Legal Disclaimers and Policies

POP Biotechnologies Financial Conflict of Interest Policy

POLICY #: POPFC072022
Updated on: July 14, 2022
Next Review Date: June 30, 2025
Approval Date: July 15, 2022
Approved by: Jonathan Smyth, Esq.

A. Purpose

Under this policy, POP Biotechnologies (POP BIO) 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 POP BIO, the governmental agency providing the funding, and/or external partners. As POP BIO 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”).

B. Scope

Any POP BIO employee or contractor 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.

C. Definitions

  • Covered Individual (“CI”): Any POP BIO employee or contractor who is responsible for the design, conduct or reporting of a PHS-Funded Research project or proposed for such project.
  • 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 certain types of Financial Interests as specified.
  • PHS: Public Health Service of the U.S. Department of Health and Human Services.
  • PHS-Funded Research: Any Research funded by way of a grant from, or a contract with, a PHS Organization.
  • PHS Organization: An agency that is part of the PHS or an organization that has adopted the PHS Regulations.
  • PHS Regulations: U.S. 42 CFR Part 50, Subpart F and 45 CFR Part 94.
  • Remuneration: Any payment for services, including salary and travel reimbursement related to responsibilities.
  • Research: A systematic investigation designed to develop generalizable knowledge relating broadly to public health.
  • Significant Financial Interest (“SFI”): A Financial Interest consisting of certain specified interests of a Covered Individual that reasonably appear related to Covered Individual Responsibilities.

D. Training Requirements

POP BIO must establish a process to inform each Covered Individual of POP BIO’s FCOI Policy and require each to complete FCOI training prior to engaging in PHS-Funded Research.

E. Disclosure, Review, and Monitoring Requirements

POP BIO must establish a process requiring each Covered Individual to disclose SFIs related to their responsibilities, which must occur at specific times as specified.

F. Reporting Requirements

Before expenditure of funds under a PHS-funded project and following identification of an FCOI, POP BIO must report all Financial Conflicts of Interest to the PHS awarding component.

G. Maintenance of Records

POP BIO must maintain all FCOI-related records for at least 3 years from the date the final expenditure report is submitted to the PHS Organization.

H. Enforcement

POP BIO must ensure adequate enforcement mechanisms and provide corrective action to ensure compliance.

I. Third Party Requirements

Any individual or organization acting as a consultant or subcontractor to POP BIO on a PHS-funded award must either have an FCOI policy that meets the requirements or follow this policy.

J. Accessibility of Documentation

POP BIO must make the FCOI policy publicly accessible and establish a process to make information concerning identified FCOIs available to requesting PHS organizations.

Contact Information:

Jonathan Smyth
President, POP Biotechnologies, Inc.
1576 Sweet Home Road, Suite 221
Buffalo, NY 14228
Email: jrsmyth@popbiotech.com