Financial Conflict of Interest (FCOI) policy
Policy Revised: August 3rd, 2021
Transtimulation Research Inc (“the Company”) conducts research and development activities which are often supported by Small Business Program of the National Institutes of Health (NIH), a Public Health Service organization. The purpose of this Financial Conflict of Interest (FCOI) policy is to document and define our standards and procedures for identifying and managing financial conflicts of interest to safeguard the integrity of research conducted by the Company and our subawardees and contractors. FCOI requirements, related to the NIH-funded research, are published in U.S. regulation 42 CFR Part 50, Subpart F and 45 CFR Part 94.
The policy applies to each Investigator, as defined by the regulation, who is planning to participated in or is participating in the NIH-funded research. The Company must be able to certify, in each application for funding, that the Company:
· has in effect, an up-to-date, written and enforced administrative process to identify and manage FCOI
· will promote and enforce Investigator compliance with the regulation
· will manage FCOI and provide initial and ongoing FCOI reports
· will make FCOI and significant financial interest information available to the NIH, promptly, upon request; and
· will fully comply with the regulation’s requirements.
I. SCOPE
A Company employee or contractor who submits a grant or contract proposal or conducts research under the NIH funding grants or contracts must adhere to the applicable NIH requirements, including those involving the disclosure and regulation of outside activities and financial interests. Specific FCOI laws and regulations are applicable to all project directors and principal investigators, whether employees or contractors, who are responsible for the design, conduct and reporting of research work under grants and contracts with the NIH.
II. DEFINITIONS
Investigator: Any company employee or contractor who is responsible for the design, conduct or reporting of the NIH-funded research project or proposed for such project, including any project director, principal investigator and any other key personnel designated as such in the NIH-funded grant application or contract.
Investigator’s Responsibilities: An Investigator’s professional responsibilities performed on behalf of an entity that proposes to undertake or undertakes the NIH-funded research.
Equity Interest: Any stock, stock option, or other ownership interest, as determined through reference to public prices or other reasonable measures of fair market value.
Financial Interest: Any interest of monetary value, whether or not the value is readily ascertainable.
Non-Significant Financial Interest (“Non-SFI”): A financial interest consisting of one or more of the following interests of an Investigator and the Investigator’s spouse and dependent children that reasonably appear to be related to Investigator’s Responsibilities:
(i) remuneration paid by an entity to which an Investigator owes Investigator’s Responsibilities, if the Investigator is currently employed or otherwise appointed by such entity, including intellectual property rights assigned to such entity and any agreement to share in royalties related to such rights; or
(ii) any ownership interest in an entity held by the Investigator or 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; or
(iii) income from seminars, lectures, or teaching engagements sponsored by a US 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
(iv) income from service on advisory committees or review panels for a US 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.
Remuneration: (i) salary and any payment for services including consulting fees and honoraria; (ii) any Equity Interest; and (iii) travel reimbursement related to the Investigator’s Responsibilities.
Significant Financial Interest (“SFI”): A financial interest consisting of one or more of the following interests of an Investigator and the Investigator’s spouse and dependent children that reasonably appear to be related to Investigator’s Responsibilities, but specifically excludes any Non-SFI:
(i) any Remuneration received from any publicly traded entity in the twelve months preceding the disclosure and the value of any Equity Interest in such entity as of the date of disclosure, when aggregated, exceeds $5,000; or
(ii) any Remuneration received from any non-publicly traded entity in the twelve months preceding the disclosure and the value of any Equity Interest in such entity as of the date of disclosure, when aggregated, exceeds $5,000; or
(iii) intellectual property rights and interests (e.g. patents, copyrights), upon receipt of income related to such rights and interests.
III. TRAINING REQUIREMENTS
The Company will inform each Investigator of the company’s FCOI policy, the Investigator’s disclosure responsibilities, and the NIH regulations. In addition, the Company requires each Investigator to complete FCOI training prior to engaging in NIH-funded research, at least every four years, and immediately, if the Company revises the FCOI policy that affects requirements of Investigator, an Investigator is new to the company or an Investigator is not in compliance with the FCOI policy or of a management plan.
FCOI training is conducted through the NIH Financial Conflict of Interest Tutorial available through the NIH, which was designed to provide education training on what constitutes financial conflict of interest. Upon completion of the training tutorial, a certificate completion is generated, which must be turned in to the Institutional official.
IV. DISCLOSURE, REVIEW AND MONITORING REQUIRMENTS
The Company requires each Investigator to disclose their Significant Financial Interests (SFIs) (and those of the Investigator’s spouse and dependent children) related to the Investigator’s Institutional responsibilities that meet or exceed the regulatory definition of SFI. This disclosure must occur no later than at the time of application for NIH-funded research, at least annually during the period of the award, and within 30 days of discovering or acquiring a new SFI.
The Company will designate an Institutional official(s) to solicit and review disclosures of SFIs of the Investigator (and those of the Investigator’s spouse and dependent children) related to an Investigator’s institutional responsibilities for a determination of FCOI.
The designated individuals follow guidelines to determine whether an Investigator’s SFI is related to the NIH-funded research and, if so related, whether the SFI is an FCOI.
The Company requires the designated official or committee, prior to the company expenditure of award funds, to review all Investigator SFI disclosures, determine if any SFIs relate to the NIH-funded research, determine if an FCOI exists (e.g., the SFI that could directly and significantly affect the design, conduct, or reporting of the NIH-funded research), and develop and implement management action plans, as needed, to manage FCOIs.
The Company follows a process to review disclosure of SFIs, make determination of FCOIs, and implement a management plan:
· Require when an Investigator who is new to participating in the research project or when an existing Investigator discloses a new SFI, the Company’s designated official(s) shall within sixty days review disclosures of SFIs, determine whether the SFI is related to the NIH-funded research; determine whether an FCOI exists; and, if so, implement, on at least an interim basis, a management plan that shall specify the actions that have been, and will be, taken to manage such FCOI.
· Require whenever the Company identifies an SFI that was not disclosed timely by an Investigator or, for whatever reason, was not previously reviewed by the Company during an ongoing NIH-funded research project (e.g., was not timely reviewed or reported by a subrecipient), the designated official(s) shall within sixty days review disclosures of SFIs, determine whether the SFI is related to the NIH-funded research; determine whether an FCOI exists; and if so, implement, at least on an interim basis, a management plan that specifies the actions that have been, and will be taken to manage such FCOI going forward.
· The Company will take such actions as necessary to manage FCOIs, including any financial conflicts of a subrecipient Investigator, if applicable, and monitor Investigator compliance with management plans until completion of the project.
V. REPORTING REQUIREMENTS TO THE NIH
The Company will send initial, annual (i.e. ongoing) and revised FCOI reports including all required information defined in the regulation to the NIH via the eRA Commons FCOI Module for the Institution and its subrecipients, if applicable, as required by the regulation and as stated below:
· Prior to expenditure of funds
· Within 60 days of identification of an FCOI for an Investigator who is newly participating in the project
· Within 60 days for new, or newly identified, FCOIs, for existing Investigators.
· At least annually (at the same time as when the Institution is required to submit the annual progress report, multi-year progress report, if applicable, or at time of extension). The annual report will provide the status of the FCOI and any changes to the management plan, if applicable, until the completion of the project.
· After a retrospective review to update a previously submitted report, if new information is discovered following completion of the review.
The Company will notify the NIH promptly if bias is found with the design, conduct or reporting of NIH-funded research and include the requirement to submit a mitigation report to explain what action(s) have been or will be taken to mitigate the effects of the bias in accordance with the regulation. All reporting elements (e.g., entity name, name of the investigator with the FCOI, nature of SFI(s), value of the SFI(s), etc.) will be included as required by the regulation.
The Company will notify the NIH promptly if an Investigator fails to comply with the Company’s FCOI policy or a FCOI management plan appears to have biased the design, conduct, or reporting of the NIH-funded research. Corrective action will be taken for non-compliance with the Company’s policy or the management plan.
VI. MAINTENANCE OF RECORDS
The Company will maintain all FCOI-related records relating to all Investigator disclosures of financial interests and the Institution’s review of, and response, to such disclosures (whether or not a disclosure resulted in the Company’s determination of a financial conflict of interest) and all actions under the Institution’s policy or retrospective review, if applicable:
· For at least 3 years from the date the final expenditure report is submitted to the NIH.
· Or, where applicable, from other dates specified in 45 CFR 75.361 for different situations.
VII. ENFORCEMENT MECHANISMS AND REMEDIES AND NONCOMPLICANCE
The Company will establish adequate enforcement mechanisms and provide for employee sanctions or other administrative actions to ensure Investigator compliance (e.g., letters of reprimand, restriction on the use of funds, etc.).
Whenever the Company identifies an SFI that was not disclosed, identified, reviewed, or managed in a timely manner (as required by the NIH and described above), the Company shall, within 60 days, review and make the determination of whether an FCOI exists, and report the FCOI if it exists, to the NIH. If an FCOI exists, the company shall, within 120 days of the company’s determination of noncompliance, complete a retrospective review of the Investigator’s activities and the NIH-funded research to determine whether any of the funded research, or a portion thereof, conducted during the time period of the noncompliance was biased in the design, conduct or reporting of such research. During the time the retrospective review is being conducted, the Company must implement, on at least an interim basis, a management plan that will specify the actions that have been, and will be, taken to manage the FCOI going forward. Subsequent to the retrospective review, if applicable, the Company will update the existing FCOI report and if bias is found, the Company must notify the NIH promptly and submit a mitigation report.
The retrospective review should be documented and included at a minimum of the following key elements:
· Project Number
· Project Title
· PD/PI or contact PD/PI if multiple PD/PI model is used.
· Name of the Investigator with the FCOI
· Name of the entity with which the Investigator has an FCOI
· Reasons for the retrospective review
· Detailed methodology used for the retrospective review (e.g., methodology of the review process, composition of the review panel, documentation reviewed);
· Findings of the review; and
· Conclusion of the review
The Company will ensure that in any case in which the Department of Health and Human Services determines that the NIH-funded research project of clinical research whose purpose is to evaluate the safety or effectiveness of a drug, medical device, or treatment has been designed, conducted, or reported by an Investigator with an FCOI that was not managed or reported by the Company as required by the regulation, the Company shall require the Investigator involved to:
· Disclose the FCOI in each public presentation of the results of the research, and
· To request an addendum to previously published presentation.
VIII. SUBRECIPIENT REQUIREMENTS
The Company will make sure that any contractor or collaborator who carries out the NIH-funded research with the Company (“Subcontractor”) certifies, via written agreement, that it will follow this FCOI policy or the Subcontractor’s own FCOI policy.
If the Subcontractor certifies that it will comply with this FCOI Policy, the agreement shall specify the time periods for the Subcontractor to report all SFI to the Company. Such time periods shall be sufficient to enable the Company to comply with timely review, management and reporting obligations required by this FCOI Policy.
If the Subcontractor certifies that it will comply with its own FCOI policy, the written agreement with the Subcontractor shall include:
· A copy of the Subcontractor FCOI policy
· A certification by the Subcontractor that its policy complies with all applicable laws, regulations, and rules (including, but not limited to the NIH regulations; and
· Time periods for the Subcontractor to report any identified FCOI to the Company defined to permit sufficient time to enable the Company to provide timely FCOI reports under this FCOI Policy, as necessary, to the NIH.
IX. PUBLIC ACCESSIBILITY REQUIREMENTS
The Company will make the FCOI policy publicly accessible by ensuring the most recent version of this FCOI policy is accessible to the public on the Company website.
Prior to the expenditure of funds, the Company shall make information concerning identified FCOIs available within 5 business days to the NIH. The information will be updated at least annually, be updated within 60 days of a newly identified FCOI, and all records should remain available for three years from the date the information was most recently updated.