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Ethical Issues Confronted In Pulmonary Clinical Trials

¹ Division of Pulmonary and Critical Care Medicine, Department of Medicine, The Johns Hopkins University School of Medicine, Baltimore, Maryland

Correspondence and requests for reprints should be addressed to Robert A. Wise, M.D., Johns Hopkins University School of Medicine, Johns Hopkins Asthma and Allergy Center, 5501 Hopkins Bayview Circle, Baltimore, MD 21224. E-mail: rwise{at}jhmi.edu

ABSTRACT

Pulmonary clinical research possesses no unique ethical issues compared with other areas of medicine, but the range of disease states and conditions in pulmonary clinical research are broad. The ethical values guiding clinical research in pulmonary medicine are defined by the Belmont Report (i.e., patient autonomy, justice, and beneficence). This article uses some of the most well-known clinical trials in pulmonary medicine to illustrate these issues and the numerous perspectives that must be considered. Ethical issues covered include introduction of new surgical procedures, placebo controls and drug withdrawal designs, smoking status in trials of patients with chronic obstructive pulmonary disease, and the tensions between community practice, clinical care guidelines, and evidence-based medicine.

Key Words: research ethics • chronic obstructive pulmonary disease • asthma • smoking cessation

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