2013 kiec - the entrepreneurial faculty: balancing academic and entrepreneur roles
DESCRIPTION
KIEC 08.29.2013, Session 8A, Debbie Davis and Allison RattermanTRANSCRIPT
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Navigating Conflicts of Interests in Research: Balancing Faculty and Entrepreneur Roles
Debbie Davis
Associate Vice President for Research
Director , Office of Sponsored Projects Administration
University of Kentucky
Allison Ratterman, Ph.D.
Director, Research Integrity Program
University of Louisville
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Conflict of Interest is not a “four letter word”…
but even in the best of times
it can be confusing to navigate
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Audience Breakdown
Universities Start Ups Active Projects Consultants
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Session Goals
Why did you join us? What questions do you have related to
COI and entrepreneurial activities?
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The Current Conflict Landscape
Institutional
Research and Scholarly Activity
Business Academics
Clinical
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Conflicts of Interest are a reality
Having a Conflict of Interest is not necessarily a deal breaker
Faculty and staff have external interests and activities that may conflict with their university roles.
The vast majority of identified conflicts are manageable
Policies and procedures are in place to mitigate identified conflicts and provide protections for the research
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Where the conflicts are…
Ownership of external entity Fiduciary responsibility to external entity Receiving wage/salary from external
entity Receiving gifts from external entity Royalty stream in conjunction with
ownership
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Where the conflicts are…
Using university role to benefit external entity
Involving students / trainees in external entity
Subcontracting to own university lab Subcontracting to own start-up company
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Common Pitfalls
Failure to disclose or fully disclose external relationship
Inability to seek alternate solutions Failure to understand applicable
regulations and policies Failure to abide by approved management
strategies Submitting incomplete/inadequate
rebuttable presumption
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Revised Federal COI Regulations
Went into effect on August 24, 2012 Key issue for entrepreneurs ◦ Small businesses seeking Phase II SBIR/STTR
funding must be in compliance with COI rules ◦ Cannot rely on policies/procedures of home
institution (sub-contractors)
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Navigating the Conflict Management Process
Fully disclose external relationships at the outset
Be cognizant of your institution’s culture
Be prepared to propose alternative approaches
Recognize inherent protections
Have an exit strategy
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Rebuttable Presumption ◦ What is it? Documents steps taken to address the preservation
of research integrity
◦ Why do I need one? Opportunity to present argument to reviewing
person/body that you should be able to participate in the project despite the presence of COI
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Keys to a strong rebuttable presumption
• Clarity of relationship to external entity • Nature of interest • Magnitude of interest
• Clarity of Role on project(s) • Clarity of protections
• Research • Human Subjects, if applicable
• Extent of potential financial gains • Potential and likelihood for oversight • Specificity of response • Exit strategy
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Questions