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Informed Consent

Edward B. Shaw, MD
Am J Dis Child. 1967;114(6):590. doi:10.1001/archpedi.1967.02090270046002.
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INFORMED consent for the use of experimental drugs and procedures, when usefulness and safety are undetermined, is especially important with children. Sometimes parental acquiescence is a most tenuous basis for these studies.

Informed consent should be extended, perhaps, beyond projects for experimental evaluation for almost every procedure for therapy or prophylaxis is, in a sense, experimental. Idiosyncracy, immediate reactions, late sequelae or side effects which are sometimes disastrous can be due to many agents. It is unlikely that parents always realize that the price of successful specific prophylaxis or treatment is the acceptance of certain unpredictable dangers.

Physicians are prone to regard possible sequelae as statistically improbable and to assume the responsibility as entirely their own. In many instances the association of such sequelae is temporal and not provable. The physician may feel confident that any subsequent events are entirely coincidental and that conclusions regarding etiology are entirely "post hoc


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