Cash: Remuneration in the form of consulting fees, honoraria, milestone payments, educational grants, preceptorships, salary or wages (other than salary and wages), and cash equivalents, which include anything of fixed and/or publicly-traded value; excludes up-front and annual maintenance fees and royalties received from Baptist and travel.
Competitor: Any institution or organization that competes for business with Baptist.
Conflict of Commitment: An external activity that interferes in a substantial way with an individual's responsibilities to Baptist.
Conflict of Interest (COI): A financial interest or relationship that could directly and significantly influence (or be perceived to directly and significantly influence) patient care, the design, conduct and/or reporting of research or any other Institutional Responsibilities.
Conflict of Interest Committee (COIC): The body designated by the Institution to review and manage or eliminate Conflicts of Interest.
Family Members: Defined as financially dependent persons, including a spouse, dependent child, stepchild, domestic or civil partner, common law spouse or equivalent same-sex partner. Also included are persons owning joint financial interests with individuals covered by this policy (e.g., businesses, accounts or property) that could reasonably influence the individual's decisions or exercise of professional responsibilities at the Institution.
Federal Funding Source: A federal organizational unit, including but not limited to Public Health Service (PHS), that funds research.
Financial Conflict of Interest–Research (FCOI-R): When the Conflict of Interest Official(s) reasonably determines that a Significant Financial Interest could directly and significantly affect the design, conduct or reporting of the research.
Financial Interest: Anything of monetary value, whether or not the value is readily ascertainable.
Institutional Decision Maker: Includes the President, Executive Vice Presidents, Senior Vice Presidents, Vice Presidents, Administrators, Chief Executive Officers, Chief Financial Officers and any written designees.
Institutional Responsibilities: Any of the professional responsibilities of an individual subject to this policy on behalf of the Institution, including research, research consultation, teaching, professional practice or patient care, Institutional Committee membership, or service on an institutional panel such as an Institutional Review Board (IRB) or Data and Safety Monitoring Board (DSMB).
Institutional Review Board (IRB): The board that is formally designated by Baptist to review and approve the initiation of, and to conduct periodic reviews of, biomedical research involving Human Subjects. The primary purpose of such review is to assure the protection of the rights and welfare of Human Subjects.
Investigator (Covered Individual): An individual who, regardless of title or position, is responsible for the design, conduct, or reporting of research, including a principal investigator, a co-investigator, collaborator, consultant, or project director. Individuals considered "responsible" in this definition include any person who is independently accountable for data, in any form, addressing the objectives of the funded or proposed research, as identified by the principal investigator. This necessarily places responsibility on the accountable supervisory staff to identify who is an investigator and potential Conflicts of Interest in their research team as it relates to funded or proposed investigation.
IRB Approved Protocol: Human Subjects research that has been reviewed and approved by the IRB.
Manage: 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, or reporting of research will be free from bias.
Outside Employment: Work of a continuing nature for a third party, such as supervising, consulting or advisory services, or other regular continuing employment for which compensation, regular or occasional, is received; specific work, usually of limited duration, for which compensation is received.
Ownership Interest: An ownership interest in any corporation, partnership, or other legal entity, including stock, stock options, or other equity interest; excludes mutual funds and stock or stock options held in blind trusts (to the extent that the identity of the companies in the portfolio in the blind trust is unknown). Ownership interest also includes any License Equity to the extent the individual is entitled to share in the proceeds upon liquidation of the License Equity.
Principal Investigator: The individual(s) who is the responsible leader of an investigative team and responsible for the design, conduct, or reporting of a research project or program.
Research: A systematic investigation, study, or experiment designed to develop or contribute to generalizable knowledge including Human Subjects Protocols and all laboratory research disciplines, as well as behavioral and social-sciences research. The term encompasses basic and applied research and product development. As used in this policy, the term includes any such activity for which research funding is available from any source, including any Public Health Service (PHS) awarding component through a grant or cooperative agreement.
Research Team: Co-Investigators, Trainees, staff members, classified employees involved with research, and internal collaborators.
Scholarly Work: Work created by an Institution's Personnel or Trainee within his/her scope of employment and in his/her area of expertise or area in which he/she teaches. This definition especially applies to creative work that is peer reviewed and publicly disseminated. Specifically excluded from this definition is consulting work for for-profit companies, including subscription-based content providers. Paid authorship must be disclosed.
Significant Financial Interest (Research): A Financial Interest that reasonably appears to be related to the individual's Institutional Responsibilities, as defined by 42 CFR Part 50, Subpart F. This definition includes the Financial Interests of the individual's spouse or dependent children, or other financially dependent persons (Family Members). Includes any of the following interests that reasonably appear to be related to an individual's responsibilities and meets $5,000 or above threshold: (a) Equity interests (such as stock, stock options, or other ownership interests); (b) Income (such as licensing fees or royalties) from intellectual property rights (such as patents or copyrights); (c) Payments or other remuneration (such as salary, consulting fees, honoraria, paid authorship or travel reimbursement) from commercial research sponsors or private organizations; (d) Fiduciary Relationships with commercial research sponsors or private organizations; (e) Gifts, endowments, sponsored travel, or other in-kind contributions from commercial research sponsors or private organizations.
Supervisor: Any person who is the primary formal evaluator of another person.
Supporting Entity: An entity that (a) sponsors an IRB Approved Protocol or other research study; or (b) provides funding for a research study either directly or through a subcontract or grant; or (c) provides a study drug, device, or other materials for use in an IRB Approved Protocol; or (d) has licensed technology and/or patents that cover the study drug, device, or other material, or its uses that are covered in an IRB Approved Protocol for which the Principal Investigator may receive a portion of license consideration. This definition does not include non-profit or philanthropic groups unless the COIC and/or the IRB determine otherwise.
Trainee: Graduate or other student, postdoctoral fellow, or clinical fellow.