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
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
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
Be cognizant of your institution’s culture
Be prepared to propose alternative approaches
Recognize inherent protections
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