Case Study

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Case Study 1

• Presented by
• Joan P. Porter, DPA, MPH, CIP
• and
• Karen M. Smith, PhD

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Disclaimer

• Case Studies These cases are hypothetical and
  drawn from a number of compliance problems noted
  in both the VA system and the wider research
  community. Any resemblance to an actual case is
  purely coincidental.

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Allegations

• PI who was also Marys physician enrolled subject
  in two research studies without consent.
• PI enrolled Mary in two research studies for
  which she was not eligible.
• Enrollment contributed to Marys death.
• PI committed misconduct.
• Complainant has contacted numerous oversight
  offices.

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? Whom would you notify about this allegation at
this point, if anyone? ? How seriously should
you take the research misconduct allegations? ?
How seriously should you take the noncompliance
allegations? ? What would you do next?
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? Have all of the appropriate individuals/offices
been notified? ? Has the initial response to
these allegations been handled properly? ?
Should the investigation of misconduct be
combined with the investigation of noncompliance
with human subject protection requirements, or
conducted separately?
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You have ensured that all relevant facility
officials and regulatory agencies/offices have
been informed. ? What kind of information do
you need next? ? Where do you find it? ? How
do you know when you have all the relevant
information?
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What We Know

• Dr. Q says that Mary was not enrolled in study
  VA-123, a natural history study. He gave her
  drug VA-123 as the standard of care.
• Dr. Q recalls that Mary was also enrolled in
  VA-xyz, involving an investigational drug being
  studied to see if it would ameliorate the side
  effects of drug 123 Mary was receiving as the
  standard of care.
• There is incomplete documentation for study
  VA-123 and no study documentation for Marys
  enrollment in study VA-xyz.

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? What actions, if any, are warranted at this
point in your inquiry? ? What should you do
next?
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What We Know

• Medical record shows drug 123 was given to Mary
  and at the same time as drug xyz.
• Drug 123 was stopped when Mary was hospitalized
  with pneumonia and for a time thereafter. Drug
  xyz was stopped also.
• When drug 123 treatment resumed, drug xyz was
  also resumed.

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? What do you do next?
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What We Know

• Mary appears to have been enrolled in VA-xyz.
• Mary appears to have suffered an adverse event
  while participating in VA-xyz.

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? What do you do next?
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? Is resumption of treatment with drug xyz, when
Mary is not enrolled in study VA-xyz, an
acceptable practice? Why or why not? ? Are
there any other places you might go to obtain
further information about Marys involvement in
research?
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Assume this is all the information you can
obtain. ? What do you conclude about
the research misconduct allegation? ? What is
your rationale for that conclusion?
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? What else, if anything, should you do at this
point regarding the research misconduct
allegation?
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You still have concerns about Marys research
involvement. ? What area of noncompliance, or
possible noncompliance, have you identified? ?
What is the appropriate official or body at
your institution to deal with these
findings? ? What corrective actions, if any,
would you recommend to that official or body?
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What We Know

• The subject participated in two research
  protocols, VA-123 and VA-xyz.
• The subject participated only in the screening
  phase of VA-123. She was not eligible for
  participation in the natural history portion of
  the study. Drug 123 was given to her as standard
  of care.
• The subject was enrolled in VA-xyz, but her
  participation was not documented in her medical
  record or in Dr. Qs study files.
• The subject was withdrawn from VA-xyz, but was
  later treated with drug xyz, an approved drug for
  another use, off label.

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What We Know

• Files for these studies were not properly
  maintained by Dr. Q.
• A serious adverse event was not reported to the
  IRB nor documented in the study files.
• The subject was not enrolled in any research
  studies for at least 8 months before her death.
• The VA Form 10-1086 was not used for either
  VA-123 or VA-xyz. This is in accordance with
  your local policy, but ORO informs you that it is
  not compliant with VA policy.

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? Are there any additional actions
or remediation that you would recommend to the
IRB, the RD Committee, the ACOS/RD,
the Medical Center Director, or anyone else? ?
Should you provide additional information to
the complainant? If so, what information?
When? How?
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