TrAMPoline Pharma, Inc. Financial Conflict of Interest Policy
Updated on: August 4, 2022
Adoption Date: August 4, 2022
Next Review Date: June 30, 2025
Under this policy, TrAMPoline Pharma, Inc. (the “Company”) strives to ensure that all work performed under Government Awards meets the highest standard of integrity and is free of any real or perceived conflicts of interest that could harm patients, the reputation of the Company, the governmental agency providing the funding, and/or external partners. As the Company must comply with government regulations when making expenditures with Government Awards, this policy governs the disclosure of individual financial interests and the management and reporting of individual financial conflicts of interest in Governmental Awards. It 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”).
Any employee or contractor of the Company who submits a grant or contract proposal or conducts research under a PHS Organization’s funding grants or contracts must adhere to the applicable requirements of the PHS Organization, 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 PHS Organizations.
Conflict of Interest Official (COI Official): Federal regulations require PHS-funded institutions to appoint a COI Official or a committee to review financial interests in sponsored research. The TrAMPoline Board of Directors shall appoint this individual. The COI Official or their designee serves as the signature authority for the Company regarding FCOI.
Covered Individual (“CI”): Any employee or contractor of the Company who is responsible for the design, conduct or reporting of a PHS-Funded Research project or proposed for such project, including any project director, principal investigator and any other key personnel designated as such in a PHS-Funded grant application or contract.
Covered Individual Responsibilities: A Covered Individual’s professional responsibilities performed on behalf of an entity that proposes to undertake or undertakes PHS-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 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: Any interest of monetary value, whether or not the value is readily ascertainable.
Immediate Family: A Covered Individual’s spouse or domestic partner and dependent children.
Non-Significant Financial Interests (“Non-SFI”): include the following types of Financial Interests: (i) remuneration paid by an entity to which a CI owes Covered Individual Responsibilities, if the CI 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 CI or income from investment vehicles, such as mutual funds and retirement accounts, as long as the CI 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.
PHS: Public Health Service of the U.S. Department of Health and Human Services, and any components of the PHS to which the authority involved may be delegated, including, among others, the NIH. A listing of the PHS agencies and their offices may be located on the U.S. Department of Health and Human Services Organizational Chart.
PHS-Funded Research: any Research funded by way of a grant from, or a contract with, a PHS Organization.
PHS Organization: (i) an agency that is part of the PHS or (ii) an organization that has adopted the PHS Regulations, but not a non-governmental non-profit organization.
PHS Regulations: U.S. 42 CFR Part 50, Subpart F and 45 CFR Part 94
Remuneration: (i) salary and any payment for services including consulting fees and honoraria; (ii) any Equity Interest; and (iii) travel reimbursement related to the Covered Individual Responsibilities.
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, including basic and applied research (e.g., a published article, book or book chapter) and product development (e.g., a diagnostic test or drug).
Significant Financial Interest (“SFI”): A Financial Interest consisting of one or more of the following interests of a Covered Individual (and those of the Covered Individual’s Immediate Family) that reasonably appear to be related to Covered Individual 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.
Covered Individuals must also disclose the occurrence of any reimbursed or sponsored travel related to their institutional responsibilities and shall 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 of the travel.
Significant financial interest does not include the following types of financial interests: salary, royalties, or other remuneration paid by the Company to the Covered Individual if the Covered Individual is currently employed or otherwise appointed by the Company, including intellectual property rights assigned to the Company and agreements to share in royalties related to such rights; any ownership interest in the Company held by the Investigator, if the Company is a commercial or for-profit organization; income from investment vehicles, such as mutual funds and retirement accounts, as long as the Covered Individual 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, or a 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.
D. Training Requirements
The Company must establish a process to inform each Covered Individual of the Company’s FCOI Policy, the Covered Individual Responsibilities, and the PHS Regulations. In addition, the Company must establish a process to require each Covered Individual to complete FCOI training within 60 days of joining the Company, prior to engaging in PHS-Funded Research, at least every four years, and immediately, if the Company revises the FCOI Policy that affects requirements of Covered Individuals, or a Covered Individual is not in compliance with the FCOI Policy or of a management plan.
E. Disclosure, Review, and Monitoring Requirements
Employees, advisors, and consultants whether paid or unpaid who receive NIH extramural funding are subject to 42 CFR Part 50, Subpart F, Objectivity of Research. Each institution, domestic and foreign, that applies for or receives NIH research funding in the form of grants or cooperative agreements is subject to this regulation. This FCOI regulation applies to both prime and subrecipient institutions, domestic or foreign, and through implementation, to each Investigator who is planning to participate in, or is participating in, such research. Investigators, including subrecipient investigators, must disclose all financial interests received from a foreign Institution of higher education, foreign company, or the government of another country (which includes local, provincial, or equivalent governments of another country).
The Company must establish a process to require each Covered Individual to disclose SFIs (and those of the Covered Individual’s Immediate Family) related to the Covered Individual Responsibilities that meet or exceed the definition of SFI. This disclosure must occur within 60 days of being hired, no later than at the time of application for PHS-Funded Research, at least annually during the period of the award, and within 30 days of discovering or acquiring a new SFI.
The Company must designate an individual to solicit and review disclosures of SFIs of the Covered Individual (and those of the Covered Individual’s Immediate Family) related to a Covered Individual Responsibilities. Adequate guidelines must be created for the designated individual or committee to determine whether a Covered Individual’s SFI is related to PHS-Funded Research and, if so related, whether the SFI is an FCOI.
The Company must establish a process to require the designated individual or committee, prior to the Company expenditure of award funds, to review all Covered Individual SFI disclosures, determine if any SFIs relate to PHS-Funded Research, determine if an FCOI exists (i.e., SFI that could directly and significantly affect the design, conduct, or reporting of the PHS-Funded Research), and develop and implement management action plans, as needed, to manage FCOIs.
The Company must establish a process to review disclosure of SFIs, make determination of FCOIs, and implement a management plan: when required for a Covered Individual who is new to participating in a PHS-Funded Research project or for an existing Covered Individual, who discloses a new SFI; and, within sixty days whenever the Company identifies an SFI that was not disclosed by a Covered Individual or not previously reviewed by the Company.
The Company must also establish a process to take such actions, as necessary, to manage FCOIs, including any financial conflicts of a Subcontractor, if applicable, and monitor Covered Individual compliance with management plans until completion of the PHS-Funded Research project.
F. Reporting Requirements
Before the expenditure of any funds under a PHS-funded project and within sixty days of subsequently identifying a Financial Conflict of Interest, the Company will report all Financial Conflicts of Interest that have not been eliminated to the PHS awarding component and will ensure that an appropriate Conflict Management Plan (CMP) has been implemented. The report will include the elements required under the PHS FCOI Rules. For subsequently identified FCOI’s, the COI Official will conduct a retrospective review to determine whether the PHS-funded project was affected by the financial conflict of interest, and if bias is found, will submit a mitigation report to the PHS awarding component. The Company will also provide an annual FCOI report that addresses the status of any previously reported FCOI’s and CMP’s related to an ongoing PHS-funded project.
If an investigator has an SFI which results in a conflict of interest and the investigator is the recipient of extramural funding from the PHS, the Company is required to follow the PHS guidelines and may be required to provide the PHS Awarding Component with a report summarizing investigator’s SFI prior to spending.
If a financial conflict of interest is identified and eliminated prior to the expenditure of PHS awarded funds, then an FCOI report does not need to be submitted.
For any significant financial interest that the COI Official identifies as conflicting subsequent to filing the initial FCOI report during an ongoing PHS-funded research project, the Company will provide to PHS Awarding Component an FCOI report regarding the financial conflict of interest within 60 days.
These reports will include:
PD/PI or contact PD/PI if a multiple PD/PI model is used
Name of the investigator with the FCOI
Name of the entity with which the investigator has a financial conflict of interest
Nature of the financial interest
Value of the financial interest in dollars or a statement that the interest is one whose value cannot be readily determined through reference to public prices or other reasonable measures of fair market value
A description of how the financial interest relates to the PHS-funded research and the basis for the determination that the financial interest conflicts with such research
A description of the key elements of the management plan including:
Role and principal duties of the conflicted investigator in the research project
Conditions of the management plan
How the management plan is designed to safeguard objectivity in the research project
Confirmation of the investigator’s agreement to the management plan
How the management plan will be monitored to ensure investigator compliance
Any other information as needed including common strategies for eliminating, mitigating, or managing conflicts including:
Public disclosure of significant financial interests
Posting of significant financial interest on the Company website
The COI Official or designee is responsible for reporting to the PHS Awarding Component in accordance with 42 CFR 50 Subpart F or the applicable contract.
G. Maintenance of Records
The Company must establish a procedure to maintain all FCOI-related records: For at least 3 years from the date the final expenditure report is submitted to the PHS Organization; and from other dates specified in 45 CFR 74.53(b) and 92.42(b) where applicable.
The Company must ensure the existence of adequate enforcement mechanisms and provide for corrective action to ensure Covered Individual compliance. the Company must stablish a policy requirement to complete and document retrospective reviews within 120 days of the Institution’s determination of noncompliance for SFIs not disclosed timely or previously reviewed or whenever an FCOI is not identified or managed in a timely manner and to document the reviews consistent with the regulation
In any case in which HHS determines that a PHS-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 a Covered Individual with an FCOI that was not managed or reported by the Company as required, the Company shall require the Covered Individual to disclose the FCOI in each public presentation of the results of the research, and request an addendum to previously published presentations and publications.
I. Third Party Requirements
Any individual or organization acting as a consultant, subcontractor, or subrecipient (“External Partner”) to the Company on a PHS-funded award must either: (1) have a FCOI policy that meets the requirements of the PHS FCOI Rules or (2) follow this policy.
Organizations with their own policy will certify that the policy meets the requirements of the PHS FCOI Rules by submitting an External Partner Financial Conflict of Interest Disclosure form or registering with the FDP Clearinghouse, https://fdpclearinghouse.org/, before submission of the Government Award. The COI Official will verify registration with the FDP Clearinghouse before submission. The contract with the Company will contain language requiring compliance with the organization’s FCOI Policy.
Individuals and organizations without their own FCOI policy are required to follow this policy. The contract with the Company will contain language requiring compliance with the Company’s FCOI Policy.
J. Accessibility of Documentation
the Company must make the FCOI policy publicly accessible by ensuring the most recent version of this FCOI Policy is accessible to the public on the Company’s website.
Prior to the expenditure of funds, the Company shall establish a process to make information concerning identified FCOIs available within 5 business days to any requesting PHS organization. The information will be updated by CIs 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 of the last payment by PHS Organization.
Eduardo Davila, PhD
President, TrAMPoline Pharma, Inc.
12635 E. Montview Blvd., Suite 125
Aurora, CO 80045