Title Slide

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Research Ethics / IRB Part II Principles and
Cases Eric D. Zemper, Ph.D. Statewide Campus
System Michigan State University College of
Osteopathic Medicine Department of Physical
Medicine Rehabilitation University of Michigan
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Research Ethics

• Four Basic Principles of Medical Ethics
• from Beauchamp TL Childress JF Principles
  of Biomedical Ethics 5th Edition New York
  Oxford University Press (2001)
• Autonomy
• Beneficence
• Non-maleficence
• Justice
• (and maybe a fifth? Rationality)

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Research Ethics
Applications of these ethical principles Case 1
A new urinary catheter has been developed, and
a clinical trial has been proposed to evaluate
whether the new catheter is more effective than
the conventional catheter. Nursing home
residents with Alzheimers disease and
incontinence will be recruited as subjects
because enrollment and follow-up will be easier
than with ambulatory patients. Any problems with
this?
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Research Ethics
Applications of these ethical principles Case 2
A 70 y.o. woman develops CHF after an MI. She
is eligible to participate in a study of the
dose-response properties of a new
angiotensin-converting enzyme inhibitor in pts
with CHF. The study involves Swanz-Ganz
catheterization and hemodynamic monitoring in the
coronary care unit when the drug is started and
again six months later. The pt has always been
reluctant to be hospitalized and to undergo
invasive procedures. Any problems with
recruiting this pt (if youre a researcher)? With
recommending she take part (if youre her primary
care physician)?
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Research Ethics

• Applications of these ethical principles
• Case 2 Some things she needs to be aware of
• The nature of the research project
• The procedures involved in the study
• The potential harms and benefits of
  participating
• Assurance that participation is voluntary
• Ensure she has no misconceptions about the
  research