When 'To Do No Harm' May Not Be an Option
PA) - In light of the recent event at a Moscow theater
where an experimental gas was used to disable terrorists
- and the overwhelming concern about weapons of mass
destruction - the need for greater experimentation on
humans seems clear. To find biomedical countermeasures
to chemical and biological weapons, human test subjects
will, by necessity, be deliberately exposed to harmful
agents. In an editorial in the November 1st issue of
the journal Science, Arthur L. Caplan, PhD
and Pamela Sankar, PhD, bioethicists at the University
of Pennsylvania School of Medicine, examine the
pressing need to establish guidelines for exposing human
test subjects to higher-than-normal levels of risk in
order to determine the efficacy of potential cures.
"If they haven't begun already, it is inevitable
that human subjects will be needed to test the safety
of antidotal measures to chemical or biological weapons,"
says Caplan, the Emanuel and Robert Hart Professor of
Bioethics and Chair of Penn's Department of Medical
Ethics. "While the specifics and the results of
such tests may necessarily be secret, it is important
that we discuss how trials would be conducted and how
we will use those findings as best as possible."
In developing effective vaccines or counter-agents,
medical science should not sacrifice safety for speed,
according to Caplan and Sankar. The bioethicists remind
academic institutional review boards - the panels that
oversee the formulation of experimental protocols -
of their duty to establish guidelines for fair and humane
treatments of human test subjects.
In their editorial, Caplan and Sankar state that "these
guidelines must also address who may be recruited as
subjects, what level of competency they should demonstrate,
how the freedom of their choice can be ensured, what
types of end points will be used, what compensation
they will be given, and what level of oversight will
be in place."
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