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? What questions do you have related to

COI and entrepreneurial activities?

The Current Conflict Landscape

Institutional

Research and Scholarly Activity

Business Academics

Clinical

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