Management of Conflicts of Interest Mission Critical in Entrepreneurial Universities

1. Management ofConflicts of InterestMission Critical in Entrepreneurial Universities Dr. Bill Hunt, ProfessorBioengineering, and Microelectronics/Microsystems in the School of Electrical and Computer Engineering

2. Compare and Contrast Conflicts of Interest and Commitment “Conflict of Interest” “Conflict of Commitment” Whenever an individual's outside activities interfere with professional obligations to the Institute a conflict of commitment may exist. The primary guide should be the intention to promote the interests of the Institute as a place of education, learning and research. • Whenever it reasonably appears that a significant financial or other interest could affect the design, conduct, or reporting of activities funded or proposed for funding by a sponsor a conflict of interest exists. • 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 institution. 

3. Legal and Policy FrameworkGIT COI Policy 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 pursuant to the provisions of this policy. Activities which constitute Conflicts of Interest where an employee has a Substantial Interest are unlawful. Full-time employees of the Board of Regents of the University System of Georgia may serve 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. However, full-time employees of the Board of Regents of the University System of Georgia may not serve as a member of a governing board of a for-profit company. Employees shall submit a written disclose not less than annually and, they must re-disclose when it changes, inform their Chair and the Office of Sponsored Programs Office when a submission poses a conflict of interest in sponsored research and they must inform the Institutional Review Board. • Official Code of Georgia 45-10-23, 45-10-24

4. Legal and Policy FrameworkGeorgia Tech Research Corporation & CoI Policy • GTRC is the owner of IP created at the Institute • GTRC is a 501(c)3, Type 3, Functionally Integrated Supporting Organization of GIT • GTRC is responsible for Bayh-Dole and contract compliance • Pre-existing rights • Reporting requirements • Enforceable milestones and diligence provisions are a must • U.S. manufacture • GTRC licenses technology at “fair market value” and is mindful of: • Obligations to all inventors • Obligations to get technology into the marketplace • Excess benefit transactions • Patent cost recovery • GTRC is also mindful of common conflicts • Option Briar Patch • Other research agreements • GTRC has its own CoI policy • Institutional Conflicts of Interest • GTRC does not vote in company shareholder actions • GTRC does not join LLCs

5. Situations That Give Rise to Conflicts of Interest and Commitment • Professional or scholarly interest in the outcomes of research • Authorship of scholarly works or teaching materials • Family employment or business relationships • Consulting agreements • Intellectual property licensing • Outside financial interests • Outside professional activities

6. Sometimes it seems as though the role of Technology Transfer is to create Conflicts of Interest • Faculty Start-Ups • License Technology from the Institution • Sponsor Research at the Institution • Involve students of the Institution • Conduct human studies • Institutional Conflict of Interest • If the institution owns equity, its decisions may not be viewed as unbiased • If an institution accepts funding from a company its research and decisions may not be viewed as unbiased

7. University Concerns The university3 must protect itself and its faculty, staff and students from any of the following allegations: • exploitation of students for private gain • undue personal gain from public funds • compromise of university priorities due to financial considerations • unfair access by a company to information or technology 3. From the Stanford University Conflict of Interest Policy http://www.stanford.edu/dept/DoR/Resources/coi.html

8. University Concerns The university3 must protect itself and its faculty, staff and students from any of the following allegations: • compromise of appropriate controls in the conduct of research such that research subjects could be harmed • use of university resources for private gain • adverse effect by those in leadership roles on the professional or academic advancement of colleagues, staff or students as a result of outside interests. 3. From the Stanford University Conflict of Interest Policy http://www.stanford.edu/dept/DoR/Resources/coi.html

9. CoI Management Plans • 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 • Provision for the employment of university students • Disclosure requirements • Relationship to other funded projects &/or proposals • Designation of parties responsible for review

10. Special Cases: GRA Funding and Other External Funding for Translational Research • Phase 0 through Phase II GRA grants are Institute funds and must be spent for translational research! • Coulter Funds are the result of a donation to the Georgia Tech Foundation and are spent as Institute funds for translational research.

11. Special Cases: GRA Funding and Other External Funding for Translational Research • Faculty members and employees of Georgia Tech must maintain a strict separation between activities performed for GT and those performed for the company in which they have or may have interests as a result of commercialization of the subject technology. • These funds cannot be used to compensate any founders or employees of the subject companies or others with a financial interest in the company. • Normal Purchasing rules apply. • Normal IRB, IACUC, biosafety, radioisotope rules, et ceteraapply. • IP that results from these projects will be assigned to GTRC and must be licensed under a separate license or license amendment. • Research projects undertaken with a goal of readying the technology for commercialization in a start-up company must be carefully firewalled from other research projects conducted by the individuals involved.

12. Special Cases: STTRs & SBIRs • Management Plan must Address • PI for the company • May not be a full time GT employee • May not be a full time GT student • PI for the award to Georgia Tech • Students; students advised or supervised by an individual with a conflict of interest involving a company funding not be involved in projects funded by that company at Georgia Tech • Level of ownership by Georgia Tech faculty, inventors, family • Relationship to ongoing and proposed research – whether federally or privately funded – in Georgia Tech • Design of research projects – avoidance of “pipelining” • Conduct – allocation of resources; data integrity • Reporting of research results – objectivity in research; insider information • Time and Effort Reporting – A Special Concern

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20. Other Common Conflicts of Interest Situations Consulting Agreements between faculty and research sponsors Consulting arrangements between faculty and companies based on their technologies. Interests senior officials, those whose jobs involve technology transfer or commercialization, and supervisors may have in start-up companies or licensees. Gifts or donations made by start-up companies or other licensees to the Georgia Tech Foundation.

21. Other Common Conflicts of Interest Situations Particularly associated with start-up companies based on Georgia Tech technology. Interests senior officials, those whose jobs involve technology transfer or commercialization, and supervisors may have in start-up companies or licensees. Gifts or donations made by start-up companies or other licensees to the Georgia Tech Foundation. These individuals are generally recused from financial, managerial or compensated roles in GT start-ups. Gifts should not be controlled by anyone with a financial or other interest in the donor.

22. Roadmap for Start-Ups! • Avoid substantial conflicts of interest & conflicts of commitment. • Firewall ongoing research from translational • research and company formation. • Do not involve students advised or taught by • faculty involved in the company • (unless they are also inventors). • Faculty with a yen to run a • company may wish to consider • a leave of absence. • Outside entities cannot use Georgia Tech • facilities without compensation and there are • formal mechanisms for doing that. • Tip: don’t use GT e-mail, address, or phone • number for the company unless it’s in ATDC. • DISCLOSURE, DISCLOSURE, DISCLOSURE!