2013 KIEC - The Entrepreneurial Faculty: Balancing Academic And Entrepreneur Roles

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

Conflict of Interest is not a “four letter word”… but even in the best of times it can be confusing to navigate

Audience Breakdown Universities Start

Ups Active Projects Consultants

Session Goals Why did you join us? ď‚— What questions do you have related to COI and entrepreneurial activities? ď‚—

The Current Conflict Landscape Institutional

Clinical

Academics

Research and Scholarly Activity

Business

Conflicts of Interest are a reality 

Having a Conflict of Interest is not necessarily a deal breaker

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Faculty and staff have external interests and activities that may conflict with their university roles.

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The vast majority of identified conflicts are manageable

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Policies and procedures are in place to mitigate identified conflicts and provide protections for the research

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 

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 

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 

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)

Navigating the Conflict Management Process 

Fully disclose external relationships at the outset

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Be cognizant of your institution’s culture

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Be prepared to propose alternative approaches

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Recognize inherent protections

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Have an exit strategy

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

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

Questions