Definitions

Below is a list of frequently used acronyms, words and phrases related to conflict of interest in research documents and discussions. We hope you will find this listing useful. Please feel free to contact us if you have questions or suggestions for this reference page.

Compensation is payment for work or services performed. In the case of conflict of interest processes, it also includes personal income in the form of licensing fees or royalties related to intellectual property (patents, copyrights, etc.).

Conflict of Commitment (CoC) involves a situation in which an employee engages in an outside activity that interferes, or appears to interfere, with fulfillment of the employee's obligations to the University, even if the outside activity is valuable to the University or contributes to the employee's professional development and competence.

Conflict of Interest in Research Committee (CIRC) means the faculty members appointed by the Vice President of Research and Economic Development to serve as the reviewing body to determine the existence of a financial conflict of interest in resesarch, and to recommend strategies to manage the interest if it is deemed manageable.

Conflict of Interest Officer (COIO) means the institutional official responsible for implementing procedures governing the disclosure, review and management of conflicts of interest in accordance with the research provisions of the University of Iowa Operations Manual, serving as a resource for faculty and staff for conflict of interest in research issues, and overseeing the University’s educational activities related to conflicts of interest in research.

Disclosure Form means the electronic, web-based reporting format in the eCOI system through which an investigator discloses outside activities and financial interests related to University responsibilities.

eCOI means the electronic conflict of interest reporting system at the University. Investigators use this tool to disclose their financial interests, related to their University responsibilities, with outside entities.

Entity Report is the form used to report financial interests with non-University of Iowa entities. A separate Entity Report must be completed for each non-UI entity with which you have a financial interest (see Disclosure Form).

Equity Interest means stocks, stock options, or other ownership interests in a company.

Fiduciary Duty means having a duty or obligation to act in the best interest of a person or an entity. In the case of conflict of interest in research, it usually refers to an investigator having a fiduciary duty to a company when he/she holds a company position such as officer, manager, member of the board of directors, etc.

*Financial Conflict of Interest in Research (FCOI) involves situations in which an investigator (faculty, staff member, or student) has a significant financial interest that may compromise, or have the appearance of compromising, professional judgment in the design, conduct, or reporting of research.

Immediate Family includes the investigator's spouse or domestic partner, and dependent children.

*Institutional Conflict of Interest (ICOI) means financial interests of the University as an institution or of a University official acting within his or her authority on behalf of the institution, that could directly and significantly affect, or reasonably appear to directly and significantly affect, institutional processes for the design, conduct, reporting, review, or oversight of human subjects research that is designed to answer questions about the effects or impact of particular drugs, treatments, or diagnostic/therapeutic devices.

Intellectual Property (IP) includes issued patents, patent applications, copyrights, trademarks and other inventions.

*Investigator means, according to the federal regulation, anyone who is responsible for the design, conduct, or reporting of research. In other words, it means the key personnel involved in the research.

Key Personnel refers to all individuals listed in the Personnel tab on a UI proposal routing form, and individuals designated as "key personnel" on a Hawk IRB application. It includes anyone who has the authority to make independent decisions about the direction of the research and the subsequent conclusions about the results. It also includes individuals who are likely to be authors on manuscripts or to present research findings at national conferences. It does not include administrative personnel or individuals who perform routine, pre-defined, or incidental tasks related to the project.

Manage means to take action to address a financial conflict of interest, which includes reducing or eliminating the financial conflict of interest, to ensure that the design, conduct, and reporting of research are free from bias or the appearance of bias.

Management Strategy is the written plan developed by the Conflict of Interest in Research Committee or the Conflict of Interest in Research Office and approved by the Vice President for Research and Economic Development which requires the signature of the investigator prior to initiation of the research; lists the obligations with which the investigator must comply in the conduct and reporting of the research.

Outside Activities means work or services related to your University responsibilities utilizing your area of expertise, performed on behalf of an entity other than the University of Iowa.

Outside Entity means an outside, non-UI organization, whether public or private. Non-profit entities, such as professional associations, voluntary health agencies, etc., are excluded, unless you are involved in research funded by the US Public Health Service (i.e. NIH).

PHS Research means research funded by the Public Health Service of the US Department of Health and Human Services. It includes research funded by the following agencies: the National Institutes of Health (NIH), the Centers for Disease Control and Prevention, the Agency for Healthcare Research and Quality, the Food and Drug Administration, the Indian Health Service, the Health Resources and Services Administration, the Agency for Toxic Substances and Disease Registry, and the Substance Abuse and Mental Health Services Administration. It also includes the Office of the Assistant Secretary for Health, the Office of Global Affairs, and the Office of the Assistant Secretary for Preparedness and Response.

Rebuttable Presumption is the standard recommended by the Association of American Medical Colleges that states that an investigator with a significant financial interest cannot participate in research involving human subjects, unless that investigator can present compelling justification to remain on the study team. Compelling circumstances will depend in each case on consideration of all of the following:

  • The nature of the science (including whether it is early-stage research or whether the research is closer to commercial application, i.e., Phase II-III multi-site studies);
  • The size and nature of the interest (payments, equity, intellectual property rights, management positions);
  • How closely the interest is related to the research;
  • The degree to which the interest may be affected by/is related to the research;
  • The degree of risk to subjects; and
  • Whether there are unique circumstances (i.e., unique qualifications of the investigator or unique resources/capabilities of the University) that require the research to be performed here as opposed to another institution.

*Significant Financial Interest (SFI) means anything of monetary value or potential monetary value held by an investigator (and by the investigator's spouse or domestic partner, and dependent children), and that reasonably appears to be related to the investigator's institutional responsibilities, as follows:

(a) With regard to any publicly traded entity, 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 the definition of "significant financial interest," 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.]

(b) With regard to any non-publicly traded entity, the value of any remuneration received from the entity in the calendar year preceding the disclosure, when aggregated, exceeds $5,000, or any equity interest (e.g., stock, stock option, or other ownership interest);

(c) Intellectual property rights and interests (e.g., patents, copyrights), upon receipt of income related to such rights and interests; or

(d) A position giving rise to a fiduciary duty, such as director, officer, partner, trustee, employee, or any position of management.

(e) For investigators applying for or conducting research funded by the PHS, any reimbursed or sponsored travel related to the investigator's institutional responsibilities (i.e., travel is paid on behalf of the investigator and not reimbursed to the investigator so that the exact monetary value may not be readily available). Disclosure of this interest will include the purpose and duration of the trip, the identity of the sponsor/organizer, and the travel destination.

The term "significant financial interest" does not include salary or other remuneration paid by the University to the investigator if the investigator is currently employed or otherwise appointed by the University; income from investment vehicles, such as mutual funds and retirement accounts, as long as the investigator does not directly control the investment decisions made in these vehicles; income from seminars, lectures, teaching engagements, or travel reimbursed or sponsored by a federal, state, or local government agency, an institution of higher education, an academic teaching hospital, medical center, or research institute affiliated with an institution of higher education; or income from service on advisory committees or review panels for a federal, state, or local government agency or institution of higher education.

Start-Up Company is a newly-formed, privately-held, for-profit company, usually based on the intellectual property of a University staff or faculty member.

Student means anyone involved in the research for the purposes of fulfilling requirements as part of an undergraduate- or graduate-level program leading to an academic degree.

Trainee includes any individual with a terminal degree participating in the research during a training or transitional period preparatory to a research or teaching career, requiring the supervision of a senior scholar (faculty member). It also includes individuals who have completed terminal professional degrees (such as M.D. or D.D.S.) and are participating as residents or fellows in specialty training programs. This does not include individuals who are employed as a Research Scientist and are not in training programs.

*University Official includes the following individuals who, because of their respective positions with the University, have the capacity to affect, or can reasonably appear to affect, University processes for the design, conduct, reporting, review, or oversight of human subject research: the University President, provost, vice presidents, associate provosts, associate vice presidents, treasurer, controller, deans, associate and assistant deans, departmental executive officers, and the heads of centers and institutes.

University Responsibilities means an employee's responsibilities carried out on behalf of the University of Iowa, involving the employee's expertise. Examples of University responsibilities include, but are not limited to, the following: participating in purchasing decisions; institutional committee membership; evaluating products or services on behalf of the University; professional practice (providing patient care, accounting services, or legal counsel); teaching (formal course or continuing education); research; service on panels such as the Institutional Review Board; etc.

*OM II.18