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."

# # #


Penn Medicine is one of the world’s leading academic medical centers, dedicated to the related missions of medical education, biomedical research, and excellence in patient care. Penn Medicine consists of the Raymond and Ruth Perelman School of Medicine at the University of Pennsylvania (founded in 1765 as the nation's first medical school) and the University of Pennsylvania Health System, which together form a $7.8 billion enterprise.

The Perelman School of Medicine has been ranked among the top five medical schools in the United States for the past 20 years, according to U.S. News & World Report’s survey of research-oriented medical schools. The School is consistently among the nation’s top recipients of funding from the National Institutes of Health, with $405 million awarded in the 2017 fiscal year.

The University of Pennsylvania Health System’s patient care facilities include: The Hospital of the University of Pennsylvania and Penn Presbyterian Medical Center — which are recognized as one of the nation’s top “Honor Roll” hospitals by U.S. News & World Report — Chester County Hospital; Lancaster General Health; Penn Medicine Princeton Health; Penn Wissahickon Hospice; and Pennsylvania Hospital – the nation’s first hospital, founded in 1751. Additional affiliated inpatient care facilities and services throughout the Philadelphia region include Good Shepherd Penn Partners, a partnership between Good Shepherd Rehabilitation Network and Penn Medicine, and Princeton House Behavioral Health, a leading provider of highly skilled and compassionate behavioral healthcare.

Penn Medicine is committed to improving lives and health through a variety of community-based programs and activities. In fiscal year 2017, Penn Medicine provided $500 million to benefit our community.