Note: The definitions appearing below are provided to assist readers in the interpretation of material presented on this website. Official definitions provided within university policies take precedence.
Covered Party: Covered parties are investigators on all research conducted under the auspices of the Johns Hopkins University (JHU), including research that is funded by or through the university, its divisions, centers or institutes, or conducted under the aegis of any JHU or JHM IRB.
Days Per Year: Outside activities are measured in workdays where one day is equal to 10 hours. JHU eDisclose recognizes numeric entries up to one decimal place. Estimates should include travel time.
Department Reviewer: A department director, division director, division chief, or administrator who can access disclosures submitted by individuals in their department or division.
Dependent Children: A son, daughter, stepchild, eligible foster child, or legally adopted child who is primarily dependent upon a parent or guardian for financial support. The child must be (a) under age 19 at the end of the year, (b) under age 24 at the end of the year and a full-time student, or (c) any age if permanently and totally disabled.
Disclosure: A summary of information regarding an individual's financial interests and/or outside activities with an entity other than JHU, JHHS, or their constituent entities that must be submitted through JHU eDisclose.
Disclosure Requirements: Disclosure requirements are specific to each division. Covered parties should consult the JHU Policy on Financial Interests and Conflict of Interest in Research and the divisional policies on Disclosure and Professional Commitment (or, if the division does not have a professional commitment policy, the JHU Policy on Disclosure and Professional Commitment).
Domestic Partner: A partner with whom an individual is committed as a family, in a long-term relationship of indefinite duration, and are socially, emotionally, and financially interdependent on each other in an exclusive mutual commitment in which they agree to be responsible for each other?s common welfare and share financial obligation.
Entity: A for-profit or not-for-profit organization or company, including private and governmental organizations.
Equity: Financial interests such as stock, stock options, warrants, and ownership interests in an entity. The requirement to disclose ownership of equity that relates to one's institutional responsibilities does not include income from investment vehicles, such as diversified mutual funds and retirement accounts, if the covered party does not directly control investment decisions made in these vehicles.
Fee: See Income.
Fiduciary/Founder Role: A legal and/or ethical obligation on the part of a covered party to act in the best interests (i.e., the financial and operational success) of another. Examples of fiduciary roles include membership on a board of directors and service as an officer, or manager, or medical director of a for-profit or non-profit company or organization.
Financial Interest: An interest in anything of monetary value, whether or not the value is readily ascertainable.
Gifts: Anything of value, whether a tangible item or a service, received from an entity (e.g., watches, briefcases, vacations, concert/theater tickets, golf club memberships, wine tastings).
Human Subject Research: Includes all research meeting the definition of "research" performed with "human subjects" as defined in the Federal Common Rule and the FDA (45 C.F.R. Part 46 and 21 CFR Part 56), regardless of the source of research funding or whether the research is otherwise subject to federal regulation.
Income: Includes, but is not limited to, monetary payment.
Institution: This includes JHU, JHHSC, and their divisions, centers, institutes and any other constituent parts.
Institutional Responsibilities: The responsibilities and roles covered parties are assigned in the course of their appointment or employment at JHU. This includes, for example, clinical practice, teaching, research, research consultation, professional practice, administrative roles, committee service, and service on panels such as IRBs.
Inventor: An individual who has conceived of an essential element or has contributed substantially to the conceptual development of Intellectual Property.Inventorship is a legal determination made by patent counsel for the University.
Investigator: Under JHU's conflict of interest policy, an investigator is: (1) The project director or principal investigator and any other person responsible for the design, conduct, or reporting of research. (Includes collaborators and consultants.) (2) All study team members on IRB applications. This definition is independent of whether one is appointed or employed by the Johns Hopkins University. The phrase "responsible for the design, conduct, or reporting of research" should be interpreted to mean any individual involved in the research who works independently enough to affect the objectivity of the design, collection, or analysis of research data or reporting of research results. In addition to faculty members, this may include graduate and post-doctoral trainees, research staff, consultants, or other collaborators. The ultimate determination as to who is considered an investigator in PHS-supported research is the decision of the PI of the project.
Key Personnel: Members of the research team who will be responsible for the design, conduct or reporting of the research or other activities of the proposed project. This can include the principal investigator, project director or any other personnel, considered to be essential to work performance and identified as key personnel in the research funding proposal.
Management Plan: The conditions under which an individual's financial conflict of interest is managed to ensure, to the extent possible, that the design, conduct and reporting of research will be free from bias. When there is a financial conflict of interest, participation in research is subject to compliance with management plan conditions.
Non-profit organization: Any organization that is not operating for the profit or gain of its individual members, whether these gains would have been direct or indirect, and therefore does not have individual stockholders.
Outside Activity: Involvement with non-JHU or JHHS entities and other activity conducted outside one's institutional responsibilities.
Private Agreement: A personal agreement or contract between an individual and an outside entity.
Project Summary: A detailed description of research (e.g., abstract, scope of work).
Public Health Service (PHS): An operating division of the U.S. Department of Health and Human services, and any components of PHS, including: Agency for Healthcare Research and Quality (AHRQ), Centers for Disease Control (CDC), Food and Drug Administration (FDA), Health Resources and Services Administration (HRSA), and all institutes and centers of the National Institutes of Health (NIH).
Purchasing (role): The ability an individual may have to direct or influence purchases made by the University or Health System or one of their constituent entities.
Remuneration: Payment or compensation received for services or employment. See also Equity, Income and Royalty.
Research: 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. This includes basic and applied research (e.g., a published article, book or book chapter) and product development (e.g., a diagnostic test or drug). Includes, but is not limited to, any such activity for which research funding is available from a PHS Awarding Component through a grant or cooperative agreement, for example a research grant, career development award, center grant, individual fellowship award, infrastructure award, institutional training grant, program project, or research resources award.
Retrospective Review: A process by which the institution reviews an investigator's research to determine if there was any bias in the design, conduct, or reporting of that research, pursuant to federal regulatory requirements. When a financial conflict of interest is not disclosed or reviewed in a timely manner, the institution must complete a retrospective review of the research.
Royalty: A payment for the rights to use intellectual property, especially patented or copyrighted works. Royalty usually, but not always, is a percentage of income from sales of the licensed technology.
Spouse: A marriage partner.
Travel Expenses: For the purpose of disclosure under university policies on disclosure and professional commitment and conflicts of interest, this includes amounts reimbursed to a covered party by an outside entity for transportation and hotel accommodations or the value of transportation and hotel accommodations purchased by an outside entity on behalf of the covered party. Travel disclosures must include the purpose of the trip, name of the sponsor/organizer, destination, and duration of each occurrence, as well as the amount of reimbursement, and must only be made when the aggregate value of any travel sponsored or reimbursed by the entity over the preceding 12 months reaches or exceeds $5,000.