Means a dean, assistant or associate dean, assistant or associate vice-chancellor, department chair, administrative director, department head or any individual who has supervisory authority at the division or department level for faculty and/or staff.
Means any corporation, partnership, sole proprietorship, firm, franchise, association, organization, holding company, joint stock company, receivership, business or real estate trust, or any other legal entity organized for profit or charitable purposes. Business excludes UC Denver-related entities.
Means those facts that convince the institution’s Conflict of Interest Committee that a financially interested individual should be permitted to conduct human subject research involving greater than minimal risk. When considering a request by a financially interested individual to conduct research, the circumstances that the COI Committee should evaluate include the nature of the research, the extent to which the interest could be directly and substantially affected by the research, and the degree of risk to the institution or to a human subject involved that is inherent in the research protocol. The Committee should also consider the extent to which the interest is amenable to effective oversight and management.
Means income or monetary value given in return for services, including but not limited to wages, salaries, commissions paid salesmen, compensation for services on the basis of a percentage of profits, commissions on insurance premiums, tips, bonuses (including Christmas bonuses), termination or severance pay, rewards, jury fees, marriage fees and other contributions received by a clergyman for services, pay for persons in the military or naval forces of the United States, retirement pay of employees, pensions and retirement allowances are income to the recipients unless excluded by law.
Conducts research means, with respect to a research protocol, designing research, conducting research , analyzing research data or serving as the principal investigator, enrolling research subjects, Professional Research Associates (PRA) and/or other research positions who’s responsibilities include, obtaining subject’s informed consent or making decisions related to eligibility to participate in research, analyzing and/or reporting research data, or submitting manuscripts concerning the research for publication.
Means information contained in documents so designated and medical, educational, personnel, or security records of individuals; anticipated material requirements or price action knowledge of possible new sites for University-sponsored operations; or knowledge of forthcoming program selections of contractors or subcontractors in advance of official announcements, or any other information that is private or sensitive in nature.
Means situations in which outside relationships or activities (such as professional consulting for a fee) adversely affect, or have the appearance of adversely affecting, an employee’s commitment to his/her University duties or responsibilities. Such activities are encouraged insofar as they are conducted in accordance with University policy (including the one-sixth rule), promote professional development of faculty and student employees and enrich their contributions to the institution, to their profession and to the community. Consulting relationships, for example, may serve to create conduits for the exchange of information and technologies that enhance the University environment and permit faculty to test the soundness of their ideas. Regent action 6/12/48. Separate policies apply to faculty in the School of Medicine, who are subject to separate guidelines and required to direct all outside professional activities through University Physicians Incorporated (UPI).
Means situations in which financial or other personal considerations may adversely affect, or have the appearance of adversely affecting, an employee’s professional judgment in exercising any University duty or responsibility in administration, management, instruction, research and other professional activities. The bias such conflicts could conceivably impart may inappropriately affect the goals of research, instructional, or administrative programs. The education of students, the methods of analysis and interpretation of research data, the hiring of staff, procurement of materials, and other administrative tasks at the University must be free of the undue influence of outside interests.
The mere appearance of a conflict may be as serious and potentially damaging as an actual distortion of instructional, research, or administrative goals, processes, or outcomes. Reports of conflicts based on appearances can undermine public trust in ways that may not be adequately restored even when the mitigating facts of a situation are brought to light. Apparent conflicts, therefore, should be disclosed and evaluated with the same vigor as actual conflicts.
Means a relationship with an individual or a Business or with an agent or other representative of such individual or Business, service on advisory boards, and any other relationship whereby the Member receives or has the right or expectation to receive, remuneration from such individual or Business in exchange for services. Examples of service include service on a Business' board of directors; professional services rendered for a Business, industry, private individuals, government, other academic institutions, or foundations; and, in limited circumstances, services for a colleague holding a Sponsored Research contract or grant at the same institution
Individuals who are responsible for the design, conduct and reporting of basic or clinical research, this includes Professional Research Associates (PRAs) and/or other research positions who’s responsibilities include, obtaining subject’s informed consent or making decisions related to eligibility to participate in research, analyzing and/or reporting research data, or submitting manuscripts concerning the research for publication.
- Research Committee Members (i.e. IRB members, DSMB Members and/or other research review committees).
- Staff who negotiate or execute research agreements on behalf of UC Denver, (Grants and Contracts).
Means a release of relevant information about significant financial interests to parties outside the institution’s COI review and management processes (e.g., to research subjects or journal editors).
Means a faculty members or UC Denver employees, spouse/domestic partner, and/or dependent children.
Means a financial interest in the sponsor, product or service being tested, or competitor of the sponsor or product or service being tested.
Means a commercial entity or professional organization with financial interests that would reasonably appear to be affected by the conduct or outcome of the research. This term includes companies that compete with the sponsor of the research or the manufacturer of the investigational product, if the covered individual actually knows that the financial interests of such a company would reasonably appear to be affected by the research. The term also includes any entity acting as the agent of a financially interested company (e.g., contract research organization, or CRO).
Means a covered individual who holds a significant financial interest that would reasonably appear to be affected by the individual’s research or other activity.
Means an entity that provides investment services to the public, including brokerage firms and hedge funds. Consulting for Financial Investment Firms or the investing public can involve inadvertent violation of insider trading laws or obligations of tax-exempt organizations. Faculty members are prohibited from serving as Consultants for financial investment firms or the investing public – regardless of the amount of compensation – without both prior approval by the COI Committee and a contract review by the University General Counsel. (Private equity or venture capitol firms that evaluate new technologies for their own benefit are not considered Financial Investment Firms. Consulting for them involves the institutional pre-approval process that is required when consulting for entities other than Financial Investment Firms).
Means honoraria include one-time payment for presentations, lectures, articles, visiting professorships, article reviews, editing services, expert witness testimony by accomplished faculty who have achieved a level of expertise sought by others outside the University. If there is a contract or other formal agreement, or if there is an established reward, those payments are not considered honoraria.
Honoraria are generally modest amounts of money which are provided in exchange for presentations by accomplished faculty who have achieved a level of expertise sought by others outside the University. Honoraria include one-time payment for lectures.
Exempt Honoraria need not be assigned to the Faculty Practice Plan. Exempt Honoraria include one-time payment for lectures, articles, visiting professorships, NIH study sections, and service on boards for non-profit corporations.
Token payment for a one-time activity. Includes but not limited to speakers' bureaus, CE (Continuing Education) and other presentations, article reviews, editing services, expert witness testimony. If there is a contract or other formal agreement, or if there is an established reward, those payments are not considered honoraria.
Means all research meeting the definition of “research” performed with “human subjects” as these terms are defined in the federal Common Rule (45 C.F.R. part 46 and 21 C.F.R. Part 56), regardless of the source of research funding or whether the research is otherwise subject to federal regulation. In the event that the Common Rule definitions of “human subject” or “research” are modified through rulemaking, any such revisions shall apply for the purpose of this guidance.
Means securities law broadly prohibits fraudulent activities of any kind in connection with the offer, purchase, or sale of securities. These provisions are the basis for many types of government enforcement activities, including actions against illegal insider trading. Insider trading is illegal when a person trades a security while in possession of material nonpublic information, including information from clinical research trials, in violation of a duty to withhold the information or refrain from trading in the security. “Tipping” other traders of such non public information who then trade a security affected by the tip is also illegal, as is acting on an illegal tip.
Means The Institutional Review Board (IRB) is the group charged with and responsible for the Protection of Human Subjects or any other committee or group that is charged with responsibility for compliance with federal regulations for the protection of human subjects in research and/or reviews all research proposals and related activities involving human subjects in order to protect their rights and welfare.
Means any discovery for which legal protection is sought. For example, a patent, copyright, know-how, mask work, tangible research property, trademark, trade secret, and other forms of intellectual property legally recognized now or in the future. Please see Administrative Policy Statement for Intellectual Property Policy on Discoveries and Patents for Their Protection and Commercialization at https://www.cu.edu/policies/Academic/IP-Discoveries.pdf
Means basic research, animal research, or other research that is not Human Subjects Research.
Means outside Income includes consulting; speaking or other fees; honoraria; gifts; licensing revenues (royalty income); equity interests (including stocks, stock options, warrants, partnership and other equitable ownership interests).
Means to be part of the described activity in any capacity, including but not limited to, designing or directing research, serving as the principal investigator, research collaborator, expert witness, or provider of direct patient care. The term is not intended to apply to individuals who provide primarily technical support or who are purely advisory, with no direct access to the data (e.g. control over its collection or analysis), or in the case of research, to the trial participants, unless they are in a position to influence the study’s results or have privileged information as to the outcome.
Means the provision of information about significant financial interests by a covered individual to responsible institutional officials and to the institutional COI Committee, or the transmission of such information within the institutional channels (e.g., from the COI Committee to COMIRB).
Means the circumstances that a reasonable prudent layperson would expect a covered individual to maintain given the need to accomplish a specific task related to UC Denver activities but having significant financial interest. Reasonable circumstances might include the extent of the conflict to the institution and the potential effect of the conflict upon the research or activity itself, the institution, and the sponsor or external party.
Means payments to the University to the Staff member or Employee, that are directly related to reasonable costs incurred in the conduct of research as specified in the research agreement(s) between the sponsor and University are not considered Significant Financial Interests.
Means royalty income (or the written contractual right to receive future royalties) directly or indirectly under a patent, license or copyright, where research is directly related to the licensed technology or work.
Means a scientific advisory board, data safety monitoring board, steering committee for a clinical trial, executive committee for a clinical trial, or other committee of a pharmaceutical or biotechnology company. Service on an Advisory Committee is not “fiduciary service.”
- Salary or payment for services, Consulting fees, honoraria (including honoraria from a third party, if the original source is a financially interested company), gifts, or other emoluments, or “in kind” compensation from a financially interested company (or entitlement to the same), whether for consulting, lecturing, travel, service on an advisory board, or for any other purpose not directly related to the reasonable costs of conducting research or activity (as specified in the research agreement) that in the aggregate have in the prior calendar year exceeded the de minimus amount of a value equal to or greater than $5,000, or are expected to exceed that amount in the next twelve months.
- Equity interests, including stock options, of any amount (or entitlement to the same) in a non-publicly-traded (privately held) financially interested company.
- Equity interests, including stock options (or entitlement to the same) in a publicly traded financially interested company of either a value equal to or greater than $5,000 or 5% equity ownership which ever is less.
- Royalty income or the right to receive future royalties under a patent license or copyright, where the research is directly related to the licensed technology or work.
- Compensation from a financially interested company (or entitlement to interests (e.g. stocks, stock options, or other ownership interests); and intellectual property rights (e.g. patents, copyrights, and royalties from such rights) that in the aggregate have in the prior calendar year exceeded the de minimus amount of a value equal to or greater than $5,000, or are expected to exceed that amount in the next twelve months.
- Membership on a Board of Director’s.
- Proprietary interest related to the research of any value.
- No arrangement has been entered into where the amount of compensation or the value of the ownership interests will be affected by the outcome of the research.
- Salary, royalties, or other remuneration from UC Denver or its affiliates (Veteran’s Administration, Children’s Hospital Colorado, University of Colorado Hospital, National Jewish Hospital or Denver Health and Hospital Authority).
- Interests held in a diversified, independently managed mutual fund.
- Income from seminars, lectures or teaching engagements sponsored by a Federal, State or local government agency, or a research institute affiliated with an Institution of higher education.
- Income from service on an advisory committee or review panel sponsored by a Federal, State or local government agency, or a research institute affiliated with an Institution of higher education.
Means research, training, and instructional projects; or involving funds, materials, or other compensation from outside sources under agreements that contain any of the following:
- The agreement binds UC Denver to a line of scholarly or scientific inquiry specified in a substantial level of detail. Such specificity may be indicated by a plan, by the stipulation of requirements for orderly testing or validation of particular approaches or by the designation of performance targets.
A line item budget or modular budget is involved. A line-item budget details the expenses by activity, function, or project period. The designation or overhead (direct and indirect costs) qualifies a budget as “line item.”
Financial and/or programmatic reports are required.
The award is subject to audit.
The agreement provides for the disposition of either tangible (for example, new equipment, records, technical reports, theses, or dissertations) or intangible (for example, rights in data, copyrights, or inventions) properties which may resume the activity.
Means a security that represents part ownership, or equity, in a corporation. Each share of stock is a proportional stake in the corporation's assets and profits, some of which could be paid out as dividends.
Means the right to purchase stock in the future at a price set at the time the option is granted (by sale or as compensation by the corporation). To actually obtain the shares of stock the owner of the option must “exercise” the option by paying the agreed upon price and requesting issuance of the shares.
Means any process, method, product, compound, drug, device, or any diagnostic, medical, or surgical procedure developed using UC Denver facilities, equipment or funds, whether intended for commercial use or not.