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Conflict of Interest and Technology Transfer Sherrie Settle

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

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Conflict of Interest and Technology Transfer Sherrie Settle

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  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.  - UNC Policy Manual

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

  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. University: Write and direct research protocols Grants and contracts Publish Precept trainees Supervise staff Develop and patent new technologies Company: Equity Royalties/Licensing Office/Board Consulting Promotion Develop and patent new technologies What Do You Do? 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 • Equity • Royalties/licensing fees • Indirect – family member

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

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

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

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

  13. Best Practices • All agreements negotiated independently by appropriate University offices (OTD, Sponsored Research, OCT, University Counsel) • Clear separation of personnel, funds and supplies • Transparent boundaries between University and company activities • 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 • 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: • Research activity • Trainee projects • Other supervisory roles • Administrative responsibilities • Develop plan to manage

  17. Who Is Involved? • University Researcher – critical • Supervisor • Technology Development • School COI Committees • Monitoring Committees • 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 • 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 • External Professional Activities for Pay • Approval by chair or dean • No entitlement to a specific number of days for external activities • Uncompensated activities also take time

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

  21. Management Not Cure

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

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

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

  25. Questions?

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