INFORMED DECISIONMAKING

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INFORMED DECISIONMAKING

• The process and documentation of informed consent

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INFORMED DECISIONMAKING

• What is informed consent?
• Informed consent is a process (presenting
  information, explaining the meaning, answering
  questions, discussing)
• Informed decisionmaking includes informed dissent
  (subjects right to refuse)
• Elements of informed consent
• Preconditions
• Competence (to decide and understand)
• Voluntariness (in deciding)

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INFORMED DECISIONMAKING

• Information elements
• Disclosure by investigator (of relevant
  information)
• Understanding by potential subject
• Consent elements
• Decision by potential subject
• The consent form
• Documents the consent process
• Cannot substitute for the consent discussion
• Purpose of consent form is not to provide legal
  protection for researchers purpose is to enable
  subjects to be familiar with details of the
  research

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Informed Decisionmaking

• Why is informed consent needed?
• Respect for Persons principle
• Treat people as ends-in-themselves, not merely as
  a means (instrument) to the ends of others
• Distinction between research and therapeutic
  context
• Past abuses of research subjects
• Atrocities committed by physician-researchers in
  Nazi Germany
• Plutonium injections by US researchers in 1940s
• Other examples
• Tuskegee syphilis study
• Jewish Chronic Disease Hospital

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Informed Decisionmaking

• Nuremberg Code
• 1947 response to Nazi experiments
• The voluntary consent of the human subject is
  absolutely essential
• What must be disclosed?
• Purpose of the research
• Procedures to be undertaken (including
  methodological aspects such as randomization,
  single or double blinding)
• Foreseeable risks, discomforts, inconveniences

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Informed Decisionmaking

• Appropriate alternatives, if any
• Benefits
• Possible benefits to subjects themselves
• Benefits to others, including contributions to
  scientific knowledge
• Extent to which confidentiality will be
  maintained
• A statement that participation is voluntary and
  that refusal to participate or withdrawal at any
  time will not prejudice subjects future care or
  loss of other benefits

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Informed Decisionmaking

• An explanation of the availability of medical
  treatment for injury or compensation in case of
  injury from participation
• Additional items that must be disclosed, when
  relevant
• Additional risks to subject or to the fetus, if
  the subject becomes pregnant
• Circumstances in which subjects participation
  may be terminated without their consent

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Informed Decisionmaking

• Additional items (continued)
• A commitment to divulge significant new findings
  developed during the research that may bear on
  subjects willingness to continue
• The consent document what to do and to avoid
  doing
• Use simple, nontechnical language that subjects
  can understand
• Include risks of harm reasonably to be expected,
  including the amount of time required

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Informed Decisionmaking

• What to do and to avoid doing (continued)
• Describe fully what the subject will have to do
  before, during, and following the research,
  including the amount of time required
• Include mention of home visits, when relevant
• Distinguish clearly between the research
  maneuvers and any therapeutic or diagnostic
  procedures subjects would undergo if not enrolled
  in the research

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Informed Decisionmaking

• What to do and to avoid doing (continued)
• Avoid misleading or deceptive statements
• There are no risks to this research
• Do not overstate the benefits to subjects of the
  research
• This new treatment will improve your condition

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Informed Decisionmaking

• What to do and to avoid doing (continued)
• Avoid subtly coercive statements
• We trust that you will agree to participate and
  remain in this study in order to help us find a
  cure for your disease
• Do not include a line for spouses signature,
  except under certain specific, clearly defined
  circumstances

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Informed Decisionmaking

• What are some unanswered questions and ongoing
  disagreements?
• What is the standard for disclosure of
  information?
• Full and frank disclosure (too much
  information)
• Reasonably to be expected (too vague?)
• A very slight chance of a substantial harm
• A substantial chance of a very slight harm

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Informed Decisionmaking

• May information be withheld if disclosure will
  destroy or bias the research?
• Withholding information about the purpose in
  social science research
• Deliberate deception (providing false
  information) as part of the research design
• Withholding information in order to ensure
  adequate recruitment
• Must subjects always sign consent forms?
• Illiterate subjects (illiteracy does not imply
  inability to understand)

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Informed Decisionmaking

• Must subjects always sign consent forms?
  (continued)
• Subjects unwilling to sign because of fear,
  mistrust, or suspicion
• Signed consent forms may identify subjects in
  sensitive research (HIV/AIDS, illegal activities
  such as prostitution or drug use)