The following definitions are provided as a reference and are considered key definitions in understanding the federal regulations of FCOI. A complete list of official definitions can be found at 42 CFR 50.603.
Italicized text provides context for these definitions relevant for MBF Bioscience LLC and subsidiaries
Institution – means any domestic or foreign, public or private, entity or organization (excluding a Federal agency) applying for, or receiving PHS (e.g., NIH) research funding. MBF Bioscience LLC is one such institution.
Investigator – means the project director or principal investigator and any other person, regardless of title or position, who is or will be responsible for the design, conduct, or reporting of research funded by the PHS, which may include, for example, collaborators or consultants. In most cases, anyone at MBF Bioscience who is required to complete a grant timesheet is considered an Investigator.
Institutional responsibilities – means an Investigator’s professional responsibilities on behalf of the Institution, and as defined by the Institution, including but not limited to, activities such as research, research consultation, professional practice, and internal committee memberships. This can be understood to mean your job responsibilities for MBF Bioscience.
Financial interest – means anything of monetary value, whether or not the value is readily ascertainable.
Financial Conflict of Interest (FCOI) – means a significant financial interest (see below) that could directly and significantly affect the design, conduct, or reporting of PHS-funded research.
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.
Senior/Key Personnel – means the PD/PI and any other person identified as senior/key personnel by the Institution in the grant application, progress report, or any other report submitted to the PHS by the Institution under the regulation.
Significant Financial Interest (SFI) –
1. A financial interest consisting of one or more of the following interests of the Investigator, the Investigator’s spouse and the Investigator’s dependent children that reasonably appears to be related to the Investigator’s institutional responsibilities:
i. 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
ii. 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 interest (e.g., stock, stock option, or other ownership interest); or
iii. Upon receipt of income related to intellectual property rights and interests (e.g., patents, copyrights)
2. Reimbursed or sponsored travel: 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 excluded sources provided in the regulation. For example, if the PI travels to a scientific seminar but does not pay or receive reimbursement by MBF Bioscience directly (i.e., the travel was paid for by a third party/sponsor), the PI is required to disclose basic information to MBF Bioscience relating to the trip, such as purpose of the trip, identify of the payer/sponsor, destination and duration. MBF Bioscience is required to determine if additional information is required (e.g., monetary value) and whether the travel constitutes an FCOI with PHS-funded research.
3. The term significant financial interest does not include the following types of financial interests:
i. salary, royalties, or other remuneration paid by MBF Bioscience to the Investigator if the Investigator is currently employed or otherwise appointed by MBF Bioscience;
ii. intellectual property rights assigned to MBF Bioscience and agreements to share in royalties related to such rights;
iii. any ownership interest in MBF Bioscience held by the Investigator, since MBF Bioscience is a commercial or for-profit organization;
vi. 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;
v. 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
vi. income from service on advisory committees or review panels for a federal, state or local government agency, institution of higher education as defied 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.
FCOI training is required; each Investigator must complete training prior to engaging in research related to any PHS-funded grant and at least every four years after that.
In the circumstances below, training must be done within 7 business days:
FCOI training includes thorough review of this FCOI policy and completion of the NIH Financial Conflict of Interest tutorial (available online by clicking the link). Upon completion, each Investigator should generate a Certificate of Completion, insert their full name and date of completion, and email the certificate to the MBF Bioscience Office Manager in Williston Vermont.
1. An annual PHS Financial Conflict of Interest (FCOI) Declaration for each federally funded project is required from:
2. Individuals must complete a PHS Financial Conflict of Interest (FCOI) Declaration during open enrollment each year in December. Completed declarations are due on January 1.
3. Individuals required to provide an annual PHS Financial Conflict of Interest (FCOI) Declaration must disclose any SFI greater than $5,000 (for themselves, spouse, or dependent children) by completing a PHS FCOI Management Plan. See Part II for definitions of SFI. See also “Review” below.
4. Individuals required to provide an annual PHS Financial Conflict of Interest (FCOI) Declaration must disclose sponsored or reimbursed travel for themselves, their spouse, or their dependent children related to their job responsibilities at MBF Bioscience on the Sponsored and Reimbursed Travel Disclosure.
5. Individual investigators are responsible for maintaining a current accurate declaration.
6. If conflicts may exist, Investigators must complete a PHS FCOI Management Plan to provide additional information and suggestions for managing the FCOI, and/or a Sponsored and Reimbursed Travel Disclosure as appropriate.
FCOI administrator(s) responsibilities
FCOI administrator(s) will work with MBF staff and management to:
FCOI administrator(s) will review:
FCOI reviewer selection and responsibilities
FCOI reviewers will be selected if and when any Investigator discloses a potential FCOI. MBF Bioscience management will choose reviewers with no related financial conflicts of interest. Among the reviewers will be people with a good understanding of finance/conflicts of interest, and the science and technology related to the affected PHS-supported project(s).
FCOI reviewers will:
Guidelines for determining if SFI represents an FCOI
FCOI reviewers will employ their understanding of the PHS-funded research and the nature of the SFI declared by the Investigator to reasonably determine whether the SFI is related to the research. In other words, if the SFI could be affected by the research in question and if the financial interest is in an entity with financial interests that could be affected by the PHS-funded research.
If the SFI and the PHS-funded research are found to be related, the reviewers will reasonably determine if the SFI could directly and significantly affect the design, conduct, or reporting of the research. If they determine that it could, an FCOI will be identified for monitoring and reporting as described in this policy.
Acceptable strategies for managing, reducing, or eliminating FCOIs include:
Initial, annual (ongoing), and revised FCOI reports will be submitted to the PHS funding entity (e.g., to the NIH via eRA Commons):
The PHS funding entity will be notified within 30 days if an Investigator fails to comply with this policy or if the FCOI management plan appears to have biased the design, conduct, or reporting of research and will include a Mitigation Report outlining the management plan.
Compliance with this policy is a condition of employment with MBF Bioscience.
As per the FCOI Regulation, within 120 days of MBF Bioscience determining noncompliance, MBF Bioscience will complete a retrospective review of the Investigator’s activities and the PHS-funded research project to determine if there was bias in the design, conduct, or reporting of research. MBF Bioscience will document the retrospective review.
All FCOI records (disclosures, management plans, retrospective reviews) will be held for three years after the final report is submitted to the PHS funding entity.
Before grant application is made, all collaborators/subcontractors must:
The MBF Bioscience FCOI policy will be publicly available on the internet at mbfbioscience.com by entering “fcoi” into the search box on any page on the website.In the event that FCOIs related to PHS-funded research are identified and are still held by the
Investigator, information regarding the COI and the Investigator will be publicly available in the form of a written response emailed or placed in postal mail to any requestor within five business days. Our responses will note that the information provided is current as of the date of the correspondence and is subject to updates on at least an annual basis and within 60 days of identification of a new financial conflict of interest; such updates will be available within five business days of a request in the form of a written response emailed or placed in postal mail.
Information to be made publicly available is to include, but is not limited to: