Academic Staff Member: Any instructional or research staff member listed in Article XVII, Section 1 of the Cornell University Bylaws (see Related Resources).
Conflict Management Measures taken to address the risk of bias or the appearance of bias, protect research subjects, and maintain public trust in the institution’s research and its personnel when research personnel may have a real or apparent financial conflict of interest (fCOI).
Conflict of Commitment When an employee of the university engages in an outside activity that burdens or interferes with their fulfillment of primary commitments and obligations to the university, even if the outside activity is valuable to the university or contributes to their professional development and competence.
Design, Conduct, or Reporting of Research Oversight, decision-making, or participation in research that includes creating the structure, roles, and/or protocol of a research project; participating in the execution of the research roles and protocol; participating in the publishing, presentation, or discussion of the research results.
Direct Administration of Research Oversight or decision-making impacting research that includes, selection of vendors, determining the allocation of funds, sponsor negotiations for the research project, protocol review and approval, or managing resulting intellectual property and licensing opportunities.
Disclose/Disclosure To provide relevant information about research personnel’s financial interests related to a research project to parties inside and outside the institution to assure full awareness of potential conflicts and institutional efforts to address them. Compare with Report.
Domestic Partner A person who meets the Cornell-Ithaca definition of domestic partner and whose partner has registered that relationship with the university in order to obtain benefits.
External Commitment An obligation or activity (e.g., management, employment, advisory, or consulting role) that is not related to primary commitments or obligations to the university.
External Entity An entity other than the university.
Financial Conflict of Interest – Real, Apparent A real fCOI arises when a financial interest, or other opportunity for personal financial gain, is likely to compromise or influence the objective design, conduct, reporting, or direct administration of research. An apparent fCOI arises when there is a reasonable apprehension, which reasonably well-informed persons are likely to have, that an individual’s opportunity for personal financial gain could compromise or influence the design, conduct, reporting, or direct administration of research.
Financial Interest Anything of monetary value, whether or not the value is readily ascertainable.
Human Participant Research A systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge, involving a living individual about whom an investigator (whether professional or student) conducting the research obtains (1) data through intervention or interaction with the individual, or (2) identifiable private information.
Institutional/Cornell Responsibilities Activities that contribute to, arise out of, or are impacted by research, teaching, service, outreach, publications, professional/clinical practice, other scholarly pursuits or Cornell administrative duties, such as service on panels or committees. This includes consulting, lectureships, service on external panels or committees, expert witness testimonies, book promotions, etc. that are related to or arise from an area of Cornell expertise and activities.
Key Personnel Individuals responsible for the design, conduct, or reporting of a research study.
For sponsored research: (1) principal investigators, co-investigators, and any other individual named in a sponsored project key personnel list; (2) anyone else who is independently responsible for the design, conduct and reporting of research, as determined by the principle investigator and any of the co-investigators on the research project; and (3) anyone who during the course of a sponsored project assumes a role synonymous with the roles above.
For non-sponsored research: Those whose role on the research project is synonymous with the roles described above.
For Institutional Review Board protocols: Principal investigators and co-investigators consistent with the procedures of each campus.
Management Plan See Conflict Management.
Non-Sponsored University Research The pursuit of professional interests through research that is supported by university funds including, but not limited to, internal allocations, gifts, endowment income, fellowships, licensing income, and cost sharing.
Public Health Service (PHS) Agencies Within the Department of Health and Human Services (DHHS), the following eight agencies are designated components of the U.S. Public Health Service (PHS):
- The Agency for Healthcare Research and Quality (AHRQ).
- The Agency for Toxic Substances and Disease Registry (ATSDR).
- The Centers for Disease Control and Prevention (CDC).
- The Food and Drug Administration (FDA).
- The Health Resources and Services Administration (HRSA).
- The Indian Health Service (IHS).
- The National Institutes of Health (NIH).
- The Substance Abuse and Mental Health Services Administration (SAMHSA).
Report [Ithaca] / Conflicts Survey [WCMC] To provide information to the university concerning one’s external commitments and financial interests. Compare with Disclose.
Report File Information submitted on a report, and any pertinent information gathered in relation to a report required for a complete review of external commitments and financial interests.
Research Research, for the purpose of this policy, includes all sponsored projects, including research and extension, and all non-sponsored university research.
Research Personnel Any individual independently responsible for the design, conduct, or reporting of research, including key personnel, as well as those independently responsible for the direct administration of research.
Research-Related An external commitment or financial interest that is likely to bias the outcome of research.
Significant Financial Interest (SFI) A financial interest consisting of one or more of an individual’s family’s interests that reasonably appears to be related to an individual’s Cornell responsibilities:
- With regard to any publicly traded entity, a significant financial interest (SFI) exists if the value of any remuneration received from the entity in the twelve months preceding the disclosure and the value of any equity interest in the entity as of the date of disclosure, 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, an SFI exists if the value of any remuneration received from the entity in the twelve months preceding the disclosure, when aggregated, exceeds $5,000, or when an individual or his or her family holds any equity interest (e.g., stock, stock option, or other ownership interest).
- Related to intellectual property rights and interests (e.g., patents, copyrights), upon receipt of income related to such rights and interests.
- As required by the federal regulations and only for research personnel on PHS funded awards or cooperative agreements issued on or after August 24, 2012, any travel that is reimbursed or paid on the individual’s behalf, related to the individual’s Cornell responsibilities, and determined by Cornell to constitute or contribute to an SFI. This excludes any travel that is reimbursed or sponsored by Cornell University, a federal, state, or local government agency; a U.S., non-profit institution of higher education as defined at 20 U.S.C. 1001(a), an academic teaching hospital, a medical center, or a research institute that is affiliated with an institution of higher education.
The term significant financial interest (SFI) does not include the following types of financial interests:
- Salaries, royalties, or other remuneration paid by Cornell to an individual, including intellectual property rights assigned to the institution 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 individual does not directly control the investment decisions made in these vehicles.
- Income from seminars, lectures, or teaching engagements sponsored by, or income from service on advisory committees or review panels for a federal, state, or local government agency, a non-profit U.S. institution of higher education as defined at 20 U.S.C. 1001(a), an academic teaching hospital, a medical center, or a research institute that is affiliated with an institution of higher education.
- Any paid for or reimbursed travel determined by the Cornell not to constitute an SFI.
Sponsor An external entity that funds or supports research. Sponsors include federal, state, and local governments and private entities, both nonprofit and for profit.
Sponsored Research Research funded by a sponsor through a grant, contract, or agreement.
Travel Disclosure PHS Regulations, effective August 24, 2012, requires the disclosure of all reimbursed or sponsored travel related to a PHS-funded Investigator’s Institutional Responsibilities within 30 days of completing travel.
Sponsored travel means (a) travel expenses paid to an Investigator or travel paid on an Investigator’s behalf, by a single entity in any twelvemonth period, and (b) travel reimbursed to or paid on behalf of an Investigator’s spouse, domestic partner, or dependent child by a single entity in any 12-month period ONLY if such travel reasonably appears to be related to the Investigator’s Cornell responsibilities. This disclosure requirement does not apply to travel that is reimbursed or sponsored by Cornell University, a federal, state, or local government agency, a U.S., non-profit institution of higher education as defined at 20 U.S.C. 1001(a), an academic teaching hospital, a medical center, or a research institute that is affiliated with an institution of higher education. The details of the disclosure will include at a minimum, the purpose of the trip, the identity of the sponsor/organizer, the destination, and the duration.
Unit A department, research center, institute, program, business service center, office, or other operating entity of the university.
Unit Head A chair, director, or administrative lead in an operating unit of the university.