Financial Conflict of Interest Policy
Effective Date: July 15, 2025
I. Purpose
This Financial Conflict of Interest (FCOI) Policy of Anise Health, Inc. ("Anise Health" or "Institution") is established to comply with the regulatory requirements of 42 CFR Part 50, Subpart F, "Promoting Objectivity in Research," and 45 CFR Part 94, "Responsible Prospective Contractors," applicable to Public Health Service (PHS) grants and cooperative agreements, including those from the National Institutes of Health (NIH). This policy aims to ensure the objectivity of 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 FCOIs.
II. Applicability
This policy applies to all Investigators participating in, or proposing to participate in, PHS-funded research.
III. Definitions
Financial Conflict of Interest (FCOI): A Significant Financial Interest (SFI) that could directly and significantly affect the design, conduct, or reporting of PHS-funded research.
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 such funding.
PHS Awarding Component: The organizational unit of the PHS that funds the research (e.g., NIH).
Research: A systematic investigation, study, or experiment designed to develop or contribute to generalizable knowledge, including behavioral and social-sciences research. The term encompasses any such activity for which research funding is sought from PHS.
Significant Financial Interest (SFI):
A financial interest consisting of one or more of the following interests of the Investigator and their immediate family members (spouse and dependent children) that reasonably appears to be related to the Investigator's institutional responsibilities:
With regard to any publicly traded entity, 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.
With regard to any non-publicly traded entity, 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 their immediate family) holds any equity interest (e.g., stock, stock option, or other ownership interest).
Intellectual property rights and interests (e.g., patents, copyrights), upon receipt of income related to such rights and interests.
2. The term SFI does NOT include:
Salary, royalties, or other remuneration paid by Anise Health to the Investigator if the Investigator is currently employed or otherwise appointed by Anise Health.
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.
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.
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.
IV. Disclosure of Significant Financial Interests
All Investigators must disclose their SFIs (and those of their immediate family members) that are related to their institutional responsibilities:
Prior to Application: At the time an Investigator is planning to participate in PHS-funded research, or at the time of application for PHS funding.
Annually: At least annually during the period of the award.
New SFIs: Within thirty (30) days of discovering or acquiring a new SFI.
V. Review and Management of SFIs
Anise Health will review all disclosed SFIs to determine if they constitute an FCOI. An SFI is an FCOI if it could directly and significantly affect the design, conduct, or reporting of the PHS-funded research. If an FCOI is identified, Anise Health will develop and implement a management plan to manage, reduce, or eliminate the FCOI. Examples of conditions or restrictions that might be imposed to manage an FCOI include, but are not limited to:
Public disclosure of FCOI.
Monitoring of research by independent reviewers.
Modification of the research plan.
Disqualification from participation in all or a portion of the research.
Divestiture of SFIs.
Severance of relationships that create FCOI.
VI. Reporting to PHS Awarding Component
Anise Health will provide FCOI reports to the PHS Awarding Component as required by regulation, including:
Initial FCOI Report: Before the expenditure of funds, for any FCOI identified.
Annual FCOI Report: At least annually, for the duration of the PHS-funded research, for any FCOI previously reported.
Revised FCOI Report: Within 60 days of identifying a new FCOI or identifying an SFI that was not previously disclosed or reviewed.
VII. Subrecipient Requirements
Anise Health will require subrecipients to comply with this policy or to implement their own FCOI policy that complies with 42 CFR Part 50, Subpart F. Anise Health will establish a written agreement with subrecipients that specifies whether the subrecipient will follow Anise Health's FCOI policy or their own, and includes timeframes for reporting SFIs to Anise Health that enable Anise Health to meet its reporting obligations to the PHS Awarding Component.
VIII. Training
All Investigators must complete FCOI training:
Prior to engaging in PHS-funded research.
At least every four years.
Immediately when Anise Health revises its FCOI policy in a manner that affects Investigator requirements.
When an Investigator is new to Anise Health.
When an Investigator is found to be noncompliant with this policy or a management plan.
IX. Record Retention
Anise Health will retain all FCOI-related records for at least three years from the date of the final expenditures report for the PHS-funded research award, or until the resolution of any PHS action involving the records, whichever is later.
X. Non-Compliance
Failure to comply with this policy may result in disciplinary action, including but not limited to, removal from the PHS-funded research, and may require Anise Health to take appropriate action to mitigate any actual or potential adverse effects of the non-compliance.