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September 17, 2021

Financial Conflict of Interest (FCOI)

Financial Conflict of Interest (FCOI)

Platelet BioGenesis, Inc.

Financial Conflict of Interest Policy

(Adopted September 17, 2021)

It is the commitment and responsibility of Platelet BioGenesis, Inc. (“PlateletBio”) to promote objectivity in all research performed by or for the company. This policy outlines the standards that provide a reasonable expectation that the design, conduct and reporting of research will be free from bias resulting from financial conflicts of interest (FCOI).  This policy provides a framework to comply with the FCOI Regulation (as defined below).

PlateletBio shall maintain this policy as an up-to-date, written, enforced policy that complies with the FCOI Regulation and shall make available via a publicly-accessible website. PlateletBio, its employees, consultants, trainees or other agents shall comply with this policy and applicable regulations in all research conducted by PlateletBio.

Purpose:

The intent of this policy is to promote objectivity in research; to identify, eliminate or manage any possible threat to the integrity of the research conducted by PlateletBio; and to satisfy current federal regulations for disclosure.

Scope:

The policy and associated procedures are immediately applicable to all sponsored program activity at PlateletBio carried out by its employees, consultants, trainees or other agents. These procedures will be followed whenever PlateletBio or any employee acting on its behalf submits a request for funding from any external agency, whether it is the PHS or another federal agency.

Definitions:

“Corporate Legal” means the person from PlateletBio’s legal department responsible for oversight of the FCOI Policy.

“FCOI Official (FCOIO)” means a person responsible for the implementation of the FCOI Policy.

“FCOI Management Plan” means a plan developed to manage, minimize or eliminate a FCOI.

“FCOI Regulation” means 42 CFR Part 50 Subpart F, “Responsibility of Applicants for Promoting Objectivity in Research for which Public Health Service Funding is Sought,” which applies to both grants and cooperative agreements.

“Financial Conflict of Interest” means a Significant Financial Interest (as defined below) that could directly and significantly affect the design, conduct or reporting of research funded by NIH (as defined below).

“Immediate Family” means an Investigator’s spouse or domestic partner and dependent children.

“Institution” means any domestic or foreign, public or private, entity or organization (excluding a federal agency) that submits a proposal or receives NIH research funding.  For purposes of this policy, PlateletBio is an Institution.

“Investigator” means the Project Director or Principal Investigator (PD/PI) and any other person, regardless of title or position, who is responsible for the design, conduct or reporting of NIH-funded research, including subgrantees, contractors, consortium participants, collaborators or consultants.  

“NIH” means the National Institute of Health.

“PHS” means the 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 the NIH.

“Significant Financial Interest” or “SFI” means:

  1. A financial interest consisting of one or more of the following interests of the Investigator (and those of the Investigator’s Immediate Family) that reasonably appears to be related to the Investigator’s institutional responsibilities:
  1. With regard to any publicly-traded entity, a Significant Financial Interest exists if 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. For purposes of this definition, remuneration includes salary and any payment for services not otherwise identified as salary (e.g., consulting fees, honoraria, paid authorship), and equity interest in stock, stock options or other ownership interest, as determined through reference to public prices or other reasonable measures of fair market value;
  1. With regard to any non-publicly-traded entity, a significant financial interest exists if 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 the Investigator’s Immediate Family) holds any equity interest (e.g., stock, stock option or other ownership interest); or
  1. Intellectual property rights and interests (e.g., patents, copyrights), upon receipt of income related to such rights and interests.
  1. Investigators also must disclose the occurrence of 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 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 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.  
  1. An SFI does not include the following types of financial interests: salary, royalties or other remuneration paid by PlateletBio to the Investigator if the Investigator is currently employed or otherwise appointed by PlateletBio, including intellectual property rights assigned to PlateletBio and agreements to share in royalties related to such rights; any ownership interest in PlateletBio held by the Investigator; 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 or 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.

Policy Statement:

A Financial Conflict of Interest related to PlateletBio’s activities may occur when an Investigator employed or appointed by PlateletBio has a Significant Financial Interest that compromises, or appears to compromise, that individual’s independence and objectivity in the discharge of PlateletBio responsibilities in the design, conduct or reporting of PlateletBio’s research. Investigators should avoid conflicts and the potential for conflicts resulting from financial arrangements with third parties that could have a special interest in PlateletBio’s work.

Training Requirements:

All Investigators must complete FCOI training and affirm their understanding in writing—

  • Prior to engaging in research related to any NIH-funded projects;  
  • At least every four (4) years; and
  • Immediately upon the occurrence of one of the following circumstances—
  • PlateletBio revises this policy in a manner that impacts an Investigator’s responsibilities,  
  • An Investigator is a new hire to PlateletBio, or
  • The FCOIO determines that an Investigator is not in compliance with this policy or with a FCOI Management Plan.  

The training shall inform the Investigator of this policy, the Investigator’s responsibilities regarding disclosure of SFIs and the federal regulations concerning FCOI.

Procedure:

  1. All Investigators who plan to participate in or direct a sponsored research project must complete an SFI form in order to disclose any known SFIs (and those of the Investigator’s Immediate Family).  This disclosure shall be made at least annually, prior to the submission of a research proposal to any federal agency, and within thirty (30) days of the discovery or acquisition (e.g., through purchase, marriage or inheritance) of a new SFI.  
  1. PlateletBio will maintain the confidentiality of the disclosure statements except as required by federal law or agency award items. In no case will a disclosure statement be released to a federal agency without prior notification to the affected individual.
  1. SFI disclosures will be reviewed by the FCOIO to determine the existence or potential for a FCOI.  
  1. If the FCOIO determines that a FCOI exists, the FCOIO will develop a suitable FCOI Management Plan within sixty (60) days of its identification. The FCOI Management Plan must be approved by the FCOIO and signed by the Investigator before any related contract, grant, sponsored project or any other transaction is executed. The FCOIO shall be responsible for monitoring and enforcing any management plan.  
  1. In the event circumstances change regarding an Investigator’s SFI while an Investigator is engaged in a sponsored project, the Investigator must notify the FCOIO and complete a new SFI form within thirty (30) days of discovery. The new SFI form will undergo the same review process as all SFI forms.
  1. If an FCOI is not identified or managed in a timely manner, including any failure by—
  • The Investigator to disclose an SFI that is determined by the FCOIO to constitute an FCOI,  
  • PlateletBio to review or manage the FCOI, or
  • The Investigator to comply with the FCOI Management Plan,  

PlateletBio shall, within one hundred twenty (120) days of the determination of noncompliance, complete and document a retrospective review to determine whether any PHS-funded research was biased in the design, conduct or reporting of such research. If a bias is found, PlateletBio shall submit a mitigation report to the NIH, in accordance with 42 CFR 50.605(b)(3), that shall address the impact of the bias on the research project and the actions it has taken to mitigate the bias.

  1. For each new grant submitted, the FCOIO will identify the subrecipients and establish, via a written agreement, whether the subrecipient will follow this policy or the subrecipient’s policy. If the subrecipient will follow its own policy, the FCOIO will obtain a certification that the policy complies with the FCOI Regulation.  

Reporting:

Prior to the expenditure of any funds under the award, the FCOIO will –

  1. Report the existence of any FCOIs to the PHS Awarding Component and provide assurance that the interest has been managed, reduced or eliminated in accordance with the FCOI Regulation; and
  1. Make publicly accessible (via website) information concerning identified FCOIs. The information will – (i) include regulations, (ii) be updated on an annual basis or within sixty (60) days of a newly identified FCOI, and (iii) remain posted for three years from the date the information was most recently updated.  

As required by the FCOI Regulation, the FCOIO 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. For any interest that the FCOIO identifies as conflicting subsequent to FCOIO’s initial report under the award, the report will be made and the conflicting interest managed, reduced or eliminated, at least on an interim basis, within sixty (60) days of that identification.

Roles and Responsibilities:

Corporate Legal shall be responsible for—

  • Ensuring overall compliance with federal regulations by developing, communicating, and enforcing this policy and making it publicly-accessible on PlateletBio’s website.
  • Designating an FCOIO to solicit and review disclosures of SFIs of Investigators (and those of the Investigator’s Immediate Family) related to an Investigator’s institutional responsibilities.

The FCOI Official (FCOIO) shall be responsible for—

  • Informing each Investigator of this policy and of the Investigator’s responsibilities regarding disclosure of SFI.
  • Ensuring each Investigator completes the FCOI training as outlined in this policy.
  • Using federal regulations as a guideline for determining whether an Investigator’s SFI is related to PHS-funded research and, if so, whether the SFI is a FCOI.
  • Managing PlateletBio’s FCOIs, including the FCOI of subrecipients, through the development and implementation of an FCOI Management Plan, and if necessary, a retrospective review and mitigation report.
  • Providing initial, annual and revised FCOI reports as required by this policy.
  • Promptly notifying NIH if—
  • Bias is found with the design, conduct or reporting of NIH-funded research by submitting a mitigation report in accordance with the FCOI Regulation, or
  • An Investigator fails to comply with the FCOI policy or a FCOI Management Plan, and that non-compliance appears to have biased the design, conduct or reporting of the NIH-funded research.
  • Maintaining all SFI disclosure and FCOI disclosure records for a minimum of three (3) years from the date the final expenditures report is submitted to the PHS.

The Investigator shall be responsible for—

  • Participating in training and complying with the FCOI policy.
  • Completing required SFI forms in a timely manner.
  • Take necessary actions to eliminate or mitigate FCOIs as identified by the FCOIO and documented in the FCOI Management Plan.  
  • Monitor subrecipients’ Investigators
  • Taking reasonable steps to ensure that subrecipients –  
  • Comply with the FCOI Regulation by incorporating as part of the written agreement the requirement that the subrecipient possesses a written FCOI policy that is compliant with the FCOI Regulation.  
  • Confirm in writing, prior to the release of funds, that – (i) the subrecipient possesses a written FCOI policy that is compliant with the FCOI Regulation, (ii) the subrecipient’s policy applies to the sub-awarded portion of the research project, and (iii) the subrecipient agrees that any identified FCOIs and the resultant FCOI Management Plan will be submitted to the awardee institution for required reporting purposes.
  • Provide PlateletBio with a written copy (and subsequent revisions) of its FCOI policy within fifteen (15) days of execution of the written agreement or any revisions to the policy.

If the subrecipient does not have a compliant FCOI policy in place, the subrecipient must agree in writing to follow this policy.

Noncompliance or Failure to Disclose:

Any suspected non-compliance with this policy shall be handled by the FCOIO in accordance with the FCOI Regulation. Based on findings and recommendations of the FCOIO, research may be stopped or research funding withheld in order to ensure compliance with this policy, any FCOI Management Plan and/or applicable federal FCOI regulations. Failure of any Investigator to comply with this policy shall constitute grounds for disciplinary action.