FPT Financial Conflict of Interest Policy

This Financial Conflict of Interest (FCOI) on Federal Grants Policy has been adopted by Function Promoting Therapies, LLC, of 220 South Avenue, Weston MA, and applies to all employees and contractors working on behalf of Function Promoting Therapies, LLC.

Overview

Purpose

The purpose of this document is to ensure that Function Promoting Therapies, LLC is in compliance with the requirements of the Financial Conflict of Interest (FCOI) on Federal Grants Policy set forth in 42 CFR 50, subpart F, “Responsibility of Applicants for Promoting Objectivity in Research for which PHS Funding is Sought” (hereafter referred to as “FCOI Regulation”). This policy statement documents the practices and procedures to be followed by Function Promoting Therapies, LLC (hereafter referred to as “FPT” or the “Company”).  These practices and procedures are designed to ensure objectivity in research by establishing standards that result in design, conduct and reporting of research funded by federal grants to be free from bias resulting from investigator financial conflicts of interest. Furthermore, this policy provides procedures to identify, manage and resolve any investigator FCOI.

Applicability

The FPT FCOI Policy Statement applies to all investigators, staff and contractors working on behalf of Function Promoting Therapies, LLC involved in federally funded research or cooperative agreements, with the exception of SBIR Phase I grant applications or funded projects which does not fall under the FCOI Regulation.  This document was developed in response to the FCOI Regulation, which was used during the development of this Policy Statement,

Definitions

The following definitions apply to this policy.

1.    Designated Official(s): person designated by FPT to determine when an investigator’s Significant Financial Interest is related to PHS-funded research and when related, will determine if the Significant Financial Interest is a Financial Conflict of Interest.

2.    Financial Conflict of Interest (FCOI): a significant financial interest that could directly and significantly affect the design, conduct or reporting of federally funded research.

3.    FCOI Report: the institution’s report of a financial conflict of interest to the relevant PHS Awarding Component.

4.    Financial Interest: anything of monetary value, whether or not the value is readily ascertainable.

5.    Significant Financial Interest (SFI): exists if specific situations (defined below) apply to the investigator and/or the investigator’s spouse or domestic partner, children, and immediate relatives (siblings and parents) involving companies that appear to be related to the proposed research.

6.    Investigator: is the Project Director or Principal Investigator (PI), Co-Principal investigator (Co-PI), and any other senior or key personnel, regardless of title or position, who is responsible for the design, conduct and/or reporting of federally funded research. This may also include collaborators or consultants working on behalf of FPT.

7.    Institution: any domestic or foreign, public or private, entity or organization (excluding a Federal agency) that applies for or receives PHS research funding.  FPT is considered an institution for the purposes of this policy.

8.    Institutional Responsibilities: an investigator’s professional responsibilities on behalf of the institution and as defined by the institution in its policy on financial conflicts of interest. For example, activities such as research, research consultation, teaching, professional practice, committee memberships and service on panels such as Institutional Review Boards or Data and Safety Monitoring Boards.

9.    HHS: the United States Department of Health and Human Services and any components of the Department to which the authority involved may be delegated.

10. PHS: the Public Health Service of the US Department of Health and Human Services, and any components of the PHS wo which the authority may be delegated including the National Institutes of Health (NIH).

11. PHS Awarding Component: the organizational unit of the PHS that funds the research that is subject to this part.

12. PHS Act: Public Health Service Act refers to the statue codified at 42 U.S.C. et seq.

13. 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). As used in this part, the term includes any activity for which research funding is available from a PHS Awarding Component through a grant or cooperative agreement, whether authorized under the PHS Act or other statutory authority.

14. Management Plan: procedures to identify, manage and report financial conflicts of interest.

Significant Financial Interest (SFI)

Significant Financial Interest (SFI) exists if one or more of the following situations apply to the investigator and/or the investigator’s spouse or domestic partner, children, and immediate relatives (siblings and parents) involving companies that reasonably appears to be related to the Investigator’s institutional responsibilities:

1.    For publicly traded companies, a SFI exists if the value of any income received during the twelve months preceding the disclosure exceeds $5,000 in aggregate from the entity. For purposes of this definition, examples of income include salary, and any services not otherwise identified as salary such as consulting fees, honoraria, paid authorship, stock, stock options, or other ownership interests as determined through reference to public prices or other reasonable measures of fair market value.

2.    For non-publicly traded companies, a SFI exists if the value of any income received during the twelve months preceding the disclosure exceeds $5,000 in aggregate from the entity, or when the investigator, or the investigator’s spouse or children, holds equity interest such as stock, stock option, or other ownership interest.

3.    If income is received from intellectual property rights and interests (e.g., patents, copyrights).

Investigators much also disclose any reimbursed or sponsored travel (i.e., that which is paid on behalf of the investigator and not reimbursed to the investigator so that the exact monetary value may not be readily discernable), related to their institutional responsibilities, which is paid for by any entity other than a Federal, state or local government, an institution of higher education, an academic teaching hospital, a medical center or a research institute associated with an institution of higher education.  At minimum, this disclosure must include the purpose of the trip, the identity of the sponsor/organizer, the destination and the duration of the trip. In accordance with this FCOI Policy, the Designated Official will determine if further information is required, including a determination or disclosure of monetary value in order to determine whether the travel sponsorship represents a FCOI with the PHS-funded research.

Significant Financial Interest does not include the following types of financial interests:

1.    Salary, royalties or other remuneration paid to the investigator by the institution if the investigator is employed or appointed by the institution, including intellectual property rights assigned to the institution and agreements to share in royalties related to such rights.

2.    Ownership interest in the institution held by the investigator, if the institution is a commercial or for-profit organization.

3.    Investment income such as mutual funds and retirement accounts, as long as the investigator does not directly control the investment decisions made in this vehicles.

4.    Income from seminars, lectures or teaching engagement sponsored by Federal, state or local government agencies, 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.

5.    Income from service on advisory committees or review panels for 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.

Institutional Responsibilities and Procedures

Record Keeping

Function Promoting Therapies, LLC will maintain an up-to-date, written, enforced policy on financial conflicts of interest that complies with the FCOI Regulation, and will make such policy available via a publicly accessible Web site, and will be provided to any requestor within five business days of the request.  FPT shall adhere to this FCOI Policy and shall provide FCOI Reports regarding identified FCOI to the PHS Awarding Component in accordance with the FCOI Regulation and within the required timeframe.  Specifically, FPT will:

1.    Inform each investigator of the FCOI Policy and train each investigator on their responsibilities regarding disclosure of SFI.

2.    Require that each investigator submit an FCOI Disclosure in a timely manner and maintains up-to-date training at least every four years or immediately if:

a.    FPT revises this FCOI Policy

b.    An investigator is new to FPT

c.     FPT finds that an investigator is not in compliance with this FCOI Policy or Management Plan for FCOI.

3.    Require that each investigator submit an updated FCOI Disclosure annually, and and updated FCOI Disclosure within thirty days of discovering or acquiring, through marriage, purchase or inheritance, a new SFI.

4.    Certify that subrecipient’s investigators will comply with the subrecipient’s FCOI policies or FPT’s FCOI policies and procedures.

5.    Provide guidelines consistent with the FCOI Regulation to the Designated Official to determine whether an investigator’s SFI is related to PHS-funded research, and if so, whether the SFI is a FCOI.  A FCOI exists when the Designated Official reasonably determines that the SFI could directly and significantly affect the design, conduct or reporting of the PHS-funded research.

6.    Provide initial and ongoing FCOI Reports to the PHS Awarding Component regarding all financial conflicts of interest from each investigator participating or planning to participate in the PHS-funded research.

7.    Maintain records related to all investigator disclosures of financial interests and the institutions’ review of, and response to, such disclosures even when it did not result in a determination of FCOI.  FPT agrees to make these records available promptly upon request and shall make every effort to comply with the FCOI Regulations.

8.    Take such actions as necessary to manage financial conflicts of interest, including any financial conflicts of a subrecipient investigator. The

Training

Function Promoting Therapies, LLC will be responsible for investigator training, collecting and evaluating FCOI disclosure forms, and enforcement of this FCOI Policy in order to facilitate and promote compliance with the FCOI Regulation. This policy will be available on fptherapies.com, and FCOI Disclosure forms made available to all investigators.  Training will be repeated at least every four years and immediately if FCOI policies and procedures have been modified, or if an investigator is found to be in non-compliance with the FCOI Policy or with FPT’s management plan related to FCOI.

Disclosure Requirements

All participating investigators are required to fill out and submit a FCOI Disclosure statement on the form provided (FCOI Form) which will be reviewed by the Designated Official to assess the potential for a conflict and initiate the review and response procedures outlined below.  In addition, all investigators must submit an updated FCOI Disclosure form annually during the period of the PHS award and to update any information regarding any previously disclosed SFI.  Any newly discovered or acquired SFI, whether it be through marriage, purchase or inheritance, must be disclosed by the investigator within thirty days. New investigators added to a project after the start date of the project must also complete a disclosure form, including situations when previously non-investigator employees take on the role of an investigator. New or changed investigators will also complete the training as describe above.

Subcontracts

If the federally funded research involves a subrecipient (e.g., subcontractors or consortium members), FPT will take reasonable steps to ensure that any subrecipient investigator complies with the federal policies by:

1.    Establishing with the subrecipient whether FCOI policies of the subrecipient institution or of FPT will apply to the subrecipients investigators on the project:

a.    If the subrecipient’s investigators must comply with their institutions FCOI policies, the subrecipient shall certify that these policies are in compliance with the federal policies.  In the absence of this certification, the agreement will state that the subrecipient’s investigators are subject to the FCOI polices of FPT and will disclose SFI that are directly related to the work for FPT.

b.    Whether the subrecipient’s investigators must comply with the subrecipient institution’s FCOI polices or the FCOI policies of FPT, the written agreement will specify a deadline for the subrecipient to submit a FCOI disclosure so that FCOI may be identified, and reported, if necessary, to the relevant federal agency.

2.    Maintain records of FCOI Disclosures and provide FCOI Reports to the federal agency regarding all financial conflicts of interest of all subrecipient investigators consistent with the FCOI Regulation.

Management and Reporting of FCOI

Prior to the Institution's expenditure of any funds under a PHS-funded research project, the Designated Official of an Institution shall review all Investigator disclosures of SFI to determine whether any SFI is related to PHS-funded research and to determine whether a FCOI exists.  The Designated Official will consult with company executives and outside counsel to review situations where SFI may constitute FCOI. If it is deemed that a FCOI exists, FPT will develop and implement a management plan that shall specify the actions that have been, and shall be, taken to manage such financial conflict of interest. Examples of conditions or restrictions that might be imposed to manage a financial conflict of interest include, but are not limited to:

1.    Public disclosure of financial conflicts of interest (e.g., when presenting or publishing the research)

2.    For research projects involving human subjects research, disclosure of financial conflicts of interest directly to the participants of the study

3.    Appoint an independent monitor capable of taking measures to protect the design, conduct, and reporting of the research against bias resulting from the FCOI.

4.    Modify the Research Plan

5.    Change the investigator, or other personnel or the responsibilities of the investigator or other personnel or disqualify personnel from participation in all or a portion of the research.

6.    Reduce or eliminate the financial interest (e.g., sale of an equity interest); or

7.    Severance of relationships that create financial conflicts.

Whenever, in the course of an ongoing PHS-funded research project, an Investigator who is new to participating in the research project discloses a SFI or an existing Investigator discloses a new SFI to the Institution, the Designated Official of the Institution shall, within sixty days: review the disclosure of the SFI; determine whether it is related to PHS-funded research; determine whether a 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 financial conflict of interest. Depending on the nature of the SFI, an Institution may determine that additional interim measures are necessary with regard to the Investigator's participation in the PHS-funded research project between the date of disclosure and the completion of the Institution's review.

Whenever an Institution identifies a SFI that was not disclosed timely by an Investigator or, for whatever reason, was not previously reviewed by the Institution during an ongoing PHS-funded research project (e.g., was not timely reviewed or reported by a subrecipient), the Designated Official shall, within sixty days: review the SFI; determine whether it is related to PHS-funded research; determine whether a FCOI exists; and, if so:

1.    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 going forward

2.    In addition, whenever a FCOI is not identified or managed in a timely manner including failure by the Investigator to disclose a SFI that is determined by the Institution to constitute a FCOI; failure by the Institution to review or manage such FCOI or failure by the Investigator to comply with a FCOI management plan, the Institution shall, within 120 days of the Institution's determination of non-compliance, complete a retrospective review of the Investigator's activities and the PHS-funded research project to determine whether any PHS-funded research, or portion thereof, conducted during the time period of the non-compliance, was biased in the design, conduct, or reporting of such research. The Institution is required to document the retrospective review; such documentation shall include, but not necessarily be limited to, all of the following key elements:

a.    Project number

b.    Project title

c.     PD/PI or contact PD/PI if a multiple PD/PI model is used

d.    Name of the Investigator with the FCOI

e.    Name of the entity with which the Investigator has a financial conflict of interest

f.      Reason(s) for the retrospective review

g.    Detailed methodology used for the retrospective review (e.g., methodology of the review process, composition of the review panel, documents reviewed)

h.    Findings of the review; and

i.      Conclusions of the review.

3.    Based on the results of the retrospective review, if appropriate, the Institution shall update the previously submitted FCOI report, specifying the actions that will be taken to manage the financial conflict of interest going forward. If bias is found, the Institution is required to notify the PHS Awarding Component promptly and submit a mitigation report to the PHS Awarding Component. The mitigation report must include, at a minimum, the key elements documented in the retrospective review above and a description of the impact of the bias on the research project and the Institution's plan of action or actions taken to eliminate or mitigate the effect of the bias (e.g., impact on the research project; extent of harm done, including any qualitative and quantitative data to support any actual or future harm; analysis of whether the research project is salvageable). Thereafter, the Institution will submit FCOI reports annually, as specified elsewhere in this subpart. Depending on the nature of the financial conflict of interest, an Institution may determine that additional interim measures are necessary with regard to the Investigator's participation in the PHS-funded research project between the date that the financial conflict of interest or the Investigator's noncompliance is determined and the completion of the Institution's retrospective review.

Whenever an Institution implements a management plan the Institution shall monitor Investigator compliance with the management plan on an ongoing basis until the completion of the PHS-funded research project.

Prior to the Institution's expenditure of any funds under a PHS-funded research project, the Institution shall ensure public accessibility, via a publicly accessible Web site or written response to any requestor within five business days of a request, of information concerning any significant financial interest disclosed to the Institution that meets the following three criteria:

1.    The SFI was disclosed and is still held by the senior/key personnel.

2.    The Institution determines that the SFI is related to the PHS-funded research; and

3.    The Institution determines that the SFI is FCOI.

The information that the Institution makes available via a publicly accessible Web site or written response to any requestor within five business days of a request, shall include, at a minimum, the following:

1.    the Investigator's name

2.    the Investigator’s title and role with respect to the research project

3.    the name of the entity in which the significant financial interest is held

4.    the nature of the significant financial interest

5.    and the approximate dollar value of the significant financial interest using the following dollar ranges:

a.    $0-$4,999

b.    $5,000-$9,999

c.     $10,000-$19,999

d.    amounts between $20,000-$100,000 by increments of $20,000

e.    amounts above $100,000 by increments of $50,000)

6.    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.

If the Institution uses a publicly accessible Web site for the purposes of this subsection, the information that the Institution posts shall be updated at least annually. In addition, the Institution shall update the Web site within sixty days of the Institution's receipt or identification of information concerning any additional SFI of the senior/key personnel for the PHS-funded research project that was not previously disclosed, or upon the disclosure of SFI of senior/key personnel new to the PHS-funded research project, if the Institution determines that the SFI is related to the PHS-funded research and is a FCOI. The Web site shall note that the information provided is current as of the date listed and is subject to updates, on at least an annual basis and within 60 days of the Institution's identification of a new FCOI. If the Institution responds to written requests for the purposes of this subsection, the Institution will note in its written response that the information provided is current as of the date of the correspondence and is subject to updates, on at least an annual basis and within 60 days of the Institution's identification of a new FCOI, which should be requested subsequently by the requestor.

Information concerning the SFI of an individual shall remain available for responses to written requests or for posting via the Institution's publicly accessible Web site for at least three years from the date that the information was most recently updated.

In addition to the types of FCOI that must be managed, an Institution may require the management of other FCOI in its policy on financial conflicts of interest, as the Institution deems appropriate.

Reporting Financial Conflicts of Interest

Prior to the Institution's expenditure of any funds under a PHS-funded research project, the Institution shall provide to the PHS Awarding Component an FCOI Report regarding any Investigator's SFI found by the Institution to be conflicting and ensure that the Institution has implemented a management plan accordingly.  In cases in which the Institution identifies a FCOI and eliminates it prior to the expenditure of PHS-awarded funds, the Institution shall not submit an FCOI Report to the PHS Awarding Component.

For any SFI that the Institution identifies as conflicting subsequent to the Institution's initial FCOI Report during an ongoing PHS-funded research project (e.g., upon the participation of an Investigator who is new to the research project), the Institution shall provide to the PHS Awarding Component, within sixty days, an FCOI Report regarding the FCOI and ensure that the Institution has implemented a management plan in accordance with this subpart. Where such FCOI Report involves a SFI that was not disclosed in a timely manner by an Investigator or, for whatever reason, was not previously reviewed or managed by the Institution (e.g., was not timely reviewed or reported by a subrecipient), the Institution is also required to complete a retrospective review to determine whether any PHS-funded research, or portion thereof, conducted prior to the identification and management of the FCOI was biased in the design, conduct, or reporting of such research. Additionally, if bias is found, the Institution is required to notify the PHS Awarding Component promptly and submit a mitigation report to the PHS Awarding Component.

Any FCOI Report required shall include sufficient information to enable the PHS Awarding Component to understand the nature and extent of the financial conflict, and to assess the appropriateness of the Institution's management plan and response. Elements of the FCOI report shall include, but are not necessarily limited to the following:

1.    Project number

2.    PD/PI or Contact PD/PI if a multiple PD/PI model is used

3.    Name of the Investigator with the financial conflict of interest

4.    Name of the entity with which the Investigator has a financial conflict of interest

5.    Nature of the financial interest (e.g., equity, consulting fee, travel reimbursement, honorarium)

6.    Value of the financial interest using the following dollar ranges:

a.    $0-$4,999

b.    $5,000-$9,999

c.      $10,000-$19,999

d.    amounts between $20,000-$100,000 by increments of $20,000

e.    amounts above $100,000 by increments of $50,000)

f.      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

7.    A description of how the financial interest relates to the PHS-funded research and the basis for the Institution's determination that the financial interest conflicts with such research; and

8.    A description of the key elements of the Institution's management plan, including:

a.    Role and principal duties of the conflicted Investigator in the research project

b.    Conditions of the management plan

c.     How the management plan is designed to safeguard objectivity in the research project

d.    Confirmation of the Investigator's agreement to the management plan

e.    How the management plan will be monitored to ensure Investigator compliance; and

f.      Other information as needed.

For any financial conflict of interest previously reported by the Institution with regard to an ongoing PHS-funded research project, the Institution shall provide to the PHS Awarding Component an annual FCOI Report that addresses the status of the FCOI and any changes to the management plan for the duration of the PHS-funded research project. The annual FCOI report shall specify whether the financial conflict is still being managed or explain why the FCOI no longer exists. The Institution shall provide annual FCOI reports to the PHS Awarding Component for the duration of the project period (including extensions with or without funds) in the time and manner specified by the PHS Awarding Component.

(5) In addition to the types FCOI defined an Institution may require the reporting of other FCOI in its policy on FCOI, as the Institution deems appropriate.

Remedies

If the failure of an Investigator to comply with an Institution's financial conflicts of interest policy or a financial conflict of interest management plan appears to have biased the design, conduct, or reporting of the PHS-funded research, the Institution shall promptly notify the PHS Awarding Component of the corrective action taken or to be taken. The PHS Awarding Component will consider the situation and, as necessary, take appropriate action, or refer the matter to the Institution for further action, which may include directions to the Institution on how to maintain appropriate objectivity in the PHS-funded research project. PHS may, for example, require Institutions employing such an Investigator to enforce any applicable corrective actions prior to a PHS award or when the transfer of a PHS grant(s) involves such an Investigator.

The PHS Awarding Component and/or HHS may inquire at any time before, during, or after award into any Investigator disclosure of financial interests and the Institution's review (including any retrospective review) of, and response to, such disclosure, regardless of whether the disclosure resulted in the Institution's determination of a financial conflict of interest. An Institution is required to submit, or permit on site review of, all records pertinent to compliance with this subpart. To the extent permitted by law, HHS will maintain the confidentiality of all records of financial interests. On the basis of its review of records or other information that may be available, the PHS Awarding Component may decide that a particular FCOI will bias the objectivity of the PHS-funded research to such an extent that further corrective action is needed or that the Institution has not managed the FCOI appropriately. The PHS Awarding Component may determine that imposition of specific award conditions under 45 CFR 75.207, or suspension of funding or other enforcement action under 45 CFR 75.371, is necessary until the matter is resolved.

In any case in which the HHS determines that a PHS-funded 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 a financial conflict of interest that was not managed or reported by the Institution as required, the Institution 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 presentations.


 

Revision History

Rev #

Doc #

Effective Date

CHO

Description of Change

001

CORP-0003

April 20, 2021

N/A

Initial Version

001.01

CORP-003

April 22, 2021

N/A

Minor edits