Conflict of InterestMichelle Stickler, DEd

mstickler@psu.eduOffice for Research Protections

www.research.psu.edu/orp

PSU Policy

• RA 20: Individual Conflict of Interest– Definitions– COI Committee– Disclosure requirements

• Guideline on disclosure coming soon

Definition:Conflict of Interest

“Situations in which financial considerations may compromise, or

have the appearance of compromising, an employee’s

professional judgment in designing, conducting, evaluating, or reporting

University Research and Technology Transfer programs and

other scholarly activities.”PSU Policy RA 20: Individual Conflict of Interest

Definition: Significant Financial Interest

• Significant Financial or Business Interest– Compensation or other payment for services– Equity interests– Intellectual property rights– Holding a management position or advisory

role

• ≥ 10K or 5% interest• $0 de minimus when human

participants involved

Why do We Care about Financial Ties?

• Financial interests MAY:– Introduce bias into research

design, conduct, or reporting – Place human participants at

greater risk– Compromise students’ academic

pursuits– Misuse university resources

Example 1

• Professor is a majority shareholder in a start up company related to PSU research

• Startup applies for federal funding to do research

Example 2

• Professor involved in a startup; majority shareholder

• Startup gives $9000 gift to the Professor

• Professor wants to use gift to pay grad research assistants for work they had been doing on an NSF grant

Example 3

• Professor holds 10% interest in a company

• Company awarded an SBIR and subcontracts to University to do work

• Professor is the PI on the subcontract• Professor consults for the company

Example 4

• Professor is a paid member of an advisory panel for a for-profit company

• Company sponsors Professor’s research to test a company product on human participants

Potential COI When….

• Sponsored research and equity ownership

• Consulting

• Start-up company

• Student involvement in privately sponsored research

• Human participant research and consulting or advising

Disclosure Requirements

• Annual disclosure

• When submitting proposals or accepting awards

• When submitting IRB applications

• Before involvement in technology transfer

• Prior to business start-up

Disclosure Process

• Complete disclosure forms available on the ORP website: – www.research.psu.edu/orp

• COI Committee reviews• No COI – notified of no further

action needed• Existence of COI – collaboratively

develop a management plan

Management Techniques

• Appoint a monitor• Create clear delineation between University

work and other work• Appoint a student advocate• Disclose COI in consent document• Remove PI from consent process• Recuse PI from daily involvement in

research• Divest PI of financial interest