Conflict of Interest

Conflict of Interest
Type of Policy
Administrative
jgastley3
Policy No
5.4
Effective Date
Last Revised
Review Date
Policy Owner
Ethics, Compliance & Legal Affairs
Contact Name
Darryl Lunon
Contact Title
Deputy General Counsel & Chief Ethics and Compliance Officer
Contact Email
coi@gatech.edu
Reason for Policy

The purpose of this policy is:

  • To set forth acceptable parameters relating to possible conflicts of interest which may arise from the outside professional activities of an Institute employee;
  • To define and establish a mechanism to reduce, eliminate, or manage a situation that may pose a real or potential Conflict of Interest;
  • To ensure the integrity of research, education or business transactions of the Institute and to identify real or potential Conflicts of Interest;
  • To ensure that sponsored research at the Institute is conducted in compliance with regulations promulgated by the sponsor thereof including but not limited to the National Science Foundation and the National Institutes of Health as appropriate [Ref. NSF - Investigator Financial Disclosure Policy: October 7, 1996 http://www.nsf.gov/pubs/stis1996/iin117/iin117.txt, and NIH Guide – Objectivity in Research http://www.gpo.gov/fdsys/pkg/FR-2011-08-25/pdf/2011-21633.pdf]; and
  • To articulate activities that would be prohibited.
Policy Statement

State laws governing ethics and conflicts of interest are based on the premise that public employees are acting on behalf of government for the benefit of the public. As public employees of an institute serving the educational and public purposes of teaching, research, and professional service, there is an obligation to conduct research and official duties on behalf of the Institute in such a manner consistent with statutes and regulations. The avoidance of conflict of interest is vital to ensuring the integrity and objectivity in conducting and reporting research.

Overview
Based on State and federal law and regulations, the following two rules will be followed as a matter of Institute policy:

  1. Activities which constitute a Conflict of Interest where there is Significant Financial Interest are prohibited unless a plan to reduce, eliminate or manage the Conflict of Interest has been expressly approved in accordance with the provisions of this policy; and
  2. Activities which constitute a Conflict of Interest where there is a Substantial Interest are unlawful.

If you are a faculty member, you are governed by Policy 5.6 Conflict of Interest and Outside Professional Activity as defined in the Faculty Handbook.

If you are an employee conducting research, you are governed by Policy 5.6.4 Disclosure of Real or Potential Conflicts of Interest as defined in the Faculty Handbook.

Only faculty who do not accrue annual leave may report consulting days for time spent consulting, as described in Section 5.6.5 of the Faculty Handbook.

Scope

All staff at the Georgia Institute of Technology should be aware of this policy.

Policy Terms
  1. Agency
    any agency, authority, department, board, bureau, commission, committee, office or instrumentality of the State of Georgia.
  2. Business
    any corporation, partnership, proprietorship, firm, enterprise, franchise, association, organization, self-employed individual, trust or other legal entity.
  3. 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.
  4. Conflict of interest Illustrative examples of such situations include, without limitation, the following situations:
    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.
    • 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.
  5. 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 general faculty appointed by the Executive Board of the Institute. In absence of a standing Committee the Executive Vice-President for Research shall appoint an ad hoc committee as dictated by the circumstance.
  6. 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.
  7. Consulting
    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.
  8. Employee
    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.
  9. Family
    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.
  10. Full-time
    30 hours or more of work for the state per week for more than 26 weeks per calendar year.
  11. Individual Conflicts
    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.
  12. Institute/Institution
    the Georgia Institute of Technology.
  13. 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.
  14. Institutional Responsibilities/Institutional Obligations
    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.
  15. Investigator
    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. [NIH Guide - Financial Conflicts of Interest and Research Objectivity: Issues for Investigators and Institutional Review Boards, June 5, 2000 http://www.grants.nih.gov/grants/policy/coi/index.htm FDA "Guidance: Financial Disclosure by Clinical Investigators" (March 20, 2001) http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM341008.pdf ].
  16. Part-time
    any amount of work other than full-time work.
  17. Public Official
    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.
  18. Responsible Representative of the Institution
    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).
  19. Responsible Unit Official
    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.
  20. 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. 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 http://coi.research.gatech.edu/ for answers to frequently asked questions.
  21. Sponsored travel
    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.
  22. Substantial Interest
    is “the direct or indirect ownership of more than 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.
  23. Transact Business or Transact any Business
    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.
Procedures

Activities Not Considered "Consulting"

  1. Publication
    Scholarly communications in the form of books, movies, television productions, art works, etc. though frequently earning financial profit for a non-faculty member and for another party (e.g., publisher), are not viewed as consultation.
  2. Professional Service
    Service on national commissions, advisory bodies for governmental agencies and boards, granting agency peer review panels, visiting committees or advisory groups to other universities, and on analogous bodies is not considered to be Consulting. The fundamental distinction between these activities and consulting is that they are public or Institute service. Although participants may receive an honorarium or equivalent, these professional service activities are not undertaken for personal financial gain.
  3. "Moonlighting"
    Employee may pursue a variety of endeavors for financial profit that are not directly related to the person’s field or discipline. These efforts are part of the non-faculty member's private life and do not come under Institute regulation for this consulting policy. Such endeavors may be pursued only after the primary commitment to the Institute has been fulfilled and upon prior approval from a Responsible Unit Official of the Institute.

Use of Georgia Institute of Technology Facilities
In competing for consulting, employees are not to take advantage of their access to Institute facilities. State law precludes Institute employees from using State facilities or property for personal gain or benefit. The facilities and services of the Institute may not be used in connection with compensated outside work, except in a purely incidental way. This is not envisioned to exclude contracts with the Institute for the use of facilities or services such as the Computer Center or the Library or other facilities for which cost centers have been established.

 

Consulting Services for Other State Offices
As a general rule employees of the Institute may not receive compensation for services performed for other state offices. [Official Code of Georgia 45-10-20]

Employees of one State agency may teach or work as consultants for another state agency provided the work falls within one of the following classifications and provided the conditions stated below are met.

Employees of one state agency may teach or work as consultants for another state agency if the transaction involves part-time employment by the state agency seeking consulting services of a chaplain, fireman, any person holding a doctorate or master's degree from an accredited college or university, a licensed physician, dentist, psychologist, registered nurse or a licensed practical nurse, or veterinarian.

The chief executive officer of the department or agency desiring to obtain the services of a person falling within the class of exceptions shall certify in writing the need for the services and shall set forth why the best interest of the state will be served by obtaining the part-time services of such a person in lieu of obtaining such services from a person not presently employed by the State.

The chief executive officer of the department or agency employing the person in the class of exceptions shall certify in writing that the person whose services are desired is available to perform such services, that the performances of such services will not detract nor have a detrimental effect on the performance of the person's employment, and, where appropriate, that the part-time employment of this person will be in the best interest of the State.

The two departments or agencies involved will then agree on the procedures under which the employee shall perform the additional services. The agreement shall specify the means of employment, whether as a part-time employee or as a consultant, the compensation, and other pertinent details and conditions of the employment relationship. The agreement may be terminated at any time by either of the parties to the agreement.

Prohibited Activities
No employee shall undertake any activity which constitutes a conflict of interest except as may be expressly approved and/or managed pursuant to the provisions of this policy.

It shall be unlawful for any full-time employee, for himself or herself, or on behalf of any business, or for any business in which such employee or member of his or her family has a substantial interest to transact any business with the agency by which such employee is employed; provided, however, that neither this section nor any other provision of law shall prevent full-time employees of the Board of Regents of the University System of Georgia from serving as members of governing boards of private, nonprofit, educational, athletic, or research related foundations and associations which are organized for the purpose of supporting institutions of higher education in this state and which in furtherance of this purpose may transact business with such institutions or with the Board of Regents of the University System of Georgia.

Except as expressly permitted by law, it shall be unlawful for any part-time employee, for himself or herself, or on behalf of any business, or for any business in which such employee or member of his or her family has a substantial interest to transact any business with the agency by which such employee is employed. See Official Code of Georgia Annotated Section 45-10-20 et seq.

Disclosure to the State of Georgia
Except as provided in subsection (b) of the Official Code of Georgia Annotated Section 45-10-26, any Public Official or Employee whether for himself or herself, or on behalf of any Business, or any Business in which such Public Official or Employee or any member of his Family has a Substantial Interest who transacts business with the state or any agency thereof, shall disclose such transactions. Such disclosure shall be submitted prior to January 31 each year to the Secretary of State on such forms as he or she shall prescribe and shall include an itemized list of the previous year's transactions with the dollar amount of each transaction reported and totaled. Such disclosure statements shall be public records. [Official Code of Georgia 45-10-26]

Disclosure to the Institute
Every employee of the Institute, including all who participate in outside professional activities and/or sponsored research must complete an annual disclosure using the online Conflict of Interest system. In answering the questions, if an employee has indicated an actual or potential conflict, the system will notify the COI Office for review. Employees must update their disclosures on an ongoing basis when circumstances change.

Disclosure to Sponsors
Any person involved in the design, conduct, or reporting of research (technical and financial) or educational activities proposed for funding by a sponsor must complete the Investigator Financial Interest In Research Report via the online Conflict of Interest System disclosing any potential or actual Significant or Substantial Financial interests of the employee (including those of the Employee’s Family). (See http://coi.research.gatech.edu/ for this system.) Disclosures should include, but is not limited to:

  1. Performance or business transactions related to the sponsored activity;
  2. Equity interests in or fees from either the sponsor of the research or a subcontractor;
  3. Intellectual property rights.

Each such Disclosure needs to be updated via the online system by the employee during the life of any award, as new Significant or Substantial Financial Interests are recognized.

In completing a disclosure on the Conflict of Interest Online System, the employee is certifying to the following:

"In submitting this form I affirm that the above information is true to the best of my knowledge and I certify that I have read and understood the Conflict of Interest and Outside Professional Activity Policy as set forth in the Georgia Institute of Technology Faculty Handbook, that I have made all required disclosures, and that I will comply with any conditions or restrictions imposed by the Institute to manage, reduce or eliminate conflicts of interest."

In any proposal submitted to a potential sponsor, the Office of Sponsored Programs is responsible for certifying that the Institute has implemented a written and enforced conflict of interest policy that is consistent with the provisions of Grant Policy Manual Section 510 of the National Science Foundation, the National Institutes of Health Guide for Objectivity in Research and other applicable sponsor regulations. In submitting the proposal, the Office of Sponsored Programs certifies that to the best of their knowledge all financial disclosures required by such conflict of interest policy have been made and that all identified conflicts of interest will have been satisfactorily managed, reduced or eliminated prior to the Institute’s expenditure of any funds under the award, in accordance with the Institute’s Conflict of Interest and Outside Professional Activity Policy.

Disclosure to the Institutional Review Board
Investigators submitting protocols to the Institutional Review Board (IRB) for the use of human subjects in research or other activities shall disclose any and all Significant Financial Interests that may appear to affect the design, conduct or reporting of such research. It is imperative that Investigators fully disclose to the IRB an ownership interest in any Business proposing to test any drug, device or other technology with human subjects or any potential financial interest in such technology that the Investigators, or the Investigators Family might have. The IRB, in collaboration with the COI Office, shall conduct an independent review and may or may not impose restrictions, including denial of approval for the protocol, as it deems is in the best interest of the subjects and the Institute.

Disclosure to Students
Special care needs to be taken when dealing with students involved in research so that a potential or actual Conflict of Interest does not adversely affect their education, i.e. their ability to graduate or publish. Prior to retaining students on research projects that may involve a potential or actual Conflict of Interest, the Investigator and senior personnel will disclose to the student as well as to the COI Office and Responsible Unit Official, any interests in outside companies that may be perceived to benefit from the student’s research. Should a conflict of interest exist, the COI Office, the Responsible Unit Official, the conflicted Investigator, and the Conflict of Interest Review Committee, will design a conflict management plan to manage, reduce or eliminate the conflict prior to the student’s involvement in the project pursuant to the procedure provided for in Section 5.6.4.

Review of Financial Disclosures and Resolution of Conflicts of Interest
When a financial disclosure or report of a conflict of interest is made via the online Conflict of Interest module and forwarded to the COI Office, the COI Office reviews the disclosure per the COI Office Procedures.

Should an actual or apparent conflict of interest exist, the COI Office and the Conflict of Interest Review Committee will design a conflict management plan to manage, reduce or eliminate the conflict prior to the Institute's expenditure of any such funds.

In developing a management plan, the COI Office and the Conflict of Interest Review Committee will work with the conflicted employee and with the Responsible Unit Official and will consider the relationships between the employee and the Institute to ensure adequate conditions or restrictions are in place to manage, reduce or eliminate the conflict(s).

Such conditions may include, without limitation:

  1. Public disclosure of significant financial interests;
  2. Monitoring of research by independent reviewers;
  3. Modification of the research plan;
  4. Disqualification from participation in the portion of the sponsor funded research that would be affected by the Significant or Substantial Financial Interests;
  5. Divestiture of Significant or Substantial Financial Interests; and/or
  6. Severance of relationships that create actual or potential conflicts.

Conflict management plans and/or restrictions must be in writing and forwarded to the conflicted employee and the Responsible Unit Official(s). The COI Office and the Responsible Unit Officials will monitor compliance with the plan. A copy of the plan and relevant documentation will be maintained in the COI Office.

Upon recommendation by a Responsible Unit Official, the Conflict of Interest Review Committee may determine a) that imposing conditions or restrictions would be ineffective or b) that any potential negative impacts which may arise from a Significant or Substantial Financial Interest is outweighed by interests of scientific progress, technology transfer, or the public health and welfare. In such cases, the Responsible Unit Official and the Conflict of Interest Review Committee may recommend to the Provost that the Institute allow research to go forward provided that any conflict management plan includes ongoing monthly review by the Responsible Unit Official and the Conflict of Interest Review Committee.

Notwithstanding the foregoing, nothing herein shall permit the Institute to authorize an activity that is contrary to the laws of the State of Georgia, federal regulations, or other restrictions imposed by regulation or contract by research sponsors. Furthermore, no activity involving human subjects may be authorized that has not been approved by the Institutional Review Board which in compliance with 45CFR46 may, in its sole discretion, deny such approval.

Should the Responsible Representative of the Institution find that the Institute is unable to satisfactorily manage a conflict of interest prior to the Institute's expenditure of any such funds, the Responsible Representative of the Institution shall immediately notify the COI Office and the Office of Sponsored Programs.

All determinations made or actions taken by the COI Office, and/or the Conflict of Interest Review Committee shall be in writing and together with all financial disclosures made hereunder, be maintained until at least three years after the later of the termination or completion of the award to which they relate, or the resolution of any government action involving those records. If the Investigator is engaged in any research or other sponsored activity supported by the Department of Health and Human Services including but not limited to the National Institutes of Health, the Responsible Representative of the Institution shall forward this information to the sponsor in compliance with regulation.

Written management plans must be reviewed annually or upon a change in circumstances affecting the plan and appropriate disclosures should continue during the ongoing management of any conflict.

Conflict of Interest Training Requirements
Conflict of interest training is required for all Investigators before engaging in funded research and every four years thereafter.

Penalties
Any employee who violates this policy shall be subject to disciplinary action up to and including dismissal.

There are also sanctions under State law [Official Code of Georgia Section 45-10-28] as described in the following paragraphs.

Any appointed public official or employee who violates Official Code of Georgia Annotated Section 45-10-23 ("Full-time employees prohibited from transacting business with own state agency; exception to prohibition for Board of Regents employees"), Section 45-10-24 ("Part-time public officials with state-wide powers prohibited from transacting business with any state agency; part-time employees prohibited from transacting business with own state agency; exceptions to prohibitions"), or Section 45-10-26 ("Public officials and employees to file yearly disclosure statements concerning business transactions with state; statements to be public records") shall be subject to:

  • Removal from office or employment;
  • A civil fine not to exceed $10,000.00; and
  • Restitution to the state of any pecuniary benefit received as a result of such violation.

Any business which violates Code Section 45-10-23, 45-10-24, or 45-10-26 shall be subject to:

  • A civil fine not to exceed $10,000.00; and
  • Restitution to the state of any pecuniary benefit received as a result of such violation.
Form Links
Conflict of Interest Form
Responsibilities
Party Responsibility
The responsibilities each party has in connection with Conflict of Interest are:
Conflict of Interest Management Office Ensure compliance with policy.
Office of Legal Affairs Offer assistance with policy interpretation.