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COI Definitions

 

(CLINICAL) AFFILIATE

CWRU’s affiliate/partner hospitals:

  • University Hospitals Cleveland Medical Center (UHCMC),
  • Cleveland Clinic,
  • MetroHealth Medical Center (MHMC), and
  • Louis Stokes Cleveland Veterans Affairs Medical Center (LSCVAMC)

CONFLICT OF INTERESTS ("COI")

An individual conflict of interest exists when an individual covered by the CWRU Conflict of Interests policy has a financial interest that might adversely affect or appear to a reasonable person to adversely affect the individual’s judgment in carrying out University responsibilities, or that might adversely affect or appear to a reasonable person to adversely affect the University’s responsibility to the public, the safety of research subjects, or the integrity of research.

EQUITY

For purposes of financial interest disclosure, equity is any stock, stock option or other ownership interest in an outside entity. For a publicly traded entity, determine the value as of date of disclosure through reference to public prices or other reasonable measures of fair market value, such as www.nasdaq.com or www.nyse.com. For stock, stock option or other ownership interest in a non-publicly traded entity, disclose the percentage.

EXCLUSIONS FROM THE DISCLOSURE REQUIREMENT

Examples of activities in which individuals may engage without disclosure include:

  • Accepting reasonable meals and other customary business amenities (such as pads and pens) that are provided as part of a seminar, course, meeting, or other business-related gathering.
  • Honoraria for writing or reviewing scholarly manuscripts for publication by academic journals or presses.
  • Travel that is reimbursed or sponsored by a federal, state or local government agency, an 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.
  • 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, or teaching engagements sponsored by a Federal, state, or local government agency, an 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.
  • Income from service on advisory committees or review panels for a Federal, state, or local government agency, an 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.
  • Royalties or other payments extending from intellectual property rights assigned to the University, and agreements to share in royalties or other payments related to such rights.
  • Grants and contracts administered through the University or its clinical affiliates.

FAMILY MEMBER

Defined as yourself, your spouse/domestic partner, dependent children, and any other dependent person living in the same household.

(CURRENT) FEDERAL REGULATIONS

On August 25, 2011, the Department of Health and Human Services revised its financial conflict of interest regulations, 42CFR50, "Responsibility of Applicants for Promoting Objectivity in Research for which Public Health Service Funding is Sought," and 45CFR94, "Responsible Prospective Contractors." Regulations can be viewed in the Federal Register.

(OUTSIDE) FINANCIAL INTEREST

Anything of monetary value, whether or not the value is readily ascertainable. Examples of outside financial interests include the following:

  • Officer, Director, Trustee or other officer position with any entity outside of the University or its clinical affiliates, with advisory or fiduciary duties, even if uncompensated,
  • Equity such as stock, stock options or other ownership interests, including equity that individuals covered by this policy know they will inherit,
  • Salary, income, honoraria, remuneration, consulting fees, advisory board fees, membership on a speaker’s bureau,
  • Intellectual Property licensing agreements, inventors’ shares, royalties not assigned to the University,
  • Other Financial interest such as gifts/favors or other emoluments, "in kind" compensation, non-university grants, non-university contracts and debts and loans, and
  • Travel expenses and reimbursement, other than those paid for by the University or its hospital affiliates, or reasonable travel expenses paid for participation in scholarly and academic endeavors and/or those described in the Exclusions section of this document.

INSTITUTIONAL / UNIVERSITY RESPONSIBILITIES

Professional responsibilities conducted on behalf of the University. Examples of institutional responsibilities include activities such as research, research consultation, teaching, professional practice, institutional committee memberships, and service on panels such as Institutional Review Boards or Data and Safety Monitoring Boards.

INTELLECTUAL PROPERTY ("IP") RIGHTS AND INTERESTS

Intellectual property rights and interests (e.g., patents, copyrights) except intellectual property rights assigned to the institution and agreements to share in royalties related to such rights.

Disclosable intellectual property rights and interests are as follows:

  • Licensed technology (patented or unpatented),
  • Fixed payments (upfront fees, milestones, annual fees),
  • Royalties,
  • Copyrights, and
  • Patents owned by investigator (not owned by institution)

INVESTIGATOR

For purposes of research, CWRU follows the NIH definition of investigator as the project director or principal investigator and any other person who is responsible for the design, conduct or reporting of research, or proposal for such funding, including the person’s spouse and dependent children and/or any other collaborators or consultants.

An investigator for purposes of financial interest disclosure is any personnel listed on any sponsored project through CWRU (not only research, but also including administrative, training, fellowship or assessment projects), and/or an investigator conducting research at CWRU or one of its clinical affiliates.

NO ACTIONABLE CONFLICT OF INTERESTS

Individuals who have an outside interest that is not significant, or is found to be unrelated to University research or responsibilities, will not require further action regarding their outside interest. Such individuals’ annual outside interest review will be marked as "no actionable conflict of interest."

OFFICER OR DIRECTOR

For purposes of outside financial interest disclosure, the "officer or director" holds a board membership or other officer position involving advisory or fiduciary duties with any outside entity whether uncompensated or not.

OUTSIDE ENTITY

For purposes of financial interest disclosure, an "outside entity" is any corporation, partnership, proprietorship, firm, association, organization, or other entity outside the University and its clinical affiliates (but excluding federal, state or local government agencies). If the disclosing individual has received disclosable remuneration or other financial interest from a person, then the person is also an "entity" by this definition.

POPULATION REQUIRED TO DISCLOSE

Any individual pertaining to one or more of the following populations, Faculty*, Investigators* and Senior Staff, is required to disclose per CWRU COI policy.

Faculty

Disclosure is required from full-time faculty. A University full-time faculty member ("full-time," according to the Faculty Handbook denotes Board of Trustees-appointed full, associate, or assistant professor; senior instructor or instructor).

Investigator

For purposes of research, CWRU follows the NIH definition of investigator as the project director or principal investigator and any other person who is responsible for the design, conduct or reporting of research, or proposal for such funding, including the person’s spouse and dependent children and/or any other collaborators or consultants.

An investigator for purposes of financial interest disclosure is any personnel listed on any sponsored project through CWRU (not only research, but also including administrative, training, fellowship or assessment projects), and/or an investigator conducting research at CWRU or one of its clinical affiliates.

Senior staff

[NOTE: As of with the 2013 reporting cycle, the Office of General Counsel will be collecting forms for all Senior Staff and non-research staff.] 

A University officer, senior official or staff member. "Senior officials" required to complete the form comprise the Provost, Senior Vice President for Administration, Chief Financial Officer, Vice President for Medical Affairs, Chief of Staff, vice presidents for Development, University Relations, and Diversity, Inclusion and Equal Opportunity, and any other person that the President designates. Staff with purchasing / vendor responsibilities are required to complete the form (as designated by salary grade and purchasing limit), and any other employees at the request of their supervisors. Please contact the Office of General Counsel for instructions about completing the form.

*NOTE: CWRU will accept the outside financial interest disclosure form of a clinical affiliate, if the individual has a primary appointment in a clinical department of that institution. For a listing of conflict of interest offices at the affiliate institutions, click here.

REIMBURSED OR SPONSORED TRAVEL

Investigators must disclose the occurrence of any reimbursed or sponsored travel related to an individual’s institutional responsibilities. 

"Sponsored" travel is travel that is paid on behalf of the investigator and not reimbursed to the investigator so that the exact monetary value may not be readily available.

Excluded from the disclosure requirement is travel that is reimbursed or sponsored by a federal, state or local government agency; institution of higher education; academic teaching hospital; medical center or a research institute affiliated with an institution of higher education. 

The details of the disclosure must include:

  • Purpose of trip,
  • Identity of sponsor/organizer,
  • Destination, and
  • Duration

Examples:

  • Two trips within the previous year reimbursed by company "ABC" have a total estimated value of $4000. There are no other disclosable financial interests with company ABC. Disclosure of the travel is not required (aggregate <5K).
  • Two trips within the previous year sponsored by XYZ Foundation have a total estimated value of $4000. Consulting income with XYZ Foundation for the year was $3000. Disclosure of the travel is required (aggregate >$5K).
  • A trip including investigator, her spouse and their child was reimbursed at total estimated value of $6000. Disclosure is required (aggregate >$5K).

The Conflict of Interests Committee ("COIC") may require additional information, including an estimate of monetary value, in order to determine whether the travel may constitute a financial conflict of interest.

ROUTINE FOLLOW-UP

Routine follow-up is review that is intended to assist the investigator and the University in fulfilling the CWRU policy as well as NIH regulations--to identify and manage any financial conflicts of interest with research. The Conflict of Interests Committee staff will work with the investigator to summarize their financial interests and related University responsibilities for the COIC. Where the COIC determines there could be the appearance of a conflict, the Committee works with the investigator to manage the conflict.

Please note - in many instances, there is a determination of "no conflict of interest," and in that event, no further follow-up is required.

SALARY

Disclosable salary and remuneration is salary and any payment for services not otherwise identified as salary (e.g., consulting fees, honoraria, paid authorship).

SIGNIFICANT FINANCIAL INTEREST ("SFI")

In a research context, Significant Financial Interest ("SFI") means a financial interest of the Investigator (and those of the Investigator’s spouse and dependent children, domestic partner or anyone else living in the same household), that reasonably appears to be related to the Investigator’s institutional responsibilities. Note: When outside multiple financial interests for the same outside entity or source are disclosed, the information will be reviewed in aggregate for significance.

EXAMPLES

INDIVIDUAL CONFLICTS OF INTEREST EXAMPLES

  • While serving as an investigator on a research project that related to a company’s products, an individual is receiving consulting fees from and has equity in the company.
  • An individual manages the renovation of departmental offices and participates in the selection of an architectural firm in which his spouse is a partner.
  • A faculty member with a financial interest in an outside company serves as the direct academic supervisor of a university student employed by that company.
  • While serving on the board of directors of a business, an individual acts as an investigator on research sponsored by the business.
  • An individual makes referrals to a business in which he or she has a financial interest.

INSTITUTIONAL CONFLICTS OF INTEREST EXAMPLES

  • A vice president of the University signs off on a procurement decision involving major purchases from or supply contracts with a commercial entity of which he is a director.
  • A department chairman serves as an investigator in a research project sponsored by a company from which she receives consulting income.
  • As patent-holder, the University stands to gain royalties from intellectual property licensed to a company, and that intellectual property is being investigated under a research contract with the University. A company that has made a major gift to the University has requested special consideration in the bidding process as a vendor. The individual considering the bid is a consultant for the company.
  • A start-up company partially owned by the University has requested a discounted rate in utilizing several University core facilities. The facilities are overseen by an individual who is the chief scientific officer of the company.

For more information, email the COIC staff at caseoic@case.edu, or call 216.368.5963. If you leave a voicemail, please spell your name and provide your email address to help us get back to you promptly. Thanks!

This page was last updated: 2016/12/20