5.6.2 Definitions

5.6.2 Definitions abruneau3 Thu, 06/26/2014 - 18:10

Definitions as used in this policy, the term:

"Agency" means any agency, authority, department, board, bureau, commission, committee, office or instrumentality of the State of Georgia.
"Business" means any corporation, partnership, proprietorship, firm, enterprise, franchise, association, organization, self-employed individual, trust or other legal entity.
“Conflict of Commitment” occurs when an Employee undertakes external commitments which burden or interfere with the Employee’s primary obligations to the Institute. Conflicts of Commitment may arise out of consulting arrangements or with an entrepreneurial interest when a faculty member is involved in a startup company.
"Conflict of Interest" means any situation in which
1. It reasonably appears that a significant financial interest could affect the design, conduct, or reporting of activities funded or proposed for funding by a sponsor; or
2. The personal interest of an Employee or his or her Family may prevent or appear to prevent the Employee from making an unbiased decision with respect to the Employee’s employment with the Institute
  
  Illustrative examples of such situations include, without limitation, the following situations:
- The Employee, or a member of his or her Family, has a significant financial interest in a business which transacts business with the Institute.
- The Employee, or a member of his or her Family, has a significant financial interest in an entity that competes or may compete with the Institute for sponsored activities.
“Conflict of Interest Review Committee” shall mean an advisory committee to the Executive Vice-President for Research that shall be composed of the Chief Legal Counsel, the Vice-President for Research, a representative for the student body, and a member of the Faculty appointed by the Faculty Executive Board. In absence of a standing Committee the Executive Vice-President for Research shall appoint an ad hoc committee as dictated by the circumstance.
“Conflict of Interest Management Office” (COI Office) shall mean the central office designated by the Institute to review all disclosures that present actual or perceived conflicts of interest. The COI Office works with the COI Review Committee and the Responsible Unit Official to ensure that any conflicts of interest are reduced, managed, or eliminated in conjunction with federal, state, and local regulations and Institute policy.
"Consulting" means any professional activity related to the person's field or discipline (e.g. consulting, speaking, scientific advisory boards, paid attendance at company meetings, expert witness services, etc.), where a fee-for-service or equivalent relationship with a third party exists. Consulting includes organizing or operating any educational program outside Georgia Institute of Technology.
"Employee” includes all Institute personnel who receive salary or wages from the Institute. Students and trainees are included if they receive pay from the Institute. Also included, by way of example without limitation, are Visiting Faculty and Scientists, Professors of the Practice, Adjunct Faculty, Emeritus Faculty (if they are engaged in part time work for pay), and Tech Temps.
"Family" means spouse or partner and dependent children [Georgia Official Code 45-10-20] and anyone who could reasonably be assumed to be family in the context of situations in which there may be the appearance of a Conflict of Interest stemming from an action of an Employee in combination with such persons.
"Full-time" means thirty (30) hours or more of work for the state per week for more than twenty-six (26) weeks per calendar year.
”Individual Conflicts” means a Conflict of Interest that arises when an Employee has the opportunity to influence research, academic or Institute decisions in ways that could lead to personal financial gain. The financial gain may be derived from owning stock in a company that is sponsoring research, from ownership interest or employment in a company that may benefit as a licensee of an invention, or from the existence or expectation of entering into a consulting arrangement with a company sponsoring research.
“Institute/Institution” means the Georgia Institute of Technology.
“Institutional Conflicts” occur when the Institute, or one of its affiliated entities such as the Georgia Tech Research Corporation, Georgia Tech Applied Research Corporation, Georgia Tech Foundation or Georgia Advanced Technology Ventures, has a financial stake in the outcome of its research programs or licensed technology. The conflict may arise out of an equity interest in a start-up that licenses technology from the Institute or in the nature of royalties to be earned from licensing such technology.
”Institutional Responsibilities/Institutional Obligations” means Investigator’s professional responsibilities on behalf of the Institution, including for example, 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.
"Investigator" means the project director or principal investigator and any other person, regardless of title or position, who is responsible for the design, conduct, or reporting of research, which may include, for example, collaborators or consultants. If the research involves human subjects, it includes all personnel named in the protocol submitted to the Institutional Review Board. [from NIH: Financial Conflict of Interest http://www.grants.nih.gov/grants/policy/coi/index.htm and from FDA: Guidance for Industry: Financial Disclosure by Clinical Investigators http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM341008.pdf].
"Part-time" means any amount of work other than full-time work.
"Public Official" means any person elected to state office or any person appointed to a state office where, in the conduct of such office, the person so appointed has administrative and discretionary authority to receive and expend public funds and to perform certain functions concerning the public which are assigned to him or her by law.
“Responsible Representative of the Institution” means the person designated by the Institute to oversee the solicitation and review of financial reporting statements from any Investigators who will be participating in Research. For purposes of this Policy, the Responsible Representative of the Institution is the Vice-President for Research or his/her designee(s).
"Responsible Unit Official" means the supervisor of the school, laboratory, or department of the person making a disclosure. For such supervisors, the Responsible Unit Official will be the person he or she reports to at the next supervisory level. For any other cases, it will be an individual designated by the Executive Vice-President for Research.
"Significant Financial Interest," as defined in current Federal Regulations, means:
1. A financial interest consisting of one or more of the following interests of the Investigator (and those of the Investigator's spouse and dependent children) that reasonably appears to be related to the Investigator’s institutional responsibilities:
  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 the Investigator (or the Investigator's spouse and dependent children) holds any equity interest (e.g., stock, stock option, or other ownership interest); or
  3. Intellectual property rights and interests (e.g., patents, copyrights), upon receipt of income related to such rights and interests.
2. The term significant financial interest does NOT include the following types of financial interests:
  1. Salary, royalties, or other remuneration paid by the Institution to the Investigator if the Investigator is currently employed or otherwise appointed by the Institution;
  2. Intellectual property rights assigned to the Institution and agreements to share in royalties related to such rights;
  3. Equity in and 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;
  4. Income from seminars, lectures, or teaching engagements sponsored by a federal, state, or local government agency, an institution of higher education as defined in 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;
  5. Income from service on advisory committees or review panels for a federal, state, or local government agency, or 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.
3. Investigators who receive US Public Health Service funding (e.g. NIH) or a subcontract from another entity that receives funds from a US Public Health Service funding agency, also must disclose the occurrence of any reimbursed or Sponsored Travel, related to their institutional responsibilities; provided, however, that this disclosure requirement does not apply to 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. The disclosure must include the purpose of the trip, the identity of the sponsor/organizer, the destination, and the duration. Please refer to https://procurement.gatech.edu/travel for answers to frequently asked questions.
“Sponsored travel” means travel expenses that are paid on behalf of the Investigator and not reimbursed to the Investigator so that the exact monetary value may not be readily available.
“Substantial Interest” is “the direct or indirect ownership of more than twenty-five (25) percent of the assets or stock of any business.” [Official Code of Georgia 45-10-20]. An Employee, alone or in combination with Family, may not have an ownership interest of more than 25% of the assets or stock in any business which Transacts Business with the State of Georgia including the Institute. Therefore caps of 24.9% are placed on the percentage of ownership an Employee, alone or in combination with Family, may have in any business which Transacts Business with the Institute. Ownership interests below this cap may be managed as provided in this policy.
"Transact Business" or "Transact any Business" means to sell or lease any personal property, real property, or services on behalf of oneself or on behalf of any third party as an agent, broker, dealer, or representative and means to purchase surplus real or personal property on behalf of oneself or on behalf of any third party as an agent, broker, dealer, or representative.