Acronyms & Definitions

Acronyms

COI Conflict of Interest
FCOI Financial Conflict of Interest
FDF Financial Disclosure Form
HHS Department of Health and Human Services
IR Institutional Responsibilities
IP Intellectual Property
NIH National Institutes of Health
PD Project Director
PHS Public Health Service
PI Principal Investigator
SFI Significant Financial Interest
OVPR Office of the Vice President of Research

Definitions 

Financial Conflict of Interest (FCOI)

An Investigator’s significant financial interest, as determined by the Dean/dean’s designee in conference with the Provost’s Office, could directly and significantly affect the design, conduct, or reporting of PHS-funded research.

Institutional Responsibilities 

An Investigator’s professional responsibilities on behalf of the University, which may include for example: activities such as research, research consultation, teaching, professional practice, University committee memberships, and service on panels such as Institutional Review Boards or data and safety monitoring boards.

Investigator

The project director or principal Investigator and any other person, regardless of title or position, who is responsible for the design, conduct or reporting of research funded by PHS, or proposed for funding by PHS, which may include, for example, consultants or collaborators.

Postdocs and graduate students may also be considered an “investigator” if they meet the definition as outlined above.

Management plan

Specifies the actions that have been or will be taken to manage, reduce or eliminate the financial conflict of interest. Management plans must be approved by the dean (or designee) and the Vice Provost for Faculty Affairs.

PHS Awarding Component

The organizational unit within PHS that funds the research that is subject to the NIH regulation and GW policy.

Research

Means a systematic investigation, study, or experiment designed to develop or contribute to generalizable knowledge relating broadly to public health, including behavioral and social-sciences research. The term encompasses basic and applied research (e.g., a published article, book or book chapter) and product development (e.g., a diagnostic test or drug). The term includes any such activity for which research funding is available from a PHS Awarding Component through a grant, cooperative agreement, or contract, whether authorized under the PHS Act or other statutory authority, such as a research grant, career development award, center grant, individual fellowship award, infrastructure award, institutional training grant, program project, or research resources award.

Significant Financial Interest

In addition to the interests described in Section III. A of the Policy, a financial interest consisting of one or more of the following interests of the Investigator (and those of the Investigator’s spouse/domestic partner and dependent children) that reasonably appears to be related to the Investigator’s Institutional Responsibilities: 

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); equity interest includes any stock, stock option, or other ownership interest, as determined through reference to public prices or other reasonable measures of fair market value;

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 spouse/domestic partner or dependent children) holds any equity interest (e.g., stock, stock option, or other ownership interest);

Intellectual property rights and interests (e.g., patents, copyrights), upon receipt of income related to such rights and interests; or

The occurrence of any reimbursed or sponsored travel.

Investigators, including sub-recipient Investigators, must disclose all financial interests received from a foreign institution of higher education or the government of another country (which includes local, provincial, or equivalent governments of another country.

Sponsored Travel

Refers to travel that is paid on behalf of the Investigator and not reimbursed to the Investigator (so that the exact monetary amount may not be readily determined). The disclosure of reimbursed or sponsored travel must include, at a minimum, the purpose of the trip, the identity of the sponsor/organization, the destination, and the duration. 

Financial disclosure form

 The form that must be completed by Investigators who plan to participate in research funded by the Public Health Service (“PHS”) or proposed for such funding. This form is in addition to the annual disclosure form, and asks you to provide information regarding outside Significant Financial interests. Investigators are asked to disclose any Significant Financial Interests that reasonably appear to be related to their Institutional Responsibilities at GW.