Ethical Issues for Institutional Review Boards: Conflicts of Interest

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• Ethical Issues for Institutional Review
  BoardsConflicts of Interest
• Alan Sanders, PhD(c)
• Director, Center for Ethics
• Saint Josephs Health System, Atlanta, GA
• System Ethicist
• Catholic Health East
• WWW.CHE.ORG/ETHICS

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Etiquette

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Conflict of Interest

• A conflict of interest is a situation in which
  someone has competing professional, personal,
  social, etc., obligations. A conflict of interest
  arises when anyone has competing obligations
  within one area of concern or between different
  areas of concern.
• These competing obligations can make it difficult
  for the person to fulfill his or her role. The
  conflict may involve no unethical or improper
  acts, but it can create an appearance of
  impropriety that may undermine confidence and
  trust in the person or system in which the person
  operates.

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General Examples

• A For-Profit Health System
• A Working Parent
• Self Appointed Congressional pay raises
• A Pharmaceutical Company
• Knowledge of impropriety of a trusted friend
• Marriage
• Some of these examples are intended for humor,
  but also to demonstrate that not all conflicts of
  interest are substantial ethical issues.

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Conflicts of Interest in Research

• Therapy versus Research
• Payment for Recruitment
• Ownership and Financial Interest
• Notoriety, Professional Advancement
• Academic Institutions and Private Industry

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Examples

• Tobacco The Classic Example
• The Gelsinger Case
• Nancy Olivieri
• David Healy
• Vioxx and Celebrex
• Antidepressants Suicide Adolescents
• Synthroid

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Conflicts of Interest on the Large Scale

• Politics
• Profit
• Prestige
• Career Advancement

• Integrity
• Selective suppression or emphasis
• Debated interpretations
• Questionable protocols

• Harm
• Human Subjects
• Adverse Events
• Investigators
• Undermine Confidence

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Resources

• Sismondo, S. Ghost Management How Much of the
  Medical Literature is Shaped Behind the Scenes by
  the Pharmaceutical Industry? PLoS Medicine
  www.plosmedicine.org Sept. 2007, Volume 4, Issue
  9, e286.
• Trotter, G. "Interpreting Scientific Data
  Ethically A Frontier for Research Ethics." In
  Research Ethics, Ana Iltis (Ed). Routledge, New
  York 2006.

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NIH

• Maintain a written, enforced policy on financial
  conflict of interests
• Inform research investigators of that policy, the
  associated reporting responsibilities, and
  related federal regulations
• Report to awarding offices the existence of any
  conflicts of interests and assure that interests
  have been managed, reduced, or eliminated

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NIH

• Ask investigators to complete a short
  questionnaire in which they are asked whether
  they or any other person responsible for the
  design, conduct, or reporting of this research
  has an economic interest in, or acts as an
  officer or a director of any outside entity whose
  financial interests would reasonably appear to be
  affected by, the research.
• Provide instruction to IRB members during their
  orientation on how to identify and respond to a
  perceived financial, academic, or other conflict
  of interest.

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Conflicts of Interests IN the IRB?

• Who is on the IRB?
• What other positions do they hold?
• What is their political/financial power within
  the organization?
• What importance does research play to the
  organization?

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Case 1

• The IRB at a local hospital is getting ready to
  examine a new Cancer protocol. The principal
  investigator of this particular protocol, who is
  on the IRB, is asked to leave for the discussion,
  she returns when the discussion is over.

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Case 2

• Saint Under Pressure has a large financial leg in
  its research organization. Other portions of the
  system, such as the hospital, are suffering
  financially and really depend on the success of
  their research program. They are currently
  reviewing the protocol of an investigator who is
  a high performer and brings in a large portion of
  money to the organization.

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Case 3

• The IRB at Saint Small Community needs another
  scientifically trained person on their IRB. The
  VP of the Oncology Services at the institution
  volunteers. A large portion of the protocols at
  this institution are cancer trials.

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Case 4

• Doctor M. submits a new protocol. The IRB
  recommends numerous changes before approval and
  has serious concerns about the protocol. Doctor
  M. is good friends with the chair of the IRB.
  Doctor M. asks the chair during a game of golf
  why the IRB is taking so long and giving him so
  much trouble over his protocol.

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Case 5

• The IRB is currently reviewing a protocol testing
  for a new cardiac drug to be tested in
  conjunction with the current standard of care.
  Doctor C, who is on the IRB, is not an
  investigator on this protocol, but she practices
  in the same cardiac group as the principal
  investigator.

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Case 6

• A nurse believes that a protocol involving
  children should have a separate assent form for
  children over the age of 14 as well as an
  informed consent form for parents. The chair of
  the IRB, a physician, disagrees because he
  believes that the informed consent form is
  enough, and doctors have enough forms to deal
  with anyway.

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Conflicts of Interest In the IRB?

• Politics
• Profit
• Prestige
• Career Advancement

• Integrity
• Selective suppression or emphasis
• Debated interpretations
• Questionable protocols

• Harm
• Human Subjects
• Adverse Events
• Investigators
• Undermine Confidence

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Conflicts of Interest on the Large Scale

• Politics
• Profit
• Prestige
• Career Advancement

• Integrity
• Selective suppression or emphasis
• Debated interpretations
• Questionable protocols

• Harm
• Human Subjects
• Adverse Events
• Investigators
• Undermine Confidence

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Discussion