Purpose of this policy
The Financial Conflict of Interest (FCOI) regulation, 42 CFR Part 50 Subpart F, promotes objectivity in research by establishing standards that provide a reasonable expectation that the design, conduct, and reporting of research performed under National Institutes of Health (NIH) grants or cooperative agreements will be free from bias resulting from investigator financial conflicts of interest.
This Policy requires that each Investigator, subrecipient, subgrantee and collaborator affiliated with Protillion Biosciences, Inc. on a Funding Agency project be in compliance with 42 CFR Part 50, Subpart F for grants and cooperative agreements (and 45 CFR Part 94 for contracts). In addition, these regulations describe NIH’s commitment to preserving the public’s trust that the research supported by the NIH is conducted without bias and with the highest scientific and ethical standards. Protillion intends to comply with these regulations for all other Federal agency grant and contract efforts, as tailored or amended accordingly.
A Financial Conflict of Interest (FCOI) exists when Protillion reasonably determines that a significant financial interest could directly and significantly affect the design, conduct or reporting of Funded Research.
Funded Research is any research funded by a Funding Agency but excludes applications for Phase I support under the Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) programs.
Investigator means any person (including subrecipients, subgrantees, and collaborators) who is responsible for the design, conduct, or reporting of Funded Research.
Management of an FCOI means taking action to address an FCOI, which can include reducing or eliminating the FCOI, to ensure, to the extent possible, that the design, conduct, and reporting of Funded Research will be free from bias.
Policy Coordinator means the Protillion FCOI Policy Coordinator.
Significant Financial Interest (SFI) means a financial interest of the Investigator consisting of one or more of the interests described below (including those of the Investigator’s spouse and dependent children) that reasonably appears to be related to the Investigator’s institutional responsibilities.
An SFI Disclosure is a report that each Investigator shall submit to the Policy Coordinator: (a) at the time of application for Funded Research and prior to the expenditure of any Funding Agency funds therefor; (b) annually thereafter; (b) in the event of certain sponsored travel, as set forth below; and (c) within thirty (30) days of the discovery or acquisition by an Investigator of any SFI.
Significant Financial Interests
What is an SFI?
- With regard to any publicly traded entity, an SFI exists if the value of any remuneration received by the Investigator (or the Investigator’s spouse or dependent children) 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.
- With regard to any privately held company, a SFI exists if the value of any remuneration received by the Investigator (or the Investigator’s spouse or dependent children) 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 in the entity (e.g. stock, stock options, or other ownership interest).
- For purposes of the definition of an SFI, remuneration includes salary and any payment for services not otherwise identified as salary (e.g. consulting fees, honoraria, paid authorship); and equity interest includes stock, stock options, or other ownership interest, as valued through reference to the public trading price or other reasonable measures of fair market value.
- An SFI exists with respect to intellectual property rights and interests (e.g. patents, trademarks, copyrights) upon receipt of (or right to receive) any income or other value related to such intellectual property rights and interests.
- With respect to a Significant Financial Interest, Investigators also must disclose (and such disclosure shall constitute an SFI Disclosure) any reimbursed or sponsored travel (i.e., travel 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 a federal, state, or local government agency, an institution of higher education as defined at 20 USC 1001(a), an academic teaching hospital, a medical center, or a research institute that is affiliated with an institution of higher education. This disclosure will include, at a minimum, the purpose of the trip, the identity of the sponsor/organizer, the destination, and the duration.
- The term Significant Financial Interest does not include the following types of financial interests: salaries, royalties or other remuneration paid by the institution to the Investigator if the Investigator is currently employed or otherwise appointed by the Institution, including intellectual property rights assigned to the Institution and agreements to share in royalties related to such rights; any ownership interest in the Institution held by the investigator, if the Institution is a commercial or for profit organization; income from investment vehicles, such as mutual funds and retirements accounts, as long as the Investigator 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, 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.
Training, Reporting & Record Keeping
Training: All persons subject to the Protillion Financial Conflict of Interest Policy will be required to train on the policy by reading and affirming their understanding of, and intent to comply with the FCOI policy and every four (4) years thereafter. Immediate training will be required if Protillion revises this policy in a manner that affects the investigator, senior or key personnel, when an investigator, senior or key personnel is new to Protillion, or as a result of a finding of noncompliance with this policy or a management plan, or other related misconduct.
Senior and key personnel, or investigators and study directors may also demonstrate understanding of FCOI by using the NIH web-based training which can be accessed online.
Unless otherwise covered by a third-party FCOI Policy as agreed with Protillion, each investigator, and senior and key personnel are required to complete training on Protillion’s FCOI Policy by reading and affirming the policy or demonstrate training on the NIH web based training on the following occasions:
- Prior to engaging in research related to any Public Health Services-funded grant,
- At least every 4 years, and
- Protillion revises the FCOI Policy in a manner that affects requirements of investigator, and senior and key personnel,
- An investigator, or senior and key personnel joins Protillion, or
- An investigator is not in compliance with the FCOI Policy or management plan.
Reporting: As required by 42 CFR Part 50, Subpart F, Protillion shall file a report with the NIH providing information on every identified FCOI and the manner in which the FCOI is being or has been managed, reduced, or eliminated. Reports shall include the elements required by these regulations. Protillion will notify NIH promptly if bias is found with the design, conduct, or reporting of NIH-funded research, and file a Mitigation Report in accordance with federal regulations.
Records Management: The records of all financial disclosures and all actions taken by Protillion will be maintained for at least three years from the date of submission of the final expenditures report.
This policy will be publicly available on Protillion’s website at www.protillion.com/fcoi, and certain information regarding FCOIs will be available within five days of a qualified written request.