Abstract
Research involving children with mood disorders should generally offer a reasonable
prospect of benefit to those involved, unless the risks are minimal. While federal
regulations require a prospect of direct benefit, from an ethical perspective indirect
benefits, such as the advantages of being in a clinical trial, are relevant. Standard
care should not be presumed to be preferable to treatment in the context of a clinical
trial, particularly if it has not been evaluated in well designed studies involving
groups comparable to the patient. Similarly, active treatments in a controlled trial
should not be presumed to be preferable to placebos, particularly in studies involving
mood disorders where the placebo effect is more likely to be substantial. Innovative
therapy—using approved drugs for unapproved purposes—may be more problematic than
research, on theoretical and empirical grounds. Studies with no prospect of direct
benefit and more than minimal risk are problematic when the patient is incompetent
to provide meaningful consent. Whether or not a controlled trial involving children
with mood disorders can be ethically justified depends on several factors, including
the validity of standard treatment, the seriousness of the disorder, the likelihood
of adverse consequences if treatment is delayed, the burden of the proposed intervention,
and value judgments by parents, working collaboratively with a caring physician.
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Article info
Publication history
Accepted:
April 25,
2001
Received in revised form:
April 25,
2001
Received:
December 29,
2000
Identification
Copyright
© 2001 Society of Biological Psychiatry. Published by Elsevier Inc. All rights reserved.
