Financial Conflict Of Interest (FCOI) Policy for Public Health Service (PHS) Funding
1. Policy Statement
FluGen, Inc. (FluGen) is committed to the design, conduct, and reporting of Research in an objective manner, free from bias or undue influence due to financial conflicts of interest (FCOI). The purpose of this Policy is to promote objectivity in research for all grants, cooperative agreements, or contracts funded by any PHS agency or from any other non-PHS organization that has adopted the PHS FCOI Regulations.
FluGen and each Investigator participating in any Research or Research through subgrantees, contractors, or collaborators that is funded by any PHS agency or any non-PHS organization that has adopted the PHS FCOI Regulations are required to comply with this Policy.
This Policy is effective as of May 21, 2021 and will be updated annually, maintained, and made publicly accessible in compliance with current FCOI regulations.
This Policy is intended to comply with the requirements of federal regulations, including, but not limited to, the conflict of interest regulations of the U.S. Department of Health and Human Services Public Health Service (“the PHS FCOI Rules”) as found in 42 CFR Part 50 Part F (titled Promoting Objectivity in Research) and 45 CFR Part 94 (titled Responsible Prospective Contractors) and the Federal Acquisition Regulation FAR 52.203-16 (collectively referred to as the “Financial Conflict of Interest Rules”).
A. Financial Conflict of Interest: a significant financial interest (SFI) that could directly and/or significantly affect the design, conduct, or reporting of PHS-funded Research, as determined by the IO.
B. Financial Interest: anything of monetary value, whether or not the value is readily ascertainable.
C. Institutional Official: the Chief Executive Officer of FluGen, responsible for enforcing this Policy, reviewing disclosures of SFIs, determining whether disclosures constitute a Financial Conflict of Interest, and managing such conflicts.
D. Institutional Responsibilities: an Investigator’s professional responsibilities on behalf of FluGen, which may include: activities such as research, research consultation, Institutional committee memberships, and service on panels such as Institutional Review Boards or data and safety monitoring boards.
E. 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 funded by PHS, or proposed for funding by PHS, which may include, for example, consultants or collaborators.
F. PHS Awarding Component: the organizational unit within the Public Health Service that funds the research.
G. 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 encompasses basic and applied research (e.g., a published article, book, or book chapter) and product development (e.g., a diagnostic test or drug). 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, such as a research grant, career development award, center grant, individual fellowship award, infrastructure award, institutional training grant, program project, or research resources award.
H. Significant Financial Interest (SFI): a financial interest consisting of one or more of the following interests of the Investigator, the Investigator’s spouse/domestic partner, and the Investigator’s dependent children that reasonably appears to be related to the Investigator’s Institutional Responsibilities:
a. With regard to any publicly traded entity, a SFI 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 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. With regard to any non-publicly traded entity, a SFI 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.
c. Intellectual property rights and interests (e.g., patents, copyrights), upon receipt of income related to such rights and interests.
d. The occurrence of any reimbursed or sponsored (i.e., paid on behalf of the Investigator and not reimbursed to the Investigator so that the exact monetary value may not be readily available) travel, 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 regulation.
e. A significant financial interest does not include the following:
1. salary, royalties, or other remuneration paid by FluGen to the Investigator if the Investigator is currently employed or otherwise appointed by FluGen;
2. Intellectual Property Rights assigned to FluGen and agreements to share in royalties related to such rights;
3. any ownership interest in FluGen held by the Investigator;
4. 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;
5. 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.S. 1001(a), an academic teaching hospital, a medical center, or a research institute that is affiliated with an Institution of higher education;
6. income from service on advisory committees or review panels for a federal, state, or local government agency, 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
7. travel that is reimbursed or sponsored by a federal, state, or local government agency, an institution of higher education, an academic teaching hospital, a medical center, or a research institute that is affiliated with an institution of higher education.
4. Policy Instructions and Disclosure Procedures
A. Responsibilities of the Institution
1. In compliance with PHS FCOI Regulations, the FluGen Institutional Official (IO) will ensure that all Investigators are informed of and in compliance with this Policy regarding financial conflicts of interest, the Investigator’s responsibilities of disclosing SFIs, and with PHS FCOI Regulations.
2. As applicable, the IO will maintain records of all Investigator disclosures of financial interests and FluGen’s review of, and response to, such disclosures under FluGen’s Policy or retrospective review, regardless of whether a disclosure resulted in the Institution’s determination of FCOI:
a. For at least three years following the submission date of the final expenditures report or from the date of submission of the quarterly or annual financial report; or
b. From other dates stipulated by 45 C.F.R. 74.53(b) and 92.42(b).
3. All records of Investigator disclosures of financial interests and FluGen’s review of, and response to, such disclosures will be maintained in hard copy and electronically in the “FCOI” folder on the FluGen server.
B. Policy Application to Subawardees, Subcontractors, and FluGen Affiliates
Subawardees, subcontractors, and other FluGen affiliates collaborating on PHS-funded research must either: 1. Have a FCOI policy that meets the requirements of the PHS FCOI Rules or 2. Comply with this FluGen Policy.
C. Mandatory Training Requirements
1. Per PHS FCOI Regulations, all Investigators will be required to complete FCOI training on both Federal and Institutional policies. This training must be completed prior to engaging in research related to any PHS-funded grant and at least every four years, and immediately if any of the following circumstances apply:
a. The FluGen FCOI Policy or procedures contained within or the PHS Financial Disclosure Form are revised in any manner that affects the requirements of Investigators;
b. An Investigator joins FluGen; or
c. FluGen is made aware of an Investigator who is not in compliance with this FCOI Policy or management plan.
2. To fulfill the Institutional training requirement, FluGen Investigators will be required to read through this FluGen FCOI Policy for PHS Funding and sign to attest to the fact that they have read and understood all policies, rules, and regulations contained within this document, and that they understand their responsibilities as an Investigator to disclose any and all significant financial interests.
3. To fulfill the Federal training requirement, FluGen Investigators must complete the NIH Office of Extramural Research’s web-based “Financial Conflict of Interest Online Tutorial” (http://grants.nih.gov/grants/policy/coi/tutorial2011/fcoi.htm). At the end of the tutorial, each person should fill out the Certificate of Completion.
4. All records of completion of training requirements will be maintained electronically filed in the “FCOI Training Documentation” folder in the “Financial Conflict of Interest” folder in FluGen’s site.
D. Investigator Disclosure Requirements
1. Per PHS FCOI Regulations, it is FluGen’s Policy that any and all SFIs be disclosed to the FluGen IO:
a. At the time of application for funding by each Investigator, including sub-recipient Investigators as applicable, planning to be involved in PHS/NIH- funded research.
b. Annually by each Investigator, including sub-recipient Investigators as applicable, involved with the award for the award period so as to update disclosures of SFIs.
c. Within 30 days of an Investigator, including sub-recipient Investigators as applicable, discovering or acquiring (e.g., through purchase, marriage, or inheritance) a new SFI.
2. FluGen will solicit and review disclosures of SFI(s) of all Investigators and their immediate family (including spouse/domestic partner and/or dependent children) related to the Investigator’s institutional responsibilities. All Investigators will utilize the “Financial Disclosure Form for Investigators in PHS Research” to either disclose SFIs or declare that there are no SFIs.
5. Management of Financial Conflicts of Interest
A. Review of SFI disclosure
All disclosures of SFIs will be reviewed by FluGen’s Authorized Official(s) in a prompt manner such that within 60 days of receipt of the disclosure, the SFI can be assessed, a management plan developed, and all reviews and approvals necessary can be obtained.
The Authorized Official(s) will:
1. Record and review all “Financial Disclosure for Investigators in PHS Research” forms from PHS-funded Investigators at FluGen;
2. Assess the nature of the SFI to determine whether the Investigator working on the PHS-funded research has a FCOI;
3. Provide information concerning FCOIs to the expenditure of PHS funds, which will be updated at least annually and within 60 days of changes to Statement of Financial Interest Disclosure forms, whichever occurs first.
B. Management of FCOIs
The FluGen Authorized Official(s) will develop a management plan based on the nature of the FCOI and will monitor investigator compliance with the management plan on an ongoing basis until the completion of the PHS-funded research project. Examples of conditions or restrictions that could be established include, but are not limited, to:
1. Public disclosure of FCOIs;
2. Appointment of independent monitor(s) who will be able to prevent the FCOI from biasing the design, conduct, and reporting of PHS-funded research;
3. Modification of the research plan;
4. Change of Investigator(s) or roles/responsibilities of Investigator, or exclusion of Investigator from participating in all or a portion of research;
5. Reduction or elimination of the financial interest (e.g., sale of an equity interest); and
6. Severance of relationships that create FCOIs.
C. FluGen Reporting Requirements
1. Per PHS FCOI Regulations, FluGen will submit to the NIH through the eRA Commons FCOI Module both initial and ongoing FCOI reports:
a. Prior to the expenditure of funds;
b. Within 60 days of identifying a new FCOI during the period of the award; and
c. Annually when grantee is required to submit the annual progress report, including multi-year progress report, or at time of extension, to report on the status of FCOI and any changes in the management plan.
2. As per the PHS FCOI Regulations, FCOI reports will include:
a. Grant number;
b. PD/PI or contact PD/PI;
c. Name of Investigator with FCOI;
d. Name of entity with which Investigator has FCOI;
e. Nature of FCOI;
f. Value of the financial interest, reported as a range ($0-4,999; $5,000-9,999; $10,000-19,999), in increments of $20,000 if between $20,000-100,000, in increments of $50,000 if above $100,000, or a statement that the value cannot be readily determined.
g. Description of how the SFI relates to PHS-funded research and basis for FluGen’s determination that the SFI conflicts with this research; and
h. Key elements of FluGen’s management plan.
D. Public availability of FCOI disclosure
As per the PHS FCOI Regulations, disclosure of SFIs that are still held by the Investigator for the PHS-funded research project, determined by FluGen to be related to the PHS-funded research, and determined by FluGen to be a FCOI disclosure of FCOIs will be made available as a written response within five business days of a request. The information made available by FluGen in a written response will include the following information:
1. Name of Investigator with FCOI;
2. Title and role of the Investigator in the PHS-funded research project;
3. Name of entity with which Investigator has FCOI;
4. Nature of the FCOI;
5. Value of the financial interest, reported as a range ($0-4,999; $5,000-9,999; $10,000-19,999), in increments of $20,000 if between $20,000-100,000, in increments of $50,000 if above $100,000, or a statement that the value cannot be readily determined through references to public prices or other reasonable measures of fair market value.
6. Enforcement of Policy and Noncompliance
A. All Investigators and relevant FluGen personnel and collaborators are required to comply with this Policy in full. Violations of this policy may result in disciplinary or other appropriate action.
B. If an FCOI is not identified or managed in a timely manner (including Investigator failure to disclose SFI(s), FluGen failure to review or manage FCOI(s), or failure to comply with the management plan), FluGen will within 120 days of the determination of noncompliance notify the NIH and submit a retrospective review, as per PHS FCOI Regulations.The retrospective review will include the following information:
1. Grant number;
2. Grant title;
3. PD/PI or contact PD/PI;
4. Name of Investigator with FCOI;
5. Name of entity with which Investigator has FCOI;
6. Reason(s) for retrospective review;
7. Detailed methodology used for retrospective review (e.g., details of review process, composition of the review panel, documents reviewed);
8. Findings and conclusions of the review; and
9. If warranted by the retrospective review, update and revise the previously submitted FCOI report.
C. In the case that a retrospective review finds that Investigator non-compliance with this FCOI Policy, the PHS FCOI Regulations, or a management plan appears to have biased the design, conduct, or reporting of PHS-funded research, FluGen will promptly submit a mitigation report to the NIH Awarding Component.
The mitigation report will include:
1. Key elements documented in the retrospective review;
2. Description of the impact of bias on the research project; and
3. Management plan(s) to eliminate or mitigate the bias on the design, conduct, or report of research.
D. After a mitigation report is filed, FCOI reports must be submitted annually.