1. Conflict of Interest and Technology Transfer Sherrie Settle Assistant Director, Research Compliance Program Institutional Conflict of Interest Officer March 5, 2009

2. What Is It? Conflict of interest relates to situations in which financial or other personal considerations may compromise, may involve the potential for compromising, or may have the appearance of compromising an employee’s objectivity in meeting University duties or responsibilities, including research activities. Conflict of interest relates to situations in which financial or other personal considerations may compromise, may involve the potential for compromising, or may have the appearance of compromising an employee’s objectivity in meeting University duties or responsibilities, including research activities. - UNC Policy Manual - UNC Policy Manual

3. Academic-Corporate Relationship Context Go, do! Go, do! Bayh-Dole Act Bayh-Dole Act Economic development mandate Economic development mandate Institutional support of entrepreneurial activities Institutional support of entrepreneurial activities Policy on External Professional Activities for Pay Policy on External Professional Activities for Pay Wait, stop! Public/Media Public/Media –High profile cases –Skepticism Professional Association Guidelines Professional Association Guidelines Legislation Legislation Legislators Legislators Sponsor regulations Sponsor regulations

4. So how do I eliminate Conflicts of Interest while working with corporate partners? You don’t. You minimize and manage them.

5. Conflict is Inherent to Research Enterprise COI is a situation, a confluence of potentially competing factors that arise when roles and relationships have different objectives COI is not a reflection of character or integrity Entrepreneurial faculty will have these conflicts

6. Not Everyone Sees It That Way….

7. What Do You Do? University: Write and direct research protocols Write and direct research protocols Grants and contracts Grants and contracts Publish Publish Precept trainees Precept trainees Supervise staff Supervise staff Develop and patent new technologies Develop and patent new technologiesCompany: Equity Equity Royalties/Licensing Royalties/Licensing Office/Board Office/Board Consulting Consulting Promotion Promotion Develop and patent new technologies Develop and patent new technologies Any of these may introduce conflicts of interest when company responsibilities intersect with University duties

8. Personal Financial Interests Anything of real or potential value Income Income Equity Equity Royalties/licensing fees Royalties/licensing fees Indirect – family member Indirect – family member

9. Non-Financial Interests Board membership Board membership Executive position Executive position Scientific or technical advisor Scientific or technical advisor Trustee Trustee

10. What are the Potential Problems? “Pipelining” of University technologies “Pipelining” of University technologies Biased Research Biased Research –SBIR/STTR Placing Study Subjects at Risk Placing Study Subjects at Risk Exploiting Students/Trainees Exploiting Students/Trainees Use of University resources to advance personal interests Use of University resources to advance personal interests Unfair Purchasing/Contracting Unfair Purchasing/Contracting Gifts exert influence Gifts exert influence

11. Management Principles Transparency Transparency Separation Separation Independence Independence Protection of Human Subjects Protection of Human Subjects Protection of Trainee Experience Protection of Trainee Experience

12. Management Tools Management Agreements Management Agreements Public Disclosure Public Disclosure –Publications –Presentations –Research Group Independent Review Panels Independent Review Panels Monitoring Committees Monitoring Committees Facilities Use Agreements Facilities Use Agreements Alternative Options for Trainees Alternative Options for Trainees

13. Best Practices All agreements negotiated independently by appropriate University offices (OTD, Sponsored Research, OCT, University Counsel) All agreements negotiated independently by appropriate University offices (OTD, Sponsored Research, OCT, University Counsel) Clear separation of personnel, funds and supplies Clear separation of personnel, funds and supplies Transparent boundaries between University and company activities Transparent boundaries between University and company activities Care of each party’s confidential information Care of each party’s confidential information

14. The Problem with Wearing Multiple Hats… …is that you only have one head. Your role in any transaction determines whose interests you represent and what resources you can command.

15. So What Happens? Declare external relationships prior to licensing negotiation Declare external relationships prior to licensing negotiation Policy: Individual who holds equity in, is an officer or director of, or provides consultative services to an entity that has licensed or otherwise acquired rights to University invention(s) will be deemed to have a Conflict of Interest

16. So What Happens? Review what University activities could be affected: Review what University activities could be affected: –Research activity –Trainee projects –Other supervisory roles –Administrative responsibilities Develop plan to manage Develop plan to manage

17. Who Is Involved? University Researcher – critical University Researcher – critical Supervisor Supervisor Technology Development Technology Development School COI Committees School COI Committees Monitoring Committees Monitoring Committees COI Officer COI Officer This team protects the University’s interests and the inventor

18. Not All Conflicts Can Be Managed Complexity of relationships obscures boundary between University and company activity, decision-making and accountability Complexity of relationships obscures boundary between University and company activity, decision-making and accountability Rebuttable presumption that investigator may not participate in human subjects research in which s/he has a financial interest Rebuttable presumption that investigator may not participate in human subjects research in which s/he has a financial interest

19. Conflicts of Commitment Primary responsibility to the University Primary responsibility to the University External Professional Activities for Pay External Professional Activities for Pay Approval by chair or dean Approval by chair or dean No entitlement to a specific number of days for external activities No entitlement to a specific number of days for external activities Uncompensated activities also take time Uncompensated activities also take time

20. Institutional COI University financial interests: University financial interests: –Royalties/licensing fees –Equity –Personal interests of decision-makers Concerns: Concerns: –Biased review –Unfair business practice –Risk to study subjects

21. Management Not Cure

22. Who’s Looking? Government Government Sponsors Sponsors Competitors/peer institutions Competitors/peer institutions Employees/colleagues Employees/colleagues Media Media Public Public

23. Safeguards Transparency Transparency –Institution (event-based disclosures) –Supervisor (annual review) –Staff –Trainees Maintain boundaries Maintain boundaries Adhere to management plans Adhere to management plans

24. How does all of that really work? Dhiren R. Thakker, PhD UNC Eshelman School of Pharmacy

25. Questions?