What is a Conflict of Interest (COI)?
A “Conflict of Interest” is any situation in which it reasonably appears that an employee’s financial interest could bias or appear to bias the design, conduct, or reporting of activities funded or proposed for funding by a sponsor. Or the personal interest of an employee or his/her family may prevent or appear to prevent the employee from making an unbiased decision with respect to the employee’s Institutional duties.
What are some examples of situations may create a Conflict of Interest?
In direct relation to research, these types of financial interests could create COI if they could bias or appear to bias the design, conduct, or reporting or research: A.Equity interest in or payments (e.g. consulting fees, gifts, or other remuneration) from a company/entity whose products or services are being studied. B.Equity interests in or payments from the sponsor of the research or a subcontractor. C.Intellectual property rights in the subject matter being studied (e.g. patents, trademarks, copyrights).
What is an Institutional Conflict of Interest?
Institutional conflicts of interest occur when the Institute or one of its affiliated entities (including but not limited to Georgia Tech Research Cooperation, Georgia Tech Applied Research Cooperation, Georgia Tech Foundation, or Georgia Advanced Technology Ventures) has a financial stake in a particular outcome of its research programs or licensed technology. A conflict might 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 therein.
What is a Conflict of Commitment?
A Conflict of Commitment can occur if an employee’s outside professional activities hinder the employee from fulfilling their institutional duties. To ensure that this is avoided, the GT Faculty handbook section 5.6, states the following: Conflict of Commitment: The purpose of the policy on consulting and related activities is to state with both clarity and generality the limits on the time that an Institute Faculty member may spend in consulting. The limits set forth below are intended to strike a balance between consulting and regular duties within the Institute and serve to safeguard the interest of both parties. In cases of ambiguity, the primary guide should be the intention to promote the interests of the Institute as a place of education, learning, and research. It is the Faculty’s obligation to obtain prior consent from the appropriate Institute officer.
Why does Georgia Tech care about COI?
Georgia Tech cares about Conflicts of Interest, to preserve the public’s trust in the knowledge discovered and disseminated by the Institute. As well as to overtly protect both the Institute and the faculty member from the appearance of bias or other forms of undue influence.
Are all Conflicts of Interest unfavorable?
No, conflicts are to be managed as opposed to feared. As they are indicative of the natural outgrowth of successful research and commercialization efforts. Many faculty members manage these conflicts within the Institute’s policy.
What is a Significant Financial Interest?
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). N.B, The threshold for “Significance” is currently $5,000 (fees, equity or a combination of both.) A.Anything of monetary value, including but not limited to, salary or other payments for services. Examples: Consulting fees or honoraria. B. Equity interests, e.g. Stocks, Stock options or other ownership interests. N.B, Any equity interest in non-publicly traded entities is “significant”. C.Intellectual Property Rights, e.g. Patents, trademarks, copyrights and royalties from such rights.
What does not classify as a Significant Financial Interest?
Income from seminars, lectures, or teaching and service on advisory or review panels for governmental agencies. Institutions of higher education, academic teaching hospitals, medical centers, or research institutes affiliated with an Institution of higher education. As well as income from investment vehicles, such as mutual funds and retirement accounts. N.B. As long as the individual does not directly control the investment decisions made in these vehicles.
If cost sharing is part of the sponsored research agreement, it must be recorded in the University's accounting system, included in financial reports submitted to the sponsor, and taken into account when calculating Facilities and Administrative (F&A) rates. Whenever cost sharing is proposed as part of a sponsored project, the source of funds must be identified and approval obtained from the individual with authority to commit those funds.
How does my employment status with the Institute affect my ability to participate in outside consulting relationships?
A. Full time employees of the Institute may not simultaneously be employees of another entity and total professional obligations may not exceed 100%. B. Employment by a company is distinct from contracted consulting, which is limited under current policy to 1 day, weekly. C. Full time Georgia tech employees cannot generally serve as PI on projects awarded to any outside entity. D. Part Time Georgia Tech employees who serve as PIs on company projects may encounter conflicts between the obligations of their two employers.
What are the COI Management Plans?
COI Plans are designed to ensure that Conflicts of Interest are appropriately managed, reduced, and or eliminated. Below is a list of common management plan tools: •Disclosure requirements •Reporting to funding agencies •Limitations on who may serve as a PI on a sponsored project •Distinction between activities appropriate for consulting and for sponsored programs. •Limitations on ownership of stock or stock options •Technology transfer or licensing provisions •Designation of responsibility for control of donated funds •Provisions for the use of university facilities •Provisions for the employment of university students •Relationship to other funded projects and or proposals •Designation of parties responsible for review
How is the COI Office notified of Conflicts of Interest?
The COI Office is notified of potential conflicts in one of the following ways: 1.eCOI notification (EAR, AC) 2.OSP Transactional SFI 3.IRB, IACUC, OTL 4.Start-Up Proposal 5.Manual Submission (email, phone call from investigator, etc.)
What happens when the COI Office is notified of a potential conflict?
The COI Office reviews the investigator’s financial interests to determine whether a conflict exists under the Georgia Tech Policy or under state or federal regulations. If a potential conflict is not identified then a “No Conflict” notification is sent to the investigator. If a potential conflict is identified, a case is prepared and presented before the COI Review Committee.
What is the Conflict of Interest Review Committee?
The COI Review Committee is composed of various faculty members, representing different schools across campus, ICAC and IRB representatives, Legal Affair and Ethics representatives, and GTRI compliance officers. The COI Review Committee is tasked with the responsibility to review GA Tech employee’s financial relationships and other non-GA Tech activities that have been disclosed to the COI Management Office in accordance with the GA Tech Conflict of Interest Policy (Faculty Handbook Section 5.6). The Committee reviews employee disclosures and determine whether a conflict exists. If the Committee determines that the conflict is unmanageable then the activity is not approved, therefore not allowed. If yes, then the Committee determines whether the conflict is manageable. If the COI is manageable, the Committee determines the requirements necessary to manage, reduce or eliminate the conflict.
What is generally included in a COI Management Plan?
While all Management Plans are tailored to address the unique conflicts of each case, there do exist general trends. Typically, a Management Plan always includes demands for various disclosures and for mandatory Annual Monitoring Reports.
What is an Annual Monitoring Report and how does it relate to a COI?
An Annual Monitoring Report is mandated by every Management Plan issued by the COI Office. It is the required completion of a “Conflicted Research Form”. This will be sent to you two weeks before the due date mentioned in your Management Plan. They must be completed and submitted by the due date, every year for the life of the grant. If they are not completed in a timely manner, the project is subject to lose funding.
What happens if the COI Committee deems my conflict unmanageable?
If your Conflict of Interest is determined by the Committee, to be unmanageable the proposed activity must be modified so that it can be managed. If this is not possible the activity must be eliminated.
What sort of training is available on Policy requirements and regulatory therein?
Training is available on the extent of Investigator Disclosure, information to be reported to Sponsor (e.g. NIH), information to be made accessible to the public and reporting of reimbursed or Sponsored Travel. A.FCOI training is required for Investigators before engaging in sponsored research immediately under designated circumstances and every four years thereafter. Links to training materials are available on the COI Management Office website. Follow the link below to navigate to these materials.Follow the link below to navigate to these materials. B.Annual Certification Acknowledgement: “I have read, understood and will comply with the Federal regulations and the Georgia Institute of Technology (Institute) policies and procedures regarding Investigator’s responsibilities for disclosing significant financial interests. Detailed information on regulations and policies is available here.”
What regulations govern Georgia Tech’s Conflicts of Interest policies?
Georgia Code of Ethics for Government Service (O.C.G.A. § 45-10-2) NIH Rules - Objectivity in Research:. NSF – Investigator Financial Disclosure Policy: October 7, 1996 Georgia Tech Faculty Handbook – Section 38 “Conflict of Interest and Outside Professional Activities”:
As an Investigator, what is necessary to disclose to the Institute?
All Significant Financial Interests related to the Investigator’s “Institutional Responsibilities” including all consulting relationships as well as other relevant external activities should be disclosed. The Institution is responsible for determining whether a Significant Financial Interest relates to PHS-funded research and if it presents a Financial Conflict of Interest (FCOI).
Where is the Disclosure process completed?
Disclosures are completed via the eCOI system. Use the following link to navigate to the eCOI system.
What are some examples of Start-Up related duties that may present a financial conflict of interest?
A. When faculty members serve as company officers, they owe a fiduciary duty to the company. B. If the faculty member’s fiduciary duty to act in the company’s best interest might conflict with his/her duty to the Institute as an employee. This is one of the reasons why faculty members should never negotiate with the Institute on behalf of their start-ups.
When should I discuss my Start-Up plans with the COI Office?
The best time to address any potential COI is in the landscaping/preliminary phase of the Start-Up. The COI policy plays a significant role in how a Start-Up should be designed. If faculty are aware of the policies beforehand, it is likely that managing any potential conflicts may be easier for both faculty and any other parties involved in the Start-Up.
What role can my students have in Start-Up projects?
Startup company formation and licensure of IP related to GA Tech research is almost always fraught with real and potential conflicts of interests and the Committee is responsible for determining whether conflicts can be managed or eliminated and prohibiting activities that pose unmanageable conflicts of interest. When students are involved in the startup the issues are more complicated and place GA Tech in the position of not only meeting its entrepreneurial goals but also protecting students and the educational mission of the Institute.
What are some examples of Supervisory Conflicts?
A. Example: An Institute employee works for a faculty member’s start-up company and also reports to that specific faculty member at the Institute.
B. The employee’s performance at the company has an impact on the employee’s promotion/salary potential at the Institute.
C. The employee conducts company work on the Institutes time or with the Institutes resources.
D. Mentor’s company employs his/her graduate students or directs student into a project that appears to benefit the mentors company.
Can an Institute facility and resources therein be utilized for a Start-up?
Use of the Institutes resources (including but not limited to computers, email address, phones, office or lab space, lab equipment, or Institutes funds etc.) by a faculty member or company employees to conduct company business or purchase goods and services for the start-up. A clear line must be established that separates Institute activity from company activity. Unauthorized use of Institute facilities or resources for the start-up company’s business may result in termination of employment and possible criminal charges for misuse of State Resources.
May I use my Georgia Tech Email address and or phone for my approved Consulting relationships?
No, institute resources may not be used for any outside professional, for-profit activities. This is clearly stated in the GT policy:Unauthorized use of Institute facilities or resources for the start-up company’s business may result in termination of employment and possible criminal charges for misuse of State Resources.
What should I consider before entering a consulting relationship?
"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. The Institute recognizes that properly managed consulting relationships are a benefit to both the institute and faculty. All faculty, staff and personal must seek prior approval from their department chair before engaging in any consulting activities. Disclosures addressing these relationships must be filed and updated at the following link.
What is “Moonlighting” and how does it relate to Consulting?
"Moonlighting" Employees 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 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. Moonlighting is related to consulting because it does constitute an outside activity however, it is entirely separate and has no effect on a faculty member’s primary obligations to Georgia Tech.
How many days may I allocate for my Consulting relationship?
A limited amount of "averaging" of consulting time is permissible if, on occasion, a Faculty member plans to consult for more than one day per week but no more than thirty-nine days for an academic year. Thirty-nine (39) days of consulting per academic year, or fifty-two (52) days for a calendar year of active duty, is intended to be a liberal allocation, yet one that is fair to the Institute.