FCOI Policy

Financial Conflict of Interest (FCOI) Policy for PHS-Funded Research

Introduction

This policy implements regulations under 42 CFR Part 50 Subpart F, promoting objectivity in research funded under Public Health Services (“PHS”) grants or cooperative agreements. These regulations establish standards to provide a reasonable expectation that the design, conduct, and reporting of research funded under PHS grants or cooperative agreements will be free from bias resulting from Investigatory financial conflicts of interest.

Background

A potential conflict of interest arises when an individual’s personal interests may compromise, or appear to compromise, the individual’s professional obligations, including those obligations related to any externally funded research or activities. This policy addresses financial conflicts of interest that may compromise scientific impartiality in research funded by PHS (including NIH). The purpose of this policy is to provide information regarding the situations that generate conflicts of interests in the context of PHS-funded research, to provide mechanisms to manage those conflicts of interest, and to describe certain prohibited situations.

Scope

This policy applies to Investigators (as that term is defined, below) involved in, or planning to be involved in, PHS-funded research.

Definitions

• Financial Interest: Anything of monetary value, whether or not the value is readily ascertainable.
• Significant Financial Interest (SFI):
  1. 1. A Financial Interest consisting of one or more of the following interests of the Investigator (and those of the Investigator’s spouse and dependent children) that reasonably appears to be related to the Investigator’s institutional responsibilities:
        1. With regard to a publicly traded company, the aggregation of any remuneration received in the prior 12 months from the publicly traded company and the value of any equity interest in the publicly traded entity exceeds $5,000.00;
        2. With regard to a non-publicly traded company, any remuneration received in the prior 12 months from the non-publicly traded company that exceeds $5,000.00 or any equity interest in the non-publicly traded company; or
        3. Intellectual property rights and interests, upon receipt of income related to such rights and interests.
     2. Reimbursed or sponsored travel related to an Investigator’s institutional responsibilities, unless the travel 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. Exclusions from SFI: Remuneration from Syntis Bio; remuneration from U.S. federal/state/local government agencies, U.S. Institutions of higher education, academic teaching hospitals; and remuneration from investment vehicles (such as mutual funds and retirement accounts) that are not controlled by the Investigator.
• Financial Conflict of Interest (FCOI): An SFI that could directly and significantly affect the design, conduct, or reporting of PHS-funded research.
• Investigator: Any person, regardless of title or position, who is responsible for the design, conduct, or reporting of PHS-funded research, or proposed for such finding, including collaborators and consultants.
• Institutional Responsibilities: An Investigator’s professional responsibilities on behalf of Syntis Bio, including, but not limited to, research and research consultation.

Investigator Responsibilities

Investigators must:

• Disclose all related SFIs prior to applying for PHS-funded research
• Update disclosures annually and within 30 days of acquiring a new SFI
• Complete NIH-compliant FCOI training before initiating NIH-funded research and every four years thereafter
• Submit disclosures to an official designated by Syntis Bio (“Designated Official”)

Disclosure and Review

Investigators must disclose SFIs to the official designated by Syntis Bio. This Designated Official will determine whether an SFI is related to PHS-funded research and constitutes an FCOI. An Investigator’s SFI is related to PHS-funded research when Syntis Bio reasonably determines that the SFI could be affected by the PHS-funded research or is in an entity whose financial interest could be affected by the research. No NIH funds may be expended until disclosures are reviewed and, if needed, a management plan is implemented.

With regard to disclosures related to reimbursed or sponsored travel, the Investigator must disclose, at a minimum, the purpose of the trip, the identity of the sponsor/organizer, the destination, and the duration.  The Designated Official may determine that additional information is needed, including but not limited to, a determination or disclosure of the monetary value, in order to determine whether the travel constitutes an FCOI with the PHS-funded research.

FCOI Management

If an FCOI is identified, Syntis Bio will establish a written management plan that shall specify the actions that have been, and shall be, taken to manage such FCOI. Management strategies may include, but are not limited to:

• Public disclosure (e.g., publications, presentations, informed consent documents)
• Monitoring by independent reviewers
• Modification of the research plan
• Change in personnel roles or responsibilities
• Divestiture of financial interest

Reporting to NIH

Initial FCOI reports must be submitted via eRA Commons before expenditure of funds. Additional FCOI reports must also be submitted:

• Within 60 days of identifying a new FCOI (either from an existing or new Investigator) during an active award.
• Annually, updating the status of any previously reported FCOI.
• Following retrospective review and mitigation if bias is found.

An FCOI report 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 Syntis Bio’s management plan. This information shall include, but is not necessarily limited to:

• Project number;
• PD/PI or Contact PD/PI if a multiple PD/PI model is used;
• Name of the Investigator with the financial conflict of interest;
• Name of the entity with which the Investigator has a financial conflict of interest;
• Nature of the financial interest (e.g., equity, consulting fee, travel reimbursement, honorarium);
• Value of the financial interest (dollar ranges are permissible: $0-$4,999; $5,000-$9,999; $10,000-$19,999; amounts between $20,000-$100,000 by increments of $20,000; amounts above $100,000 by increments of $50,000), 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;
• 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
• A description of the key elements of Syntis Bio’s management plan, including
  • Role and principal duties of the conflicted Investigator in the research project;
  • Conditions of the management plan;
  • How the management plan is designed to safeguard objectivity in the research project;
  • Confirmation of the Investigator’s agreement to the management plan;
  • How the management plan will be monitored to ensure Investigator compliance; and
  • Other information as needed.

Training Requirements

All Investigators must complete NIH’s FCOI training before participating in NIH-funded research. Refresher training is required every four years, or sooner if policy changes or noncompliance occurs. The required training module is available at:

https://grants.nih.gov/grants/policy/coi/tutorial2018/story_html5.html

Public Access and Disclosures

Information on FCOIs held by senior/key personnel will be made publicly available upon request in accordance with 42 CFR 50.605(a)(5). Upon request, the following information will be provided in writing within five business days for any FCOI held by senior/key personnel:

• Investigator’s name, title, and role on the NIH-funded project
• Entity in which the SFI is held
• Nature of the SFI
• Approximate value (range), or statement that the value cannot be readily determined

This information will remain available for at least three years from the most recent update.

For clinical research, any FCOI must also be disclosed in public presentations and publications. Investigators must amend prior disclosures or publications as necessary. Disclosure may also occur in informed consent documents, study protocols, or other materials, as required by NIH or the IRB.

Noncompliance

If an FCOI is not disclosed or managed in a timely manner, Syntis Bio will conduct a retrospective review. If bias is found, the mitigation report will document the project, affected individual and entity, review process (including a detailed methodology), findings, conclusions and corrective actions submitted to NIH. Investigators may be subject to disciplinary action, including suspension from NIH-funded activities.

Subrecipients

Subrecipients must either follow their own NIH-compliant FCOI policy or agree in writing to abide by Syntis Bio’s policy. All subrecipient FCOIs must be reported to Syntis Bio in time for required NIH reporting.

Record Retention

Syntis Bio will maintain all FCOI-related records for at least three years from the date of the final expenditure report, or longer if required by law or contract.

Contact

All questions or disclosures should be directed to the Designated Official. Compliance with this policy is mandatory.