Research will be free from bias. Other components of the plan may include public disclosure, independent review, modifications of the Research plan or other steps as determined by the Company and its Policy Coordinator.
PHS Awarding Component – The PHS awarding component is any sub-agency of the PHS or HHS.
Disclosures/Reporting Process – The Company’s Policy Coordinator will review all “disclosures” and evaluate whether they contain any FCOI. If no FCOI is found, the “disclosure forms” will be filed in the SFI binder. If a FCOI is identified, it will be put on the FCOI report through the eRA Commons FCOI module prior to expending any funds, and the Company will undertake Management of a FCOI. If any interests are identified as conflicting subsequent to the initial report, they must be reported to the Company within 30 days. The Company will then report it to the PHS Awarding Component that has issued the award within 60 days. Each Investigator must submit an updated disclosure of an SFI not less than annually.
Records Management – The records of all financial disclosures and all actions taken by the Company will be maintained for at least three years from the date of submission of the final expenditures report.
Research – PHS research is any project governed by PHS regulation, but excluding applications for Phase I support under the Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) programs.
Compliance and Penalties for Non-Performance – Failure to comply with the Company’s FCOI 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 CO 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:
- formal admonition,
- ineligibility of the individual to apply for federal research grants,
- additional sanctions per research funding agency (such as requiring investigator to complete financial conflict of interest training), up to and including sponsor suspension of function per application federal regulations (note: the Company will comply with federal financial conflict of interest requirements regarding non-compliance retrospective review and corrective action), and/or
- termination of employment.
Point of Contact – If you have a conflict of interest or if you have a question to discuss, contact the BECARE LINK Chief Medical Officer.