FCOI Policy

HMRI Financial Conflict of Interest Policy

Policy Statement

 

It is the policy of Huntington Medical Research Institutes (HMRI) to ensure that HMRI personnel avoid situations in which personal interests may affect, or have the appearance of affecting, their professional judgment in exercising their duties or responsibilities, or in conducting or reporting research. This policy provides guidance to help personnel manage situations in their personal affairs, employment outside HMRI, and financial activities that may appear to conflict with their responsibilities to HMRI and our clients. HMRI personnel should promptly disclose the circumstances of any situation that might be covered by this policy. Failure to comply with this Policy and associated procedures may result in disciplinary action, up to and including termination of employment with HMRI.

 

Specific Public Health Service Requirements Regarding “Objectivity in Research”

 

Procedure Statement(s)

 

This procedure is designed to comply with Public Health Service (PHS) regulations (42 CFR Part 50 Subpart F, Financial Conflicts of Interest (FCOI) for Grants/Cooperative Agreements, 45 CFR Part 94, Responsible Prospective Contractors). These standards and procedures are intended to ensure that the design, conduct, or reporting of research funded under PHS grants, cooperative agreements, or contracts will be free from bias resulting from Investigator FCOIs. HMRI’s Financial Conflict of Interest Policy implements the requirements of these federal regulations.

 

Disclosure Requirements

 

By the time a proposal is submitted to PHS, all investigators/project directors requesting PHS funding—whether grant, cooperative agreement, or contract—are required to have submitted to the Business Manager a Significant Financial Interest (SFI) Disclosure Form. These completed forms either indicate that the investigator/project director has no Significant Financial Interests (SFIs) or includes a listing of known SFIs (and those of the spouse and dependent children) in entities whose financial interests would reasonably appear to be affected by the research for which PHS funding is sought. Financial disclosures must be updated by all investigators/project directors on an annual basis during the award period or as new reportable SFIs are obtained, whichever occurs first.

 

Responsibilities

 

PHS-Funded Investigators

 

  • Must complete FCOI training prior to engaging in a PHS research project and thereafter, every four years.
  • Must complete and submit to the HMRI Business Manager a Significant Financial Interest Disclosure Form prior to working on PHS-funded projects.
  • Must update the Significant Financial Interest Disclosure Form annually or within 30 days of a change in financial status (acquisition of new financial interest), whichever occurs first.
  • If serving as HMRI’s project manager/principal investigator, PHS-funded investigators must complete and submit to the HMRI Business Manager Project Scope, describing the project scope and the names of all co-investigators on the project.

 

HMRI Business Manager

 

  • Must record and review all Significant Financial Interest Disclosure forms from PHS-funded researchers at HMRI.
  • Must determine whether an HMRI researcher working on a PHS-funded research project has an FCOI.
  • Must provide required information concerning FCOIs to the expenditure of PHS funds, and must update such information at least annually and within 60 days of changes to Statement of Financial Interest Disclosure forms, whichever occurs first.
  • Must prepare the Public Financial Conflict of Interest Disclosure Form, including the following information, for reported FCOIs such that it can be made publicly available upon request:
    • Investigator’s name
    • Investigator’s title and role with respect to the research project
    • Name of the entity in which the relevant SFI is held
    • Nature of the relevant SFI (e.g., equity, consulting fees, travel reimbursement, honoraria, etc.)
    • Approximate dollar value of the relevant SFI (dollar ranges are permissible: $5,000-$9,999; $10,000-$19,999; etc.)
  • Must prepare FCOI subcontract reports including the following information:
    • Agreement number and title
    • Name of project manager
    • Name of Investigator with the FCOI
    • Name of the entity with which the Investigator has an FCOI
    • Nature of the SFI
    • Value of the SFI
    • Description of how the SFI relates to the PHS funded project and the basis for HMRI’s determination that the SFI constitutes an FCOI
    • Description of HMRI’s FCOI Management Plan, including role and principal duties of the Investigator with the FCOI; how the FCOI Management Plan is designed to safeguard objectivity in the PHS research project; confirmation that Investigator agrees with the FCOI Management Plan; and how the FCOI Management Plan will be monitored
  • Must maintain for three years records of all Statement of Financial Interest Disclosure form records and FCOI Management Plans.

 

Definitions

 

For the purposes of this procedure, the following definitions apply:

 

Agreement refers to HMRI’s contract, cooperative agreement, or grant for a Public Health Service (PHS) research project.

 

FCOI Management Plan means the HMRI actions addressing an FCOI, which can include reducing or eliminating the FCOI, to ensure that the design, conduct, and reporting of the PHS research project will be free from bias.

 

FCOI PHS Report means the HMRI disclosures (initial and annual) to the PHS of a Financial Conflict of Interest with regard to a particular PHS funded project. This report must be provided in advance of spending PHS funds.

 

FCOI Public Disclosure Form means the document used to make information related to FCOIs publicly available upon request. The completed form must be available for release in advance of spending PHS funds.

 

Financial Conflict of Interest (FCOI) means a Significant Financial Interest (SFI) that could directly and significantly affect the design, conduct, or reporting of the PHS-funded research as determined by the HMRI Business Manager.

 

Financial Interest means anything of monetary value, whether or not the value is readily ascertainable, including remuneration, salary, other payments for services (e.g., consulting fees, paid authorship or honoraria), equity interests (e.g., stocks, stock options, or other ownership interest), intellectual property rights (e.g., patents, copyrights, and royalties from such rights), and reimbursed or sponsored travel unless the sponsored travel is paid for by 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.

 

Investigator means the principal investigator, project manager, or other person, regardless of title or position, who is responsible for the design, conduct, or reporting of a PHS research project, as specified in the relevant Agreement or as additionally defined by the HMRI project manager, including any persons who are Sub-recipients.

 

SFI Disclosure Form is the document used to identify and transmit SFIs to the HMRI Privacy Officer.

 

Significant Financial Interest (SFI) is defined as one or more of Investigator Financial Interests (and those of the Investigator’s spouse and dependent children) that reasonably appears related to the Investigator’s institutional responsibilities, and where the value of such Investigator Financial Interest exceeds $5,000, existing at the date of SFI disclosure and going back 12 months. For avoidance of doubt, SFI does not include: (1) salary, royalties, or other remuneration from HMRI, (2) salary, royalties, or other payments from any source other than HMRI that, when aggregated for the Investigator and spouse and dependent children in the 12 months preceding disclosure, are not expected to exceed $5,000, (3) income from seminars, lectures, or teaching engagements, service on advisory committees or review panels 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, (4) an equity interest that, when aggregated for the Investigator/Project Director and spouse and dependent children, does not exceed $5,000 in value as determined through reference to public prices or other reasonable measures of fair market value, or (5) income from investment vehicles, such as mutual funds and retirement accounts, as long as the Investigator does not control such fund’s or account’s investment decisions.

 

Sub-recipient means any party that has entered into an Agreement with HMRI as a subgrantee, subcontractor, collaborator, contractor, or consultant.