Financial Conflict of Interest Policy

Policy Statement

It is the policy of RTI to ensure that RTI 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 RTI, and financial activities that may appear to conflict with their responsibilities to RTI and our clients. RTI personnel should promptly disclose the circumstances of any situation that might be covered by this policy. For the purpose of this policy, "RTI personnel" is defined to include RTI Governors, officers, and employees. Failure to comply with this Policy and associated procedures may result in disciplinary action, up to and including termination of employment with RTI.

Procedure 1.4.8: 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. RTI’s Conflict of Interest Policy 1.4 and this procedure implement 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 Ethics Officer 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 RTI Privacy Officer a Statement of Financial Interest Disclosure Form prior to working on PHS-funded projects.
  • Must update the Statement of 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 RTI’s project manager/principal investigator, PHS-funded investigators must complete and submit to the RTI Privacy Officer Project Scope and Roster forms, describing the project scope and the names of all other investigators.

RTI Privacy Officer

  • Must record and review all Statement of Financial Interest Disclosure forms from PHS-funded researchers at RTI.
  • Must determine whether an RTI 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 Client 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 RTI’s determination that the SFI constitutes an FCOI
    • Description of RTI’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.

Vice President of Corporate Compliance

  • Ensures compliance with FCOI policy and procedures.
  • Maintains RTI’s FCOI Policy and Procedure on the RTI external website.
  • In cases where the Privacy Officer determines that a potential FCOI exists, develops and coordinates implementation of FCOI Management Plan in consultation with the RTI project manager. The FCOI Management Plan must be completed and provided to the Privacy Officer, in advance of RTI expending PHS funds – and a summary of the management plan must be included in the FCOI Client Report (see Exhibit A).
  • Coordinates the submission of annual reports related to the FCOI Management Plans through the Office of Contracts.

Office of Contracts

Certifies in all PHS research project proposals that RTI (1) has in effect at RTI an up-to-date, written, and enforced administrative process to identify and manage FCOIs with respect to all PHS research projects; (2) shall promote and enforce Investigator compliance with FCOI requirements, including those pertaining to disclosure of significant financial interest; (3) shall implement FCOI Management Plans; (4) agrees to make information available, promptly upon request, relating to any FCOI; and (5) shall fully comply with the FCOI requirements contained in the referenced regulations in the context of PHS research projects.

Proposal Development Office (PDO)

Remind RTI proposal leaders to ensure that RTI staff members expected to work as Investigators on a PHS research project complete and submit the significant financial interest disclosure form prior to proposal submission

Financial Administration Office (FAO)

Obtains assurances (where such assurances are not otherwise included in a Teaming Agreement) from Sub-recipients (if PHS research project proposal involves Sub-recipient Investigators) that such Sub-recipients: (1) have an FCOI policy that complies with the PHS requirements contained in the referenced regulations and will ensure the disclosure of Sub-recipient Investigator FCOIs to the RTI Privacy Officer, or (2) agree to comply with RTI’s FCOI policy and procedure and will ensure the disclosure of Sub-recipient Investigator SFIs to the RTI Privacy Officer.

Global Supply Chain (GSC)

Obtains certification from Sub-recipients (if PHS research project involves Sub-recipient Investigators) that such Sub-recipients: (1) have an FCOI policy that complies with the FCOI requirements contained in the referenced regulations and will ensure the disclosure of Sub-recipient Investigator significant financial interest to the RTI Privacy Officer, or (2) agree to comply with RTI’s FCOI policy and procedure and will ensure the disclosure of Sub-recipient Investigator significant financial interest to the RTI Privacy Officer.

Definitions

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

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

FCOI Client Report means the RTI disclosures (initial and annual) to the PHS client of a Financial Conflict of Interest (FCOI) with respect to a particular PHS research project. This report must be provided in advance of spending PHS funds.

FCOI Management Plan means the RTI 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 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 RTI Privacy Officer.

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 RTI project manager, including any persons who are Sub-recipients.

Project Scope and Roster Form means the form available through RTI systems used in conjunction with the SFI Disclosure Form to determine if an FCOI exists in the context of a particular PHS research project.

SFI Disclosure Form is the document used to identify and transmit SFIs to the RTI 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 RTI, (2) salary, royalties, or other payments from any source other than RTI 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 RTI as a subgrantee, subcontractor, collaborator, contractor, or consultant.