Conflict of Interest and

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

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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 employees objectivity in meeting
  University duties or responsibilities, including
  research activities. 
• - UNC Policy
  Manual

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Academic-Corporate Relationship Context

• Wait, stop!
• Public/Media
• High profile cases
• Skepticism
• Professional Association Guidelines
• Legislation
• Legislators
• Sponsor regulations

• Go, do!
• Bayh-Dole Act
• Economic development mandate
• Institutional support of entrepreneurial
  activities
• Policy on External Professional Activities for
  Pay

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So how do I eliminate Conflicts of Interest while
working with corporate partners?

• You dont.
• You minimize and manage them.

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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

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Not Everyone Sees It That Way.
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What Do You Do?

• 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

Any of these may introduce conflicts of interest
when company responsibilities intersect with
University duties
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Personal Financial Interests

• Anything of real or potential value
• Income
• Equity
• Royalties/licensing fees
• Indirect family member

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Non-Financial Interests

• Board membership
• Executive position
• Scientific or technical advisor
• Trustee

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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

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Management Principles

• Transparency
• Separation
• Independence
• Protection of Human Subjects
• Protection of Trainee Experience

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Management Tools

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

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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 partys confidential information

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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.

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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

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So What Happens?

• Review what University activities could be
  affected
• Research activity
• Trainee projects
• Other supervisory roles
• Administrative responsibilities
• Develop plan to manage

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Who Is Involved?

• University Researcher critical
• Supervisor
• Technology Development
• School COI Committees
• Monitoring Committees
• COI Officer
• This team protects the Universitys interests and
  the inventor

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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

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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

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Institutional COI

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

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Management Not Cure
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Whos Looking?

• Government
• Sponsors
• Competitors/peer institutions
• Employees/colleagues
• Media
• Public

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Safeguards

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

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How does all of that really work?

• Dhiren R. Thakker, PhD
• UNC Eshelman School of Pharmacy

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Questions?