1. Conflict of Interest Michelle Stickler, DEd mstickler@psu.edu Office for Research Protections www.research.psu.edu/orp

2. PSU Policy RA 20: Individual Conflict of Interest –Definitions –COI Committee –Disclosure requirements Guideline on disclosure coming soon

3. 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

4. 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

5. 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

6. Example 1 Professor is a majority shareholder in a start up company related to PSU research Startup applies for federal funding to do research

7. 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

8. 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

9. 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

10. 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

11. Disclosure Requirements Annual disclosure When submitting proposals or accepting awards When submitting IRB applications Before involvement in technology transfer Prior to business start-up

12. 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

13. 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