Glossary of Terms
- Affiliated PHS Investigator
- Any person other than a Faculty or Staff member, who serves as project director or principal Investigator or who, regardless of title or position, is responsible for the design, conduct or reporting of research funded by the Public Health Service and conducted by the University. Affiliated PHS Investigator may include, for example, a collaborator or consultant.
- Financial Interest
- Anything of monetary value, whether or not the value is readily ascertainable, consisting of one or more of the following interests of a Faculty or Staff member or an Investigator (and those of the Faculty or Staff member’s or the Investigator’s spouse and dependent children) that reasonably appears to be related to the Investigator’s Tulane responsibilities, including any of the following received by an individual in any capacity or for any reason (note that for this purpose the term “individual” includes the individual and any member of the individual’s Immediate Family):
1) Any payment(s) received from or equity interest(s) held in a publicly traded entity during the 12-month period prior to the disclosure with a value that, in the aggregate, exceeds $5,000;
2) Any payment(s) received from a non-publicly traded entity during the 12-month period prior to the disclosure with a value that, in the aggregate, exceeds $5,000;
3) Any equity interest in a non-publicly traded entity;
4) Income of more than $5,000 (from any one entity) generated from intellectual property rights and interests, unless paid by Tulane to an individual employed or appointed by Tulane;
5) Reimbursed or sponsored travel with a value that exceeds $5,000, unless reimbursed or sponsored by Tulane or a federal, state or local government agency, an institution of higher education as defined in 20 U.S.C. § 1001(a), an academic teaching hospital, a medical center, or a research institute affiliated with an institution of higher education.
A Financial Interest must be disclosed by Faculty, Staff and Investigators if it is related to that individual’s professional responsibilities on behalf of Tulane. These responsibilities may include, for example, activities such as research and research consultation, teaching, professional practice, institutional committee memberships, and service on IRBs or safety monitoring boards.
Notwithstanding the foregoing, a Financial Interest does not include the following:1) Salary, royalties, or other remuneration paid by Tulane if you are, or your Immediate Family member is, currently employed or otherwise appointed by Tulane, including intellectual property rights assigned to Tulane and agreements to share in royalties related to such rights.
2) Income from investments in which day-to-day control of investments is held by a person not subject to this policy or any other Tulane conflict of interest policy.
3) Income from teaching engagements, seminars or lectures paid by a federal, state or local government agency, an institution of higher education, an academic teaching hospital, a medical center, or a research institute affiliated with an institution of higher education.
4) Income from service on advisory committees or review panels for a federal, state or local government agency, an institution of higher education, an academic teaching hospital, a medical center, or a research institute affiliated with an institution of higher education.
- Immediate Family
- Spouse or domestic partner, children (including adoptees) and other dependents.
Because of strict conflict of interest rules required by federal and state law, the definition of Immediate Family for a member of the Tulane University Medical Group and for other health care providers is: Spouse or domestic partner, children and other dependents, natural or adoptive parents, siblings, stepparent, stepchild, stepbrother or sister, father-in-law, mother-in-law, daughter-in-law, son-in-law, brother-in-law, sister-in-law, grandparent, grandchild, and spouse of grandparent or grandchild.A healthcare provider is a physician or other health care professional or Staff member who orders medical items, supplies (including for example pharmaceuticals) or services for patients or who refers patients to other health care providers or suppliers of medical items, supplies or services. A physician or other Staff member who performs no patient care services, directly or indirectly, and whose duties encompass no direct or indirect patient care is NOT covered by this definition of healthcare.
For purposes of evaluating Vendor relationships, Immediate Family also includes parents, siblings, parents-in-law, and siblings-in-law.
- Institutional Review Board (“IRB”)
- Any board, committee or other group formally designated by the University to review human subjects research, and which was established and which functions and operates in conformity with Part 46 of Title 45 and Part 56 of Title 21 of the Code of Federal Regulations. IRB Members are those persons who constitute the IRB.
- Any Faculty, Staff or affiliated person who serves as a project director or principal investigator or who, regardless of title or position, is responsible for the design, conduct or reporting of research. Investigator may include, for example, a collaborator, consultant, or contractor.
- Leadership Role
- 1) Employment in any executive or administrator capacity,
2) Consulting in any executive or administrator capacity,
3) Serving asa. a member of a board of trustees, directors, or administrators
b. an officer
c. a member of an advisory committee, advisory board, or subcommittee of a board of trustees, directors or administrators
Any such employment, consulting or service by your Immediate Family member constitutes a Leadership Role on your part.A Leadership Role may be compensated or non-compensated.
- Mitigation Report
- Report submitted to the entity funding the PHS-Funded Research after a Retrospective Review. The Mitigation Report will include: the key elements noted in the Retrospective Review, a description of the impact of the bias on the research and a description of the actions taken or planned to mitigate the effect of the bias.
- PHS Financial Conflict of Interest
- A set of circumstances in which a Financial Interest of a PHS Investigator could directly and significantly affect the design, conduct or reporting of PHS-Funded Research.A set of circumstances in which a Financial Interest of a PHS Investigator could directly and significantly affect the design, conduct or reporting of PHS-Funded Research.
- PHS Subrecipient
- An individual or legal entity that is a subrecipient, subcontractor, or consortium member under a PHS-Funded Research project.
- PHS-Funded Human Subjects Research
- Research involving human subjects that is funded by the Public Health Service or by an entity with Public Health Service-delegated authority, including the National Institutes of Health.
- PHS-Funded Research
- Research funded by the Public Health Service or by an entity with Public Health Service-delegated authority, including the National Institutes of Health.
- Primary Commitment/Employer
- The time, energy, fiduciary obligations, and loyalty that any Faculty or Staff member is required to dedicate to Tulane.
- Professional Interests
- Academic, research, personal, professional and/or institutional integrity, patient safety and welfare, or any other interest that may be added to this policy from time to time.
- Research Financial Interest
- 1) Any investments (whether in the form of debt, stock or other equity ownership, options or warrants to purchase stock or other securities or similar instruments) or interest in a Sponsor, research or health care-related organization;
2) Royalties on any patent or other intellectual property interests, unless paid by Tulane;
3) Income, salary or remuneration in cash or in kind, emoluments, benefits, gifts, honoraria, travel expenses, goods or services received from a Sponsor or research or health care-related organization.
A Research Financial Interest does not include holdings in mutual funds or other equity funds in which day-to-day control of investments is held by a person not subject to this policy or any other Tulane conflict of interest policy.
A Research Financial Interest has no dollar or ownership thresholds; therefore, any interest related to a Sponsor or to the research must be disclosed, however small.
- Research Oversight Official
- Faculty and Staff of any institutional office or body (for instance, all Institutional Review Board (IRB), Institutional Animal Care and Use Committee (IACUC), and Institutional Biosafety Committee (IBC) members) at Tulane who perform research oversight functions in which they exercise professional or administrative-level discretion. All Designated Officials in the Tulane University Policies on Conflicts of Commitment and Interest are also Research Oversight Officials.
An Investigator is not a Research Oversight Official simply because he or she is an investigator.
- Retrospective Review
- Review of PHS-Funded Research when non-compliance has been found. Documentation of a Retrospective Review will include: the number and title of the research project; the names of the project director or lead Investigator and the Investigator with the Conflict of Interest of a financial nature or PHS Financial Conflict of Interest; the name of the entity with which the Investigator has the Conflict of Interest or PHS Financial Conflict of Interest; the reason for the Retrospective Review; detailed methodology of how the Retrospective Review was conducted; and the findings and conclusions of the Retrospective Review.
- Secondary Commitment
- An activity that is not part of your Primary Commitment to Tulane (where Primary Commitment means the time, energy, fiduciary obligations, and loyalty you are required to dedicate to Tulane) and which imposes demands from outside entities, organizations, or projects for your time, energy, fiduciary obligations, or loyalty. Secondary Commitments may include but are not limited to employment, consulting, or other participation in outside businesses or organizations, as well as non-Tulane Leadership Roles and other such compensated or non-compensated activities.
Any such employment, consulting or service by your Immediate Family member may constitute a Secondary Commitment on your part.
Secondary Commitments do not include activities conducted entirely on personal time, which have no conflicting effect on one’s Primary Commitment and which do not reasonably create the appearance of such a conflict.
- The entity that is sponsoring or funding the research and the entity’s affiliates and subsidiaries, and any entity that monitors research, collects or arranges data for research or otherwise performs any services related to or supporting research, including without limitation assisting in applications or responses to the United States Department of Health and Human Services and/or the United States Food and Drug Administration.
- Subrecipient PHS Investigator
- Any person responsible for the design, conduct or reporting of research funded by the Public Health Service and conducted by the University through a PHS Subrecipient.
- Any individual, business, partnership, corporation or other entity that sells or conveys goods or services to Tulane, or that arranges for the purchase or sale of goods or services to, for or by Tulane.