Title Slide

1
Research Ethics / IRB Part I A Little Hx 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

• A little history
• Hippocratic Oath (the version that survives was
  probably actually written by followers of
  Pythagoras). First, do no harm actually
  comes from Epidemics by Hippocrates. Primum
  non nocere (First, do no harm), the phrase
  often seen in Latin, is attributed to the Roman
  physician Galen.
• Nazi experimentation during WWII led to
  Nuremberg Code (1948), then Declaration of
  Helsinki (1964)

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Research Ethics

• Nuremberg Code - 1948
• First international document on research ethics
• Voluntary consent must be obtained - cannot
  experiment on humans against their will
• Subjects have right to withdraw at any time
• Experiment must benefit society
• Studies must be conducted in a manner that
  avoids unnecessary injury to subjects

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Research Ethics

• Declaration of Helsinki - 1964
• Duty of physician to safeguard patients
  protect health, privacy and dignity of research
  subjects
• Informed consent must include info on study
  aims, methods, benefits, potential
  hazards/discomforts
• Design of research protocol must ensure
  adherence to proper research ethics, and
  risk/benefit ratio is acceptable
• Urges extreme care in use of placebo... only
  in absence of existing proven therapy

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Research Ethics

• A little history
• Hippocratic Oath (First, do no harm)
• Nazi experimentation during WWII led to
  Nuremberg Code (1948), then Declaration of
  Helsinki (1964)

• Tuskegee Syphilis Study (started in the early
  1930s and continued into the 1970s) led to the
• Belmont Report (1978) and new federal laws
  requiring IRBs
• (The Belmont Report can be found at
• http//www.hhs.gov/ohrp/humansubjects/guidance/bel
  mont.htm)

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Research Ethics

• Belmont Report - 1978
• Respect for the person (Autonomy) - recognizes
  individual autonomy, grants special protection
  for those with diminished autonomy
• Beneficence - maximize benefits and minimize
  harm
• Justice - subjects should be selected fairly,
  to evenly distribute the risks and benefits of
  research burden

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Research Ethics

• Belmont Report - 1978
• Autonomy
• Four conditions that follow directly from the
  principle of Autonomy
• Consent to participate in research must be
  voluntary
• Consent to participate in research must be
  informed
• The research subjects privacy and
  confidentiality must be protected
• The subject has a right to withdraw from
  participation in research
• without penalty

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Research Ethics

• Belmont Report - 1978
• Beneficence
• Four standards that follow directly from the
  principle of Beneficence
• 1. The risks of the research must be justified by
  the potential benefits to
• the individual and/or society
• 2. The study must be designed so that risks are
  minimized and potential
• benefits are maximized
• 3. Any conflicts of interest must be managed so
  that bias in important
• judgments related to the research conduct
  is unlikely
• 4. Finally, Are the research subjects treated in
  a way that I would want
• to be treated in this situation?

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Research Ethics

• Belmont Report - 1978
• Justice
• Three standards that follow directly from the
  principle of Justice
• 1. The potential risks of the research should be
  born equally by the
• members of our society that are likely
  to benefit from it
• 2. The research does not systematically select
  specific classes or types
• of individuals simply because of their
  ease of availability or their
• compromised positions, as opposed to
  reasons directly related to
• the problem being studied
• 3. The research does not systematically exclude
  a specific class or type
• of person who is likely to benefit from
  participation or in whom
• the results are likely to be applied

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Research Ethics

• Belmont Report - 1978 (cont.)
• Refined informed consent to include procedures,
  purposes, risks, benefits and alternative
  procedures
• Specified that consent language be
  understandable and comprehendable by the
  subject
• Specified that consent is voluntary without
  coercion or undue influence and that there must
  be no penalty for subject withdrawal