Conflict of Interest (COI) and the Consent Process

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Conflict of Interest (COI) and the Consent Process

• Role of the Physician/ Investigator

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COI and the Consent Process

• Fall 2003 Mary Weiss convinced her 26 year old
  son to come home to Minnesota where she could
  help him get treatment for his apparent
  psychiatric illness
• November 2003 Dr. Stephen Olson, MD recommended
  that the patient be committed to a state facility
  because of his delusions

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COI and the Consent Process

• Mid November, Dr. Olson changed his opinion and
  declared Mr. Markingson had begun to acknowledge
  his need for treatment
• November 20,2003, a judge ordered Mr. Markingson
  to follow Dr. Olsons treatment plan

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COI and the Consent Process

• November 21, 2003, the subject signed an informed
  consent document to be a volunteer in the
  antipsychotic drug study called CAFÉ, Comparison
  of Atypicals for First Episode (randomization
  between Zyprexa, Risperdal or Seroquel). He also
  signed a hospital discharge summary that told him
  to follow Olsons instructions, take his
  medication and attend all study appointments

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COI and the Consent Process

• Winter, 2003, 2004 Markingson received Seroquel,
  is a psychotropic agent belonging to a chemical
  class, the dibenzothiazepine derivatives

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COI and the Consent Process

• December 8th, 2003, the Mr. Markingson was
  transferred to a half way house
• Winter 2004, his mother wrote Dr. Olson and Dr.
  Charles Schulz head of the University of
  Minnesotas psychiatry department, about her
  concerns regarding her sons continued delusions
  and that they consider other treatment

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COI and the Consent Process

• She considered but did not achieve legal
  guardianship.
• May 8, 2004, Mr. Markingson killed himself and
  upon autopsy, no drug was found in his system

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COI and the Consent Process

• Many questions regarding the consent process are
  raised by this case
• Capacity
• Comprehension
• Coercion

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COI and the Consent Process

• The patients mother claimed in a law suit that
  the investigator had a conflict of interest since
  he had the dual role as her sons primary
  physician who diagnosed his schizophrenia and the
  investigator who determined he met eligibility
  criteria for the clinical trial.

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COI and the Consent Process

• The universitys web site offers guidance and
  advises recruiting in a non-biased
  non-power-based manner and goes on that doctor
  patient relationships between the investigator
  and participants should be avoided, when
  possible, to eliminate any-power based coercion.

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COI and the Consent Process

• Pose this question
• Should physician/ investigator who has this dual
  role be the one to manage the consent process
  with a prospective participant or
• is the perception of COI or the danger of a COI a
  real concern

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COI and the Consent Process

• A conflict of interest is a set of conditions in
  which professional judgment concerning a primary
  interest tends to be unduly influenced by a
  second influence.
• Conflicts of interest are conditions not
  behaviors

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COI and the Consent Process

• Financial conflicts of interest are well
  recognized, specifically in the realm of
  pharmaceutical sponsored clinical trials
• Potential for non financial conflicts of
  interests between the personal interests and
  agendas of the investigator and those of subjects
  is inherent in all research involving human
  subjects

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COI and the Consent Process

• Examples of these non financial conflicts
  include
• Benefits of publications, grants,
• Need for future funding
• pressures to complete a study and publish
  positive results
• The conflicts cannot be eliminated, but need to
  be recognized and managed if risks to subjects
  are to be minimized

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COI and the Consent Process

• If an investigator is also the personal health
  provider of the potential research participant,
  there may be an additional conflict.
• Therapeutic misconception on the part of the
  potential participant
• Confusion on the part of physician/researcher
  regarding his/her role as care giver and
  investigator
• Fear on the part of the participant that he/she
  will disappoint or anger the physician if he/she
  does not agree to participate

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COI and the Consent Process

• Yes, the physician already knows the patient,
  history etc. and there is the belief that
  physicians can judiciously balance the patients
  interests and those of the scientific protocol
• No, the physician can become conflicted by the
  two roles and the patient can also become
  confused and see the investigator only as a
  caregiver

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COI and the Consent Process

• According to Alan Sugar MD, chair of the New
  England Institutional Review Board and professor
  of Medicine at BU, the problem is exacerbated
  when people are vulnerable, such as psychiatric
  patients. The IRB cannot resolve the problem, but
  must be aware of these issues, discuss options
  and offer viable solutions

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COI and the Consent Process

• There are others who believe that all prospective
  participants who receive treatment as part of the
  clinical trial or who receive free services as
  part of the research are just as vulnerable

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COI and the Consent Process

• Proposed Solutions
• Have another investigator present the consent
  form and manage the process after the physician
  has identified that the patient may be eligible
  for the study. This person can also be available
  to answer questions.
• Education for physician/researcher to review
  regulations, the consent process and the dangers
  of COI or the perception of COI

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COI and the Consent Process

• Continued education for the IRB members
• Assessment of policies and procedures at your
  institution
• Monitoring of the consent process for high risk
  studies

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COI and the Consent Process

• None of these solutions is perfect.
• Non financial conflicts of interest are more
  subtle and cannot be eliminated
• Require vigilance on the part of the IRB,
  institutional leaders research mentors if they
  are to be managed successfully