Conflict of Interest

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Conflict of Interest

• Michelle Stickler, DEd
• mstickler_at_psu.edu
• Office for Research Protections
• www.research.psu.edu/orp

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PSU Policy

• RA 20 Individual Conflict of Interest
• Definitions
• COI Committee
• Disclosure requirements
• Guideline on disclosure coming soon

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DefinitionConflict of Interest

• Situations in which financial considerations
  may compromise, or have the appearance of
  compromising, an employees 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
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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

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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

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Example 1

• Professor is a majority shareholder in a start up
  company related to PSU research
• Startup applies for federal funding to do research

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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

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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

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Example 4

• Professor is a paid member of an advisory panel
  for a for-profit company
• Company sponsors Professors research to test a
  company product on human participants

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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

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Disclosure Requirements

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

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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

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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