Conflict of Interest in Human Subjects Research

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Conflict of Interest in Human Subjects Research
Bette-Jane Crigger, PhD
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Diverging Interests Competing Responsibilities
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Defining conflict of interest

• Over and under interpreted
• Not every financial interest is a conflict of
  interest, ethically or legally
• Not every conflict of interest involves financial
  interests

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• Conflicts of interest are a set of conditions
  in which professional judgment concerning a
  primary interest (such as a patients welfare or
  the validity of research) tends to be unduly
  influenced by a secondary interest (such as
  financial gain).

Bekelman JE, Li Y, Gross CP. Scope and impact of
financial conflicts of interest in biomedical
research. A systematic review. JAMA
2003289454-65, 454 emphasis added.
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Conflict of interestwhy worry?

• Potential adverse effects on
• Safety, well-being and rights of human research
  participants
• Integrity of research and quality of data
• Dissemination of data and scientific
  collaboration
• Public safety and well-being
• Public trust in the research enterprise

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Types of conflict

• Conflicts involving benefits received (financial,
  professional, etc.)which can be institutional as
  well as individual
• Conflicts involving dual roleswhich again can be
  individual or institutional
• Conflicts involving institutional structures and
  processes

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Benefit-driven conflicts

• Significant financial interest
• Consulting fees, honoraria, gifts, in kind
  compensation from a financially interested
  company
• Equity interests
• Royalty income
• Nonroyalty income not directly related to the
  costs of the research
• Service as an officer, director, or in another
  fiduciary role for a financially interested
  company

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Role-driven conflicts

• Incommensurate responsibilities
• Clinician-investigator
• Promote the health and welfare of the individual
  patient
• Promote the advancement of science in the public
  interest

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• IRB
• Protect human subjects of research
• Serve the interests of the research institution

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Structural conflicts--IRBs

• Reporting relationships that can compromise
  independence
• Disproportionate representation among members
• Institutional vs. noninstitutional
• Professional vs. lay
• Departmental/disciplinary diversity

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Managing conflict

• Conflicts involving benefits received
• Disclose competing interests
• Monitor conduct of research
• Divest
• Forgo research in which there are significant
  conflicts that cannot be effectively managed

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• Conflicts involving multiple roles
• Disclose research responsibilities
• Prohibit recruitment by treating health care
  professional
• Prohibit research involving investigators
  current/former patients

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• Structural conflicts
• Maintain structural distance in reporting
  relationships
• Separate responsibilities for financial decisions
  and research decisions
• Assure diversity of perspectives and
  institutional relationships in IRB composition