Any corporation, partnership, sole proprietorship, firm, franchise, association, organization, holding company, joint stock company, receivership, business or real estate trust, or any other legal entity organized for profit or charitable purposes.

Any experiment in which a drug is administered or dispensed to, or used, involving one or more human subjects. An experiment here is any use of a drug, except for the use of a marketed drug in the course of medical practice.

Any experiment that involves a test article and one or more human subjects, and that either is subject to requirements for prior submission to the Food and Drug Administration under section 505(i) or 520(g) of the act, or is not subject to requirements for prior submission to the Food and Drug Administration under these sections of the act, but the results of which are intended to be submitted later to, or held for inspection by, the Food and Drug Administration as part of an application for a research or marketing permit. The term does not include experiments that are subject to the provisions of part 58 of the chapter, regarding non-clinical laboratory studies.

Any domestic or foreign, public or private, organization (excluding a Federal agency) from which an Investigator (and spouse and dependent children) receives remuneration or in which any person has an ownership or equity interest.

A situation in which significant financial interests in a business, or other personal considerations provided by a business, may compromise, or have the appearance of compromising, an Investigator’s professional judgment in conducting or reporting research, the results of which could affect the aforementioned business, either directly or indirectly. An FCOI exists when the University, through its designated official(s), reasonably determines that an Investigator’s Significant Financial Interest is related to a research project and could directly and significantly affect the design, conduct or reporting of the research.

A living individual about whom an Investigator conducting research obtains data through intervention or interaction with the individual, or identifiable private information.

An individual who is, or becomes, a participant in research, either as a recipient of the test article or as a control. A subject may be either a healthy human or a patient.

The Investigator’s spouse/domestic partner and dependent children.

Any domestic or foreign, public or private, entity or organization (excluding a Federal Agency) that is applying for or that receives NIH research funding.

An Investigator’s professional responsibilities on behalf of the University, which include research, teaching, and service as, e.g., outlined in the Policy on Faculty Professional Responsibilities

A product of the intellect that has commercial value, including copyrighted works, patents, business methods, and industrial processes.

The principal investigator and any other person (regardless of title or position) who is responsible for the design, conduct or reporting of research or educational activities. This may include faculty and research staff (research associates and assistants, postdoctoral fellows, graduate students, visiting scientists engaged in research conducted at the University) as well as consultants.

This is the first step for institutions in determining whether a financial conflict of interest exists. A significant financial interest is related to the research if an institution, through its designated official(s), reasonably determines that the significant financial interest could be affected by the funded research, or is in an entity whose financial interest could be affected by the research.

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.

A systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. Activities which meet this definition constitute research for purposes of this Policy, whether or not they are conducted or supported under a program which is considered research for other purposes.

An individual company, or any entity which takes responsibility for the initiation, management, and/or financing of a research project, but which does not actually conduct the investigation.