Conflicts of Interest and Disclosure A Critical Assessment of the Current COI Policy and the Value of Integrity Susan S. Night, JD, LLM health Policy and Ethics Fellow Baylor College of Medicine Houston, Texas

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Conflicts of Interest and Disclosure A Critical
Assessment of the Current COI Policyand the
Value of IntegritySusan S. Night, JD,
LLMhealth Policy and Ethics FellowBaylor
College of MedicineHouston, Texas

• Office of Research Integrity
• 2009 Research Conference on Research Integrity

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Overview

• Integrity
• History
• Disclosure

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Defining Integrity
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Current Perspective

• Integrity in Research
• Individual
• Intellectual honesty
• Objectivity
• Personal responsibility
• Transparency in conflicts of interest or
  potential conflicts of interest
• Institutional
• Promote responsible conduct and foster integrity
• Anticipate, reveal and manage individual and
  institutional conflicts of interest

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Revised Perspective
What are my values and beliefs? What do I think
is right and wrong? What are the standards of my
profession? Do my personal beliefs conflict with
my profession?
Reflection of commitment to beliefs. Standing for
something even at personal cost. Typically
requires courage.
Reevaluate beliefs of right and wrong. Correction
or reevaluation of commitments given changing
circumstances. Integrity as a continuous
process.
Say that ones actions are consistent with what
one believes is right. Forthright in explaining
what one is doing.
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Conflicts of Interest
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Is it possible to promote and even accelerate the
progress of research while maintaining public
trust in research by having a balance in, but not
eliminating industry-academia relationships?
Prohibition
Capitalism
COIs are a prima facie wrong

• Any interaction with drug industry presents
  fundamental COI

• All interactions of physicians with Pharma
  unethical and serious cause of COI

• Zero tolerance policy for IRB members to have
  financial interest in studies

• No legitimate justification for institutional
  decision makers to have financial interest

• Disclosure is only a warning flag to alert
  possibility of future problems, not a fix

• Delicate balance has swung too far toward
  private profit at the expense of public trust

• Unacceptable, faculty members makes decision
  not in institutions interest

• Financial COI of institution subject to
  oversight and management

• COIs are ubiquitous and inevitable, learn to
  recognize and manage them

• Dont promulgate rules that prohibit conduct of
  reasonable corp. research

Academic capitalism is the present and future
of research in AMCs
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What is a COI?

• A conflict of interest may occur when a
• clinician, researcher, public official, IRB
  member, university official, author, reviewer,
  editor
• allows a secondary interest
• financial gain, publication opportunity, career
  advancement, outside employment, personal
  considerations, relationships, investments, gifts
• to interfere with a primary interest
• patient welfare, research validity, publication
  of research, obligation to act in the best
  interest of another

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History of Conflicts of Interest
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History

• Prior to 1940

• 1940s

• Foundations are primary funding source for
  research
• Federal funding threat to scientific freedom
• Employment by industry
• domination by government vs. domination by
  industry

• Research on behalf of the country-partnership
  with industry
• Beginning of federal funding for research
• Mertons objectivity
• COI - meetings

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History

• 1950s

• 1960s

• Industry sponsors retain publication rights and
  restrictions
• COI related to federal employees

• Academia and industry address drug safety
• COI related to defense of public interest
• Federal funding now 60
• AAUP report on COI

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History

• 1970s

• 1980s

• Mandates on disclosing COIs McCarthyism?
• Disclosure more than required by federal statute
• COIs environmental and occupational exposure

• Bayh-Dole
• Pajaro Dunes COIs managed according to special
  circumstances and traditions

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History

• 1990s

• 2000s

• NIH policy on COI withdrawn
• AAMC, AAU, AAHC reports on COI

• 8 reports on guidelines and/or recommendations
  for COI

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Disclosure
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Goal of Disclosure

• Objectivity in research reduce bias
• Prevent harm
• Increase public trust

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Impact of Disclosure

• Advantages
• Consistent with policy approaches in other areas
• Stock analysts
• Sarbanes-Oxley
• McCain-Finegold
• Can help management govern better
• Consistent with principle of autonomy
• Reduces the need for other remedies e.g.
  regulation

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Impact of Disclosure

• Disadvantages
• Shift responsibility away from one who discloses
  caveat emptor
• Does not achieve goal of Objectivity/Elimination
  of Bias
• Implicit and unconscious bias
• Banaji and Loewenstein
• www.tolerance.org/hidden_bias
• Does not meet the criteria for Integrity
• Discernment NO
• Act yes
• Speak yes

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Disclosure in the Real World

• Individual researcher disclosure
• In order to manage this conflict of interest,
  the Committee requires that you keep your
  consulting fees from XXX to an amount equal to or
  less than 10,000 on an annual basis.In doing
  so, you will eliminate your conflict of interest
  as defined by.policies and PHS regulations.
• Institutional Conflict of Interest
• Virginia Commonwealth University
• Master Service agreement with Philip Morris

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Final Thoughts

• History tells the story of collaboration
• Honesty and objectivity disclosure
• Integrity encourages exploration of unconscious
  bias
• What would Cicero say?
• There are 3 questions when considering a course
  of action
• What is honorable?
• What is useful?
• What is apparently useful conflicts with what is
  right
• for when the useful seems to pull them forward
  towards itself and rectitude seems to draw them
  back in its direction, the mind as it reflects is
  tugged in opposite directions, and this makes for
  troubled indecision