When 'To Do No Harm' May Not Be an Option

(Philadelphia, 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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