Scope: Objective research is of paramount importance to Biopico Systems and our subgrantees and defined vendors herein, to ensure public trust and meet scientific, program and ethical goals of our National Institutes Health (NIH) grant efforts. To address the increasing complexities related to financial interests held by biomedical and behavioral researchers, the Public Health Service (PHS) and the Office of the Secretary of the U.S. Department of Health and Human Services (HHS) has published their final rules. Biopico Systems believes we have fully addressed the requirements (including those of our defined sub-level vendors) of this ruling although we will continue to update this policy as needed, particularly related to any changes in personnel FCOI issues or upon further DHHS guidance.
Purpose: Effective August 17, 2021, Biopico Systems’ policy requires that each investigator, subrecipients, subgrantees and collaborators affiliated with Biopico Systems, 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. Biopico Systems intends to use this same FCOI standard for all other Federal agency grant and contract efforts, as tailored or amended accordingly.
The following are key term definitions and Biopico Systems’s policy guidance for principal or program investigators, subrecipients, subgrantees and collaborators affiliated with Biopico Systems. This policy and all FCOI Biopico Systems guidance will be also available at https://www.Biopico Systems.com (or this document, the Financial Conflict of Interest (FCOI) Policy, August 17th, 2021, Addendum A, to Biopico Systems’ Employee Handbook) so that all interested parties, including the general public have access to this Company policy.
Conflict Management Plan: the document specifying the actions to be taken to manage a Financial Conflict of Interest.
External Partner: a consultant, subcontractor, or sub-recipient performing work under a Government Award who is not employed by Biopico Systems
Government Award: government grants and cost reimbursement contracts including research grants or contracts, and other types of government financial assistance (e.g., cooperative agreements, loans, loan guarantees, property, donated supplies, and direct appropriations) that Biopico Systems receives directly from government agencies or indirectly from pass through entities.
Financial Conflict of Interest (FCOI): a significant financial interest that could directly and significantly affect the design, conduct, or reporting of a research study or other government funded project.
Immediate Family Member: a spouse, domestic partner, child or step-child, parent or step-parent, or sibling or step-sibling.
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 or proposed for such funding, which may include, for example, collaborators or consultants.
Institutional Responsibilities: An Investigator’s professional responsibilities on behalf of Biopico Systems, which may include, but is not limited to: research, research consultation, teaching, professional practice, institutional committee memberships, and service on panels such as Institutional Review Boards or Data and Safety Monitoring Boards.
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.
Remuneration: salary and any payment for services not otherwise identified as salary (e.g., consulting fees, honoraria, paid authorships).
Biopico Systems and all defined sub-level vendors are required to complete training related to Financial Conflict of Interest (FCOI). If any conflicts of interest are found or known, they must be disclosed. The training must be updated no-less than every four years or as designated based on grant or role circumstances. Information and other resources developed by NIH will be updated as appropriate and can be accessed through the NIH Web site. (https://grants.nih.gov/grants/policy/coi/index.htm).
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 reasonable appears to be related to the Investigators institutional responsibilities: With regard to any publically 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 remunerations 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 (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 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 Institution’s FCOI policy will specify 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. In accordance with the Institution’s FCOI policy, the institutional 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 institution to the Investigator if the Investigator is currently employed or otherwise appointed by the Institution, including intellectual property rights assigned to the Institution and agreements to share in royalties related to such rights; any ownership interest in the Institution held by the investigator, if the Institution 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, 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 Biopico Systems reasonably determines that a Significant Financial Interest (defined above) could directly and significantly affect the design, conduct or reporting of NIH-funded research.
Management of a FCOI
Means taking action to address a FCOI, which can 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.
Biopico Systems‘ designated official(s) will review all “disclosure” 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. If any interests are identified as conflicting subsequent to the initial report they must be reported to Biopico Systems within 60 days. Biopico Systems 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.
The records of all financial disclosures and all actions taken by Biopico Systems will be maintained for at least three years from the date of submission of the final expenditures report.
Compliance and Penalties for Non-Performance
If an investigator fails to comply with Biopico Systems’ FCOI policy, within 60 days, Biopico Systems shall complete a retrospective review of the Investigator’s activities to determine bias. If a bias is found, Biopico Systems shall submit a mitigation report to the NIH, in accordance with 42 CFR 50.605(b)(3), that shall address the impact of the bias on the research project and the actions it has taken to mitigate the bias. Biopico Systems will work with the Investigator to set up an FCOI management plan to mitigate the situation. Biopico Systems is required to mandate the Investigator disclose the FCOI in each public presentation with research results if it was not reported up front. In extreme cases of bias, the Investigator may lose the right to work on the project or receive any future NIH funding.