This Financial Conflict of Interest (“FCOI”) policy applies to all Investigators employed by the Floreo, Inc. (“Floreo”) who intend to pursue research funding (including contracts, cooperative agreements, grants and fellowships) from the U.S. Public Health Service (PHS), which encompasses the National Institutes of Health (NIH).
Floreo encourages its staff to engage in research activities using the highest ethical standards and preventing the introduction of bias into their research.
This Policy is intended to comply with the federal regulations concerning objectivity in research (42 CFR Part 50 Subpart F and 45 CFR Part 94). The federal regulations and Floreo’s policy promote objectivity in research by establishing standards that provide a reasonable expectation that the design, conduct, and reporting of PHS-funded research will be free from bias resulting from Investigator financial conflicts of interest.
Each Investigator who is planning to participate in PHS-funded research must disclose to Floreo’s Financial Conflicts of Interest Officer (“COI Officer”) the Investigator’s significant financial interests (and those of the Investigator’s spouse and dependent children) no later than the time of application for PHS-funded research.
Each Investigator who is participating in PHS-funded research must submit an updated disclosure of significant financial interests at least annually, in accordance with the specific time period prescribed by Floreo, during the period of the award. Such disclosure shall include any information that was not disclosed initially to Floreo or in a subsequent disclosure of significant financial interests (e.g., any financial conflict of interest identified on a PHS-funded project that was transferred from another Institution), and shall include updated information regarding any previously disclosed significant financial interest (e.g., the updated value of a previously disclosed equity interest).
Each Investigator who is participating in PHS-funded research must submit an updated disclosure of significant financial interests within thirty (30) days of discovering or acquiring (e.g., through purchase, marriage or inheritance) a new significant financial interest.
Completed FCOI Disclosure Forms will be reviewed by Floreo’s COI Officer to determine whether an Investigator’s significant financial interest constitutes a FCOI. The Investigator’s significant financial interest will be considered to be a FCOI if the COI Officer reasonably determines that the significant financial interest could directly and significantly affect the design, conduct, or reporting of the PHS-funded research, or is in an entity whose financial interest could be affected by the research.
Management and Reporting of Financial Conflicts of Interest to PHS
Upon determination that a significant FCOI related to PHS-funded research exists, the COI Officer will develop and implement a written management plan that will specify the actions that have been, and shall be, taken to manage such FCOI. Management plans may include one or more of the following conditions or restrictions: public disclosure of FCOI (for example, when presenting or publishing the research); for research projects involving human subjects research, disclosure of FCOI directly to participants; appointment of an independent monitor capable of taking measures to protect the design, conduct, and reporting of the research against bias resulting from the FCOI; modification of the research plan; change of personnel or personnel responsibilities, or disqualification of personnel from participation in all or a portion of the research; reduction or elimination of the financial interest; and severance of relationships that create financial conflicts. The Investigator must agree to the management plan by signing it before performing any PHS-funded research.
When Floreo identifies a significant financial interest that was not disclosed in a timely manner for whatever reason, within sixty (60) days the COI Officer will review the significant financial interest; determine whether it is related to PHS-funded research; determine whether a FCOI exists; and, if so, implement a management plan for the FCOI. Furthermore, whenever a FCOI is not identified or managed in a timely manner, Floreo will complete a retrospective review of the Investigator’s activities and the PHS-funded research project to determine whether any portion of the PHS- funded research conducted during the noncompliance time period was biased in the design, conduct or reporting of such research. This review will be completed within one hundred twenty (120) days of the noncompliance determination. Floreo will follow PHS regulations regarding reporting of a FCOI or non-compliance to the regulators.
Floreo’s FCOI policy will be posted on the Floreo’s public website. Prior to the expenditure of funds received under a PHS-funded research project, Floreo will ensure public accessibility, via written response to a requestor within five business days of receiving the request, of information concerning any Significant Financial Interest that meets the following criteria:
- The significant financial interest was disclosed and is still held by the senior/key personnel as defined by this subpart;
- Floreo determines that the significant financial interest is related to the PHS-funded research; and
- Floreo determines that the significant financial interest is a financial conflict of interest.
Floreo will maintain records relating to all Investigator disclosures of financial interests and Floreo’s review of, and response to, such disclosures and all actions under Floreo’s policy or retrospective review, if applicable, for at least three (3) years from the date the final expenditures report is submitted to the PHS, or, where applicable, from other dates specified in 45 CFR 75.361 for different situations.
Subrecipients on PHS/DHHS-funded projects are subject to and required to comply with and follow the regulations as set forth in the Financial Conflict of Interest Regulations, Promoting Objectivity in Research (42 CFR Part 50 Subpart F and 45 CFR Part 94), even though the subrecipients are not directly awarded the funds from PHS or any PHS/DHHS agency. Subrecipients must demonstrate or provide adequate assurances that the policies and procedures of their institutions are in compliance with the regulation.
The following definitions are provided to assist in understanding this Policy and are derived from federal regulations.
Financial Conflict of Interest (FCOI): A significant financial interest that could directly and significantly affect the design, conduct, or reporting of PHS-funded research.
Financial Interest: Anything of monetary value, whether the value is readily ascertainable, received or held by the Investigator, his/her spouse, or dependent children.
Institutional responsibilities: An Investigator’s professional responsibilities on behalf of Floreo, and as defined by Floreo in its policy on financial conflicts of interest, which may include 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.
Investigator: The project director or principal investigator and any other person, regardless of title or position, who is responsible for any part of the design, conduct, or reporting of research funded by the PHS, or proposed for such funding, which may include collaborators or consultants.
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 includes any such activity for which research funding is available from a PHS Awarding Component through a contract, grant, or cooperative agreement, excluding Small Business Innovation Research (SBIR) and Small Business Technology Transfer Research (STTR) Phase I Programs.
Significant financial interest: (1) 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 Investigator’s institutional responsibilities: (a) if the value of any remuneration received from any publicly traded 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 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 includes any stock, stock option, or other ownership interest, as determined through reference to public prices or other reasonable measures of fair market value; (b) if the value of any remuneration received from any non-publicly traded 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 (c) intellectual property rights and interests (e.g., patents, copyrights), upon receipt of income related to such rights and interests.
(2) 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. This disclosure requirement excludes travel that is reimbursed or sponsored by Federal, state, or local government agencies, U.S. institutions of higher education, research institutes affiliated with higher education institutions, academic teaching hospitals, and medical centers. For each travel event, disclosure includes the purpose of the trip, the sponsor/organizer, and the destination, duration and approximate monetary value.
(3) The term significant financial interest does not include: (a) salary, royalties, or other remuneration paid by Floreo; (b) intellectual property rights assigned to Floreo and agreements to share in royalties related to such rights; (c) any ownership interest in Floreo held by the Investigator given that Floreo is a commercial and for-profit organization; (d) income from investment vehicles, such as mutual funds, retirement accounts, or 529 funds and other college savings funds, as long as the Investigator does not directly control the investment decisions made in these vehicles; (e) income from seminars, lectures, or teaching engagements sponsored by a Federal, state, or local government agency, U.S. institutions of higher education, research institutes affiliated with higher education institutions, academic teaching hospitals, and medical centers; or (f) income from service on advisory committees or review panels for a Federal, state, or local government agency U.S. institutions of higher education, research institutes affiliated with higher education institutions, academic teaching hospitals, and medical centers.
Required Education on the FCOI Federal Regulations
NIH provides online training here: https://grants.nih.gov/grants/policy/coi/tutorial2018/story_html5.html Training must take place prior to engaging in the PHS-funded research. Please be sure to print a certificate of completion at the end of the training session and send a copy to the Sponsored Research Office.
Financial Conflict of Interest (FCOI) regulation (42CFR Part 50 Subpart F – Grants):
Financial Conflict of Interest (FCOI) regulation (45CFR Subtitle A Subchapter A Part 94 – Responsible Prospective Contractors):
Adopted: April 29, 2019