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Respect is embodied in the
informed consent process – recognition that the subject is capable of
self-determination “Yes, I want to participate. Or “No.”
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Likely the most important
principle and certainly the one that gets the most attention
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Concrete product is the
“consent form” but essential that it be an on-going process
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Must be an “active”
process
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Must encompass-
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Information – description of the research and what is expected
of the subject
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Comprehension – appropriate to subject population
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Voluntariness
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- Freedom to withdraw
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- Free from coercion
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The consent document is not
meant to reassure the subject, quite the contrary, it is meant to raise every
possible concern that might be relevant to the subjects decision to
participate (many consent documents are quite frightening, not unlike reading
the PDR or the package insert in a drug)
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