Conflict of Interest in Research (COIR) means a Significant Financial Interest that could directly and significantly affect the design, conduct, or reporting of sponsored activity, as determined by the university. Note: COIR is also referred to as FCOI (Financial Conflict of Interest) and FCOIR (Financial Conflict of Interest in Research) interchangeably.
Declaration/Disclosure means an Investigator’s formal or explicit statement disclosing Significant Financial Interests (SFI) to the university.
Investigator means 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 sponsored activity. Investigator can include but is not limited to: professorial faculty, research associates, emeritus faculty, research collaborators, post-doctoral students, graduate students, visiting scientists, and individuals with courtesy appointments, external collaborators, or outside consultants, regardless of whether paid or unpaid. The term Investigator does not usually apply to, but does not preclude, departmental grant administrators or financial staff.
Institutional responsibilities means an Investigator's professional responsibilities on behalf of the Institution, and as defined by the Institution in its policy on financial conflicts of interest, which may include for example: activities such as research, research consultation, teaching, professional practice, institutional committee memberships, and service on panels such as Institutional Review Boards or Data and Safety Monitoring Boards.
Key Personnel means an the program director/principal investigator (PD/PI) and other individuals who contribute to the scientific development or execution of a project in a substantive, measurable way, whether or not they request salaries or compensation. Key Personnel is sometimes referred to as Senior Personnel.
Manage means taking action to address a financial conflict of interest, which can include reducing or eliminating the financial conflict of interest, to ensure, to the extent possible, that the design, conduct, and reporting of research will be free from bias.
A Management Plan is an agreement between a researcher and the university designed to create action steps to manage, reduce, or eliminate any actual or perceived conflicts of interest. Generally, Management Plans set up additional oversight mechanisms to help ensure that the researcher's private interests do not compete with their university responsibilities, and to promote objectivity in the design, conduct, or reporting of research.
Public Health Service (PHS) means the Public Health Service of the U.S. Department of Health and Human Services, and any components of the PHS to which the authority involved may be delegated, including the National Institutes of Health (NIH).
Research means a systematic investigation, study or experiment designed to develop or contribute to generalizable knowledge. 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). It includes any activity for which research funding is awarded through grant, award, fellowship, training, project, or research resources award.
Significant Financial Interest (SFI) means
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:
- 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 declaration and the value of any equity interest in the entity as of the date of declaration, 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 declaration, when aggregated, exceeds $5,000, or when the Investigator (or the Investigator’s spouse or dependent children) holds any equity interest (e.g., stock, stock option, or other ownership interest); or
- Intellectual property rights and interests (e.g., patents, copyrights), upon receipt of income related to such rights and interests.
- Any reimbursed or sponsored travel (i.e., that which is paid on behalf of and not reimbursed to the Investigator), that, when aggregated, exceeds $5,000 per individual entity and that is related to the Investigator’s institutional responsibilities, including the purpose of the trip, the identity of the sponsor/organizer, the destination, and the duration; but not including travel 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 affiliated with an Institution of higher education.
Significant Financial Interest does not include the following types of financial interests:
- Salary, royalties, or other remuneration paid by the university, including intellectual property rights assigned to the university and agreements to share in royalties related to such rights;
- Income from investment vehicles, such as mutual funds and retirement accounts, as long as the Investigator does not directly control the investment decisions made in these vehicles;
- Payment from 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 affiliated with an Institution of higher education for seminars, lectures, or teaching engagements; or service on advisory committees or review panels.
Subrecipient means any Investigator outside the university community receiving Research funds from the university through subaward, subcontract, or consortium agreement.