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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. What Is It?.

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slide1
Conflict of Interest and

Technology Transfer

Sherrie Settle

Assistant Director, Research Compliance Program

Institutional Conflict of Interest Officer

March 5, 2009

what is it
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

academic corporate relationship context
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
so how do i eliminate conflicts of interest while working with corporate partners

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

You don’t.

You minimize and manage them.

conflict is inherent to research enterprise
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

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

What Do You Do?

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

personal financial interests
Personal Financial Interests

Anything of real or potential value

  • Income
  • Equity
  • Royalties/licensing fees
  • Indirect – family member
non financial interests
Non-Financial Interests
  • Board membership
  • Executive position
  • Scientific or technical advisor
  • Trustee
what are the potential problems
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
management principles
Management Principles
  • Transparency
  • Separation
  • Independence
  • Protection of Human Subjects
  • Protection of Trainee Experience
management tools
Management Tools
  • Management Agreements
  • Public Disclosure
    • Publications
    • Presentations
    • Research Group
  • Independent Review Panels
  • Monitoring Committees
  • Facilities Use Agreements
  • Alternative Options for Trainees
best practices
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
the problem with wearing multiple hats
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.

so what happens
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
so what happens1
So What Happens?
  • Review what University activities could be affected:
    • Research activity
    • Trainee projects
    • Other supervisory roles
    • Administrative responsibilities
  • Develop plan to manage
who is involved
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

not all conflicts can be managed
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
conflicts of commitment
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
institutional coi
Institutional COI
  • University financial interests:
    • Royalties/licensing fees
    • Equity
    • Personal interests of decision-makers
  • Concerns:
    • Biased review
    • Unfair business practice
    • Risk to study subjects
who s looking
Who’s Looking?
  • Government
  • Sponsors
  • Competitors/peer institutions
  • Employees/colleagues
  • Media
  • Public
safeguards
Safeguards
  • Transparency
    • Institution (event-based disclosures)
    • Supervisor (annual review)
    • Staff
    • Trainees
  • Maintain boundaries
  • Adhere to management plans
how does all of that really work

How does all of that really work?

Dhiren R. Thakker, PhD

UNC Eshelman School of Pharmacy