University Policy 1.7
Research Related Conflicts of Interest and Commitment

Any instructional or research staff member listed in Article XVII, Section 1 of the Cornell University Bylaws (see Related Resources).

Oversight, decision-making, or staff support of activities impacting research or research compliance that includes, but is not limited to, selection of vendors, determining the allocation of funds, negotiation with sponsors for the research project, protocol review and approval, compliance of research activities with regulations and Cornell policies, and managing resulting intellectual property and licensing opportunities.

Any member of the Board of Trustees or the WCM Board of Fellows.

Measures taken to address the risk of bias or the appearance of bias when members of the university community have real or apparent conflicts.

Administrative staff under the CRCO that support the RCC. At the time of promulgation of this policy the CMO for Ithaca is the Office of Research Integrity and Assurance (ORIA) and for WCM is the Conflicts Management Office.

Written plan detailing the measures to mitigate actual or perceived conflicts of interest or commitment for conflict management.

A situation caused when an individual undertakes external commitments that may burden or interfere with their primary obligations and commitments to the university, even if the outside activity is valuable to the university or contributes to professional development.

An actual, apparent, or potential conflict of interest may arise when the interests, activities, or relationships of any Cornell individual to whom this Policy applies compete with or are perceived to compete with the interests, activities, or concerns of the university such that the individual’s actions or decisions on behalf of the university, or related to the individual’s employment responsibilities, are compromised, or appear to be compromised.

Research conducted with or enabled by the support of Cornell University resources beyond the usual computer and office resources available to all Cornell employees.

Any entity that is created to license Cornell-owned technology, is expected to or has licensed Cornell-owned technology or is founded predominately on the basis of Cornell-owned technology.

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.

To provide relevant information about an individual’s external commitments and interests to parties inside and outside the university to assure full awareness of potential conflicts and institutional efforts to address them.

A person who meets the university definition of domestic partner and whose partner has registered that relationship with the university in order to obtain benefits.

An obligation or activity (e.g., management, employment, advisory, or consulting role) that is not part of one’s primary commitments or obligations to the university.

An entity other than the university or one of its units.

An individual, and that individual’s spouse, domestic partner, parent, sibling, child, or any other blood relative, if that other blood relative resides in the same household.

Research 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.

Any employee, faculty, or governing board member of Cornell University.

An Institutional COI occurs when the financial interests of Cornell have the potential to unduly influence institutional decision-making or compromise the integrity of the underlying decision(s) or transaction(s).

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.

Anything of value, whether or not the value is monetary or readily ascertainable.

Information created by or under the auspices of Cornell University including Patents, Copyrights, and other proprietary data, materials, assets, and technologies.

Senior Leader responsible for research. Currently the Vice President for Research and Innovation is the IO for the Ithaca, NY; Geneva, NY; and Cornell Tech (Manhattan, NY) academic campuses, and the Provost for Medical Affairs is the IO for WCM campuses.

Individuals responsible for the design, purpose, 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, purpose, 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.

The pursuit of professional interests through research that is not supported by a sponsor. Non-Sponsored research includes, but is not limited to, research supported by an individual’s base salary, internal allocations, gifts, endowment income, fellowships, licensing income, and cost sharing.

To provide information to the university concerning one’s external commitments and interests. Compare with Disclose.

Information submitted on a report, and any pertinent information gathered in relation to a report required for a complete review of external commitments and interests.

A systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge. (As defined in 45 CFR 46.102).

Any work or activity related to the design, purpose, conduct, reporting and Administration of Research.

The faculty committee empowered to create procedures for identifying conflicts related to research, approving Conflict Management Plans, and declaring conflicts unmanageable. Currently the WCM RCC is the Conflicts Assessment Panel (CAP), and the Ithaca RCC is the Financial Conflicts of Interest Committee (FCOIC).

Any individual responsible for the design, purpose, conduct, or reporting of research, as well as any individual responsible for, or involved in, the Administration of Research.

An external commitment or interest that is likely to bias or appear to bias the outcome of research.

1. With regard to any publicly traded entity, a significant financial interest 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.
2. With regard to any non-publicly traded entity, a significant financial interest 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).
3. Related to intellectual property rights and interests (e.g., patents, copyrights), upon receipt of income related to such rights and interests.

The term “significant financial interest” (SFI), however, 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, 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 or reimbursed travel determined by the university not to constitute a significant financial interest.

Any of the following:

• President
• Provosts, Executive Vice Provosts, Vice Provosts, Deputy Provosts
• Executive Vice Presidents, Vice Presidents
• Deputy General Counsel and Secretary of the Medical College
• Deans
• Senior Associate Deans of the Medical College
• President and CEO, WCM Physicians Organization
• WCM Chief Medical Officer
• Chief of Staff and Special Counsel to the President
• Chief Investment Officer
• University Auditor
• Chief Compliance Officer
• WCM Chief Financial Officer

Note: IRS and other regulations may require inclusion of “five highest compensated,” “key employees,” “interested persons,” “disqualified persons,” etc.

An external entity that funds or supports research. Sponsors include federal, state, and local governments and private entities, both non- profit and for profit.

Research funded by a sponsor through a grant, contract, or agreement.

Undue influence occurs when an individual is able to persuade another's decisions due to the relationship between the two parties. Often, one of the parties is in a position of power over the other due to elevated status, higher education, or emotional ties. The more powerful individual uses this advantage to coerce the other individual into making decisions that might not be in their long-term best interest.

A college, research center, institute, program, business service center, office, or other operating entity of the university.

The dean, director or other leader of a unit and/or the campus Human Resource professional, who, individually or together shall be responsible for ensuring unit compliance with this policy, which may include supervising a Conflict Management Plan or drafting Conflict Management Plans for individuals who are not Research Personnel. In the event the chair, director or other leader is the subject of the concern at issue, that person’s immediate supervisor shall serve in their stead.